Event ID: 1364429
Event Started: 6/11/2009 8:15:57 AM ET

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Good morning, everyone.Good morning. Thanks, everyone, for joining us. And welcome to the 19th meeting of Secretary's Advisory Committee on Genetics, Health, and Society. I will go through some of the universal formalities. The public was made aware of this meeting through notices in the Federal Register and notices on our website and the LISTSERV. We welcome all of the members in attendance. There are members of the public listening on our website, we welcome you as well. Before we begin I want to extend a welcome to Charmaine Royal, welcome. Charmaine is our new SACGHS member. Her scholarship has the goal of enhancing research with behavioral and humanities research. Welcome, Charmaine.

We also have new ex officio members from the Department of Defense. The colonel, who is from trip ler medical center. In 2008 you returned from a 16-month deployment as medical director at camp liberty in Baghdad, we welcome you home and thanks for your service and welcome to the committee.

I also wanted to make you aware of some additions to our staff. Brian and Alex have joined the staff for the summer.

There he is.

Good.

From the University of Wisconsin. Brian is doing a rotation with us for a few months and will help us to analyze some survey data. We'll hear more about that in a minute. Alex has an internship with us. He's in his senior year at UVA. He also will be working with the education and training committee and will be helping to develop the review of the literature. Welcome to you both.

We also have a second intern who is not here yet, Suzanne, she will be here next week.

Let me go over the agenda with you. We're moving ahead with a number of our priority topics. We'll begin by hearing about the work on the genetics education and training task force. After that we will hear about HHS's work in developing the health information infrastructure. We're particularly pleased that we'll have a federal official for that work. He'll talk about the development of the infrastructure, it will affect how we deliver healthcare, it will be very important to the future of how we deliver genetics care in the healthcare system.

We will follow-up for the bulk of the day with a discussion of genetics and the future of the healthcare system. This is a continuation from our last meeting. We will explore how genetics may shape the future of the healthcare system and how system changes may also shape the development of genetic technologies. As with all of our priority topics, we will look at some of the important issues in health disparates disparates. For today's session we'll hear from payers, patients, advocates, providers and an expert from the federal industry. Should be a rich and interesting discussion. After we have a chance to talk with our guests we'll have a chance to discuss where we want to go and see where we can add some value to this discussion. The last item for today will be a quick update from the gene patents and licensing task force.

Tomorrow we have a full agenda, as well. We'll hear from the direct to consumer genetics testing task force. They began their work at the last meeting and has labored to provide a draft report, it's in your binders, we'll look to see if we can't move that forward tomorrow and come to consensus on some next steps. Following that we'll have an informational session on another priority topic. They will discuss the evolving landscape of comparative research. And the afternoon we will hear about federal activities relating to genetics, including presentations from CMS and other updates on family history project and genomics and health information technology. A couple of other items, on Tuesday and Wednesday of this week Andrea represented us at a workshop. This must have been a week of genomics meetings, thank you for doing that. At that meeting they discussed policy issues around personalized medicine for cancer therapy. You presented the findings on the oversight of genetic testing, thank you for that.

In May CMS proposed not to cover testing for warfarin dosing. They are proposing that patients who are enrolled in certain types of trials will be covered. I think many of you were part of the discussions when we talked about coverage with evidence development within our oversight group, this is one of the ways we hope to get some of that information. CDC is publishing in the MMDW good laboratory practices, it should be available on the web today. Getting my notes here. The recommendations serve as guidelines for improving areas of lab practice and the procedures for patient confidentiality. You should have it in front of you. All of that will be available publicly, as well.

Um, FDA's office of invitro [ Indiscernible ] is addressing issues in pre and post areas. They're looking at regulatory issues.

Before we get into the main part of the agenda I think it's apparent to everyone here we have an incredibly diverse committee. That's a great strength of our committee. Our mandate is broad. We have experts from a wide variety of disciplines. Because the issues we address are multifaceted our discussions are enriched by all of those different disciplines, ideas and perspectives that all of us bring to the table, even though we may not be expert in the specific topic under discussion. We appreciate you asking the hard questions and helping us to move forward to address the important issues. Sarah, this is your moment -- to talk to us about ethics rules.

To remind you, because you all know them very, very well, I know. I will highlight two of the rules that govern special govern employees that are serving on the committee. Before every meeting you provide us with information about your conflicts of interests that could compromise your objectivity. We also rely to a great degree on you to be attendive during your meetings to the possibility that an issue could arise that could affect your interest in a specific way. We've provided each of you a list of your interests as a reminder. These two pose a conflict for you if they became a focal point. We would ask you to leave the room. Lobbying is also printed prohibited here by government employees. Just keep in mind wevy the Secretary's Advisory Committee on Genetics, Health, and Society, not the Congress. We appreciate how conscientious you are about the rules.

Great. Let's get on with the meat. The first agenda item is a report from the genetics education and training task force. Barbara Burns McGrath has been busy leading this group and will now update the group on where they are. She will be joined by several other colleagues, Vince, David, Dale, and Kate. Greg, I understand you are back to private practice in Maine and stepping down as chair of the work group. We want to thank you for the information and energy that you brought to the committee over the past few years.

I would point out that I'm not quite dead.

[ Overlapping Speakers ]

July 6, we have a few more weeks to tap you.

You're not fooling anyone, you know. [ Laughter ]

Thanks, Greg, for all of your contributions. We wish you well up there in Maine. Let me also thank Dr. Dale that has stepped in here and agreed to take up the cause. Barbara?

Thank you. Great. Our level of activity has been increasing, you will see more of us over the next couple of meetings. Today is one of the more brief ones, I think. We have a couple of goals, I will give a report about where we are in the progress. And the bulk of the time is on the data gathering activities. Each of the leads will talk about their specific activities. Then we've saved about 20 minutes to discuss work group policy directions. Let me explain. We have not completed all of our data gathering activities, you will hear where we are in that process. Clearly we're not at a point to have any final policy directions, but we have thoughts on them, we will present them to you today. What we're asking is for you to give us feedback and guidance on a conceptual level as we draft the guidelines. However, we're not looking to fine-tune our recommendations at this point. There's chance for that in the future. I'm asking for you to think in the big picture area. We're past the point of bringing in all ideas, we're in the middle point of looking for information from you.

Here is our roster. Each group will describe who is on their committee. As you can see it's pretty good. We're in good competition with the oversight committee, I think we've got a pretty robust group. The other people I would like to add --

[ Speaker/Audio Faint or Unclear ]

It takes a village. The other people that need to be added on this are the staff, Kathy, Brian, and Alex. As you know we've organized ourselves around core concepts, healthcare provider group, and the public health provider group group. Today Kate Reid will represent their report. A quick backup, at the last meeting we went through how we came to be formed as a committee. Each work group gave a bit of an overview of their activities. What our plan -- as we've been developing our plan for how to proceed we've been guided by a couple of things. I wanted to point them out to you. When possible we've been looking for comparative data. We've tried to final data sets we can replicate. Another big goal is we would like to shed light on the needs of underserved populations. We've tried to hone in on that. And finally, we would like our recommendations to end up ones that are measurement. So the task force has an easier time looking at this than us. As you are listening to the reports from the three groups, perhaps if you could think of those things and give us advice to achieve our goals.

Today's meeting we will talk about these policy directions, concept ule recommendations, looking for feedback if you have any specific questions about methodology or questioning. Our data collection is not complete, we're nearly finished. The data analysis has been ongoing. We expect to complete it by the end of summer. At that point the final draft should be finalized. We're fairly along the way with that. September 15 you all will receive a draft report of the task force. We'd like you to read it in preparation for the October 8-9 meeting. We will look at the report and recommendations and we'll ask for approval from you. Around November it will be released for public comment. We anticipate getting all of the comments back and integrated in the spring. In June it gets transmitted to the Secretary, that's our timeline. I think we're pretty much on it. We've got great people pushing us forward.

The next things -- each task group will talk about what they've been doing and present data. Each group has data to present. We'll ask -- we'll have a discussion at the end. You may have questions about methodology or ideas of different groups you think should be surveyed, I ask you to hold that until the end. Some of your questions may be answered by others. Okay. The first person is Vince talking about consumer and patients, thanks.

Good morning. What I would like to do is start by thanking the work group, they've been working hard over the last few months. Many of the members are here today. I encourage you to talk to them individually with regards to any suggestions, guidance, directions, concerns you may have with regards to helping to identify recommendations for the committee with regards to the needs of consumers and patients. Again, I want to appreciate their work and their commitment to provide the best advice to the committee.

I want to take a second and think about question of the public. And patients and consumers. And when you think about this country and the diversity of the country and the types of people that may seek genetic information. We've made a decision that our focus is on the issue of those individuals that are seeking information. When you think about consumers seeking information and patients that are seeking information through providers, through various websites. We're not thinking about the general public that may not be thinking about their needs with regards to genetics, but those that are seeking out information. I think that's an important -- as we think about the context of the work that the work group has been doing. The specific charge is to provide recommendations that address the genetics, education needs of consumers and patients. This is foe kissed on those seeking out information.

What I want to do is talk really about the design of our collection of data process. I'm the only work group that doesn't have data to present today. We want to focus with you on our design to collect information to help us analyze and make the recommendations that we'll ultimately make. We're focused our work on a variety of things. First, report on federal agencies activities. We will be collecting information across the different agencies. What other activities are going on? So we have a sense of the activities. There's a lot going on at this point in time. To provide recommendations for health-related information for the public. The how, what, when and where. And to review best approaches to consumer and patient level genetics education. We'll come back to that. And to provide an appendix of consumer and patient education resources so this can be of assistance to the agency and to the Secretary.

Our specific data gathering methods, I would like to focus in the four areas. The first is an environmental scan. We've conducted some qualitative work here. We've done 11 interviews with experts in these areas. Each of these were telephone interviews, but they were transcribed. There were one or two individuals being interviewed. We found advantage to have two individuals from the same expertise area on the phone answering the questions. They were able to bounce off of each other and add and make the data rich. The majority of the interviews were done with two individuals at a time.

I want to identify the individuals that we had an opportunity to talk to. They all provided a great wealth of information. You see they're coming from different backgrounds. We had individuals around health and genetics education. They provided us information with their own research and others. Those that are experts in genetics and science education, we foes cussed on having a better understanding in that area. And clinicians, individuals caring for patients at different levels around their experiences and the guidance they provide. We also had national advocates from several organizations that are not typically involved in the genetics organizations, committees or the traditional group that we reach out, clearly they were of importance. These were recommended by the advisory committee and so we had the opportunity to provide -- an opportunity to hear their voices and perspectives. We did reach out to the industry to try to get a perspective from those individuals who are reaching out directly and working with consumers and are seeking to provide them services and provide them information on what their perspectives with regards to the needs of the public, particularly consumers of genetic testing. Finally, we focused on the perspectives from a policy perspective and the things that are being learned here. Dr. Hudson had an opportunity to share her perspective related to the needs of the public and of patients.

The second area is an area where we have collected quantitative data. This process is going on. Some of you may have received this through various ways. The work group developed this with inbut the from other -- input from others. It was sent out to the genetic alliance to their 1000 affiliates and 71 organizations which are healthcare advocacy organizations that are not focused on genetics, but dealing with disease areas or broader health concerns or issues. I want to highlight one of the things because of the importance of thinking of the questions of unserved populations. We oversampled for minority and underserved communities, we sought to make sure that the voices of those organizations are part of what we're learning with regards to the needs of education for patients and consumers.

We really used this process to get additional information from the experts. At this point in time, as of June 9, we have 301 responses. And 29 partial. We will be able to use their data. We have 330 responses to the survey that we will analyze. The second area of data collection we will use is with regards to a national survey that was done by a marketing survey company, they provided us the permission to use their 2008 report where they did a national random sample of a thousand individuals across the country. We will have a national view, we have national data around issues of genetics and the perceptions of the public. Clearly many of their questions they have are very important and relevant to the work. We have access to that data, that will be incorporated into our analysis and recommendations.

The third area is some work that is also going on at the NIH. This is related to that work, NIH has commissioned the academy of education development, AED, to prepare a literature review report with regards to the scientific literature and what is in the public, newspapers, magazines. It will provide us great detail of information about what studies have been done, the perceptions, commentaries, various view points. We've the opportunity to use the literature to help inform the work of our work group. This work has been completed by AED, we will be now using that as one of our strategies of coming up with our recommendations. The work that we've done has been to try to reach in various different ways to collect information. Actually collecting new information through the qualitative interviews and the empirical survey method we've used, but also to gather information from other groups that has been done. These various strategies to collect information so that we can really move forward to provide you with the best information. Thank you.

Next steps in policy direction. Let me share with you, again, we're early with recommendations. These are just directions to give you a sense to themes that we're seeing across the data. One area is providing patients and consumers with tools to identify knowledge. This is a question of seeking out creditable experts when they are trying to make decisions. To develop models to enhance literature for the public. Can we develop different models? To enhance k-12 education. The issue of probabilities and risk. How do we provide that information? How do we educate the public in understanding risk? It's a common theme in our qualitative interviews that we had. And the issue of understanding the role of genetics and environment, so that people do not perceive that genetics plays more of a role.

Next steps is to complete data analysis, to identify gaps and barriers. Thank you.

Thanks, that was beautifully done. With the healthcare providers work group you may see a less elegant approach. I would also like to thank the health group provider work group members. They played an integral role.In reviewing the data, um, for presentation today. You can see up there there are a diverse number of groups represented, and types of healthcare providers.And today I'll present only a portion of the information gathering process that our group is undergoing. There's a literature review that is ongoing. Judith is working on workforce issues for the report, which is separate. Briefly, the goals of our work group. As you will see in a minute we're duplicating a federal survey from 2004 to inform this group. We want to compare and contrast the results and gain insight. With the activities that I will talk about today, we want to get a snapshot in time of what the health professional groups are thinking. There's a slide bias to physician primary care. That's one of the areas where the need is the greatest given the volume of care that is delivered in the United States through that particular set of provider types. And then I think from queerying the groups we want a sense of their future plans to help to enable their goals. The federal survey -- won't spend a lot of time. I put a lot of information into the slide. I think you've already heard this. Duplicated a survey from 2004 essentially. We attempt today make it less own Russ than the last one. We cut out some of the materials that made things more challenging.

We distributed it in early 2009 and sent out emails. We had about 85% response rate. However, only 45% completed survey rate. A number of these agencies responded back saying that they really didn't have much to report. We had six agencies in common between 2004 and 2009. We should be able to do some comparisons back and forth. Three agencies had no reply in 2009 despite reminders.

About 295 pages of PDF documents. We're looking it over from a qualitative stand point. Brian is working on a database to compile this information to make it more accessible. I think at the end a meaningful analysis is probably unlikely. We'll get to a couple of comments that point this out. The first comment -- the CEC is not able to fully develop this area due to a lack of resources, et cetera, et cetera. NIH, the response was interesting. The individual institutes responded separately. The challenge with the NIH response is extracting core health education activities from others. There was a large award for the national center for [ Indiscernible ], to train information tigses to use health-related information. Does that really represent the kind of education that we're talking about?It's a qualitative decision as to whether that counts or doesn't count.

Possible policy directions -- I think it's one where we can start a discussion from. The Secretary should establish, empower and fund this area. It's interesting to note there's such a diversity of perceptions of what the activities are across the various agencies. I think that is an interesting challenge moving forward when trying to decide is there coordinated movement in one direction. A little about the health profession survey, we elected to target a diverse group of organizations. We had a bent towards primary care. We surveyed the AMA, American college of physicians, et cetera. We accident go to the specialty oriented organizations. That gives you an idea. We created the survey within the committee, piloted it with the board [ Indiscernible ], the survey was looked at in the fall of 2008 for reasonableness. In early 2009 the survey was distributed. Email and phone call follow-up occurred. It targeted eight organizations, eight education organizations, and 28 overall organizations that provide advocacy for health professionals. The response rate was 58%.I think there's interesting information right there in terms of the level of interest in the survey among the different types of groups. 329 pages of PDFs from this group. There's a database being created of this information. I think we'll be able to do analysis that is meaningful in this area. I wanted to walk you through some of the questions. This first questions looks at overall what level of importance does the organization put on educational activities in general? What you can see, I will draw your attention over here. One is not much importance. Five is a lot of importance. All of the organizations organizations ranked that education is a high priority. If you move to what importance do you place on education related to genetics and genomic? You see a spread. The overall scores are still high, but the general professionals there's this tail to some folks responding one, and here people are responding two or three.

The next question, I cut out some of the raw data here, what overall priority does genetics have to other priorities facing your organization? For the general professional organizations it's on the horizon, it's there, but it's not a high priority. Whereas the genetics folks felt it was high priority. This starts to point out would we can do to change this. Would you can see here is the median scores the general professional organizations and the professional education organizations gave low scores about how proficient their they thought their leadership was in topic area. That might point out a direction of targeting leadership to get them thinking about the topic area.

Likewise, this question is telling. To what extent is your membership satisfied with the emphasis on education? Among the professional organizations they say they're mediocrely satisfied. We could ramp up the activities there. What are the barriers? I thought this was interesting. I expected the education organizations to really harp on this issue, this one comes up a lot. Neither ranked this that high. This popped up here. Competing priorities is clearly the task at hand, how to get this up in the queue for things that need to be done. Possible work group direction for this. The Secretary should facilitate to develop and implement a coordinated strategy for education in the United States. I think that would be a fairly reasonable starting poijt for discussion. -- starting point for a discussion.

The last point is a meeting that just happened this week, it folded nicely into this evidence gathering process. We brought together a group of leaders from primary care organizations, organizations. The goal of bringing them together was to engage them in a discussion for the neck five years, to draw out what they should happen in the next five years. I think overall the meeting went well. No one stormed out of the room. They all got along nicely. I don't really believe this type of meeting with diversity of physician groups has happened before.So, again, very preliminary. The meeting captured by a transcriptionist. I put down some of the general things that came out. It was pretty plain they did not think that genetics and genomics education would fly as a separated aon to the educational process. It needs to be integrated throughout existing infrastructure.They felt there was a great need for better coordination between the physician groups. We had some folks from the nursing activities present and PA community, I think there was a recognition that the similarities of lack of knowledge might overcome the differences between the groups in some respects. There was broad consensus that family history should be a major focal point for care and education. At this point in time a number of folks expressed a dismay that it was different to capture family history in their tools that they use day-to-day. There was a general agreement that the pipeline for genetic specialists needs to be expanded. Right now many of them expressed concern in some areas of the United States there's not well trained genetics professionals readily available. They thought the transitions in care were important to genomic medicine. A team-based approach really would help to alleviate that. But it would require a coordinated activity between the different members of the medical home to make it happen, again. There was a clear discussion around the clinical utility issue and how important that is to getting folks to adopt genetics and genomics education. It was indicated that everyone felt that the [ Indiscernible ] and [ Indiscernible ] processes are key points of influence that could be approached in the near term. There was a consensus they would like to get back together again to review progress and do planning for future activities. So, I think that's the end of my presentation.

Last but not least -- thank you. All right. I'm going to present where we are with the public healthcare work group. We lie somewhere in between the other two. I have some preliminary information to present. One of the things we will ask is ideas of other groups that we can -- we may be able to include in the survey to collect the real data that we need here. First, this group has come together quite well and is representative of different areas. Joseph has really been a great force to keep us moving. I think we have a very -- I'll talk about this in more detail -- one of the major challenges with this group is to define our population. If you look at the IOM reports, anyone interested in health at the population level. That's a very broad audience that we're trying to capture and get information from. That has been a challenge. Joseph has been really great in helping focus our efforts here. I will say that I came into this sort of midway through, any mistakes that I make in this presentation are mine alone.

So, would we have done at this point is there has been an online survey developed. The group focused on competencies. They're applied skills and knowledge. These have been developed by a number of groups. We were looking at six overall, five overall, to see what is already developed and try and use iterative process to find out what is common. This core set of competencies that different groups have said this is what public health professionals need, opposed to coming with our list. The purpose is to -- as it is with health professionals -- is really to structure education programs and define what public health professionals should be doing in terms of knowledge and skills.

The other thing that I want to comment about, we have had significant discussions about this genetics versus genomics. For most of the 12 we used this combined term. The reason is we didn't want the terminology to be a barrier for people to be able to answer the questions appropriately. There are some that deal specifically with genetic health services that we only use the term "genetics." I also want to mention there have been other efforts to survey the public health professionals using -- to determine what activities are ongoing, how important genetics is in public health, how it's been integrated, the challenges. The latest ones I could find were really completed in 2001-2002. They've been done with numerous groups. One of the inputs will be what is the appropriate group for us to be surveying here and have we captured them? The groups we've already sent out our survey to are the state genetics coordinators. They're responsible for whatever the state defines as genomic activities. A survey went out, Sylvia was in charge of that survey in 2002, looking at who is doing what, to what level? We do have some data on that. The APH state affiliates, they are responsible for participating, implementing and advocating on behalf of public health issues related to the priorities of APHA. We also sampled 366 members of the genomics forum. This is a recently-formed group. It's a group of individuals who are generally involved in public health, they're not necessarily APHA members. They're interested in genomics, and that's what we know about them. Those are the main groups that we have preliminary data from. On June 9 the association of state and territorial health offices were contacted. We gave them examples of state genetics coordinators, we want to get a broad audience. We have received 133 full responses. This comes up to a response rate of about 26%. Looking at past surveys it's within the range.

Our survey has three main pars. One, your role. Second, the importance of public health within your setting. And the competencies. We will talk through the preliminary results for each of these. One of the first things to get -- is what level of public health you work in. Things to note is that 31% of the sample is academic. 49% is federal or state. This is something that will be important to keep in mind as we analyze further. Those two groups are going to have different priorities, resources that we need to take into account along the way.

This doesn't include the recent mailings, again. What is your job title? What this is it's the larger the font the more responses were given with the words involved. This is a quick visual to show the diversity of individuals involved in public health and answering this survey. Also it's important to keep in mind that the groups we've surveyed so far are more likely to be involved in genetics.This will likely change. The idea and scope will likely change as we continue to broaden the population that we're sampling.

The part two was to look at the importance of genetics and genomics genomics. Looking at the responder's job responsibilities, 75% think that it's important to their job or responsibilities. This also will be very important to look at based on would role they have within public health. Not only if they're working at the state or federal level, but also if they're working in a.m. democratics or other settings. A 2001 survey looked at a similar question, but sent it to six groups in public health. They sent slightly different surveys to maternal and child health individuals, lab directors, health officers and chronic disease. They found in terms of job responsibilities is there's different senses of how important genetics is to each of those depending on responsibility. Maternal and child health would see it as a higher level of importance, that's where newborn screening lies. As we move forward with this analysis it will be interesting to be able to -- we won't be able to directly compare the data. It will be interesting to see generally given job title whether this falls out in a similar distribution of importance.

We also asked how adequate are your resources? As you can see there's 74% responded that the results are at some level of adequacy. Earlier data said one of the major concerns is the lack of funding. The fact that people are perceiving that resources are available is a positive thing, maybe awareness is growing. We need to note this and then we may need to figure out exactly if this still falls out to be true. The third part is to look at the competencies specifically and ask how important each is, how confident are you in demonstrating this, and how frequently do demonstrate? The point of this is to do a couple of things, one, to get a sense of are the competencies things we should ask about? And where do they fall?

Given that very preliminary data would we have tried to do is come up with some very general ideas about the policy direction. Again, these are -- these are based on what we know from the literature. It's not hard to fallout that likely the policy directions are in two areas. One, who is being trained now? And how do we improve the education in current trainees and how do we begin to educate the current workforce? A couple of things that I think will be important to keep in mind that I have already mentioned -- one, the diverse nature of this group. Doing general education programs for public health professionals may or may not be useful given the different uses at each of the roles in public health. Another aspect, looking really at -- we had a conversation about this, the idea of translation. How do we educate about the knowledge base but also the actual translation aspects of genetics research and how do we use that to almost bolster the need for education within this group? There are some current activities going on. Dr. Curry is working with people atNCI to look at what current activities are ongoing and how they map to the translational highway. To look at what activities are ongoing, that may be informative in creating policy directions, as well. Thank you.

Great, thank you. I think it's obvious this is a really many-headed beast. We could go all over the landscape and talk about education and training needs. The danger is we would cover everybody but it would be meaningless. The other direction is to narrow in and lose track of some of the important players in this, that's been a challenge since we started. I think the three presentations show where we decided to focus. You may have some suggestions about groups to pull back in. That would be good feedback to hear from you. I think we will put up some of the recommendations. We have about 15 minutes, or something like that, to open it up to discussions. Our next task is to sit and put pen to paper and start writing recommendations. We want any suggestions from anyone on any of the three task forces.

I'm going to represent my interest as a member of the group. The -- it seems we need to think about the idea of the movement towards point of care, just in time education in the EHR. I didn't necessarily identify individuals or groups within the survey that were asked about genetics relating to that. That may be because this is sort of a [ Indiscernible ] group, there's not a real go-to place. I want to make sure we don't lose that. I believe that many of us believe that will be critical in terms of the ongoing post graduate education for healthcare providers.

[ Speaker/Audio Faint or Unclear ]

It was not specifically in the surveys. It did come up in the physician meeting the past several days. It was thought to be most relevant to the practicing clinician and how do you reach them. It was a point that will come out in our summary from that.

I wondering if you -- large differentiatal set of needs. I wonder about timing of their needs. Some of the people that have less direct involvement and don't see a lot of immediate applications that are germane to them. In terms of our recommendations and how to roll these things out over a period of time. I wonder if people talked about when they think they will be ready for this, across these different constituents.

Steve --

[ Overlapping Speakers ]

From the data we've gathered. I think there's different timing. We made decisions of those that are already seeking. We have a level where timing is already recognized. I think there may be some things in the data that may be of value.

I think implicit in the issues that were reflected in the health professional survey around barriers and their priorities of genetics you see some of what you are getting at, right now it's not really on the horizon of the primary care groups. However, there's also the question about how [ Indiscernible ] you feel your leadership is with this area? It's hard to decide, given how rapiddedly this field is evolving. They understand it and it's not a priority, or they don't have enough knowledge base to fully appreciate it. What you saw in the two-day meeting was that a number of the folks that came there, the unwashed, same in and listened to some of what was said and realized pharmacogenomics there's a lot of labels out there that we need to think about.Maybe there is a bit more urgency in that area than they would think otherwise.

That was -- question. Is it okay to interrupt?

Go ahead.

Are there any areas of critical need that regardless of our process and the Secretary's process, but areas for which there is the potential or actuality of harm without some additional information that in some way we need to accelerate knowledge of that critical need?

I would say that coming out of the physician meeting PGX was an area. The direct to consumer movement, and concerns about how to deal with that. Cancer genetics and family history. Those were areas that they felt were vastly underused. There needed to be thought given to will we lose a bunch of our ability to provide information if we can't capture family history.

Got it. It doesn't sound like there's one physician group or task that is so egregious, but more broadly getting this information to folks.

I was going to comment. I was thinking about Consumer Reports, you are glad it's there, it's a relatively unbiased review of all of the most common things that you want. We need something like that, I think the public does, but not every day. That's a way of thinking about a target.

A representative from Consumer Reports presented here --

Two meetings ago.

I don't know. Maybe we need to reach out to them to find out where they're going. A question in our discussion with the industry was to get some sense of the kinds of information that they're providing that's more general education that's not targeted to marketing of their services. Many of the companies are thinking about general information that needs to be provided to the public.

And just from looking at the public health competencies and all of the data, one area that is a thorny one is how to move towards looking at complex diseases and the role of the environment. It's a difficult concept to grapple with. One of the areas in public health that show up, those folks could be the ones to help us to move forward to a greater communication of the role of environment. I would put that on the high list.

I wanted to speak as one of the previously unwashed. I have two responses. One, I don't think this committee it's wise for us to get too deeply involved in the tension between the specialists and the primary care docs. It's clear here that most of the genetic information we want to see is probably best embedded in specialty care and that most of the hard information, the best evidence, is probably if specialty care. It would seem to me that we document want to lose sight of that. The other thing is that education -- we want to see improvements in education. There's evidence in all groups we could do better. On the other hand, we don't want to get ahead of ourselves at some level. I guess that tension about what the down side of being too aggressive about education efforts and overemphasizing some areas and underemphasizing others -- I was struck by that.

In terms of recommendations to the Secretary I was interested to know -- that were thinking about labeling, is the labeling being provided by FDA useful to them? Is it something they find that is helpful for them to understand what they need to do with the product and how it should be incorporated into their practice?

I would say I don't have the depth of enough discussions to really comment on that. People are concerned about it. They feel like the information is there but they don't really have a good handle on the next steps. And what the implications are for following or not following. There's been label information about farm pharmacogenomics. There's been confusion as to what it means. Am I at liability if I don't do something, et cetera?

Exactly. I think that would be useful for the Secretary.

I wanted to amplify on what Paul said. We have to be careful that we don't inappropriately push genetics education. As somebody who does some general degree of medicine, these competing interests are valid. And oftentimes they should outcompete genetics education. The way to deal with that is by -- by getting to prioritization, to really prioritize our education efforts. And those priorities should be contingent on evidence of how it affects health outcomes. And where those are not present and lacking we should not try to argue too strongly for education. I would, however, I was agreeing with Paul, I'm not sure if we should just assume that the place to focus is the specialists. When I think about where the most bang for the buck is I think Greg's focus on family history is most appropriately in who people see for the most part. Which is at first generalists. We don't want to neglect them. They funnel people into areas where genetic knowledge is necessary.

Yeah. I would just like to follow-up on what Jim said there. I think the other point that I would make is I agree we need to focus on things that we have evidence.It's a thorny problem. The solutions are not obvious. It's also clear that attitudes about whether or not this is really critically important in day-to-day practice are developed in that venue. If we don't step up to the plate to see get this a mentoring to take place within that post-medical school but pregraduate setting, I think we're going to have a much greater problem down the road.

I guess just -- to followon and build on the comments before, also to take my consumer and educator hat. One of the most important things to do is figure out how to put it into context. Genetics -- how it relates to the environment and all of the other decision making. That's one of the things that is missing with consumers. You look at the testing and what is going on in the education. You don't know how that relates to other things. I think of it from the consumer view point. I also think there's a provider view point about how -- where this relates and where it doesn't relate. And where the genetic information has value because you can make decisions based on it, and where it has no evidence and no value.

One of the other issues related to this mentorship approach to education is con fluent to that and the fact that this field changes so rapidly. How do you balance evidence base, which takes years and years, and the fact that there are things coming out that have amazing face value, it's hard to say that you shouldn't think about them. I think that's something in the report that really needs to be --

Yeah. I completely agree. It's not an easy matter to prioritize. Some of the things are pretty obvious. I think other things may rise to the level where we want to emphasize education based on a looming impact. I think, for example, of multiplex arena. Those will take judgment around the table. I want to get my bid in for taking a nuanced approach. So are not just perceived as evangelists, right.

[ Overlapping Speakers ]

The very --

[ Overlapping Speakers ]

-- related to.

[ Overlapping Speakers ]

Have we had --

[ Overlapping Speakers ]

I think that's going to be critical to get engagement with that group. As I envision how pharmacogenomics will evolve that will fall within their bailiwick.

Actually, I could easily with your approval, reach out more to that community. I was in a meeting about two months ago where pharmacists were talking about this. They're chomping at the bit to become more involved. Metabolism of drugs is our business, they want to get involved in this. We could bring that into the report with good information.

One thing that I think we can do in response to the tone here, I think the report will give the landscape of where -- if this is a committee about the needs of society, of where society gets genetics information. We all know the statistics that a lot of people would like information from their physicians at point of care. A lot of steps happen before they make that first step. We need to talk about the molt it will steps in the community -- about the multiple steps in the community.

Have you talked to the Med Co people? We were at a conference a couple of months ago in Baltimore. They've implemented pharmacogenomic testing for their prescription -- prescribing practice. They're the largest provider of those pharmaceutical services to the insurance companies. I wondered if you had talked to them.

Russell Teagarden is the guy that runs it.

He presented at a meeting hosted here in DC. They were there. They are playing a huge role in this process. In the past week a study that they're doing on Tamoxifen closed. We should get interesting results from them around their work. They're clearly in the mix. [ Interference ]

What is impressive is not only your work, but the stunning gaps that exist in all arenas. I wonder if the task force has stepped back to look [ Speaker/Audio Faint or Unclear ] and whether there's a way of leap frogging. The leap frogging could be in personal health records. Given the tempo, the rapid advances we expect in the years ahead, whether we could use this information to give us a new model, a new paradigm for how consumers and doctors can be guided to new evidence and best optimal care. Because what you have shared is wonderful, but it's very, very traditional. I wonder if there's a breakthrough way of thinking. We have so many new tools available to consumers, and also that we know that health professionals need life-long learning. This is an area that be accelerated.

It's a great charge, thank you. [ Laughter ]

I mean, one suggestion is really the concept of all of us having PHRs. They would contain a tremendous amount of demographic information, preventive services and needs. Also we could embed decision support for the physician, be it specialist or primary care or other health professional. As we gained new information, whether it be pharmacogenomic information, that could be fed into that process. I just look today -- if we look at preventive services or common chronic illness, if we miss the mark half of the time just think of the gaps that we have -- think where we will be in the genetic arena.

That really gets to something that Mark has brought up time and time again about just-in-time education. It fits with the rest of our session today about healthcare reform. It's all part and parcel.

[ Captioner Transition ]

The second point I think is that it may be useful to separate general and permission from actionable information. And if you don't do that these are hard to [ Indiscernible ] apart.

I was wondering if you have also reached to the laboratory community.

Here lies the issue of expanding the net. Because the pharmacists are involved in the lavatory and are involved and you have this wider and wider net and we grapple with this and the work group. And where is going to be the most likely paying for our buck. And to some extent there are a lot of applications, and guidelines. There is already a fair amount of effort directed towards them. We're as primary care folks there may not be and there is also a feeling that the laboratory community is probably better off at least right now than primary-care. And as an is to bring in the pharmacist, it is true but you probably should not be talking to him and whole why do we pass this next?

And talking about the pharmacies and the laboratory and and we have been educated and continuously educated. I cannot tell you how many times they call me to see what these mean. So that might be the electronic medical record but also the laboratories have a very active role in educating genetic information. And we have certain communities that are really on board but we have to have the whole laboratory and community. So that is a critical component that could played a very big role in the education of the health-care providers.

What I'm hearing is that there's a lot of overlap between these groups. And in utility thinking about educational efforts. Because the health providers are also consumers so is it the general education that everybody needs something that can be -- can it be less to the consumer group and we think that will get health providers of to a certain level. And then we need to have gone that extra level versus laboratorians who are a combination of health providers and public health. Is there any way of thinking of it and a step wise fashion, if that is not what we are doing?

We'll thanks to you and all of you on the panel for all of the work that you have done and are going to do. I know that directionally you have indicated where you are headed. And next time we will be looking at things in a lot more specific level and the kind of things that are likely to be actionable that we can measure and monitored going forward. So we look board to that discussion and appreciate everybody's comments and input. So at our next meeting we will have this report which Barbara said he will have seen in advance. And we will march through it systematically looking at each of these recommendations and getting everybody's input. Thank you very much.

So we will move to the period for public comment period and that is one of the important things that we do. We provide a forum for deliberations and to hear the concerns of individuals and organizations. And we really value that opportunity. And we set aside time each day to allow us to do that. And we ask our presenters to keep within a five minute time limit. And we have one of those individuals here today. And that is Janet with the partner in held futures and she is here representing the Association for molecular oncology. Please come on up and we have a copy of your statement here in your notebooks so you should have that in front of you in your table folders. So Janet, we look for to what you have to say -- look forward to what you have to say.

Sorry about that. Good morning, I am Jennifer Lee and here I am giving comments on the Association for molecular pathology which I will call AMP and we had a comment for the effectiveness research. And in those comments AMP identified a number of issues that I would like to share with you today. We first encouraged the development of a comprehensive and the structure for laboratory tests and created a panel of expert stakeholders' with little clear diagnostic expertise and a transparent and widely available electronic clearing house for information on CER projects and standards for the collection and storage of data for and interoperability and that they be generated from CLEA, CAP, ISO or certified institutions. And we also discussed the translation of genome it research and as more information becomes available there is a reasonable exportation that it will be incorporated into routine practice. And AMP for does that funding for large trials be coupled with finding that complement randomized controlled trials by including those patients who do not necessarily need [ Indiscernible ] criteria for perspective trials. And the third is the effectiveness of genomics test and the lab which they are performed and to benefit from innovative molecular tests and all laboratories and the high performance standards. To that extent review recommend funding for programs to develop reference materials and efficiency testing methods as alternatives to the circuit test specimen and the development of a profit and plans for new technologies such as whole genome sequencing. On a related issue of reimbursement in February AMP made public comments to the CMS meeting as they considered expansion of Medicare coverage. And AMP maintained that the coverage required for most tests should not differ from the requirements for other diagnostic tests. And AMP also spoke about the critical linkage of genetic testing in the evolving field of personalized medicine and commented that CLIA and other programs health with the validity of molecular tests. And finally today I wanted to mention that AMP has submitted to your advise the committee the comment on the draft report on gene patent and licensing practices. As many of you are where AMP is a lead plaintiff in the lawsuit brought by the American Civil Liberties Union challenging the validity of the DRC1 and 2 patents. And and visible from exclusive and restrictive licensing practices such the genes assisted with SMA. All of our complete comments and materials submitted to your committee as well as the coordinating council can be found on the AMP Web site. Thank you very much.

Thank you, my apologies for getting your name wrong.

And we always benefit from your input and you have covered a lot of topics from let me open up briefly to the committee to see if anybody has any comments or questions for Jennifer.

And hopefully you can be here tomorrow we will be talking extensively about the issue of comparative effectiveness and that is a high priority going forward.

I look for to that.

Thank you very much.

Thank you.

We come to the break. So why don't we plan to be back at 10:30 a.m. and we will have the -- and we will have David Blumenthal here to share his thoughts on health information infrastructure.

HHS SACGHS on break until 10:30 a.m. EDT

All right everyone. If you could rejoin us, we will get going. Welcome back. We want to turn out to a topic that we have touched on many times and probably heard about some this morning about Health Information Technology . As many of you are where Dr. David Blumenthal was recently appointed to lead the HHS efforts to speed the efforts of the Health Information Technology and you will have that done by 2014, is that right?

Sooner.

Okay.

And as the new National Coordinator for Health Information Technology, David will be administering $20 billion in federal funding from the American recovery and reinvestment Act, ARRA, and Health Information Technology is only the latest thing what David has done. Prior to joining HHS he was director for the Institute of Health Policy at Massachusetts General Hospital where he designed some influential policy studies on our time green cheek from academic relationships, determining behavior access to health services and dissemination and many others. Earlier in his career he worked for the Senate subcommittee on health and scientific research and was national correspondent for The New England Journal. And he and I actually go way back. He and I were classmates in college. But I did not spend enough time [ laughter ]. End David's commitment is an early adopter and has been using HRs in his own primary-care practice. And we know how busy his schedule must be, overflowing, and we are delighted that you could be here. And we talked about the importance of Managing the information flow that will be flowing out of genomics and using that as a tool for clinical decision-making. So we are delighted to have you here and we may have some questions beyond health information infrastructure but let me turn it over to you.

Thank you. It's a pleasure to be here. I am grateful to have this opportunity to talk to you all about genetics and Health Information Technology . I want to start by saying that I am now entering or finishing my second week here. I think by some standards in this current administration this makes me a veteran [ laughter ] but there are still many empty offices in this building. And those of us here still await our colleagues. But I want to assure that I have a lot to learn from you all about how Health Information Technology can advance our understanding is of genetics influence on health and disease. And how a more advanced information infrastructure can promote human health through better understanding of genetics. What I would like to do briefly is tell you is a little bit about the work that we have ahead of us. Some of the main know this already and I apologize if I repeat things that you already know. But some of you may not be familiar with the mandate that the national of coordinator and Health and Human servers is held by ARRA in February. It is a very substantial undertaking. And if you play out its full implications, it could have a revolutionary effect on the delivery of health services and our health system. And I think of that in my optimistic face. There are also risks that we are paying a lot of attention to it and trying to manage. Briefly as Steve mentioned there is a $20 billion price take often associated with this high tech legislation and actually it wanders depending on who is doing the calculation. Because that is an estimate. It incorporates assumptions both about how many physicians and hospitals and other providers of care will adopt electronic health records and at what pace they will do it and how well they will use it. And how well we will measure the use it and the way we hope they will. And the estimates for spending actually varies and it also incorporates, by the way, some Congressional Budget Office assumptions about saving resulting from that answer level of adoption and use. But probably the actual numbers Perry from maybe 30 billion to $45 billion. And having said that the office of the national coordinator is a responsible for spending about $2 billion in discretionary funds that are intending to health providers of care adopt a meaningful use electronic health record. And the expenditures for incentive payments which account for the other money, the rest of the money, a big bulk of the money will be paid by for the center of Medicare and Medicaid services. And will be the subject of the rulemaking process. And they will be administered and the setting who receives incentives and what amount those incentives will be. So we're focusing on policy the element and we are focusing on providing technical support. And both of those are substantial and theory interesting challenges. The policy development involves helping to understand what it is we would like physicians and hospitals and other providers actually to do with their electronic health records. Once they have required them, set them up and have them operated and that is the concept of meaningful use which is an inspired concept. One which will be the object of a great deal of discussion over the next several months as we began to think about what meaningful use should be at each of the faces and the deployment of the electronic health record overtime. We have to have some preliminary definitions in time for the 2011 time frame when the payments become available under Medicare and Medicaid and the intended meaningful use to be a definition that evolves over time. And I think about it as if trying to get on an escalator and moving up the escalator toward a more powerful definition of use and one that is more transformative and contribute increasingly to population health and a more efficient health-care system using the capability of information technology. So that is sort of our big policy challenge. We have another big challenge in the form of providing support to thousands and thousands, hundreds of thousands of physicians and thousands of hospitals. Even if they have all of the best intentions about adopting these electronic systems, will need health the same way that all of us who work in institutions depend on informations systems support to keep our electronic capabilities up and running. And to maintain them and to update them to increase the capabilities to deal with breakdowns and the inevitable system failures that occurred. So especially for small practices and small hospitals that do not have any current information technology support or any health with transitioning into this new world of electronic records. For that average practitioner or member of a three or five person group and the average 100 to 200 hospital these are very challenging technical tasks to undertake. And we're not talking here about getting computers on to -- into nursing stations. We're talking about the intended legislation, as it previously indicated, not to just get them there but have them used any meaningful way. I cannot think in my own policy experience of a time when the federal government has tried so intimately to affect the did the work of physicians and hospitals. In effect, to take this $2.6 trillion health system and change the way it moves information and the way it uses information and to do it with the goal of making population health better and individual health better and eliminating waste and inefficiency. We have changed payment systems and many things in the health and medical sector getting people to use a different record keeping system, and a different way of moving and managing information in their practices and between hospitals and between hospitals. And that is a very different kind of growth process that we're asking people to engage in. It is very challenging and also creates enormous opportunities. Opportunities for improvement and also opportunities for research. And we hope as we roll this out use whatever influence that we have to lay the groundwork for successfully more sophisticated uses of our electronic health information systems. We cannot promise that everybody's needs and every conceivable use that will be possible in year 1 or year 2 or year 3 but we understand that we have a great opportunity to lay a foundation for many, many purposes and functions over time. And that is part of what we have to think creatively about three how to leave open those possibilities even if we don't realize them. So it would be one of the things, Of course, of what we would want to do is support the kind of relationships. The understanding of relationships between fundamental physiological and other biological characteristics of humans. And they're people -- and their evil been held over time and recovery from disease and maintenance of health -- -- and their recovery over time. And how to collect information on genetics and link it to information on human experience to the extent that that could be captured in the electronic health record. We also want to be able to support, it has been called comparative effect of this research, but the efficacy of alternative treatment and we want to be able to support things like surveillance of drugs and devices. And looking at their impact on human health. And we want to be able to support surveillance of the adverse effects associated and the positive affects assist you with immunization -- associated with immunization and we may be in the aspect of a pandemic flu outbreak which the administration is busily helping to secure a new vaccine and we want to know what the impact of that vaccine is on human health. And we hope the systems that we are preparing would be able to take it bandage of fact. So that is an overview of what we are trying to accomplish. We will be, next Tuesday, and these -- in the second meeting about Health Information Technology policy committee which is an advisory committee created by the high-tech legislation we will be having the first discussion of the work that that committee has been doing on meaningful use. What it should consist of initially and over time. And we will be discussing a number of aspects of our mandate. So let me stop there and I would be happy to answer any questions. But mostly I hope I can learn from you about what you see as the agenda and the opportunities related to genetics and human health and the church that we have to promote adoption and meaningful use of electronic health record.

Thanks, David.

Julio.

I have a question because you raised a very important point that I do not see in any discussions about electronic medical record which is the issue of adjusting because if you think about stimulus money setting it up and different places putting some budget to create it. But the maintenance and the continuous upgrading and complex ability and management of this is not be trivial. And I don't think it should be under emphasize to say, once we haven't then things are okay but a about the institutions don't have it are very rushed to develop it. And I wanted the ability of small or mid-sized institutions to do a very great job over time in terms of confidentiality, the genetic information and adjusting to new things that come up.

I think I hear to questions there. One is about the ability to maintain and upgrade records overtime and the other is about confidentiality of genetic information. And on the former we are bearing much aware that that is a challenge and it has been a major barrier to adoption. Understanding what physicians and hospitals have about the demands and getting value of that system. And part of the reason I think the Congress gave us the discretionary funds that we have went to try to address that. And we have plans to do so that we will be discussing more so over the summer. Ultimately, though, this is a problem that has to be solved by the market. By demands from the purchasers of these systems that benders' produce systems that are intuitive -- vendors produce systems that are intuitive and easy to use. And that they maintain the systems and upgrade them as it becomes possible to do that. In terms of confidentiality there is not a lot of genetic information in these records right now. That is part of a generic issue of privacy and security of many types of sensitive personal affirmation. And we are working hard on that. We will be looking at technologies related to security of information and related to the identification of information to try to assure the public that we have minimized the chances for breach and violation of safety of information. And also that we have control over the uses of that information.

I just wanted to mention two things that are somewhat pecularly germane to genetics and one is the mundane issue of presentation to data. There are a lot of things where text is the best way to do that. I think though if you talk to almost any geneticist one of the frustrations with most electronic medical records is the inability to represent pedigrees in most of these things. I think it has been barely a neglected and the general electronic record type of environment in our division. We probably are not supposed to be but we keep show charts for exactly that reasons and family histories are exceedingly a cumbersome. I would put a plea in to keep that in mind. It's not hard technical problem but often one that gets overlooked. And the about privacy, whether people should or should not, I am still not sure. But people do seem to accord their genetic information of privileged status and I would just put in a bid to keep that in mind parade and I think in some ways as they get into the more robust analysis of the genome in people some of that information may need to be treated in a way that we privileged like psychiatric information in the overall medical records. So I agree with the idea that you could safeguard to keep the medical record confidential but there may be some layering and sentiment out there that genetics necessitates.

I wanted to circle back to the point that Julio made and continue on from there. I think one of the issues relating to maintenance relates to standards and interoperability and if we don't have a national standard that everybody can adopt and have the interoperability we will have lost an opportunity. And that was a large focus of the last couple of years. Particularly related to the health information's community, an advisory community to the HHS has some and is transitioning to the private partners. So having the opportunity to not only sit on this advisory committee but a couple work groups of the AHIC it seems like there are some issues related to standards and interoperability which would also facilitate looking at meaningful use in a deployment environment. And the ones that have come up in here and that Jim has mentioned his family history. Something the we have been collecting for millennia. But have really lived behind in terms of representing in records. And while he and I have a bit of a different idea of what needs to be represented the reality is that the representation of that is taxed based and is extraordinarily on useful if you want to drive decision support Princeton one of the things that I think would be a reasonable target to look at it is to take the standards that were developed from the AHIC personalized Madison were grouped around family history and how those can be -- medicine workgroup around family history and any meaningful use around family history where that can provide benefits to care. The second national issue that seems to lend itself to this would be in the area of newborn screening. There was a specific work group under the task force around newborn screening for every state has a program. These are in relatively rare disorder so any position will be exposed to them on a relatively rare -- they do not see them very often prints of the opportunity to have embedded within the report, education and direction in terms of what to do. And would also seem to be a reasonable target for looking at meaningful use since we have that deployed across the country. And the third thing which is probably a legal bit behind the other two but will be merging fairly rapidly relieved to genetics and genomics and former coach -- pharmacogenomics and testing will be essential for certain medications. And I think it has been fairly well concluded that without the ability to represent these types of tests that we will have a lot of problems in terms of really being able to use these optimally. So in my view from the perspective of this group and the clinical decision support and personalized Madison group's of the former genomics it seems like these would be a reasonable target that are relevant to our content that could translate sparely straightforward into cases of meaningful use that could be incorporated at some point along the road map into my question, if there is one, given that you are really just starting this process, is this something that you see that is being represented as this discussion goes forward? And a more generic question, the things that have emerged from the road map of the AHIC and translating those into the meaningful use roadmap?

The meaningful use discussion is just about to go public. And there will be ample opportunity for you and many other groups to make the case for what you see as the optimal definition. We will always, since we will be the recipients of this excellent advice, we will always be seen, okay, how demanding is it? How far we is it from current capabilities? How much lead time to the vendors need? How much training to the physicians need to manage its?

Because ultimately we want to get people on the escalator and we don't want them to jump off because the records that we are demanding that they use are simply beyond human comprehension or use. But we will have a very open conversation about this and we would welcome these and other suggestions. And I think in terms of the AHIC, the AHIC formulated its request for standards in terms of something called use statements which were very specific instances of the Ministry of requirements. And the how information technology standards panel -- the Health Information Technology panel and I don't want to overwhelm you, but we have asked a group that has generated a lot of those standards to reconfigure them in terms of meaningful use. And we're we have standards that we need and where we are lacking. And you start with meaningful use and work back to standard.

We have time for a couple more.

Let me get to Sam and Paul and Jeremy.

David, the nation is fortunate to have someone who understands HIT and health services and policy so we not only wish you well but want to support you in this vital role. The comment relates to affordability and in terms of using Health Information Technology in terms of patient centered Health Research and linking the bat to the emerging fields -- linking that to the emerging field of the clinical validity of genetic tests. And when you look at meaningful use it strikes me it's not only about the conductivities, the elements that need to be built into medical record interoperability but observational studies. And you think that we will never have efficient dollars to will get all comparative effectiveness research and we will start with big items like the use of CT and approaches to surgical procedures that are very common. But to take on the genetic issues with the fact smaller numbers of people we will need to gather data very differently. So could the meaningful use elements of electronic health records be pivotal and enabling us to collect that observation so that we know down the road how these genetic tests will be applied and how the outcome of cancer therapies can be guided by pharacogenomics and other ideas.

Those are excellent point and thank you for your voice of support. The more I am here the more I value such sentiments [ laughter ] the fact is that we want to build in the capability to do genomic related research over time. And that means building in critical data elements so that they will be there when they're needed. Exactly what those are, we welcome suggestions about. What the minimum is and what the ideal is and where we might settle in between the minimum and the ideal. So having that edition of where we want to get it is going to be. Important to us. And then we can work back to what we can insist upon over the short-term and then over time.

I just wanted to at's my colleague's comments about family history -- I does wanted to echo my colleague's comments on family history this agency has developed a lot of money and tools to approve the eighth occasion of family history. And the integration of that into a health record and then families from that who would benefit from further testing for existence. It is a measurable outcome that could show immediate benefit of the effectiveness of having electronic health records. So I just wanted to say in the large extent that I think family history would be a good early target for improvement to be measured in terms of the impact of the electronic health record appeared and I also wanted to raise another issue which is around this committee for a while which is the general and integration of laboratory data into the electronic health record. And there are enormous issues embedded in that and problems with the recording of laboratory data and the way that laboratory data is generated currently into a standard health record. And obviously this committee is representing a kind of set of laboratory results it is interested in that and looks for a way -- or has looked for ways to improve reporting standardization or maybe a new coding system or descriptor system so the information is new. So just some attention to that general area would be certainly consistent with the mission of this committee as well.

Just to follow up again on Jennifer's comments on what we call about the genetic conceptualism of genetic information and both the patients as well as probably health care providers and others and the need to link with the folks involved with genomes, the genetic information discrimination Act of. And where the loopholes might be, there might be ways of linking or just monotremes who has access to the health information -- monitoring who has access to the health informations.

Thank you so much for being here and the knowledge Management and what we see as an emerging area. So we are delighted that you are there and we are delighted that you came. And we appreciate your willingness to engage with us.

Thank you and all the best.

[ applause ]

So it's great to have somebody like David there to health us move all of those important agenda as forward. We will now turn to the topic that we began in the last meeting which is genetics in the future and to order relates to health reform. I will not go into much detail because I know our next speaker is up to a close timeline. And in the last meeting we heard primarily from payers and the issues surrounding genomics and the changes in the health-care system. In today's speakers are going to cover some different topics including disparities and issues of equity and what this might mean for providers and different professional groups and different advocacy groups and so forth. So let the end of this we will want to come back to a discussion at what we can do. And how what we see as the future of genomics can be fulfilled in the health-care system and the kind of changes that we can anticipate and what the secretary might be able to do to fulfil that future. That will be the agenda at the end and what we will be doing is having a series of speakers and hopefully many of them can stay to the end and participate in our discussion later this afternoon. But our first speaker today is a Sarah Gehlert. She is the director of the director University of Chicago and she is covering everything from the environment down to the jeans and hopefully she can provide us some insight into how we can reduce disparities in this country which I think we all know remain a problem. And how we promote health equity. So we are delighted and look forward to what you have to say thank you. I am sorry I have to run out but I have to be on the NIH campus.

Can you hear me?

There is a button to push.

Okay.

No?

Yes.

I will talk about the marriage of genomics and the social and behavioral scientists for family reading health disparities and talking about the work at my center and one of the eight centers that were funded by the National Cancer Institute and the National Institute of Environmental Health Sciences and the National Institute of aging in 2003 to health address health disparities and the issue mandated that social and behavioral and genetic Sciences work together Trans disciplinary. That is a word that I have learned to love. And it meant that they work on projects that are completely interdependent answering one question instead of a group of questions and shared research designed and using the best of their theories and coming up with new methods of analysis. So our center is called the Center for interdisciplinary held research which we call CIDR otherwise it's hard to say and we are located at the University of Chicago. It was not in the biological sciences division or the social sciences division so one way of knowing was not privileged over others and we are also at the University of [ Indiscernible ] in Nigeria and for lack of time I will not talk about the work in Nigeria for today. We are five scientists and I am from the School of Social Services Administration and also a biological anthropologist and Martha and the symbol and Tomas is the chair of surgical pathology and we are from one school at the University of Chicago and most of us had never worked together in the past and what brought us together was the question, how do factors and women's social environment contribute to the African-American disparity of breast cancer in the United States. And we knew that access to care was an issue and we knew that even when access to care is controlled as in the U.S. military or in clinical trials, that there is still a black/white disparity in mortality from breast cancer. And looking at data from NCI it is always the case that white women were more likely to get breast cancer. But if you look on the right black women are more likely to die from it. And white women's odds have improved over time but there has not been any improvement for black women. Things started changing in the early 1980's so that now black women in the nine it states are 37% more likely to die from breast cancer. This is an overview of our mutually informative multilevel multimodal approach. And I am going to introduce the term upstream and we talk about the factors on the right S.p.A. factors and these include neighborhood factors including things like crime, efficacy, the Social efficacy, neighborhoods, are there sidelocks? And housing. -- sidewalks. And housing and social circumstances and the psychological states. So obviously it goes in both directions and we have four projects. And they use animal models and they use [ Indiscernible ] mice and Martha works with rats in open caging. She manipulates them socially only appeared in the animal models give us a way of how to understand they can reduce mammary tumors. So we concentrated on social isolation because of a large body of data and social integrations with better health outcomes. From work by Jim House and others which I don't have time to mention. And Martha took individual female rats at various points in the life span and took them out of the social groups and there in cages by themselves with St. Everything other than the social grouping or lack of social grouping. And she found that in time, this is about 510 days in a 1,000 a life span and the isolated and females had spontaneous mammary tumors. And these are two sisters one of whom was left to per devices, to her own devices and one was socially isolated and you can see the big whopping mammary tumors and she quit attempting to groom herself. So understanding how isolating animals caused tumors, Suzanne began looking at stress response. And she found that after moving the cage and moving it from one center to another which is a fairly mild stressor cost differential rises in recovery and corticosterone versus the isolated animals. So the cort levels came up and came down as you would expect. And from baseline rise and recovery. But in the isolated animal levels of cort went up and stayed up so they were patient in levels of cort for a long period of time. And they were able to predict from the rise and when tumors developed and from recovery how long the animal died. So we thought that we might be onto something in terms of how the social environment got under the skin. So this is work from Suzanne. And she found that the cocoa hormone receptors increased as the tumors became more invasive -- the gluco hormone receptors. And she found at the same time in the minds as the tumors became more invasive the estrogen receptors and pedestrian -- progesterone receptors decreased. And the negative and triple negative tumors have poured out, and they tend to be more common in African American women. And she found that isolation increased fatty acids and glycolytic path gene expression which both contribute to breast cancer growth. And the isolated mice had a higher stress response which had a higher interventions and molecular biomarkers and our targets such as fatty acid synthesis which we are exploring for breast cancer prevention. So the lessons learned from the end it can work should be considered in understanding the biology of health disparities that hormone response is a conduit. So as we move into the human work, we saw at the population level we are talking about social isolation and the psychological component which is about loneliness. Which is my part of the picture moving to the individual level. And Martha's animals when they are socially isolated become vigilant. And instead of exploring the stand in the corner of the cage, even when they are put back in the social group the to not interact with other animals and also through endocrine response which is my work and pay for and Suzannes. So we needed a trans disciplinary team to put this all together. Had we been looking at just one part of it we would have missed the bigger picture. Some moving to what we are doing this is the scheme of the approach of working with women and we began working with women who we enrolled at women who are not insured or women who are on Medicaid at Chicago hospitals and these are women with insurance. So we are falling women on the South Side of Chicago who are all African-American and Caribbean but have a range of service in genomics statices. Some are quite affluent and some are homeless. So we follow them into the surgery suite and get the tumors so that she can characterize the tumors. And my team interviews women before to six weeks after surgery. And we see them for a two day visit every six months of for a year and have so ten visits per women. And they are all African-American social workers who live in the neighborhood so they are geographically and racially similar to the woman. And we look at functioning and we do a very social social network analysis and what people want from the social network and what the network of boards. We look at health behaviors and perceived discrimination which has been linked to health out, and we measure celery cortisol four times a day for three days in a row. And while we planned to look at Community level variables geocoded to women's dresses and we can get data on crime and we create a buffer zone are around the house and we can count the crimes or threats and compare costs women. And we have data from collective efficacy from Robert Samson and dilapidation of Housing and how safe every house is. And we look at vigilance been around a lot of time Crime and unsave housing behalf to be vigilant to stay alive. And we left something out. We could not really can find enough to end data here. So we put -- we could not get enough buying to end date here so we measured each woman's house and we looked at features that would impede or enhance social interaction and. So enhancing social interaction might be a vacant lot or a attractive park or lots of small shops. And impeding social interactions with the vacant buildings that are dangerous or vacant lots into they have things on them or traffic can women get outside their house? And if we look here we do satellite mapping of each of four black area and then we go out and measure the vacant lots. And I had this on my desk one day and also this slide from Sarah's Students work in this is what I tell you about the measured of acquired vigilance. So this is looking down into the open cage of the rat and this is an overturned food dish which we should make the rat carriers and turquoise is the measured footprint so of this is one rat, is isolated and one is grouped and just how much they flourish in the environment in a short period of time. So the group helps animals explore their environment and the isolated animals and those that are taken out during a period of puberty become hyper vigilant. They do not interact and it occurred to me that we were seeing the same thing. In the same way that we created vigilance in the animals. Neighborhoods creates vigilance of some women by their danger. So women have to be hyper tuned to threats as to the animals. I am not talking very much about the results of the work but when we looked at the stress hormones I decided to factor analyze and look at variation within the group. But we've found a group of women who looked like the isolated rats during the date the stress levels came up and came down. And what was the -- what was frightening is that some women did not respond to the stress anymore. And I know that that is called a weathering hypothesis, you lose stability to react. And I had to go to my friends to understand endocrine burnout to bring these two groups together and when we asked this groups of women -- this group of women, what is the worst thing? And my stomach this group said my breast cancer, my whole life revolves around it. And in this group of women breast cancer was the third or fourth most important thing. And use of the woman that we had a hard time piling up with. and these were the women that we have a hard time following up with creative within group variability and health disparities people do not look within the group. They take blacks, whites, Hispanics prepared and when you look within a group you see variability. And cortisol response must be considered in designing intervention and we know from Rebecca's article and JAMA and Marshall's work for all the money that we put in disparities very few intervention's impact it's so I think this is a very important lesson. Just to show you this is logistic regressions. And we can about half the time from the social variables the upstream variables and the robberies and homicides and the women's response to them in this depression and predict which two groups those women are in. So biological factors with clinical implications can be targeted with need neighborhood factors. And we can figure out who needs resources and we can target to prevent the clinical and biological outcomes. So this is sort of a messy slide but it gives you the idea from the SBA factors which to launch are degraded infrastructure and neighborhood crime and unsafe housing through special assault we can find a significant pathway, another significant pathway. And we get to the psychosocial function.

And those that had what we can only credit as -- they have no place in the universe and they were entirely alone and we talked about disenfranchised groups. And then we had a significant pathway to the stress response through nighttime rise in cort. And we also have a pathway here. And through the animal work we've found that -- We identified gluco receptors and metabolic genes.

Part in the interruption, this conference contains less than one person so if you like to continue please press *1 now.

And the number of sexual assaults and their age, so that the number of sexual assaults goes up there more likely to have triple negative tumors and their more likely to be higher his logical -- historological grade. And this is the model, the upstream factors and those social circumstances that we associate with race and not biology of race to isolation, acquired a vigilant and depression and inflammatory gene functioned. And we think that if we interview here at the neighborhood level weekend prevent some of the downstream changes. So basically the neighborhood level intervention decreases social isolation to increase social support and safety to increase skills for negotiating complex systems. And we then will measure at the clerical level whether or not it leads to increase adherence to treatment and women undergoing chemotherapy which we believe to be the case. And at the biological level we expect increased salivary cort regulation and increased inflammatory response and increased regulation of that distribution which is suggested by Suzanne's work. And we also might think it affects changes in metabolism. And we think the social factors may lead to matted metabolic changes and a redistribution of fat. So we're moving our models to rural impoverished areas where black and white women are very pour so we can test hypotheses and look at food and sufficiency and food intake. So that is a quick and dirty of what we are doing. And my method is best transdisciplinary and we know that the genome is shaped by the environment. And we don't think that genomic medicine alone is efficient enough and we don't think that attention should solely be the social determinants of health. The proof is in the interaction. And you really need to, I think, Foster crosstalk between social and behavioral sciences and geneticists such as we have already begun to do. And we have found in other meetings earlier put together that we were two different cultures. One thought that the others measures were soft and mushy and the other felt the same way. So I think anything you can do to bring scientists together and approached these complex problems the better chance we have a diminishing health disparities. Thank you.

There will be a few questions for you and one of the things that we are looking for here is how this all fits in to health reform. And as we talk about health before we talk about the downstream clinical care and how to do with those issues particularly in genomics and the importance of dealing with these upstream issues as well. I was wondering if you could reflect a little bit.

If you improve access to care you will probably decrease the disparity of breast cancer by 40% but there will still be 60%. If you aim upstream but there are very specific ways that you can improve improve neighborhoods. Very simple ways. And it is taking a multilevel approach because upstream changes have downstream changes. And also my colleague Nikki and I are talking about when you were talking about information earlier including Social information in trying to understand how to make critical decisions about patience is important. And knowing what neighborhoods they come and what their socio-economic status is really does make a difference. So that is where we are. And thank you.

Do you have time for another one or two?

Yes.

One of the things we heard earlier in our education task force was the focus on medical health and how it might take place in the medical home. And it seems to me at least naively I had flashbacks of my Intro Psych course at the University of Wisconsin but it seems like a medical home has the potential at least to address both sides of that. And if that is a model that you think is also reasonable, how might we use that type of model in sort of the genomic Round to accomplish that?

I think a medical home makes a great deal of sense. Unfortunately there is a great deal of variation in the quality of health care facilities especially in impoverished neighborhoods. But I think working with federal the qualified health centers might be the way to go. And trying to make sure that someone is assigned a clinician and not only assigned a clinician but a sign to others such as a social worker or nurse who really can follow them. We have talked about patient navigators' at large and not so much capital the qualified health centers. And that certainly would health. Part of our intervention into which I went into no detail is really to halt women in neighborhoods -- to help women in neighborhoods that they can go back to often and finding save places in neighborhoods which could be a federally qualified health center and I think that makes a great deal of sense. And I think in my experience women very much are appreciate if -- appreciate having the information and we have taken Rick through many neighborhoods to talk to women and I am impressed by the fact that women with master's degrees and women with fourth or fifth grade education are on the edge of their seats and they are too seldom talked to directly so I think that would be a big change.

Certainly.

Great work, Sarah and I think this is where we need to go. And the point that you made at looking at black/white differences and not within groups is an excellent point. I think Bill when we talk about what our terminology -- I think when we talk our terminology is important and when you say upstream and downstream am looking at your model it's looking at having this linear approach to how these interact and what we think about interactions. And we're thinking about a web. With there is really no up and down, they are interacting which makes it more complex. So I'd just think in communicating the message about the complexity, upstream and downstream and minimize that complexity and really holds us to this from your approach.

Point will taken. I believe we did have a caveat that I think you are completely right. Thank you.

Thank you so much and it is an important reminder to the interaction of all of these things with the need to deal with these complex disparity issues are all different levels. So thank you for taking the time to be with us. We are going to now turn --

[ applause ]

Dashed to the providers and our first speaker today is going to explain some ideas for reforming health care delivery and provider payments. Dr. Michael Barr has been working on provider payment and delivery reform and Vice President, Practice Advocacy and Improvement, American College of Physicians and has been deeply involved in the topic that has come up many times here. So Michael, we look fuller to your comment.

Thank you very much. Can you hear me okay? I am struggling with a little bit of a sore throat. There we go. Thank you very much and I appreciate the invitation to speak today. I know I am standing between you and one did so I know what time to wrap up.

Maybe noon ish.

I think with this audience I do have to talk about the piece for health care reform. We have health care especially for the uninjured and services and a link between the cost and quality so high cost does not mean better quality and we have a payment system and if you compare us to International Data of we are lagging especially for primary care and we have the impending collapse of primary care. And not for lack of trying have a lot of different ideas of what we can design and all of the different factors that we need to address within the health-care system. So if we created universal health coverage but to not adjusted work-force issues we would have anybody to deliver the care. If we try to put forward a HIT infrastructure but do not reform payment policy and all of these things with meaningful use we will spend the money and not get the kinds of returns that we need. I will not say that the patients entered Nicole's home is the answer to all of this I hope that you'll agree with us that it's part of the solution -- the patient centered medical home. It's a vision of health care as it should be and a framework for the delivery system as a practice and at the societal level. Most importantly we don't think that we have everything figured out and as I mentioned earlier, it will not solve anything by itself. So bear with me on that. And we also use it to describe a pathway to excellent health care. And as physicians and other clinician to represent the folks involved in this effort, with their families inappropriate. And it is very much a team sport in this is a cultural change that we need to work on. We are working together with others because of low none of us can solve the issues or health our patience. And we need to educate the primary work force and others in here is a good example, we have a system based orientation for providing health care and the tools and the resources for education at the points of care is critical if we're going to get to the end that we needed. And most poorly if we want to address the workforce issues we have to articulate a model that is attractive for making decisions right now and in the future so they choose primary care specialties. To put in a graphical context, we think the medical home could be the essential pieces around such as quality, cost, satisfaction and access with all of the components lines above. Unfortunately the model that we have been pushing for which is primary care also has a weakness. And a little bit of statistics, only 2% of 40 medical students decided to go to general internal medicine and about four times the practice as their colleagues and his specialty medicine -- as their colleagues under special the medicine so we have our problems ahead of us. What are we talking about? The medical home model is not new and this is then brought forward in what we are doing is reinvigorating it at AAP in the American osteopathic Association and this is heavily based on Ed Wagner's model and all the systems and this is how you organize the health care system and because of time I won't go into these. But the critical part is that you don't get to the improved outcomes unless you have a team based environment and a gauge patient. So what we put forth in January 2006 was the advanced medical home and we talked to patients that thought it was one step away from hospice care for a single home. So we tried to link it to the literature or pediatrics so there was etiology for it. And when we started talking about it we started talking to employers and we were in approached by two gentlemen from IBM and they made the rounds and said, we really like what you are talking about, this medical home concept or the future family medicine that pediatricians talked about and reelected so much that as a global company we have this and other countries but we have a hard time finding a cure. If you put your ideas together we will go around and bring the largest employers in the company and work together to try to reform the health-care system. And the principles that were released in March of 2007. They are the part of the basis for the Health Care Act at the end of 2006 which has the demonstration project under Medicare for the medical home. So you see it has other colleagues here and this is a team based practice that comes from organizations and we want to emphasize that it's a team based model. And we talk about taking care of the whole person and Courtney in the care we don't provide it correctly. and coordinating the care when we don't provide it correctly. And the access of care should probably be at the top of this list. If you look at any of the data, if you approve access to health disparities the start to disappear so access is critical. And we started talking to all of the employers and others about this pretty much based on this -- it sounds like this is the type of care that we thought we were purchasing and this is the type of care that we would like to purchase prepared but unless you change the payment system this will never be sustainable because it does not approve this kind of health care system so I will talk towards the end about payment models. Another way to look at this is the position patient family community with the previous speaker talking about the health and you have the integrated delivery system and many of art -- or the past majority are provided in position offices of less than five positions you have to talk about virtual teams. And they will not appear in the four walls of most practices so you have to figure out how to create a system when the patient needs those services they are accessible and coordinated across all the means with did receive care. Another way to look at it, this also includes care givers both formal and informal. I work for community health centers committees health centers and trying to educate them about self management and exercise was a challenge when many of them lived in a neighborhood where they could not exercise outside after certain hours. So trying to figure out the impact of society on them is important and remain so. And we talked about the model and those to -- And they said that is great but we will not another dime into anything unless we know what it looks like. So the National Committee for Quality assurance have a model of there, the physician practice connection and we worked with the Institute over several months to develop the physician practice connection for the home. And there are nine domains in this is a recognition process. Does not define the medical home it is a way to tell whether the practice has the ability, capacity, and is doing some of these things right now in the idea of the speed demonstration project and be able to see how they're doing on quality, cost, efficiency and satisfaction. So I will described to you a level 1 medical home but this is not the definition of a medical home and people in this sort of locked into this check box recognition process. So the three levels based upon the point score would increase in complexity. And tying this back to the payment model for a second the idea is that the payment model will health practices move along the to that tree from a level that level 1 to two or level three. So exceeds the incremental cost and we talk about is level 1 practice in this is one where you can achieve it. Develop timely access and communication processes. They have to see a patient when the request to be seen within a certain amount of time and when the college and wanting that results for referral or prescription renewal this is what our policies are and the recognition process, show us our policies and shows that you're following your own policies. And anything that is way out of balance will probably get picked on. So the electronic paper based practice you need to organize your cards. I don't know how many of work with electronic health records I have worked with paper and electronic and I can tell you I have seen very well organized paper based practices and disorganized electronic based practices and that is the problem that David Blumenthal has and meaningful use. So we track age appropriate conditions and evidence based guidelines based into our tracking and documentation process. And among the population that we identified the three most important conditions for which we want to make sure we are doing the best care possible. That that those are the only three but the proxy ensure that your falling preconditions with in your practice. And with nutrition they will be different than if you are in -- HIV practice. And addressing health literacy and attracting referral and what was the comes back. And you probably would be surprised how poorly that it untypically. And you're not looking at the data to make sure that you are doing better. The idea is that the practice would reflect upon this up and look at the data that they generate, and generate and each of the practitioners and their practice to determine if there actually improving. This is level 1 in when I talk to a lot of different audiences how many of them to the field are practicing to level 1 and very few raise their hands. And can you actually achieve this? And most the with some help and support they can achieve this. How many of you as patients go to a practice that is organized in this matter to your knowledge? So the challenge is to define the level of the practice that is distinctly different than what we tip domestically expense and not making it so challenging that we disenfranchise those out there. So for the most part we're talking things that are achievable even by small practices. And key point, it does not require a electronic health record at this first level and as you add more and more functions it becomes much more easier to have electronic how record and to do this on paper. And we will require registry and tracking functions to look at those patients with in the specific needs, diabetics are patients with congestive purple year and follow those appropriately. So looking at access and still want. And forming the base our platform upon which you can build more and more features of the medical home. And moving from level two to three improving access options for patients and you do e-mail and personalized health records were they have access to the patient portal and population management and advanced recording and technology solutions and clinical decision support and guidance. And clinical decision support systems link health observations with knowledge for improved health care. And in the context of providing information around genetics and screening and counseling and all of the issues that this group is working on I think this is an opportunity that I don't think currently exists to put that information in the hands of primary care clinicians at the point of care. So we're talking about points of care, evidence based guidelines and the most important affirmation that they need to that they can use it when it's appropriate in the interest of time I will blast -- not that I have been going slow, but the features of medical home, we use everybody to the highest capability and we try to train practices and let every practices to that level and all were to take a panic everybody on the team. It is a good way to practice and a good way of Personnel management. And we need to talk about cultural competency Training and many practices are blind to what is happening around them and do not make those kinds of connections. It's a busy day it's hard to do that. Source of management support and getting feedback from the patient's family and an advisory group and providing written care plans and adhering to does care plans and health patients and families overcome them. And painting traditions of care seriously. A couple key points. It is not a gate keeper system. Many people start thinking that this is managed care. Basically this is to facilitate care and health patients find the proper care and inappropriate time line with the appropriate information and engaged in their own care. We have been talking about 45% of our members and we talk with ourselves and the different models. And some some specialty practices may very well be great as they speak. Think about an infectious disease specialist taking care patients with HIV. Why not? And think about neurologists' taking care of real diseases. And all of their acute illnesses. If they were able to provide appropriate care, why not? And to create a really robust primary care for the some specialists and other specially is not as well organized we have missed half the battle. So try to get them organized along some principles and people are starting to talk about a medical home neighborhood. So strengths and weaknesses and you have this graph and slides so I will not take a lot of time on this and I want to look at the threats. And the thought that this is a zero sum game and where's that money coming from? There's a lot of access and a waste in the system and we ignitions or portable hospitalizations and read missions -- read missions or portable has Lusatians and if we can look at those. So looking at new requirements in processes turns them off immediately so our objective and challenge is to health make the system available so that they can go through this process. And then we have a consumer challenge. People don't like the medical home concept but when you start talking about what it means and what we're trying to create it does get there instance. So we do have an education issue. And we can never predict the intended consequences. And payment models. There are many to consider and let me go over these three. You see the traditional fee-for-service and you enhance the relative based value and the codes that doctors use are better bellied pigs so some things are undervalued and overvalued so revaluing them appropriately -- and the problem but that is that it continues the incentive and you want to get paid when you see them. So to the far right using Global payment. And let's take a look at the primary-care practice looking at this patient and then paid them additional certain procedures and the challenge with that is getting to the right number. And having some risks associated with it and the Middle bucket which is the one that we have been advocating with our colleagues is a blended or hybrid Model printed it reserves the fee-for-service as we described earlier and you add a prospect the payment that takes into the account the medical home and where they are on the scoring and risk adjusted for the patient population that they are seen. Such a highly complex patient population is different if they see a very wild population. And that is the prospective payment that they get that offsets the offset of the technology in the care coronation and the e-mail visits and all of the things that we would like to see done that are currently not in the current system. All of these have an element of performance based compensation in some of the best models of that would be shared incentive. So it's reinvested in the system. And this is the model that many of the experts see. And for our colleagues that are not medical homes and to some of these services if we value care coordination and the exchange of information we should paper that were ever and a curse so the concept here is on an all-out carte basis. And for that episode of care they do all of the care coordination for someone, they are taking care of radiation therapy and the surgical oncologist to the chemotherapy and home care and we should be paying for that. So the idea that those a la carte codes it paid on in as necessary basis. And this goes away from the volume driven system and supports the current non reimbursed activities as I have described and we have built the systems of care for the benefit of the patients. The last few slides as you look at the payment models and the criteria that we think we should be looking at. So it supports specific policy to ensure accuracy and predictability and the increasing volume. It should be supporting patients centered care and decision making. One of the challenges is that conditions do not have the time and space to engage in the conversations or the tools and resources. Some make the space and time and paper that time because when the are doing that they are not doing this it so that is how they get paid. So I will let you scan the other and positions and nurse practitioners and midwives and the whole range of conditions that can provide services. We need to have a smart work force policy. And technology is going to be critical. It is necessary but not sufficient. You can spend a bottle of money and not get good health care. So it's important that we do this in a smart way and we are on the right trajectory. And there's a lot of money that is clean to be spent some. So practices differ. So we have an idea that we want to aspire to overtime. And one of the big challenges and disincentives for people who go into primary care at are the administrative pathways' console as you look to make sure that they are built to do this kind of care we need to start about relaxing the administrative burdens that the management that is why many of them don't go into primary care in the first place. They see the intern with no -- and that is not a ideal situation for most of them. And these are some of the principals from the AQA alliance. They should be selected and with there is a strong consensus. They should be appropriately this congested and stratify and they should reflect the spectrum rather than the simple care. And as we put health information technology and performance measures that cannot be elected from electronic health records we need to think about how we can roll this up and the conditions that are treating the patient. Right now this is an impossibility based on the current level of technology and performance measures. This is ongoing and people are working on it but I think that is the future. So in sure you're talking about a commitment to excellence and communication and care and involving them in their own care and providing the access to care. And that helps remove health disparities. And we're talking about implementing an Electronic health records or health information technology in general. And evidence based guidance at the point of care and feeding the people the information that they need both the patients in conditions so that they can make the decisions together. If we don't measure and improve and measure can be will not continue the cycle of improvement and broad transparency and accountability. And at the very end of course, if we do not create a state health care system. So in 20 minutes or so I gave you the broadest thought that I could on speed, performance models, health and permission technology and that we'll stop right here and ask for your questions.

Thank you, Michael.

[ applause ]

I am sure the committee has questions about how genetics and genomics a bit into this.

Yes, a very impressive presentation. Perry will -- very welcome. What I am interested in seeing is the problem is around the special the medical home and this relates to genetics because in a speech by we have an unusual position in the medical organization and that we are a primary medical specialty but we look at a Super sub specialist and we are taking care of very complex patients with rare genetic diseases and we struggle with this and how do we interact with primary care physicians. So I want to make a diagnosis and send them back and there are others that would want to adopt much more of a medical home. So I guess the point is that if you're looking to talk with someone outside of your special the organization and internal medicine we would be excellent partners in addressing the medical home.

[ Captioner Transitioning ]

They would not endorse it if it was a zero-sum game. I wonder in the current environment if the not worse, if the issue is not reduction in would we get. I'm just curious line coming out correctly.

We can look at data from other countries or health system demonstrations. You see where they're saving money. The question is that going to be sufficient to fund this model? Some of the things I have talked about cost more. It shift some payment. It will cost more for some screening. There are some unknowns in model. That's why it's been difficult to score it. There will some shifts, unfortunately. There's a lot of codes where you have things that come in and get valued early in their life cycle, as things get easier they stay. I don't think the solution is just around the medical homes looking at multiple different ways. Frankly, some of the payments that some specialists get probably need to looked at across the board. Not a very specific answer, but general.

Continuing the line of thought here -- when we think about paying for performance one of the challenges you had in the primary care setting is paying for counseling that is effective, be it for tobacco cessation or diet and exercise. I can imagine the same issue for genetic counseling to understand the risks and talk about the future steps. Has there been discussion about how to Orient that and make that more [ Speaker/Audio Faint or Unclear ].

I'm not aware of any specific discussion around genetics and counseling and pay for performance. The broader question is how to make the time and space for screening right now. We are doing better on tobacco, but think about depression screening or any real common guideline that we're supposed to be doing now. If I'm a physician in a busy practice and if I find depression I have to do something about. I would love to talk to Mark for example. If we engage primary care physicians now we need to figure out how to get them to the right people at the right time and we both get paid for the services that we're rendering.

So, I want to step on back. Because we're talking -- you're headline is patient centered care. I work with the cancer surviver community, which is a different population. You said earlier that patients didn't necessarily accept the model and the name. I would think they would accept the model but the naming might be the issue, not the concept. Have you talked to patients about the model and the concept?

Yeah. In my speech I misspoke. With we described the model to folks they like the model, they don't like the name, exactly what you said. ARP consumer union, [ Speaker/Audio Faint or Unclear ] did research on the names and brochures being developed. Understand the challenge. I would expect if it's a proven model some of the names will change as others pick it up. The concern we have is as other folks test the medical home it's not just the medical home -- that it becomes something different to different people. Within the last month or so the same sites released guidelines for projects to say at the end of the day with we look at results we want to make sure that we're comparing apples to apples as much as possible. ACP is not the leader, the consumers are.The consumers are very vigorous participants.

Last one.

Michael, we're pleased to work with many other health plans and support your initiative in the patient centered medical home and the projects to show outcomes value. I was struck as you reviewed the NCQA levels there wasn't more discussion about wellness, health counseling and areas that are going to be very important in optimizing wellness and health for the future, including genetics. I know there's a focus in communication and infrastructure. As you look at that is something we could modify going forward? It strikes me, again, that big element is absent. It's a key element in what the informed primary care professional can do.

Great question. The answer to the question about NCQA and the recognition process is we always understood that something would evolve over time. We know we've gotten everything right, as I said earlier. Some of the criticisms is there is not a patient centeredness in the original model. If you think of where it came from, physician practice connections. [ Speaker/Audio Faint or Unclear ] the idea, again, forming the base of the pyramid and understanding that other things need to be layered on. There are issues about coordination and communication and counseling with others. You have hit on what we need to build into it. The other part is we always envisioned in this the context of demonstration projects which would measure those elements. Those things can't be built until. They have to be measured. Sort of a retrospective look. There's somebody in between where we can look and continue to collect data to make sure. The NCQA is taking recommendations from many stakeholders to revise the tool for the medical home with a one or two-year time horizon. Thank you, great comment.

Thank you very much.

My pleasure.

This is important work. You tell by the questions there's a lot of basic things here that people relate to. We look forward to having some interaction.

Great.

Seeing how the world of genetics and genomic and information management fits in.

I welcome any questions by email.

Thanks for coming. [ Applause ]

We're going to take our lunch break. Those of you that ordered the boxed lunches they're outside. If not -- the cafeteria is down the hall. We will regroup at ten of.

Session on lunch break until approximately 1:10 Eastern Time Zone.

Problem with the anticancer drugs is we [ Speaker/Audio Faint or Unclear ] 3/4 of the anticancer drugs in clinical development fail at phase 3. This was the purpose of the translation research working group that Steve mentioned. I can tell you what is happening if you look at this process flow kind of thing you can sort of summarize it. This drug discovery business has become rapid and efficient. What is new is there is increasingly use of biomarkers that aid and speed up the process and many of these are genetic or genomic biomarkers. We move from a very inefficient drug discovery and development process, remember for many years most of the anticancer drugs were cytotoxic drugs. These drugs I can tell you the more you put into a dish the more cancer cells you will kill. How much could you put into a person that they could stand? You do a strategy like this, your phase 1 drug development, you get more and more into populations of people until they can't stand it and have some sense for what goes wrong for when you get up there. At that point you move into every cancer you can afford to try and treat, you have no clue what type of cancer it will work. If it works in ovarian you have to figure out if it's better than the best that is already available there.

I would argue that most commercial drug development houses this is already done, we go into a trial and we use genetic and molecular markers for two things. The goal is to determine the optimal biologic dose. Any more drug than necessary will only give side effects that can't be beneficial. We need a marker. The other [ Speaker/Audio Faint or Unclear ] this is often using a molecular biomarker of risk. This is usually a somatic genome assay.

We can look at a example that is familiar to you all. This is the targeting of the gene rearrangement. It took us a long time to figure out this was a enzyme that was generated by [ Indiscernible ].[ Speaker/Audio Faint or Unclear ]. They figured this was an enzyme, they can fit into a creativance. There was a lag that didn't need to occur. The thought was that you couldn't develop a selective small molecule. A few guys believed that you could and were vigilant. They tested for [ Speaker/Audio Faint or Unclear ] turns it out it fits into this crevasse.

My point is look how they took this into the clinical trials. They were not going to use this drug for anyone who did not have CML and a [ Indiscernible ] gene rearrangement. Look at this phase one, two trial. They begin to inhibit the kinase. The targeted population has astounding clinical responses. This was approved on the basis of this trial, so compelling was the evidence that it worked. If it doesn't work here you stop, right. You wouldn't take it more and more and more people to eek out a response. Many people believe it's close to a single gene defect as we have. Would about the big solid organ cancers? What have we been dealt? Many others have been sequencing away. You can see here crome so manies here, the heights of these peaks. The scorecard looks like something like this. 60 to 80 driver point mutations. That's what you are dealt. They seem to cluster in families that are parts of molecular pathways, that's a reduced complexity. The first yield of this ought to be better ways to detect cancer, I'm sure it going to be. They call it molecular beaming. Here is the key, in stage 1, 2, 3, 4 they find mutant DNA that could only come from cancer in the stool. Could something like this serve as a resource allocating tool? If the negative predictive value were high enough then you could say this person doesn't need colonoscopy this year. The recommendation is that everyone age 50 get one. If we did the price would be very high. We have disparates in its application and use.

Epigenetics are probably present ten folds higher. There's areas that are not typically methylated. Cancers often have genes inactivated [ Speaker/Audio Faint or Unclear ]. Look at how this can work to refine staging. This is stage 1, what they did was take the lymph nodes and looked at a couple of slices, can we see the cancer change? All of these had negative lymph nodes, if they were negative they did much better. If you saw cancer DNA in the node they did much, much, much worse. Our inclination at this point is to do trials of therapy for all of these people. It's clear these people need it much more than the others do. You can imagine this could serve as a resource allocating tool. The other is to anticipate which drugs work. Brain tumors there's a active agenda that assaults guanene bases. Many brain cancers have inability vatted this enzyme, thus they're more likely to respond to treatment by [ Indiscernible ]. You can do a test for this. You can see if you -- brain tumors are devastating for anyone. You do far better with treatment if you have this repair enzyme in activated. If you don't have it inability vatted you might as well have not taken the drug. Pharmacogenetics are still in play, as for all diseases. It turns out Tamoxifen is not the active part of this drug it turns into this agent. It's interesting that this metabolism requires the P4 enzyme. This is highly polly more Fick. Look what happens. If you take a randomized trial for breast cancer in which inhibitors are shown to be better than Tamoxifen let's look at this more carefully. Let's look at what happens. Look at this. If you are wild type there was no benefit to the inhibitor. The inhibitor prevents the production of estrogens. The major side affect is bone loss. Tamoxifen didn't cause that, in fact it treats it. You increase the safety of treatment, you can take women that can be treated with Tamoxifen. These women should not take Tamoxifen. By allocating drugs more logically you can reduce costs. That triple ripple is hard to get to. That's what genetics has the possibility of doing in cancer medicine. You know this quite directly, the power of the genomic industry is astonishing to me.Our ability to do this will rapidly improve. Having said that, it's created a different problem for us. We happen to have a great information technology asset and resource. Our sequencing efforts generate more than a terabyte of data every quarter. 1/3 of all storage of information has to be medical imaging. We've had to design new architecture of servers and whatnot.We're going to have to think about the way to allocate those resources, as well.

What I have tried to show you is germ line and [ Indiscernible ], [ Indiscernible ], [ Indiscernible ] information will impact screening, early detection and the like. In the same way hopefully they will reduce the costs of new drug development to get better drugs at cheaper prices out to more people. Any questions?

Let's ask you to sit here and listen to the second speaker and then we will capture questions.

Our next speaker is Beth Pletcher who will focus on genomics on pediatrics.We look forward to hearing how you think genomics will field the pediatric field.

Thank you very much. I'm happy to be here today. I'm a pediatrician. I spend clinical time as a genetic ist. I look at workforce issues, which is not the focus of my talk, but if we have questions that pertain to that --

I will try not to be a genetic evangelist today. These are topics or ideas that I think that will be woven into my comments today. There's a lot of promise and talk today about genetic technologies. We need to have some application paradigms. We've heard a lot about them today, as well. We also know about financial barriers, and educational and ethical issues. I thought about the crystal ball, how will I think about how future technologies will apply to pediatric patients? We're doing some of these things today. The Human Genome Project provided us the great promise, as we mapped all of the genes, but mapping genes is very different than understanding and characterizing the genes. In addition to understanding each individual gene we need to know how the genes interact with each other and the environment. The promise for genetic technologies and testing, as we've heard, has to be through prevention. If we can prevent a cancer or disease by knowing about someone's makeup we may be able to do lifestyle changes. As a pediatrician, when we think about early identification we may go back to prenatal or birth. Early identification presents some great challenges. In our current practice most of us deal with rare conditions, single gene disorders, it has a limited scope. We often are not able to do the testing we want for those unusual patients with rare conditions. If we think about the future and how the technologies may be applied in the future I'd like to think more about our newborn screening model that we use today. They're tested for conditions where there's something we can do to improve their health, something that is modifiable and treatable. We also are looking at pharmacogenetics. I will not spend time talking about that today, that is part of the future of genetics and will continue to expand. It has lot to do with cost savings, optimal treatment, and personalized medicine.

I love CGH, I love chips, it's a piece of art. This is helping us to understand a lot about minor and major virations in individuals. We just heard -- this is great, about next generation sequencing, which will enable us to sequence multiple genes in a single assay at a reduced price. That information can allegation be used to -- also be used to treat and help patients.

I have to take a step back. What are the barriers? I think that we need to think about this ahead of time before we get to the point where we start to implement these technologies. We have a limited knowledge today about many genes and the gene/gene interactions. We need to understand that to make this useful. Most importantly has to be the selection of specific conditions for which that information is valuable to the patient. That's what we need to think about as we treat patients or as we do screening programs. Is intervention feasible? Is this going to help this patient? On top of that are the cost issues. Other than just doing the cost analysis and looking at the testing that we're doing we need to think about once the results are known we have to have an infrastructure to interpret that and implement strategies. Just as newborn screening has been that kind of paradigm we need to think about that. When we identify a disorder we then have to treat that child and make sure they get connected and get the treatments they need.

Then the workforce -- one of my favorite things. We need to have a workforce that can interpret the results and start the treatment. And once again the ethical conditions. Here's the pediatrician's medical home. Not just the patients with simple illnesses, but children with complex medical problems. The pediatrician serves the primary purpose. Those of us that graduated medical school before '90 have had limited exposure to technology. My children learn more about genetics and genomics than I learned in medical school. In 2007 I went back and did a calculation, how many geneticists are there? Although we are a mean force of nature there were 1200 in 2007. I have two here in the room with me, at least two. There were 4.3 million children. Each one of us would have to go over test results on a screening test of over 3000 of these newborns. If we find something we have to explain that to the family.

How do we create a useful model? I think we need to consider that pediatricians still need to be the center of the medical home. We need to have a way to educate pediatricians and other primary docs about what these conditions are that we're looking at. Just as with newborn screening programs we need a hotline. If a pediatrician gets a result that they don't know about they need to have someone to call and manage the patient with. The follow-up services, in addition to that hotline, need to be in place. The way I might envision it, these are all my own personal opinions, maybe have a group of experts from all areas overseeing the screening process to help with some of the interpretation of the results. This is my wish list. This is what I would like to see as the basic needs. First we should develop a panel of experts. People from the laboratory side of things, from the diagnostic side, from the clinical side, consumers, we need a group to look at this and see how this could be applied to patients. The testing needs to be cost effective. We need high through put technology.Once again the intrastructure needs to be there and resources for the primary care providers.

I'm very much a nontech person. It would be great to be able to use this information in a way that can be transmitted from place to place. I'm hoping someday that I'll be able to carry my medical records on a chip or a flash drive. We need protection for the databases, but the databases are not valuable if we don't think ahead of how to look at this data long-term. What are the outcomes? If we begin a screening program and we don't find out if what we're doing is effective we will not go far. The educational initiatives we need for the primary care docs, but we also need to educate' parents. Somebody was talking about Consumer Reports earlier.

How do we measure outcomes? For many of the outcomes we have to look long-term. We have to make sure that over the years we continually assess the effectiveness. If we develop a screening program looking at six specific risk factors that are important over time we may learn those are not the ones we need to continue to look at. We have to add new ideas and new genes or new paradigms as we go along and get rid of some those that are not affective.

General population screening is whole another avenue. As the costs come down that maybe less of an issue. Today with newborn screening the hospital may pay for the screening, but indirectly the taxpayers and insurers pay for the tests. Now I get into my little soap box. We have moral obligations. We think about the ethical issues and what are we doing and how to protect the patients. We only want to introduce tests that are promote and will appropriate and will promote health. Then we need to have ongoing assessments to make sure what we are doing is right and get rid of what is not working. I think finally we need to make sure that the financial burden of this testing, if we decide to go forward with it, is mitigated in a way that it benefits all patients in this country, and not just some patients. Okay. These are my closing thoughts.

This has a lot to do with workforce and what I think about as we care for children in this country. Money that we spend on prevention and health for children has the potential to reap great benefits for this country. The future of our country depends on a healthy workforce, we need to intervene early. So early identification and intervention is really where it's at. Ultimately this is the goal, to have healthy and happy kids. I bet if you look at these children you can't figure out which ones are mine, they don't look like mine. Mine are in the lower right. They don't look at all like me. Thank you very much. I'm happy answer questions if I can.

Great. Thank you. Bill and Beth -- we'll open it up to a few questions or comments. A couple of different ends of the world.

Dr. Williams?

Um, this comes back to a point that Dr. Bar made earlier related to medical home. You used the example of mental health as being problematic in the sense of where do you create the time and space? I wanted to propose a model that is relevant to genetics and will have impact on the work that Barbara's group is doing. We've embedded social workers in primary care practices so that all of the patients get appropriate screening with depression screening vehicles. Also those that present with complaints of behavioral issues meet with the social worker who then provides the triage function. Where do you fall on the scale?What is interesting about deploying that is not only do we have better care and improved satisfaction for patients and providers, but the productivity increase by the primary care physicians because they're not sorting out the complex issues -- and doing the triage function themselves actually pays for the person to be there. I would contend we could think about a similar kind of model. I don't think that our current workforce of geneticists and counselors is probably up to the task, I think we're also way too expensive to perform this function. If you could imagine an entity that looked like a diabetes educator, but they're educated around genetics so they could perform a risk stratification and interpretation and then perform that same sort of triage function. These are the things that you should focus on, or wait a second this looks like a BRCA family this needs to kick up to someone else. You can envision the return. The other advantage of having the person embedded is there's ongoing education taking place in the point of care. This would also seem to be supported in the medical home model. I'm interested in your reflections on whether that would be something that would support your vision of where things are going. And whether -- what would be needed to have that happen.

Absolutely it makes a lot of sense. If we do we widespread screening that make as lot of sense. I guess where I worry is one of the problems in workforce is it's not just the numbers of physicians, but it's a distribution of physicians. What I'm thinking about is some practitioner out in New Mexico who doesn't have a large office and maybe we can do the virtual or online consultations. But you wouldn't have that genetic educator in every practice, it wouldn't be that practical, but to have that resource available across the board sounds wonderful to me.

I wanted to ask about the oncologists -- do you expect that most or all onologists will need to be educated in genomic medicine? If so how will that happen?

That's a great question. It dove tails. Right now the thought is there's about 25% of the supply of medical onologists as needed. One of the advantages -- if you look at outcomes for cancer care in this country as opposed to others they're remarkably better. Why? One arguement is that the medical population we have single payer. Another is that we have pretty defined standards of care. You don't say you look like a little of this and a little of that -- there's care standards that are widely distributed. The third is the fraction of people we put on clinical trials, 4% overall across the country. I think if we maintain a strategy that emphasizes those standards and improving them we will -- as a follow-on we will begin to educate healthcare providers. The other looks like a medical home, it's a specialty home. Many people sample a lot of care providers. In a referral-based strategy his doctor said go see this person down the hall, now go see this person over here. The consumer-driven notion is saying I would like to see the assets in one place to have a plan that makes sense. That's a great way for elite services. I suspect at the end the treatment plan may be the whole game. That's often where you are flagged that breast cancer is in the family, for instance, what about other family members?

One more question --

I really enjoyed the talk. Every time I was listening to your points I had this -- that's right, but -- one point, in your imagine of [ Speaker/Audio Faint or Unclear ] there was this implicit [ Speaker/Audio Faint or Unclear ] and nothing else, which is not true.

It was developed as inhibitor originally.

I don't want people to have the impression that we have a new way of targeting drugs to only one gene or receptor. The second point, in the earlier slides this whole notion of preventing disease and doing with germ line sequencing.Third, on the specific case of colow reccal cancer screening, we have effective technologies. What is the added value of this test compared to the others? So far the preventive services task force has not weighed in to say that's an effective test.

I will start with the last first. There's a number of tests out there working their way in. I wanted to create the arguement that is test if it has a high enough negative predictive value is a tremendous asset to screening. To do every colonoscopy to every 50 year old, can't do it. The test -- the bar is very high. It has to have a high negative value. That is going to be a test, not that one, but some one. Back to the original one. In terms of [ Speaker/Audio Faint or Unclear ] you can probably make one that is very selective.This is a very active question in our feel. You can make one, whether it's affective. And the middle question -- it would involve sequencing, absolutely.

I'm sorry I don't have more time. I know there's more questions here. We thank you for your perspective. Thanks for joining us. [ Applause ] I know this is very rapid tour. We will change from the provider side to the patient side. We're going to listen to a couple of speakers who serve as patient or consumer advocates and can provide their perspectives about the future of the healthcare system. The first speaker is Katie Hood who is the CEO of the Michael J. Fox Foundation for Parkinson's Research.She blogs with the Huntington Post. So -- we'll turn it over to her to talk about issues around new therapies. Then we will follow that up with Myrl Weinberg.

Thanks. Glad to be here. I have to admit when I got the invite my first thought is we are a patient advocacy group, but we don't meet the traditional definition.

I think the first thing to realize about us is we were founded in 2000 with clear objectives. That is drive the best Parkinson's research and discover improved therapies and a cure. This stems from Michael Fox himself. He said that's where I want to be and focus is required. Unlike many patient advocacy groups we're focused on working on science. It's interesting sitting here today, the discussion that was had about electronic medical records and the fact that for a long time record-keeping has been left to the record keepers. Now there's more thinking about what should be happening and how. That's been our experience as we focus on the translational space. We have funded research. Michael Fox does not fund this himself. We get over 40,000 contributions a year. Back to translational research, when we started out we thought more money faster is better. What we realized is that was good but it wouldn't get us there. We ended up -- we had no PhDs on staff in the first year, we now have eight. We did a landscape assessment. We went through every institute, every private funder, and said where is the money and where the activity? We saw in 0 4R -- '04 this translational gap. Gaps guide our actions and priorities. The most important subpoint is it's not always [ Speaker/Audio Faint or Unclear ] funding, it's a combination of funding and leadership. A lot of my comments about the future of genetics and how to hardness the potential faster comes down to not just dollars but leadership and organization. Then at the bottom -- how to derisk investment for other players? It's not lost on us that our dollar is a relatively small drop in the bucket. We try to fund the work that will be a tipping point of sorts for our funders to come in.

[ Captioner Transition ]

And in better guiding therapeutic development. Parkinson's has a series of failed triose and what keeps me up at night is what a far definition of Parkinson's is frankly too broad and everything that we tried will fail because we need to be a little bit more segmented and specialized in our approach. And the third point is time to genomics variation, which is an important part of the puzzle and people who treat Parkinson's disease PC clinical subtypes of this disease and whether these correlate with genetic causes of the pathology of the disease. And it's basically because these are large-scale investments that need to be made and everybody is shying away from that. That is what keeps me up at night, for Parkinson's and other diseases I wonder if we can crack the case if we don't invest in those long-term projects. And obviously we have value of diagnostic and prognostic markers in the clinics for sure. And I don't talk all lot about biomarkers a lot the that is another area are foundation is involved in. And harnessing the critical genetics. How can we identified the complete genetic map? Data sharing is a critical and this is not lost on anyone in this room and the studies happen everywhere but they are frequently under powered and inconclusive. Plus the amount of data produced in these studies can be overwhelming. Coordination of large-scale replication is required. And what do we do with genetic findings once we find them? There is not a system and process wearing new gene is identified and in Parkinson's that is what we are trying to do but it is definitely missing in other diseases. So what we have done, we've funded the first geno study and some of the investigators were little bit hesitant to do. The first genome Association came out and we said, we need to validate it. And the trip was, we did not validate it. So the second step was, here is just this and it is great and now there are 100 other researchers working people are the real? It is a really important question. So in 2004 we needed to fund more collaboration efforts for genetics and we have five projects that were funded then that explored gene expression and PD. And what we did today we find at birds in gene discovery and subsequent validate -- we've fund efforts in gene discovery and have been focused on to the genes in particular and the reason is listed on this page. And when we are focused on something, we have our team on staff, Ph.D. and business combination mapping out what needs to be done in those two and was doing what and where the gaps and we need to bring together. So what to the future of PD genetics look like? It is pretty clear that technologies will accelerate advances. And the Internet has been kept out of the discussion as a new technology that can really health in this area. I know its early days and I will talk about [ Indiscernible ] because we have a collaboration with them. And our view when you come back to the point, we have to try things that have not been tried before. Our general view is that experimentation is critical for progress. And the Internet really and what that bodes in terms of larger amounts of data that can be collect, if done well, how that can hold for the patients is huge. In genetics there is a rapid increase by patience and understanding the consumer genetic testing. But I think it's truly driven more broadly by coach tries to shift and use about technology and information -- by culturalized shifts and about technology and information. I will talk about other efforts that we have to increase the usability of the Internet to gather clinical research data. We think that this is happening and we would rather be on the front and then the back end. I am sure that we will make a lot of mistakes but I think in five, ten years this is where it is going to be paid so actually before I get to them specifically, about two years ago we launched a RFA to fund efforts between clinical researchers, epidemiologists and tech people to develop Web based services for clinical information. A perfect program that was launched and a lot of people said that that was crazy and we said, we know that it's very likely crazy and it may not work out but we have five teams now working on test that could be administered over the Internet or devices that could transmit via the Internet. And this is an institute in Senate Bill, California and we apply to work together on this -- in Sunnyville, California and they are working on surveys. So what has gotten a lot of attention is they came to us and said we want to increase the number of people and the Parkinson's community. They have a founder and his mother has Parkinson's and he has to genetic risk factors that we talked about. And they said, we think this numbers thing is going to be incredibly important. And the critical thing for us though, is that we need qualified interjections to people because otherwise if we offer discounts to those tasks we cannot offer a PD database because people will be coming out of the woodwork signing up for $25 genome test so they started with the Parkinson's Institute in ourselves -- and ourselves and they're looking to build a 10,000 person Parkinson's community. And it will have your genetic information and also these surveys there looking to put in surveys about exposure data, you know and different risk factors that we know of for the disease. And we know how problem brought the solace but we view this as a giant experiment -- this all is but we view this as a giant experiment that could pay off. We frequently talk about the health care and medical research when in truth they really go together and parted the reason our costs are so high for health care because they create new drugs and it does us disservice to the discretion to not link these two things together more than we do today. So as progress speed so will the efficiency and creating diagnostic prognostic tests with an old man and power -- emboldment and power. And I really believe that the date is not far away when once genome is an integral piece of what they consider with their doctor and going back to the education of doctors. You'll find some that are really open to thinking about this and you will find others that are not. And I remember early days when I came to the foundation doctors would say to me, really great doctors they would say, my patient came in with all these questions off of the Internet and they should just listen to me I can give them the best advice. I feel like we are past that now appeared that is not part of a common practice in going with your genome printout is now -- what are they doing? And I think there is a long way to go before this is indicated but I think accelerating the pace at which it is indicated is important. So the one thing that I really wanted to say at the end of this is that I really think this issue of disease is very very important. And I think things can be done in isolation to speak both Genetics impacts on research process as low as in the clinic . But without this broader discussion, are really looking at Parkinson's, are they five different things and I think it's important and really undervalued.

Thank you. Why don't we wait. Please join us at the table and we will get to Myrl and then take some direct questions for both of you. So we want to welcome Myrl Weinberg who is our next speaker. She is president of the National Health Council. And for people with chronic diseases and she is a member of an expert group which provides genetics research and return to her as we're looking towards people who think about the future of health and health care. And she provided us some important insight. So we are very happy to listen to some of your thoughts about the future of the health-care system and how genetics' shape it. So thank you for being here.

First thank you for allowing me to present and for those of you who are not familiar with the National Health Council it is unique and a nonprofit umbrella organization. And we have as our core constituency leading patient advocacy organizations like American Cancer Society, Huntington's Disease Society, we have about 50 of those. And we also have in our membership professional health and medical organizations as well as health insurers and industry representatives. The National Health Consul's mission is to provide a united voice for people with chronic diseases and for their chronic care givers. That is roughly about 40% of all Americans and the number is somewhere in excess of 133 billion people. At the council we do not work, and specific issues but rather I'll together we work on systemic issues that affect everyone. One does things and I want to make up front is that people diagnosed with chronic decisions, conditions are different than the average consumers. Average consumers are generally in good health and go in and out of the health-care system. But we know people with chronic conditions and track with the health-care system their entire lives and seek answers for a more normal life and a healthier life. And in all of our research what they say is that they want health care that meet their individual personal needs and goals. In 2000 National Health Council had a nationwide telephone focus group with patience to gauge their understanding of genetic research and their thoughts of genetic testing and we asked, do they want to know that they carried the gene for disease that has no cure. And how would this affect their life choices? How the people balance receiving information that can be devastating with the possibility of having knowledge that could health them and their health providers plan treatment that could optimize their future. While many of the participants believed the societal benefits outweigh any concerns and risks, they also believed that to achieve the benefit could controls need to be in place. They know that many serious diseases are determined by complex interactions between genetic predisposition and the environment. They felt that it was important that people be educated in a way that they can understand the limitations of the technology. Not surprisingly the focus group is up and streamline between manipulating genes in order to cure or prevent disease which was acceptable or in order to pick the characteristic of your child which was not acceptable. Participants in all groups did raise some concerns about credit go so far as, their language was that, we would be "playin God." And they were concerned that they might face health coverage decisions, decisions on one's genetic makeup. And we hope that the genetic information nondiscrimination Act will health alleviate those concerns. We need to remember that in order to provide true value and health care in emerging technologies should be used in ways that promote the best interest of individuals including those who have been diagnosed with one or more chronic conditions. To win the support of the patient community we need to listen to them and their wants and needs. And that is why we at the National Health Council have created the campaign to put patients first. Based on the input that we have collected over the years and the advocacy organization members the National Health Council believes that an order to have meaningful health-care reform it should be billed on five basic principles. We believe any effective and efficient health-care system for people with chronic conditions should cover everyone, should curb costs responsibly and the Polish exclusions for pre-existing conditions and assured access to long-term and end of life care. And many of you know of Dr. Jack Limburg who is a leading expert on medical practice variation. And he said to improve the quality of health care and control costs responsibility there need to be organized delivery systems that in his words are aimed at rationalizing the care processes. To us there is nothing more rational when it comes to health care delivery than to focus on the end user of the situation, the patient. So how does this relate to health research and health the reaffirm? We must take into account the life circumstances of individual circumstances. The stimulus package passed by Congress included I am sure you know significant funds for clinical effectiveness research. But the legislation allows be safeguards to insure that that research will be truly patient focused. We believe strongly that we need to disentangle the findings of good compared to effectiveness research from coverage or reimbursement decisions. That we need to break the immediacy of that relationship in order to avoid denial of appropriate care. Eventually we know that coverage decisions will be based in part on these teacherage findings. The comparative effectiveness research results must not drive the facto coverage or reimbursement recommendations until they are evaluated in real-world setting is to determine their impact on individuals and some populations. Take for example in man in his 50s who drives a bus. If a particular medication is determined to be the most effective method for treating his condition but that medication makes him drowsy or confused, he will not be compliant or inherent patient. For some mental health patients they have negative sexual side effects which can complicate their family life and important support system. Life is full of trade talks and no segment of the population understands this better than people with chronic conditions. They wrestle every day with decisions about whether to prolong life or enhance life. And for those with conditions like ALS or Alzheimer's they face the fact that there is not a realistic treatment today. The critical factor that patients are concerned about it is the possibility that it would be used inappropriately to deny access to care or to funnel patients into a one-size-fits-all approach. Comparative effectiveness research should suppliers with good evaluations and the net and evidence about what works and what does not work permit it should not be one product against another or one process against another. We really need to look at how different health care delivery systems operate and be able to compare those in the context of health care reform. The National Health Council has created a chart to illustrate what a health care delivery system that meets the needs of patients with chronic conditions would look like. From the patient's perspective as I said, True Value incorporates both quality research and the patient's circumstances which include genetic, ethnic, religious, and socio-economic factors at the point of care. We describe this as balancing sound science with patient focused application, the right-side of the program. I think we would all agree that better diagnostic tools used in alignment with the patients individualized goals represent the best health care and the best health outcome. A more effective and efficient health care delivery system would pay for an McCready care shown with the arrow at the bottom of the screen and would reward patient compliant with limited or no on the pocket costs. We show this at the top. And going hand in hand with health and medical research and a value based plan designed is the need for care coordination to bring all of these elements into alignment. This is represented in the diagram by the center square. This care coordination would be orchestrated using individual care plans. That care coordinator working with the patient and their family might be a physician but it might be nurse, social worker or some other person. At times the focus will be on strengthening the patient's body and preparing the patient's mind for inevitable death. Just like the life goals change over time the health care system must be flexible to health the individual fulfill his or her goals. It would need to be value based in cognizant of the cost both to society and to the person. We know that the cost of health care is that the hot part of the most health-care discussion today. And we need to eliminate the perverse incentives that promote the practice of inserting the medicine and we have found that as much as one-third of the $2.5 trillion spent on health care each year is for duplicated tests and unneeded procedures. We know that health care expenditures account for approximately 15 to 16% of the country's gross national product and that chronic disease accounts for roughly 75% of this expense bids at the more and more patients with chronic diseases are having to dig deeper and deeper into their own pockets. And take Richard as example, some of us have met him and he cared for his father for three years spending more than $100,000 of his own money before his father suffered form ALS and then there is the date is 65 and all the health cancer survivor and when she applied she spent more than $300,000 of a purge pocket before -- out of her pocket before she was allowed to medication again. If we expand coverage and increase access without addressing the out of pocket cost issue people with chronic conditions will face overwhelming challenges with their carefree we must not lose sight of the overarching goal to make health care first and foremost patient focused. We really do need now to put patients first. I want to put one final important fact. The fact is that people with chronic diseases and disabilities are pragmatic. They know they cannot have it all. But they will fight for better treatment and hears. Not just for themselves but also their children and grandchildren. Hopefully that they will be spent from a simpler than at similar diagnosis. They want to take the discussion to a much more can you level that recognizes their specific life circumstances. I want to thank you for recognizing that the patient voice is important and needs to be included in this process. Thank you very much.

Thank you, Myrl.

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Thanks for reminding us about the other dimensions that we talk about. So let's give just a moments. Let's hear from our committee is.

I wanted to thank you for your comments about using the Internet for promoting research, particularly with Parkinson's. I had a specific question about the 23 and me relationship. A lot of the information that your client are interested in Parkinson's but most of the information they get is not about it. And some of that might be on one did in the sense that it might be -- It might be on wanted and most of it will not have any information value could how do you deal with that in constructing it?

Thank you. So I think the way, First of all, the first thing we said is that this is a choice. And I think there are people who believe that people can be entrusted with a choice and people who feel like they need to be protected from the choice. And I feel like people should be empowered to make a choice and they need information. So when the letters that went out to people who identified themselves to us as people with Parkinson's. We said this is a serious decision. You may find that there is not a lot of value for Parkinson's right now. This is sort of a project to see if this could turn into something else that could provide relevant information. But you could find things out. And even in the 23 and Me study now, you have to like double, triple check that you want information before alerts, for example. There will be some people that don't want to do this and some people who do, more power to you. But it's sort of a grand experiment. So we took it very seriously actually. It comes down to 23 and Me itself, which obviously there are about the people involved who do not have Parkinson's and are just interested folks. If they do not have genetic counseling. They clearly states go, go to genetic counselors. I don't want to speak to them but people feel like, should you give this information without a direct hand off to a counselor of some sort and I'm metabolizing any debate or discussion but we are airing more on the side of giving people the choice to be part of the experiment. I don't know if that answers your questions or not.

Mine is a follow-up, 23 and Me has the research around 23 and Me. So everyone who participates from the PD communities there also consenting to then joined the research arm of 23 and Me?

What do you mean by research arm?

You said that they do the analysis and then you can opt in to have your information included in a big database, you know, and that is the research arm.

Truthfully I don't know of any of you have talked to them and if you have not you should because it's interesting. Their goals are very Research Center could. I am glad that it's not my business to run because I don't know what the business model would be and I am saying that with great respect but they have a very altruistic intent about the intent of this all to affect research. And in the sense they will sort of have subgroups to look at the Parkinson's only but you are part of the Baker database as well -- part of the bigger database as well.

And if you read the end user agreement for 23 and Me, essentially the consent if you will is broad and open to basically give you often he will be opting and for the inclusion in anything that they come up with. And they are not federally funded so there is not any specific, there is not anything to look like what we would with IRBs and everything. It is a different model and slightly less sanguine about the altruism. I don't understand the business model necessarily.

I am not here to talk about 23 and Me actually and I knew that you'd be interested in hearing about it. I think we are foolish though not to think about new models the breakup of the existing models because the existing models will not get us there. The numbers are we too large and the traditional clinical model for these are not going to function, it is going to be far too expensive when we talk about these studies that we need to do about the complex interactions over time all of these different factors. Nobody is going to find those studies so we have to figure out a different way to fund the studies. Otherwise we will have the same discussion in ten years. I should not have even said that comments about the business model. So kind of like a throw off comment like that I am not a representative of 23 and Me. I may represent representative of a group with Parkinson's that says we need to try experiments that are not been tried elsewhere.

Hi. So I don't know a lot about 23 and Me and I'm a patient advocate as well. But I have a couple comments. I don't know and I don't know if anybody around here knows what the informed toys process is in 23 and Me and that is something that is a concern -- the informed choice process. And I agree with you and I have done a lot of work on some of the trials and I understand particularly cancer which is the area that I work can, very low participation of people in clinical trials. But there is the tension of increasing people and I have also read a bottom of the literature. Increasing the number of people at all costs and doing something that really protect the patients and gives them an informed choice. So I think there is the intention there that needs to be considered.

I could not agree more.

The other thing is, and a disclaimer I am not involved with that but the American Association for Cancer Research where I work is involved with it. There is a model that has come up which is called the [ Indiscernible ] Employment and she has gone out and it's primarily women who have not been diagnosed with breast cancer but some women who have and they can sign up to say that they would be interested in taking part in clinical research. And then researchers come to her and their research studies are bedded and then there is an e-mail and communication that goes out to the people and then they can choose participate in it. So they are qualified in a certain way. I think there are multiple models and multiple considerations, I don't know. That we talked about a little bit on our conference call.

I want to clarify that I get all these concerns and these are early days for all of this stuff. And our organizational philosophy is that we would rather be on the leading edge of the creed of the early days of this stuff than waiting back. And the risk that comes with that is that there are valid criticisms and I mean that honestly. There are valid concerns that people raise. But that is our organizational philosophy and from the get go it has been about not being confined by traditional way of doing things. Just so you know, and if it's not working, been part of trying to figure out what might work instead.

Okay. I think we probably need to move on. Thank you all for your thoughts. All right. Moving on to yet another aspect of this as we think about what the technology developers are doing in considering the pharmaceutical and diagnostic industry are final speaker is Murray at IMS Health and they provide health care analyses and prior to joining IMS he had a 14 year career with Mackenzie and company and the senior vice president for IMS Health he speaks regularly on this subject about the impact of the muck of health care system changes on the pharmaceutical and diagnostics industries.

Thank you. I know that the number of slides has declined and since I am the last speaker in the group I have no slides. I am glad that we sorted that out. I am pleased to be here and I have some words, however, not slides. And I am happy to share the perspective of IMS Health on this very important topic in particular and how the prospect of health-care reform which is the elephant in the room that we have not been talking about quite as much today is going to come together with all of the excitement around genomic Development and by way of introduction, IMS Health is the world's largest provider of market intelligence both to the pharmaceutical and broader health-care industries. We have more than 50 years of experience and operate across 100 countries around the world. We work essentially with every pharmaceutical company that has commercialized products and we also work with a large number of governmental agencies and entities. What I want to do is cover three topics. First, the current and near-term future state of the pharmaceutical industry, commercial challenges, the pressures on the ongoing funding of research and development, and at the same time the opportunities that are very much front and center with four genomics based research on the diagnostic and therapeutic side. Secondly, I want to talk about some of the ways in which health care system changes which are currently under discussion can enhance progress in genomics diagnostics through the lens of these companies and their lead to describe some of the unintended consequences -- and to describe some of the unintended consequences in the private sector and that is where I hope I can be helpful to you as you develop your device to the secretary as we work for the next few months of discussion around health care reform. So let me begin briefly by summarizing the current state of play and here I will be representing the pharmaceutical center and when I talk about that I mean companies who have business models that depend on the discovery in clinical development of new chemical or biological therapeutics and the sale of those products around the world. Not just in the United States, but globally. These companies are collectively take seen some significant commercial challenges over the next five years which places at risk the ongoing funding of genomic based innovation. And the global pharmaceutical industry has sales of pharmaceutical products amounting to about $750 billion last year. And that includes sales around the world from all companies regardless and both patented and protected products as well as generic version is and bio tech and therapeutic products that are used in hospital settings and pharmacies. Over the next five years through 2013 products that have global sales of $135 billion are expected to lose their patent or other protection and face generic competition. And about $90 billion of that $135 billion are for sales of their products in the U.S. market. There are about 18 products that have sales in excess of $1 billion such as Lipitor, Plavix, Aricept that are included in these totals and they came from markets in the mid to late nineties. And they will essentially see the end of their life cycle by 2013. Although they will continue to be used in very significant ways as generic products. But the magnitude of the commercial impact that arises from the loss of exclusivity from these products is very unlikely over the next five years at least to be offset by new products coming into the market and the silt of those products. Over the last several years we have seen some very innovative products emerge from the industry pipeline and pass regulatory scrutiny. And while these products have bought a new treatment option for the treatment of oncology, autoimmune diseases HIV and HPV it has been insufficient for the loss of sales. In 2007 and 2008, for example there were 38 new chemical or biological entities that became commercially available in the United States market. And their total sales since launch amount to about $3 billion. During that same two years products that have failed $26 billion based patent protection and lost about $19 billion in commercial value. At the same time the overall demand for pharmaceuticals has been increasing at ever slower rates since 2006. Total prescriptions, retail descriptions in the United States in 2007 grew by 2.7% over the prior year. In 2008 increased by .9%. And for the first three months of this year the amount of prescriptions filled by .6% over the same period last year. And in terms of branded products it's even more dramatic. It failed 9% in 2007 and 16% decline in 2000 feet and a 12% decline in the first quarter of 2009. So this slowing weight of growth some of this is attributed to the slowing economy. Even before the onset of the current economic crisis. As all is the response of patients who are facing higher copayments, deductibles and coinsurance payments for their health care and drugs. So when we take all of the dynamics that affect the demand for pharmaceuticals and the commercial sales by manufacturers we have seen a significant decline over the past few years. And we expect similar trend of the next five years. So this year, for example, we are forecasting that the sales value of pharmaceuticals at the manufacturer point in the United States will decline one to 2%. And globally we see growth of 2.5 to 3.5% and these are unprecedented. And when we look further out to 2013 our model been suggested that there will be no net growth in the United States. And globally, annual growth between Pete and 6%. So what does this mean for companies that are pursuing genomics based technology toes? Whether they are large companies that have multibillion-dollar budgets or smaller companies whose ability to raise funds is dependent on investors' having confidence in the commercial opportunities for their products in the future. What this means is increased pressure on the availability of ongoing funding for the research and development of innovative applications of genomics to develop a new diagnostic and therapeutics that are possible and heard about this afternoon. We do not expect that companies which are doing business in an environment that is not showing any growth and with their ability to increase sales is severely limited are going to be able to continue their levels of investment that we have seen in the past. Moreover the costs and complexities of developing new products has been rising substantially relative to their eventual commercial value over the past several years for several reasons and attrition rates remain very high especially for the innovative approaches to therapeutics. So the total research Research acquired for one successful product are rising. And regulatory aright requirements are understandably rising and resulting in more expensive clinical trials and evident prior to the truck being able to be made available to patients and on going risk-management programs. Once the product has been lost are also adding to the overall cost and complexity. And at the same time we see a much lower level of commercial opportunity for companies and a constraint on funding availability, we to see the significant commitment by companies both large and small to allocate significant funds and efforts in the area is of genomic technologies. The scientific advances are clearly very promising already and we have heard more of that this afternoon. In the future prospects are transformative in terms of the ability to diagnose and treat many diseases. Beyond the scientific it dances we also see high interest among peers and the recognition that it can be applied to health care issues to result in lower health care system costs as well as the improvement or acceleration of a positive patient outcome. Genomics research does not represent the threshold that can bring benefits to a broad range of stakeholders. But the ongoing funding of private sector research is contingent on a commercial environment that rewards innovation adequately. And the near-term commercial challenges for the private sector even though we considered the prospect of health-care reform over the next year or two, those challenges are daunting. So with that backdrop and understanding and frankly I think a lot of folks do not have a clear sense as to where this industry is right now and the prospects faced because it has been so successful his Berkeley but as you know history is not a good predictor of the future. So let me have the impact of the health care changes under discussion and how they may play out. Overall we see health-care reform enhancing and not hindering progress in genomic diagnostics and therapeutics. And to tackle the issues that have been seeing for a long time as intractable are to be thwarted and the relationship between the myriad parts of our health-care system, the extreme level of fragmentation in the delivery of health care. The dynamic feature of the scientific issues that underpinned our understanding of health and disease and the role of the incentives to drive behavior throughout the system. And to address the uncomfortable realities of the expensive health-care system that does not deliver a particularly good outcomes. So we're trying to get our arms around these issues and something we see as very positive. We see potential for reform in three areas have been the most specific impact on genomics technology. First he brought the adoption of comparative effectiveness, changes to the drug reimbursement system and third the adoption of health information technology. And without having the details of the specific proposals it's impossible to define the impacts expect in fairly general and directional terms. But it is important that the ways that they may promote the advancement of genomic technology. It's important that they are understood and considered prior to decisions being made. So let me talk about each of those three big first comparative effectiveness. The systematic evaluation of alternative approaches to health care can bring benefits to patients as it can try providers to have a better understanding of what to do for their specific patient and when to do it. We are aware of the potential benefits of evidence based medicine and clinical protocols and new science based understanding. What we have not had in this country is a broadly recognized body or even accepted approach that can really health fans this. The prospect of the creation of an entity that can provide leadership and guidance is a welcome one. And the notion of being able to identify what works well in health care is entirely consistent with the science based objective of genomics technologies which are being developed so that we can enable a better genetic based understanding of what works well. So let this level this is a welcome level of health care reform. And we have experience with health systems that have already adopted national comparative effectiveness reviews in one form or another over the past decade and there is no firmly established best system and in every country there is a high level of tension among stakeholders about the usefulness and application of the uplands of comparative effectiveness research. And they are dynamic with methodologies and approaches to changing pretty significantly over time. But there are some learned lessons that can be applied here and United States as we design and implement our own approach. And these can be thought of in three ways, who are we comparing? What are we comparing? And how are we using the results? So first comparative effectiveness research will be conducted in such a way that it enables the effectiveness to be assessed a patient level rather than the total population level. And the challenge is determining the definition of a patient statements and genomics is complicating this because it enables these segments to be defined based on the presence or absence of specific genetic markers and there are other bases for segmentation as well such as regression and the definition of the patient segment may need to change overtime based on advances in clinical understanding. What is critical that we do not adopt a one-size-fits-all approach which is completely and the pedicle to the scientific direction that we're heading in. The most effective way to compare things is to do so at the most meaningful level. And getting the definition of the patient signage rate is critically important. And what is being compared? There's a trade-off between comparing something that is specific and narrow as to isolate its comparative effectiveness and in a way that is meaningful to the overall objective function of health care. And what I mean by that the isolated comparison of one diagnostic text versus another without consideration of the full ramifications downstream in the health-care system may lead you deftly with a technically correct but hardly useful comparison. And it must be done in the context of the full course of intervention for that patient. And episode of care approach or approach that recognizes the full range of activities that can influence an outcome must be utilized when defining what is that is being compared. And how are the results of this comparative effectiveness is being used? And we know that comparative effectiveness often undertaken by some type of Health Technology Assessment agency can be used in many different ways. From setting broad treatment protocols for all patients to being used as a patient for rationing of health care and restricting access based on cost effectiveness. What is most deporting is that there are mechanisms in place whereby the output of comparative effectiveness can be applied in the practical setting of a doctor's office or clinic or hospital to be patient based on their defiant characteristics and consistent with the segment definition that was used to compare alternatives in the first place. And again, this is an area where the prospect of health IT and the incentives which I will come to in a minute play a critical role and must be designed so to be supportive of a more evidence based approach about what therapeutics to apply to which patient and when. And we also know from experience in this country and other that findings that emerge from any kind of comparative effectiveness effort take time to be integrated into standards of care. And this process requires active and ongoing support and it will not happen on its own. An additional complication to the implementation of comparative effectiveness findings is that we operate in a very dynamic a scientific field. And there is a need for continuous one entering of retrospective as well as prospect of analyses to make sure the findings and conclusions are updated and current based on the best available information. Prospective studies certainly are the step that the central for pivotal Research & they are too slow for research purposes. So properly designed retrospective analyses data that can be performed by the public or private sector are central to meet the ongoing needs of providers and patients. So the direction of reform with regard to comparative effectiveness, we would say is positive. But the challenges in designing and implementing comparative effectiveness research are very substantial, dynamic and interrelated to other parts of the health-care system. That being said without transparent, mechanical approaches to comparing alternatives we will never realize the potential of the innovations including genomics based innovation which is coming available to patients let me turn to reimbursement and incentive issues and when we look at the current drug and diagnostic reimbursement approaches. And these are based on some level of assessment with a combination of cost and value of the procedure or therapeutic. But we know that there are substantial distortions and current level of payments and fundamentally we have encouraged the health-care system where most of -- where more of everything generates more revenue and profit to providers and suppliers. Health-care reform element that helps support a major shift toward rewarding wellness, prevention and efficient management of patients can provide an end the it is support genomics diagnostics. And it can result in substantial efficiencies in the diagnosis and treatment of patients and our health system is weighed down with redundant test and trial and error of potions and patients having to return again and again to their physicians to determine if they are responding to a particular course of their peak and if not, beginning them on alternative treatment and a further tests. The cumulative time to get a patient optimally treated can be weeks or months of testing and trialing and the cumulative cost and that is what we see in our spending increases and a growing health care fund deficits. Moreover the cumulative costs to the system includes a crowded boat waiting rooms and patients who have to take time off work and walk into the system and stress in their lives and also in their families. The process of health-care reform is that we can move towards a more rational system that rewards efficient use of bar provider system, more accurate diagnosis and quicker resolution of a patient's health event. That will require an approach to reimbursement that says that higher costs in some part of the health care budget can be more than offset in lower-cost of other parts of the budget. And potentially higher spending on better and quicker diagnosis and optimal treatment options can lead to lower overall spending on treatment and the profit four genomics approaches that can enable patients to be pre identified to determine which Therapeutics will be the most effective and what dosage. That is an approach that must be fully embraced by are reformed health-care system. And his critical to their adoption and further development. Managing health care costs in silos of expenditures with a budget for diagnostic tests and drugs and physician services and hospital stays and surgical interventions and rehabilitation services. That does not and does not enable the entire system to be optimally inch and leads to higher health-care costs. Managing health-care costs will reduce overall cost and reward those parts of the system that can health will lower overall costs while maintaining or improving patient care and outcome. That must be a part are preformed. And mechanisms to reinforce such approaches will in hand and not hinder the genomics based innovation the adoption of Healthcare Information Technology and e-prescribing standards will health support this. And to provide a greater flow of information will enable providers to leverage the scientific understanding of sissy with biomarkers -- associated with biomarkers and have better outcomes but we are aware of the limitations of their current systems that provide. Large parts of our health-care system. And replacement of the systems with approaches that provide the interoperability and access by corporate users at appropriate times when critical decisions need to be made as we heard from David this morning will enhance the prospects for genomics based approaches vary substantially. And the ability to retrospectively nine large pools of patient information including their genomics markers will be enhanced by full information of HIT and this will give scientists the ability to identify new areas of research and development and supplement existing approaches. So bringing the right information at the right time and with all the necessary patient privacy protections in place, Of course, this will accelerate the benefits of genomics based research reaching patients. So what are the risks to speak? And we would say the major risks to genomics technology seen through the minds of the private sector is really the prospect that there will be less funding available for private-sector investments in the high-risk research and development activities that are still needed and will be needed for a long time to sustain the innovation drives and deliver the promises of these technologies. It's clear that the overall approach to reforming the $2.6 trillion health care system results understanding the issues and the cost burden that the system is placing on all of us and our children. It's much less clear today on how these are likely to be tackled and especially who is going to pay for what. And I guess that is what under discussion literally as we speak. The greatest risks from our perspective is the prospect of reduction in reimbursement rates or cost control that reduces the funds that can be provided to companies that are putting their capital at risk in the hope of advancing genomics technology appeared in the current proposal for example to increase Medicare drug rebates and high-cost treatments should simply cost less regardless of the value that they bring to the health-care system. These proposals will inevitably dampen the willingness of companies to continue their investments at current levels or, indeed, increase their spending in order to accelerate the dances. As mentioned already the ongoing funding is already under pressure further stressed by price cuts or other expectations for lower expenditures for innovative diagnostics and therapeutics will potentially slowdown or even stop the willingness of the private sector to invest in these areas. So in conclusion, the potential for genomic technology is clearly an illness. And the benefits can accrue not only -- is clearly enormous and the benefits can accrue not only to patients but the broader economy through lower health-care expenditures. And changes can accelerate our progress to the full realization of these benefits through the use of comparative effectiveness and changes and drug reimbursement incentive systems and through the adoption of Healthcare Information Technology. We must make sure that the focus of reform is on the ultimate design the out come from the entire health-care system and that we work back from there to identify the more specific changes that are needed. And we for measures must understand the innovation cycle that exist in the public sector, and academia and the private sector. To make sure that on going support for efforts that have already brought exciting results and even more exciting prospects for improved health to all Americans. Thank you very much for your time.

Great. Thank you.

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To questions, we will start with you, David.

It seems to me that many of the dances in genomic based technology is leading to useful -- the advances in genomic based technology comes from big companies that little companies what is the future for the company's?

Right now they face a difficult near-term caused by the economic crisis and the essential freezing of funding from the venture capitalists into small companies. There are various reports about reports companies that have less than six months and they will only be able to continue to attract venture capital if there's the prospect down the line in ten or 15 years that the outcome, the output of the product will be reimbursed that there will be a commercial market for those products. I think part of the reason that we have had a very poor environment for small companies in the last couple years is because that expectation, that prospect is it the less clear now than it was five, ten, 15 years ago. And all of the talk about how high-cost medication and the cost of health care is a little different than we see things. But those prospects in the prospects that prices will have to be cut and someone, that puts a dampener on capitalists and where to assume risks. So is a real issue for those small companies.

Genome, thank you for an intriguing inspective on health-care reform and particularly in the field of pharmacology. And I am wondering if we could step back in a little bit. And a comment on this and then I have a speed specific question. If we look at the last six or seven years and the expenditures on new drugs are same class agents, correct? So we have not seen the breakthrough that we might have expected in the past. So between this and a breakthrough there is a progression. And that progression, the way science progresses is really iterative. And I think most people who have not spent part of their clear in science believe that so many discoveries will be revolutionary opposed to evolutionary. So how do we, how can you suggest a reform proposal that might encourage greater investment in sort of the area of new molecular diagnostics or pharmacological agents particularly with the consolidation, and a corollary of what David said. Not a small companies with a single products but the larger companies where we have two major mergers going on, do you think that we will have more discovery coming out of those or will we see less discovery? That is what I wonder if he could dress, innovation, not health-care reform but the model but the consolidation that we're seen in the pharmaceutical industry.

Those are all interesting topics to delve into piper stop with respect to consolidation within the industry. First half with respect to consolidation within the industry there is no evidence that bigger is better and from the productivity perspective, the reality is that this is still an extremely fragmented sector. And even with the mega mergers, no one company has more than 10% of the commercial market or the spend on R&D and if you have 1% of the market you are still a top 20 player. This is still a fragmented sector of innovation, despite the fact that some of the R&D budgets are many billions of dollars. And the other issue, though, in terms of for the innovation comes from and incremental versus break through. I think now we are at an interest ing period where payers, and this is a global statements. And let's be real, the U.S. is not the only place that pays for drugs. And companies that invest in new drug development rely on China and Western Europe and Japan to find their investments -- fund their investments. And they are clearly pushing back on the incremental improvement. And we see that there for having an impact on what is coming through the pipeline. I think five to ten years ago we saw a lot of incremental innovation coming through. We are seeing less of it now because in the last couple years for example, products that are incrementally innovative have not been reimbursed. Or have not been accepted in the health-care system. Meanwhile the early stage pipeline of most companies is full of very high risk, interesting and more likely to be a breakthrough kinds of therapies including genomics based. But we have five to ten years before they come to the marketplace. Which is why we are concerned about what impact near term health-care reform may have on this whole sector. And whether it can tip the balance for companies in terms of their willingness to continue to invest in these high risk break through kinds of innovations. So that is why we need to be very deliberate about how we think through the impacts and unintended consequences of what is being discussed right now.

I would agree with you as someone who has tried to write small business plans, challenges to intellectual property and now not having a pharmaceutical industry necessary as an exit. It makes writing a business plan considerably more challenging. But my question is on another point that you made. I think you said that there were $135 billion of their picks coming off patent over the next period of time. So what happens when a pharmaceutical comes off patent? The amounts of money being spent declines because of lower cost generics. So what happens to the difference? The amounts of money being spent on a patented medication and a lesser amount or is it a lesser amount when you add up the generics in the market?

It is A lot lesser amount and it represents a savings to the health system that one would hope can be identified and managed appropriately. Whether it be allocated to fund to the maxim higher cost more experimental kinds of approaches or other parts of the health care system. But right now I am not sure that we have a good means in a sense to follow with those savings flow.

Right, in the immediate term one potential offset to the decline in investment that the private sector might make an innovation is to capture that transitional money.

Yeah.

And one of the problems, of course, among the big drivers of the increasing costs, and technologies in the aggregate have cost more overtime and we are talking about some of these that are not cost-effective but are really going to add net savings. And where I would like to see this go is to get greater to drive greater efficiency in the health-care dollar. And you again said that some of these things are on the horizon. It has been pretty rare where we see things that saved us money. And that is true of population health as well as the health-care system. I think this is a continuing challenge for all of the technology department. I wonder if you could reflect, how realistic is it that we will see over a relatively short period of time some of these innovations. And over the long for period, things go to America and what not. But it has been pretty tough to make that case for technology.

Part of a is because we don't quite know how to measure the cost of health care. And we don't quite have a good way of picking a number on what it cost to have a patient to flow through a treatment episode with relatively poor diagnostic approaches. With the lack of Health IT. What does all of that at the to? And I don't think any of us can put a number on it which makes it difficult to say, here is an alternative. So one of the reasons that we don't have a good sense of the cost savings is because we don't do a very good job of being able to identify what the various parts of health care from a patient and event perspective really cost us. I am very confident that the ability to use diagnostic tests to predict which patients will respond to a particular treatment, that can take a very substantial costs of the the system. We need to have a way of counting and putting your finger on where dance. And I think that opportunity is there. And that is the promise for a genomics test and their critics. And are replaced by the weight to private companies -- our advice to private companies is that you better get started in teaching in the health-care system from a payers perspective to health them understand what they currently spend. So that you can then come in with an ability to say, here is how much less you can spend in aggregate by applying these diagnostics or therapeutics. Even though they may cost you more.

Than a specific reference to genetics, I will go back in little bit, and with the technology out there, the developers want to see it used appeared frequently you have these groups to whom it provides a real lead manage but you see it being used much more widely. How do we get to a better partnership where whether it's the providers, payers, patients, or developers getting us not just -- to health create the system where we get, as you said or somebody said earlier, the right technology to the right patient at the right time at the right price.

I think that is one of the opportunities to really try to break down the barriers between the various silos of health care and I think CMS is a place we're that can be driven from given their role as payers. But that requires them to pay take a different posture than they have in the past and I am not sure whether we need to set up a new entity to do its when CMS in it's quest ticket value for our money really does have the obligation to do that. And I think that is why I am positive about this year been the year that everything is on the table in terms of health care. And if we have the right intent, and we have the right mind cent without being Polly Anna-ish about it, I think we can make some progress.

Thank you very much. We are going to go ahead and take a 15 minute break and when we come back it's time for us to do the heavy lifting and figure out where it is that this committee can begin to add some value to this discussion. If we try to visualize a world with personalized health care as a personal part of the system, what is it that we can be helping the Secretary identify that will health us get their? So why don't we take a break. We will all be prompt so you can give us the answers.

Thanks.

HHS SACGHS on break until 3:15 p.m. EDT

All right. Let us regroup and we will get going.

Okay. Folks, can we regroup?

All right. It's getting tough, later in the afternoon, but Marquez something to say -- Mark has something to say.

Are you ready to start?

Let me give a word of intro.

Can we turn the whole thing over to Mark?

Sure, if you could plan going for we could get through a lot of this. Last time we had some good discussion with the payers and today we heard from consumer and add advocate groups a little bit of what is going on from the industry's perspective and the providers. And now the question is, are there some opportunities within all of this which we should seize? I will try to [ Indiscernible ] and little bit because she could not be here to spearhead this discussion. And if I could frame what she last told me was, if we visualize the future that has a substantial piece of the kind of personalized health care, genomics based care that we think it could have real health benefits. And we wanted to talk about the kinds of things that we could advise the Secretary to do to health us realize that future in thinking about it in the broad terms of health care systems and health-care reform. Is there something that we have to contribute? Clearly the legislature of process, the chances are it will go much faster than we will. But we have some ongoing activities to health shape that and what will that look like? Some of the things that we have talked about or the policies needed to promote the development of cost-effective genetics and genomics technologies and what kind of things impede those technologies. And some proposals to what we can do to minimize that so that these technologies get to those who can benefit the most. And facilitate their implementation and translation into care. We have heard some of those today about the different thoughts about how to organize the health-care system and Health IT. We have heard about comparative effectiveness but I would like to defer that is a little bit since we will be talking about that is extensively tomorrow -- at talking about that extensively tomorrow and timing and when these technologies will be ready. So the discussion I would like to have today is what are the things that we think we might consider taking up to health us realize -- help us realize that future.

Mark your finger is on --

-- the pulse of America [ laughter ]

We are representative on the genomic level. We have the group and we are proud of it. So there are perhaps two elephants in the room that I think influence the discussion. In the first one is one that perhaps understandably has not been clarified for this group. But I think is critical when we think what do we take on? And that issue is how low is the current secretary -- how is the current secretary in gauged with this group in terms of what she is looking for us to do? And this seems to me that if we go any direction that the secretary is not particularly interested in that we may be tilting at windmills. And I don't know if we can get any sense of that but it does seem to me to be a fundamental issue in the second issue is to use the sports analogy if anybody says it's not about the money, it is always about the money. And I came close to despair on the sense that one of the things that is critical to be able to track the value, the dollars. And while we can pick up pieces of this that I think we can take ownership of the discussion in the very last presentation that Paul highlighted with the idea that people that are engaged with certain parts of the activity are not the ones that will necessarily we seek the award from this participation. So is there anything that we can to in the realm of genetics, genomics, and personalize medicine and health-care reform to say that if we were to reform this aspect of how we accounted for the flow of dollars this would impact facilitate work in this area which we think would add value. And those are obviously unhelpful in terms of a brief turpitude discussion but I thought they needed to be said -- A brief target to discussion but I thought they needed to be said.

[ Captioners Transitioning ]

I have no information to share with you. We do continue to work on those channels and keep those open, so we know what the opportunities are. I think the issues are general enough. We can take the -- you know, we can find the qualities and the issues that we want to tackle. We have a lot of homework to do our ourselves.

Are you thinking of a letter, a format of what we did on the last consideration, specifically written to the secretary on the health-care reform or do you have a process?

I don't know if we want to get into that. We have highlighted some of the issues and the initiatives in the communities that we wanted to take up. We have outlined some of the letters that Paul eluded to. We are looking at the priority items for the implementation.

[ Overlapping/Multiple Speakers ]

That's what that stands for, we sent that forward. I think there is a policy on the congressional, the debate, and what that is right now. It may not hurt what we feel the genomics will deliver in a short period of time. It may be relevant and preserved as people do the horse training here; for instance, the ability to embed the genomics or the elements of the genomics for the personalized medicine deal, and put that in to a health record. That would be a valuable thing to have preserved, whatever, and however the health care reform comes about and how the electronic health records play a role in that. Similarly, as Mark just said, there is a problem on who is going to pay for the innovation of the genomics. So if we believe that the personalizing of the health care genomics and reform is going to add value to the health-care system, then some sort of improved mechanism to pay for it as it delivers that value would be -- would be important.

I'll comment. I want to echo what Paul just said. That is the opportunity now is to have or create a health information technology system that has the longitudinal health patient records, so five, ten, 20 years from now, we will know what happens with people, and with currently collecting the genomic data, I would say that the data banks are the tissue, if not the analyzed tissue that is going to provide the opportunity in the future for the population analysis. That is the real opportunity right now. The technology is advanced enough to do that. Certainly, the materials could be stored for future analysis so that you could project for patient specific outcome data.

Just a clarification question, if we look at the current legislation that has been proposed through the senate health or finance proposals or as the House takes action, have we systemically looked through that and seen where there are references to the genetics, genomics, and data research? I think we have to think what is expected today. I think we know that. But, for example, the legislative examples and what is being produced; there lies an opportunity for our voices to be heard. People are debating the meaningful use. We have the input there and we can formalize through the communication. It will move rapidly, and the velocity will be great. It will be over a broader time interval. I am wondering if there is a time frame that we are looking at there. Is there a recommendation from the 19 previous meetings? I think that is dedicated to what you said previously, but I think we need to look at the health care page and others as we come to an individual opportunity.

We need to be channeled through the secretary. It is not obligated as such. I did a quick research. There are a few places where it is at. One of those is about quality and the other is about the comparative effectiveness. I do realize our advisory role, but I think since we have been told by the administration, I think we are looking at the Congress -- the shared leadership, and the opportunities.

I think there are some things we can do in the short-term here that are in the back drop, but there are things we want to do in the longer term.

One of the challenges is that it is such a moving target and it is so huge. You are going to have a finance committee zone, a house moving zone, and all of that, so I don't know at this time that we have the manpower and the resources to figure out exactly what it is and advise on it. There may be a better way to focus on that, what is in the past, and what is going on in the office, what is going on out in Arc, are there things that are being implemented, and the grant that is distributed under the stimulus, maybe there is a recommendation where you have a tissue storage and requirements. I think this administration is not afraid to make that recommendation on the federal dollars. I think it is effective to look at what is already there. It is still moving quickly, we need to have a good impact on what this committee is. This will enable us to give more specific advice to the secretary and the agencies and the offices and we can rate the profile of the committee with her.

Yeah, I want to second the idea that Sheila just brought up. It is a rapidly moving target. It seems hard to anticipate where their priorities are and what they want to here is not the best way to go about it. We need to move in a methodlogic manner. We don't know. We have to focus on what the guiding principles are that will allow us to figure out what is good and what is not moving on in the future. I think it would be premature to identify specific things that are going to be the future of genetics and medicine. We don't know yet, we have to focus on the methods and the procedures.

I think just to follow up with that, one of the challenges that I have experienced is that there is nothing specific to demonstrate. We talk about the value, we talk about the cost-savings, and we believe that is going to occur, but that is a real sticking point. Every time we get to the logics where it is advanced, you know, in the medicine, it's the opportunity to bring people in, do a survey, and we can use the authority of this committee to convene better information. We have the reach to turn that around. Just to follow up before we go to Liz and Allen, but we can put in different principles that are considered advice there. If we have a group that did that, we could move that forward, an we would be ready for the October meeting. I don't know if it is timely enough. Building on the principles, some of the issues we are discussing for the health care reform, we have tracked through all of the resourcesful we are look agent some of the -- resources we are looking at some of the issues. That is the volume system information, health information system, and the standards, privacy status, clinician support, can we pull that from the work we have done from the specific issues that we know are provided and are they going to be part of the health care form.

So from you, I am hearing that we can go back through some of work, do what we are going to be hearing tomorrow, put it together, but do it more broadly, and we have --

Look at the key elements.

Yeah, look at the key elements.

Move forward.

Maybe it is not principles, maybe that is not the right word Z but components --

[ Speaker/Audio Not Clear ]

And then at the same time we can move forward on the issues with the health care reform. We can bring people in and continue with those deliberations. You know, the [ indiscernible ] reimbursement keeps popping up and up. And the -- [ Speaker/Audio Not Clear ]

So this is on this topic or another one.

Allen?

Yeah, I agree with a number of the comments that have been made, specifically with the ones that Sheila and Jim have made. I think the community can in a sophisticated and knowingly way, can move towards that impact. There are issues that we have that would be important to have as we go forward with the new leadership of the department, not just the new secretary, but the senior leaders across the department, and they may have a fair and sophisticated interest in the medicine and genomics. It will move us to provide health care reform information with the new leadership to move forward with some new types of conversations. I think doing the background, those pieces and points, and doing that together, and the changes in health care, which we don't know what it is going to be yet, but it could be quite useful.

I hope I am not repeating, but I want to say one of the ways to potentially move forward is to take some of the things and put those in one thing. I think Sheila is right. In order to move forward, there has to be a standardized tissue and banking. It has to be -- I'm sorry -- it has to be mandated by the NHI directors. Perhaps by outlining the major points that we want to establish, outline those, list the challenges, and then the goals and that would be worthwhile in doing and it wouldn't be as erroneous as tackling the whole world.

I agree with looking at what the economy has done, that would be useful. Going back to someone else's comments and thinking about priorities of the secretary and the department. I go back to thinking about what Obama has introduced. So we may want to look at that. I don't know to what extent in what they have done with that field and how that field would move forward if it does. I think it can give us ideas of what senator Obama was thinking was. President now, but Senator then.

She attended this meeting, right?

Didn't she?

Right.

She was.

Yeah.

Mark?

So I want to propose a new direction that actually builds on --

Before you go on to new directions, I am ahead of you in that queue, but are there other things in this discussion?

This is related to where we started before left.

[ Laughter ]

We need to put together some white-paper, issues, slash, considerations that we are moving forward on. It should be done on a fast track, and it should be done repressively before our next meeting, which may be operationally, and technically difficult, and that is one thing we can do. Let me get back to, Liz, and then we will get back to you Mark.

Thanks, Steve.

You will still get the last word.

[ Laughter ]

People have brought up the ideas of tissue banking, tissue banking, tissue banking, and I have been working with Carolyn, and she is a colorful character, and I am on two different chairs and committees, and this is an area on genomics. It is not just tissue banking, there is a huge amount of specificity and it can make the profound discoveries and validating the discovers and so on. I would recommend, perhaps, that we should -- maybe we can bring Carolyn in to speak to that, and she is in NCI. And we can, perhaps, talk with the secretary and focus on that. It's one of the things that if it is not there, it's going to be extremely hard to move forward.

I am hearing two things.

One of them is the -- [ Speaker/Audio Faint & Unclear ]

Right.

Are you suggesting that we bring that together under one umbrella, or are these separate things?

I think I can --

Dr. --

[ Overlapping/Multiple Speakers ]

I think it is what Liz is thinking too.

It has to do with the foundationally infrastructure.

Uh-huh.

It triggers me because it goes to what Mark and Paul were stating at the beginning of the discussion. We can't hope at some point down the road to capture the value of genetics, genomics, tissue banking, whatever, if we have the [ inaudible ] that don't allow us to handle information. I was not reassured from the discussion that we had earlier about the direction that Health IT was going. The concerns that I have is that we may be moving away from the standards that are clearly gaps at the present time and handle the information that is going to be absolutely critical. It's going to be able to handle the genetics, genomics and personalized medicine, and the market may not be requesting things in the long term that will have genomic values. Mike talked a lot about that in the standards talk. Was it is last meeting?

Yeah.

At any rate --

[ Overlapping/Multiple Speakers ]

So I was going to propose that we have appropriately deferred to the person in AHIC. It doesn't exist anymore.

Yeah, and the division and support group that was within that.

Exactly.

I think absent of any [ indiscernible ] appearing in the near future, it may be appropriate for us as a committee to consider taking ownership on the Health IT aspects genomics personalized banking tissues, et cetera to make sure that health I tissue will have the capacity to move towards it as we move on through the cycle.

I agree with Mark, but I think the problem is that we are already behind the training. The funding on the RSAs are already coming out already. They are not coordinating and the people that are responding are the states and the organizations in the states and we need to figure out how we can make this all work. Somebody is going to get funding from CDC to do Health IT database, and somebody is getting funding from [ indiscernible ], and we are getting a blood spot money, and we are getting Health IT, and then there is an health IE funding and it's all not coordinated. We are behind the training that -- funding that is leaving. I don't know how fast we can work to make the recommendations when the train has left the station already.

I think I agree with everyone.

[ Laughter ]

You know, I really think that what the committee can do, I think, just to be non-political, is to cut to the chase and help the secretary to advise what is possible and not possible at this point. Jim's point of: We just don't know is exactly right at this point. We don't know if genomics is going to help to understand and prove that it causes diseases or not. We know that genetics testing is causing a certain number of diseases that is plaguing man kind. It's useful and it's helpful. But beyond that, we don't know. I think it is critical. We have talked about the directive consumers, the GYs and we have enough information of what can and can't be done at this point. And also we have a clear picture of what could be done with the personalized medicine. The reason we are focusing on the electronic health records and the farm MA cogenomics right now is all we can do -- pharmacogenomics right now is all we can do. It is the information that is going into the Health IT information that is critical. The issues of tissue is absolutely critical, but there is blood, urine, and all sorts of things that need to be taken into account. There is real interesting information that can be antetotal and if you don't do analysis on the first moments of taking blood, it doesn't work. When you put in the micro-formats and all of that, you have a big problem. We have a lot of issues here, we have a lot of data, and we can be most valuable to the secretary by accumulating, putting all of the information together that we have. What could be done at this point? What could be done and how do we get there? You guys are the experts at this. You thought about it a lot. We are here to help, so ...

I just want to -- I think I agree with Michael.

[ Laughter ]

I think there is a point that you and Jim made and that is we really don't know. I can agree with that. The problem with that is: If we don't collect the information that is important, we will never know. If we can at least have the capacity to collect the information so we can learn over time, we can do so.

But it's more than genetics.

Yeah.

The rules are not difference for genetics. We have to -- yeah, I am a big believer that genetics have the potential to transform medicine. Somewhere to suggest that --

[ Overlapping/Multiple Speakers ]

I think we need to continue to hone in on that. The blood test that you are talking about can be represented in the health records. Genomics cannot. That's the gap. That's why there is an argument for the genetic conceptionallism. I think that should be an emphasis.

This has been an important conversation, but I am not sure I understand the coherent plan of action. I think that is what the charge just was from our chair. It is a [ indiscernible ] because back in December we tried to do precisely this. We were trying to identify the core issues, anticipate what is likely going to be, and then to elevate those contributions from this group over the past several years, and those are directly relevant to those issues. Now, we are 6 months smarter than we were back in December. There are a lot more energy around these issues, but we are faced with the mechanisms and the strategic conversations in this group. People working on the health reform bills are getting hit every day with hundreds of special interest groups. We run the risk that we are the genetic special interest groups jumping up and down with the genomics, genetics, epi-genomics -- nobody knows what that is -- [ Laughter ] -- and we have a coherent message that is essentially strategic to what this group is and fitting that in to a facility to a complex and chaotic public deliberation. We have to have specific guidelines of what we are trying to accomplish. We need a general understanding about this group today and how we are going to move forward with it. When we put it together primarily with Sara and Steve, which is a little bit of the process, but we have to agree what we are going to move forward on. We have to negotiate it, think it through, and then have it put together by October. That's not possible unless we set up a process today that is going to accomplish that. I think we need to strategic in the way we think of things. We need to recognize the processes that have been astrained as well as constrainted over the past couple of years, and then get together with Sarah and Steve and come up with a consensus and what are the actions that we need to do to make this worthwhile.

Tamara, are you on the phone?

Some one is on the phone.

Rochelle.

Hi, Rochelle, just to bring --

I have been listening all along, I got disconnected and reconnected.

Did you hear the discussion today?

Yes, I did.

Mara, I tried to say what I thought you had said to me earlier, but do you want to articulate what your idea was? I thought I heard her. No?

No?

Okay.

No. I think we can redo most of the things we have reviewed. This has been one place or the other, the type of work we have done today. We have not identified the [ indiscernible ] We didn't focus on the [ indiscernible ] I don't recall some of the issues that we have focused on such as the privacy and the protection issues, but we can go back and --

But, Steve, I --

I'm sorry, but -- as I remember the document that you created, the summary document that was created, I don't know that that is a focused strategic, meeting Paul's criteria, strategic, for the moment of a health care reform and documents that we want to put forward right now. I agree with what Paul just said, but I am not sure that that document is what we need.

I agree. What I heard is -- at least the items I heard were the issues regarding the blood specimens. I heard about privacy concerns. I heard about DTC, laboratory, health information, technologies, decision support, AHICs, coverage and reimbursement, right, both, and all of those things we have done this for. We have core issues. We didn't lay them out that way in the report, but certainly they are there and we can hear the others. I hope you have read the DTC summary. If not, that is tonight's assignment, and it is in your book. That will be rolled into tomorrow, and we will discuss that. That is some things that need to be rolled out. They are of importance. I think Mike said it nicely. This is not a strategy for you?

No, I think I would like to be much more -- I would like not to have a long laundry list of things to do. I want to think about as Mark said, as we are in the health care reform, there is going to be something different from now, so what are the one or two or three things that we have to have in that that it is moving along and all of the things we are here for are going to happen.

You are talking about a reduced level --

A much reduced level.

As opposed to more.

Yeah.

If you go to a reduced level, I think the comments that we have heard today, and we have a an idea of the legislation, and there is a specific idea of changing the delivery systems, the effectiveness of the research, but you need the infrastructure for these, and we have identified the reports the need of infrastructure.

Uh-huh.

So the moving trend has left the station or is moving the station, we know what information is necessary for the privacy issues, technology, policies, and all of that that is going to take place. If we can start laying out the infrastructure needs to move forward, either in more detail, I think that is what we need to work forwards.

We can do that.

I suspect this is not going to be specific over the technical areas that we have talked about. I want to re-emphasize that there is work underway with a tight time line with Health IT. We know there is a time line on the competitive initiatives. I would think that we can go back -- not rediscover of the work in the past years, but take the work, reframe it, and take that into consideration and then we can conform that dialogue and all of the potentials of understanding the genetics. That's where I was coming from. Since this will be a journey, then the elements will be within legislation and the secretary will be reached, and that is where we can address the technical observations.

That is a strategical thing to do now?

Sheila?

Well, you have been there and you have done that, but you have been on the receiving end of this.

I think what I am hearing is coming together. I think maybe -- I was thinking, you know, as I was sitting here, as I was sitting in Rick's seat before. What is most useful for me from sitting in the secretary's chair. It doesn't have to be an action or a recommendation, it can be something that we are sake, you know, -- saying, you know, and the infrastructure, and here are the key issues that are somewhere in the state of play. Is it trying to get the genemics and the -- genomic standards of the health care reform infrastructure, here are the issues that are being talked about a lot Z and they are still being talked about, but these are the type of infrastructure things that are building into the larger reform however that emerges. That may be concise in a direct way. We may be able to integrate the new proposals. Here are the things you should pay attention to as you develop the initial grants on the comparative effectiveness research. The influenced worker, you know, the things like that that are going on. We need to reiterate it a little bit in the transition of that. I would say, you know, as people come in across the agencies, they really don't know. They have the books on the bookcase, and they are all blue, and you don't know where to start, and they are all very thick --

[ Laughter ]

-- and you look at the things that you can get to quickly. I went out to Arc, and, you know, what do you do in this area? Why is it important to the portfolio and the secretary? If we can look at it that way and through the lens that they are looking through, it would be important to the secretary, the staff, and then let her know this is the resources, this is what we need, this is what exists, and -- you know, a lot of people go to the doctor and they say, wouldn't be great that we have electronic health care records, and there are all of these things that need to be done, and then you would have someone say, well, let's get started on that. I have several duplications and I've said, oh my gosh if I only would have known. We have building blocks and we identify the two or four items under that. We take each of those in the following meetings to really dig into the details at as granular level.

I am hearing this evolving to a short list of things that we can get an agreement on today that we can actually do fairly quickly, capture, and then, perhaps, elaborate on, again, as we go forward?

I want to make one point. You know, the specimen infrastructure and the tissue banking that you are talking about are part of the larger measurement infrastructure. That is one aspect. The rest of it is with the IT piece that goes into analyzing the measurements as well.

I understand what you are saying. We will have to --

The key to that is linking the clinical data to the --

We heard about the cancer today, but we didn't hear about the long-term cancer survival as it relates to the factors. I have worked for 20 years in this field, but I wished 20 years ago I would have known now about building a bigger bank.

What?

I guess I am a little -- I always get strategies and tactics confused.

[ Laughter ]

It seems to me what we are talking about here is if we have the larger strategies and the tactics here in this reform, I think we have to engage only after the dust settles and after they show up. I am not sure we can do that now. I am hearing that we need to consider something that is more tactical. Where are the things that we know the work is happening, it relates to what we are doing, and we can give the specific recommendations and suggestions as you are saying, here is something that you should not forget in order to tackle the Health ITs and that sort of thing. Ultimately, it's going to help with our strategies down the road, it's not a big over-arching, but it is actionable within the frame work of what is happening today.

I think even if we say -- take the bio-banking, I know it's not an area that I really know, but we have to talk about the standards, the processes, and policies that the community is going to agree with things. We talk about the bio-banks, linking the records and there is a set of issues that we need to flush out under that one item that allows us to say something that is concrete rather than saying we need an infrastructure to make it happen. The flip side of the coin is that you don't necessarily need to solve all of the big issues that you are talking about. The people are already doing their bio-banking under some certain set of rules, IRB, or something else. If they are all collecting the data and the representatives the same way, then, ultimately, as the bigger pieces resolve and you don't have to scale it, you don't have to deal with the fact that you have 5500 bio-banks around the country working with 5500 difficult systems that we are going to have to somehow figure out and reconcile. We have to take the efforts that are fairly mature around the standards and the infrastructure and we have to discard of them and start over.

The interesting thing -- kind of following up with Mark is saying: You can collect the data, but there is a profound difference of the tissue that is clicked on Friday and Monday. It sits on a fridge from Friday to Monday, so you have to have the rules. So the difference from the expression level and in recognizing the performance of number and what they do. There is no standards to that.

There has been a lot of work that has been done in that particular area. There is a lot of work that --

Right.

-- there is also CAP already involved in some of the issues. CAP is involved, and I was going to say that there is a group that has thought about the issues and brought them down to the table.

Yeah.

[ Overlapping/Multiple Speakers ]

I'm confused about what this conversation is about.

[ Laughter ]

We are talking about bio-banks and we can talk about those for the next day or two, easily, and we are not going to come up with discreet recommendations about bio banks in a short amount of time. I don't think that is what the focus should be. The intent here, the involvement here, is to put together a page which includes a list.

[ Overlapping/Multiple Speakers ]

[ Laughter ]

The intent is to put together information and provide it to the secretary, and then, number two, the bullet points those have to be something that we can come to a conclusion about and say something about. Right? I would throw out there that the medical record is one of the things that emerges. It's a timely thing. I think we probably all agree that we are making sure that the electronic and medical records as they are developed have some capacity and functionality with the genetics in mind is reasonable. I want to throw that out there. I don't think we should get too tactical, I think we need to stick to a few bullet points.

What are the bullet points?

I heard one.

The record.

What else?

The evidence development.

Evidence development, yes.

Since there are demonstration products in the medical home, I would agree, we need to put together very tactical issues, and they are not highly technical, but they are bringing out the meanings that have been addressed today. I am thinking one to three pages, bullet points.

Can I make a comment?

Was that Michelle?

Can you speak loudly, Michelle, we can hardly hear you.

I think we were talking about the relationship with the primary --

Michelle, can you start over, now we can hear you.

Sorry. I want to pick up on the medical home issue, and the remark that Mark made earlier when he talked about the relationship between the primary care position and the home position, and the characters. That is going to be a distraught relationship. The medical care is paid for by delivering cognitive care to patients. I am wondering if doctors are going to be as quick to refer patients to the [ indiscernible ] IR think it is going to be a real problem. There is a question there of: What motivation are the doctors are going to have? That is something we want to comment on when we talk about the reimbursement plans.

I heard that they were part of the team. It's the availability of the expertise at the level that is appropriate.

Right.

So if the new model of the reimbursement is a coordination and a team model, and that is the housing of the team, --

[ Overlapping/Multiple Speakers ]

That would vary by location in how that care system worked.

Paul, Sheila, and [ indiscernible ]

Having participated in the same process earlier, I am just wanting to be sure that the lessons we learned was shared with the group. I'm not sure it is the best use of the 15 minutes that we have to identify each bullet point which is at a broad level and quite technical, but rather to, basically, suggest that a small group of the committee deals with this conversation and we basically put together the bullet points in a coherent fashion that is representing this conversation, and we can frame those bullet points in the broader context that is elevating the work of this committee. It is elevating the claims of the health care reform's contention and it will transend the other groups in this initiative. The other criteria that we didn't pay attention to long before and we need to recognize it, but the information and points that we want to make, we should ground those. We should draw heavily by the work that is generated by this group or we don't have the legitimate signs and buildings -- legitimacy -- -- legitimate signs and buildings and legislate sei -- the bio-banking the genomic family history on the HR, the products and the selections and all of the issues that are being ensured on the recognitions of not averaging everything. It is the patient advocation and post marketing effectiveness and the designs. I was trying to figure out from what I was hearing and can we bring it down to a --

[ Overlapping/Multiple Speakers ]

How do we develop the coordinated system of care whether it is a systemic of home and the care.

I would just rather concentrate that we have the adequate translation of innovation. There is a system to -- -- and financing to use that towards the comparative stuff. This is a challenge to financing. Are you talking about the reimbursement and financing?

That's certainly part of it.

Well, I'm talking about the -- well, I'm talking a little bit about R & D. But the R & D is not --

I'm talking about the environment in which the innovation -- where the innovation can be developed.

This is integrated granularityy. Some of that can be shaped in part of that to --

Please pardon the interruption. Your conference will be disconnected at this time. If you would like to continue, please press one now, and your conference will be continued.

[ Overlapping/Multiple Speakers ]

Whether that is a public or private, you know, there is a system transition that is integrated now, that is a transformation of the reform, and Jim and then [ indiscernible ]

So I am trying to bring us back to what the bullets might be. I am a little confused as to why the bio banking would be a bullet and what we would say about it. This committee spent a long time addressing a very closely related topic and issuance of the letter to the secretary which had to do with the large population and study. Would we be saying that we think there is a big national blood bank? I don't think many are ready to say that. I would advocate not having the bio banking on this short list. I think we have addressed it. It is a contentionous issue, and I don't think it is something we can address in such a brief period of time.

This is [ indiscernible ] Another issue. When we talk about the bio bank and the support of it and the research of the enterprise, there is something that struck me the other day is that there RO some of the grounds -- there are some of the [ indiscernible ] that is proposing the measurements of the genes and so on and so forth, and it may be done in laboratories or not.

[ Speaker/Audio unclear due to strong accent ]

I'm not sure we want to bring the issues up with the measurements that are going to be part of the quality control or the research environments and the [ inaudible ] of laboratories, and then we need to research materials to make sure the quality of the measurements are applicable to what we need to do.

[ Speaker/Audio Faint & Unclear ]

So I just want to comment now, because I didn't understand what Paul was saying and what hi meant in terms of transition, but I think it is important that the [ inaudible ] needs to be defined. Bill is co-chair of the clinical trials and the working group of NCI. Well, the translation of the research in NCI is different than what Paul was talking about with the translation. I just attended a translation research meeting which I thought would be one in a cancer community. It means different things in different communities. I think it is important when we are doing this that the definitions are clear. They will be hearing from all of the different clues. That is why I was side barring, that's the talk. I think it is important. Translational is a --

I agree.

I think all of the things we are talking about here are post R & D translation based. This is something that is --

Right, but --

[ Overlapping/Multiple Speakers ]

Let me tell you in the translation research, if you are --

[ Overlapping/Multiple Speakers ]

Right.

One, two --

Right.

You are hearing the --

[ Overlapping/Multiple Speakers ]

Absolutely.

No.

So that's just one -- I that's just -- that's an issue that I think is clinical and I think people will understand it in different ways.

That's all I want to say.

Are you talking about the bio banking and the Health IT stuff, I call it technology infrastructure.

We have to be specific enough here that things are going to need to be meaningful.

It is

I know.

I don't want to do a whole lot of word checking right now, that's not something we can do. I want to make sure we have the high level issues pretty well under control, and then we can get -- we can can get a small number of volunteers or designators to get something together and get a draft out and get that embedded and get it -- decide whether we can get the consensus over the summer.

I'm sorry, Jim?

I don't see back there very well.

Again, what I am hearing things related to the electronic infrastructures, I am hearing about the comparative effectiveness evidence, medical home, coverage and reimbursement and medical care, and that is five.

Do you want me to take a vote on those? Are there others? Is there something that you think should be dropped or?

You are looking at me like I have it wrong?

Oh, no, no, no, it's fine.

HIT, electronic health records and all of the standards and things that go a long with that, elements, comparative effectiveness, how we get the information --

[ Speaker/Audio Faint & Unclear ]

Right.

Third, bio banking. Fourth, with coverage reimbursement and how we pay for the new technologies. Fifth, the medical care and home, and making sure the genetics are integrated in that. That is the five I heard. I don't know. Is that --

What I was saying is that you could put the Health IT and all of the other measurement infrastructures in support of the evidence and everything else. You could call it one big thing.

You know, you --

(Speaker/audio unclear due to distortion and feedback, as well as speaker/audio unclear).

Frs phs

[ Overlapping/Multiple Speakers ]

What is number four?

Is the oversite playing in or not? Are we done with that?

It wasn't on my list right now, but Andrew brought it up.

I don't -- I was just going to say that -- I think it's going to be important, but it is probably not part of the congressional activity at the moment in all of --

[ Overlapping/Multiple Speakers ]

I would argue that we have done bio banking.

We need --

[ Overlapping/Multiple Speakers ]

-- just as a --

As [ Overlapping/Multiple Speakers ]

What was number four?

There's one more thing for the focus. We are advising the secretary and not Congress. We need to be able to give her advice in a way that she can execute it. She has at her disposal the agencies at HHS, those resources and some of these can be large and cross-governments. Those are going to be important. This is something that can really take ownership of in the Department of HHS.

[ Overlapping/Multiple Speakers ]

Right.

I think we are -- well, there is a lot of legislation that is going on, and she can influence that, and is that the only piece of it? The questions are --

I'm sorry, Rochelle, do you a comment?

Someone, hit me for you, Rochelle?

Guess not.

Okay.

Can we make -- I'm going to go with -- maybe some of the larger issues, the electronic delivery, health records, et cetera. Technology, bio-banking reference materials and so on. And then we can do the comparative effectiveness, so we only have three or four big headings, but there is a couple of bullet under each of those so we get all of them in.

I think that dilutes it. I think it is sneaking it under the table. I think we should have one page with three or four bullets with something to say. Not just vague and nebulous.

I think your earlier points are well taken too. If there is something to say, there are initialives we can take up in the future. Not reinvert the wheel, but to follow up with bullet one and two, and come to us if you need help. We have resources and we can direct you and help you and your staff understand the resources that are existing across the department and they are really vast.

Let me make a suggestion here. Two things we have not had a lot of deliberations about the bio bankings there is a lot of population studies and there are a lot of things we need to discuss there. It is probably not the key issue in the health reform over the next few years. I would keep it to the immediate things. We can take up the bio banking, it's a good topic, but we limit it to the other items we have on the high-level bulleting and we get a small group together to do that. To the extent that we can draft up a short piece, is fine, but I don't want a long laundry list here.

I am agreeing to that strategy, but I am sympathic of what Silvia said.

[ Speaker/Audio Faint & Unclear ]

[ Laughter ]

We heard Dave -- no.

[ Overlapping/Multiple Speakers ]

You should know my days in the industry, when you make the sale, you close the bag.

Mark is working on the appendix now.

[ Laughter ]

I'm working on the programmatic issue where the Health IT policy is meeting next week. It seems to me if the small group deliberation and the possibleness of this group may be out of the station before then. If this is important and we can craft something that can potentially get to the policy meeting --

One thing we can do, Mark, and as you know, we send thank you letters to people who are offering the expertise. We can send those off to David, and we can reiterate that. And the other thing that I may suggestion -- and it may be easy and it may not. It's to suggest that there is a liaison between that committee and this committee.

Are we in a position to offer anything new? That's the question. This is not going to be something that the reconsidered. It's part of the table among other things. I think it is a good thing.

It's not new, but I am thinking it is important.

Our role is that you remember the --

[ Overlapping/Multiple Speakers ]

Right.

There is already old work that has been done. It's been a couple of years now on the genetic information, the family history, and how we are going to pull and use that in these cases. We have to make shower all of the work is done in this. We have to remember that, we have to pay attention, it's important. Is there anything in the --

Well, we can do some of that, but I was going to suggest that Mark write a paragraph with a bullet point, pull it together, and we vote on it tomorrow. We get a resolution, and we incorporate it and we get it back to him. That is separate with anything that we do on the --

Do I have a small number of people who are willing now to help craft --

No.

[ Laughter ]

I've got David. Sheila? Paul? Andrea? Paul? Okay.

The others are free to volunteer, and if we can get --

Who?

David, Paul, Andrea, David, -- oh, Sheila and Paul. Paul W and Paul B.

We only have --

Yeah, we have be dePauled here.

[ Laughter ]

All right. Thank you. I think we have come a good way.

This is the list?

What do we do with the HR?

Well, I think we can put that in there, and they can think about whether it needs to be in the broader technology context or the HR context.

Okay.

All right.

Thank you.

I think that was a very productive discussion. I am not sure this is going to be the last time we talk about what to do on those issues.

Since we last met, we have had the opportunity to benefit on the public comments on the patents report and licensing. So Jim is going to spend a moment and let everybody know where we are and where we are going.

I want to express a huge amount of thanks to the task force members who have spent a lot of time and are going to spend a lot more time now that the public comments are in. This is a difficult processful I want to thank the public. The response was really good. We have a lot of great comments. The public comment period closed as of May 15th, we received 77 formal comments. They amount to 392 single spaced pages, and I have read them all, and I am going through them a second time now. They range from 7 lines in an e-mail to 82 pages.

[ Laughter ]

They come from a wide variety of sources. There were 11 from professional associations, 16 from transfer offices, industry organizations and life sciences, and they represented 11 comments, and five of them with by academic organizations, 9 from health care providers, 12 from private citizens. They were all well-thought out. Adjectives --

[ Overlapping/Multiple Speakers ]

[ Laughter ]

I did a word search for erotic and there and --

[ Laughter ]

I would say that the range of the opinions reflects to the openness of the process. This is a very open process. We have as attested to that we got lots of comments that are ranging all over the spectrum. I was worried about what we would see. It is scary to spend all of this time and [ indiscernible ] over this kind of thing and then we lay 300 and some pages out there for anybody in the world to comment on those. I was gratified once I started reading them. It was criticized at times hardly, but the criticism came from opposite ends, both side of the spectrum from the ones that have little desire to see the changes, and from the ones who care about seeing the whole genetic landscape. I feel we have a good junction which you juncture. The hard part is going to enSue. It's going to be an -- I think the diversity that is on this is the strength. This has ramped the process and the balance that we have and that is far demonstra tiffly. I'm not sure who got stuck with the 82 page one. One of the obvious -- and really, in some ways, the easiest tasks is to correct any factual omissions or errors that occurred. We will do that with the consultants of the process, et cetera. We will be discussing the policy options because, of course, and I will remind the task force of this and the first conference call will be Monday. As we are discussing the comments, we need to figure out what our final aim is. And the final aim needs to be part of the recommendations and the final reports. We will be reviewing in October the final task force proposed recommendations. They will then be discussed and hopefully some consensus can be come to around this table. And the way we are going to approach this as we discuss it at the task force level is that we are going to go through each of the policy options that are going to be thrown out to the public, and we are going to identify the ones that have the general support for adopting that recommendation, and the ones for the general agreement that we should abandon the recommendation and those who can pursue it, those who are most difficult will have the majority of the support from the task force, and for those which have the dissent and for those who have the minority and the support for and but the ones that need discussion by the full committee. I think we are going to have to have sufficient time in October to talk about these things. I anticipate there is going to be disagreement, and this is not going to be like genetic discrimination, and I think we all agreed that it was a pad thing. It's not a contentionous issue. There are going to be people who do not agree.

I would remind you, unless you want to, but you don't need to read the whole report, be look at the range and the recommendations. Some of those are exclusive. If you adopt other -- adopt certain ones it precludes others.

[ Speaker/Audio Faint & Unclear ]

I don't have the faintest idea. With that, it would mean, simply that, you know, somebody wasn't really happy, but they think it is generally okay and it doesn't need to be debated. Where as there may be one or two people on the task force where they say, we need this aired by the community, and I don't think we should stifle any discussion.

[ Speaker/Audio Faint & Unclear ]

[ Laughter ]

You know, actually, --

It is pretty good.

I made a note to myself, and the 82 pages I want to go back and --

It's very thoughtful.

And it was really neat to see the range of contributors. They range from the patients and the ones who take care of the patients and it gives you a view of the importance to the people out there and we have a certain sort of tasks. It's part of what this committee is really trying to do. We are going to look at the variety, the trade offs and how we can represent the [ indiscernible ] interest as best as we can.

Okay.

Thanks to Jim, the committee and all of the staff. You have a little bit of work ahead of you.

And a special thanks to Darren and Sarah who have been instrumental in the forum.

Any other items or comments?

As we come to the end of the day -- it's been a productive one, and thank you for your attentiveness and your participation. I want to particularly thank the staff who labor hard and long behind the scenes. I want to thank Abby and her staff who take care of the logistics. I want to thank her for doing all of that work. For those of you who are planning to come to dinner, hopefully you have signed up at 6:30 and it's over at the Heart and Soul, at 415 New Jersey. Please read the report in task 5. That is the draft on DTC. And that is what Silvia is going to be discussing tomorrow, and I would like to get through the conclusions. I would like to free up you guys and I can see you tomorrow morning at 4:30.

Thank you.

(Music playing).