Personalized Health Care Initiative Workshop: "Understanding the Needs of Consumers in the Use of Genome-based Health Information Services". Panel 3: What is Currently Useful to Consumers, and What Can They Expect in the Future?


MS. MCGRAW: Okay. Thank you very much. I wrote down a couple of things in that during the first panel that I thought were really interesting. The one was from the Yankelovich survey data -- people assume medical privacy. I think that’s a really interesting point, and I’ll come back to it in a minute.

I think the other piece that was interesting was that to the extent that we’ve delved at all into privacy and security issues, we kind of went sort of more to towards the security pieces -- the data is secure, people can't hack into it or it’s encrypted or whatever. And we see a distinction between privacy and security, but both are quite important and I’ll go into that in a little bit of detail, too.

And the other thing that I thought was so interesting about the marketing presentation that we got and what the different types of consumers, is just how valuable data that could target marketing and advertising would be. Which, if none of us had a sense about just how valuable that identifiable data about what people might be predisposed to get in the future or even what particular conditions they have, would be to advertisers, you know, there’s certainly good evidence for that. So I don’t think anyone in this room would disagree with the statement that the privacy component is very important, as is the security. And the truth is is that what protections we have are a bit of a mixed bag. There’s some better news today than there was in the past because of the passage of GINA, but what so often is the case is that we are either understating or overstating the amount of protection that we do have. And the protections really are important to think about in two ways. One is, what can people do with the information? This is the privacy piece. What are the permissible uses of health information, whether it’s genetic information or information about health status? The second question is, if you’ve got that information, to what extent can it be used in ways to harm you? And this is what people tend to focus on most; can it be used to discriminate against me?

Can it be used to hurt me in terms of getting health insurance? Can it be used to hurt me in terms of employment? Can my employer fire me or not give me promotions? Et cetera.

The good news about GINA is that at least with respect to health insurance and with respect to employment, you can no longer use a piece of genetic information for discrimination purposes in health insurance and in employment. But we didn’t quite finish the job; we still have some work to do because, number one, if you have the manifestation of the condition for which you have the genetic marker, the information -- that is that you’ve been treated for a certain condition, that you have a chronic condition -- isn’t in fact protected under GINA, and the extent to which a health insurer can use it for underwriting -- sorry, Reed -- underwriting purposes or the extent to which an employer can use it if they are able to obtain it for employment purposes kind of depends. You know, we have the Americans with Disabilities Act on the employment side; there are some protections on the insurance side under HIPPA, some under some state laws, but it’s a very incomplete picture. So while we have taken care of some things with respect to genetic information, we still have the problem that Matt raised, which is that the information once you actually have a condition can often be used in ways to harm you.

Now, getting to the point about HIPPA, that privacy is assumed. It’s so interesting because the point there, I think, is that people often assume that when they are entering their health information on a website or even with respect to the information that their physicians or hospitals have about them, that that information can only be used in certain ways. And typically people really significantly underestimate the extent to which health information can be lawfully used. And the point I’m making more than anything is that I’m the transparency point -- is for consumers to have a much better understanding of what are the permissible uses of their information, and not so that when they’re seeking care, when they’re seeking to get a genetic test, they have an absolutely complete understanding. And I couldn’t agree more with the folks who said earlier that if you’ve met one consumer with respect their privacy concerns, you have met one consumer with respect to their privacy concerns.

There are an awful lot of people for whom -- who are willing to disclose a fair amount of information about themselves in the interest of whether it’s furthering research, whether it’s as part of a social networking site, et cetera. Again, since I’m a privacy advocate, I think that’s nuts. But there are people who will do that, but the policies about what that information even to the extent that it’s disclosed by those folks will and won't be used is really important, and it’s not just a matter of what the legal regime is. I mean, how many -- you know, in terms of even just looking at a privacy policy and understanding what it is that the company that you’re entrusting your information with can and can't do with your data, you know, there’s lots of evidence out there about how people don’t tend to read them and if they read them they don’t understand them. I don't know when the last time was that you signed up for something and, you know, just scrolled through that privacy policy and clicked that box at the end. I’ve done it myself. It’s not the most protective way to do this.

So getting to HIPPA, that is the federal law that we have that governs the uses of information, the privacy protections, the security pieces that need to be in place for covered entities. A lot of the folks who are obtaining medical information now are not currently covered under HIPPA. HIPPA’s coverage is pretty limited - - it’s hospitals, it’s physicians, it’s pharmacists, it’s labs, but it’s not everyone who’s now in this space to protect this information, which then puts the onus on the consumer to be that much more aware of what are the potential uses of this information? Again, because it is so valuable. I think the other thing to keep in mind with HIPPA is that because genetic information by itself without a link to some other piece of information isn’t necessarily identifiable, again, depending on its context.

Identifiable information is also not protected health information under the law. So the bottom line being is that we sort of have a patchwork of protections here, so when the question comes up for consumers, you know, “Will my information be kept private?” The best advice that I contend to give people in this context is, “Well, that depends. Who has it? Who’s holding it? Is it linked to other identifiable information? For example, is it part of your medical record or is it part of a research study where it’s in a great big databank?” So I think we have some work to do in terms of being able to assure people that when they’re getting these tests their information will in fact be kept private and secure, and that to the extent that there will be uses made for it to treat them or to help pay for their care. These are the ways that the data can be used, and these are the ways that the data cannot.

DR. TUCKSON: Very good. Thank you for a very interesting first round. As the audience starts to think about what it wants to ask you about, let me -- as promised, Jeff, let’s go back to this issue of getting beyond your competitors ex who’s not as nearly as nice of guy or company as yours is. How do we -- what is your view as a private-sector person trying to run your business and provide an important service to the American people -- what is your view of the adequacy of oversight that can give a consumer, your momma out there somewhere, confidence that the test does what it’s supposed to do?

DR. GULCHER: Good question. I think, you know, currently the oversight for a test sold to an American or whose results are given to an American is that CMS or FDA have to have certified or -- they’re the ones that regulate laboratory derived tests or testing kits, and those are already in place. What we’ve tried to do is emphasize that we’re CLIA compliant in the context of CMS and FDA. And now whether or not consumers understand all of that, you know, that’s a different story, but we try to emphasize that there is a regulation that covers analytical and clinical validity with laboratory-derived tests and that’s the extent of it. But if the question then becomes, is there a need for further oversight or beyond what oversight already exists, I guess that’s a different question for the consumer.

DR. TUCKSON: Let me just ask, Sarah Carr (phonetic) just remind me for my information, is the report from the Secretary’s Advisory Committee with its recommendations to the Secretary, is that up yet online or is it dependent upon waiting for the Secretary’s Office?

MS. CARR: It’s online.

DR. TUCKSON: It is online. So I would urge -- first of all, I would urge all of the private-sector companies that are doing this work to review, if you would, the Secretary of Health’s Advisory Committee on Genetics, Health, and Society -- easy to find; and look at the report on the recommendations regarding the adequacy of oversight. And I think that the question becomes, if private-sector is convinced that there may be an issue here of a few holes, that we might want to have private- sector come forward and partner with public-sector to hurry up and plug those holes and try to get this thing done. I won't say any more as the moderator because I’ll start to sound like what I am, which is an advocate. But I am concerned, and I believe that this needs to get dealt with in an expeditious way and that the Secretary’s office shouldn’t be down here trying to figure this thing out, I think the public-sector should step up to the plate and help to close that deal. Do you have a comment to make on that?

MS. PHELAN: I do. And I think the private- sector is stepping up to the plate and, to some degree, trying to figure out where the regulatory environment currently has left off and where the industry can try to help create guidelines and, you know, best code of practice and things like that. So I think you’ll be hearing more about that.


MS. PHELAN: But can I take a cut at your answer on do we have enough regulation for the consumer to decide?


MS. PHELAN: So, right now, the unfortunate thing in this industry is that these terminologies: FDA oversight, FDA approved laboratory tests, CLIA -- these don’t mean anything to the consumer. So at DNA Direct, we offer tests that are done in CLIA labs and with medical guidelines established. And we put all that on the site, but it doesn’t stop a consumer from looking at another website for a genetic test for -- I’m just going to use a random thing like, you know, for baldness -- male-pattern baldness -- something that may or may not have scientific rigor, and looking at it and saying, “Well, my assumption is this -- it’s on the web, it should be regulated by the government.” And I think this is really what caused California to actually step up with its cease and desist letters that it issued to a number of companies over the last two weeks. Is, you know, a question was, “Are they providing these with medical oversight or are they doing it in CLIA labs,” but also, this big question that ultimately all of these companies, all of us have to demonstrate, is are the tests that are being offered scientifically valid?

DR. TUCKSON: Well, I appreciate the point. And we’ll get into some -- obviously we’re getting into some very interesting issues here. You know, you said, “I have to wonder,” I was very much impressed by your slide of your test case that you’re going to do on Alzheimer’s, APOE, I thought that was pretty good. I kept wondering the level of education that the consumer would have to have to be able to deal with that. I mean, you’re right there, you’ve got the words, and I’m sure there is an explanation of clinical utility and clinical validity --

MS. PHELAN: Oh, yeah. It’s --

DR. TUCKSON: I’m still trying to think back to the so-called average American. It’s like, you know, you’ve got to work your way through it, so unless you can figure it out to know whether you’re in a risk or not risk, I mean, in some level it seems to me there ought to be a common (inaudible) that says, “Hey, this is legitimate.” And you shouldn’t as a consumer have to sort of be lucky enough to be able to stumble into whether or not you’re in shaky ground or not.

But let me ask you, when the people call you all -- and I’m not sure what population of people call you -- what are they saying? Is there anxiety on their part around -- and I doubt it, but let me just ask -- you know, reliability, validity, and/or privacy; what happens in those conversations?

MS. PHELAN: All right. I think that looking at the Yankelovich study, I have to say that our population has always been what I refer to as the rightly worried, which is not a particular category that you had, but it’s one we use. And these are people who have a known personal or a family history of a medical problem. And to answer the literacy question, it cuts across all educational, social strata. And it’s because they have an underlying concern about a health care issue, and what they do is they read up. And so, believe it when somebody has a family history of cancer -- early-onset breast cancer -- they are going to learn about the BRCA gene.

Now, you know, should they all have to wade into that level of depth? No. But for those who want to, they need to. And any site or service has to be able to provide that.

When consumers are approaching testing, they do it very thoughtfully. This is not a booming business of people throwing down $3000 for testing for no good reason. Believe me, people think through genetic testing. They think through the pros and cons, they think through the privacy issues, they think through privacy even in their own family. They want to know, if I test what does that mean to my other family members, do I need to provide them with the information around the results? I mean, these things have a lot of implications. They think through their insurance, what’s going to happen if they have not yet had cancer or known anything symptomatic, and that’s part of what we do and it’s called counseling. It’s to help people really way that and think through it.

DR. TUCKSON: Well, thank you. I must say, I was very impressed with Eric’s example that he went out and -- Dr. Topol -- and did his own and he looks at these probabilities and -- and you’ve talked about probabilities and you’re made some decisions based on probabilities.

And I continue to wonder, how does the public know that those probabilities are right? I mean, upon what -- who’s -- you’re making a -- I mean, there’s so much subjectiveness here for a person, and at the end of the day, okay, it’s 1 in 6; well, who says it’s 1 in 6? How do I know that’s right? Who are these people that are saying these things? And is there any argument about -- is it really 1 in 7 or 1 in 8, did somebody’s paper disagree with Bob Smith’s paper on that? How do I go back and actually know that? This is fundamental. But Deven, as you look at this stuff from a macro-policy point of view, “If you’ve met one consumer,” you say, “you’ve met one consumer.” How does one then suggest to the extent that you would advocate for any level playing field of public policy; how do you make public policy when you have this range of, not only genetic variation, but personal decision-making variation?

MS. MCGRAW: Right. Well, you know, one thing is to consider that there ought to be a baseline below which -- you refer to it yourself, the sort of baseline of either oversight, a set of sort of ground rules that all the companies in this space, the health care providers have to follow. That’s certainly the pattern that we’ve got, you know, in terms of our own privacy laws in this country. There’s the federal baseline of HIPPA and some of the states have chosen to go beyond it, and some providers in fact even go voluntarily beyond it. And then the ability of folks to, with all of the right information and tools in hand, to be able to make decisions that are sort of very individually centric and be able to say, you know, for me, I’m okay with sticking my entire genetic sequence on the web. I’m okay with that; I’m even okay with sticking my name on the end of it. You know, you’re permitted to do that, but that doesn’t -- even if there are some -- there is some variability in terms of consumer taste and concerns, it doesn’t absolve us of the responsibility for creating at least a set of rules below which, you know, no one should fall. So --

DR. TUCKSON: All right. Well, the floor is open, and I can't believe it, but Kevin -- Father Fitzgerald is first in line. And we can only go wonderful from there. And you’ll be next.

FATHER FITZGERALD: Thank you. Kevin Fitzgerald from Georgetown University and also from the Secretary’s Advisory Committee on Genetics, Health, and Society.

Question which could be for any panel, but since this panel is more focused on the consumer, I thought it was more appropriate here. People are talking about doing the good; no one doubts that someone wants to start a company to do something wrong or evil or bad. All right. So no one’s questioning that; the question is, how do you determine the good? Who is good? Who is deciding what the good is? Especially in a situation where we have such problems that we see all the time, in research in particular, with what we call therapeutic misconception.

Is that a concept familiar? This is basically, you know, someone comes into a phase one trial, you go through all the informed consent forms, you sit down with them, you go through the entire thing, they go through the six months of chemotherapy or whatever it is -- if it’s oncology -- they come out, six months later you go back and you ask them, “Why did you go through that?” And they say,“Because I thought it would do me some good,” in spite of the fact it was a phase one trial. So what -- and this, again, we heard before, you know, “This is probabilistic, it’s statistics.” True. It is statistics, but it’s not baseball we’re talking about. If you have a debate between whether batting average is better than on-base percentage is better than slugging percentage, that has some significance in some part of the world. We’re talking about people’s health, their own understanding of their well-being and who they are. How do you address that concern in your industry? Do you address it, and if not, what are you going to do?

DR. GULCHER: Yeah. And let’s (inaudible) our industry, I’m not sure what you’re referring to. If we talk about the need, the un-medical need for risk assessment, okay, that’s a medicine-wide issue. Right? And a demand for that, that’s the basis for why all these studies have been done -- the genome-wide association studies have been done. That’s what we’re searching for here, right, risk assessment. So it’s not just somebody creating a new industry out of -- and trying to create a need that doesn’t exist; there is a need. Right? As I mentioned with prostate cancer, you have very limited information that you can impart to a patient to help decide how vigorously do you search for cancer. All right. And the best treatment for prostate cancer is early detection, so I would contend that actually there is more of a demand from physicians and the health care system for this kind of information, rather than the industry sort of pushing it on to consumers or patients or physicians.

FATHER FITZGERALD: Well, okay. But that’s still in a sense doesn’t somehow recuse you of the responsibility for addressing it.

DR. GULCHER: Oh, no. Yeah, okay. Responsibility to make sure the information that we create is reliable, and I think we described that. Is it useful? That -- whether or not it’s useful really is between the physician and their patient, right, or a guidelines among professional societies or whatever, and this information feeds into those guidelines, right, because it’s setting an additional risk -- it’s adding additional risk to other things that are already being assessed, and that may trigger whether or not you do something different with your physician. But we’re not telling patients what to do with this information other than act on it only in the context of a physician, right? We don’t -- we offer genetic counseling, but we don’t pretend to think that our genetic counselors are going to tell patients what to do with this information. They may help try to frame what risk means, but it’s really the physician who can work together with the patient to act on that information, just as physicians act on other risk information. It’s just another clinical risk, there’s nothing new about that.

DR. TUCKSON: Then the issue then ultimately -- and we raised it earlier, is, again, how do we educate the physician to know what to make sense of it and upon what database does the physician make those choices? I think it gets down to, again, I think that as we get ready for Muin’s question, it’s the notion of how much oversight does there have to be with, you know, heavy-handed government looking out for vulnerable people. And the Lord knows that if there were ever a vulnerable people, this is a case of vulnerability versus having the industry (inaudible) large, sort of, say, “Okay, we’re going to put some best practices” -- I think you used that word, Ryan in your -- you know, in terms of industry standard best practices, so you don’t have to have the poor Secretary of Health have to come in and ride roughshot over this thing.

DR. KOUHRY: Just to elaborate a bit more on your clinical validity and utility issues. I mean, if we’re looking for credible information that -- as a consumer who is savvy with numbers -- I mean, I love numbers, but it’s, you know, I’d like to get sort of the most up to date information that’s credible for my own health care and disease prevention. Now, the problem with the existing literature right now -- and you’ve alluded to it -- it’s risk factor information. I mean, right now, we have a database of about 35,000 genetic association articles, and, you know, you do the meta analysis and the, you know, all the GWA’s, and you put them together. And then you try to go from replication to a risk estimate for an individual. And the three companies do it in slightly different ways, and I’ve had reporters talk to me where they took the three tests and they got three different, you know, sets of advice from three companies. It’s the same genome; however, it depends on how you read the literature and how you put the information together. I mean, one company puts out lifetime risk estimates. The other company puts out incidence rates over the next ten years. Basically, the data that are used for the second tier analysis is not from these papers, it’s from existing data sets, like, see registries for cancer incidents in the population. And then you extrapolate from here and there, and when you say your lifetime risk for Type 2 diabetes is 1 out of 3 as an average, that’s an average risk for Type 2 diabetes for a person born today, not the person who is 50-years-old who might be taking your test tomorrow morning. So I think playing with numbers -- this is not BRCA1 or Huntington disease anymore where you follow the modes of inheritance, its chromosomic dominant and recessive. This uses extraneous pieces of information to arrive at these clinical validity estimates, and without industry wide standards -- even with the best possible intention -- there’s going to be severe variation that is going to be translated to different sets of advice from one group to another, and perhaps different courses of action.

One more thing. Clinical utility, you told us your wonderful story about prostate cancer. I mean, I don't know if we replicate your story a 100 times and we do a clinical trial about a situation like yours, whether or not there will be clinical utility from having had your genetic test done. I mean, I’m not questioning your own, sort of, decision for what you’re going to undergo -- and that’s strictly a personal decision, but there has to be some clinical trials to accompany this kind of individual thinking because at the end of the day somebody has to pay for these procedures. And if we’re going to label the whole population into risk strata across thousands of data points, we’re all going to be at increased risk of something and decreased risks for something else. So unless we standardize this and collect the kind of information that we’re going to use for medical practice, it’s going to be a mess out there.

DR. TUCKSON: That’s a very, very thoughtful question. Let me ask you, Ryan, how --

DR. GULCHER: Are we allowed to respond to it?

DR. TUCKSON: Go ahead. Okay. Sorry. We got a couple minutes. We go -- by the way, I was given leeway since we started late, we get to go until 10 after, so, but Ryan let me just -- and before we get to you. How freaked out are your counselors by the first part of Muin’s question and saying -- I mean, do you feel like when your folk are sitting there on the phone doing this counseling interaction, that you’re sometimes sitting on what could or could not be a shaky database around which you are giving this kind of advice.

MS. PHELAN: No, not at all. But that is because we’re not in a shaky territory. We’re not doing genome-wide arrays across the board, so I’m really not the one to answer your question. But I do have an opinion about the difference between clinical utility and personal utility, and you saw that up in my slide. I think that personal utility is something that we’re all going to have to wrestle with here. As all of this testing is coming aboard, people like Jeff -- if I can just use you an example as a consumer for a minute -- are going to find value with some of this information, that they may make health care choices with. It may be very different than what would be reviewed as clinical utility down the road, and I think that is something that -- you know, that is going to be a tension that we have right now because it’s going to take a long time for some of these new technologies to actually get all of the way through to where there’s proof of clinical utility. And so it’s not what I do.

DR. TUCKSON: Great. Thanks. Jeff.

DR. GULCHER: Yep. Well, first of all, the last statement you made that, oh, if we do deCODEme or 23andMe or Navigenics, we’re going to find out that, oh, I’m at higher risk for some things and I’m a lower risk for other things. Well, that’s the nature of the beast, right?

That’s the whole point, right? You have -- we have differences in risk, right? Some of us will be at higher risk for cancer, other people will be risk for cardiovascular disease, et cetera. And isn’t it better to know that, understand that risk early on so that you have the opportunity of either preventing those diseases, or maybe you’re more highly motivated to finally quit your drinking and excess eating. Okay. Or you can do something about it with management with your physician, or early detection in the context of cancer. So that’s the whole point. The question is, is that -- is the magnitude of this risk high enough to act on, does it save money in the health care system overall, does one need to do a 15 to 20 year outcome study, right, those studies don’t exist. Same thing for prostate cancer; there is no such thing as a long-term outcome study for prostate cancer, right? But yet, there are guidelines that suggest once you achieve a certain risk -- 20 percent lifetime risk for breast cancer, then you should have -- and I think a lot of companies like Reed’s pay for extra attention, extra MRI screening in addition to the usual mammography for breast cancer. But you have to reach a certain risk, right, before that happens, and that risk is dependent on various things, which can also include validated markers for genetic risk that can put you up to that threshold.

And then you fit into the established guidelines that say, once a woman achieves a certain five-year risk or lifetime risk, these are what the recommendations are.

DR. TUCKSON: Well, this is fascinating, and I think that Muin’s ending point was, at the end of the day, somebody’s got to pay for these assumptions. And so, does CMS, with all of its active budget problems right this second, does CMS actually start to say, okay, if you have this kind of a mathematics that you put on your slide -- something like it -- and I don’t want to make it personal to you, but just say you put mathematics up there that come up with a number, at what point should the public insurance reimburse that prostatectomy, and how do you, sort of, make those decisions as a society struggling with some real choices. So I think your answer was responsive, and I think Muin’s ending thought was also very important. As we get to these last couple questions, Deven, I just want to make sure that I ask you real quick, though, one thing I was going to make sure we get at, and that is -- I’m -- so I’m going to flip this whole thing around. Where everything here has been cautious and conservative, and at the end of the day, how do you -- as somebody who I think is an advocate for caution -- can we pile on so much caution that we just stifle this whole dangone (phonetic) thing and we don’t wind up with diddly squat?

MS. MCGRAW: Well, I certainly hope not. I like to label myself as the privacy advocate who, like was said in the very beginning, I don’t believe in using the word balance because I think you can have privacy protections and advanced medicine through increased knowledge and grabbing on to the most promising information that’s out there, whether it’s genetic testing or what it might be.

But you have to really focus on both because without consumer trust in either the testing enterprise or the use of the information, we really won't be able to move this forward in ways that we want to. And too often, the balance question means that, well, we won't -- you know, we have enough privacy and security and we need to --

DR. TUCKSON: Diddly squat, by the way, is a highly technical concept.

MS. MCGRAW: It is.

MS. AVEY: I just thought I would comment on -- I don't know if this is on -- but Muin’s point. We take that --

DR. TUCKSON: Right. Would you tell us your name?

MS. AVEY: I’m sorry. Linda Avey with 23andMe. And the comment about a person getting the testing done with the three companies and getting some differential data back, we fully admit that that is the case. And in fact, Mari Baker and Ryan Phelan and Jeffery Gulcher and I, along with the Personalized Medicine Coalition had a breakfast this morning that -- and this was really started by Navigenics -- they realize the importance of all of us working together in this new nascent industry, that we need to develop standards. So that is something that we’re working on. We’re really excited to have the PMC take the charge on this because they’re a neutral body and they can bring in some of the other stakeholders in this space who really want to have a voice in how we set up these standards. But we do realize that that is a problem right now, and that’s why we need to work together, because we do have to make certain assumptions. Do we look at lifetime risk, do we look at risk over ten years?

Those are assumptions that we can all come together as a community and decide what is the best way to do this, and then we will conduct it that way. So I just wanted to make that point.

DR. TUCKSON: Well, I think that should be applauded. And I would just say, ya’ll better really start moving fast. [LAUGHTER]

Because it’s so necessary. And that’s responsible behavior, but ya’ll got a whole big gap to hurry up and close or else somebody else is going to try to close it for you. Last comment.

MS. JOHANSEN: Katie (phonetic) Johansen from the American Medical Association. Two quick questions -- one for Jeffrey. I’m curious about what the reaction of your primary care physician was when you brought in your deCODE results, and whether you think that that is -- was a general reaction or whether that was specialized because you obviously were an employee of deCODE. And then the next question is for Ryan, and maybe it’s more of a comment, but I question the appropriateness of having on your DNA prospective sheet, the last question about personal utility because I think by including that question about, you know, would this information be helpful to you, with a test that has very low predictive value and low clinical validity, I think that question implies that that test is going to give you the answer to that question when really the low predictive value and the low clinical validity just don’t add up for that test.

DR. TUCKSON: Those are good. First and then second. Good.

DR. GULCHER: Yeah. So you would say I was stacking the deck on my primary care physician, I guess. Although the -- when it comes to -- and he was very of course intrigued by the reports that I brought him. But the urologist, I think, is the more interesting -- how his behavior changed -- that normally, somebody with a PSA of 2.5 in my age range, he would not have acted on, and he was more interested in the genetic profiling as being the determinative of whether or not he would biopsy or not.

But I should mention, there was a preventive cardiologist that had a patient brought in a PSA of 3, who was 55- years-old and dint have any other risk factors, and he had ordered deCODEme for the patient in the context of cardiovascular profiling, and then the patient had higher risk for prostate cancer. And he was just biopsied last week and had even more cancer in his prostate than I had.

But when it comes to, you know, this type of information, how do we educate physicians, or inform them at least of this, we try to encapsulate what the information is. We try to document the clinical validity, okay, with all of the different articles. And we’re not talking about the 35,000 different genetic association articles that Muin was talking about. We’re talking about, this is a different era, which I think Dr. Topol addressed. We’re now talking about markers that do indeed replicate; we’re not talking about the articles that end up somehow on molecular psychiatry that don’t necessarily replicate, right? We’re talking about articles that get published in peer-reviewed journals like New England Journal and Nature Genetics where the standard now is much higher, admittedly, than even two or three years ago --

DR. TUCKSON: Jeff, one just -- just -- would your -- based on your guesstimate on your conversation with your urologist, what would he or she have said if the biopsy had a 1 percent of --

DR. GULCHER: Right. Or was low-grade?

DR. TUCKSON: Would you think that he or she would have changed her advice to you?

DR. GULCHER: Oh, absolutely. If it were a low- grade tumor or there was no tumor, then, of course he wouldn’t have recommended a prostatectomy. Because it was intermediate-grade and had, you know, 15 percent in my prostate --


DR. GULCHER: -- that by itself, you know, indicates --

DR. TUCKSON: Okay. Last half, and then we’re closing off.

MS. PHELAN: I’m going to partly answer his question about what do physicians do with this information. We do outcome studies -- not a study, but outcome research on our customers. What do they do with medical information that they get from DNA Direct? The vast majority share it with their physician, no surprise with the Yankelovich document. And when asked, did the physician find it of help? Very high -- 80 percent satisfaction. And did they use it to make a better health care choice? Very high numbers. So these are people who take that information to their doctor and use it for health care decision-making. And yes, the personal utility is a little confusing up in that one, but again, it was a placeholder so we’ll work on that one.

DR. TUCKSON: Thank you. And would you give our good panel a round of applause? [APPLAUSE]

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