Event ID: 1040436
Event Started: 7/7/2008 8:07:25 AM ET
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this is the 16th meeting of the Secretary's Advisory Committee on Genetics, Health, and Society. I am Steve Teutsch. The public was made aware of this on the Federal Register, as well as [indiscernible], I want to welcome members of the public in attend apps, as Aance, as well as anyone tuning in via webcast. Many of you have provided important comments, which is informing our work. Certainly appreciate that. Tomorrow we will a public comment session at 1:15 is and we encourage the public to sign up at the registration desk if you haven't let us know already.
I would now like to welcome Michele Cooper d ryfuss, new member of the -- the New York City school of law, two national of science committees investigating intellectual property issues, and past chair of the American association of law scools intellectual property committee. Earned a masters degree in chemistry and -- a working chemist. We had Pauline new man last year, sharing reforms on patent legislation in -- [indiscernible] that was terrific.
A couple members are unable to be here in person today. Andrea gone Andre And Gonzales is in Europe and [indiscernible]. We are welcoming Charles Connector, bhrgz administration for children and families. Martin [indiscernible], staff director of the U.S. commission on civil rights. We wish Martin the best in his new position. And Charles, we look forward to working with you as well. We have had a change in it representation from the office of public health and science, Dr. [indiscernible] left this month for har Harvard, pursuing post doctorate stoties in -- Dr. Mike -- who we know well, will be serving as ex officio -- thank you very much.
All of you know this has been a rather momentus few months since we last met. I want to take a moment to -- a few of those things. First, we need -- enactment on May 21, 2008 of the genetics information on genetic discrimination and need to thank those who brought this to fruition, a large number of you are in the room today, and thank you very much.
Our nation now has a federal law to protect consumers from discrimination in health insurance, employment on the basis of genetic information. Analysis of [indiscernible] current law, public comments documenting public fear and concerns about the misuse of genetic information, that federal legislation is needed and we made it our highest priority.
At the same time we know much is to be done to implement protections afforded by the law that don't take into effect until July 2009 for health insurance and December of 2009 for employment. Doesn't cover all types of insurance, life, disability, long-term care, or prevent all possible misuses. For today, we will celebrate this achievement, salute the president, and congrangzs to all of you played a role in bringing this to fruition.
We have a large agenda, focusing this morning on future priorities, what we view the status of our other current priority issues, except to say that in April, May, our reports on oversight, pharmacogenetics was submitted to Secretary Leavitt, and I am sure you were relieved -- on those reports.
We are aware that careful consideration is being given to both reports and recommendations we put forward. In April Dr. Gonzales and -- about the oversight report. We know our recommendations in that area were much anticipated, probably more than that, asked us to deliver them, appreciated and they are now being activity reviewed and discussed.
The Secretary's office took a close -- recommendations on pharmacogenomes, and -- some of the recommendations, we look forward to receiving the reports in the future on the department's process and in the directing policy and programmatic gaps in these two areas. You look puzzled.
[indiscernible]
I am trying to understand our next steps in terms of comments on the report. Of :
We are waiting to hear back from the Secretary's office, but we will make it a point, too, to do follow-up with them along the way, see what the progress is, what additional things they could use from us and try to make sure there's an orderly transition in these recommendations over the next few months as we get a new administration.
Thank you. One recommendation had a time sensitivity to it, where we talked about convening a piece, a group of people within HHS sometime in the fall.
That was to help shape the registries.
Yes.
I am not aware that has been scheduled. As you know, one thing that probably could happen is to bring the agencies together for that issue, but to look at implementation and I think those are the kind of discussions we need to continue to have with Greg and the Secretary, obviously they wanted these, hopefully they will take action on them.
Acknowledge the report, spend so much time going through it. Thank you.
Steve Teutsch: The three main agenda items over the next two days, deliberation on study priorities, exploration of marketing of personal genome information, proposed action plan associated with genetics, education and training of health professionals.
Our morning will be focused on discussion of the highest priority issues, the scoring process that took place in June -- Paul Wise, who has been chairing will -- and -- our role is to develop a shorter, more refined list of issues to research further and finalize at our meeting in December.
Tomorrow we will focus on personal genome services, including the state of the science, consumer perspectives and public policy considerations. Representatives from several companies have agreed to come, talk with us and are going to participate in a round table that will explore the information provided by the services, as well as the company's plans for helping consumers interpret and use results in healthcare decision-making.
As part of our exploration of personal genome services, we have a great opportunity. We will be participating in the workshop this afternoon sponsored by Secretary Leavitt's personalized healthcare initiative, understanding the needs of consumers in health based genetic services, three topics: What is known about consumer interest in genome based health information services, TGHIS, can't say that again. And the consumer understanding of what is being offered, what is fwheeded to maximize health benefits, minimize harms, and what consideration should be made by the organization for privacy consideration and informed consent. We appreciate the Secretary coordinating these meetings, it's been a major effort, and we appreciate the efforts to accommodate us.
[ disa bus will be waiting outside this building to take us to the world trade center for the workshop. If you ordered a box lunch, pick it up from Abby and go to the bus, if you didn't you can get something at the cafeteria of the world trade center and fwring to the workshop.
We will hear from -- the task force created in November, will provide an update on two task force products, the charge modified based on discussions in February, and proposed action plan for this group.
Two staffing developments I want to mention. Suzanne left the staff in May to pursue doctoral [indiscernible] served on the staff of predecessor committee, had a lot of perspective on the work of what we were doing, part of the historical memory of our group. She was tremendously dedicated to her work, writing, analytic skills were exceptional, lead person for staffing and reimbursement, and the jms report, cross-cutting role in issue identification and helping plan, manage the committee's work. It's really gratifying to see her interest in genetics policy goes deep and she will focus on that in her doctoral work. We hope, expect to see her again putting her talents to work in the genomes area. Done next year, maybe we can recruit her back, anyway, recruitment is underway to fulfill Suzanne's position, hopefully be done soon.
I would like to introduce David Slade, here somewhere, David has been interning on the SACGHS staff this summer, he's an MDJD candidate, focused on health law, bioethics and innovative law, working with Paul Wise, the priority setting task force, some of his labors this Morning. Thank you for spending our summer helping us, clearly we need all your assistance.
For the highlight of the morning, here to help us understand the rules of the road --
Good morning everybody. As you know, you have been appointed a special government employee on this committee. You are subject to rules of conduct that apply to regular government employees. These are outlined in a document called standards of ethical conduct of -- branch. I will highlight two of the rules that we expect you to follow. One is on conflict of interest. Before every meeting you provide information about your personal, professional and financial interests, information used to determine if you have real, apparent or potential conflicts to compromise your ability to be objective in giving advice during the meeting. We raise conflict of interest for general matters, we believe your ability to be confliktd will not be effected we rely on you to be attentive to the possibility that an issue could arise that will effect or appear to effect. We have financial interests, relationships that could be a -- if it became a focal point of deliberations. If this becomes the case we ask you to recuse yourself and leave the room.
Lobby as individuals or committee, if you lobby in professional capacity or private citizen it's important to keep that activity separate from this committee. We are advisory to the secretary of health and human services. We don't, the committee does not advise the Congress. As always, we thank you for being so attentive to these rules and all the others you are obliged to follow. We thank you very much.
Thank you. Wise words. Before I turn the agenda over to Paul Wise, any items of a general nature?
If not, we are on to the focal point of this morning's discussion, work going on by the quality setting committee Paul ablely led.
Paul Wise: Thank you very much, Steve. Few minutes before the slides are required. You remember back in the February meeting the committee for setting priorities was established, with the primary goal of facilitating, guiding the process of identifying new priorities for this committee, for the coming several years.
The committee is made up of these sides, as you can see. If I use the mic I can't see the screen -- my clairvoyant clairvoyant limits. Either I can see it or you can see it. Let's take a vote. Now to the fun part.
The priority setting process, to review, discuss the issue items that you all voted on and exploration of the results, how to best put together, digest those results. To reach consensus of the high priority issues, categories of issues worthy of developing a further issue brief over this subsequent few months. Here to A agree and review the next steps in the process.
A timeline to remind everybody, beginning in February of our meeting, subsequent activities I will go into greater detail in a moment, 73 issues were identified for assessment by the task force. The items were listed, sent out to members, ex officios for score nothing ing in join.Y results are in, today we should come to some consensus on the 73 issues that met further exploration by the full committee. From July to November the issue briefs will be developed, and sent out to the full committee for a review and deliberation. In the December meeting, final decisions will be made on study priorities.
The process for identifying the issues for consideration had several different elements. The first is discussion back in the February meeting, careful notes were taken, issues brought up were put together as part of the general list of issue items.
We then solicited additional items for consideration from the full committee, particularly the members, and then a conference call with the ex officios to explore further potential issues that should be considered by the committee. Our quest for public comments also went out, generated a large number of helpful suggested items, and also conversations with people that we called horizon scanners, people thinking about the constitute you future of how genetics will inform societal choices.
The public comments, went through the usual mechanisms, the Federal Register, the rebs, and website, special outreach efforts to reach a variety of consumer -- associations, groups focused on healthcare disparities, representatives of business groups and payers.
The horizon scan, basically a prolonged interview with some selected people who travel in this arena. After taking suggestions from members, discussing it, talking with potential availability of a variety of these people, these five people were interviewed by task force members. You can see their names and affiliations here on this slide.
We then had to make sense of how we would begin the prioritization process. That was done through the scoring of the issues. Of the 73 issues, the majority came from the public comments. 16 came from the horizon scanners. The committee and staff ex officios generated 18; office of the Secretary generated five and one of the articles discussed back in February suggested one. This generated the full list of 73 issue items.
The 73 items were then sent to members and ex officios for scoring based on a simple one through five scale. One being not important, five being very important. The criteria for the scoring were the same as has been used if the past, that accompanied the request for public comments, accompanied the request for scoring. To quickly go through them, the urgency and national importance of the issue, the extent to which the federal government has jurisdiction, authority over the issue, the need for federal guidance or regulation on this issue, whether the issue raises concerns that only the federal government can address, whether the issue raises ethical, legal, social concerns that warrant federal government involvement or leadership. What are the committees advice that significantly issue society.
Continuing, whether the failure to address this issue would prolong any negative impact the issue may have on society, whether sufficient data exists to inform policy add advice or whether -- is better equipped to address it. Whether the charter of this committee --
Basically the scoring was built on the score's general summation of these issues rather than voting on each individual criteria. This is a histogram of the results. It basically shows here the two lines which point out the top 10, and the next 10 rankings of the issues, where they fall in the general distribution of the scores. Tease These are scores that are the general member and ex officio scores.
This is the top 20 items that were scored highest by the committee members. I am not going to ask you to memorize this list, we will go lieu through it in some detail, but you can get a sense some issues scored higher than others, and also that many of the issues relate to one another; that certain clusters of issues that were identified as high scorers, just by the simple one to 20 ranking. The ranking, how to make sense of 73 issues with individual scores, we could just take the top tern as are listed here, just hand them off for the development of the issue briefs. More detailed exploration of these issues for consideration by the committee, voting in December. However, it was pretty clear that not only on their face, many of these issues relate to one another, all also, there were likely to be patterns in the voting to help assess the clustering of issues where there are categories for further development. We basically employed a mechanism to look at the profile of voting patterns.
This is just a [indiscernible] map -- [laughing] it shall be explained. The genetic -- were recognized -- exactly what this is. Basically this pattern is the [indiscernible] of fifes, fifes, and the very -- is a one. You can see that this doesn't become totally clear at this point, but that you can begin to see that in fact the members which are here on the bottom, and the issues over here, that in fact, some of the members voted in very similar ways to other members. In fact, when you look at the voting pattern, how well it matched, sort of looked like Harmony.com, says something about your personality, the issues you voted on. These brackets on the left, along the top are graphic depictions of how tight the relationship and the voting patterns are between different issues, and between different voters.
So I will move on, blow up one randomly-selected portion of the graph and magnify it. You can see what the -- very tight bracket here with short distance from the margin implies a very tight fit. The long distance, like this cluster versus this, tall brackets, implies not a very good match, in fact, dissimilarities between the two. When we begin to look at the clusters of the issues to see which issues look very much like other issues based on voting patterns, rather than just substance as we see from the issues, you begin to see clusters emerge.
What I have done here is put in the red arrows the top 10 issues as they emerged from the -- and the yellow here are the next 10 in the overall -- score. You can see there are clustering of high scorers in certain arenas. What it did is allow us to not only look at the top 20, top 20 list, but also begin to see that, in fact, there are clustering of voting patterns that also, should also, inform the way we put these issues together for further consideration.
The red, top 10 -- brownish, 11 through 20, then the next 10 are the yellow. You can begin to see the clustering, not only -- I will go into some detail, this is just to show clustering, not the elements. But basically of the top 20 to 30 highest-ranking scores of the 73, this is the general pattern that began to group these together. I will go through these in detail.
We wanted generic description of categories, genetics, healthcare reform represented a cluster. Insuring the clinical utility of genetic information was another; and some people might read this as more of a translational set of activities, the public health applications of genomic research, consumer access to genomic information, informed consent for genomic data sharing -- for genetic services, health profession genetics and health disparities.
Interestingly, and importantly, many of the individual issue item that's hit the top 20 were generated by the public comments. Suggested from public comments.
Looking at genetics of healthcare reform cluster, this is the issues that were rated highest, the role of genetics in healthcare reform, information of genetic -- clinical decision support, collection of genetics into electronic medical records, and implications, structural changes in heeling healthcare delivery. All outlined in greater detail in the book that accompanied the scoring for each issue item.
I will put this up on the screen to get a sense of how the clustering seemed to take place, and makes sense, people did not vote randomly, in fact elevated thing that's tended to fit certain patterns.
The clinical utility of genetic information, all heavy hitters, came up in the top 10 except for this last one that fell below, but was in the top 20.
Question: I understand the [indiscernible] I understand the clustered voting patterns, I don't think that it means indeed they belong together. Evidenced development is extraordinarily important and -- is important, I don't really see those as being in the same category.
Paul Wise --
Good.
From a voting standpoint -- ultimately logic will have something to do with it.
Perfect.
Paul Wise: [indiscernible] the voting and clustering I am suggesting should provide guidance to the process, but nothing more. We have the ability in the discussion today, as well as subsequently, to reA rage rearrange these, create new clusters or categories that are worthy in and of themselves. This is merely a starting point to provide guidance, but it does provide guidance, and the scoring did produce, did result in definitely the elevation of certain issues in the devaluation of others. That guidance is important in that it is merely guidance. We will have time to rearrange these. The public health applications of genome research --
[indiscernible] question. the question I had is based on your last statement, does that mean the criteria we used for the -- voting would be part of the consideration when we decide, the prioritization of these -- as well?
Yes, the suggestion is that the criteria for voting would also be the guiding force in how we ultimately decide, by December, on the most pressing priorities for the committee's subsequent action steps.
Thank you.
Access to genome information, heavy hitters in the top 10 can be identified here. Again, some of these we could pull out, some of these people may find are not appropriate for certain of the criteria. Others committee brought in, explored differently, but based on the issue item and their voting pattern and the voting -- this area seemed to be extremely important.
Informed consent for genome data sharing is another -- reimbursement for genetic services was felt to be important, but did not rise to the top 10, it was in the 11 through 20. Education of health professions on genetics was quite important, in fact among the very highest scores, and that's good because we have the standard task force dedicated to address this issue. I will talk about that in a minute.
[indiscernible] health disparities, clustered not among the top 20, but very close to the top 20, tween 20 and 25.
Next steps. Basically the next steps would be a discussion here to both comments and consensus, general approval of the process that the task force pursued and generally the list of important potential priority items for the committee. The development of issue briefs, in other words, clustering or categories of issue items that are worthy of further exploration by the committee. This will coordinate intensely with the evaluation and task forces, may undergo some change, but is clearly recognized that many of the issues we are identifying as high-priority would likely fall into the purview of what we are calling the evaluation task force. In speaking with Mara and Steve, the suggestion is that we -- the issue briefs for categories of issues that will likely relate to the purview or charge of the evaluation committee and education task force. [indiscernible] close coordination if -- [indiscernible]
Those who may have forgotten, we did have a agreement about a year and a half ago to create a task force based on issue briefs that dealt with a series of economics issues, deferred, approved by the group, committees work was deferred to get on with the oversight report, Mara agreed to lead that effort, has a group of people that have already been identified. But that work is now beginning, as opposed to the education one, which has already moved nicely along.
Including other things that come up over the course of the conversation, discussion, the [indiscernible] on these issue items to provide general guidance to the development of these issue briefs. The briefs will then be distributed to the committee for a review and we will vote on these and ultimately select the priority issues for subsequent action steps.
I expect that generated some questions, we now have time to have open discussion on issues you may want to raise.
How we organize our thinking and the process going forward, couple of hands I saw, Jim?
Sure, I saw, think that one productive thing might be to using the heat map generated categories as a start. It might be use to refine, here's a category, what we think is important. I would, for example, bring up that high on the list, no matter how you look at it, is the issue of the impact of personalized medicine on heeling the healthcare, role of genetics, genomes, very important issue of clinical utility, evidence-based medicine, et cetera. So I would say that perhaps those should be teased apart into two different, but both very important categories.
I think that's very important. Clearly a consideration as we were looking at how best to put together the clusters, I felt somewhat relieved in doing this to know that this is likely going to be an important focus for the, what we are calling the evaluation task force, to sort through some of these things to see where logically these things may fit, and where other arenas of activity for the committee may be more appropriate. My placing them together in this way reflected not only the heat map associations, but also the conversations that came out of the February meeting. I expect it will be explored in great detail by the evaluation committee and development of the evaluation briefs.
Thanks, Paul.
Congratulations on your work, first of all, looks like it took a tremendous amount of time. I don't understand it, but it looks like it's very impressive. I particularly like the colors. A couple of thoughts about it, comments, then I guess a question. When I was filling it out, it struck me, and I raise this to test it rather than anything, really at the end of the day we really have about, at most, five things, that we're going to do. So at some point, all of this detail, the 73 lists really comes down to identifying five things. That was how I thought about it in terms of these are the things I would really like to do, these are the things that are interesting, good, but ultimately should falloff the list. It struck me, from your presentation, that as you cluster these things around, can see that in the back of your head as you were going through it, in some ways, one way to approach it is to create issue areas to come up with the five issues, the details are that can almost kick-start the process of priority-setting within the particular committee, to say gee, here are some is potential things you should look at within the context of healthcare reform or something. These are ideas, but really it's up to the committee to tease that out. That might be a way of capturing all that information, making sense of it and moving it into the next process.
The other thing, and here's my question regarding the analysis. I was struck, there, in terms of the member scoring and the ex officio scoring? In other words, if you can walk us thru either the great deviations or the great similarities between what the ex officios thought the committee somebody all about, going into the future, vis-a-vis what the members thought. That would be helpful.
[indiscernible] heat map, the ex officios were slightly [indiscernible] as you can see from the heat map, I am kidding. You actually can see differences. We did analyses, correlations between the ex officio and the -- there were differences. The ex officios seemed to focus, not surprising, on areas represented there in the arena of activity. Tended overall to score everything lower. So whether it was normalized, it fit pretty well -- [indiscernible] knows exactly what I am talking about. The point, ex officios generally conformed to the same kind of hierarchy of priorities as did the members. It shifted things slightly, but not significantly, in moving things from the bottom to the top. So we felt comfortable, after looking at that, that the total average scores for E fishios ex officios and members was the best --
We received a member's voting extremely recently, has not been integrated into the scoring. However, looking at the results this morning, basically it conforms very nicely to the scoring priorities the rest of the committee already did, don't expect any changes.
You have the most recent version, you can do the discrepancy scoring. I fountain oud it interesting that I couldn't figure out the overarching message myself. Why I was trying to see, it strikesly after going through the numerical discrepancies the numerical line up globally -- The scores Paul has shown are the scores of both the ex officios and members. That's telling, that's important.
Yes?
Question: Paul, thank you, I thought that was obviously clear from what you presented. We just need more education in [indiscernibleics for the lawyers.
One question, when you came up with your categories there seemed to be a difference we might want to take into consideration as we go forward in deciding, not to say these things aren't important, but for instance when Jim talked about personalized medicine being something we have to address I would say yes, we have been working over the last three reports, certainly now, with the education and efficacy reports. Personalized medicine would be pulling it altogether. That would be the global approach. Something like the effectiveness or the need to ensure clinical utility would be a piece in each of the reports that we have gotten, so it's kind of an intersection, not a combination of everything. So it seems some of the topics we have discussed, some would be relatively focused, easier in a sense to get at, where others may be important, but we will run into the same issue we have before, like the oversight of genetic testing, what's a genetic test? The oversight of testing, and if, not saying we shouldn't, if we really go for the broad global thing we need to know ahead of time and set up a goal accordingly.
Thank you. Basically, what you are identifying now, and the -- of your thinking and suggestion would be precisely what should be captured in the issue briefs that are the next step. In other words, to refine this, objectify what does this really mean, already done by the committee, what's ongoing by other committees advisory to the federal government, so the committee members can have a far more detailed understanding of what this issue would involve and the best way, perhaps, to approach it.
This is my expectation from the next step. As Paul pointed out, I was basically trying to take 73 individual item and turn it into maybe 10 to 12 categories of high priority items, and how they fit together, where they belong, we can set up time to move forward the discussion we have now will alert our committee, the evaluation task force, education task force, about how members feel about strategies, approaches to take.
I want you to elaborate a little more, you can almost -- which kind of strategy would make more, you know --
Right.
Better framework. Getting back to something we have been wrestling with a little bit explicitly, but also more so implicitly, as the committee goes forward, how does the committee wish to focus its resources? And it see itself as the group that provides the 50,000-foot overview, which is going to, of course, set a certain dynamic for how you approach things, what kind of topics you take on, or is this a group that needs to get more details, fine-grained, and look at issues like clinical utility, incredibly important issues across the board, but aren't going to be addressing everything. So that was sort of -- it's a general kind of criteria, but one you can look at in whatever topic you pick up. It's another way of breaking out --
I don't think that's explicit --
No no no, one thing tackled can't be very broad.
Exactly.
No, I am saying it sets two new large categories that one could look at, see where your topics fall into.
I see two things. One is a comma, the other a question. If part of the decision, we as the committee have to make related to the criteria, seems we we have to think about mapping with the fine will 20 priorities, a straight map or grid map. I don't know if you know, but in social statistics you always have interrelationships, which is what I think we are talking about. One way you get around that is then look at things related to that, getting away from the idea that everything is related to everything, part of what we are saying. A grid map would work, suggestion to the committee. The other question, do you see, as we think about these priorities, have two task forces related to this, there would be some kind of demarcation of the areas between the two task forces, which would make logical sense, and the education, for example, would focus a lot on some of the issues related to -- [indiscernible] have the other for evaluation. Something you were thinking about or not?
Yes. How our task force, priority setting task was related to -- the highest priority for us was respecting the process we embraced for setting priorities. We felt that the process of voting needed to be respected, process of the way we tried to capture as many items as possible needed to be respected, and so the requirement for respecting the process is that the other task forces also respect the process. Just so happens that education professionals in different arenas came up with the priest priorities. It was a full embrace of the task force, education activities, and the expectation would be that that task force would very much be involved, if not take the lead of developing the issue briefs related to education that would then come to the full committee for consideration. The evaluation task forces still in development, but clearly based on the interest, commitment and expertise of the members on that task force, and the general mandates of that task force, we would expect that many of these issues or a few of these categories of issues would fall to that task force for exploration for doing precisely what Kevin is suggesting, and that these priority-setting task forces will rely on the evaluation task force for guidance and assistance in this arena. The categories begin to break out pretty well, clearly the education, falls squarely within the task force, and the other, we will have to see how best to approach it. Intensely coordinating with the evaluation task force. We see this as highly-integrated process, but respecting the priority-setting process set forward in the February meeting.
We haven't really discussed if the products of the new topics will all be the same as what we had in the past. Talking about these things as large topics, fact-finding, larger reports at the end of that. Is there any enthusiasm for the smaller topics, white papers -- won't require the same timeline, resources? Are there going to be different categories of topics and products, or only large topics?
Well, this may fall outside the work of the priority-setting task force, but my general sense would be that among the very highest priorities, there may be different appropriate action steps taken. Some might be best served by a quick white paper kind of thing. Others may require much more involved full report generation, but the full committee is standing forces, would be able to chew on priorities identify said ied in in ways that would make most sense to have the most effective resummits. sults, I see my charge as the highest priorities, how best to address them may be the work of the task forces, the chair -- interruption, your conference contains less than three participates at this time. If you would like to continue press star 1 now or the conference will be terminated.
Pause
I think that's an issue we started to discuss, I personally very much agree. We need to be action-oriented. There's some issues that require the extensive time we have had on recent reports, other issues, both, because of timeliness, work already done, that may be very easy to do on a relatively short time frame, and articulate issues, concerns of the committee. From the evaluation task force, I very much want to be both proactive, action-oriented and have the ability and Steve it's fair to say you were comfortable that, have the ability to parse through in a way that is most personalized, specific to each issue, when we are looking they all did not need to be the same extensive year-long process, but that was part of the prioritization from the groups. I am taking by the fact so many important issues came from us and particularly the public comment period. To get to the top 10, if we do in the serial very long process we won't be able to get to them. At least personally it's important to get to them so we will need to both prioritize and figure out a way to get effective comment on it quickly, in the shortest period of time.
I think, hope we don't lose track of some of the ones that fell down for the 11 to 20 as well. Some didn't fit as separate category, but would be maybe part of the others, particularly the globalization and -- doesn't stand on its own, but fits in others in the idea of increasing communication, coordination, bodies in Europe, Asia, seems like it would be one to not forget, infuse into some of the others, like informed consent. Not necessarily healthcare reform in the U.S.
I should take this it opportunity to say that that was one I voted high on. A little red spot up there. Did not come out high in the voting, came out in the bottom, ex officios hated it more than members. We have always had the opportunity, however in development of issue briefs to, elevate, pick certain things, recognize integrity scored low, but made sense, things change over the course of six months, it fits squarely into the exploration of items that did score high, it warrants inclusion. This is guidance. It's not divine law. I think points like this need to be continually brought up, because this is just guidance, but it is guidance, tells us something about the relative importance of issues by the committee members, but does not preclude ongoing exploration or inclusion in another category.
Yes?
I wanted to add to --'s comment, lead off from there, to suggest that the committee may want to think about doing something a little different, entirely different, during this period of time. Those of us who are in the executive branch are already updating our presidential transition briefing books. Whatever happen ins November, we know new leadership will be in charge in all the departments, and it is a opportunity for this committee if there are a handful of three, five, six things you want to tell the new incoming administration, these are the three priorities, five priorities you should have. It is a opportunity if you get your timing right to be able to put those ideas forward during this transition period. Then you have a opportunity over the rest of the tenure of the committee to dive more deeply into issues. You may think of things you want to say to the new administration and leadership as they come in about their priorities.
I tend to agree with you. Mara captured some of this, we want to do things relevant, need to engage the new administration, whatever it is, effectively. There's a lot of work this administration, even if it moves us back to the -- won't get to older work, need to make sure the reports, pharmacogenomics -- I believe we -- so we are informing, responsive, not just talking to ourselves.
In the evaluation committee, is there going to be a list of criteria for priority-setting that will be agreed upon? I am hearing a lot of different perspectives.
Yes, there will be, but we were not -- my sense is we are not going to re-write the prioritization we had for the whole committee. A lot of work has gone into putting the overall 73 issues together. It's taking the short list and reprioritizing them both on Sherry's point, we talked about how to do that, vis-a-vis the new administration, if this becomes an issue with the new administration, becomes relevant. The issues Paul went through in terms of priorities will remain mostly -- not going to restart that process, everyone voted on them in that light, but to take two or three at the top, say okay, those are the key priorities. How do we then move forward with a list of a smaller number from that. Paul mentioned logic. I think about it as logic and logistics. We need the logic that says which are the most relevant, and logistics to understand how we can do something that's important, action-oriented, and quite frankly, can be staffed from SACGHS as well, we can't take on six new issues, hope to get them done in a reasonable period of time. The balancing act between priorities, action and resources to get it done. The focus on a brief look at the issues is several of them can be done relatively efficiently, given what's already out there and the strong views of the committee.
Joseph?
Yes, it's interesting, the direction of the conversation of the one of the things, what was pointed out, fact pointed out was the choice, prioritization of the categories by the public, other public comment, something that as a criteria, seems it will have to be thought about, given what is being said. The second thing is that there are categories, areas that have been in play as far as discussion goes, quite a long period of time, really haven't been addressed at the level of that. It seems to me if we are going to look at using both the criteria we have, and look at what has been said, we also need to think about historically what we have not actually paid attention to, that keeps coming up over and over again. I think that is consistent with what we are saying. If we take what was suggested in terms of top five or whatever, that can be actionable, that we probably -- makes sense to think about those aspects as well. From a consumer advocacy perspective it's critical.
If you look at the top 20, I believe 14, what the committee voted as top 20, 14 came from public comment. What we are quite creative here, says the comments we got in from the public were critical not only in the 73, but creating what we saw as the top priority.
Any observations or comments on the degree to which topics, novel, rehash of things done before, pretty well addressed but people are just not aware of that?
That was one of the crit criteria, there theoretical, but in the development of briefs, some effort will be made to identify the opportunity in front of us on this issue, which has already been covered by this committee. Others where, has this issue been ignored, despite importance, that should be part of the issue brief development, to inform, guide the committee's judgment about ultimately setting the highest priorities, will be crucial certainly in how I think about it, and part of the issue brief process.
Can I just say a couple things, looks like we have a lull in the conversation, one is to thank the staff putting this altogether. I get the easy task of presenting it. They have the very hard job of putting this altogether. So David, Sarah, Betsy, Cathy, thank you very much, David particularly, as a rookie, did a spectacular job of keeping the scores, almost on an hourly basis for a while, supporting the task force's activities.
Can I just ask very specifically, any questions or concerns about the process we used?
Thank you. And we do have more time.
I would suggest, one thing we do -- make sure we not only got the sense of what other things folks think are high-priority clusters, what we call them, how we get to the list, if it looks like we can tackle in a reasonably organized fashion.
It can I suggest we start, not go through perhaps each one of these, but start with the one that tends to generate the most conversation, couple of them that do. One had the highest number of elements that rose to the top. This is not one of those, but this was. It may be that this set of topics is dispersed or becomes an element of other arenas; but the elements of personalized medicine and genetics and moving forward, let me find it. Personalized and direct to consumer provision of genetic testing, clearly became a cluster, not only in the conversations in February, but showed up in all the cluster analysis of the voting patterns, that this not only got high ratings, but people clustered these together in the way they were voting. Can we begin by comments or guidance, in this arena?
I am sure this will come out in the issue brief, but I was struck this particular area is one we are not aware there's a lot of work being done in HHS, public forums kind of committee work by other groups. I think particularly as the issue brief is developed for a particular area, looking carefully, both within government and outside, who is dealing with the set of issues. To me it doesn't seem to be one getting a lot of attention, focus, could be a real opportunity for this committee.
SUPERFLUSH I would, as the heat map suggests, I see the top one as perhaps a difficult topic to distill down. Maybe it's not actionable, but extremely important, the affordable sequence will have huge effects on so many different things. To put it in to a category that to me hangs together really well in those remaining four things seems a little illogical. I really like the list, broad list you came up with, showed a few minutes ago. I am not sure if those were together in that. It seems the bulk of those issues can be subsiewmed under one category, and that is consumer impact, the access by consumers. I would suggest that perhaps that top one be teased out, not thrown away, it's an incredibly important issue. Do you see what I am saying?
I do. I think people, the way they voted, the way I voted, as being relevant to this cluster is basically because making it affordable does a lot of things. What was most, of greatest concern, the way people were voting, that it would basically mean consumers would have high access directly to genetic --
The heat map is important, but we have to remember how the heat map groups things, as to similarities in what you voted for. Done the mean that because you rated two things with great similarity, they ever lap in the people voting for them, people even thought of those as related. I would say this is one of those instances.
I would add, and combine with Mara's comment that possibly what Jim's concern is, certainly the way I am thinking about it, the outcomes are very different between the two groups. One way to think about some of the issues is the bottom four lend themselves quite nicely to product or activity, to stuff this committee can do. The top one is a more global think piece that becomes harder for the -- it is important, granted, but harder to envision what the deliverable might be, other than maybe descriptive or something, and so matching that, focusing on what are going to be the core deliverables that come out of this committee, that have come up before, we can envision coming out of the committee, is also a good way to winnow down, focus this committee, not saying that other issues are not important, but to really begin to zero in on where can this committee add value with product and activities.
As we go -- making sure we have the clusters correct, either as Paul laid them out, or important things missing or need reframed. We have guidances, and one way to do it, coment on whether the clusters are right is helpful. The second thing, if we can get to reasonable agreement on these or some modification of them, then it's helpful to go through the specifics. As you look at specific pieces, issues, think they belong in separate clusters, whatever, they will be important to bring out. So we have as good guidance as we can before the next meeting. I will get quiet, but Mark, are you on the phone?
Mark?
I am here.
Good, congratulations on the wedding, we are in the midst of discussion on priorities.
I am enjoying it very much.
What the chair recommended and the colleagues -- I would agree this is not in this grouping, but argue, 3.8 -- actually driving the other three. Modification, consumer strategies, would drive everything else, if you look in terms of group, category, deliverable. We decided to look at [indiscernible] strategies, then below that what are some of the tasks that would come under that. This would fit that way. If you look at it, the way I look at things, map out outcomes, steps -- the outcome is developing a model that this committee comes up with, strategy with elements to those areas, independent of the very first one. Other bit that's fit in, these fit together that way. I would suggest given what we just said is a way to look at this would be to keep the category. I would just be clear to define assets, what access are you talking about? Access in terms of whether something is utilized or not, more than one element. In health service literature, you would look at it that way, my recommendation, keep it for this one, but group in categories, something to do that fits in with what you just suggested.
That's really helpful. Thank you. Kevin?
I would like to build on what Joe said, but first say I disagree with Mark. So we can get that clear. I think there's a question here that needs to be clarified in order to figure out how to group this. What is it consumers are purchasing? What is it we are protecting them from? Something where they are purchasing their sequence [indiscernible] protection.
What's the target? Something supposed to have clinical utility? If so, that's a different question. Consumer is just purchasing something for the heck of it, fun to have your 3 billion plus sequences up on your wall, whatever. One of the things for me that would make a huge Denvers difference in how this area gets circum scribed. If it is supposed to describe utility, or just truth in advertising, or whatever. Perhaps one way of getting around that is to draw up the protection aspect, say implications of genetics as consumer products. Then that could address, or one could subsiewm into that -- legal implication, standards, et cetera.
Paul?
I don't mean to return to tactical considerations, but it concerns me that these topic areas, because of their breadth, may exceed past the sweet spot, let's say of this committee. Thinking about how resources are going to be used for these -- created as we make the discussion, and highway we are how we are going to prioritize, obviously very essential activity. I am thinking about the role of other committees and other large bodies of work that might be done, let's say, on healthcare reform. Let's take that as a topic. I suspect there's resource there in the government done on healthcare reform. Maybe I am wrong. Certainly has an effect, that's a separate story. How will we limit the [indiscernible] in a sense, to focus the briefs on things we can then do something about going forward?
Seems that's part of the role of the group that is working on the development of the brief, to help propose back to the committee what specific issues within the cluster should have the highest priority. I don't know if -- that answers your question, but one of the most important things. Also suggest perhaps what specific strategies we should -- action plan for addressing the issue. That gets to --'s point about, Mara also, that we don't need an in-depth study on every matter, one of the highest priority issues might be, we decide, committee might decide to write a letter to the Secretary, urgently, to make the point. That would be another aspect of what comes back to the committee in December, to actually operationalize all this.
The other thing we are doing, need to do between now and December, look at what's going on elsewhere in the government, so we have a better understanding of where we could actually make a contribution that would be -- that will be part of the process between now and December, so that we can be clearer with the whole committee, where we think the issues are that we could inform.
Six months in the life of this committee seems like a long time. If we could pull the plug on some of it, focus earlier, that would be a good idea
Blood pressure
The carbon footprint is very high, not good for the environment. The other is that the comment Kevin made, very important, because as you said, the people have the sequence for their own sake, one thing, some sift companies we will hear about tomorrow, they say you are at risk for this or that, if the sequencing comes with some kind of interpretation, supposedly at higher risk, it's a specific story to address.
Thank you, this will be an essential consideration.
Other comments on this category? we can come back to issues as they come up.
Let me go on to --
Paul, can I --
Some of the specifics are vertical. Like the second one, standards for monitoring, it's not easy, but -- somebody should come up with, group to come up with them over this period of time, what we think are the five standards that should be -- that's how I think through the horizontal, vertical. Probably need a balance, some things important enough to -- same time, my priority is not having them all that way. Having at least a few time sensitive, action oriented we can, and relevant, given Joe's comment about the public, relevant so we can say standards for -- example, so important right now, how we think it should go forward, do in three months, relevant bodies, another six months. Does that -- how I think about -- to Michael's questions, having that balance for things that really are relevant, timely, let's get to them, issues. Might be a 10-page letter, five-page, I can only hope. Horizontals, vertical strikes.
I just think the committee has a real opportunity to, at this stage, decide what the priorities are, to really make an impact. With the transition of the government coming up, along with a lot of very cool topics to think about, neat to consider. We run the risk of spending a lot of time on stating, worrying about things we may or may not have impact on. If we take a deep look at what these topics are, there's some really important issues that could be addressed if we delve a little deeper, not just take the first pass of voting as the final, because there are things that I think about a lot, like are the tests really even accurate. There are very basic issues we could have an impact, we should consider.
Well, I think everybody would agree what your suggestion and your, I think, strong support for moving forward strategically, quickly, I think it's also a good reminder when you have committees of task forces coming together. My job, basically was -- issues, to try to identify clusters of issues that were generally felt as being [indiscernible], and to winnow down 73 to something we can really get a handle on. It may be that we want to move more quickly than putting issue briefs together and voting in December. Would hope the committees, other task forces could help push this more quickly to seize opportunities as they arise in ways that would make the full committee more useful, effective on a larger stage.
[Captioner transition.]
I would say don't get caught up on the "cool things," but
From my understanding, you're right.
{LAUGHTER}.
Um, but clearly, the world is moving quickly, with perhaps one of the things we should do is we listen to this discussion and we hone it down, we should actually focus on a subset of these clusters or issues right now, and sort of say well, what's the process, and then later on we can come back as we, you you know, take on other topics.
That's exactly it. I mean, frankly, I'd like to pull the plug on some of the clusters.
Well --
Right away.
Well one discussion to have is A) what's missing, B) which of these things should be dropped and which ones should we grab on to? And we all agree we want to be impact full and all that sort of thing so to the extent that you all have clear notions as to where the meat is right now, we need to talk about it.
I completely agree with what you're saying but I think we first have to define what are the categories that people thought was important and then the next step is to say well yeah, that's cool but we aren't going to get any traction on it, we're not going to do it in a timely fashion so it moves down but first we have to go through it and --
That's fine.
Forge these categories.
And then we can maybe triage it.
Yes.
I have a question that we also have to be a little realistic, not only in what we can do but also what the Secretary could do, because just hypothetically, the Secretary said that, you know, evidence based guidelines for genetic technologies is really the highest priority and we went with that. I mean, we said that, you know, that became the highest priority for the committee. Can the Secretary, you know, what are they going to do about it? They have the reports and recommendation, so what impact would a recommendation from the Secretary have on the issue? given I'd say if we do our job in a timely fashion, and do the best possible, the Secretary agrees and makes like the strongest recommendation, if that isn't going to impact on the issue very much, should we go that direction so I think we should try to triage also thinking of things that not only as a committee because I think the best outcome of the committee would be for the recommendation by the Secretary and there for something to be done. If that something else could be done would have a real impact, then those are the things we should do, because if everything goes okay and then the Secretary agrees and as you know, everything is the best of both world's, and then it doesn't impact on reality, I don't see very much of a point. And there are things that the Secretary can, there are things he or she or whoever the new one is, you know, we have to try to understand that.
That's an important reminder and it underscores certain of the evaluation criteria that were listed.
Yeah, I, um, just am wondering from the committee, after seeing topics and seeing everything that has been submitted are there any new ideas that came out of your thinking after seeing thing sns I mean, for me, I think a broad topic might be, you know, investment in technology, because there are major technology gaps that are missing that are going to allow these things to come to fruition, and that's one idea.
There's always opportunity to exert new ideas into the considerations of the committee, so if people have other ideas, things they want to suggest, we can bring that into the process through the development of the issue briefs, and subsequent so this does not preclude bringing in new things, in any way. Any comment specifically on this set of issues?
I'm sorry?
Not surprised that it showed up as clearly as it did on the map, because certainly in the last three reports that we put out, one of the batch docs that we constantly came up against was this idea of is it going to do any good? What in the end, how in the end do we measure the good that's supposedly going to be done by large population studies or by testing so again I think it might be important how we delineate it, but it's something that we've seen over and over again. It's something that I think just has to be addressed, because this ultimately from what I understand would be the gold standard everybody would like to apply.
Joseph?
Um, a question, okay, a question again on just the way that you group these, and from the way that I'm looking at it is that you have, what's your operational definition of utility is, and it's whether it's you have outcomes and then you have that leading to outcomes here, so there's two and maybe three fall together and then first the other two would fall together, so I'm wondering if that's, I don't know what the committee said, but it sort of falls in that category again, particularly from all of the discussion that we've had had about cutting to the chase, on what are sort of the priorities in how you would group these, so it's both a question and an observation. Sorry about being confusing on that but I'm just trying to make sense of this grouping that you have here.
Yeah, I'm new to the committee so partly this is a question you you probably all know the answer to. I'm a little confused about the difference in consumer and patient. This one seems mostly directed to patients are how a doctor would actually treat a patient in the use of personalized medicine and yet that direct-to-consumer categories are in there and it seems to me those are really different things. Maybe I'm wrong about that but it seems to m, personalized medicine can be about I thought how doctors use genetic information to treat patients and not about how consumers might wish to do that, so I wonder if that third one belongs there and if I'm right that personalized medicine is actually about treating patients rather than consumers buying products, and then questions of access to it, the costs of personalized medicine, the costs of personalizing medicine and the effect on cost to drugs, all of those seem to fit into that category.
Well, I think that's important and it has been raised as we went through this as whether it belonged there, but as a clinician, I can tell you that the consumers have direct-to-consumer genetic information, it quickly becomes a clinical issue, because they walk in with a piece of paper or please check this website, this is my genome, tell me what to do, it crosses some of these boundarys.
But that seems to me to be Incorporated in the previous question of how do consumers understand this, how do you explain it to consumers. It doesn't seem to be quite the same as actually how do you operationalize genetic information clinically.
I'm sorry, go ahead.
Joseph?
Well, that's what I was referring to when I said how do you operationalize the word assets because there's more than two elements to this. Assets is structural and it's personal, so you have to think about this that way and the definition just used in terms of someone walking into your office with information, it is where it moves from a structural part to a personal part, but then there's overlap, so you have to kind of make a distinction between the two. I'm sorry to jump in.
no, that's helpful.
In my mind, I'd feel like three of these items, the first one, um, and the last two, are very clearly put together in a logical fashion. I mean, I think most of us who ranked these things were very enthusiastic about efforts to address and apply evidence based medicine in the genomic field. I think those get to that and I think those other two, I agree, the third one is about kind of falls into the last category and well I think the second one is extremely important but it's one of these very broad things that goes far beyond just the issue of clinical utility. So I would move that the second and the third be placed in different categories but the other three seem to me to hang together very well.
Yes?
in fact a lot of this was addressed in both the pharmaco genomics and the oversight report and we had a whole chapter in that report on outcomes research and utility guidelines so at least a substantial part of it seems to me to have been recently addressed and I thit will be important if we want to take this on to figure out then what is new here, what do we have that we didn't say in May? And maybe there is. The other part is that some of this, if we decide that, you know, as Paul said perhaps it can be what we need to do is assure that the recommendations we've already made happen rather than we did this, that leaves us with a subset of these that may fit into one of these other categories that we can actually do some rearranging and emphasize what's now called impact to personalized medicine on healthcare and those sorts of issues.
Right, but I think that's part of the triage issue. It's fine if we get some logical categories and then say okay O, this was addressed in large part by this committee or that committee, so there for, it obviously falls low on the list of going forward, right? But it seems to me, again before we get to triage, we have to figure out rational way of thinking.
Right.
So before we go into the triage step for this category, I was hoping we could consider maybe adding one or two related categories that probably don't get the highest topics. One, which I think overlaps with the last category, last topic here is the research priorities for pharmocogenomics and to me, that is one actionable thing that is not in the p harmacogenomics report that is done which goes into the whole issue of what kind of research topics are we funding so here we are especially saying outcomes research but maybe within that also what categories of drugs, genes, disorders, and how to go about funding them or prioritizing the funding so that might be one and then in the other pharmacogenomics category, there's the use for improving the safety and efficacy of existing medicine. So, that again may be triaged out but it does seem to fit into the clinical utility aspect of the genomic information.
Other suggestions? Should we go to the next?
Comments? Comments on this issue?
So, I came up with the same clustering you did here had, when I was going through this.
{LAUGHTER}.
This is a really interesting topic, but I don't know where else it fits and the reason I just want to put an editorial comment, the reason I think it's a really interesting and important topic is that many of the implications from genomics are really going to be not so much in the individual doctors offices as often in the realm of public health but I have no idea where it goes with the rest of the things.
We just got to tell it.
{LAUGHTER}.
You know, it's funny when we were trying to think of the topics, we did not, I mean the National Office of Public Health Genomics and I did not give this as a high priority because all of the elements, I mean if you look at the issues of health disparity, that's a public health issue. If you look at the issue of clinical utility. If you look at all of the other issues, the public health implications of genomics research is is always what we're trying to do to and the fact that you ended up with a cluster that has only one line to me says that all of the other issues are part of this, so, I mean, it's kind of funny that we ended up this way, but a lot of the other issues are encapsulated on the public health implications of genomics research including screening, including consumer awareness, including education of providers, including policy and including oversight, this is all public health again only O ics.
Including the sessions I spent 20 years at the CDC, but I did one of the interviews with Kathy Bosi from DAP as part of horizon scanning and I found it particularly interesting because her perspective on some of of these topics was really very different than the conversation we tend to have and some of the things she brought up were about, um, in the work site. What do we do? She's a chemical manufacturer and equally applicable, I think you you actually brought up some of these things, that, you know, you're dealing with a whole variety of exposure and what is the -- how do you realistically, approach the testing issues both from an eth it nal, from an appointment, other kind of perspective? That was one side. The other side that she talked about was the environment in which we all live, and sort of all of the ethics and sort of how should public Heather gauge in understanding, you know, exposures and their genetic susceptibility in a public and community level? Very different issues, much of O it is ethical but practical as well, which, you know, I think within the broad scope of the committee that's in here but what's really interesting is how low that scored on the process that we went through, so it seemed to me there were at least some things that fit broadly into this, and some of my colleagues heard me talk about this is a portfolio Management issue, do we want to do that, make sure we cover all of those bases, is that the kind of thing we should be in and I agree with Paul, we needed to be guided by what we have done here, but there are things that fit into this kind of a category, it seems to me, that are really rather different than specific things that we talk about more in terms of clinical utility and more in terms of sort of public health utility and Management.
I thought that the concept of sort of environmental or occupational genomics really is one of the few topics that struck me as being one that was relatively Novel, out of the per view of what we've talkeded about, again and again, and maybe bears a little bit more attention and certainly my organization would be very interested occupational genomics and the implications.
Well, it may be that there's some times, excuse me, the reports are most effective by mapping the landscape, rather than documenting individual trees, and it may be that we come to a point where the issues like minority health and some of the others as pointed out that already identified in other clusters, may be most effectively addressed through a single framing like this, so that, I think still is an option for us, based on what we think would be the most effective use of the committees expertise and energy, particularly our strategic wealth that it may be a report on this gets consideration for some of the other clusters, may be the most effective use of time. Yes?
So, is it possible to set a list of really near term quick hits along with some major, you know, product output goals that may take longer to develop and more extensive research needs to be done as the background, but in consideration of the timing with the government changing and everything, get a high priority list of quick hits that we can really go after that are high impact and then look for the broader issues to tackle.
Well, that would probably not conform well to the process we've identified. The process is supposed to -- the process of identifying priorities in December, um, however, the Task Forces would be able to pick up the ball and run with some of these things prior to that if it comes through in these sdubingzs, certainly through the voting as meriting direct attention, but right now, the next step would be to develop these issue briefs on a very select group or categories of of issues and as part of the issue brief, it would be to identify what kinds O of long term, short-term impact, what kinds of action steps would be required.
But getting back to sherry's point, timing is of the essence now. I mean, in this we're preparing our strategic plan that's going to be ready the first week of December. That is, it's going to be an executive summary of a bigger Strategic Planning process, but it will be available and ready for the transition teams, because they're going to hit the agencies right after the election, and that's when you have the biggest opportunity.
All right I hear and respect your judgment.
I think that it would be useful to have this category, the definition for having it so long as you make it more explicit as to what is it adding on beyond the clinical utility aspect, and given my experience with the discussion of the Task Force, a couple of the areas not tackled by them , one was occupational medicine, absolutely, but another one would be, for example, areas such as obesity and interventions, some of them occur in the clinical setting, some of them occur in the community setting which are not, they don't have a direct interface with the clinicians, so if you can map these out as to the other areas where the other topics won't be impacted it would be useful.
Yes, I'm going back a little to the priority issue, given we have some time on the agenda tomorrow, and, you know, a pretty full discussion today, and in the interest of time, because if we pick all of the issues in December, the new administration is already clear and then it takes it awhile to get started but so maybe either at the end of this discussion today, I would suggest or tomorrow that there's an identification of one, two, or three, so relatively small number of issues that the group believes are time sensitive and I know it's a little bit different from the process but I'm pretty comfortable because they're all I think most likely going to be part of the top 20, so they're already part of the process that we identified as the high priority and maybe we pick one or two and say they're high priority and use the time between now and December to go pay little bit further than the issue brief. I mean, my bias is it can't be one of the implications of topics because it can't be done in a short period of time but if there are some things we know are going to be part of healthcare reform which is likely to be part of somebody new in the administration or there are some issues that are time sensitive and many of the ex oficio members are aware of those, why don't we identify them and get a small subset of evaluation committee or some other group to start to look to get into a little bit more detail by the December meeting so at the December meeting we'll have some issue briefs on some and we'll have some, you know, early position statements on one or two time sensitive issues. So I guess I'd like to formally suggest that to deal with this issue of losing six months but do five months between now and December but on the other hand not losing the very important relevance of this committee right out of the block with a new administration. So Michael, does that get to your issues, and Sherry your issues and then we right out of the, right at the beginning of new administration, we're seen as action oriented with clear thought and direction.
I think that's very helpful. You know, I'm working at a suggest of a full committee, and I would be very open to moving this discussion forward and particularly to tomorrow if we're all comfortable with the identification of some quicker moving issues that could be taken up by one or two, um, by the Task Force as we already have or other things, I think that would be all right we should consider that. Some of us have been involved with Presidential transition, administration transitions, and know the ins and outs of opportunities and doors opening and windows closing, um --
{LAUGHTER}.
-- and, um, the illusion of doors opening and windows closing --
{LAUGHTER}.
-- but we need to consider that but also consider the requirements for the formal decision-making that would require a meeting, but Paul?
One thing that in light of this conversation that I'm not quite clear on is to what extent does this committee's recommendations fit within sort of the overall governmental transition planning? Does this committee basically, and maybe some of the ex oficios can sort of alert me. Does this committee end up being like one paragraph in the HH S sort of transition report or is it something that is tested? You know, what are we, in a sense, talking about? I mean, I've been involved in transitions too from not inside the government but outside the government, and I'm trying to get a sense of where this committee is an outside advisory Board fits in in terms of both HHS and sort of this overall government transition so that I have a better sense of what the product should be looking, should look like to be most helpful and influential and valuable over the next sort of six months because I Think regardless of what happens in November, you you know, the horse is out of the barn come the second week of November, if not sort of before, um, and that's when it is, the December sort of things are sort of setting up by January, sort of the first wave is already to come in and so we need to be sort of thinking about that timeline. But I'm just, it's a process issue.
Comments?
Yeah, sure.
Well, there's inside government and outside the government transition process and I wasn't suggesting this committee should be speaking to the outside government transition.
Yeah, I'm worried about the inside.
We don't really have a mechanism to engage that.
And that wouldn't be appropriate, no.
But inside the government transition process and certainly one of the other ex-officio's position can comment , from a staff persons perspective having a committee like this of experts say that this issue and this problem needs to be solved under your administration doesn't necessarily need to have the answer, it's something that I can put in a briefing book that supports my arguments with leadership. So it's something that I can, that I'm already working on, everything is already worked on, to say that I've been telling you for six years to know it's important if the committee agrees with me, you guys really need to invest resources here, come on Board with us and move in this direction. It's something that staff can use as evidence of support that there's a knowledgeable group who has been charged with addressing these issues, believes that this is an important priority, there are important problems that need to be addressed by government.
Sure, I just want to at least remind us all that we have that we have a men daiingzs that are out there, for genomics , oversight, reimbursement and coverage, we'll soon have, Jim left just as I said that --
{LAUGHTER}.
-- so we have a number of things regardless of how quickly we can get this process together, which hopefully, um, will inform the processes in each of the agencies because as we said in the beginning, this administration is only going to get so much accomplished in the next six months and those issues will continue to be there and we think as far as I know, we still think they're important to move forward. So, I hope, Sherry, that those at least happen and anything we can do in addition would be, you know, would be helpful.
But I think the question is, do we need to either reissue , I mean it sounds to me that there are two things going on. One is we already have issues out there and making sure those are articulated for the new administration, obviously there are a lot of people in HHS that continue, so it's clear but maybe rearticulating what those issues that we already have outstanding would be useful, but I think secondly, what the discussion is is should we maybe before the next meeting or right at the next meeting because it's only two weeks after the election, be very clear on the one, two, or three, highest priority issues, even before we get into depth on them and I guess that's what I'm suggesting before and I'm hearing that there's some agreement on doing that but I think, Steve, with your point, there are probably two of those to make sure that we're clear about what exists and we add to what should be the priority going forward.
Okay.
To that end, I mean, perhaps we don't need to see this in , you know, a completely either/or sort of approach. I don't think we have to say that some issues should be addressed in a more time sensitive fashion and then consider it to be completed. We could do, right, so one thing we could take into consideration would be the possibility of looking at what we've already done as we've mentioned, say take clinical utility as an example. It's in the reports in the pharmocogenomics reports, we have recommendations A5, B,c, D, and they all look at the clinical utility. In the genetic oversight I don't recall exactly what the recommendations are, but the idea would be to build on that, maybe could lead to a letter to the Secretary saying, considering the fact that we've addressed this now in three separate reports from three different perspectives, one could say globally that this is an issue that should cut across all of personalized medicine; however we end up describing that, and then say that we will then as a committee, consider how we might go forward-looking at this, but in the meantime, in the interim, as the new administration comes in, this is something that this committee has obviously identified but would like to broaden that identification and say regardless of what area personalized medicine we look at, this should be something that needs to be concretely addressed.
Well, moving forward in this way would require some convergence, some consensus emerging from our conversations today, if there's no convergence, no coherent consensus, then it would in many ways preclude moving forward more quickly on certain items, so the fact that there has not been enormous chaotic discussion here makes me more comfortable with the idea of entertaining this kind of mutually exclusive approach, so I think that we should keep this as a framing principle for the rest of the discussion this morning and also, um, for the later discussion, but in many ways, it's going to have to respond to the general consensus that comes out of going through these categories.
As we move forward, , comments, concerns, enthusiasm?
Well, not to continue to say the same thing, but --
{LAUGHTER}.
-- again, you have structural changes, recommendation and you have specific changes recommendation, and so the recommendation would be that genetics and healthcare reform, in terms of this committee, may be broader, it may be bigger , you know? We're talking about what we can do that's action able within a reasonable period of time. Some of this may be recommendations to another committee that, you know, on this, and I say that just to be cautious about it, because we can make recommendations but healthcare reform in and of itself is actually a very large structural activity that requires way more than what this group can have. We can make a contribution to it in terms of recommendations , but exactly what we can do on that, so I think there's a simple part of the letter, you know, I expect with any context, there's also a structural element, that means changing structure, which means the first one is the role of this and then the last one which is actually the healthcare delivery system itself, it's like we could do that, then, you know, wow, we would be sitting much higher than what we are in different ways, if you know what I mean, Kevin.
{LAUGHTER}.
But I'm kidding.
{LAUGHTER}.
But, um, I would just say this, there's structural elements to this and then there's specific elements to this and if we can make recommendations, this would be one where it just simply would be a set of recommendations in a very short thing, I don't, it fits into these other groupings. Because this is a very broad area, it's like health disparity which is a very broad area that you can only make right now recommendations because it requires significant structural changes to really do something like that which there's a lot of other groups working together on and maybe that would be as to what other groups working together we could recommend for them. That's just my thoughts.
Yes, please?
Um, yeah, I just wanted to talk a little, I realize I'm Novel to this, but, um, you know, when I was voting on it, I certainly Indiana tiered the issue of the incorporation of genetics to public health records and electronic health records --
Sorry about that. It's Spanish.
{LAUGHTER}. Yes! A little bit differently, outside of the sort of broad topic, um, in that I interpreted it actually in my own sort of mental clustering with something like the informed consent which ended up in a separate cluster of its own, just coming to it, fresh after several years apart from these types of topics, it seemed to me that there had been, you know, obviously due to the affordability issues and so on, the vast increase in the amount of data, that's being generated, on individual genomes, and that this issue then, and the data was obviously, you know, very quality, that's an issue, but for various sources without any particular sort of standardization or integration, so it seemed like there's now a lot of data and in the near future, there's going to be a continuing acceleration of the increase in data generated but unless this data achieves some kinds of integration and comperability and so on, it's not going to be used effectively so it seemed to me to be a very initial up front issue was to figure out how this data can be combined, and it even goes back to that separate cluster that you talked about in public health issues, the ability, all of these people generating their genomes, is there going to be a way to take this data from different consumer types of tests and just from different consumers and somehow combine it so that we can do population studies, so I just interpreted the cluster a little bit differently and saw a theme that you haven't articulated necessarily as a cluster here.
That's very helpful, and again, we have the opportunity to both insert issues into a cluster like this but to rearrange different elements of these clusters and put them into other places if it makes more sense as the issue brief begins to get put together, so your confession about how you voted on this, um, is very helpful because it's actually mimics I think the way we all did, a bit of a shock activity for some of these --
{LAUGHTER}.
-- and this discussion is very helpful in identifying best ways to recluster or reinsert. Other comments?
I should point out that several comments have been made about links this to other clusters, and we're attentive to that, and we certainly can integrate that into one or more of the categories. Kevin?
Just again for clarification purposes, I know this is, it can be more broadly conceived, and so even as we go forward, it might be important just to make it clear that this would probably also have to include things like privacy and confidentiality and the whole idea of when your private information gets into these databases and all, how is that presented to the consumer or the patient, however we're going to delineate that as to what sort of security might be there, who has access because we start doing these large population databases, obviously as the information is pulled together, the ability to pars out an individual becomes, you know, greatly enhanced, so all of those issues kind of fall into this.
Just a quick question. Did any of the past reports deal with this issue?
Oh, yes.
That's what I thought. The pharmacogenomics one quite extensively.
Yeah.
Okay.
{LAUGHTER}.
You know, I love the coverage and reimbursement report, I think it's one of my favorites.
{LAUGHTER}.
Really, I think it's very very central to the what the group has done but because I think it's so excellent, I scored these lower because I thought this was water under the bridge, but the fact that they're coming up again, are we missing something with that? Is there something we haven't followed on with? Is there something else that the responses, or the fact that these have come up as recurring topics, there's someone trying to tell us.
They may be telling us to not read the original report, but clearly, one of the criteria was is this an urgent issue that has not been covered, but it came through anyway, so your question to the group is it's still worthy of some of the discussion.
You know, I think is it's like the predecessor of this committee Erecommended that GINA be developed in the past and then this committee just continued to revisit the issue, they have testimony, pulled together information, send and collect that information to the Secretary, continue to, you know, support that movement occurring, and this may fall in that kind of category is already what's reported out there, it may be an issue of following up and continue to raise it as an important issue and getting public input in a variety of ways and putting that forward to the decision makers.
I also, I wondered about the same thing. I actually voted it high, but partly because we haven't seen any major changes as a result of our report and other reports, so maybe one of the things again back to what I said before is that I would definitely recommend that with the change of administration, we have a very clear, again I don't, some of you know this better whether there's a list or a letter or something that articulates what we've done and what we think are the continuing issues that need continuing focus, and a lot has happened in the current administration in HHS that's been so cooperative with us in many ways but not all of the work has been done, so to me, I put this as it sounds like you do at the top of the list, to say that we've had some progress, where are we now, don't lose track of it just because we did the report in 06.
Mark, are you still with us?
Yeah, I am.
Do you have any comments about this conversation about how to think about and how to approach issues O of coverage or reimbursement particularly in light of the prior report?
Um, I think that it's important to recognize that we did have a conversation with representatives, the Secretary earlier this year to discuss several aspects of the coverage and reimbursement report, and, um, I guess the question as I'm listening to this is as we think about the role of SACGHS , whether, um, when we produce a report, such as the coverage and reimbursement report, do we have an obligation in some ways to continue to engage in follow-up and have regular report backs? I agree with some of the other people that have been talking and they say that it doesn't make much sense to sort of redo it. It sounds like we may need to think about it and perhaps this would be something that would be worth an hour or two of discussion about how do we, um, maintain engagement around a report or some other thing that we have generated so that we can really see, well what is happening, and then that in many ways would inform us about are there specific pieces of information or other things we need to do, hence the movement of the report going forward.
Mark, thanks. I know there was a letter written to the Secretary about this in February, which you saw at the meeting, but we do have the, it's clear lift still important, a lot in that recommendation that didn't happen that we need to do but one of the things of course we can do that gets back to what do our products look like, is that one of the things we can do is monitor these things and make sure that we move them along, so it can remain a priority but not necessarily generate a large report, but make sure that it remains on the agenda and my sense is that it was important from the perspective, yeah.
Steve, might it be a possible approach, it would be to in our monitoring try to discern what it is that may still be an obsticle to the fulfillment of the recommendations and then see if there's something specific that we could then address in sending fourth yet again another letter and saying, you know, here is a recommendation to look at that.
Sure.
And Steve, I think this keeps coming up because I think this is one of the biggest blocks of doing any of the other things that we have recommended, education, access, health disparity, I mean, this is the biggest stumbling block and I don't know how we can impress upon the administration to put this as a very important thing in the transition plan. Because if we can get this, the reimbursement part done, then we can do so much more and everything else we've recommended.
Okay. I have a question, again. I was wondering, one of the things, I know that we have recommendations and we have a letter or we have some way of following up, I'm just wondering whether or not one of the strategies to use in terms of the development of this is the development of the recommendation itself, but also a development of the strategy or the task related to getting specific information back. For example, with this issue, and the other ones, they do keep coming up because there are other groups besides this one that are working on the very same issue, and then everyone is sort of drawing, you know, the same conclusion that is constantly something that we have to push. Like ATHA's work on this, other kinds of groups and organizations working on that. One of the recommendations would be whether or not we could have or make recommendations for some tasks like we've gotten before which is a multi-committee or multi- organizational group that's sort of out of the Secretary's office, that can report on these cluster issues because I agree. What we need, if we put together the list of like here is what we have accomplished, and some priorities that we recommended and then the next question of course would be what other groups and organizations are also working on this because, you know, and even the list we have SR they still out there, are people still out there and we assume we know why, but now, can we also be part of whatever the work would be, can we get reports back on that as part of our function? And I'm wondering as a committee, can we put that in part of what it is that we do because it seems to me that there's the short-term and there's a long term follow-up on these things to reach a conclusion and I think the GINA really stations a clear example of something where there's a short-term and long term follow-up that may be because of the climate we're intakes longer to actually actualize over time. I don't know if that was clear or not.
Any questions about this? Comments? Any other comments or questions on this? I think that you provided some very good guidance. this clearly falls into the domain of the Task Force on education, and it was very nice to see this come to the top as a very highly ranked set of issues. Comments, suggestions, for the Task Force? Good. We'll move on then.
The fact that these are in yellow is because they did not rank within the Top 20. But were pretty close to the Top 20, and clustered in this way.
Could those three become one topic and that be moved up?
{LAUGHTER}.
You could add them up and give them another score?
{LAUGHTER}.
Yeah, we put this together, well because the Top 20 is totally arbitrary. The other thing is that the distance between Number 20 and Number 25 was extremely small. But also, because this in many ways was generated by conversations in February and was deemed important in another context that we group this cluster to give us more substraight for issue briefs.
I think that this is like the third list of all of the things that need to be woven through any of the priority topics that we address, so we have priority topics, and then we have a list that says, that you must address these things , and one is healthcare disparities in minority populations is I think that as a cluster, it might not rank in the top 20 that it definitely is something that you have to address in anything that you rank.
Kevin?
Again, this might be one where we can, um, acknowledge the broad concern for the general issues as pointed out that are just there and then maybe say obviously, genetics is another area that could play a role in either concretely addressing these issues or exacerbating them. I don't know how we would have to do too much more than that because again, a lot of these are also mentioned in the previous reports, perhaps a little, in a little more cursory fashion but still they're mentioned. These are things that have to always be kept in mind so again this might be a relatively easy one to address.
The only question I have of that is when we do over arching, they tend to disappear like clouds, and I remember the conversation in February and actually some of the public comment here is that maybe there's a more pointed question of is genomics decreasing health disparity in our country, just more of a pointed question rather than of course when you do attend to these issues with all of the other ones, it would be a really hard question to answer but I don't know if anybody else, it keeps coming up and this seems like a good body to sort of really address that question was really from data.
Or maybe the opposite, could it increase health disparity ?
Well, yeah.
Paul?
It comes back to my earlier question or comment, that I've been sort of thinking about through this conversation is SIA degree, this is an important issue and it's sort of in the fence and I agree with Sylvia. It's a thread issue, maybe more so than sort of a standalone issue, but with this and some of the other things I'm having sort of trouble and maybe this is a lack of creativity on my part but of wrapping my head around what it is at this point , given the other report that is going to be sort of our deliverable, sort of, you know, in terms so all of these issues are important in some ways. Some of them are, some of them lend themselves and that's kind of what I was focusing on as I was doing my marking of it is what are the things that this committee can sort of deliver and add value to and sort of create a product to, and those are the things that we should be, I think, that we should be focusing on rather than saying that these things are important, don't forget about that, and I think that, and maybe that, you know, some of those are sort of the details that are best left for sort of the individual groups to come up with some of those priorities but with some of these topics, I'm having a hard time thinking about sort of what it is that at the end of the day, we say other than in a sense, I mean, not to be, well yet another letter to either this Secretary or another Secretary to say, don't forget, this is important and so on, as opposed to coming up with, here is a body that says here is some informed consent standards that we think are really important. Here are some ways that we do that you should change Regs on reimbursement with respect to genetic testing. I mean, concrete kind of things that a new administration, regardless who it is, is going to say, wow, that's a good idea. Let me run that through our process and say, you know, either yes or no, that's it or not, rather than I'm having a hard time saying, you know, yes, of course, health disparity is bad. Do you know what I mean?
Had exactly.
And that's the struggle that I'm having with this conversation, and given the fact that we, the reality is that we've got maybe at best, five things, three things that this committee can do, I think that we should focus on three or five things that we, within the next 12 months, can sort of deliver, put on the table and say here it is, we take the pieces as I think Kevin had said a number of times that are already contained in the other reports, pull those out and say here are the things that are still left to do, here are five new things that we've delivered and that's in a sense our agenda.
Well, I think you articulate extremely well the challenge to the group in sorting these things out. In part, or in large measure, the issue briefs are supposed to make the case for each of these clusters. So then we have more time and more detail to make these judgments in this way. I think Mark, you have your hand up?
{LAUGHTER}.
Mark?
Actually, yeah, that was for the previous comment that I made, you sort of anticipated the little e-mail that I sent to Sarah.
{LAUGHTER}.
Joseph?
Just the only, I agree with what was sai, and I think one of the other considerations is actually the ownership question, is that do we have to do that? I mean, can we also , would we be looking at the fact finding part of this? There are clearly others working on these issues and probably do we, either a better job of moving in that direction, and just simply, you know, saying that there's another group that really should get supported because they are due to these issues without us having to go through what was just recommended. I mean, we could make that as part of our recommendation is that if you know there are a group of organizations and individuals working on this, you know, more power, let's recommend it. That should be supported and let's focus on what it is we have. I would recommend that. I recommend that these are critical issues but we don't have to take ownership to have to deal with that, because the issue here is that what can we best recommend to be most effective in terms of actionable things to do, and if we consider that working with others or even recommending others who are doing it as one of our strategies.
But that's a burden that any of the clusters, any of the issues that we adopt will have to meet, and the suggestion is that the issue brief will have to make the case including identifying which groups are doing what as far as we can tell, and then the committee can make judgment in that way. Other comments specifically on this because what I'd like to put up is the Summary.
Of the groupings that we've just run through. Yes?
Yeah, I just want to say one thing for practical consideration is that I think historically, as I best remember, you know, most administrations do most of the things that they're going to do with the highest impact within the first six months of the administration, the first , you know, like when the democrats got Congress, the first 120 days, they always set these timeliness as priorities and they try to get a lot done in that first time, and there is a HONEYMOON period, you know, in a new government, oftentimes, so the quicker the better we can move on these things.
Other comments, questions about this list? We would like to move to try to gauge the general consensus about these kinds of categories, these categories as, um, the basis for creating the issue briefs. Paul?
Well, so before we codify this in some further way, it does seem to me that we should map this back on the work that's been done by the committee so far. I mean, that seems to be something everyone is saying. I can't like right off the top of my head as Steve, you seem to be able to do, pull out a chapter in the little verse of where it appears in the last four years --
{LAUGHTER}.
That's fantastic and that's why you're the Chair, so but it would be, I think quite useful to really do a mapping back so that we can say something intelligent about what the brief we want to do.
Laura?
I would agree. I'm trying to think about timing wise to be able to do that, whether that's a realtime issue or that's between meeting issue, but I think it would be helpful, and will have to be done anyway to move forward, so we're not repeating things unnecessarily, but I guess I'm going to go back to the comments about time sensitivity. How do we want to deal with that issue as we've heard a lot of times, take advantage, given some challenges but to be able to prioritize --
Pardon the interruption. The conference contains less than three participants at this time. If you you would mribing to continue press star 1 now, or the conference will be terminated.
Wait for the key E, two digits there. Okay. So, separate from the issue, what I've heard from this discussion maybe then is two key things. One is reviving in some way what we've done in the past to insure that it continues to be a priority with the next administration, and in an action oriented way and not just for the sake of listing it, and then secondly, the potential of fast tracking a couple of issues so is that when the administration is coming in and maybe immediately post the December meeting, hence work between now and December, that we have some prioritization of issues that can go to the administration, and given that may have to happen right after the December meeting, I think we need to discuss it today so that we can do the work between the meetings to get it approved this group so it's ready in December.
Comments, suggestions on what Mara is proposing? There is the part of the next steps.
Yeah, it's basically an additional next step, that would be required between meetings. To me, it doesn't change the fundamentals of the process you outlined which I think are the right ones for our long term priorities but insuring that as a group, we hit the ground running with the new administration on summarizing the existing issues and prioritizing one, two, or three new issues. So, I heard a lot of consensus about that but I just want to clarify it that because whether it's the evaluation Task Force or another Task Force there's some additional work to be done that can be presented more specifics at this meeting in December.
Kevin?
Just to build on to that, some of the issues that Paul brought up, again, when we identify the things that we have already addressed, perhaps with some comprehension, it might be helpful to also identify if we can, why we think these things have perhaps not yet been fulfilled or our recommendations have not yet received the kind of traction we thought they should and maybe then come up with further specific recommendations to say on this issue then, we recommend in addition XYZ. That, I think, kosh done in a relatively good way without, perhaps, having to Garner a great deal more information, or expert opinion, although we probably have to certainly make sure there's public consultation.
Other comments, questions? Concerns? Okay. Just to remind everybody that the last time the committee went through the priority setting process, I believe there were 12 issue briefs created, so the fact we've identified a smaller number of candidates, issue briefs right from the get go, and it may be given that we have two standing Task Forces already up and running that clearly one would have direct relevance to some of these topics, the other, it would be more engagement with the committee, with the Task Force to identify specifically which of these arenas it might capture, but there is an infrastructure already in place that could fast track some of these issues to move it forward more quickly, as opposed to relying strictly on creating a new structure, so I think we're well situated to respond to what Mara is suggesting. The Sarah, do you want to make any comments on fast tracking certain selected issues that we can identify here today?
Well, I think, I think that it's not the decision for the committee to make. It's the consensus that you want to do that. I think that we want to be sort of have honored as process but not to the point where you're not comfortable with the process, and you you think that there's some things that, um , you need to take precedent, so I think we should be open to that.
Other comments?
What kind of time schedule, I mean, I think we should do that. What kind of time schedule, what's the available time during this meeting to hammer out what we would think should be fast tracked?
Well, we have time until 11:30 today but then we have time again tomorrow to have further discussion, but what I would suggest is that we get through agreement without talking about exactly what we're going to do or what the priorities are, but get some consensus that these are the right clusters. If we can get there, now, I think we will have gotten part of this done and then we still have, you know, we can delegate that to the priorities Task Force exactly what these issue briefs will look like and they don't have to look the same for everything, if it's on reimbursement and coverage, it's probably more of an update of what's going on and as Kevin says, what would it take to move to the next step, it might have to be more elaborate because they're new and then tomorrow, we can deal with the issue that I think Paul Billings brought up and I've heard now come up in other sites SR there some things we can move forward now that are at the top of it that we really want to focus on so we can move more aggressively on them and typically if there's a topic or two that we can, if it fits in with the evaluation Task Force that we can say we actually want to move on more quickly or move into the education group, then I think we might be able to meet most of the needs that I've heard here today. Paul?
Along those lines, maybe I'll say something concrete. I would recommend that on the cluster issue called informed consent for genomic data sharing, sort of following up on Kevin's point. I would broaden the title of that. And you might, you know, one way of doing that is to sort of add a couple of commas. You might say informed consent, privacy, and discrimination, maybe throw discrimination in there, maybe not but to sort of broaden that out to sort of those family of issues that go around genomic data sharing, and I think that would more appropriately describe the kinds of issues that that cluster would sit through and do.
I would agree with that and I think it addresss the one thing that seemed lacking. I think it's a great general cluster. I think one thing that is lacking at least in any kind of explicit way are two of the issues that were in the Top 20 regarding the electronic medical record and that would be the place for that. The other thing that I would suggest as far as these broad categories is I think consumer access to genomic information just seems perhaps implications of genetic information as a commodity or as a consumer commodity, so it's something along those lines because I'm not sure what is meant by consumer access to genomic information. We need a different header for what needs to, what was addressed.
Maybe given the broad issues there, it's consumer issues with access, you know, with future access to genomic information, because it's this afternoon and tomorrow, it's so broad --
[INAUDIBLE].
Yeah, I didn't want to get into implications but just what are the issues because the deliverable here may be identified in the myraid issues firsthand and the second level may be what do we want to do with them so we're trying to be action oriented and specific.
Yeah.
That's real helpful. And clearly, it would fit easily .
Just as a comment, and I'm sure this can be done by when we work on the issues briefs but on the first one, genetics and healthcare reform, it just seems so broad and daunting. The two things that were soft of discrete in that is the electronic medical records and genomic data integrated into that and then the clinical work flow issue and the support, those I think are fairly discrete items to work on, and this topic is a fairly broad topic, but that could be done in the issues brief.
When I looked at this, I thought healthcare reform is a very political topic, that's not like within the scope of the healthcare reform and whether or not to put Jen it ics there because people with genetics and healthcare reform, you have to talk about healthcare reform because we are the best group of people to be discussing healthcare reform.
I think that the issue rose because of the specific implications that the rise of genetic medicine has for healthcare delivery, and the structure of healthcare, which of course has a big impact in healthcare reform, so, you know, my personal feeling is that that's a reasonable thing to have on there. Now, it is very broad and whether it's something that should be triaged, you know, to a high position or not I don't really have an opinion on it at this point but I do think there are very specific aspects O of genetic medicine that have a big impact on healthcare delivery.
But if it's not in the political agenda to do healthcare reform right away then the whole thing dies.
I would suggest that we do healthcare delivery. Healthcare reform may sort of come with it, a connotation, sort of implied within it that we as a committee might or might not, or appropriate or not want to sort of say but really what we're talking about is whether we reform the healthcare system or not, we're really talking about the issue of genetics and either, I actually like healthcare delivery or the healthcare system, regardless of whether it says the same or reforming.
Can I suggest because I agree. I think reform has political implications. I just think about it in the future of healthcare. I would prefer, I like a system more than delivery because it may be broader than delivery. It's everything from products to structure to the fundamentals of it, so I would go with system or future. I think I know I wrote one of those and what I meant is not necessarily somebody's capitol letters, healthcare reform but rather how healthcare will be reformed and will be changed by genetics, so the future.
Yeah, I was up for system. Future sounds subtle.
Too big.
Yeah.
Steve?
I do have a comment, that within the write up were the implications of the innovation for the healthcare system and it is about innovation and the economics some of which were probably felt will merit the evaluation group anyway, that are embodied within this.
Can I get in here? This is Mark.
Hi, Mark.
Part of the discussion that's gone on before about that we could address that's relevant to this idea of healthcare reform, I mean, this is a huge topic and obviously there's a lot of variables but I think there's one very specific thing that is very relevant to genetics and genetic testing, and the Department of Health and Human Services and that is how Medicare is going to define us in respect to their preventive medicine exclusion, and that's something that, you know, is to some degree at least under the perview of the Secretary and I would think that working to try to and understand how CMS is going to be interpreting these tests as relates to their preventive medicine exclusion would be extremely important and actually would be doable in a relatively short time frame.
Thank you Mark.
Are we finished? Are we cutting out the conversation?
No.
Okay, what's not up there and maybe this is our next step is I think a lot of this was part of running through the discussion most of the morning which is of these clusters, and of the subject of subgroupings within these clusters, what have we already addressed? And first of all, so second of all some recommendations were made that we look at the individual, you know, broad groupings under each one of these, and made recommendations specifically to retool the needs as well, maybe that's the next step as opposed to what we're doing now.
Yes. That would be included in the information of the issue brief , so that the decisions about priority setting could be made on the basis not only on the importance of the issue, its nature, but also its strategic role in this committee ultimately taking effective action. Have we done it before? Are other groups doing it? What's left to be done? What continues to be undone in the real world.
Well, okay, I guess my point is that we are walking through agreeing or not agreeing whether or not these clusters make sense and we want to follow it through but it seems to me that part of the information is missing from what we've already discussed and we need to include that in this, because we repeat this process, again, once we sort of follow through with that, so that's kind of the point I'm making is that should we go back to some of that information that we've already agreed to and come back before we, you know, in looking at this, because it sheds a different light on this, that if we take this other information that we've already discussed which are categories, which are the recommendations and that sort of thing. That's the point I'm trying to make.
Can you give an example?
Yeah, for example, we look, it was brought up earlier, public health applications in genomic research. One of the points that was brought up was that and also as public health is that several of these categories, for example, the education of health professionals and consumers and genetics and insuring, um, the whole issue of genetics and healthcare within a system, all actually fall under the broad category of public health application.
It does fall under it, but it's not coincident. It's not the same thing. There may be other aspects of public health that do not fall under the other categories and the issue brief will try to identify what those are including occupational and some other things that came up, to see if it should be renamed, if it should raise issues that we haven't yet discussed here , for deliberation by the committee and if it's felt it just doesn't cut it then it falls to the wayside, but the question is: Is there sufficient utility in that category as it relates to moving forward with an issue brief. Nothing more than that, and that's where I would hesitate, just checking the whole thing, on the basis of what we've got so far.
But you just made my point. It's not so much as checkinging the whole thing, it is the restructuring based on the discussion we've had because you just restructured it and said that we need to relook at it. That's actually the point I'm remaking.
Great.
Okay, just, um, for clarification, because to try and avoid some of what Joe is hinting at here, or clarifying, one of the things we've run into before is this distinction between genetics and genomics, and if you look up there, sometimes we say genetics and sometimes we say genomics so I think we have to be careful when we determine our clustering exactly what we're talking about with regard to that, and then to respond to Barb's question before about the minority s and the healthcare disparity, one of the issues we ran into is the fact that there isn't good evidence as to the potential exacerbations or the potential positive contribution that genetics and genomics can make to addressing those issues so again that would be an example of a concrete suggestion or recommendation we could make to the Secretary and I think we've addressed that in some of the reports, but to say, in order to get at this somebody has to come up with this data, not that it's going to be easy to do.
Well let me see if I can pull some of this together. What I've heard here is that these general topics, and we've heard a lot of suggestions about how they can be somewhat reconfigured, whether they need to be standalone, whether they're cross-setting, I've not heard a lot of suggestions about topics that have been missing from here, and that we've got a lot of advice about how we can recraft the names , how we move around some of the subtopics but that people are generally okay with this set of issues. Before we break, if we have two and a half minutes, can we get agreement that this is a reasonable set of issues and --
As long as you get the electronic medical record since that's such a big topic.
And it was one of the issues within this that, um, that Paul showeded us, that there's going to be some, we've got a lot of specific suggestions about what needs to be tweeked and sort of what are likely to be priorities or issues that need highlighting, but I've got the sense that this is a reasonable issue.
Yeah.
I think it shows that perhaps contrary to past President we voted with some logic.
{LAUGHTER}.
Don't get carried away.
{LAUGHTER}.
I got the sense that e-harmony works too!
But we have to be careful.
{LAUGHTER}.
So anything to that set of issues? If not then what we'll do tomorrow is we'll come back to some of the, we have an hour, and what I'd like to do is deal with some of the things that were mentioned earlier, are there things that it's not even worth the time at this point that we should drop off and are there a couple of issues that we should highlight that one of our committees or other kinds O of things that we should take up with a greater sense of urgency over the next five months before we, um, reconvene and actually rollout our priorities. Is that a reasonable agenda for tomorrow?
With that then, first, let me thank Paul, um, for his enormous amount of help.
{APPLAUSE}.
And for the staff for pulling all of this together. It was, um, it was an enormous effort, and most appreciative , Paul, for leading us through this discussion. So we're going to wrap it up and we're going to now depart for the Regan Trade Center. There is a bus that's outside the building on Second Street for those of you that have lunch, you can pick them up here or for those of you who didn't, you can, um, get them over at the Regan Building.
And we will not return here.
No. And arrangements for dinner tonight?
It's in your folder.
Tomorrow.
Oh.
I think you can leave things as long as they don't have intrinsic value.
{LAUGHTER}.
That's your definition.
{LAUGHTER}.
The information in dinner is in your folder, 7:00 tonight over at, um, Union Station.
This Conference Call haend ended and captioner will now disconnect. Thank you and have a great day!