Event ID: 616101
Event Started: 11/13/2006 8:18:32 AM ET
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... he had a few ideas in particular, thinking that we ought to transform some of the reports, recommendations into manuscripts. We took this to heart, working on an article on -- talking to some of the people like the general health affairs, others, working hard on that, and we want to have you start to think about places in your domain where you have influence or where you think it would be important for us to get our reports and recommendations out.
I will be very very eager to see that, and our terrific staff team would be happy to help facilitate that. Our committee has a very broad mandate and charter. Guided by a strategic plan that we developed as a committee through a systematic process in March of 04. As you know, every meeting I will pull out this chart, and I am going to do it now. I think it is critical that you keep in front of you what it is we said that we wanted to achieve. We have to keep checking ourselves to see whether or not we are meeting our expectations for our work. Importantly also, I think, time to be thinking about modifying what our a jend a is. I want to be pretty rigorous with reviewing, but quickly, about what we are doing and where we are in our strategic plan.
2004 was a while ago. At some point we will need to revisit the strategic plan. First, public concerns about genetic discrimination have been our highest proirt issue. priority issue. We commissioned a legal analysis of law, significant set of public comments on the issue, almost like a phone book size. Documenting public concerns, we produced a DVD, a summary of our testimonies. We will get an update on the status of congressional activity.
Two, produced a report, nine recommendations on coverage and a good meeting with CMS, they have those evaluations recommendations, evaluating.
The training of health professionals, how that should be enhanced, written several letters to the -- prompted several collaborative efforts among agencies. We heard updates from the working groups formed to address concerns about direct consumer marketing, and in July the efforts culminated in the publication by the Federal Trade Commission on this consumer alert on direct consumer marketing, business in accordation of FDA and CDC. An examples of the agencies working together to solve a problem. You should feel good for highlighting it, and the officials in making it happen. Raising consumer awareness on the in facts about "at home genetic tests", crawgz cautions it's not be evaluated and be ware wary of claims made by those marketing the tests. To consult a healthcare provider and --
We were please pleased and impressed by the collaboration, and the team at FDA, CDC, Linda Bradley, Julie Gesh eding, and her letter, in tab 3, affirms the importance of these efforts.
Earlier we wrote to the secretary to commend has leadership in the advanced infrastructure, vocab Larry, to support the security of genetic data. I will say more about the effort efforts in this area in a moment. A major focus of this meeting, population studies. The t force made extensive revisions based on feedback we received.
We will have an update update from chair Huntington F. Willard and let me be clear, the goal for the session will be to come to closure on the -- come to closure on the report so it can be sent to the secretary in final form.
One thing we will do this this meeting, again, introducing every topic area, you will be very clear about what it is you are supposed to do today, so when you ask the great smart questions, or put the great input you do, it's designed to get us to a goal. The goal on this one is close the report and send it to the secretary in final form.
Gene patents and licensing, moving forward with a study on patient access to genetic technologies. The committee established a task force to define the scope and study plan and they have a detailed scope, work plan and timetable for us to review today. Work will also continue on the priority issue of pharmacogenomics, the task force refined the draft report, recommendations, we will begin a very focussed discussion about it in just a few minutes.
We will be look being closely at looking closely at development of genetic tests, and have a discussion whether SACGHS should take on a role in this area. New to the committee, up to speed about the history, evolved out of an earlier committee, the issue of oversight on genetic tests. We have been able to turn our atongs attention aattention to other issues, and whether we need to be -- an extremely important discussion for us in a few minutes.
The cross-cutting issues of genetic exceptionalism, awareness, integrated into all of our other work. That's where we are with the priority issues. I ask you to keep that in mind, we want to revisit it.
In your briefing books, left hand pocket, is an annual survey we are suppose to do fill out, about your perspectives, our effectiveness, and whether we are meeting our goal and priorities. If you have not done so, you are supposed to do that before we leave. So the thing is, if you don't think we are making the progress we are supposed to make, then, you know, you have to say that. But we have to then figure out what we are not doing to meet the objectives we have. But one thing, at least we are focussed on the work we are to be doing. The foundation -- to assist us, and new work secretary Leaf it would like us to undertake in the future.
I would like to say something about secretary leaf it. I am extremely excited about his leadership. In a way we have not experienced before, attentive in an unusual way to the committee. Talking to me, as your chairman about this. He's made his key staff available to us. We have an opportunity that we've never had before, which is to really get input, guidance from the secretary about his agenda, and how he wants to see us move that agenda forward. I really want us to spend a minute as we pay attention to that agenda, what he's really focussed on is improving quality and cost of healthcare and making that quality and cost transparent to consumers. The president advanced in an executive order, requiring agencies add administering healthcare -- part Drk of they Medicare program, working hard, in a number of meetings with him on planning, preparing for a potential po influenza pandemic.
Taking a systems approach over the next teen 10 years he wants to see healthcare reach new 41 frontiers. Enabling healthcare to become more preventive, predictive and certainly more personalized. The Secretary recognizes jen omics is playing a larger role, and how to incorporate this new information. I met last month with both Sheila and Greg to discuss our work, how we might be helpful in advancing the Secretary's agenda. What we are doing, integrating genomics, particularly in the area of pharmacogenomics is already on the secretary's radar. The effort, called American Health AHEC, aimed at getting the best thinkers across healthcare and those who pay for hilght care healthcare to put together -- health information technology, and data, allowing people to make better choices, decisions, having physicians and healthcare professionals have access to information so they can make better choice and decisions and do it in a way that protects privacy, security within the consims of interoperatable --
Last meeting, a HECK formed a personalized group, very important for us to stay tuned to some of that work. The Secretary asked me to make you aware of a request published in the federal register November 1. A copy of that document was sent to you last week, another is in your table folders. Seeking input from the public and private sectors on plans for developing and using health information technology, genetic and molecular medicine for health outcome evaluation and research. Seeking information on a wide range of topics and we will hear about that in a minute. I encourage you to respond and share with interested colleagues. Due back by the first of next year. With that, again, because this moment of trying to bring together this health information technology, ability to have information about personalized genetics, combined with enhanced consumer decision making, combined with health providers and hospitals having the information, coming together in a new and interesting way, I want to turn to Sheila, see if she can bring us up to date on what is going on, how from the point of view from the secretary's office the committee might be helpful and thank you for joining us.
Sheila: Thank you for the opportunity to join you and the members here today in your important work. The work of this committee is highly relevant to the secretary, one of his top 10 initiatives, accelerating personalized healthcare. Improving the safety, quality and effectiveness of healthcare by leveraging advances in jen omics. A powerful ful force, enabling better clinical outcomes. Focus is on how to improve health in a more patient-centric way. To fully realize the potential we need input from many important stakeholders. At your prior meetings you discussed many of the areas important to science and public policy, we eyingerly await the work of this committee. I brief the Secretary extensively on the work you are doing and he is eager to see the work you produce over the next several in sync months.
What we are working on in the Secretary's office and NHS. He's been highly focussed on using information technology to advance healthcare. At the October meeting, a formal working group established to acknowledge personalized healthcare. Recommendations you can expect from the group include standards on how to incorporate genetic information, genomic test information to personal electronic health record. Other issues this working group may address include inthe greating databases and including genetic test information as part of analysis for clinical decision support. I would like to say we recognize the many hours this committee devoted to these important issues. The list you had up really highlights the focus areas we have been discussing in the Secretary's office over the last several months. We have a count down clock. The Secretary feels a great sense of urgency to accelerate this area. I have it on my desk, we have less than 800 days, to focus on what we can lish in the near term, but to make sure we are on the track, to continue the work beyond his tenure in this important public health area.
On behalf of the Secretary and Dr. we thank you for having us here today. Hope you allow us to come to your next meeting and allow us to give you a briefing on where we are. Look forward to seeing you then
I want to acknowledge Greg as well, the secretary asked Sheila to come back downtown, Greg you have been attending, however long you are going to be here we want to use you, you will follow-up. I know we have a busy agenda and I want to move us forward, but any questions you may have I Sheila or Greg since we have them here, I want to keep centered for you, that 800 days, it's not a countdown to figure out how quick they can go home. The countdown is, they're going to make some changes. From where I sit, you may see the impact from where you sit. This activity they are engaged in, both the AHEC, can President's order, health data, information, transparency of information being fed into quality and performance being fed into physicians, hospitals and consumers, this stuff is transforming the way in which healthcare is delivered. It's a sea change, like with IBM commercial, this changes everything. This is one of those this changes everything. I want you to think a lot, especially with this pharmacogenomics stuff, all of that is connected in here. You really want to be making sure we are in that 800-day agenda.
Sheila: And I want to recognize Dr. Greg Downing, he's the director and done a lot of work in a short period of time; is an incredible force supporting the Secretary in this initiative. It's important for us to keep in mind all of the activities going on in this area, close coordination, transparency of activity, meaningful participation of stakeholder groups is necessary to achieve the objectives, and I thank thank you for supporting us.
We may have naild this, looking to be sure there's no question. I know you have to go Sheila, but Greg, as long as you can stay you are welcome.
A couple of things before we move to the pharmacogenomics session, public comments excuse meed for both days. Individuals who have not signed up should do so. Housekeeping matters relate to do important topics, lunch, dinner. To save time at lunch, I encourage committee members to order a box lunch. Fill out the form in front of you or Abbey Smith will be upset with you. We are having a group dinner tonight, let abbey know if you can attend at the first break.
The commercial from our sponsor, the technical rules about the ethics.
I want to highlight a couple, do this at every meeting, I know you probably know what I am going to say by heart. It's important, bears repeating. As you know, you are appointed to the committee as special government employee, to serve the Secretary and the public. This is a special category, but you are nonetheless subgeek the to subject to the same rules that apply to government employees, ort lined in a large document you received when you were appointed. I will highlight two of those rules. Conflicts of interest: Before every meeting you provide information about personal professional and financial interests. To determine whether you have real or apparent conflicts of interest that could compromise your objective of giving advice in the meetings. We waive for general matters, believe yourability won't be faiveght effected by your interests, we require you to be attentive to issues that could arise, appear to effect your interests. We provided each of you with a list of financial interests, covered relationships that would pose a conflict if it became a focal point of committee matters and if so ask you to recuse yowrdz and yourself and leave the room.
If you lobby in your professional capacity or as private citizen it's important you to keep the activity separate from the activities associated with this committee. Keep in mind we are advisory to the Secretary of Health and Human Service and don't advise the Congress. I thank you for being attentive to these rules and we appreciate your consciousness very much.
Now to the meeting.
As you know, we are in the process of developing a report to the secretary on pharmacogenomics, the opportunities and challenges associated with this integration in healthcare and public health. At the last meeting in June we discussed preliminary straw man recommendations. Following that meeting the loen group prepared a draft report, and staff revised, and -- our colleague kef fitz, the chair Kevin T. FitzGerald will present the work, discussion of the issues identified and the revised recommendations. We will spend about four hours on this important topic. By the end of the session we need to have reached consensus on whether the draft report is ready to be released for public comment or whether further work by the task forces needed. A copy of the draft report is in your tab 4 of briefing book. With that, again, listen to these things, go through systematically, and make a choice about whether or not the report is ready to be released or has to go back for t force, for public comment or back to the t force. With that, Kevin.
Dr. FitzGerald: Really, I am just a spokesperson for Suzanne. I will have the privilege of giving you an update on where we are with the report on pharmacogenomics, and I would like to ask your patience while I begin by giving you a little more background. Reid has give uh some, before we dive swo the report, first, much appreciation for the t force committee. People have worked very hard, given marveleous insight, and as usual there are names missing from who to thank, orderless of how much, Sarah, Suzanne, e vit a refuse. Don't forget them, the incredible work they have done in getting to where we are today
Why are we here? We just heard the great impetus to pursue personalized medicine, and delivering the right drug, right dosage to the right patient at the right time. There a variety of drivers behind this impetus. We have broken these down into research and development, public policy, right out of the Secretary's personalized initiatives, one of the major for the Secretary. The reason is that pharmacogenomics has significant promise. You all have the slides in front of you, the handout from today. Currently on number 5.
You don't have to twist your necks around and pretend to be owls or whatever. Just read off the paper. For our Internet audience out out there who don't have the handouts, in addition to pharmacogenomics, improved safety, efficient use of drugs, there obviously many challenges in order to get pharmacogenomics integrated into the clinical and public healthcare practice. Our role? As indicated, identifying the opportunity and challenges that are ahead of us, advising the Secretary on how the federal government can help to advance the opportunity necessary this field and to address the challenges. In other words, to develop this report, these recommendations specifically for the Secretary.
A little history, as you heart, we had the informational sessions -- you haven't heard this yet. A year and a half ago in June, the approval of report outline a year ago in October. Activities you can find in appendix A. They are extensive, important to be aware of what's going on. This will be part of the challenge of integration. The development of the draft recommendations put forth in June, we took your feedback, responses on those and tried to rework the report integrating those responses, trying to move ahead to develop a report, recommendations for the secretary. Following the June meeting the staff revised the draft recommendations based on discussion and in spite of the guidance of the new task force chair we were able to move ahead and the Loen group, if you need to identify the group, look for the people in the room who look the most harried and dependent on caffeine. That would be that group there in the corner.
We dragged the horse to the middle of the stream to put them on a speedboat, send them down the river. They took our recommendations from that time, put them in the draft report you see before you today.
What had are we here to do today? As we heard, we want to ensure all the major opportunities and challenges have been identified. We want to ensure the draft recommendations address these high priority issues, and we want to ensure that the draft recommendations are the appropriate solutions for addressing the issues. As Reid mentioned, we want to reach consensus on whether the draft is ready for public review. The most important goal, not on the slide, to keep Reid happy. Why we will work efficiently through these hours to a kef achieve consensus on where we are. We want to get to this point so the next plannedded steps might be pursued. Those steps will be to revise the report based on today's input. The Loen group will go out, look for input from 15 federal and non- federal stakeholder ers on various pharmacogenomics issues, scheduled to be done this winter, will seek public comment late winter, into the spring. Love to finalize the report next summer and release the report in fall 2007 so we don't take too many days off the Secretary's 800. Or as few as possible.
The way the report has been structured for today, we took three overarching themes, research and development, who are the gatekeepers facilitating, inhibiting the development of pharmacogenomics, appropriately or inappropriately, to improve outcomes in clinical practice. As far as the research and development piece, clinical research, also the infrastructure enabling research and the -- issues in research and development. In this section we had five subparts, we will go through piece by piece to identify if we have covered the terrain well and have articulated what the recommendations should be. We will then move on to the next section, the geat ceerps, third-party payers and clinical practice guideline developers.
In this, one set of recommendations, 6, that has three subparts. It may appear to be a smaller section, but was identified by the t force as critical to pharmacogenomics moving forward and requiring our direct addressing of these groups. Finally we will look at the implementation of pharmacogenomics, and that will involve education and guidance, information technology, economic implications, the -- issues, and coordination of all the HHS, pharmacogenomics activities, and as you can see, a variety of recommendations here with 14 subparts.
We would like to walk through the three overarching sections one at a time. Go through the issues identified in each section to make sure we hit the major ones, obviously not going to be able to do everything, but we want to hit the big ones, consider the recommendations drafted; consider if they will be adequate to the task of over identifying issues, and finally, since no institution can do everything all at once, the thought is to identify the recommendations of highest priority, not written in stone, but thought it would be useful to give back to the secretary recommendations we consider to be particularly ly high priority.
High priority versus low, a simple high, low identification, the t force identified 12 of the 31, and we have identified those by the little bouncing star on the right.
As we know, stars may appear to be permanent, but they are not. They erk vofl too, we can remove them, place new stars somewhere, it's our chance to play God. We can do that this report. We want your feedback to give to the public and get their feedback. One thing we learn, repetition, repetition. Again, why are we doing this? Issues are does the report cover the major issues, issues that have not been but should be raised? What are of the highest priority. Recommendations, do they as worded sufficiently address a high-priority issue. Any that have not been but should be included? Any that should be deleted because they are a low priority? Not enough of impact on problem or not implementable at this time.
When, the prioritization, to what extent will addressing this issue via this recommendation advanced the goals of pharmacogenomics, is the government in a position to advance this recommendation? After hearing this several times everything is clear. We can start to get into the first section, recere much and development. This breaks down into the four subgroups I mentioned before.
We want to look at the issues at this time. We will get to the recommendations after we have gone through the issues.
Here are the issues: Basic and translational research.
Safety and effectness of drug treatment. More translational research needed to apply the pharmacogenomics technology. Translational research studies, if designed carefully can themselves be a source of data for downstream studies of the clinical validity and utility of pharmacogenomics tests. We identified. When one looks at co-development of pharmacogenomics, drugs and diagnose ticks other -- concern for market segmentation, uncertaint about -- and requires new collaborations between drug and diagnosic industries and development of processes. This can result in expedited FDA approval, fewer label changes, greater likelihood for provider uptake.
What about the oop application of pharmacogenomics drugs, fail in a broad enough population group. A post hock analysis, information available can 2345EUB8 the rescue of abandoned drugs for use by smaller populations. In this area, again, it's important to look at what the incentives are for pursuing Ind cage occasions for -- we have the breakdown, not in the report as structured here, but what we put together. If you look at patent status, for instance, you can see an industry might have more incentive if the drug is still, device is still underpatent. Less incentive if it isn't. If the adverse drug reactions are more severe. No availability of alternate treatment, if there is, less incentive to pursue this application.
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Debt to the research so that across the board providers would have access to at information about which drugs would work best. That, I'd think is gaining some interest in momentum, and I'm just wondering if it should be addressed even if it is in just a small way in this report because it sounds on its face incompatible with the notion of a personalized Madison, but I think there can be placed to reconcile it as well. And I'm wondering if some passing reference to it would be worthwhile. You might want to expand on this because I haven't been participating in that group, but I know that there are several sectors of the health-care industry calling for this and I think each 8S is aware of it.
I don't know if I know a lot more than you. The key issue is, as you have underscored, people really do want to have information about whether this new thing, whatever the new thing is, does it work better than the old thing? And if it does, is it more cost effective when you look at the total management of the condition from diagnostics through the therapeutic implications to the testing cost implications to the safety and convenience. So I think it is right down the middle of the plate because what this optimally is saying for these new personalized pharmacogenomics products is, do these things -- how do they fit into the overall health care landscape in terms of bring out all stock and replacing it with new stock or this synergistic or additive work, initiative or whatever. But if you don't have that information and the health care that is costly like this with 48 million uninsured people, it will be very difficult for the new thing to ever break through.
I also would like to comment on the -- I guess the initiation of some type of comparative analysis in terms of diagnostic tests. I know that we have commissioned Dell looked at various tests for genetic cancer disorders. And one of the things we have asked to take a look at is the effectiveness in terms of not only effectiveness but also the accuracy of the tests looking at measure of accuracy in such things as specificity, receiver, characteristics as well as selected ratios. So in that instance, yes, there are comparative tests which might be applicable in terms of determining whether or not one particular test is more appropriate than another.
Thanks. One of the practical issues with implementing pharmacogenomics in the big U.S. standard of care of medicine is the need for rapid turnaround and results. And clearly many circumstances where one would like to adjust the plan about what the right to prescribe or what goes to prescribe are not well served if it takes a week or more for that test to be returned. So the press Gropper can make that decision. And in fact I think this could be quite a major issue. Until such time as everybody has their entire genome already pre sequenced and sitting in their medical record where it simply becomes a matter of a computer search to get the genotype, we are going to be very much at the mercy of what kind of technologies provide the kind of a point of care, rapid turnaround result. I did not specifically see that flag as a research and development priority, but clearly that could well turn out to be limiting. If we have a wonderful day the killing for instance that in the presence of a particularly burleycue to medical elements a particular pharmacogenomics test would be valuable in terms of eliminating what drug and dose to give, but you can't get that result quickly enough to actually influence that decision. Then people will continue doing what they have been doing. So this notion of coming up with a means of accelerating turnaround time for these kinds of the dean of typing experience is when it comes to pharmacogenomics, it seems to me it is probably not gotten as much attention as it should because until now most genetic tests are done in central laboratories where samples are shut can if it takes awhile for the results to come back that has not been critical, but here it could be. We want to flag that as another potential research need.
Thank you.
I did want to bring up another issue to the community. I sit on one IRB panel N within our institutions. There are four panels that look at this review. One of the things that caught my it isn't going to our current plan draft report is that it is very important as we move forward for translation and research in the clinical research that went testing is point to be dubbed to go back to the patient or to put patients in different categories because you have a certain the genotype, or you are at the point on a specific research from the laboratory that these tests need to be performed in a certified laboratory. So there is good regulation because even research laboratories are not clear if there will report back to result. I'm not sure if all of them throughout the country are really aware of these issues. So either through communication of the office or some other venue we must make all IRB aware of this regulation.
To follow after Doctor Collins point about the practical of the cases of how to get the tests done at the right time, there is the prospect of doing pre symptomatic testing said that you have those results in hand at the time you need them for an acute LS or for acute needs. The military has a little experience in the area of during testing before hand in case you need anti malaria's that may or may not cause problems depending upon what your tests results are. And the same sort of approach to an illness might be the verse to a certain pre-Socratic testing for pharmacogenomics applications.
Would you see that the falling under the same issue?
In terms of practicality, but it does raise a lot of ethical questions when you go down that road, but it will come up. If you are in practice and you want to prescribe a particular medication but no you will run into problems based upon the genetic profile of your patient, then you can know ahead of time that you need to sweat out a particular drug with better benefits.
Great. What I would like to do is just get a sense of the Committee on where we are all these things because nobody can do everything. We can't put everything in the report and all that. So from what I heard so far we have three issues that we can certainly put in. Now let's start with Cynthia this she had the first. Could you restate its and state it to as you see it specifically relevant to the research and development section? Because this is the section it will be going into rather than the application section which people get to later, but if you want to bring it up later it might be applicable.
I was short because I had a couple of issues written down and I was trying to categorize them. I thought this could be other research or coverage. I don't know how to characterize it. It certainly doesn't matter to me where we put it. I know it is out there and is part here get? Maybe when we have someone from ARC perhaps others could inform us a little better.
Okay. I my just guessing that when Michael -- so Francis definitely looking in R&D, how would you specifically phrase that?
That need for a research and rapid turnaround cost effective point of care to pharmacogenomics for -- genotyping for pharmacogenomics.
Great. And Andrea?
Test a sentence or two and I'm not sure how you deal with this issue been aware the secretary can work with OHRP to remind IRBs us throughout the country that we need to have laboratories performing testing when results go back to the pet -- patient either troops putting patients in different [ indiscernible ] or different doses. When testing is back to the patient it must be done in a certified laboratory.
I think what we may have to do is when we get the report more fleshed out people have a good idea where that could slide in.
In terms out adding upon and coming up with specific wording and whether or not to put it in this section or the other section, it might be something like in addition, to looking at the clinical utility and the critical levity of the test also evaluating -- it measures also evaluating accuracy should be taken into consideration.
Okay. All right. Thank you. And is that good what what Francis said for incorporating what you -- okay.
I think so.
One of the areas of research I have noted as I'm trying to implement pharmacogenomics in a health care system setting is cost effectiveness research. What is the cost effectiveness of spending the money to do a test on 100 percent of patients were you know 10 percent of them will have a variant versus, what is that sending you an adverse outcomes. This type of research is really needed to support the clinical implementation of pharmacogenomics testing.
Currently we have that in the third section of the report. We could -- we could put --
So there are research parks in the third?
I'm not sure our it goes. But what do you mean by research? There is certainly the edification of a need for that kind of information. As one tries to apply what the basic science and transitional the debt is going to be to the clinic -- if you think it is important to have a statement about that in the R&D section --
There are public health faculty who wanted to this research but don't have the funding opportunities to support their effort.
Okay. Michael?
In reading the report I think there seems to be some assumptions I want to make sure I understand. The assumptions are, as Mr. Owens was saying, that the tests are accurate. And I want to make everybody to understand that there are only a handful of clinical diagnostic tests that currently have a standard reference materials available. That is out of the 1500 or 2,000 tests that are done all the time. The other part of this is that in order to make that dream a reality of pharmacogenomics and Tech get that some of the basic pieces that you need here as far as gene expression for everyone, Genetics for everyone, to really make this happen, the technology simply is really not there right now. And in order to add to -- in order type, as Doctor Collins said, have a gene sequence for everyone it would still cost about 1 million -- he's gone. Roughly $1 billion per person, where that has the get down to $1,000 or less. The accuracy of that gene expression measurements, that clinical Micro race and things like that, this has a major program in trying to find how to make those tests work better, just a signal transduction problem, a big issue. So there is a great deal of hope and this, but the technology just doesn't exist to really make that happen.
Would you see -- Emily, okay.
I just want to address that comment. I think that technology Ted to rapid genetic testing are coming along and it is actually an RFP out from CDC to develop testing for a ban and funds that based on genetic analysis. And what you will see coming out of that is funding for a number of different technology platforms which could then be leveraged across because you are still during genetic testing whether you are doing infectious diseases and that -- and Texas disease genetics. So one of the things we should do is make sure we are closing the loop between those kinds of activities within CTC and an area which might be perceived as quite different from this. And understand that that same technology but form that CDC is funding is helping to move forward in terms of getting too rapid point of care and molecular testing it can also be applied then and pharmacogenomics. So it is double bang for your buck.
There are a lot of the HMS that have tons of money going into genetic testing and buyout threat agents that could be leveraged against what you are doing, as well. The other part is using this data set to study and learn from it to and implement new discovery. Dr. Got men will tell you, I think, if you look at the FDA would set there have been no new protein bio markers approved by the FDA over the last 10 years. So that system for discovery is a bit broken right now, and I think you have an opportunity right here to change that.
Both the two of you, and the report as it stands now there are a couple of different places where we emphasize the need for -- all call Ed education or public access information, and this could certainly be in their ads -- we certainly want to discuss the hopes and the goals of pharmacogenomics, but also make it realistic. And we want to let people know where it is we stand now. That is already in there. We can be more specific in that regard, but I also get a there is the issue of the cooperation and the interaction of these different groups that are already involved in it. We also try to involve that in the report at some places. We can be more specific in the report as to the issues you raised as that needed to that, but then there was a third thing I was hearing but was actually it sounded to me to be more specific. You were talking about it in particular. They're is a step that needs to be taken that is very concrete. Could you just outlined that again?
I think it was really reiteration of Francis's point that it is wonderful to discover bio markers and validate bile markers, but if you cannot deliver the result back to the patient in a timely way for a position to take action then you have missed the implementation part of it.
Okay. Good. Thank you.
And if it is all right and we do want to keep moving, let's get on to the recommendations because that is where people have the rubber hit the road here. We have now again -- we are looking at the wording of the recommendations, do they sufficiently address what they are intended to address? Are we missing any? And are there some that are there that don't need tepe there? Because it is not a high priority or they won't have a high impact or they are taught not implement the ball at this time. So how will these recommendations advance the goals of pharmacogenomics and is the government in a position to act upon this recommendation? Here is our first one. If you wish, in your Executive summaries starting on page five you have the entire recommendation is spelled out. On some of the slides we have truncated it a little bit obviously due to space limitations. So if you want to follow along, page five of York executive summary you have the recommendations beginning, we will start with the basic and translation of research once and this is 18 that the NIH should invest more resources into the research of bio chemical pathways is a city with drug action Cortines and Balkan these pathways in gene functions related to the safety and development of drug treatments. And I think that is exactly how we have been thwarted in the executive summary. So these two are the same. Any comments on this particular recommendation? Debra?
Well, it is really dead jeans and teen variations. We very often note that scene but may not have the gene variation. So somehow bad gene variation from person to person is key to the recommendation.
Soap you would want to put in bad genes involved in these pathways and Jean variability and function? Or would you just --
You could say it gene variation and functions related to the effectiveness.
Great. Thank you. Everybody else is comfortable? Great. Next. And I it should support more transitional research focused on the development of clinically useful pharmacogenomics technologies. These are sort of boilerplate in one sense, but these are things that certainly came out of the report. There are more, I'm sorry. There is more there in the Executive summary if you want to look at that. Okay. Yes?
Is it appropriate to comment on the philosophies that do these sorts of things? Up to this point a reduction of philosophy has been used of one protein and one gene at a time. There is some broader work being done, but up to this point I think some of these, like I said, they have been bio markers. So are we doing -- I think it may be important for us to an element of the philosophies use up to this point. The nubile markers in 10 years is pretty significant to me. Are we taking the right approach or should we be taking a more systems approach working at the systems medicine or systems biology approach to some of these banks because right now things are moving quite as quickly as we hoped.
Now are you -- we can certainly raise that issue, and I think it is a good thing to bring up in the research and development section two said this is how we have cut into where we are. And in that process this has raised the question that you raised, do we need to be more open than we are currently to a more systems approach? We can do that. Does that translate into a specific recommendation or is it okay to put that into five tepe clear and put that in the issues?
Eye open it to the committee to discuss.
Okay. Yes, Deborah?
I'm concerned about the statement that there haven't been any nubile markers and 10 years because I'm aware of nubile markers being introduced into the clinical testing the every day dearly. So I'm not sure where that statement is coming from.
It is really if you look at the web site and look at that new p.m. A and diagnostic, I'm talking about protein bile markers. There have been some new genetic line markers approved.
What about the [ indiscernible ]? Francis, maybe you can comment as well. I don't want to be hanging in out here on my own.
I'm a little confused by this discussion as well because we are not talking about the whole universe of piled markers. We are talking about to the extent we have identified promising but not fully clinically valid visit of examples of Sagittariuses that are associated with drug response. Take how all of the opportunities and the key 0RC once and all the things we know about tepee empty. I would not say that all we are in a circumstance where there hasn't been progress. What is missing is that next step of full-fledged clinical validity established in perspective trials. But we don't need a systems biology approach to identify the potential candidates to put into those trials. The main step here is the trials themselves.
To follow up on that, but the recommendation 18 and 1C should come before one be.
Okay. You want 1C Tech come before one be.
Or didn't he should put 1A and 1C together. He should collect this information and draw the conclusion, take that next that.
Just a quick question, do you think -- and I think we broke these out, not that they are not related, but to try to emphasize each particular piece. Are you saying it would be more effective to put see together with a?
No, no, no pre.
Test change the order.
Okay. And I have a comment I want to make which will make it more clear.
Again, the order as Suzanne reminded me, is based on how they are discussed in the report. We can certainly look at changing even in the report to just create a better flow. Okay.
Kevin, perhaps one be could be expanded to include Francis's point and Emily's on the pharmacogenomics technologies that are being developed have to be able to provide answers in a clinically timely manner. That is what the purpose it's turnaround time. So that as part of the technology and development.
We could say there development of clinically useful on a timely development of clinically useful pick five. Is that enough or do we need to be more.
We need something more explicit about the need to have technologies that give you more turnaround for pharmacogenomics. But that could fit into that particular recommendation just fine. It just must be fleshed out a little bit.
Okay. Thank you. All right. Now we have already talked a little bit about one see, but let's --
I was going to make a specific recommendation. They're is a tool that we have, a mechanism "for clinical trials where we list of ongoing trials. That is -- there have been numerous editorials in The New England Journal for Madison and everyone who does the early funded work which there. Those who do industry support across the want to be published in the bill in the Journal want to be listed there and I think he could encourage its further use to enable collaboration work pharmacogenomics components could be added on or even designed into clinical trials at the outset. So for example the registry could list other materials have been collected and whether DNA has been collected and whether it has been consented for pharmacogenomics studies. I do that as part and parcel of discovering the clinically valid knowledge that later on you want to implement into tests that are available rapidly at the point of care, but you must know what you are doing first and you have to utilize the tiles and studies that are already ongoing by adding a pharmacogenomics component. A mechanism exists to do that if it were upgraded a little bit. And those who run the registry are interested in doing it. They just need the recommendation for government encouragement to do it. It is a matter of collecting the right field and encouraging and enabling research.
That would be great. The more specific we can get is wonderful. So we can certainly -- I have the sense that that could work.
Is that registry you design in your own institution the research and then posted in that registry?
The clinical trials is want of an actual Library of medicine. It is a project and it's self and anybody can post information to it. They make available the deal to do it and then a trowel designer must voluntarily submit that information.
For publication purposes? Her is that ties to publication?
For the journal editors the get together and said we want to promote this kind of sharing of information. If you want to get into our journal, he better be using that registry.
But what we are trying to say here is before you engage in these clinical trials meet with certain people that do research or actually clinical trial saugh develop these in a systematic way that get this the right information so that it can be used for the down the road for applications with the FDA.
I was thinking about the trials. In the context I was presenting things I thought the trials would be important to the discovery, discovering the information. But at their genotypes and medications they are taking and discovered the link that he later what to evaluate through the right kind of outcome or evidence base studies that should be implemented and clinical practice. But I consider the fact that basic discovery of those connections, that knowledge and the first place and that is what I'm seeing up the basic and transitional research recommendations here.
I thought that we also we're looking into increasing some of the values of these early on clinical trials.
We are in total agreement there. Increasing the light of research is already getting done.
Good. Indeed.
I thought it must be useful to that end under the list of research clinical trial outcome of research also cost effectiveness to highlight that as such a key point in this area. The other thing I wonder about this been holed up there is a separate section on Elsie to bring that into this section where you are talking about justice of research has not just a separate type of research but something imbedded in a transitional research preadapted they add and cost-effective studies.
I see. Okay. Cost effectiveness in LC. Now with the Web site, obviously that information doesn't get put in there too. Could that? Is that 85.
That information meeting --
Cost effectiveness LC issues.
I would say no. Think of it as a registry. It simply presents to the world that a group of researchers or a company are planning to do a trial or are doing a trial and this is what we are studying and this is to you contact and these are the enrollment criteria and this is what is being collected. It enables researchers to the ethnic connections and doesn't dictate what kind of research is done. It is not a funding mechanism.
We can put that in but we can make sure that some of it breaks out in one direction and others is there for people to --
What we are trying to say here is that we want to encourage research to coordinate with the outcome research while they are doing study design. What you are talking about is listening what other people are doing so they can communicate with each other and hopefully not repeat some of these studies.
That works. Yes?
Perhaps this is littered but this position is getting into recommendation three which loosest validity. So the cost effectiveness else the issues are certainly part of that also. Are we testing and combine all recommendations or will be keep them in certain places?
We are trying to set the as discreet as possible. On the other hand, we up to make -- we must make sure we do the proper amount of emphasis on various issues. That's why we are going to this now. If we need to jump back and forth a little bit, we can do that in this section. We can also do this in some of these other sections as they regard applications, but that is okay. People to that. [ indiscernible ] they should encourage the best bet is to consult FDA when their research reaches a critical state and they could have the conduct of the flaws least doubt and critical studies making higher party scores to cities that are designed to satisfy F.D.A. quality of evidence standards. Again, this is a recommendation in an attempt to tie things together which we thought was an important thing to do. Every is good with that? All right.
That is just a little bit awkward and that in IA to doesn't actually give priority scores. They symbol review panels that do appear review. I would say some --
Right. Review panels.
Funding decisions should account or give weight to satisfying if the a quality of evidence standards.
I think we just dropped the word scores.
Prior to the scores.
A [OVERLAPPING SPEAKERS]
Hobbs.
Do you think here that maybe education to research is during transitional research and how to conduct some of these statistical studies?
We have some other educational ones.
So workshops or some other venue?
Let me try to figure out the most efficient way to do that and get it . Ises captured and accuracy of testing is to be evaluated. There are only a handful with a standard reference materials.
Well, we talk later. When we get to a recommendation three we talk about the validity and utility and we can certainly add in accuracy at that point. That might fit the concerns that -- yes. Okay. Is that okay?
It is a question which is more a point of clarification, I think, to ask to the NIH. I guess I have always been under the assumption of looking at the weight to these are reviewed priorities are already given to those that are methodologically sound already. I thought that was already in existence and I'm wondering whether that is true. Maybe the way we should be is something along the lines of if there will be integration, that it should be continued to be enforced or I guess remind people. If it is already there it seems a bit unnecessary to say they should do something they are already doing.
I think you are correct that they already give the higher scores to be statistically rigorous and well-designed studies. You are right. I believe and I did not craft this of its own recommendation. There was some intent here that the FDA sought specific and unique means and sometimes they felt that we should lend to funding to types of studies they need to see done. Am I accurate? I think that is what made the effort be a single that made this a different, but you are right, review groups already give the best scores for merit to the most well designed studies.
Right. I think the implication -- we can we were this to make this more clear. What is in the first paragraph is part of what should be the what is considered to be much allows police sound and statistically rigorous. That is not necessarily but to be as strong as the moment.
This is Liz man feels from the FDA. I would just encourage you not to put the cart before the horse here and that studies are typically reviewed and funded prior to having been done. The way this is written it appears they would only seek FDA advised after they had reached a certain point. So I am not sure how review boards could say something was meeting FDA specific studies and hadn't even started yet.
Right. In the second paragraph we have NIH should encourage him this is to consult FTA when their research reaches a pivotal state. Is that what you're --
But then the next section said you would encourage funding to cities that are designed to satisfy it F.D.A. quality of evidence standards. I think those may be somewhat in conflict with each other. As far as I understand you tend to get funding before you reach a pivotal stages.
I agree that you are on the right track. I just think that it will be hard to say, this will meet FDA quality standards before the funding has been given.
Family?
I think what we've or trying to get to is the next level of study beyond the tantalizing early results study. So now you will design a study that really is a validation study and having been into FDA once or twice and been told that one of the things FDA would like to see is some good published studies done independent from the manufacturer indicating that that marker has clinical utility and validity. What we port trying to get to was encourage people to link those studies separate from whatever company might sponsor a device said to those in a rigorous way so that FDA could consider that as a reasonable piece of literature.
That is entirely reasonable. Maybe just a little clarification.
When you read this you are hearing that the third paragraph sort of stood out on its on, and that is what we are getting from both Joe and you. So that third paragraph is leading people away from the first to somehow. Okay. In 28 -- 2A now this is development of pharmacogenomics products and helping with services should provide FDA but let necessary resources to provide guidance documents about best practices for the code development of pharmacogenomics drugs and diagnostics. Diskettes should promote diagnostic -- operation between the drug in diagnostic industries and clarify the review process or code developed process where the drug is subject to FDA review but the laboratory developed companion diagnostic test may not be. This is actually in your incentive summary it is 2D. It was moved up. If the list is actually somehow some kind of proposition, which it isn't. In any case it is now upon 2A.
Can I ask a question here? I thought FDA had advanced on the code development. Has this not being done?
It is actually a white paper right now headed towards balance status.
So this is under way? Did you need to have a recommendation on this?
I got beat -- got the sense of the task force was that this could only help move this process forward and that there was a desire to make sure this was emphasized.
Yes, there is a desire to get the draft guidance out, but it had been previously released as a white paper and not a draft guidance.
Update. Okay. For 2B, at the age shouldn't fight research opportunities related to the development of pharmacogenomics products and should facilitate the research through its critical path initiative. And then 2C HHS should advance the further development of abandoned drugs by facilitating access to information about such drugs. Incentives will be needed to encourage the voluntary submission of proprietary data by pharmaceutical companies. Again trying to address some of that gap problem that we identified in the issues earlier. And then what is now 2D the -- back 2C on terra.
It is so clear where that data will be housed. It says to encourage manufacturers to submit proprietary data to home or where would that be to be housed?
It doesn't say that there either.
It is housed at FE8 right now, right?
Do you have a specific place you want it to be housed or case FDA okay?
The intent is to try and have the data available to others kept take it further. I'm not sure if that will be feasible. So I'm not quite sure what the intent was after the manufacturers release it. If we are still saying FDA is not as accessible to others what it meant the purpose is?
Can you ask for a development of incentives to encourage the eventual release? Because right now there are no plans to release any of that, right?
The voluntary to Numic debt? Had no, I suppose any company that submitted could release it if they wanted to.
How can we get a mike?
Yes, FDA has a voluntary to Numic --
Identify yourself.
[OVERLAPPING SPEAKERS] they have a voluntary submission process but the information that comes into it is confidential. It helps FDA but not the rest of the industry or academia. So I think we are talking about a process for making it public.
Right.
So how would we go about that? That is what the needs to be determined.
And as far as incentives, I think you would want to make some concrete suggestions of what those incentives might be.
Now you want those in this report are we can't just put that forward to the secretary and allow the secretary to make those determinations?
That's up to you.
Can I ask a question here. Are we talking about two different -- it is an abandoned truck will the drug company have done a submission to that FDA? If they have gone through trials -- are we talking about something that would even be submitted to the FDA here? I don't think so.
Drugs can be abandoned at many stages and may have been submitted 2013.
But they may not have.
But they may have been abandoned prior to that in developmental stages.
So we may not be capturing all the abandoned trucks if we are talking about the debt that is submitted to that FDA. So I think we need to incentivize the drug companies to further develop or move for abandon drugs using pharmacogenomics Technologies, and I don't know what those incentives would be. You would have to ask drug companies what would incentivize them to the move drugs board for a smaller market than what they were originally anticipating.
I'm not sure that we need here to -- there are a variety of reasons one could abandon a drug in the development process. That all drugs are abandoned because of a population problem. Do we need to capture all abandoned drugs are we tried to incentivize the ones that might fit this profile of being able to target a smaller sub population?
I think we should be careful about making recommendations feasible or that we have no inkling of how we could ever incentivized because we have a an inkling about how one could and said let's drug companies to make such affirmation public. I'm concerned that we delete our recommendations if we just say, he should do this or we should insist was without any idea but.
In the fact-finding stage that is next week is certainly ask. We could ask what those concrete incentives would be. We can certainly ask industry what they would consider incentives. Ability.
Are there concerns that we need to keep these here?
I think that second paragraph is really valuable because the individuals I know at FDA have all worked hard with industry for the voluntary submission of dynamic data and to reinforce that voluntary submission of proprietary data to an agency that can gain in its balance as it makes decisions about drug approval -- this is not for abandon drugs. This is what things in development now. That is a wonderful thing. Coming from the NIH side of the fence I would like to permit that ultimately being made public. Realistically how many companies will voluntarily submit data to that NIH -- FDA they think they will be forced to make public. That will have a chilling effect on the Hill and submission system. So I understand the competing nature of the issues here. What you have resent is good in that second paragraph. The confusion as at applies to more than a band and drugs. It applies to things in development now.
It certainly could, right.
It does.
The question is could we narrow the scope?
I think your fact finding suggested to the group can't make careful recommendations with a system that already exists is a good idea. You might want to fight to find more or you will drop out to deep and have an unintended consequence. Would you agree?
I think we can certainly in looking for instances discover that. Michael?
If the community is saying is this something that is absolutely needed the move pharmacogenomics along -- and you can't identify any real way of doing it with the existing data, should you also consider another recommendation cadet corps of implementing that? If this is not the only way to do it --
You are saying if this turns out to be one of those things that is up and lamentable then what do we do, right? Let me see. That is definitely a conditional statement. Since we don't know what the if it is true I don't think we can quite get to the then. But that is certainly something we will have to look at. We but have to then address that particular situation. That is a good point.
What is the resolution? The resolution can stand at the moment but we must find what those incentives might be so we can be more specific in recommending to the Secretary, this is what we have discovered from industry or from or fact-finding and not to say that you have to do it this way, but we would at least be able to make some concrete recommendations along those lines. Such as, we are doing some of these recommendations were we say such and such is already under way. We could say, these are things that have been identified as possible incentives. Deborah?
But these seem to be too different recommendations that are bundled together here. One is abandoned drug and encouraging industry to move abandoned trucks Ford if they are abandoned because of an adverse drug reactions in a small population but it shows effectiveness and those that don't have the adverse reaction or other things that pharmacogenomics testing could help with to identify the populace is that would be helped by these abandoned trucks. Then that the incentives part really applies to all drugs. You want the farmer could genetic information for any drug and not just abandoned ones. It seems there are two things here being mixed together and appropriately.
Okay. What we were trying to do was to narrow this down. We could broaden it. If the community thinks this is better you could just Saddam -- HHS should advance the facility of drugs about what incentives would be needed for voluntary submission. We could just drop abandoned. We don't have to have that in there. Emily?
I think the original discussion about this was this whole concept of a drug rusty. There are probably good drugs out there where if you could eliminate a few individuals who had bad reactions to them would be great for the majority of people for whom they are effective. And so I don't want to -- and I think we were trying to take a very narrow defined sub set where we thought it might not be as sensitive hot it. Your truck was abandoned or pulled off the market anyway. So you are making no money off this. Is there some way that pharmacogenetics could help bring that back for the benefit of patients? So I don't think this was ever intended to be a broad recommendation that every drug and every company had to collect this information and review it to the public. It was really in its initial discussion was focused on this small subset of the things that are off the market now for one reason or another. So the stakes are pretty low from the company point of view because they are making no money for them right now, and this might be a way to resurrect something.
She is saying this is the data that would have been submitted ordinarily.
So what do you think of it? The idea was to pick a battleground.
I understand what family is saying which is what I was saying about this first part of a slide 39. By facilitating access to get permission about such trucks -- facilitate information to home to what with is just very vague. What you want to do is encourage the pharmaceutical companies to the move to these drugs for word by using pharmacogenetics. Do they have to give proprietary information to anybody?
My experience is that most companies, once it is done it is done. So the chance for them to resurrect it is not as good. It is an emotional thing within the company. It is much more likely that some other company would take it on and buy the rights for that drug and do these studies and try and show that although the drug was not safe or the total population, if you do this test it then could be used to effectively.
So is this recommendation capturing what needs to be done? I don't think it is before we get too deeply enmeshed in one, I'm going to pull a read and we are going tough like this for just a moment and we will come back to this if we have time at the end but we will say this is a problematic recommendations and we will try and see. If we don't get back to it today people certainly try and rework it in such a way to make it certainly more clear what the intent of the recommendation is and how it addresses the issue. We are running a little behind.
May be what people can do a test to help out our chair person, if they could drop on a little piece of paper what you think it ought to say. Just try to give him the solution to the problem and had set in and he can look at it on the break.
That is good. Going on tasks 2D, this is one that was a flight as a high priority by the task force that FDA should examine the humanitarian [ indiscernible ] so it is extended to pharmacogenomics tests that are intended to be used in conjunction with the drugs. Yes, sir?
FDA again.
I want to hear you.
First of all I want to make sure everyone understands the humanitarian device exemption extends to test that art intended to be run on 4,000 people or less or on a population of 4,000 or less depending upon how you interpret the rules. There is no clinical validity required in order to have a humanitarian device extension, and that is based on the assumption that a potentially flawed test is better than no test. I'm not sure -- I suppose you could read write the regulation to model it differently, but I'm not sure that is where you want to go with orphaned trucks right now. I also think that if you extended it to that 200,000 that orphan drugs are now allowed you would create an extremely unlevel playing field for Genetics courses every other kind of test. That would probably be a somewhat upsetting to the rest of the community.
So now in doing what this says, from what I understand you just mentioned, it apparently would change the rag for tests so that they would have to have clinical utility, right? Because they would be falling under the orphan Drug designation.
I am saying the current humanitarian bright exemption requires an assumption of clinical Lidice, not utility.
Right.
Right. So my feeling on reading this was that he simply wanted to talk up the number of patients who could receive the test under this exemption.
If it is done in conjunction with an or fund drug.
Right. So what I'm suggesting -- suggesting is that as the exemption is written now you are running a test on 50,000 people for which you have no clear political validity with the assumption that the ACT test may be flawed and that a flight test is better than no test.
Thank you. We may have to go back and look at this also.
That is good information.
We will also flagged this to go back to. When we will go down to that whole area of clinical below the pharmacogenetics utility of the pharmacogenomics and the people who mentioned accuracy can recommend wherever they want that to be put in. Here is our first recommendation in this area that HHS should provide 88RQA, CDC and it NIH with additional information to identify pharmacogenomics technologies that are important from a public health standpoint to address gaps in evidence through which clinical validity and utility evidence is lacking. So CTC working group and he genet and 8H part to seek to program may be appropriate mechanisms or models for identifying such technologies and specific evidentiary and research needs. This was applied by the test as a key recommendation.
I'm sorry.
Please.
An addition to political validity and clinical evidence, as I say, we have to somehow incorporate measures of accuracy. And all sober utility evidence, I think we must go further than that. Some people think that pharmacogenomics tests are diagnostic tests. And diagnostic tests will get clinical accuracy and accuracy tests and also at how this test will be used in terms of management of the patient. I think the wording of management will must be incorporated in this because if I'm evaluating a specific technology, not only CMS, but also other insurers -- if tests are lacking in terms of accuracy, at least that should be demonstrated that if a physician uses that test and the result of that test will dictate his or her change in management of the patient, if there is some way we can incorporate management because that is what we look at when we look at a diagnostic test. How does this best alter or continue the management of that patient?
Now the management issue, is that one that we want to put in R&D or could that be later on in the application?
It is also applicable in north seven, but if the studies do not show that the management can be altered -- if the studies cannot be shown that these tests help in the management of the patient then it would be difficult to say how it is applicable in terms of a clinical application. You might even look at a decision tree depending upon the results of the test. Does the position to eight, B, or sea. It is all involved in the management of the patient.
But just wanted to bring up that to address Jams issue about accuracy, the easiest solution here would just be to talk about analytic and clinical validity the way to do in the narrative because that will cover analytic sensitivity and repair disability and fell your rates and all of that accuracy.
Just one second. What page are you on?
Thirty.
Let me read what we have in the report for clarification purposes. If you look on page 30 of the draft report under the section of clinical quality and utility -- I'm not saying that we can still make this more specific, but it says clinical utility -- comical validity refers to accuracy with which a test predicts a given political outcome. Clinical utility refers to the ability of a pharmacogenomics test to inform critical decision making which might include management. Prevent adverse health outcomes and predict outcomes and considered important to individuals and family. You may be aware we are not getting the thing here. We are not getting this into the recommendation. Not everybody understands these terms in the same way. Does that capture --
I was it just going to say the sentence before that was the description of analytical liberty which is a very important in this context.
Okay.
I was just going to say I think clinical utility as it is defined in management seems like it is encompassed in utility.
Maybe would we need to make that clear at the recommendation or is that okay to make that clear in the report to?
When we do technology for example somebody said that it cyber genetic testing. And they submited a lot of articles talking about a specific marker. But they don't connect or they don't blank how the results of that marker is going to result in the management of the patient or change the management of the patient. That is a link which I don't know if we are stressing hard enough. There has to be some kind of link between the results and help the patient will be managed depending upon the results of that particular test.
That is critical utility.
Time to sign if you ask a clinician and clinical utility that is exactly it. It is the management of the patient.
We can work to make sure that is clear in someplace.
The idea would be to add analytical and clinical validity and utility.
The political thing is easy to do predigest put analytical in there with clinical.
Right.
Two things, I support the suggestion. It is the intent of this to focus the political outcomes and not to validity. I'd think we need to capture getting that information. So perhaps you could do that in the first recommendation when you are talking about basic research. There is no mention about analytical validity here. So the intent of this is to focus on the clinical outcomes and to make sure that we don't use that any way in these recommendations. Week could perhaps make it more specific in the first recommendation.
The first being which one?
De NIH should support the basic -- in my reading developing new knowledge about a test, there is the specific language about analytical performance of the test. And so if the intent is to leave the recommendation more focused on the comical of comes and we could be more specific and laying out the political performance in the initial studies.
But so what you are saying it is none of them -- put it in there?
Right.
Following on Reese suggested on right where it would go and give it to us at the break that would be happy to get back to that.
And second, it was I'm speaking here from our perspective. The evidence based practice program is identified, but when we do these reports or technology assessments they are useful and pointing out the gaps in evidence. There is not enough or amenable to creating new knowledge or doing it out comes research to fill in those gaps. And I'm reading through these and only within the you see we have some -- A sub sector where [ indiscernible ]. Here we are making conditional in certain circumstances. So I'm not sure what are the mechanisms for Britain in creating new knowledge for clinical outcomes? We don't really specify that in any of these brief here. We could make more clear by specifying both Denton's, [ indiscernible ]. We would then be identifying mechanisms to fill those gaps. That would be programs like the deciding that work at ARC or the search program at ARC which are more creative for creating new evidence as opposed to appraising existing evidence.
As we did here we are happy to be specific, but would you want that here? That could also probably got here.
It could go anywhere. I did want to raise it that I don't find it.
So we could add that here or over here. It looks like that would be a good place. Thank you. Okay. All right. 3B is one that was passed as the "taskforce as high Purdy. FDA should encourage [ indiscernible ] and post market surveillance. Request manufacturers permission to make this bid available to the public. Manufacturers should disseminate any specific and not specific findings on the validity in clinical utility of pharmacogenomics Technologies through publication in peer review journals. Yes, Emily?
Reading this the gain in isolation which manufactures are we talking about, drug, a device? I think it needs clarification.
We need to clarify.
I'm not familiar and done with the regulations of drugs enough to say, but for devices evidence of clinical utility is currently not a strict requirement. Many companies are performing these tests and would like to get them to market as quickly as possible and it is my assumption that is what the community would like as well. If you delay giving top market by enforcing the provision of a strict clinical utility, you may be working against yourself.
Some supposition of clinical utility is needed, but actual outcome studies and so on generally take a long time and are not traditionally done for devices.
And this one -- short, Deborah. Go ahead. Allen, yes?
Your bike is not working, I think.
A few minor points. You might want to include at the age should encourage a manufacturer to include a pharmacogenetics. Right now is all particle utility data.
On this one -- okay. Deborah, did you have something?
I want to point out that in December seeder develops a table of by markers and tests that actually have an indication of three levels. One is informational and the second is it is recommended and the third is that the testing is required. And it provides information with the drug label and it has references in that table to the studies that have been done to support the pharmacogenetics tests relative to a specific drug. And it was initiated in September and updated in October and I think this community should encourage Cedar to continue to update that table of information because it is extremely useful as a help system. When we found that it actually supported some of the pharmacogenetics implementation stuff that report doing. So in this recommendation the FDA is actually making this information -- I assume cedar is part of the FDA. I have problems of knowing who is what. But it's the cedar of the top of this table thing. So the FDA is actually doing this, and that is great.
We could put that down if it is okay. We have e.g. through publication of turtles or through the table that is being --
Through the Cedar Web sites?
Right. Just a clarification on this to address your issue, Elizabeth. If this said FDA should encourage drug manufacturers to submit, that would take the focus and put it on the drug and we wouldn't have the device issue. Is that correct?
I think so, yes.
That is the specification and then we could do the pharmacogenomics, pharmacogenetics as well as the clinical utility data.
I would also make one other recommendation here. This is to request manufactured permission to make this available to the public. I certainly, encourage it but I'm not sure what you mean by request. When FDA makes a request it is viewed as a regulatory matter. So maybe the wording used to be changed.
Right.
Increase.
Encouraged.
Good. Thank you. We don't want to intimidate anyone. Keep moving. Draft recommendation three c. In certain instances public and private health plans should facilitate the knowledge but pharmacogenomics technologies. To collect data on the clinical validity and clinical utility of pharmacogenomics Technologies. Did I read that correctly? It didn't sound good. Anyway we draft coverage with element initiative which serves as a model for this practice all right. The our good on that one. The.
Am a little concerned because you are mixing payment with clinical research. And is this clinical Research meeting informed consent? And the person doesn't consent they don't get payment for their [ indiscernible ]?
Okay. What we could do is, I guess the lack of clarity here is in certain circumstances. Aha all right. So considering the question you just raised, I think we need to potentially address that problem.
Yes, and whether it is identified data port on identified data, you know, it is kind of --
Lets up like that one. If we put it out here now we have to deal with those issues. In fact, Soviet, if you could just got something done for the break, that would be great. We will see if we can work that around. We move on. Now we are moving on to the research databases. So HHS should work with the private sector to improve data sharing in it dropper ability among research, health record in claims databases. HHS should work with existing organizations to create uniform to Numic data standards and if what ways to harmonize data and analysis methodologies and develop an infrastructure to enable the exchange. Comparable efforts to standardize data is also needed. Again, flag by the task force committee as extremely important. This ties to get at the question we mentioned before about how the different group and databases can talk to one another. Everybody happy with -- yes, this is all right. And then for be, as did his share privacy of patients and research subjects should continue to be of paramount concern and HHS should take steps to ensure that the confidentiality of their data is not compromised, identified by the task force committee in goes back to the balance I mentioned before we are trying to strike.
I have an observation. I don't know the solution, but if privacy is of paramount concern [ indiscernible ].
Yes, it will. That was what I mentioned earlier. It seems to be that --
Clearly this was written to allow a institutions to hold onto as much data as possible when it comes time for them to deposit into databases. This will give them reasons that not want to share their data. Is that exactly the way you want to push it? Please comment.
I'm glad or so but this up because I think this will be an issue for all kinds of issues and pharmacogenomics will be one example. Kelly privacy and confidentiality are absolutely important principle, but if one decides that that is the only possible, then basically you have no research databases at all because somehow they might leak or somebody might get access to show that. This is worded in a way that almost makes it sound like that would be your intention. So I'd be, perhaps, choosing your wording a little more carefully here Ted say that confidentiality and privacy are critical principles and every effort should be made to maintain them while also making certain that research can go forward by providing access to a qualified scientific researchers.
I think that is a very well crafted solution here. I think it is -- and I think the community knows it's obvious we have to push hard on the privacy Paramount attentiveness. I know a lot of this stuff is happening in America's health information community which we talked about earlier and it is really threatened by the concern of the public around this privacy confidentiality deal. In some ways if we are not attentive it makes the whole agenda a nonstarter. I think the way Francis raised it is the way to get at it and if somebody has that language I hope you are writing it, not that you need to say it again.
My only fear is the way that you stated it does the exact reverse. It says that -- just listening to the way you phrased it, this is an important concern, but the research must go forward. The must is the key. It makes it -- I agree with you we must balance this in our language, but I think you all right.
You don't work here.
I think we currently have -- there are regulations to protect the privacy of human subjects that interest up this research that can be used in to these databases are clerical validity except. We use identifying information. So the king is of what is currently in the regulation to these will suffice that we assure some of the privacy of these individuals but then we allowed to continue research.
Go ahead.
I think that was the same point. We will get the demographics out of the shares will still protecting the privacy of individuals.
Sure.
And the other thing, this is a battle but outside of my purview, but I would suggest that you have a couple Edie's on some of these things. There are models that exists like comical networks and that sort of thing that may be considered how they go about doing the data sharing and still protect -- all tamale project privacy. So I will say e.g. along clinical network lines that I think some of the people --
For this is the concern was kind of with the language, were is the bottom line going to be. And I think we will work on that to show this will be a continuing thing. The question is will it be creative or destructive? And hopefully we will make it created. We are scheduled right now -- how many more to give? Fifty-three people 25 and take a break. All right. At the age for guidance population data draft recommendation number five. Race and ethnicity categories should not be used along when analyzing differences and drug response. They said develop guidance that encourages the connection of other biological factors that make the jury finds differences in drug response. When drugs are shown to be effective in certain racial and ethnic Serb populations FDA should require manufacturers to conduct additional studies to identify biological markers that underlie the differential drew response.
The only problem I have with that is the requiring manufacturers to conduct the studies. These are extraordinarily complex reasons that range from environment to genetic factors that may be responsible for different racial and ethnic categories responding differently. And I meant that by demanding an explanation by that when those things are so complex they have proven extraordinarily difficult to work out. I to think that is overstating it. Let me see if we can get at this in some creative way because I understand what is being said. It says we should require manufacturers to conduct additional studies. Doesn't say required manufacturers to identify.
I don't know. I would argue that if you do show in a statistically rigorous way that a certain group be the people with blond hair or people who live in Love Canal respond differently to a different drug. I think it is laudable to look for those, but I'm not sure if requiring those studies is something that makes a lot of sense from the FDA stepped point.
I think I'm not sure either of what this is trying to do. When you pile on all those burdens on the manufacture it release instead me to have a discernible effect of bringing a product to market. And I'm not sure tell what advantage you get here.
The sense I think we were trying to capture here and obviously many of you are aware of this in the literature discussions going on about the potential effects of pharmacogenomics rather than a million rating racial categories and particular disparities in health care delivery that these would actually exacerbate. We could probably take require and put encourage progress I think you address it poorer well and the first two paragraphs and I don't think a third paragraph as much and does make it rather confining. So I think testing at the third paragraph makes it very reasonable.
Alan?
The -- as you know there is a drug out there that currently has proof of that. So I'm not sure what you are exactly recommending. Are you recommending we take it off the market?
No, the recommendation is that we -- and there have been articles addressing this issue. If one did a study of the population that is supposed to target, what would still probably find a spectrum of response to that drug and one might even find a response to the biennial competition outside of that particular group or you have high responders. So the question here is, is using the category African American something that is socially problematic, problematic to a particular undershirt group as it is in such a way as to say this social detriment basis issues that we need to address, not necessarily by taking the drug off the market, but perhaps by better informing ourselves as to what it is that delineates that population for which that particular chart is actually beneficial or significantly beneficial. And that is the intent.
I would make a recommendation -- I would actually make a comment that some of these racial and other criteria are an international agreement and that is just one comment. What you are really aiming for is to encourage us to move forward from a racial to aging comic, pharmacogenomics --
Absolutely. That is the idea.
We might be revised to state that so that race and ethnicity are found to be determining factors, pharmacogenomics should be looked into.
I'm not sure if I getting to where you are going.
I think we will try to get that in the second paragraph foreshore, but in any case -- all right. So one of the recommendations is to cut out paragraph three is what you are saying?
I think what we really are here is that when you make an interesting observation that there ought to be efforts that other facilitates the further research into what is actually going on or the recommendation is that you are trying to make sure that there is a database made available to support such research -- and it looks like you are trying to use that to the team as a way of facilitating access to the data that researchers can then use downstream, and the question ultimately becomes -- I think if I here the people speaking at everyone would be -- would say that it is a good thing to learn more about what this observation means and we ought to say yes. But the second question is, can you put on the back of the manufacturer a requirement to do that? And I think we are rejecting that in this in per referee. The second question is can you put that on the back of the FDA to supply some mechanism for that to occur, and it seems to me that FDA is saying that might be problematic as well and I'm not sure what your answer is. What we think we are left with is this is an important thing to study and people must pay attention to get in in the best of all worlds we should go after it that smart people would decide to think about it.
If we put HHS in instead of FDA, that takes the burden of of the specifically but it allows greater breadth.
So let's not undercut this too severely. Many people do believe that the ideal experience was an unfortunate one. I happen to be one of those buried the re-education of the racial categories in a decision about to get this drug war that truck both does a disservice to the public health because it substitutes and imperfect proxy for what may be much more specific information that this wasn't collected that might be too would respond and. And has the other possibility of applying to the public that race is something that is biologically determinate and because the FDA has approved this drug for African Americans they must be somehow different which is a vast overstatement of the biological facts of the matter. So I think it is highly inappropriate in this set of recommendations to put something into discourage that kind of occurrence again and I think FDA, appropriately, should be asked to develop ads just as your second paragraph says here to encourage manufacturers who are putting forward this kind of a test to do better next time.
I have somewhat of a conflicting opinion. I think that race and ethnicity are certainly very imperfect surrogates. On the other hand, to be want to say if that is the only surrogate you can come up with, forget it. You don't have a drug. I'm not trying to say he said that. I'm saying my opinion.
Joe?
Yes, knowing that this is more than -- I'm looking the wording they are using which is -- I think surrogate and proxy were the words used. A really what is the meaning behind this and what is the intent to do and what I'm sensing is along the lines that there are areas at which disparity's occur through which there are unevenness of ways this is done. Maybe the point here at the first two paragraphs but then to refer to add put something in a low but stronger language in your Elsie the section to be able to do this. We then get at the intent as well. You can start with the intent and leave it at that with the first two paragraphs. I would agree with my colleague here. Then gutted the issue blessed to help spur the which seems to be something that the community and everybody is in agreement as to be addressed. But maybe you can make a stronger case or that. That is something that came up in our group as well, we could find a better place or something like this. That would be my recommendation because I think why try to -- I think it is very confusing many many times to use the proxy or use the other terms being used. Plainly this is what the intent is and I would recommend that.
And we do have in the third area some of those. We could job the paragraph out here and make sure it is emphasized.
You could always say this is the recommendation for the intent here. I think you do need to address the tenth.
I would just like to emphasize where Joe is and take Francis's point. I think what we need to state -- I need people are reading to different things here and so I think we ought to describe what your concern is. And Francis T. it up very well. Because you don't want to see a misuse. However, in the more positive activity there be a step be the attitude to encourage research. So at think if you did what your -- because nobody else knows what you are talking about here. So you need to declare what your anxiety is.
Okay. All right. We are a little late for our break, but let's do it right here if that is okay with everyone. It is 11:00 now. We are supposed to have a 15 minute break. If you are not here at 11:15 a.m. all well will be fall you. And we will have the cameras turned to your response so all of America will know you are not here.
[15 minute break.]
Thank you all for resuming. We appreciate it. Right on time for -- as always. What a great crew you are. We are at a critical part of this discussion. I cannot talk in the latter. We are going to shoot to Anna. She didn't hear me. Well, I mean to tell you the there are so few people with whom will will be fall. It is amazing. Mr. Chairman, let's keep going.
All right. First of all, I did want to thank everybody for the comments and the insights. They are greatly appreciated, however I did overstate the case did little bit earlier when I said this was our opportunity to realign the universe and move stars around. The one thing I brought to tell you is we cannot miss with time. It just keeps going. So we must keep going. If we hadn't can be more insistent and targeted in our comments that would be greatly appreciated. But I do not wish to cut you off from making comments. So we bought move on to gatekeepers. It is important to understand what we mean by this term, and these were the groups that we're identified as those that can enable, ," or redirect the course of pharmacogenomics technologies. And therefore they affect the integration in the piece it access. We divide these entities into four groups, industry, the FDA, CMS and other third-party payers and clinical practice guideline developers. Again, these were the ways that we put it out and thought this was perhaps the most constructive way to do it, but we are willing to hear from you on that issue. And looking at these groups the points of our discussion covering the major issues and is there anything we are missing and what are the high priorities. So looking at the role of industry observers manufacturers perceptions of risk and return on investment, and floods, whether and how far could Numic products are developed and marketed. So there are disincentives to develop pharmacogenomics products. It can lead to a segmented market which can lead to decreased profitability. It can cause additional responsibility involving coordinating code developed products. Then there is the role of that FDA, FDA approval defects manufacturing practices, conduct of clinical trials, post marketing surveillance, access Tech pharmacogenomics products and their use in clinical practice which raises questions about the adequacy of genetic test regulations which we built also get into this afternoon so we don't have to solve all those issues here. The extent to which genetic data submissions will be required, premarket review of product and labeling of pharmacogenomics products. The goal of CMS and other third-party payers, ability to obtain coverage in federal reimbursement critical to manufacturers' willingness to involved in R and D of new products and the challenges here include the fact that Medicare does not cover preventive services and private plan coverage may be difficult to obtain, especially because of limited chemical LSD and utility information. Reimbursement may not be adequate and uncertainty about the region and plans evidence expectations. And then we have the role of the clinical practice developers. So the availability of the guidelines affect the coverage of products and their uptake by health providers and evidence based practice guidelines for pharmacogenomics products are indeed lacking. So looking at this, are these the major issues, have we missed anything, are these the things of highest priority and I open it to your comments. We haven't got into the recommendations, it just the issues. Everybody seems all right. This is good. We like this brevity. Let's look at the recommendations. Do they work as they are currently worded? Is there anything we are missing and should some be deleted. In looking at these regulations this is 68 which was flagged by the task force as being of higher priority. CMS [ indiscernible ]. He did. I looked at you and then I looked away.
It is true that CMS looks at certain pharmacogenomics test as being diagnostic and the patients who have signs or symptoms of a specific disorder. It does not look at pharmacogenomics test as bank diagnostics in patients who don't have signs or symptoms of a particular disease. Again, going to the point of, we don't cover preventive services and for a person to have a predisposition for a specific genetic disorder even though he or she may not have signs or symptoms of it, for that reason it would not be covered under that specific scenario, but if a patient did have signs or symptoms, then it would be covered. And I think this is one of the recommendations which was made that we made earlier. And I think that is purely -- the secretary is looking at whether or not Congress can give us a designation for a prevention category. But at the current time we don't have that.
And if this were to stay at is -- as it is written it would be supporting that change. You would have a pension category.
Correct.
Correct.
Said the question is do we want to support that change?
We should make it a recommendation to support that change so the undersurfaces are being met.
Pardon?
Could we make a recommendation to support that change ticket.
Well, this does, I think in essence, do that. You want to be more specific and say, for example recommending that --
You could say for example in addition, to covering patients who have signs and symptoms of a particular disorder we are proposing that patients who have a predisposition for genetic disorder, even though they don't have signs or symptoms, the genetic test should be -- they should be allowed to --
And as I have just been informed that would make us consistent with the coverage report we have already sent along. I think that specificity is fine to put in there.
Yes?
And I think another way to say it, if James think this is the title, this should be primary and secondary prevention and it is bidding at the heart of the matter, primary prevention when individuals are a symptomatic and don't have the signs and symptoms, Medicare would not pay for it. But increasingly there is secondary Branson when there are signs that Medicare would potentially before.
I guess I'm a low confused about signs and symptoms of we talk about pharmacogenomics. If somebody comes in who has a diagnosis, signs and symptoms of an illness and they need a treatment, the treatment would be optimized if a pharmacogenomics test was first done to assist with this was the right drug at the right dose. Would that be acceptable under Medicare's definitions of when they will cover this kind of test?
Yes, because the patient would have signs and symptoms and/or signs or symptoms of the disorder. But they wouldn't get have signs or symptoms of an adverse drug reactions, you are not requiring that?
No.
That's good. But this would say is the earlier conversations we had about done prospective pharmacogenomics testing is for instance with ARC PD in the military would not be something Medicare would currently cover. You would have to come in with a bag possible signs and symptoms containing illnesses for which drug therapy is needed before a -- Medicare would cover the cost of doing that pharmacogenomics test.
At the current time that is correct.
Obviously I would agree then if it is time to expand the universe of opportunities to the perspective, that would be a good thing and it is consistent with what ADDS is currently recommending.
Okay.
I don't know if we need a recommendation on this or not, but I know that CN asked as employed the device or approach of the least costly alternative and in the area of pharmacogenomics perhaps that doesn't apply or is more difficult to apply because you can't just say here are two drugs that are comparable and we are going to pay for the cheapest one. They're is budget reason for that and I'm not saying it is invalid, but as we drove down deeper on the science developed such that some people could not use the least costly alternative, perhaps there is room for at least acknowledging in the body of the report. I'm not certain it rises to the level of a recommendation, but as long as we are at the CMS section I thought I would bring it up. I'm not certain what the recommendation would be. With.
As part as this recommendation goes that would still be in place even if we extend this recommendation to a preventive mode as well as a diagnostic one where signs and symptoms of already present, is that correct?
Well, this is --
Test.
And the other would be more once you have the test would there be with you use.
All right. You got that? All right. Thank you. All right. I think we are definitely following gems and Francis's comments. We will definitely make this more specific and make it more clear that it is consistent with our earlier coverage report. Okay. 6B, health insurance plans should be more transparent in terms of how they make recommendations for pharmacogenomics Technologies by developing guidelines that define the type, quality and standards of evidence that might be bad for pharmacogenomics, technologies to be covered. Whenever a specific pharmacogenomics is denied coverage because it does not meet these evidence theory standards, health insurance plans should inform the test developer what additional evidence is needed. Yes, there?
I mean the skunk at the party. Topeka and I don't know if it goes there and I think these mechanisms are in just fine. The question that I miss -- and I don't know if it rises to the level of a recommendation or suggest simply be touched on briefly in the report. That is the impact of pharmacogenomics on the development and use of health plan formularies. Formularies are used in an aggressive way to help figure out what their piece our best, how can we manage cost, and this is something that is quite extensive in the private sector -- sector and of course Medicare is subjected to that as well. There is a difficult tension between figuring out what drugs and their piece you are going to have on your formulary and reimburse for and pharmacogenomics because you may have a certain drug on your formulary which you will pay for, but some person could not benefit from that drug or therapy because of a particular genetic issue or marker. So I'm wondering if it is worth considering a recommendation about not making when we have evidence like that, concrete evidence, not making that individual go through a rigorous appeals process, you know, the standard thing you have to do if you are going to go off formulary. I don't know what the recommendation would look like. I haven't thought enough about it.
What about -- I don't want to jump to the next one before anybody comes in, but the next is about addressing evidenciary gaps, and that is pretty broad, but it would sound like to me in one sense you are addressing in evidence theory gap.
I'm saying is that when the evidence is out there already, how do we manage the tension between health plans to use up formularies and making sure that people have access to the therapies that they need that may not be on the formulary. We don't want to eliminate a formulary, but we need to somehow reconcile the two.
Read?
I am going to be careful here because I'm from that industry. I don't have a conflict. But the use of the word more, they should be transparent. It implies that they are not and I don't think that helped spur a.
I see.
Rather than --
We are just trying to get all the flaws out of the class, that's all. Mark?
All right. Thank you, Cynthia come on that. Do you think we need a recommendation directly to that? A formulary recommendation?
If I had one I would but it out, and I don't. I think that a minimum it should be acknowledged.
Okay.
As an issue.
But perhaps someone else has an idea.
If you do later you can always drop a line. Okay. HHS should provide resources to relevant agencies to address evidentiary gaps identified by health insurance plans. That is mentioned. We are good.
I mean, I'm just trying to be -- I want to -- I don't want to be the start of the party here either.
We are getting so many that it doesn't much matter.
To say that the secretary should provide resources so felt evidentiary gaps, the budgeting process and the prioritization, are we getting ready to come back with a large pot study or there is a lot of stuff going in play here. I think it is kind of tough to make a serious recommendation that HHS should provide -- it is pretty definitive year that we are saying this is more important than some other things. I'm not sure how to handle this.
Of Cauvery's point and maybe Doctor Dunning can't comment as well, I'm not sure if this recommendation what Ford of the secretary's office would know what to do with it. There is more in the briefing prep package, but it is a bit broad --
I'm just making sure it is the same at it is in here.
The problem I have with it is as much as from a manufacturer's point of view I want to say this is all on HHS shoulders. I don't really think it is. I think there is an obligation for both parties that manufacturers, drugs and devices to play a part in closing the gap of evidence so that HHS can move into normal clinical practice and it is not just a HHS activity.
So would you want to delete or be right or --
Well, you know, I don't know. I'm not in the delete mode, but I think you need to definitely say, encourage public-private partnerships or something in Baird said --
Okay.
I am in the delete mode. I think this is so broad as to be meaningless.
But you don't have any specification you would give to it to make it meaningful?
No.
I'd just want to go back for a second. Different health insurance plans will help to their make a judgment call on standards of evidence and whether or not something merits inclusion in their and their services. So there may well be that different insurance plans will have different interpretations of this and offered different pharmacogenomics coverage. That will be a marketplace issue and within the consumers to go out there and say I like this insurance company because it provides me with this service. Is that the intent of putting a burden on the insurance plans to sort of make that judgment?
Should we at least be transparent about what they are doing?
Sure. Or even be in that will and the first place. So each insurance plan will then have expertise on making judgments about pharmacogenomics. Right to give.
I think this takes us back to the general conversation about genetic conceptualism and so forth. At the end of the day all pharmaceutical and technological issues are very clearly -- all health plans follow a pretty rigorous and pretty standard way of viewing the evidence for any of these new things. A lot of it is based on a CMS Bennett's first of all and so see him as is enormously important in this and then we all have various ways of doing it. So I don't think there will be any Super special thing about pharmacogenomics per say. I think it is just simply, is it in the literature, does it state [ indiscernible ]. And then what is the stuff that Cynthia and Debra commented on in terms of the availability of cost effectiveness kinds of information so you can to the pharmacogenomics and so forth. So the point is I think is that this will be handled the way that everything else is handled having appropriate research and literature assessment available.
Okay. Thank you.
I'm wondering if this is not overlapping with 11 be which is also talking about research and coordination done by the HHS. To me it seems to be speaking to the same issue.
Okay.
So my sense what this is we may have hit a delete for the most part of this because it is rather broad.
Okay. I don't see anybody dying in this trench. We will let that one go. On to the next. So again the next part here is the implementation section. And this is taking information that is developed and the research and gone to the gatekeepers in putting this out into clinical practice. This would involve education and guidance and information technology in pharmacogenomics and economic implications, ethical legal social issues and the coronation of the HHS activities. Ability so again which are the major issues? Are these adequate and sent -- should we get rid of some which we have actually done. For education and guidance, genetic education and guidance by health professionals and regulators is insufficient. The limited information is available through labeling and practice guidelines about how to interpret pharmacogenomics test results and how to use them to inform treatment decisions. And these are the issues, Genetics education is needed to help consumers make informed treatment decisions. Direct access to the pharmacogenetics testing through over the counter sales or direct the consumer marketing may increase in the corporate use of these tests which could lead to increased health care costs potential from misinterpretation of has results and misinformed decisionmdecisionm aking and adverse health consequences. The uptick of electronic health records is still in its early stages with no consensus yet on how genetic information could be stored in these records that he should have access to the stored data. Obviously lack of harmonize standards for storage and extent of genetic data and need for pharmacogenomics decision support tools and reminder systems. Economic implications, the use of these technologies will likely add to health-care costs, at least in the short term. They need to examine the benefits and costs of investment in these technologies and there is little research. We have heard this before. What are some of the issues that we haven't raised it? Financial barriers to pharmacogenomics to all the that has been raised now. No insurance could result in excess disparities and concerns about genetic discrimination which we talked about and liability risk of the provider fails to administer recommended test. In the coordination area there are lots of activities that are ongoing. Be have a list in appendix A. There may be more there but as you can see it is an already extensive list with 23 pages and there is no single coordinated framework or action plan to address pharmacogenomics talent is or shared information about activities among the federal agencies. These are the issues that we have highlighted. Everybody could with these issues? Anything we have missed or that you think is an appropriately highlighted?
Me eye test, I do think there are some activities on behalf of professional organizations, professional medical organizations and coalitions. Slide 65 is sort of dismissing everything as insufficient. There are activities going on to educate practicing physicians to incorporate into medical curricula among the genetic counselors, among human genetic testing groups. So it is a little bit --
I particularly want to tell you the intent is not to dismiss everything. The intent is to acknowledge even in spite of what you mentioned it is not sufficient. We don't want to stop here. We don't want to say where we are is a good place. We can try to make that --
[OVERLAPPING SPEAKERS]
How about we say it is currently insufficient. Is that it?
Okay. We don't want to downplay anything because everything going on now is certainly needed, but we need more.
Attend just to touch on this point and slide 68 this implication that farmer cut genomics will add the health care costs, well maybe not of what happens there is you reduce the incidence of adverse drug reactions which cost a huge amount, both in terms of health care economics and in terms of human suffering. Somebody that is a little too strongly worded. It is not a definite uptick in the overall medical expense. I would argue that to be the case because we do have the word lightly. If you had to guess which way it would go, which we do you think it will go?
I don't know.
That is the point.
The way you could say it is that pharmacogenetics did analysis are an additional backup cost to the health care system or a new technology. The use of the pharmacogenetics is a new development in the health care system. And the need to examine the benefits and cost of investment or use of technologies is your second bullet. Is new. So it is not something that is currently being done. But in the balance the second point is the question. Is it going to be cost-effective and save on length of stay or at a press reactions such that the cost of 300 hour test out ways the savings.
Remember, these are issues, not recommendations. We are raising these as bases. And in the discussion where we look at the economic implications we do in a sense -- this is bulleting what is in here which does say, let me just read you, the rapidly increasing cost of health care is a concern in the United States with to got to go being among the drivers of those cost. It is a new technology. While new technologies may improve the blank and quality of life or be cost-effective they will most invariably increase total cost.
No, but I think --
Practices point is right.
So you just don't know?
There should be an acknowledgement in this first bullet that they may add to health-care costs, but on the other point might actually reduce cost which is different from cost effectiveness.
Cost effectiveness is it is worth the money.
It is conceivable that pharmacogenomics will save money.
That analysis has already been done. It is incorporated right now based on what we know, testing you would save money over all for the health care system because of those address events that you would predict and prevent.
When you look at that from the infectious disease when we implement testing you increase the cost of taking care of that particular patient, but the overall cost of health care has significantly been reduced. So maybe that is how we can phrase it that we and tested that patient and the overall cost would be significantly less saving.
Sent the ticket.
Another thing we should factor in, and again I don't know -- I think we could craft a bad condition on this. In the real-world application we understand the cost savings over all downstream. Federal programs have to pay attention to what the Congressional Budget Office would say. And so any changes, legislative changes in federal program coverage and other statutory changes are all going to be dependent upon whether CBO besides there are cost savings or not. And traditionally CBO does not recognize downstream savings for avoiding hospitalizations or avoiding and verse drugs. They simply say, what is the cost of the therapy and how many people would benefit from the therapy and multiplied that an ad in a few additional numbers for the woodwork effect and suddenly that is the cost. And it is some 55 frustrating for everyone and health policy because we know in the real world we can achieve savings, but in the world that federal programs have to pay attention to the can't get CBO to acknowledge those savings. If there is some way we can craft the recommendation whether it be pushing for some dynamic scoring or if that is a bad word, call it something else that would put CBO to at least consider these types of data that would help make the case. And it will lead to enhanced coverage at least in federal programs. It is a real problem that we face.
I think that would be a tremendously important idea. I didn't realize that about CPL perspective which seems unbelievably limited. And maybe that should be a separate recommendation. Take out that first bullet and say something like pharmacogenomics may increase costs ultimately in an overall sense it may decrease cost and add something about how CBO perspective --
Just for this issue if everybody would look -- it is on page nine of your executive summary. Number nine is the economic value of our Mycogen Numic -- pharmacogenomics. And that is another realization we have come to. We seem to be getting a little bit of an overlap here. So one way to deal with that would be to either change this first bullet and deal with the issue in the number nine, deal with it here. We have to just figure where we want to go with this. This first bullet could say, currently there is concern that the use of PGX technology will likely add to health-care costs or me add to health-care cost. There is concern.
Or you could just drop the first bullet. And.
And pick it up in nine, right.
I am just a little confused because these are not the recommendations we are looking at.
[OVERLAPPING SPEAKERS]
This is an issue. Nine is where we pick it up. These are the issues we are talking about here. And that goes to nine.
But then let me then argue that the text you read peace treaty because it overstates what the consequences will be pre.
Thank you. Right. So we could say there is currently the reality of concern. Some I think we can say that report that apparently we can say.
Okay.
At think everyone is kind of worried about looking at this one statement orders of magnitude and higher importance of what it needs. By taking it out are reconnecting it they can't --
They can't see this statement. This is an issue that is in the report, but we can be work that part of the report that I did read.
But the critical piece is it will cost a lot of money to develop these technologies, but the goal is to lower health care.
Understandable. All right. Good. All right. We can go back in that section and a Greek word that. Habib any other issues that we covered that are raising red flags? Okay. Then let's get to the recommendations.
I actually had one point. I am a broken record on this point for those in the other worker. The last point is one that has an argument to be made for NIH entire budget. And I hate once again to create an exceptional argument for this area of technology and would hope that the discussion and reported to acknowledges that this is not specific for this technology or this application. It is not a centralized and anyway.
To be honest and not quite sure how that comes out that the report but I will look at that and make sure that is not the case. This was flagged by the task force as a high priority. As evidence of chemical validity and utility for pharmacogenomics accused, HHS should approve the support of Technology says was summarizing the evidence base. These analyses and assess this should be disseminated to professional organizations to facilitate their development of clinical practice guidelines which gets back to something Rochelle mentioned earlier about the way people are trying to get up to speed on this. Comment?
You see a lot of analysis looking at trials as far as case control studies. It is extremely rare that you find an analysis of diagnostic studies simply because of the receiver operated characteristics as well as the changing in point. I would suggest instead of using the word match analysis use the word system reviews and you can say systematic reviews and looking at how test results produced in the management of patients or something like that. Again it is reiterating the word management, but seeking out [ indiscernible ].
This should be including this and others.
Thank you. HHS agencies should collaborate with federal, state, and progress is to develop, Kellogg and disseminate case studies and practice models and the use of pharmacogenomics Technologies. Anybody to do that good. All right. H8S should provide resources to professional organizations that will help enable their membership to meet and establish compasses on the appropriate use of these technologies. Began trying to facilitate what is already on going. We did this to be a good thing.
The drug companies and the domestic companies do a lot of this as far as working with physicians and laboratories and reference laboratories and try to teach them how to use their products. What he suggest maybe industry be included in this Cuban because we have asked industry to do a lot and maybe we can help.
Maybe we should collaborate with federal, state, industry and private organizations.
When you say private organizations does that include industry?
I think.
Update the Bucks -- if it is included in everyone is comfortable.
Providing resources to professional organizations, we are good with that. I'm sorry, said the it is not.
I throw this out to the group to find out if you think that there is a certain element of reporting that we would want to ask providers to engage in. What I tried to do is think about if there is a way to weave performance -- we've pharmacogenomics into the performance concept that HHS might be moving towards which is to incentivize positions to of physicians and other providers by paying them a little bit more to do certain things. And down the road the idea would be for quality measures, but initially I think it will start out as reporting. So if they report certain date in they will get enhanced brought Medicare reimbursement. Is there some recommendation the talk about alter preliminary that what we've been reporting of data, what kind of data that could be incorporated in the paper performance approached. I don't know if the science is still too new and we are not there yet, but if there is a step that physicians would have that would be useful if we what incentive does them to report that data somewhere then that could be moving into the paper performance approach.
We have to make sure they are covered first.
I think this is, Cynthia, right down the middle of the place for what we started the meeting off on when she was here regarding the American Health Information community and so forth. This is the essence of what that is trying to do, to find a way to connect the information about clinical practice that derives from the physicians office records and elevate that up in a more convenient way to larger activities. So I think we should try to find a way to connect that in to the activity. I think that is what we are getting at. With regard to the specific thing here I'm still struggling with this one. I think that if we are saying that HHS should work with professional society to facilitates the continuing professional development of their members, I mean that is fine. But the idea that government is somehow or another going to write a check to professional society to help them do a better job on this area, then you get their radiology imaging committee coming forward and saying, all right, where is my check for that? And it goes on and on and gives absurd. At the end of the day this is what professional societies do. That is what they are supposed to be doing. And so the idea of the government will subsidize those societies to do that, without delivering it there must be some things we can all do to help them to do their job. So we would be working with them to facilitate the continued professional development of the physician.
Soak right. Right there you are saying using the word provide resources everybody will just think money.
[OVERLAPPING SPEAKERS] expedite good point joke.
I was just thinking, because I don't know if this exists already, the effort to either provide a mechanism for coordination or to coordinate and assist professional organizations and coordinating the effort because that would mean that you have a cross organizational or even a collaborative if you will group that has representation of organizations that will probably continue to work on what they are working on, but would have a number of the things built and which is the transparency issue that we needed to talk about, accountability issues that will be there, as well as having an up today real-time assessment of the assessments that are going on. So that is if I am recommending that instead of correlation you provide [ indiscernible ] but the idea would be that you make a recommendation. And this may be a recommendation that is there that this is to be tweaked a bit. That would be a very cost-efficient way. Along the lines of what real was saying but I would say that would actually be a better thing. I think that is terrific because it reminds me Ted nuance my comments. On the one hand I am a legitimately concerned about the idea that HHS would be sending public Monday that is in short supply and even shorter to the society's to accomplish this. On the other hand, the society's get very freaked out if government is going to try and coordinate their efforts to tell them how to practice medicine. I and you must be -- I think the idea of facilitating a rational efforts where people are trying to work together, but the government certainly should try to coordinate medical societies in terms of how they will practice their profession. That is their expertise, but they must be supported. The way he phrased it was good. I just realized I need to give the other half of that balance nuance here.
What do we have here?
How about to facilitate the ongoing professional development of their members oppose that will enable their membership to establish competencies'.
Facilitate sounds -- I know this is -- can you say it works with, work with professional organizations because you sure don't want to imply that the government is going to be coordinating or facilitating could also mean giving money.
I understand that facilitation been difficult because it is what to do, but it -- it's sent to be there are models. And I guess my point is that whatever way the wording comes out it really needs to be a joint collaborative efforts with the HHS and professional organizations.
What we can say is the HHS should work with and then along the lines