>> and they either do or don't take the advice and that's not going to particularly help. it could even help people from doing it if they think they are at low risk and that is of potential harm but i think the case for me at least is much clearer for cancer. if you knew that you had a 2 or

3 fold for individuals snips 1 or 2 fold, which i think is much more clinically relevant, if there is a clinical intervention, which for some cancers, is it something we want to deny people. then i think it becomes a queue. in a u.k., for example, should it be nis or via consumer testing or private health? i think in the usa it's probably a question whether you'll get reimbursement for it and at the present time, i would guess the statistics and the evidence is t good enough to get reimbursement and that this will stay in the director/consumer commercial market. so ihink what the house of lourdes committee recommended and you referred to nis is that at the moment they appraised drugs and they're not popular with the pharmaceutical industry because sometimes they say the

drug -- there is sufficient evidence or there is not sufficient evidence, but it's proposted there should be a new program of nis established which should praise the clinical effectiveness and clinical utility of these studies. and although peter donnelly, i think, cautiously said that he thought these would come in to routine practice and he's talking about in the nhs within 10 years, my guess is that for some diseases, it will be shown that that -- that the models that include snips will be more he have effcasious. i wouldn't want to predict when. >> we're going to move on at this pnt before we create a genetic accountability office, there will be plenty of time to

discuss these issues as the remaining afternoon and morning as the program continues. greg? >> okay. thank you very much for inviting me today. i think this is going to be a little different than some of the discussions here. i certainly don't have the medical and scientific background you all would have and my staff would say, oh, that's an understatement. we did do an investigation in 2006 and based on the last 45 minutes or so i've been in the room i seems very relevant to those in the room and i'll going

to give a background of my unit at gao and i'm going to talk about the investigation we did in 2006 and give you a little bit of the objectives methodology and results from that. and i certainly would participate in the questions and discussions here for as long as you'd like me to. a little bit of the background on my unit. it's t prince of gods special investigations. we do mostly antifraud work and special investigations and a little bit of security vulnerability assessments. you see we do some of the motherhood apple pie kinds of things looking at fiscal changes in our nation which is an understatement. i could spend hours talking about that alone. ethics, stewardship, internal controls and a little bit of homeland and national security issues. and relevant to discussion today we have the authority and oftentimes to undercover testing which really enlightens people about what's actually going on out there and that will be very relevant to what i'm going to talk about here. we looked at the tests, the

director consumer marketing of them getting into consideration where they were going to recommend certain lifestyles based upon your genetic profile. the nutrigenetic and we limited it to those types of tests which i assume are still out there today. we did this work for the senate special committee on aging really to validate the legitimacy of the claims that were being made by these companies. we did not do a statistical sample so we could not project the results to all the companies out there that are doing this on the internet and no one could possibly identify all of the companies that are out there. it's probably a moving target on a daily basis or a weekly or monthly basis but we selected four websites that were doing these nutrigenetic and it was 4 to 19 jeans that were looked at

and they would create a dietary and lifestyle recommendations based on the genetic profile. they all stated their product would not test for predisposition or a diagnosis. so we bought 14 of these from these four sites so we could do a variety of results and you see back when we looked at these and i assume these prices changed over time but the prices were between 89 and almost $400 per kit. the methodology -- what we did we created fictitious consumers or bogus individuals who we were going to send the information in on. we actually had real people who provided the dna and the way that they did it was the little cheek swab you're probably -- it's almost like the q-tip thing that you swab in the cheek. i can't remember how long it was. i believe we each time did two samples. we used a 9 month old female and a 48-year-old male and just to

let you know who was female was, it was myaughter actually at the time. we did consent i don't know if we would break the law at that time but that is, in fact, what we did. we did the questionnaires and in addition to providing the dna samples each company had a specific questionnaire that we filled out and we filled them out with 14 different individuals of differe ages, sexes, different types of dietary practices, smokers, nonsmokers, et cetera and we turned these in. and we certainly consulted with experts because we did not have the in-house expertise to fully evaluate these results. this shows the profiles of the people, our 14 fake people. as you can see it's a wide range of ages from the 20s to the 70s, males, females, and what you don't see is the specifics where some of the people smoked, some were overweight, and some were under weht, some drank excessive amounts of caffeine, some didn't. we put a variety of profiles out there and then it was 14 sets, 12 of these were with my

daughter and the other two were one of our special agents, a male who was 48 at the time. this is what we got. and it's kind of interesting. i mentioned that the websites claimed that they weren't going to make any diagnosis but,n fact, they really did. and what they predicted here for us were these various types of increased risk, if you will, to these various types of conditions. some very serious and i heard some discussion here is diabetes is one of them. osteoporosis, cancer, reduced ability to clear toxins, blood pressure, heart disease and brain aging which i believe i am getting at this point. this is some of the specifics from the actual results we received and then there's a lot of detail behind that but just a couple of things and you can read through them about issues related to the ability to metabolize cholesterol, mineral absorpon, you got issues of

cardiac, brain, aging, cancer and then age-related conditions associated with elevated levels of dna damage. so there was discussion of damaged dna in these items. at the time we did this, and it sounds like probably still, the experts that we consulted said that the predictions did not have a basis in fact or there was not enough evidence out there for these predictions to have a scientific basis, if you will. and really so there's no parts of this. unproven at the time but also ambiguous. i mean, the way that they were written was you were at increased risk o you may be at increased risk of these various conditions s it was very strange wording if you will, something like the weatherman predicting a 50% chance for rain, you know, just about anybody in the world could meet the criteria you may be at increased risk of getting certain types of lung cancers. that was the type of results that we received with respect to to that.

on the lifestyle piece of this and this is very, very interesting. again, they claimed that the lifestyle recommendations you were going to get were based on your unique dna. and so as we filled these out, that's why we did a variety of actual people with various lifestyles. and what we found was really that depending on what we said, they said the opposite. if we said we smoked, they said don't smoke. if we said we drank excessive alcohol, don't drink alcohol. if we ate fatty foods, stop eating fatty foods. on the other side if you didn't smoke, they said keep up that good work. it was that kind of thing. it was really just commonsense lifestyle but they linked it to the genetic testing. and your unique genes. another piece of this and i don't know if you talked about the supplement piece of this but certainly several of the websites were also marketing supplements when they gave you the results of these diseases. it was clever how it was linked together a little bit to say if

youook these supplements, well, then maybe you would be at decreased risk of actually getting these serious conditions and so -- and they also said the pills were unique. well, the two people we had, my daughter, and the special acting are two different people unrelated. they both got the exact same supplement, exactly the same. so they both got the same unique supplement and we saw that throughout. that these supplements were almost pretty much the same and, in fact, they were really just glorified multivitamins that you bought at rite aid. and there was a claim that it could repair damaged dna by taking this pill and then based upon the experts we spoke to, there was at that time no such pill that could repair damaged dna. now, the next chart shows an interesting piece -- it's the cost and that's really write thought it was a consumer fraud scam in my view. we had nutritious look at this and they were exactly the same

ingredients in the vitamins at rite aid versus what we got in these supplements and you see the various types of items. the only was there was a little for these supplements on the left and sometimes b6, and iron. some of the nutritious thought that was dangerous if you had too much iron. i don't know the difference myself, certainly. but the fact of the matter is, look at the cost. 10 cents a day versus $3.28 a day for basically multivitamins. so that was really another piece of this and there was another set of the vitamins, too, i mentioned the cats colonic which was $1800 a year. and there's various products marketed. and that's really the investigation and i'm going to just say that, you know, the purpose of this was really to give congress an inside look at what was going on in this direct to consumer marketing over the internet at the time although we did see some of these kits in grocery stores and pharmacies and other things like that at that time. i don't know what the marketing is today. we certainly did not intend to

cast any doubt on the clear medical evidence out there and the promise in this field and that was never our intent. but again, it was to hopefully inform and i hope it helped inform your discussion here today. so thank you. [inaudible] >> sorry. excuse me, lee. who will speak next for the center of biomedical ethics. >> okay. can you hear me? yes. all right. first i'd like to thank the organizers for inviting me to this workshop. it's obviously a very important and timely topic. i should situate this talk by reiterating that i'm an anthropologist and my wor is bourne out of an interest in

understanding how emerging genetic technology and the information that's ten out and how it could impact predominant social ideas about difference and about our ideas about biology and social identity. so just to start, i think it would be important to think about what i've labeled here as shorthand the traditional paradigm to genetic just to see how we shifted in the last several years. and these are based on som kind of basic tenets how we think of genetics. the first is a traditional approach would genetic test justified for at-risk individuals for actionable conditions with available options. so the ideas that genetic tests should really be ordered by those -- or for those who have shown through medical history, family history a reason for taking a genetic test and that they should really be done only for conditions that are actionable or in the sense that you can actually do something about them.

another kind of basic approach to genetic testing has been oversight by a trained healthcare professional. the idea that these tests should only be ordered by a physician or another type of trained healthcare professional. and that there should be a requirement for pre post test genetic counseling that we should have high standards for validity and reliability and that there should be mechanisms for ensuring confidentiality and privacy all of which are built on this idea fundamentally that genetic information is special. now, i put this up there not to say we departe completely from this paradigm but just how to show you how we have shifted in the ways we think about directoronsumer genetics. the first there are a lot of messages out there in terms of some of the information produced by companies that individuals really have a right to information without being at

risk. so the idea that you have to somehow prove that you need a genetic test is really been kind of included by some of the companies in their messages. that there's a diminished role of the healthcare provider in the broader category of genetic experts so the idea that no longer that you necessarily need a healthcare provider to have a genetic test and that genetic expertise can come from different types of sources, namely, companies now can proide much of the information on genetic information to the public. a proliferation of that for nonactionable traits and conditions really this category of actionibility is under contention what test we should be allowing the public to have access to in terms of diseases and traits. and medical genetic testing is only part of the picture so the idea that we've been focusing

here mainly on medical genetic test but there's this other broader category of test that we might not want to distinguish from in terms of a bright line. so i know that the term "recreational" geneticing has been bandied out and it's a disservice of the regulatory measures that we should put in place in anticipation of how these tests might broaden in the future. genetic research is a catalyst for public advocacy and activism. we're going to talk a little bit more about that in the afternoon. but to really think about companies as being a site for genetic research and a catalyst for that type of research and corporateuardians of personal information. who owns, who takes care of one's personal genetic information and increasingly companies are taking up that role. what remains the same, though, i think in this -- in what we see

is a shifting landscape is the idea that genetic information is indeed special. what i want to do is just in the short time that i have is to think about some of the so i shall issues that are emerging from this shifting landscape and to have us think about or anticipate some of the regulatory challenges. and i've picked four different topics here. i could have picked more. these are four areas that i think deserve som scrutiny in terms of how we're approaching regulation and guidelines. the first is social networking and in particular, privacy protections for those who have chosen to share their information online. the second is company-sponsod research consumer, how the consumer has often been recast as a human subject. ancestry testing in terms of finding common language in describing genetic ancestry and finally behavior genetics, the testing of normal traits. some of you will recognize this

from the website who have been the pioneer of sharing architecture online. this is a compare genes that is available f customers and with it if you are a member of the communy, you can share or at least compare, i should say, your genetic results with another individual who is part of that community and you'll see here these fictitious individuals, greg mendel and lily mendel how they may be similar according to these various traits and diseases. in addition, this particular company allows an individual to create, if you will, your own family or group of friends in which you can compare and share your genetic information in

terms of increasing or decreasing similarity and then another tool that is available now at least by one company in terms of the social networking -- social networking through the genome. another set of tools that are available are these kind of virtual communities that are given space on the website to convene and to talk to each other in blogs about different genetic information that might be of interest to them. this is from the website where they talk about an instant circle of friends. here it's the pregnancy community, really trying to congregate individuals who might be most interested in certain issues dealing with pregnancy and genetics. now, i have gone into more detail about social, inning and its possible uses through

gegnomics and we talk about this in a recent article in the american journal on bioethics and we focus on the biosocialality and it's a conct that has been brought up by anthropologists in thinking about how we are starting to use much more kind of genetic information, biological information and creating our cultural and social identities. and here we talk about director consumer companies is emerging of new regimes of biosocialality where it reconstitutes the identity and builds on existing social relationships. social networking has a social to create biosocial groups that ultimately serve to overcome the nature, culture split and i think it's important to think about how companies may serve as that locus for bringing together individuals who have similar genetic profiles and to start coalescing groups that may not

have existed prior to their coalescence on the websites. so just kind of as a quick summary social networks through the genome we have an expanding infrastructure, commercial infrastructure for networking and not only on the sites of the various companies but also in terms of collaboration with different social networking platforms like facebook and myspace.com and we may be -- we may be behooved to think about or anticipate how the travel of personal genetic information may be a medium for connections but also an important site of scrutiny in terms of protections and privacy. now, this is not to say that that it's the first area -- industrial area that has tried to bring together individuals, patients online and this is from the website patients like me which is an online company that

tries to bring together patients who have been diagnosed with various conditions to talk about their experiences, to share ideas around therapeutics really as a way of creating virtual online communities around diseases. and what they've done in terms of their approach to privacy is interesting, i think. and i think it's emblematic of what we might see very soon with these other companies but it's called an openness philosophy and this is the internet which is directly taken from patients from the website it can democratize patient data in accelerant research like never before. furthermore, we believe data belongs to you, the patient, to share with other patits, caregivers, physicians, researchers, pharmaceutical and medical device companies and anyone else that can help make patients' lives better. an example of the type of transparency that we may be

seeing in terms of social, in networking of sharing of information online. we all know that the genetic information on discrimination act was passed a little over a year ago. and it does provide important legislation in terms of the prohibition of discrimination by employers and insurers. however, there's some questions about how this relates to online sharing of data. and whether or not the same type of protections will be extended to information that has been gleaned from publicly available sites. as well as kind of the inadvertent you see in the bottom -- in the bottom of taking genetic information and one of the questions that i think is yet to be resolved is whether or not this type of online-sharing of genetic information is indeed protected and whether or not we need to have additional protections for those who do decide to share their information online.

the second area i wanted to bring up and then this is perhaps a good segue to the afternoon sessions about research, but the expanding use of companies in thinking about personal genomic research and here again it's from the website, a leg of their company 23 and w research where they enroll some of their community members into various research efforts and the justification for this is the scaling up. the idea that companies can somehow take the place or at least supplement what we see in -- what we see done with traditional academic research in really speeding along some genetic research and here they state --

>> so the idea here is that companies may be taking the role of really scaling up and that through collaboration, again from 23me one would become empowered at least through the individual consumer. >> a powerful public message and this this has been translated in

the most recent effort by the company unveiled this summer called their research revolution where consumers can sign up for their services at a cut rate and be part of -- i think they have now 10 different research projects. so i think ts begs some fundamental questions about how we as a society want to approach oversight of these different -- different projects that are emerging out of direct consumer genomics. i've listed four and there's many more. what does does democratization of the genome mean for the future of large scale population based biomedical research? >> and is that transparent to the consumer when they're signing up for those services? how will consumer genetic

information travel given samples and data are stored with the company? how will questions in terms of the questions being asked of that genetic information travel and will the consumer have any control over the kinds of questions that are asked of their information? and what are the rights and responsibilities of companies and consumers as these types of research efforts and social networking practices move forward? in the remaining time, i just want to hit on two other issues that are -- that may be important in terms of thinking about or anticipating regulatory oversight of director consumer gegnomics. with the desire for -- much of the desire around director consumer genomics has been on the area of the question where

we come from and a group of us recently published an article that talks about the need for regulatory oversight of some of these services. and one of the questions that we asked in this article is really how do we find common knowledge about these terms and information that are given to the public? here on the left you'll see the different examples of the definition of origin, for example. people and communities approach the idea of origin very differently. and how can we then start to think out what we're conveying to the public in a more unified fashion and here this is an exrpt from the article. a first step may be a joint creation of a vernacular that characterizes concepts like probability, association, origin and ancestry to help minimize variability that exists in how such concepts are understood across fields, communities and

governmental and commercial entities with different vantage points. and i would argue this is certainly not confined to genetic ancestry but to the broader field of genomics. we should be mindful of the expansion of normal trait testing. this is just a quick list of what seems to be out there now. and you'll see it really runs the gambit in terms of testing for memory, food preference and intelligence. i don't know if you've seen an article of a summer camp in china where parents for $880 could sign up for a week of summer camp starting with and you'll see here in the bottom of the page where a young girl is being swabbed for her genetic sample and this is a qte from one of the parents. he says nowadays competition in the world is about who has the most talent. we can give chinese children an

effective scientific plan at an eay age and so these tests are being used for -- as a way of providing information on these children in terms of musical talent, athleticism, management skills and then the summer camp would then try to hone in on some of these early, quote-unquote, predictions of their natural talents. so i only put this up there to kind of help us think about where is this testing going? and to really disa-abuse us of this idea that there's medical testing and there's everything else that's recreational. those kinds of boundaries do not serve us well in the regulatory oversight that we want to put in place. thank you. >> thank you very much, both of you, for interesting presentations, greg and st. francis. -- sandra. as i listened, sandra, to the first two of your four topics, social networking, company

research and mentioning 23andme from stanford, i started to think only in california but on the other hand this is a global phenomenon as tim pointed out. and it's fascinating. the floor is open for questions. we have someone -- david, you'll come next. >> our recent speaker brought up a very, very important point. and she stole some of my thunder for tomorrow morning 'cause i'm speaking on some of the same issues, although, i'm going to speak on them from the economist point of view and she spoke at it more at the ethicists point of view. and one of the things i haven't heard this morning is the idea that these companies have a research purpose as well as a services purpose. i'm not particularly familiar with the companies. i work more in the precise medicine more generally. but my understanding is that

these companies -- their business model is to build a research database. that they're really focusing on that database as their long-term business objective. and so we need to think about what are the pros and the cons and the costs and the benefits of that side of things as well as the provision of direct services to consumers. because otherwise it seems to me we're missing an entire purpose of what these companies are trying to do. but i'd be interested in hearing paicularly because we have some people from the companies here, whether that's really true and what they see is the implications of that. >> this is definitely part of what i'm going to be speaking towards in the afternoon. but i he to say that as you -- one of the things that we constantly hear about in terms of these genetic association studies is obviously the power

of the studies, the number of people involved and so as we can start to expand the number of individuals who have been tested for whom we have genome types and i think it's a natural resource in terms of further discovery. so i know from a navigenics' perspective is one of the goals is to be able to utilize our patient and our client base to be able to better learn how to refine all of these risk associations, whether it be for ancestral groups or whether it would based on typical risks and such. >> sandra -- >> i just had a question actually. so does navigenics see itself as a guardian of that data or does it leave open the idea that you could sell that data set at some point to another entity and is at made transparent to the consumers when they sign up for

the service? >> essentially, we think that every individual owns their own dna and their own information and that is something tt we're very transparent about. one of the things that i'm going to discuss this afternoon is also about the specific language in opting in, to donate your dna to a kind of research endeavors, which is something that unlike some of the other companies that are out there, is an option. it's not a required comnent of our testing service. >> we have three or four people who are looking to speak. trisha and david and someone standing back here and joseph and david. [laughter] >> anyone not who does not want to speak? [laughter] >> and let me -- david, i think -- >> he's very eager to speak. >> i'm very interested in learning more about the research use and how that's envisioned

and whether -- i mean, given again the incredible hoops that academic institutions and teaching hospitals have to go through with consent forms to do anything with patient materials, i'm really interestedn seeing your informed consent processes so i'll look forward to you this afternoon. the other thing i wanted to just throw out -- not to distract us, is that genetic information is the right -- is the property of an individual but the genetic information actually has a kinship relating -- relatedness to it. that is you're not -- your genome is unique in some ways but it's shared with many, many other ways. and the issue of how far one

goes with making one's genetic information available for democratization or socialization or whatever else, there's an issue here about whether your close kin are also being dragged into this society without even knowing it, let alone consenting to it and i'm wondering if anybody is thinking about that. >> i'm glad you asked that question, david. >> would like to make three comments. first to greg's talk about the gao study from 2006. i think the field has evolved since then and it would be nice if you guys repeat the study in the current landscape. i think some of the earlier companies that probably have studied me have ceased to exist and i think they are being replaced by the new generation type companies like navigenics so i'm curious to see what you'll find and the second

comment to the research endeavor, i think the people who join these kind of research efforts are truly not representative of the underlying population. they're going to do well no matter what. mean, we have done a clinical trial where we have people receiving personal information on the basis of their family history versus receiving genetic public health messages and whags? guess what? you cannot attribute if pemple do well on the basis of being followed up because they're motivated enough and they're going to do more of the right things and you cannot really attribute that to the intervention which is a genome. i mean, it could be they're self-motivated and you need to subject these studies to the rigor to a criminal trial and i certainly hope the business models of these companies would involve that. the third question that is directed to sandra.

talk about the -- and i'm not an anthropologist and i don't play one on tv but i'm curious to see how this -- the networking that's now clustering around genetic information can bridge the genetic culture divide instead of create new ghettos that are involved in more likeness around genetics and forgetting the role of the environmental factors of disease in general. i'm curious to see how the anthropology of the nature and nurture and nature of culture might evolve as we all cluster around same genetic traits and we create, you know, new racial ethnic or other ethic classification of our genome profiles and too much stuff. i don't know if people -- >> if you'd like to make a brief response then we'll go to the professor and then to the microphone. >> great. so we're just starting some empirical work with a company on consumer -- on networking so we

don't have the data yet but i think that your question about how genetic information can trump other sources of information is something that we have seen in the arena of genetic ancestry in the sense that people who may have lived, you know, their lives identifying with a particular ethnic or racial group may receive results and all of a sudden that challenges how they see themselves and so i think it's important to do empirical work on how this is being taken up by different individuals. >> i also -- the research hot button got to me as well. and i think one of the issues that i see is whether there's going to be public or private funding of resear? this is a little like what's happened to o clinical trials in oncology which is funded by pharmaceutical trials rather than the government because the government does not have the resources to do that and then we

get trials that are really directed of the questions that the pharmaceutical company wants answered and not what we really have as a major scientific question and so on the back end when you're sharing your specimens with whoever is that going to be peer-reviewed research and is that going to be for the public good and then the confusion for the donee or the altruistic volunteer is they're just -- it's research as far as they're concerned but what is the quality of that research? are there specimens being used for a cause that has gone through a peer-reviewed process through an study that says the benefits outweigh the harms. and we had pharmacy databases sold back to the pharmaceutical companies. there were electronic companies that couldn't have a viable financial model and instead gave the electronic records free to the doctors to use and then on the back end sold the prescribing practices of those

doctors. so i think it's not to say that you don't good intentions in various companies but i think it's an issue of what kind of research are these specins going to be used for and what is the quality data and it's a volunteer population. it's not population-based. what will we be able to learn from that? >> yes, i'm going to go to the floor for the next two questions. and ask each person who speaks if they would just briefly identify themselves. this is fascinating material we're dealing with. on one hand, the medical community is being cut out and unwilling -- potentially unwilling members of racial groups and families are being dragged in. there's a lot of shifting and sifting going through here. >> could you elaborate some bit more of your idea of creating a common language of common

knowledge at formally the concept which can be translated of various groups of people. as you know we are still struggling of the old issue of two cultures and now we are faced with the idea of communicating between the molecular biologists and genomists. it has become very, very hard to communicate across the borders so what are your practical ideas? what can we do to bridge that gap? >> sort of very -- i realize it's a big challenge. at stanford we had an interdisciplinary dialog of issues around a race and human genetic variation and so we had geneticists in those same rooms trying to define the concept of race. and there was a heated discussion because there were different ways of approaching and i think you can -- race is just an example but you can tak this for many concepts that we

now use in trying to translate jamaica information -- genetic information. one step is to have interdisciplinary dialog but the next step is transparency. so revealing the kinds of assumptions that different disciplines are bringing to the table in terms of how they're defining concepts. genetic ancestry may be very different for the geneticists than a person in the community. and it may mean -- including that type of transparent language in the studies themselves in defining how they're categorizing and naming their populations. that would be the first step, i would think. >>please. >> my name is laura hersher i'm a genetic counselor and i teach genetics and ethics. i wanted to respond a little bit to what you just said. i understand the field has moved o so greatly since 2006.

and i'm se that alyssa from navigenics doesn't feel she has anything to offer with cats claw. in fact, legitimate organizations coming forward with legitimate products haven't replaced more nefarious offerings over the internet they coexisting with em. and, in fact, if you want the general population to see the difference between the offering the cats claw and the offering of more validated, you kno testing, then you're going to have to address the existence of these things out there because they will taint the whole rest of the field. i know the companies that were tested, my of them still actually do exist are offering the same products and it hadn't gone away. it's just other things that have come ithat are probably more

interesting to you. the other thing that i think your presentation brought up for me is how easy it b( to send i samples for other people as you did. now, you said maybe it would be illegal now or e'÷whatever. but i do some counseling for a genetic testing company and routinely when i call up to give people back their results and we always do them through genetic counselors and routinely the person i'm talking to who under the information i have is the person who sent in the sample well, it's actu'[ my son or my stepchild or my wife or whatever. and they're not trying to trick anybody. they just don't really see that it's a problem. but i'm telling you, it's very, very easy to do. so i just wanted to bring that point up which i think your talk raised. >> i'd like to return to this question that david raised and it's been alluded to before.

let them call them the innocent bystanders or third parties where a research project is organized within a company or when social networking around a common genetic interest occurs, it's the problem of who protects the third-party? if you want to do a full test but also it's standard for me i may be embarrassed by that. could we have a little bit of attention of discussion of the implications for others in the family or tribe or group with whom one is genetically affiliated? anyone? david? >> i just asked the question. [laughter] >> i'm seeking help with it. i think we're seeking help with all the issues that we raised. jonathan can probably deal with

it. >> well, actually, i remember when my son came back -- i think he was in third grade from his jewish primary day school one day and there was -- this is back in the early '90s and there was a flier obviously directed at his mother attempting to recruit jewish women for a breast cancer trial. and i thought that was interesting. that was the first -- that was the way i heard about that study was in his backpack.k,c i wish i'd kept the picture of it actually now for my talks of ethics and genetics. so a few years later and many people around this table know this study. some of the study from those early studies ended up on antisemetic websites because, i gather, and barbara and others know more about there's an increase of bcra1 and 2 as well so the point was see, they

really is different. there's something really wrong with them. i just take this as a comment on fred's invitation to make a comment. that, you know, groups stigmatization of something we're going to have think about. beyond the family to the way in which we think who we're connected to in various ways. >> let them ask you group stigmatization runs it's own way in this. that a very important dimension of what we're looking at. but turn it around. what about the power or right or legitimacy of a group's attempt to preclude an individual's participation in one of the exercises that sandra described? i mean, that is a possibility. >> it's a reality actually because there is a moratorium on

genetic testing on american indian tribes now because of just that. and so -- and they obviously have different status than other groups do but i think your question is legitimate in the sense that should we have group consent6@ i mean, we've kind of bandied about that talk before. >> you say there's ai moratoriu on genetic testing and native american tribes. and i am aware of that. what if an individualn a tribe wants to participate and sists? do you know of any instance where the individual has insisted and even gone so far as to -- as an individual saying that it's their right on whatever statutory or constitutional or other basis to participate? that's one of their individual rights? have you heard of any instances of this or anyone? >> i haven't. >> i could speak to that just a little bit.

over the last 10 years -- and you'll hear a little bit this afternoon collected a data set of about 108,000 people from throughout the world and we've run into this problem or question or situation, whatever you want to call it. a number of times. we do have a number of native americans that are in our data set and they've all been individually opted in essentially and it's -- and in none of these cases have been challenged so i don't know that we've actuallyrgz got to that ll where we've looked to see whether the tribe would then, in fact, challenge it. because they felt it was up to the individual to make that decision in these cases. >> but this iswac a much more general question than the genetic -- single genetic testing question. i mean, we do not have good oversight mechanisms for the benefit is the positive way but

harms the true way for thinking about group harm of many research projects and it's absolutely coming up in community-based participato research. we don't have good regulations or oversight or common rule doesn't address it. so this is something that i think we have to take on proactively as an issue well beyond that of the genetic testing. >> i mean, my own area of work, i practice environmental law in part. and the stigma attached to persons living -- who drunk the water or breathed the air in your superfund site for a generation or so -- and they feel like they have -- they're tainted by that community experience and then researchers and others want to -- want to address their situations and

that leads to the same problems and nothing to do with genetics. >> i do want to go back to one comment that you made, tim, in passing that the u.k. is now protecting the ability of parents to enlist their children fogenetic testing and that -- they should wait -- or one must wait until whether it's a should or a must -- must wait until they're at an age of consent. and that itself is a protection we would do well to think about on this side of the atlantic. >> it's not a statutory requirement. it's a view that is out for consultation on it. it's expressed. i ink in the discussion about the way that other individuals might be affected by a particular genetic test, i'm not

familiar with this sort of -- the group aspect of it. but i think it's important to distinguish between the single gene disorders and the more -- the snips which is more what the direct testing companies that i'm familiar with are carrying out. so for single gene disorders, clearly, if one individual in a family and the genetic counselors will attest to this and they're very familiar with it and have, i think, well worked out mechanisms of dealing with it, but if one family member in the context of huntingtons which is an often quoted example is found to have -- be a carrier of the diseased gene, then that has clear impact for other family members who may o may not want to know. and the protection that is afforded by other legislative implements is very important for them. i think for the children, so for

testing for single gene disorders, the viewhat i've heard clinical geneticists say if there is no treatment that is available, then there is no reason for the child to be tested until they have the ility to make that consent for themselves. and i think that clinical geneticists apply that same argument to the gy snips. now i view those two situations as being completely different, and i recall having to file an ethics application for a research project, an institutional review program essentially for a gene expression microdatabase and the review board completely misunderstood what we were wanting to store information for. and they treated this information wch was just gene expression data as being as serious and worrying as the single gene disorders so i think

there's a misunderstanding here. i think as far as the director of genetic testing for direct consumer testing for children is concerned, the recommendation or the proposal is that children should be able to make up their own mind. and so, for example, if we view this as an adventure which is as i think the doctor has sort of suggested that we don't quite know where it's going to end and that routine sequencing might become the norm, if it was available for a thousand dollars a genome, then i think one has to say, what -- how are the children going to be treated? and should they be -- should their parents be allowed to genetically test them? and i would subscribe to the human genetics view the tests need to be deferred until the children can make up their own mind. >> i have two comments. the first is around the testing of minors. i think one of the things that

has made navigenics unique in this environment is from day one we did not test minors. we felt very strongly against this type of testing for adult onset diseases and as we start to broaden where this field is going and the different types of conditions and ages of onset, i had a number of parents and physicians come to me and say, you know, well, why can't i test my children? i want to know about these risk factors for type 2 diabetes and breast cancer since there's some questions about different types of risk factors around, say, wheat at different points in age and how do you start to think about a construct for rolling out genetic information across the life cycle and so this is something we're actively thinking about while maintaining that, you know, you cannot test minors for the types of information we're currently testing for. we're actually starting to investigate some sort of ideally

public/private collaboration to start to investigate what point is it relevant and appropriate and what does the informed consent process look like? is it a consent process for adolescence at a certain age? i think there's complex questions that we need to address that we are actively thinking about but we don't have purport to think about at this stage and the second is getting arou david's original question around when you have this information that it is genetic. it is inherently going to impact family members and groups, you know, traditionally around any kind of monogenetic testing, genetic counselors had great discussion about how to share information with at-risk family members. while i think this is no different in the sense of how we inherit these different markers when we're talking about, you know, common complex disease markers, the real difference and the real struggle that we have is with, you know, the general

consumer/client patient understanding of, you know, monogenetic risk versus complex disease risk and trying to explain that spectrum because, you know, while we're -- to them genetic. and so i think it really is a struggle to try to say well, when we're talking about dozens of different markers, you know, you can't really figure out the probability on your own of what that means for your children. it really does become more of that individual needs to test themselves to understand the impact of that family information and just having that discussion. >> but going back to the question asked from the floor by the genetic counseling about the sourcing of samples, i mean, does your company -- do other companies address the issues of what we lawyers call the chain of custody issue? do you require a statement? is it sworn? what is the nature of the custodial chain between the dna submitted and the individual who submits it?

is there any constraint on my submitting anyone's dna that i might want to submit? i just -- i'm your customer but the dna might come from elsewhere. .. >> can i ask one question and make one comment?

comment is akin to others that i've made that my understanding of where the field is is that the importance of even if typing is deemed essential to making sense of this. and that's not a trivial thing. and it usually takes an intermedia who happening to be a our provider who's able to do the kind of accurate gtl assessment with a patient at hand. when the companies talk about collecting the database and having all the information about the contributors of the dna, it seems to be a disconnect there between where the academic community sets on this and with the companies set. that's the comment. the question i had was a very

fundamental one. and i don't know the answer to it. so i'll direct it at professor. is there any information at all about the freak sis with which an array of snaps from me would be found in my kin is that the code -- cosegregation or what is it -- is it likely that the array for me would be entirely different than that of my sister,rother, children. >> it would be if you have a million snipped from all in array, it would beompletely unique to you. the only other person that it could be is identical twin. so it's more -- well, it's at least as powerful dna forensic fingerprinting. and if someone else had access

to a small number of your snips, they could identity you as being part of another pool or database. so it races the question that we have debated about identification of an individual. and you don't need to know someone's name in order t be able to identify them. i think it is a risk averse to take that view. because if you don't have their snips in the first place then you couldn't identify them in the database. but if you have a small number of their snips you would be able to identify them from a large pool. >> the problem of identifying third parties isn't completely new in medicine. there's nothing new apart from the fact that this is something technical.

also i want to get on the table, there is a good case to be made that private companies do have an obligation to do research, given the fact that they are committing a lot of data that isn't going to be committed by their entities. so clearly we shouldn't go into examples they shouldn't. in fact there's a good argument to be made that they should. >> we can't leave this session without knowing what's happened since 2006 to your report. it was presented presumably to the cgress and then -- >> well, we certainly have got a lot of phone calls and a lot of interest from people that are in this field. and there's been a documentary being done that i've been interviewed. weaven't done any update. but aside from that just lots of interest on capital hill.

there was a lot of interest and fda, fdc consumer alert issued on the same day warning consumers about this and educational information. so that was the result at this point, no legislative initiatives on where. >> which part? >> why don't you tell us which parts werellegal. >> we have illegal parts a the time in testing. it's authorized legal activity. >> what about the results that you got? >> again, we do referrals on some of these. we may referred some of these to law enforcement. some of these products that are multid to us, they were multivitamins, and expensive, not sure if it was illegal, especially linking the sup

supplements and implying if you take these you reduce your risk of getting cancer and these other types of conditis. >> the federal trade commission issue, perhaps? >> yes. >> vitamins over the counter or not -- >> i'm aware in the uk of very similar situation arose with one company that attempted to market products and link them to genetic testing. there was a very public campaign by one of the gene watch uk, and as a result of that, the company decided to stop marketing that particular product in the uk. >> they came to the u.s.? >> but this brings each of them that have had a will the of concern about the testing in where there are regulation like the fda and ftc that theyeed

to step up or maybe provide resources to be able to two after these companies. this is something that these companies. >> yes, last question. >> hi, i have a comment about that. i'm a genetic counselor. one the things we do is we evaluate all of the dtc companies and allow consumers to review them and rate them. and we provide information on over 1,000 genetic test conditions and topics. we help consumer navigate this world of consumer genetics. one of the things that i have nosed quite dramatically in the last six month is a sharp drops in the companies that are out there. whereas last year my comparison chart had 14, 15 companies that were selling products, i just updated the chart a month ago

and i could find fur or five in business. i'm finding more that are emerging, but just as a note off of that. >> thank you. i didn't catch the company name. >> it's accessdna.com. >> okay. we're going to come back and recon venge at 1:40 p.m. promptly. we will t our best it stay on schedule. lunch is out in the hall, thank you. >> the director consumer genetics testing continues. some of the issues in the next

two panels are privacy concerns and the genetic testing in research. this is a little over two hours. the room first and around the table and in your seats and settled and ready to roll. yes? i'm not sure how many activity there is out in the hallway. but we'll sort things out when they hear voices. barbara, i guess you are going to -- >> thank you. so this afternoon we're going to be talking about share genes and emerging issues in privacy. as our first speaker, we'd like to invite susana beyond the genetic nondiscrimination act. >> thank you. and thank you very much for inviting me to talk today. i've worked with many of you for

many years as part of the public policy center. starting tomorrow i put on a new hat to work for a group called generations ahead. who's mission is to bring communities, disability rights, and reproductive rights, gay advocacy rights. today, i have not started that job. i think i'm official officially hatless, which is liberates which you get to talk about an issue which you might have some person opinions. any controversial opinions that i make, i claim as my own. they how old shot be attributed to any other organization. i think i want to start by saying this talk probably represents a pretty significant shift from the main themes this morning, which were primarily about the validity and utility of the testing being done in the

director and consumer context. i'm going to talk about privacy. for many years my work has focused on the nondiscrimination act and issued related to that. it would be odd in the context of talking about gina has it is known not to mention that like virtually every other important piece of civil rights law or health policy law that has passed in this country in recent decades. gina wouldn't have happened without the spectacular vision and hard work and his brilliant staff. i grew up. in massachusetts and having lived in d.c. for 15 years, i still feel like senator kennedy was and in some since always will be my senator. so my first goal today is to talk about the purpose and scope of gina, because i think it's

relevant in talking about privacy for genetic information whether it's done through director consumer or through more traditional channels. and i'm also going to talk about some state law issues that are kind of in mauve play. and i want to talk about that legal framework in terms of how the genetic testing might be implicateed. oh, that doesn't like my picture. gina is a piece of larger puzzle. many have argued that there's no need to think about genetic differently from other health information and genetic information differently. but for better or worse there's been a consensus that is there is something special here about genetics. and i want to in a very short

nutshell talk about the three big arguments for thinking about genetics differently. at an almost gut level i think that the issue of genetics and privacies boiled down to a sense that some people have it intensely personal that is short of their extra private secret code invisible to the outside world, critical to their identity. sometimes when you look at this argument very carefully it sort of boils down to something my 6 year old might say, no, mine. it's not to be shared unless i say so. so that might be one reason to think about genetics differently. a second argument raises really maybe the most basic, i really doesn't like my pictures, all right. it raises a question of fairness. my genes are not my fault.

it would be unfair to treat me or my family members especially badly in one way or another based on our risk for disease or some other negative traits and in particular this argument goes with the predictive value of genetic test is imperfect or imprecise or even unknown, i shouldn't lose the things i most need like my financial support, my health insurance, or my job when today i can do that job or today i don't have a bad health outcomes. so today my health is good. today i can do the job. my genetic information is predicted. it would be unfai to treat me about what you think you know about my future. perhaps on the most sort of concrete practical level, the third argument in favor in thinking about genetics as a special thing that the fear that individuals have had the losing their privacy and being

mistreated. that fear has interfered with the willingness of individuals to undergo genetics testing. there are many stories of people afraid to take tests or unwilling to participant in genetic resrch that could benefit all of us. so the argument here best expressed is the impact of the fear of genetic discrimination is that we allose if we don't -- we all lose the benefits of that health care and of potentially health research. so i think most of you are probably familiar with a basic tenets of gina. gina prescriptions group and health insurer from user or request or requiring a genetic test. at an employment, gina prohibts employers from using the genetic

information in job-related decision orequests, -- requesting or requiring information. before gina there was other federal laws in play that provided some detection. those laws continued to exist. from a lawyers point of view they continued to be in the tool chest of lawyers that may provide some protection. hippa protects the all health information and a broader group of genetic information which is health by the entities coffered and hipaa. we also have employment laws. even before gina, the ada was interpreted by the federal agency charged with enforcing it to protect people from genetic information on the job.

it was an interpretation that was never tested in court. part of this was to clarify these protections do exist. so there are other issues at play in the use of genetic information in discriminatory ways. typically individuals seeking genetic testing are wanting to know about their health risk. but i think it's important i know about genetic information as also revealing the possibility of vulnerablabilitityn the future. or it would predict. and illness of often results in the enable of family member to work, loss of income for wage earner. gina does not prohibit an insurer use in setting rates that are aimed to protect people from that outcome.

life insurance, or disability insurance. should insures be allowed to do that based on their genetic risk? i think this is not a simple question. i don't want to say we should or shouldn't. this is complicated insurance products perhaps considered less critical to people's well being that other areas of insurance. on the other hand, these forms of insurance are of utmost importance in preventing real financial devastation. some states have begun trying to address this issue, whether the use of genetic information in these contest should be permitted. as you can see currently there are 16 states that use life and disability and ten states in long-term care insurance. some of these logs looked at don't provide that much

protection, but maybe set a place holder for the future. clearly the activity in these areas have increased greatly in the recent past. we did a very nice job of the relates related to gina and social networking. gina will become fully affective in the fall of this year. mean time, they are trying to finalize regulations. every question everybody had about gina about what it means and what i prohibits, these agencies are trying to resolve through the federal regulatory process. there's a few of these questions that are quite relevant to director consumer genetic testing. iant to spend a minute talking

about three of them. the first issue here is the question of the care, the medical care of the genetic testing tells people they might benefit from. this is obviouslyelevant to genetic testing and all genetic test. so if my genetic test reveals that i need or would benefit from care or protectionr treatment or some kind of specialized health care or health management, who's going to pay for that care? do they promise tt that care is going to be covered? it's not clear in gina that it does. and it's much more likely to think those are issues that aren't going to be resolved through more decisions about health insurance can and can't cover. example, positive genetic test can result in recommendation from a personal physician for increased counseling, surveillance, surgery, gina

doesn't require that insurance y for that early intervention or those preventive measures. so it's fair to say that the question of follow-up care is going to be one i would think utmost in the mind of dtc client or consumer deciding whether or not to opt into some of these test that may indicate a need for further medical care. and at the very at least when a consumer is deciding to go forward knowing the extent to which they are protected in getting the care that they might need is something they should know and should be included in counsel and consent. so there are also some issues as sandra talking about a little bit swirling around the use of genetic information by employers. many of you know, many of you may participate in wellness

programs that will offered by larger employers where employers can offer health care on the job and ask employees to participate. and insist that they do so in a sense for financial incentives or penalty ifs they don't. so the debate that relates to gina focuses on wellness program that might ask for family history of cancer. these are issues where the question of family history is genetic information and whether it's appropriate to allow an employer or entity associated closely with the employer access. that's an open qstion. it's particularly relevant to our discussion today because it's my understanding that at least some of the larger testing companies are starting to offer genetic testing as part of the larger wellness programs.

so your employer might offer you access to director consumer genetic testing and work with you in order to prove your health bed on the results. so gina is very much supposed to prevent and prohibit of the collection of this history should we allowmployers to use director consumer genetic question of not just questioning history but the test results itself. the third issue i would mention that continues to swirl in the gina world is that there's an unresolved issue about the extent to which it maybe considered accidental for an employer to learn something about through the use of online sources. this can include social networking, a message posted in an online support group for a particular disease, or the social network sections that exist in some of the direct to consumer genetic testing

sights. so by deciding to join the same message group that they suspect i can be part of it if any protective genetic information. but these are unresolved issues. and i want to provide with my take on where these federal agencies should go. director consumer testing, ironically, offer people perhaps the privacy that they crave or g.i.n.a. also appeals to. let me talk about this for a minute. i want to recommend an article a same from ashg that some of my colleagued helped craft that laid out the questions about

privacy as promised. what this testing offers theoretically is the ability to receive test results outside of your regular system, off the grid, out of sight, out of pocket. and to keep it under your control and to keep it in your -- only in your knowledge. and so for people who care about privacy, dtc may seem appealing. in the long run does dtc mean your privacy is enhanced? how can you know? one the issues that the privacy offered through director consumer testing doesn't necessaril have the protection of hipaa, to hipaa's privacy does not apply. these are not covered entity, and consumer need to know this. they need to know what it

means. en if the dtc using crowd is google friendly, the context here is different and the questi of consent becoming more important. that you need to understand that by offering you -- what you may perceive as a medical service, it is not a medical entity in e same sense where your health information will be protected. and we heard this morning inform david becker's talk that in one example, i'm not picking on him because he's not in his chair, i'm going to pick on him because i saw him this morning. the policy that he offered was th privacy needs to mean an appropriate use of genetic information. and that that would be sort of boiled down and made clear to consumer. i think appropriate as in the eye of beholder.

who decided if they with appropriate is the complex issue and one whe we all need some guidance. should a consumer genetic testing sampling be able to retest it for research, for quality purposes, if they do research is irb approved, if the company goes out of business, what happens to your dada? these are the kinds of issues that come to my mind on what is appropriate. and we may differ on appropriate, but the clarity is what is important. perhaps at the even more concrete level, i think qui rightly most director-to-consumer testing once they get their results to talk to their doctor if there are some hlth care decisions to be made. as soon as i tell my doctor, as soon as i show up with the print

out, that information becomes part of my medical record. and to extent that medical record is available but protected by hipaa it's no longer under my criminal. so what i think, even if the company has a good privacy policy, but using the genetic testing if that information ends up in that medical record it could for example be requested if i'm not protected under my state law. it could be requested by a life insurance or disability insurer who asked me to consent to have my medical record examined. so the shift into outside the control that dtc offered consumer can happen quite quickly. for me, the bottom line is if you information you get directive consumer actually matters for your health, it's not going to stay private.

it almost end of with your $and it may end up with one the insurer that you choose to do business with perhaps as a result of finding out that information. so i want to just sort of end with a few additional questions, some of which has been raised this morning, and i think many of which will be discussed today or tomorrow, figures out who owns genetic information is not a simple inquiry. but understanding what a particular companies rules for use and sale and disclosure and research needs to be as clear as possible. i think the other issue when dealing with a private entity is understanding under what circumstances the rules can change. you may consent to one thing, but if the company is taken over, if the rules change, who gets to change them? underhat circumstances? what notice does the consumer have later of where those rules

go? and i also think that as we are starting o see some state laws or rulings relates to discrimination, excuse me to direct-to-consumer genetic testing under how these state laws intersect is also going to be very important. as a final note, i would say some of the discussion this morning, what instruct me was the need to understand better what some of the using of dtc think, what their experience is when they go through this, an as time goes on what their experiences are of -- vulnerability if there was in a more clinical setting. thank you. >> david, then jonathan. >> susannah, you made a comment

about having -- i have two points. if somebody is going to potage genetic information on way or the other on the web, why do you think the employer doesn't have the right to access. once you do that, it's like crying out to the world look at me, i've got xyz. to seems to m if the an individual makes a conscious decision to publicize, i don't understand why you say an employer or everybody else doesn't have a right to see it. >> i'm going to answer your question from two corrections. certainl i think there's sort of a evolving societal discussion about if you're about to hire someone can you google them? how much should you find out about them? what's the social contract for doing so? and certainly, i think younger

people who might have their -- might have pictures on theirmy myspace page are starting to thinking about reveals more. the question of whether an employer can look for information about an employee in a place that is most likely to reveal information that is not relevant to their ability to do the job. because i think is very difficult employment law question. so if my hostings are about my future health risks, should an employee who is not allowed to ask me questions and that be allowed to look specificically on the interview for information about that? if we're going to outlaw it in the interview context, is it appropriate to say anything goes on the internet?

>> well, i would just say that i think people have to have some responsibility for how they behave. and, you know, you just -- i don't find the argue at all compelling that i can't see something that some person who other wisely or stupidly puts out on the internet. >> just to argue the point, if the interviewee offers the information, the employer not asking it, may waive the right. so if you go in and say, oh, i'm 6 months pregnant and nobody asks you, are you pregnant? they know the information. so it's the same sort of thing. it's how you use it then and one can have a different argument about it. >> well, i think it depends on your view of how people do and should use the internet in their

private lives. if we assumehat as time goes on fewer and fewer people will decide in the to use the internet for the things that ey want, simply because it might come back to bite them, then we're taking away a huge portion of what the internet -- the internet has creat communities that did not exist privately. and it's connected people that woulnot otherwise be able to be connected. and it is public. but you are as an employer not allowed to go look for information in certain public database, you're not allowed to look online for articles about somebody, there's sort of a sense in g.i.n.a. that there are areas of high risk inquiry that you are not allowed to say to

somebody, how's your sister, what was wrong with her anyway in the same way you're not allowed. i think they are difficult question. and a to be fair the federal agency that is are trying to figure it out are struggling. would you -- how would you craft -- you can look anywhere you want. could i as an employer join 23 and me to go on their social network section. >> i know parents who track their kids facebook is the only way they can figure out what they kids are up to. >> we've always had different rules for employers than for parents. >> the other point is your mention of the lack of hipaa extension i think goes back to a point i was raising earlier that the line between dtc and all

other segments of society that are either collecting, analyzing, or studying genetic information i think is exceed ingly blurry right now. i have a huge conflict of interest. i'm an academic. and i don't see why if we have to live under all these restrictive protective rules other people doing the same stuff shouldn't. i mean that's not fair. right? >> thank you very much. i was listening. so i appreciate your talk. it was great. i just didn't want to walk in on the middle of it. thank you so much for bringing up these issues. i think privacy is a huge issue that as you point out we don't understand all of the ramifications yet. we are trying to work through these things.

that's why we've hired a privacy offer and try to really focus on hipaa and establishing all the hipaa rules here now as well as bringing in the 2702 level standards. we want to meet those standards to the best of ain't. kind it have talking about what happens to the data after if o company fails or it gets bought out? we think this is a legal contract that we have with our clients. and that should be passed on to anybody that buys our company or if we have to fail, we're obliged to destroy that data at that time. we feel like we're trying to meet those standards. we're not going to pass anything to anyone's insurance company. we will stand up to them and maintain our contract with our employee.

>> can i ask a question. i'm curious to know the extent to which you would be, i think some of these policies are going to show themselves as what they should be over time, sort of based on the interpretation both of the company and the users. are you -- do you have a mechanism in place or a plan for sort of reevaluating privacy as time goes on? >> well, michael cox is our plan. he basically stands toe to toe with us every day and we have a plan to keep him in place and keep evaluating this process as it goes along. absolutely we want to adapt and maintain those high standards. >> back to your slide on the insurance situation on the 16 states who was looking to pluck

holes and do some more on g. i.n.a., i've heard insurance industry people say that if the way we are going, life and ad & d insurance may no longer be profitable and they will have to go out of business. because each of us and eve maybe by googling others, other parties will have access to information that we don't have and therefore they are in an adverse selection position. what do you think about that? >> i think it's a very difficult policy issue. and i think it's one worthy of some close examination. certainly insurer say that about health insurance. one person's profitability is another person's unfairness. so i think there is -- there are real questions about how

important we think it is to impose our views of what the access to these insurance products should be for an average american. i think that the fact that our genetic knowledge is shifting over time maybe it's becoming more precise, maybe it's becoming muddier complicated the issue. so if we thought that a life insurer could make a perfect prediction of our life expectancy or as close to perfect as it is possible, if we knew we could know, would we feel different or would we say what's the point of having life insurance at all? i think they are very complicated issues. i don't have a sense to where i would want it to come out. >> this question, i remember vividly, a number of others 13 years ago identifying the problem of the disproportionalty

of knowledge in the insurance context because of genetic insights. and if the insurers are forced to act behind a curtain of ignorance, all other possession perfect knowledge, in a business where tables determine what the companies survivorrability will be, then i think we can predict the result. i would be crazy as a 45-year-old man and having three children and terrific information based on genetic, not to quote gain the insurance for my family in their interest. and that problem is going to increase. it existed then and it exists now and it will exist in the future. cynthia, a researcher, was in the same sort of circle.

he was brilliant, she had done great work. she must have been 25 years old at the time. but universal health insurance would cure because the polllation. that's probably not the exact program being discussed now. the idea of greater risk spreading. that maybe the area to investigate in order to see how to handle this issue and still ensure genetic privacy. >> life insurance is individually written and underwritten. and that modelou wouldn't have a big pool for life insurance, much of it anyway. >> that was exactly my question brought about by having heard someone speak who was doing the reveal project looking at giving out information to the general public and talking to a group of insurance executive about his

results, basically explaning him to extent of which someone can get real information. usually i worry about information being incorrect. it's unusual for me to feel protecting insurance companies from information that's too correct. this is one thing for long-term care disability insurance, if you can found out in advance, you have a high risk of alzheimers is an able real piece of information. it's hard for me to knohow the companies are going to be able to offer the insurance under those circumstances. but also while i was standing here, i would say there's a big different of yes, my child put somethin up in the facebook, that was going to get them in trouble. it's your own problem. but their other uses of the internet. and i'm not se that we don't

want to think about companies, you know, developing program where they know who are in chat groups for people who are bra1 or 2 positive. do we not want to have those sites if people are going to be able to get information. not i'm making an announcement, but something you can use as implied information. i think the implied infortion will be danger. people will get that you can't go online. they have been remarkably slow. but yet i get people will get that you can't do that. but it's -- you know, when the information is actually out there, though not necessarily legally available of every search you make and every statement you make in a chat group or something, there's a lot of implied information that can be dredged for. i think that will be the bigger

concern in terms of that. >> i certainly agree with your first point, i agree with both of your points. the apoe question and the reveal study that people do increase their uptake of long-term care policies. which makes perfect sense. this is a decide where the impact can be devastating, long-term care is exactly what people need. and the predictive value is good enough that it makes sense to make that investment. and then what do you do with that fact? the fact that unequal information on the other hand. people really need the care. a difficult question. i do also appreciate your comments about the we are net. you know, i think some of this is that we are all in my own -- in the last five years i've gone to be a nay sayer to having a

facebook presence. i don't know if they good or bad. i certainly thinking about what my kid will do with their internet presence. i expect my views to shift again. if what we say is anybody can have access to anything you ever do online and you have to buyer be ware, there's a lot of worthy uses of the internet that would need to go away. and think that would be a shame. >> thank you so much for a wonderful discussion. we're going to turn to scott woodward now on genetic identity and community. scott? >> thank you. it's a pleasure to be here. i think we may be -- i think i may be a slately different animalhan what we've seen so far today in that we are very much involved in genetic test,

in databases, and -- but not so much many medical testing. and not so much in direct-to-consumer selling but very much in building and affecting an individual sense of identity and sense of community. the foundation was started just over ten years ago in utah. it was started as the part of the university. at the time was professor of the university, working on questions of population genetics. it's a private individual that said i have some real questions about who i am. who am i? and how am i connected to the rest of the people in the

world? can you tell me somebody about it? and it was a very interesting discussion that we had over the next with or three months in trying it figure out if there was in fact a way that we cou ants some of these questions. and the big challenge that he came up to me with and that fit fairly well into my research program at the time at the university was:is there a way that we can essentially break down walls of identy, break down walls of community, and demonstrate to the world that we are in fact all connected in very real ways? that we share something that a very elementary level, something that widely shared among lots of individuals throughout the world. and so we attempted to take a stab at this. and that's what has now evolved into the genology foundation

with the book genetic and that's another item that we are bringing into ts process. this family history idea. and a directly addresses some of the questions that are -- or directly brings up some of the questions that we had about the secondary participates. especially when you add gene logical information. and bring that information together and really in -- and build the pools to help restrict their social group or reinstruct their community using that dna or reinstruct their geneology.

and his idea was to -- i'm going to fund this. i'm not going to ask anybody any money to find out this information. i'm going it fund ts, build the database, and build pools and to make this available. and so at this point, we have not asked anybody to purchase a test. but we have asked a lot of people to donate their dna and genelogical information. today we have collected throughout the world 108,000 dna samples under informed consent. we'll talk about that in just a moment. and also associated with those dna samples we've collected

extent the pedigree informatio through the process in scrubbing thiq pedigree information about a little over 90,000 pedigrees associated with those 108,000 dnas. these pedigrees are very interest that they have an average depth of 11 generations which is quite a bit of work to be able to pull that type of information from an individual who has donated dna. in our pedigree we have 7.8 million ancestral names. there's a little bit of discrepancy here in the number of names that we have, because there's overlap in the same individual appears on more than one individual's pedigree. we currently have that scrubbed

down to 2.6 million unique names. but we're not all the way through that. that there continue to grow as we finish up some of these pedigrees. we've also not collected genetic data on the number of these dna samples. we have about 77,000 immediate crop tree corral, getting whole data to have 315 of those that are in our data set and we've also looked at why some reasons for mitochondrial, when she started this we were -- and this is an interesting point in light of what we are talking about and

dealing with. we were pressured into this by the community by the individuals out there saying we would like to know something about our mitochondrial and y chrome sewn because we think this is where we need to go. our goal from the beginning and it is still at this point is to actually work with the nuclear dna and reconstructing information. we also have about 40,000y chromesone. another one that's dna on the x

chromeso can tell us something about our ankers trithat neither the y can. we have about 64,000 of types or x chromosome's belonging so far. and then the gene types that we're dealing with again about 78,000. these are spr gene types. not our snips that we'll talk about those also. short repeats. they are the last generation, two generations ago genetic information. we also have begun our large chip analysis of some of these individuals starting with the populations that now have 300 completed using the genetics.

and i'll talk about that what that's done. some of the places in the world that we've collected, i just want to use this as an example of how we do these collections throughout the world. this collection was done two years ago last month in mongolia. it look us about three years to set up the collection in that we needed to line up collaborators both with the university, the international university in mongolia was our main source, but also the governmental agencies to make sure that consent and irb that we were working under here in the united states would be transferable to what changing we had to make. make shoo that we were in compliance with the types of rules and regulation that is were in place in mongolia.

and then working with local -- where do we need to go to get a good sampling of individuals in mongolia. there are about 28 different known ethnics groups. we wanted to make sure we tried to get as many as those as possible. you can see it's not easy to read. you can see all of the different places, locales that we corrected from in trying to get an overall picture of what was going on in mongoli one of things that we found and actually it's not really not vary surprising, but when we started o lack at genetic diversity within mongolia, this is the most genetic divorce place in the world. right now, but that's not probly not true. but it's an artifact of the

sample that we've been able to sample this country extremely well and in doing so we discovered a tremendous amount of diversity that we didn't really expect going into that country to start with. as i mention, we've collected all of our samples under informed consent. originally working uer the direction of the irb at the university, four years ago we moved out -- we moved the data sets to the collection, the whole foundation outside of byu and into its own entity. at that time we did not continue to use the irb of byu but transferred that to a private irb in western irb out of

olympia, washington. we've continued to maintain that to our point. some of the things that we will to. when we started out our original informed consent, this is t real -- that's an interesting problem. and i hear it coming back and forth. and i see it all of the time. especially with consumer testing. if you have an eight page consent form, 12-point type, going out to these individuals and you even think that they can first will they read it, can they read it, can they understand it, there's a real challenge here in be able to explain exactly what it is you are.cc, what you want, and what's going to happen with that data? we've worked very hard over the last ten years trying to get that to the most understandable and cover the subject.

and still do what an infmed consent needs to do. we're town to six pages. and that's still where we are with our informed consent. talking about the risk, a couple of them have bee addressed. linking genetic results to you. loss of confidentiality that you are at risk of losing some of your -- what you think would be confidential information if you participate in this study. what benefits there are, whether there are payment, there are no payments in our study. this is voluntary. you are participating and that you may withdraw at any time. we've had 108,000 sample collecting, today we've had 17 individuals request to have their information and dna and data withdraw from our database. it would be rea