Event ID: 1431175
Event Started: 10/9/2009 7:57:09 AM ET
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Okay.
Now, the three questions on this slide to determine what we have to do next.
Let me go to the last one, are there other things that people think we should do as opposed to or in addition to doing this session.
Greg, I know you have been giving this a lot of thought. Would you like to con tribute?
Yes. I would be happy to, Steven. Thank you to all that have worked on this, and in particularly, thank you to Charmaine.
This has taken shape, and there is some commonality around the clinical Genomics. I have learned to be careful what I ask for.
[ Laughter ]
There is no mandate here by any means. I want to be clear with that. But it seems as one of the higher level and cultural thing that is going on and what we think is good is a lot more r collaboration -- more collaboration among the institution, it's a basis that is trying to get the work done so ones can collect within their own institutions. There is a lot of hard questions associated with them, but one of the things we have been looking at is some of the new partnerships across the organizations; what are the models; what are the publication issues, so on and so forth? That's just one of the areas here where we have the comprehensive databases. It's bringing enormous power and inferences. It has many aspects of biology, health, elements. This committee has engaged many other advisory committees, Health-IT, observations, and my observation over the few years is that we have -- the committees have gotten much better. We don't want to influence those committees and the outcome. From looking at the data, there SAP -- there is a great deal of aspects with the applicabilities applicabilities. The various of human life, having not only the technological and scientific means to share that information, but having the public policy perspective to be prepared and thought of as it takes more shape. We are not so much ahead of the game, but we are trying to catch up afterwards. I don't know if that makes sense. I am sure you-all are familiar with Facebook, MySpace, and Twitter. I think you are interested in the models of people who have developed the foundation and the collection of data for themselves. The President has spoke about the IEH this year, and it's using technology to use and disseminate those. One emphasize, there is no mandate for any particular outcome for this, but it's the power that it can provide. I am happy to answer questions. Steve, I hope that provides clarity.
Yeah, it does.
We will open it up for questions in a minute, thank you.
I do give a lot with this. Actually, we have given a lot of thought to this idea, and Greg is being humble here as always. He helped us put together a meeting at Georgetown, and we looked at the Genomics and health information and data sharing. We thought this would be a great group to engage. Not only those who are interested -- part of the health care arena, but those who are interested in knowing about characteristics. There is a lot to be learned here. I think as one pursues this, you could see this as a micro-cause of the broader issues. What are the goods? What are the goals? This will give you a leverage to open it up more, you have to ask people what they expect and desire if they engage in these sort of things. I see this as an opportunity for SACGHS to mandate this in the health care society and ramp these issues up and make them very r much a -- very much a part of everyone's life.
Thank you.
Why don't we open it up for discussion, and we will go back to my information. Let's open this up.
Charmaine, would you like to coordinate this discussion?
Sure.
Go ahead Sophia.
Okay.
Well, I totally support this especially since I won't have to be on the task force.
[ Laughter ]
With the other committee one of the things that is very important to us is the newborn screening and data. This is very important to us.
Mark?
I would also support doing this and bringing Silvia back in on it.
[ Laughter ]
The other thing that is interesting but not in your very nice presentation is the issues that consumers have with the data collection and for the purposes of our block that I am inflicting on you and the user agreement on the directives of the companies, and how are they going to use the data? Jim mentioned yesterday the new research model, and, again, that is really an open question as to whether it represents a new and innovative way to do research. Or is it not going to pan out? I would increase the panel to scope that as well. There's probably a less way of not using the oversight in a specific federal term here, but there is much less scrutiny in that than the other things that are referenced.
Thank you, Mark, very good point.
I think there are some way -- ways in which the work with the applications in the different ways that the government and the agencies will do. We had one not so long ago where there was a publication that provoked some interesting remarks. Someone said, it's a late -- late Friday afternoon in the summer, who is paying attention. I read the title of it, and it related to the Genomic findings and substance abuse. The notion to being able to relate to the sort of behavioral elements, patterns and the Genomic characteristics together and assimilating those together by addressing the assailant biological issues. What were the methods coming after this?
The dialogues? What is the root cause coming out from all of this? I found out that the information was not being placed in a broader context where the communities could understand that. There were comments coming out about the communications for those seeking health and they would be isolating certain populations so on and so forth. And as we have had several phone calls with a variety of people across the department, but it came to us that we didn't have the informational resources, which didn't put in to context the population-based studies and context. We have to put in a pre-emptory stage setting rather than just getting more knowledge. And the other other implication -- [ Audio Cutting In and Out ] -- of that is to have the large database and then isolate the factors of diabetes and depression. This is a real context to people. Taking that which has implications that cannot be explained easily. What you can do from the policy and the science side, that may inform the public and communication apparatus around that. We would like to use technology to explain the research findings. When you are getting publications out there, there are other things that are are setting up the structures for those things. I'm trying to lay a stage for the other parts of the work here that can be used and consumed by the other pieces of the department.
Yeah. Thank you, Greg. Those issues, I mean, they cut across the populations, but when you think of the vulnerable populations, that's a major issue. How is the data going to be used?
How are they going to access it? And the questions that follow that, how will they be answered? The researchers, their willingness to open up their data for sharing. What I have found in the groups I have been involved with, the cohorts of African American patients, the participants, and it's the researchers and the studies have not been done yet as far as the feelings on their research being shared. Some of them have spoke to me about it. Some of them have stated to me they don't want to do that because of the group and the studies. It's failing as to the populations, but not only that populations there are other populations as well.
I want to get a better idea on your vision of the scope of this effort. Will it include the more practical things? Greg and I talked about the nuts and bolts of how you actually share data, and how you actually -- you know, some of the IT tools that have to be developed to ensure the inoperability of all of these systems and I was wondering if you were planning on tackling that as well?
I didn't think about it specifically. But this forum is for what a scope might be. If the economy thinks that is an area we need to look at then we will probably explore it. I want it to be open for discussion on how the committee moves forward. There are other agencies that are looking at this issue that brought the data sharing. What can SACGHS bring? What can we bring to add to that? Share with it?
Mike, we are on record, as you know. Last time, we talked about getting the -- about the importance of getting the standards in place so we can proceed. This is what we need to talk about and how to move forward. We at least made some statements in that record.
I just want to make sure if you think you need our help that we get the right people involved.
One of the things I taked about when I came on to the committee is the advocates and the consumers and this is an opportunity to bring out the other voices. Silvia knows, because I have been working with her in [ inaudible ] There are others dealing with issues on this. I know from the tissue banking and the tissue collection point of view where the advocates that I work with are the cancer advocates that come down on this. That's a way to bring other voices in on this which could make it very rich.
Thank you. I would like to support the formation of a group like this. It's circular. The very first research that I was involved in when I came on was the population study, and it addressed a lot of these issues. There is an underlying concern which is a large concern with the population and their health. So when we talk about communicating the results to the consumers, talking to researchers about that, but that's a way, a priority, to ensure that the appropriate questions are asked. Not just the doable studies, but the importance of the studies.
Doug?
I just want to say because of the nature of the way that VA provides services and the fact that we have an enduring population, we have a lot of plans to do these kinds of studies, and we are doing a lot of gearing up for the large data collection and improving the capabilities for the data sharing. We have a real interest in this area and the conformed -- ethnics and the informed consent.
I forgot to mention earlier, one of the contributions that I took away with the [ inaudible ] that Kevin accumulated was the technology. We went looking for literature on this. What are the effective models for the communities on an ongoing basis and the uses of that information. We went through [ inaudible ] and I want to think a number of you for doing that in the past. This is more of a social science issue kind of thing, but, you know, how do you figure out what the community's needs are. There is not one common model that we found. Many studies are international in nature, so how do you take in to consideration the various cultural perspectives on ownership and asking. You know, through the native American population, here, we have learned a lot, but there is a lot of models we have is seen. Kevin, I don't know if you want to speak on that; but that is the rich points that I took away.
I agree meetly. That is what came out of our gathering. It's also important to acknowledge that their are other nations and places in the world that are ahead of us in this game. Canada and Mexico has done a lot of work in this area. We don't have to reinvent the wheel so to speak, we can better that issue and there are ways this can move quickly.
Right.
Just to move back on that, you said it is social science, but it's all of the parts within it. We have to look at the stakeholders, the patients, the participants. The social science needs to be included in the biomedical group. It's all of who we are.
It's important.
I good morning. I am the secretary of the advisory committee. We would be glad to work with this issue. I would like to add that the newborn and the rare disease community has already been grappling with these issues. This includes engaging the communities, standards development, to allow that information exchange. I would like to add that the issue of standards development needs to be -- it needs to go hand and hand with this effort. Communication won't take place unless you have the standard to community.
For about 20 years, I have seen an international registry where we have built a pattern of cooperation. But the hard part is linking the clinical and the biomedical data. The idea is to continue with the evolution and the requirements of the conformed consent particularly on the paths and the genes and the diversities that are caused. It was simple relatively, but other time, we needed to look at other genes. It's also a frame work and foundation of building a community of interested people about genetic studies as it relates to long-term health. The key feature is linking the clinical data to whatever genetic or analytical data that you have coming from the laboratory.
Is so I'm going to put Allen on the spot here. I don't know if there has been an official announcement or not, but there is some implication that NIH is going to account for some extra money in the social issues. I am trying to determine whether or not this is right for a group like SACGHS or this consortium, whatever, to help to direct some of the distribution of those funds.
I'm not sure exactly what you are speaking of, but I don't think it would be a good precedence to have SACGHS to direct the funding. I think it is great to make suggestions, et cetera, but I think it is the -- [ Audio Cutting In and Out ]
[ Speaker/Audio Faint & Unclear ]
[ No Audio ]
I'm not aware of or linking up to what you are talking about.
I'm not sure either so --
[ Laughter ]
I didn't mean to imply that we would be directing the funding, but I was wondering if there is an overall sense of the funding and if there was some interest.
Obviously, we will go back and forth. It's part of what we have talked about. I clearly think what has come out from such a group is a good idea. It will help to inform NIH and others.
I just wanted to make two comments. You mentioned one of the issues of blurring between the clinical practice and the [ inaudible ] That's an issue that happened several decades back. It's an issue that our office struggles with frequently when we are trying to figure out what is research and what is not research. It's unclear to me at this point as to why this area of genetics further blurs that line. If it is true, it would be best to inform others why that is. That is a topic to address. If so, what should be done about it if it is making the line more blurry. We have long standing policy positions regarding the identified issues and the technologies and the advancements that would cause us to rethink those. If that is the case, any advise would be beneficial to this office. All issues and specimens, the thoughts and the matters are broad when they are looking at research in general. They are not just focusing on the genetics, they are looking at any research issues and biomedicines, when was it banked? When can you continue to use those? Those are the issues they are currently looking at.
In the issue of blurring -- we can move on, but -- we recognize it is not a new issue, but there are questions about the sharing of data. Data being available to everyone. There are new questions that could be raised from the data and research. The clinician who have collected the data or whoever else, and that is the area we want to talk about. Do we want to talk about clinical or -- in general, I am getting there is a -- getting a sense that this is an area we need to focus on. We will talk about that later as we move to plan the meeting. The formation of the [ inaudible ]? I don't know. Do we take that now? I agree with you. I am hearing the subject of considerable interest. I didn't hear any dissents. So I think it makes sense to get a small group together to reshape the meeting in February.
Uh-huh.
And then we can figure out where we need to go once we have a more complete discussion. It sounds to me that we are in the market of endless volunteers and or an appointee. Charmaine, I hope we can could on you to start.
Uh-huh.
We gave the draft to Kevin, so he can't escape.
He can't.
We could use a few others to work on this.
I really want Silvia to do this with me.
I know.
No, I'm just kidding.
Well, I'm not kidding.
[ Laughter ]
I've got Mike, Silvia, Sheila, David, -- I think that is a great group to start with:
Michelle, I think we will call on you too to link these groups up.
Sandy? Don't go away. We have been talking about you.
Sandy, we had talked about the contract and what has been in place. I know you haven't been able to hear the whole conversation, but can you talk about how you see this fitting in to the committee?
Okay.
Thank you.
We have a shared interest on a number of things. I am sure Greg mentioned that. We are working together on genetics. We have a contract that will provide analytical support to the committee in this group and to the [ inaudible ] group a couple of weeks ago. We haven't kicked out the contract yet, but we will in a couple of weeks as a guide for that, we used the white paper that the committee put together, and that was last year or earlier this year. We stayed around the -- we talked about the questions that were asked, and we were searching for answers that you could find in expert panel interviews, and we will be in discussion with those who have signed up to work in this committee here. This will be a fruitful interchange because we want to talk about things that will be useful to you.
I just wanted to volunteer.
Terrific.
We are happy to --
[ Speaker/Audio Faint & Unclear ]
[ Laughter ]
All right.
Steve?
Steve? I would like to have our involvement early only because our next meeting is in January, and I would like to be able to present this.
Obviously, this is an area where we need to work together.
Okay.
Charmaine, thank you so much. That's great. Thank you for moving it forward, and thank you to everybody who has done a lot of work and prep for this over the last few years.
We will leave the rest of the questions for the subcommittee.
Yeah. I think if you can sort through that that will be great.
The next topic is the genetics education and training and as you can see, we have only allowed a half hour for this. We want to give you the input for -- give you the opportunity for input on this. Barbara wants to review with you the findings they have with their work groups and provide you with the draft recommendations which you will see in a more formal form in January.
Thank you for your work, Barbara.
I think my plan is to open up the information and then open it up to the room for discussion on this.
In terms of the life span of task forces, patents is at the end of it's life. It's ready to leave this stage.
[ Laughter ]!
I think our report is in its late teens.
[ Laughter ]
With all that might imply, so think ability -- about that when we are talking about it.
The roster.
Sorry. The channeling gear.
[ Laughter ]
The roster, they are the chain of the committee. It looks unwieldily, but it is not. They represent a broad base of expertise. The committee charged us with a big task and because of that we subdivided that in to three groups, and in another world, this is a whole separate committee and resources, but it is a [ inaudible ] We divided them in to health care professionals, telework provider network, consumer and patient group, and so these are the chairs of each of the work groups. They function very [ inaudible ] They are collecting the data and crafting the recommendations.
So today, we will be reviewing some of the findings of this report. And I will emphasize that I will be doing it briefly. In your briefing books, there is a summary of the findings. The full text of that report, you will be receiving in January or February. You are not providing all of the findings for the [ inaudible ] online, but I will go over them briefly to give you a flavor of it. Most of the time we have for today, we would like to spend talking about the recommendations. We would really like to craft these recommendations as actionable. The recommendations of the secretary's HHS, and we would like to provide her with something that she can take and decide what she can and cannot do with them. We would like to move on with the engineering perspectives and seeing the eyes glazed over. And we would like to be forward thinking about the future of Genomics, but not for the recommendations just for today, but how it may happen in the future. We are trying to be sensitive to the reality of the competing health care needs. This is also to avoid the [ inaudible ] tones that are esen trick to this report to help the consumers and health care providers who have the thought of thinking of genetics and Genomics only. We would like the recommendations with the key points, but we would also like to prune them down whether it is combining them with other reports within the committee. These are not final. We will be revising them in the next couple of months and we will be putting them in to the reports. We are not at the stage of crafting the language. We would like to focus on the contents with the was some Tom in this -- wisdom in this room and see if we have crafted them appropriately.
The time line. We will be talking about the draft recommendations. Between now and January, the committee will be going back to the drawing board, and all of the data has been presented, but we need to read it in a more [ inaudible ] format. We will take the recommendations and the suggestions of the recommendations and put those in a language that will make sense that will result in a compilation report, and that will be out in January, and that will be for your review and approval, and then it will go through the patents next early spring, and next June, we will have the meeting about the recommendations and then we will be sending it to the secretary in July.
The draft reports, you are familiar with how they look, but we always start with the recommendations and the studies of recommendations. And next is the scope of the problem. Background literature is provided in all three of the groups and the outlines within the groups. Each of the groups collected data and that is the [ inaudible ] and they include all of the raw data. The recommendations that we are going to be talking about is the number of data sets that are included in here. We started with a round table by panel experts and they gave us recommendations about what to focus on. Those are part of the recommendations. We have the structure in which we collected and the original data that was collected. There was a resolution out of 2004 which was discussions about increasing the research. One is the CDC [ inaudible ] to include the health care professionals and the public. They have been very busy and productive producing a lot of educational products for the groups and assessing the needs for the groups. At that time, the nurses are developing their own compilation of genetics. Soon there will be an article of genetics and Genomics in AGM who are addressing these specifically. They are moving, but the committee felt there is still much work to be done. Starting with the health care professional group, I'm going to highlight the key findings in the literature review. Literature review regarding the health care professionals, generally we found that genetics and health care is by a lack of inappropriate genetic communication. There is no such thing as professional education. It needs to be looked at with basic education, training, advanced training, and then continued education for both of those groups. There are different groups, different modes, and different education on different needs. The licenses right now, have not been kept up-to-date. Based on the genetics data, there is an estimate that there is only 41% of the numbers needs for the work force. This is what gets quoted a lot and is important to a lot of people. It's important to focus on the whole context of the [ inaudible ] This is to work with other health care providers and groups, nurses, patients, physicians, clinicians, and this needs to be looked at even though they are all very familiar with it.
The next one, this is the changes that have happened between 2004 and 2009 or 2010.
The larger group was to serve health care organizations. These are like professional organizations, AME, AMA, certification groups and things like that. They have distributed 33 survey, and they had a 58% survey return rate. Very briefly, the findings. These are reflecting the overall tone. There is a lot more findings, pages and pages of findings. But we found that 77% of the findings few -- genetic information is part of their goal, but they need to find other things. They will find if there is greater interest within their own organizations leadership that would facilitate the leader and Genomic and genetic education. They understand it, but there needs to be more emphasis. Competing the priorities are within the varieties of the Genomic and the genetic.
The current public health care course is -- [ Speaker/Audio Not Clear ] So they identified a gap. Those are quite verified including the roles of the work force, the paths experienced out of the group, the out of date formal training, and the utility of genetics and it is not clear to them. How are they going to use it? Why do they need to learn more about this? The data that this group found was the income -- incompetencies. They received a lot of responses. This is interesting to do a lot of numbers on this. The survey would be distributed to one person in a public health department, and then look at it and say, I don't forward it on. We lost track of who served on this survey, but we do know who filled out the surveys, and it was interesting and sur prized us.
Those 12 competencies, the most that was highest rated is this one. It read, the development of disease, interventions, screens, disease, health promotions, and those of you who do surveys, you will realize that this question is a double-barrel question, but the largest competency was the -- [ Speaker/Audio Not Clear ] Two thirds felt that the Genomic was adequate. Finally, the consumers and the patients group, there is literature that is found for the consumers and the patients: Media, TV, and a lot on the internet as we are learning about, and also from their health care providers. There is a sense from their own -- from many surveys from their self-assessments but that the consumers recognize that they are related to health outcome.
[ Speaker/Audio Faint & Unclear ] [ Audio Cutting In and Out ]
There is a continued concern about the confidentiality -- [ Audio Cutting In and Out ] Most of the those cases are geared for those who are actively seeking information. [ Audio Cutting In and Out ]
(Speaker/audio unclear and unavailable at times due to the following: Faint, unclear, audio cutting in and out, static).
This is identified from the group who has expertise and education among the consumers. Advocates of the consumers are those who are involved with those groups. A survey was developed and administered on the web to more than 1000 organizations.
[ Audio Cutting In and Out ]
[ No Audio ]
[ Speaker/Audio Faint & Unclear ]
They were actively looking for the information rather than passively looking for the studies on Genomic. They have then analyzed the [ inaudible ] consumer analysis and this was distributed to the general I believe approximatic, and the -- general public, and they shared that information with us and they put that analysis in their findings.
Some of the findings were that the authors would like to get information about the primary care providers. The government is seen as a trusted source for information. And many of the consumers felt that the government is a clearinghouse for health information.
Okay. That is a quick overview of the findings. You will see them in their great glory in a couple of months. We decided we could talk about the recommendations before you seen those. This is an area that we are all familiar with. This is not going to shock you. It's been reported: We thought we could craft it in this way to move forward on beings it's been talked about and on for so long. People in this room have a lot of experience in crafting the data. And you know when constricting the process, it's very iterative. When I say iterative, I mean, very, very iterative. One of the things that happens in that process is that the good ideas will be lost. There is a tendency for those to drift to the midlines. I alerted to the possibility that I am drifted to the midlines and lost some of the iterations over the past months. I am calling on the group to help us to ensure we have not lost the meaningful ideas. We are trying to get a harder edge with our recommendations. We can say from the literature and the data we collected that there are challenges in achieving the health care work force genetic literacy and the other health care groups. There is a strong sense of the innovative resources that talk across the [ inaudible ], and we are not just talking about the providers, and education of individuals where there is a lifetime of learning. And these innovative methods may inquire information and recommendations from state and local health care groups.
This is involving the needs of the diversed communities, the learning styles of the communities as the population becomes more and more diversed.
I would like to read through them all and talk about them at the end so you will see them as a whole.
We have a total of 13 recommendations. It's not a million. There is two or three that apply and come out of the work group, and there is two or three that comes out in the end, and I will talk about them first.
Recommendation is HHS should encourage the Genomic and genetics in the health care training initiatives that are relative to the needs by each groups. The needs will be identified by the groups rather than from above. This is a broad recommendation. It is speaking out to the levels of education, the curriculum and academic settings.
The second one is similar, but it has more of a health care delivery tone to it. See if it is distinct enough. It should provide the educational and advisory panels that will model a frame work for the certification requirements in preparing a personalized Genomic health care work force. Bla, bla, bla. You get it? That has a delivery tone to it.
Third one, health care officials, interdisciplinary collaboration. They should facilitate in to interdiscipline -- interdisciplinary settings. There is a call out to rural and underserved areas, and they should employ the technologies such as telemedicine, and then acknowledging that there is barriers to this; reimbursement is one and there should be reimbursement for the teams and the consultations that we just referred to in the rural area.
The public health care providers, the first one, this is to provide the size and the scope of the work force to ascertain current trends. As we know there is diverse trends and their role will be likely to change with the health care forum. The other issue around this, is the size of the work force and whether the numbers are keeping track with the future and the anticipated -- the future needs particularly in the genetic work force area. Because the group dealt with competencies, HHS should provide the relevant competency for all rural and health care providers. This is speaking to the reality that there is some public health care providers out there where the competencies are requiring other genetic policies. This recommendation is -- is responding and referring to two quite different groups within the public health care work group. Embedded in this is the dehands that are always in there for the health care professionals.
The next one is collaborative training. This one is suggesting that there be a promotion for collaboration for genetics and Genomics and the educational training between the medical and health care professionals for public health. For example, public health, educational schools, ANE, AMA, and this is to contribute to the health care group and narrow those Genomic and genetic groups.
Literacy, this should be based -- [ Speaker/Audio Not Clear ] The question here is whether or not to include K-12 or K-College education. This is decided clearly outside of this task force. A lot of the suggestions that came from the consumers is to a literate population.
The next one, resources. This one, embedded in here, is the idea and the need for creative resources and in how people are receiving the messages. Always with this is to not lose site that there is an underserved ethnic committees that need sources and media of information. Their needs need to be met as well.
Family histories. HHS supports the importance of family histories. They should share the accessover the tool -- access of the tools and sharing this information with the patients and the primary care providers. This may stand out a bit, but when we were speaking about the priorities, what came out from the group, if there is one thing you could teach, what is the biggest bang for your buck, and family history rose to the top of that.
Genetic research, inform the public about the risks of genetic research through the national and local efforts. This is really calling out to the committee that was just formed, the genetic Data Committee, whatever it is going to be, Charmaine's committee. We just talked about that one. A couple of recommendations that are applying across the group. This is a [ inaudible ] In the consultation with several agencies HHS should have a international planning committee which should include various individuals that don't normally cover this group, the education, the interdiscipline, and the experts outside of the field which are innovative thinkers in a technology explosive area while looking towards the future in the Genomics arena. You can see that they are saying: Let's try something different, let's form a group that is not usually formed together.
The next one is about faculty training and that is across all groups because the faculty health care professionals do identify the clinicals of forming and training of the genetics.
Translation, of course, that's across all of the groups. Should develop translating and dropments to -- developments of the health care information and training. This is a transition from -- to communication science. That's the transition. We need to do a shout-out to the prior reports that are addressing the educational needs. This is an area that was identified in the first SACGHS meeting, and that's a priority. There is a lot of report that talk about them. At least one report in this group has the education training. We have reimbursement, oversight, and Genomic oversight, and they are all specifically identifying education. We have highlighted those. They are in the folder.
Okay.
I think we have a half hour? Something like that?
Yeah.
Great.
I think we need to go over the recommendations, make them sharper, more actionable, and clearly, we will be making our recommendations to the secretaries. Also, we will talk about the other groups who may do them, but we need to talk about that and how -- we need to address both -- both audiences. Barbara, I welcome that.
Jim?
Great.
Barbara, congratulations. This is a huge task:
One of the things I wanted to mention and it might have gotten lost. Two things: One is a discreet suggestion and the other one is more [ inaudible ] In the recommendation, someone who teaches the students and the residents, I am acutely aware that the methods that we have teaching is inadequate. People forgot it. It would be helpful to have something along these lines. Genomic education should be directly integrated in to patient care when clinically necessary. I think when you look at the competing priorities that the clinicians have, they don't do the didactic stuff that we like. It's not only in a way that the patient will benefit, but it is also in a way of addressing the fact that we want to emphasize the education when it has been shown to be clinically useful. I think we can be easily criticized if we are not careful to sell genetics to medicine. And when you look at the comment on slide 11:00, one of the barriers is that the genetics is not clear to the providers and those under the sun. It's valid, right? We need to make sure we are advocating education when it is clinically useful and not just to promote our own kind of thing.
Can I ask as a follow-up question back to you. The first one is curriculum.
It is --
I.
-- it is, but I don't like the word "curriculum" that invokes sitting in a class, a course; I would like to see: How can we integrate the curriculum, if you will, in to the classroom where it is applicable.
That's what I meant when I said curriculum, but so this group and the secretary of Health and Human Services, what is her role? What are we asking her to do to take this to a different level? How do you respond to that?
Other than saying, we are asking her in that context as we would in the other context which they are more emphasizing, I'm not sure.
Okay.
Barbara, I think these are a terrific set of recommendations. And to your point of making these more actionable and more relevant, there is a whole process going forward in the professional organization of recertification. I know it is happening in medicine, nursing professionals and others. One of the ways is to focus on the innovative ways of reimbursement. If you successfully complete recertification with the genetics and the other training modules that you have in that composite you will be versatile in other areas. I think it is would be an incentive to offer that for recertification. It's one of the ways to facilitate that.
That's an interesting idea. Thanks.
I had a silly question, one of which I always ask. How do the insurance companies get their information? I mean, in the spirit of healthcare reform, that's what everybody is talking about, but is there a role for HHS to get -- to provide the insurance companies that will provide them better and more useful information.
That's for r the next -- we have to draw the line and say that's for the next task force to do. I don't think that is in the importance of looking at that here. We find it this way, but we recognize that there are other groups that have an impact on those topics.
The secretary advisory committee is also submitting the recommendation concerning the primary care specific based and they focus on primary care providers since they are pivotal on the newborn screening. Thank you for that.
I would followup on Sam's comment. We are going to suggest any funding. We are going to try to integrate the resource uses and I think that is a great idea rather than forming a funding committee. I think it's important to talk about the work that has been done at CDC, and then look at the direct ways that will be impacting the directives and the information. That's a good idea. I don't know how that will be done, but there is so much engaged in the healthcare reform and working that out, but there would be some incentives to working that out and making that active.
First, I would like to compliment you for all of the hard work that all three groups have done and your leadership in this. I know I have been in and out of the public health schools, and just to see and talk to you, it's sort of -- it's a lot of steps in here. I'm wondering, -- actually, there are two things that I have heard, but also from my own view, when I get this in the end, beings I am part of HHS: What will I do that I am not doing now? That's my thinking. For example, the development of core competencies for the public healthcare providers. We did that 7 years ago; are you directing me to do something that I didn't do? As you mentioned Barbara, the various healthcare and work force groups and their needs. The needs for training in genetics are very different from the educators and the administrators or the environmental health specialists, whatever, and we have tried to come up with that assessment over the years even though it has been incomplete because it's very hard. The work force is shifting. You know, maybe we should work on this -- between now and January so that when we come back, those recommendations will have to be a bit more crisp rather than, you know, broad by saying developing core competencies. That's good, but let's develop more. I would like to create the multi-disciplinary panels, I have no idea what that is, but I am sure it means it is cross-cutting between the healthcare professionals and the consumers. I would like to have that explained more to me. Genetic research, No. 10, I think we need more than public understanding. I think that implies that their are passive recipients and information. We need more public involvement and understanding in a way that they own this stuff, their Genomics. This is great stuff here, and I like the focus on family history.
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The other comment that I made in follow up to mark is I think it would be instructive to encourage the Secretary to the engage in defining areas of success and education of practitioners as malting for success. An example would be an out copulation [ Indiscernible ] and beta blockers after myocardial infarction and high levels after the specific recommendations. And to dig deeper is to provide the modeling specifically the points where it makes a difference.
Great suggestions.
I'd just have to comment what has been discussed here has been discussed before that some years back I did have an impeachment in L.A. with Mexican Americans and that it's a very hard to engage a community in an area that they know nothing about. So it's necessary to do education and training in parallel with the engagement. Because yes, you know, do they understand, what do they know. But if they do not have the background knowledge being treatment process is very difficult. So I think that there could be some effort to try these things -- tie these things together especially since we are discussing them both here. Establish some kind of connection between the two.
Thank you.
Just to follow up on Julio's question I think for a large segment of the population what they know about DNA is forensic DNA. I wonder if there's any way to build on the things that they do in the juvenile justice system to help bring more understanding of genetics to young people anyways.
I know there is a lot of talk about the CSI knowledge [ laughter ] Do you want to address this? Okay. Great.
You bring up a very important plead about genetics education in general. I think an analogy could be HIV/AIDS Education and the government did make a big effort and focusing on HIV/AIDS but the key here was that it had to be -- it was needed. That knowledge was needed and it was being incorporated into everyday practice. There was a need for the public to understand. Story will point on focusing on something that is tangible is very important. And I think with the recommendations and it goes back to what you were saying, what are you asking anyone to do right now? Is a genetics or genomics ready to be used by primary care providers? And is that perhaps the problem? When we with NIH and ARC began at the Genetics project in 1999 there was a great deal of enthusiasm about what was wrong with it was that there was nothing -- a very little primary-care providers could do with that knowledge and FET FET practice. That is still an issue. and every day process plan and that is still an issue. And we need to go out towards that area because its tangible and part of everyday practice.
I think you're seeing something that we found in the literature as well as our surveys. How much does the public need to know? And if you divide them into two groups, if you have a condition where you are interested in something there is access to peppy and people can get that on the Internet are glued to their proprietors. But what does the public know -- can get that on the internet or go to their providers. Is it important for the public to understand the structures and studies or the downstream on how that will affect them. That is why this is something people can do something with right away. Instead of falling on the idea that lots of us follow practices without understanding the science of its most people are not understanding exactly -- does that matter or is it more important for them to know their family history of cardiovascular disease and medication adherence. So we may want people to know what the genetic information, but competing for their attention about what is important for them in terms of public health people we have to be wise about that as. I was actually going to ask. I saw Vince here earlier if you want to review the notion of public literacy and that boundary of not being genocentric and the need for education as well as impeachment.
-- education as well as engagement.
As stated by Barbara, the technology and what to do with them when you are at a time where you need information and if they are seeking information is it a genetic condition in the family? And sort of the general public when they do need information, do they have the right knowledge to ask the right questions?
One more question.
Just sort of a comment. What I take my professional hat off and looking at all of the information's in the newspaper and popular press. Every day especially over the last three or four years there has been this new gene that has been discovered and it's like drinking from a fire hose all of disinformation coming out but yet it's so vague and the possible cure for this and that so I would support the role of the HHS providing the role as a clearing house for this information. Because it's very confusing for anyone I think to really understand the utility of this. Surly for families who have got genetic disorders or illness in their family, if the resources are available and they are critical. But what should anybody be paying attention it is the critical question?
I like to pick up on what we have been talking about and I have and HRI and have been personally involved over the past decade and lots of Education with equal opportunity centers or something but I must say over the years have gone more into the view that give me something that I can use tomorrow and I will learn to use it. Clearly I think it's an important effort that we don't waste this window of opportunity so that when they do right people are ready to use them but there is only so much can be done. I think those efforts are wonderful and we should do everything we can to encourage and support those, etc.. At the same time I do think it is the public education genetic literacy across the landscape and probably if I had to choose one which is the most significant it probably really is the surgeon general's family history initiative and that was based tool that lots of people can use and have been involved in the health records . In some ways I would say we are revising the wrong secretary. The agency that does not appear in this report is the Department of education. If we really want to educate the project, public brought the how do we do that? We do that to the public school system in the United States. I don't think -- I will make myself personally responsible here -- I don't think we have paid enough attention if we really want to educate the public broadly that is where we should go and something new that this committee could help focus on. And in terms of making some new added value that might be a direction that we might want to and encourage.
I have something to build on that comment and the fear on the privacy and not be able to find the privacy i.e. think one thing we need to educate the public is the public's fear of what Genetics will do and their association of DNA and all of this science with criminology through the media. I think that is something to be aware of when we frame all of this because people think that they're DNA -- the genetic information will be taken in used to do something that is detrimental to them. Whether it's from a criminal standpoint or from the discrimination standpoint.
Well taken.
[ inaudible ] public education committee said that that would be extremely important.
Great. I think some of the things that we will need to take home is to make sure everybody understands what the real needs and real opportunities are at this point in time and those competing needs. One thing I did not hear that builds on some of how to you get information out and get back to the electronic medical record and to get people the information when they need it and it's all part of the quality improvement process that we talked about here. So I think as we go through this report I would like to see as clear an assessment as a can of water the impact of these recommendations because they are very broad. And the priority so that we can begin to [ Indiscernible ] which of these are likely to be most impact full and free in the members from education would be really helpful in this process. Because I think we heard the would be an important player in all of this piece of thank you Barbara for all of your work and all of your committee's work. We look poleward going through these in detail at the next meeting -- look forward going through these in detail at the next meeting.
Let's go ahead and take a 15 minute break we will begin in 15 minutes with the public comments. Most of you know you can get some coffee upstairs or go to one of the local guys.
Secretary's Advisory Committee is taking a 15-minute break and will resume at approximately 10:08 a.m. Eastern.
As always we provide a forum for the public to provide input into our deliberations and on the issue so we should be discussing. Today we have four presenters. I would like to begin with Amy Miller from the personalized medicine coalition.
Amy, are you here?
Okay --
Amy, you are on. I will hold each of you to a five minute time limit it's always good to hear from you. Welcome.
Which ever signed pleases you.
[ Speaker unclear due to low audio ] I am here to speak on the educational operations and not [ inaudible ] and the reason we did it we noticed that [ inaudible ] was using more than any other personalize medicine company [ inaudible ] and some responsibility to consumers about helping that effort. So we brought together a group of academics and consumer genomics companies to come up with some sort of a consumer guide against or for [ inaudible ] [ Speaker unclear due to low audio ] you have in your hands this guide which is also available on our website. I wanted to make a few comments about it. Its not a perfect document. We recognize that. We struggled with some of the terminology in some of our members [ inaudible ] but the best work that we could come up with at that time. While we were developing this document which we did with the help of MedCo that is starting a genetics program and getting a lot of interest from their consumers on these products. So while I was walking down this road it became very apparent that the government needs to hear about [ Indiscernible ]. I have not read your draft recommendations but I think that [ Indiscernible ] that comes from the government with really good health information would reach farther than this document has. And people who are familiar with MedCo [ inaudible ] [ Speaker unclear due to low audio ] and those are my prepared statement.
One or two questions?
All right. Thanks for all of your work.
Our next speaker is [ inaudible ]. I hope that I pronounced that correctly from the National Human genome Center at Howard.
[ Speaker unclear due to low audio ] at the Howard University Research Center and I'd just want to comment on [ Speaker unclear due to low audio ] have undoubtedly transform the landscape and resulted in the increased availability [ Speaker unclear due to low audio ]. To provide information on [ Speaker unclear due to low audio ] these are the same diseases which in the U.S. have [ Indiscernible ] than other members of the population and these are a valid reason or speed these have the potential to eliminate the disparities [ inaudible ] however if these tests are not being equitably utilized then we become guilty [ Speaker unclear due to low audio ] perhaps one of the greatest indications of whether or not a new technology will be utilized is that [ Indiscernible ] are aware of its existence. Even less is known in minority populations and health surveys such as [ Indiscernible ] and the behavioral Risk factor surveillance systems have [ Indiscernible ] about general awareness and genetic tests and personal genomics and lifestyle [ Indiscernible ]. These surveys have ethnicity education and significantly predicted personal genomics test and use. Pacifically the is a service point out that African-Americans and Hispanic Pan-American are less -- Hispanic Americans are less aware of these [ Speaker unclear due to low audio ] households are less than 75% and not [ inaudible ] and find it difficult to [ Speaker unclear due to low audio ] making these tests available to only those who can afford them [ Speaker unclear due to low audio ] when and healthcare. This is summed up by William [ Indiscernible ], and he said, [ Speaker unclear due to low audio ] and not for all of society. I first heard the plan in their recommendations been read by the task forces. Most alarming was a report by the consumer and patient work group. Their charge to provide recommendations that address the genetic education needs of consumers and patients will be this advantageous to minorities without a formal awareness evaluation and assessment of who the informations seekers who the mentally are. Although data may have given us a clue of these informations seekers. This may reveal potential pitfalls which can result in an allocation -- unequal allocation of benefits and equities to enhance the genetic health literacy. Conversely, it provides the opportunity to improve public and health care provided education efforts, monitor potential benefits and harms the broker from genetic testing and develop strategies to minimize the risk and maximize the benefits from products as critical validity increases. So there's still remains of the definite need to in this about and the consumer scam awareness and use will contribute to the knowledge base that will go to the dissemination of a perfect health messages in public health materials as well as federal and state policy regarding these tests and scans. A validation of health awareness as it provides a reference of general knowledge. Ultimately the use of this product can dictate how the diseases can be prevented managed and treated and how of health care prevention such as eliminating health disparities. I am happy to hear that President of, has issued a directive to all agencies and a request for information on consumer how come it and behavior in using held in permission I believe that this is a step could identify where the information seekers' truly are and how we can make all Americans information's seekers. As we continue to apply these advances in genetics, we need to insure that these efforts have promised to reduce health the disparities is not guilty of widening the health disparities gap. It is Paramount. Not only that we educate consumers and stakeholders to ensure awareness but that it adopted to ensure a portability and Jean no applications among every one.
Thank you. Disparities is something that we do care passionately about. So thank you.
The next speaker is Ted, I understand this microphone doesn't do well for the Web cast. Ted is from AUTM. Welcome. We look for work to what you have to share with us.
Good morning to you all, my name is Ted and I'm the vice president at the University of Maryland biotechnology Institute. I am here today representing the Association of universities technology managers and as a personal note I would like to say it's good to see some familiar faces from my career in the U.S. Public Health Service and in my 11 years of the Office of [ Indiscernible ] NIH assisted technology. I appreciate the opportunity to review you today. Our comments are on licensing and patenting recommendations that you discussed yesterday and I understand will be continued to be discussed and worked on today AUTM is an organization of 3500 members that working universities, hospitals, and agencies, and companies around the world. There job is using innovation with the primary objective of making the innovations available to the public, commercial development and are strongly committed to the ID and of science and commercial development of important discoveries to improve the quality of life of people all around the world. As such we believe we are uniquely positioned to provide insight into the management of intellectual Property and licensing related to [ Indiscernible ]. While we appreciate the level of analyses cannot -- there is a conflict between commercial research and also the policy options outlined did in the report are not connected to the research findings. AUTM does not believe there is an inherent conflict between commercialization and innovation available to the public. The bases on the public benefit of licensing activity and design products that have come to the market and we do have some publications called better World Report and AUTM activity survey that we would be pleased to provide copies to all members of the committee so that you can see what those benefits have been. Regarding policy options, AUTM is deeply concerned that the policy options in the report have no connection to the research findings and conclusions of the report and rely on and hints that harm might come one day. We are concerned that despite a statement, the options will be perceived to be in correlation with the research findings. With the potential to mislead the audience to construe that the recommendations are based on the assault of the research. Regarding the [ Indiscernible ] Act, licensing Research outcomes is a complex process that requires flexibility. The elegance of this Act is that it has certain outcomes. That is the commercialization of research. The way in which that is done it is not descriptive of anyone approach. The individual technologies vary widley and managers must have the pathway to bring important technologies to commercialization. Note to transactions are the same. This has worked well for 30 years and has been copied around the world as a successful practice. We strongly believe that there is no need for an executive order or legislative review to prescribe a particular route for making those developments available to the public. With regard to [ Indiscernible ] and modification of the loose. If this process and the criteria are modified, we are most concerned that investors and industry would be investing hundreds of thousands or maybe even millions of dollars to develop and commercialize these important technologies. NIH and my colleagues there can provide you with data on the adverse effects from even a discussion of the possible changes that have occurred in interest in licensing federally funded research technology. With regard to regulation and oversight, requiring realizations for commercialization is not supported by the research in the report. Nor is it supported by additional studies conducted and recently presented at a workshop organized by Robert [ Indiscernible ], the author of the case studies. We believe there is no credible evidence that the regulation is needed to construct universities how to effectively manage under this act. Additional comment is that the case studies in the report are over a decade old. It seems there is no effort to assess how licensing is now conducted. There is no discussion of current practices. And [ Indiscernible ] mitigates many of the issues that are in the report. This is a very different process than it was ten years ago and is continuing to evolve. In summary before any substantial policy changes are considered, the secretary along with the U.S. public must have an opportunity to consider all sides of the issue, AUTM does not support additional regulations. The clarification of the USPTO role court any statutory changes to this act. The AUTM does recommend further testimony be collected with appropriate policy options can be based. We recognize the concern surrounding gene patents and support additional guidelines to augment those by NIH people we are collaborating with the American College of Medicine genetics and the Association of American Medical colleges to develop as practices that reflect our collective earnings from 20 years of the genetic revolution. AUTM also would be pleased to participate in efforts to for the participation in efforts on this issue. I thank you very much for your attention on our topic.
Thank you you have the benefit, of course, of many of our colleagues in the public comment and an extensive discussion yesterday. Unless there are some very specific questions today I suggest that we move toward and we will discuss that as a ticket back to the reports this afternoon -- as we get back to the reports this afternoon.
Our next speaker is Susan with the Institute of Ethics here in Bridgetown.
Welcome, Susan.
My name is Susan and I to work at Georgetown University at the Institute of Ethics which is currently called the [ Indiscernible ] which is funded by the Institute of Health to the National Library of medicine. We also have funding from the National Human genomics Institute and recently this fall we worked with the powder foundations over in the Middle east. For Georgetown what I do as a research associate is look for different things regarding bioethics and not because I am a lawyer, however, I to spend some time working at the State reference desk in the library every week. My comments have to do with family history and public education. I cannot agree with you more about public education regarding family history but what is a family history? Certain groups whether they are ethnic, political, or religious traces the history to [ Indiscernible ] and I cannot think of the other third one, I'm sorry. But that is a genealogy history. We are talking about family history and I am sure what you meant are the Journal's with who has what. A family history could mean anything to the public. I really do think it needs to be, what is the Family History? Medical family history? Biological family history? Let me give you some ideas of where the problems might be. When my daughter was in kindergarten, age five, they had to count of how many members were in their family. That is how it starts out on the individual level, locally. And the other thing has to do here with people who are at the other end of life such as my mother. And I have tons of things, but nothing on my father's side so there is a certain equity and balance. How far do you go back? What levels? To you want to know where people lived? Did they die of cancer? How much information do you want to know about people? And I am sure you will hear more information -- what more information, because I would plead, however it is an individual thing. You take the child and the parent, you go up from that person and then I assume you look at siblings. Offspring. I don't know what people think of as a family history and I can see the public wondering but there's a great opportunity as more people pass away and the population ages for people to pick up information as they are going through papers while they are lean out things. Plus there is also the children at the beginning of age. The problem is with the advent of the system technology, families that either have [ Indiscernible ] in the past with the adoption or artificial insemination people have not talked to them that yes, I am your biological mother but not your genetic mother. You'll have people who do not want to talk about who the father is because the mother knows it was another man. So there is a fine line of stepping on confidentiality and privacy. But I do think family history is important to know, not just genetics but there is Environmental component and how far and deep you go. Thank you.
Thank you, Susan.
Our final presenter is [ inaudible ]
Lisa, welcome. We look for it to what you have to say -- forward to what you have to say.
Good morning members of the committee. My name is Lisa and I am an individual who has benefited from genetic testing. The knowledge that I carry has been a life altering experience. And I feel that this important information has been a pity me in my family. And thus I am a strong -- has benefited me and my family. And thus I am a strong advocate. Genetic testing can help save lives, and to that end I represent, of course -- this is a national nonprofit organization whose mission is to improve the lives of individuals and families affected by hereditary of 18 cancer pick I'm here to follow up by a [ Indiscernible ] by Sue Friedman are executive director and the unrestricted marketing that has been used by genetic Laboratories specifically in the areas of genetics and how these actions are impacting the members of our committee. As soon freedman testified last year based on what we witnessed it is our belief that they discouraged [ Indiscernible ] and other health-care providers from referring patients to genetic testers. In the past, [ Indiscernible ] has denied use of this strategy and a when presented with our concerns the vice-president of marketing dismiss them as to work of a few rogue marketing statements however, the CEO was quoted as saying that it provides doctors with the tools to do counseling. And house -- excuse me, could do counseling in house. As a result positions could bill the insurers directly. The same report stated that helping doctors setting up services in their own [ Indiscernible ] is a priority which is currently 300 reps strong ahead of direct to consumers efforts in a particular geographic region. The company has carried DCC ads out in the Northeast and with Midwest. According to them, sales representatives educate doctors and nurses about who should be tested on the path analysis and how to handle the patients' questions about genetic risks. Also the sales reps attempts to reach doctors and show them the DCC ads ahead of its television area so that they can be more prepared when the patients come to their offices with questions. Having reviewed their educational materials we are very concerned that the only purpose on the hereditary syndrome. Unfortunately we believe these are misleading and in many cases they are the only information that the health care providers particular those targeted by the company received about cancer genetics. Patients might needs criteria for other hereditary syndromes for which Myriad does not test and are not receiving comprehensive or accurate information because they're not genetic experts and not aware of the other syndromes. By encouraging health care providers with limited genetic expertise to provide in-house counseling into water testing, it is our opinion that Myriad is establishing a minimum competency for providing genetic information to patients the lab is establishing a body of providers rather than providing [ Indiscernible ] and market testing for the company. They have also begun to treat a body of patients who have undergone genetic patience to act as patient advocates and speak out and be favor of patient testing on Myriad's be happy and they have unrestricted access with on balance, by this information about genetic testing for hereditary cancer. We have heard from providers who would make when they consult with Myriad staff when determining the puppet of genetic testing rather than with the genetic expert of the lab. We feel that this is a clear conflict of interest. Consulting with the employee is not the same as referring to the specialists. This is another way that this is being bypassed following up on last year's testimony we are continuing to hear some people who have been tested without the benefit of genetic counseling and received results from doctors and nurses who have no understanding of the significance of the test results. We are also learning of many incorrect or in a protest or they are at a significant expense to the consumer or their insurance company. In some cases, tests have been ordered without insurance company pre approval and they learn that they do not meet insurance criteria after they have already paid for the testing. Recently a patient who received incorrect information from a health-care provider posted her experience on the Web site. This woman into her city the Mexicans received genetic testing through a breast surgeon who was -- This woman and two of person, please recede genetic testing. They were not offered and did not receive prior genetic counseling and all three were told that their genetic test was positive this woman considering herself high a risk for breast and ovarian cancer at her healthy ovaries removed. However, a relative in another city and was referred to a genetic counselor which reviewed the original members test results and determined that, in fact, the results were not positive. In this case with this information it resulted in an unnecessary and irreversible surgery. Further between the woman and her siblings because the result was ovarian only one test was necessary. This created additional revenues for the labs and lead to unnecessary costs for the individual and her insurance company. Since no regulatory body monitress or regulate the marketing of these tests for the approved last lab and does not document reports of adverse events we really have no way of knowing just how many people are harmed every day by inappropriate genetic testing. Although the case is involving unnecessary surgery might be extreme, based on the accounts that we are receiving we believe individuals who are receiving genetic testing without consciously may experience some degree of emotional or physical harm. And well-meaning health care providers are being placed at risk for malpractice. Standard medical practice calls for referral to specialist with expertise is required.
Lisa, can we get you to conclude? Thank you.
Basically if you have a cardiac problem you see a cardiac this -- cardiologists and some who received genetic testing should we see genetic counseling. Basically we feel that Myriad has justified their marketing, claiming there is a shortage of genetics specialist which we disagree with. And we've seen a rise in inappropriate testing be we urge the Secretary committee to recommend federal action to monitor, release, and test at First -- adverse events. Thank you.
I just wanted to thank you and tell you that your experience is not an isolated one that we have seen.
Good to know.
Yes.
I also would like to say even though FDA clearly is not regulating Myriad at this moment any woman who received a adverse event may report it to the FDA and may complain that I am not picking on Myriad in particular but any other laboratories that are offering these tests and report that to FDA. You have the possibility of taking action.
And they should because that is the only way that you can become aware and take action.
Right.
Thank you very much.
I'm sorry, Paul?
This is a rather serious discussion so I think we are obligated to have or invite Myriad to respond to these kinds of allegations and representations are rather significant.
I am always happy to hear from them. Hopefully we are listening.
I think we should make them aware of it.
Very enough. We can do that.
So after that sobering tale, let's move on to the topic of consumer testing. As you know Sylvia Au and her committee has been working long and hard on a draft paper on testing and has made a number of recommendations. It has incorporated a standard amount of revisions and produced a paper which all of you have and we need to go over those recommendations and finalize the report. So with that, I will turn it over to Sylvia to lead the discussion.
The paper is under [ Indiscernible ] in case you have not read it. So here we are again. We are going to go over the direct to consumers genetic testing reports or paper. Hopefully finalize the recommendations that will go whiteboard to the Secretary because the recommendations are old recommendations that we have. First I would like to begin by thanking the task force. Oh -- thank you. So we have definitely broadbased representation and not think the new members who joined us in June. Today the goals are to come to a consensus on the key areas for the secretary's attention of course, and look again at the recommendations and actions that would be aimed at direct to consumer genetic testing and may require additional testing by committee and approved the paper for transmission to the Secretary of HHS. So as background if you have forgotten we started this in March and based on the analogy of life span and [ Indiscernible ] and I would say we're probably a senior citizen into retirement. But we had a fast growth spurt probably. We started in March of this year because Direct-to-Consumer Genetic Testing was becoming a big area with in the media. So we have been dealing with new information coming to was almost on a daily basis and I'm getting e-mails from Kathy scene, did you see this and there has been called for oversight in the article from two days ago. So this is to outline the benefits and concerns related to Direct-to-Consumer Genetic Testing and highlight our prior HHS recommendations to address these concerns and identify issues that are probably not adequately addressed by our prior recommendations. A cell in June we did have a draft paper in discussion and at that point the committee decided that we needed to go back and create an executive summary of our 29I believe page paper at that point which we thought was the size of the executive report. And make our specific actions from the prior information more relevant for Direct-to-Consumer Genetic Testing. I want to return to Sarah, who will talk to us about some recommendation that FCC [ Indiscernible ] that are offering Direct-to-Consumer Genetic Testing.
Thank you. I will provide a little bit of information and I think the letters have been made available and these are letters that FCC sent out on August 14, closing investigations of two major genetic companies. The first was the genetic, processor and marketer of genetic testing and consultation service called the "myself program" or self test. And then this was the distributor of that test and marketed and distributed the test and parted the samples onto them for processing. They also marketed their own test that included ancestry testing and community testing. So they were otherwise engaged in direct consumer testing. The myself program included a cheek swab and lifestyle questionnaire that consumers would submit and looked at five health carriers including heart, bone, and the consumers would receive a report back based on a combination of an examination of their DNA and lifestyle questionnaire that would provide them with recommendations for diet and lifestyle choices and there was no involvement of the physicians be the ones that we were concerned with its claims that the diet and lifestyle recommendations that were given as part of the program could significantly impact consumers' health outcomes including their risk of developing serious abuses. Those were both express and implied claims relating to that. There was also claims that have been a major genetic test could help you lose weight and keep off your wheat which is kind of aid site component -- keep off your weight which is kind of inside component. And we were concerned that it would not support the claim and evaluated a large amount of clinical studies related to the particular ones at issue. And the consensus of our experts in the studies at this point would not establish these [ Indiscernible ]. So we were talking to both companies about our concerns. The weight loss study by the way was actually studied by CMS and there were a number of flaws, including that it was not controlled or blind. The advice given by those companies was pretty standard to diet and lifestyle recommendations of the general population receives, quit smoking, exercise, diet. And we were concerned that there was a suggestion, a strong claim being made that for the people who have these particular genetic variations that these interventions been recommended could impact their health outcomes more than it would have an impact on and were near consumer, -- an ordinary consumer. So during the course of the investigation they agreed to stop marketing altogether. So they took down their advertising on there website for the myself program and also represented to us that they do not have any intention in the future and in teaching in genetic testing. Fiona has stopped operations and so they also agreed obviously not to market the product anymore. We also had concerns with them since they were the company that was passing the test kits about some of the consumer privacy issues. Fiona made a pretty strong confidentiality recommendations to the consumer through a consent form when they collected the DNA sample and the lifestyle questionnaire can we wanted to make sure that they were following through with the consumer. So we spoke with them about this quite a lot and they assured us that they have destroyed the consumers of DNA samples spread that was one of the thing that was promised to the consumers in the consent form that they would destroy the DNA sample after the testing was done they also have destroyed all of the lifestyle questionnaires and the reports that they provided to their consumers. They have also perched the databases of the consumer personal information, names, addresses, and contact information. So they will not be selling any consumer information. The only thing that Fiona retained were some individual data that they were using to demonstrate the Quality assurance of their implementation in the laboratory. They are selling some of them lacked equipment and they represented to us that order to maintain representation of the laboratories they needed some data and it would not be in any way traceable to individual consumers.
Do you have any sense of how many consumers were serviced?
I am not sure that I could disclose that information. These are public -- on why we close them that that will probably be proprietary information.
Is it because we have such strong confidentiality agreements with the consumers that you could take enforcement action on this if they weren't going to destroy the data and if the other company did not have a similar strong confidentiality agreement? That there would be no enforcement action by the federal agency?
I guess we are very concerned with consumer privacy generally. We have a division of privacy and identity protection. And generally the position that we take is that it's a deceptive or unfair practice if it makes representations on how they handle consumer information and it does not follow through with the representations that it makes. From our point of view, it certainly was easier to put pressure on the companies because they have made strong confidentiality cases.
So that kind of has some frightening implications on how to get around --
Well, obviously, I cannot speak hypothetically to a company that did not -- that would not have followed the same practices. But it could be a question that consumers, they go with the expectation when they're providing the medical data. I am not saying that we definitely could not have asked Fiona to take these steps.
It might have been in the little bit more typical.
Possibly. Although I don't think they wanted us to enforce action at that point.
You are also describing action against two companies. I imagine that there was further investigation in this area. Is that something that you can speak to.
I cannot disclose with or not we have other ongoing investigations. Certainly we're keeping aware of what is going on in the marketplace. Like I said we Court made with the FDA on this investigation -- coordinated with FDA on this investigation.
Thank you very much, Sarah.
So getting back to our paper. So again, the intent of this paper was to recognize that -- Well, okay, the intent of this paper. To recognize some concerns of the Direct-to-Consumer Genetic Testing are not unique to direct to consumers genetic testing but provide the base laboratory testing. We also do identify some issues that may be unique to Direct-to-Consumer Genetic Testing if the health provider is not involved in the health physicians or do not adequately protect people who are doing the consumer genetic services. We added an executive summary as suggested by the committee and I am sure all of you have read the executive summary, digested it, love it. It does highlight three key areas to the secretary's attention and five specific actions. The first key area for attention is that there may be gaps in the federal oversight of Direct-to-Consumer Genetic Testing particularly in the absence of a preview of Direct-to-Consumer Genetic Testing promotional materials and claims under current regulatory practices and lack of evidence for the direct to consumer tests. I know that if you read the paper, one of the things that we call them, that is our interpretation of them did a lot of the companies and the disclaimers in the results say that this is not health-related information. So there is a difference between what we call the test and what the company may call a test. The other area of attention is that there may be caps in privacy and research protection for consumers using this testing because most of these are private companies and to not take Federal money so they may not apply to companies often Direct-to-Consumer Genetic Testing and state level testing may be inadequate.
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We have about a half hour, and we want to bring this to some closure. The idea was to wrap it up at this time. We can do some formatting, if you wish. We have talked about some real vision. We have talked about a number of exercises, making sure they are all clear, but I think what we really need to do is go through and figure out: Are these the right things to say? And then, hopefully, we can send it forward to the Secretary. This is a moving target. There are some things as Silvia has indicated here that we need to monitor it on an ongoing basis and we need to crystalize the things we need to say to her between now and our next meeting.
The things we have here is the preambles through the joint and direct advisory, the things they are supposed to be doing and we need to make that clear, the reality versus the other claims and what Angie brought up with the enforcement. And expanding the scope to the services that only use the CLEA certified labs. They take the date, the interpretation, and they make a decision as to whether this will be clear with other companies.
Other than that -- yes, and putting appendix B, reformatting that and putting that in this report.
I don't see any specific recommendations on the continuation with the impacts of [ inaudible ], consumer awareness, the impacts and the kind of surveys that others are doing, we need to do more of these.
I think part of it is on those things that we haven't had prior recommendations on. Some of the things like the DTC testing on children, the social impact, those are some of the issues that the committee might want to take up to make new recommendations for the Secretary, and they may want to monitor and address those issues. Those are not made through the prior recommendations that we pulled out. The recommendations that we have, does the committee feel these are the adequate ones? We are going to include the CLEA one, but --
I'm not sure, what is the CLEA one?
Some of the companies contract with the CLEA certified lab, and they get the data. And the company that has the data has no enforcement. They do the interruption, some of those labs do the interruption and the testing, and everything there is clear under CLEA.
Are we trying to make the statutories clear, or --
[ Overlapping/Multiple Speakers ]
Yeah, other than the oversight report, there is a specific recommendation with CLEA, the gap, and the gap that CLEA does not regulate those services. We don't have those with us right now, but we know there is that -- [ Laughter ]
[ Overlapping/Multiple Speakers ]
Yeah, and how that differs from the, you know, the specific actions that you have.
Yeah, I think it is a more specific, explicit action.
It's not clear that we understand that part. When you talk about the laboratories, those are analytical, and we want to make sure they --
We want to be sure we are enforcing the oversight through CLEA on this part. It's not CLEA that is in accordance with the general counsel, right?
I think it is in there. Maybe not.
It's in the report, but not the recommendations.
I think the other thing we want to do is add to the prior list of recommendations, the oversight report, and it will call attention to the fact and the issue that Penny pointed out. If it is not certified or accredited, then it is not clear. You're hands are tied. We have a recommendation there that we want to include.
Do we need a specific recommendation that we need to clarity about what a health test is? I mean, shouldn't the -- I mean -- shouldn't the -- shouldn 't the Secretary finely define -- let's say that the genology is not a health test, but --
I think that is part of the recommendation that we have on the oversight report.
Yeah.
It was really to bring together FDA, CMS and other relevant agencies to look at what we mean by the health related tests and the scopes that are related to that.
I think it is accomplishing that.
So did we say -- so we are not --
So we are not as a committee, saying what we feel is helpful, right?
Reading from it: It says relevant federal agencies should elaborate to develop health related tests.
Okay.
Any other comments?
Maybe I will put in a proposal to discuss the other issues that were not reported on the reports, but we need a recommendation, something along the line to, you know, increase the priorities, the studies and to evaluate the outcome of these. The priorities of the social and behavioral research to evaluate consumer health outcomes. And we can include the certain populations, specific population, such as children and individuals like that.
That is a recommendation that we could take up.
But it's also in the oversight report under clinical utility, and that is where we discuss the issues about getting the information, about the values including the sub-population.
Okay.
That's appendix B.
I would just --
[ Laughter ]
Under Appendix B.
I just seen the one that is list d with the -- listed with the event and the approved event making.
Yeah.
Right here.
So what is the rules? Is that going to be the rules and the types of testing or --
Well, this is what happens when we had the committee make the decision of doing consumer genetic testing.
I think the idea was to make it look like a mechanism that would be possible with the authority within the agencies to address the gaps, like the ones that Angie raised. The concerns.
Otherwise, would these not require additional rule makings?
[ Overlapping/Multiple Speakers ]
What?
You want to require the additional rule makings?
That's my understanding of the current limitations of the statutories and laboratories.
Is this the consumer tests or --
Under this report, it would be only for the direct consumers related to testing.
I think we stated on the report, that it would be for all of those types of services.
Exactly.
[ Speaker/Audio Faint & Unclear ]
So I think for us in the preamble, we clearly identify that these are not specific, they are only to genetic testing; but in the action step, we are trying to focus on the direct consumer genetic testing, because this is the directives of the paper. We are hoping of the wisdom of the Secretary's office. And we are hoping they say, if you do this, we are going to look at a broader range of the direct consumer genetic testing. If they only look at the one testing, then that will be a start.
So seeing that everybody looks like they want to have lunch, this is perfect. I can hold them captive.
Does the committee -- do we take a vote on advancing this or do we just ...
Huh?
Steve?
Do we take a vote?
Yeah, I am not sure I am aware of all of the changes we went over, but I have noted the comments. We would like to have the approval of the committee to finalize the report, and I suggest that it goes out to you one more time so that you see it.
Uh-huh.
And then it can go forward to the Secretary.
And that would be going out to them by --
[ Overlapping/Multiple Speakers ]
We just want to --
Okay. So if you -- let me ask first, you are on the conversation -- beyond the conversation that we have had here, do you feel you need to put in specific edits? Will we get any if we do that?
[ Laughter ]
I can assume that most of the work is going to be done by staff. Why don't we aim to get that all incorporated and out by the fourth week of the month?
No.
When?
Before Thanksgiving with a due date of before Christmas.
[ Laughter ]
We will aim to get it back before Christmas, mid-December, with the final changes, and then the Secretary will have it for new Years.
All right.
All in favor?
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16.
Passed.
Thank you.
[ Speaker/Audio Faint & Unclear ]
So-noted. [ Laughter ]
Okay. I can tell you some stories about what happened with the turkeys in Los Angeles, and that is another story.
Why don't we go ahead and take a break. Plan to be back at 1:00. It will give you about 50 minutes. We will start promptly at 1:00, and we will go over the recommendations for the patents report.
Thanks-all.
Thanks, Silvia. Great job.
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All right. Folks, we finally have a quorum. We are going to begin. We are going to go through the Patents Support Recommendations, make sure we are okay with those. We are going through the last comments of the drafting of the final report, and then we have a few other miscellaneous items; largely, that pertains to the conversations I've had with Francis Collins. I am hoping to get us out of here at 2:30 or so. I know many of us have to leave, including me.
Make sure that the issues that are raised with those who have perspectives that differ from the -- differ from the final recommendations, we need to have those comments in here. We need comments from people in writing. We have tried to get them in the past and we have not received them. We need those in writing so they will be incorporated within our final draft. Because, clearly, our recommendations will not be universally welcomed, we need to make sure we are laying out the rational for these relations and why they were -- relations and why they were made rather than the other ones. We need to be respective of the others and why we have chosen the ones we did.
Jim? You are on.
I was pleased with the recommendations yesterday inspite of the controversy. We have made progress in the contents and the stylish features of the recommendations. The ones that are voted and approved we don't need to discuss anymore, but we have a few more missing things that need to be discussed what you are seeing now, those represent the changes, and they may have words missing since we did them on the fly, but they are are now incorporated -- are now incorporated in final form. There was no changes on recommendation No. 1. No need to discuss that.
Recommendation No. 2, do we need a last sentence? What we had yesterday was the related health care em pathys regarding the healthcare solutions. I don't think the last sentence needs to be added, but give me your reasons for agreeing or disagreeing.
The reason why is because there can be a lawsuit for aiding and abingment.
It's a little different because there it's an installation of the remedy rather than the exemption of the reliability. It's hard to make it an infringement case, so maybe we can take it out.
That's a great idea.
What I am going to do here -- going, going, gone. We will now fall back in to the rational. That's a great idea.
All right. We will include this statement -- oh, I'm sorry. This is the rational that we had taken out before. It's -- it deals with the association patents. So remember originally Recommendation No. 3 was this, and we decided that it didn't have a lot to do with it, but it did need to be on the record. We are going to pull this in to the discussion tasks. Are you okay with that? Okay. All right.
Now, between those and the remaining recommendations we feel there is an explanation required. Because the committee is offering the most effective means, and that is -- should be one and two, right?
Yeah.
Well, one --
Oh, gotcha. This is to identify the ongoing problems, the converges and the advancements, and the following recommendations should be entered to identify the problems. In other words, if they were enacted we need to mediate these. Is that Mara? [No Response]
Okay.
The next one?
[ Speaker/Audio Faint & Unclear ]
Yeah?
It looks nice to get this folded in to the access.
Wow, is there some kind of so calling in? This makes it much simpler.
Resources, using those as necessary. It will promote more than mere voluntary adherence, licensing, diagnostic genetics/technology.
The convening of the stakeholder, researchers, patients, for example, and provide a code of conduct to such technology. We have taken a variety of things and we will now fold that in to the rational. Okay. Let me blow this up. It encourages the broad licensings and accesses, the genetics tests -- and I think we should have genetics/Genomics. I don't want there to be confusion about what you said on genetics.
You are articulating in the reports that you are using the same definition. I say, pick something and use it.
Okay.
That sounds good.
We will make sure it is consistent.
I'm sorry?
[ Speaker/Audio Faint & Unclear ]
I would go -- are you still on the recommendations?
Yeah.
The industry and the academic institutions and researches, the problem with that is you have [ inaudible ] It's relative with the [ inaudible ] and the [ inaudible ] academic researchers, and if we have some CTOs, I would like to see the academic researchers. I don't know if you can explain that in the notes and make sure that the CTOs come in and make academic recommendations.
[ Speaker/Audio Faint & Unclear ]
I'm sorry? What? Okay. Perhaps the easiest way to do that is to make a note of that in the explanatory stuff. By the academic institutions, we need it in a broad sense as well as the technology transfer.
So the asterisks refers to the nine points, O CD's guidelines, exset rankings. We didn't think we should combine the whole thing. We are encouraging the licensing for genetic and Genomic. Part of the nine things to consider is relevant for the genetic tests.
Explanatory -- excuse me. Licenses should not -- [ Speaker/Audio Not Clear ] For the quality and verifications of results.
I really don't like the empowered limited use. It sounds like you are encouraging the [ inaudible ] licenses.
Oh, right there.
You should say, discouraged the [ inaudible ] use of licensing.
It's encouraging limited use.
I understand what it says, but --
Oh.
I think it is a hard thing to tear apart.
What if we say encouraged exclusive licenses.
Well, that is what we had originally, but then we have the rational in here.
Yeah and that is clear.
So we say, when warranted, exclusive licensing, okay.
All right. To be added to the rational and identifying the mechanisms, the department may need to determine the scope of its authority. For example, because it's unclear of the act of when they give the licenses for the department and the invention. If it is determined that the secretary has the authority, one of the way they can promote the adherence to the guideline is to direct those guidelines to the appropriate consortium. They can regulate the grantees to the licensing. Exceptions could be considered if a grantee can show that an exclusive license is more appropriate in a particular case, for example, because of the high costs and the development of the tests.
All right.
Transparencies.
Yeah?
So related to this and the comments this morning, I think there are some specific expressions that in fact, vital is being applied appropriately in theses areas -- these areas. I would ask that we specifically articulate that. It would then, obviously, be encumbent to --
[ Overlapping/Multiple Speakers ]
I disagree of what was said this morning.
It was said that the universities are doing what we would like. They didn't say it was by [ inaudible ] It said they are voluntarily doing this. This is not an interpretation of DOL, because NIH --
[ Overlapping/Multiple Speakers ]
[ Speaker/Audio Faint & Unclear ]
Well, what I heard clearly from the speaker this morning is that we should leave DOL E -- [Phonetic] -- out of this. I think we need clarification. We make a good case to it. But I am sensitive to the idea that this report is criticized because we did not adequately reflect the interpretations and the positions. And I don't see, since this is not a reflective interpretation or the rational and how it harms us with the comments we are receiving as part of this process.
The comment was that the universities were voluntarily doing that; I think we should reflect that. I think a lot of the universities are. I don't think this is an interpretation that anybody has made by DOLE -- [Phonetic] -- and I think we need to clarify that.
I think that is a good clarification. The universities that are doing this, it's demonstratively wrong.
Using the authorities and resources as necessary, they should explore and identify the mechanisms to make particular information about the patent licenses readily available to the public. Those are pertaining to the types of license, the field of use, and the scope of technology. And then as the rational, the means to enhance it, the licenses, the patents, by a diagnostic product, they can also use their best practices to encourage the licenses and the license es about -- licensees about continuing with their licenses. Do we want to say anything about the possibility that the Secretary can use more than mere encouragement, ala, discussion in the previous recommendations, authority, and grants; or do you want to leave it as it is?
I think the previous one --
[ Overlapping/Multiple Speakers ]
[ Speaker/Audio Faint & Unclear ] faint.
Because you have the authority of the best practices, this goes along with that.
Right.
I also believe you should disclose the non-financial information.
And that -- I think that will go a long way towards -- that can be a red flag that we don't need to bring up.
I think if you leave it as "encourage," it will be like the clinical trials that NCI has.
Right.
It's incomplete.
It's not enforceable.
I agree. Taking those in to account, and if we have disclosed the non-financial information, that will be helpful as opposed to the priority information, and then we will also use in the discussion of the previous recommendation; does that make sense?
Line 3?
Line 3 of which one?
Is it should or could?
I would say should encourage is more in the spirit of what we are doing.
I agree with that. Do the other people agree?
[ Speaker/Audio Faint & Unclear ]
Okay. All right.
And we will have the language in parallel. Okay. All right.
No. 4, advisory board of the Gene Patents and Licensing Practices, the advisory body will also provide the implementation of the future policy changes and which will include the recommendations and the support.
The only problem I have with this right now is: The public health has a narrower meaning than what we have listed. We are talking about the whole bit.
Heath -- health impact.
Right.
I'm not trying to dis public health.
This would be available to provide information about the medical data to the public. One of the advisory board's mission would be to collect information through the i-eddison so the grantees can use that through the recommendation in line 2. This is a presumption in accessing the problems. We could say: Accessing and assess whether the accessed problems are occurring to make it less majority. Monitor the access problems?
There you go.
That does assume, though, doesn't it? That kind of assumes it.
To monitor the access problems and ...
And --
To monitor access --
Oh, to monitor access -- yeah. This advisory body will be available to receive information and solve problems with the Gene Patents and Licensing Practices, to monitor the -- that seems awkward. And to identify whether the problems are occurring and to what extent?
[ Speaker/Audio Faint & Unclear ]
The first sentence, take out the word "problem."
About the patient access?
Yeah.
Okay.
Good.
So the diagnostic tests to the public and the community. And we can review the new data on the monitored access, and develop what is occurring -- maybe we can make that in to two sentences. Make that readily available to the community and to -- one of the advisory boards mentioned -- oh, we already went through that.
The advisors -- oh, we went through that.
No we didn't.
No, we didn't.
The advisory body should consist of employees and a wider array of areas, such as the federal employees, and that will include the patents across the licensing and agreements to create another committee to serve as this body. SACGHS has the expertise on the chartered focuses --
Can you add in consumer?
Oh, yeah.
Also researchers?
Yeah.
Okay. Let's put -- I think there is some concerns about expanding the mission of this committee?
We don't have a standing sub-committee.
Oh.
We could, but we don't at the moment, right?
Well, it's an option, but I don't know why we want to suggest that we want to expand our mission that way.
The reason it came out was not in a self-serving sense, right? It was more because we had the say to recommend this.
You can establish this in an existing committee.
Oh, we could.
Um ... Okay. Yeah, so you are saying, get rid of that, right? And instead say, Such an advisory body could be established within a relevant and existing committee. Great. Okay.
And then we need consumers up here, who should be fairly -- well, let's put researchers, consumers -- say what?
[ Speaker/Audio Faint & Unclear ]
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I would like to be a platoon and bias the PTO -- would like to advise the PTO off.
We have that.
Do advisory committees played this role in other aspects of the world of recommending experts, blah, blah, blah is that something that is novel?
I think it is a little bit. I was initially a little concerned about this and that having a member, a SGE in discussions with PTO, I think -- not in a public way. And I'd still think -- He was neutral on the matter on whether PTO would want to establish a committee. I don't think they are interested in such a formal body. But I think there would be some issues to work out with this.
That is my guess.
The question is because of the questions that arise about this, is it feasible, etc., are the modifications that might help it? If not it would be one that we would put out there and that could be worked out, fine, and if not. And then to add to the rationale the committee believes experts in the field could help USPTO on determinations of none of business and subject matter availability once pending court decisions such as Bilski. Do we want to say determinations on such matters as non of is this?
Also okay rid of when pending the decided -- because in six months this will be dated.
There we go, pending court decisions.
The patent matter and eligibility period will always be pending court decisions.
Period after field.
Okay. All right. Okay.
Can we go back, Jim? I still have some problems with this one. I think we want to -- This is about them getting technical expertise speed we don't have to deal with the mechanisms.
That is true.
I have not wordsmithed this but they should work with the secretaries to insure that PTO has the necessary scientific expertise available to blah, blah, blah. And they can figure out the mechanism.
So this would be something like -- here, we can erase what is above. We can say something like the Secretary should work with the Secretary of Commerce in order to insure that they USPTO has the necessary technical advice. Okay. To insure that the USPTO is kept apprised -- you were reading faster. It is kept apprised of technical and legal development. Okay. The technical and scientific development which have an impact on --
[ Overlapping/Multiple Speakers ]
-- related to genetic testing and technology. Okay. All right. And so that gets away from the whole Quesnay a liaison even work, etc. Do we want to say in the rationale that one such mechanism? Or just leave it rate like this?
Right.
[ laughter ]
The secrets of the true leader getting others to do their dirty work for them.
Such leadership.
When I shake my head, other people nod and visa versa.
Its the rattling that distracts them.
Insuring clinical access to genetic tests, the secretary should ensure that those tests shown to the clinical facility are covered by governmental and non-governmental peers. And then to get Paul's comments in the rationale such uniformity and coverage with an sure that all patients are advocacies for such equal access is nearly one component of longstanding concern of insuring equity in genetic related testing Services. Earlier reports have caused attention to the importance of adequate access to the importance of genetic testing.
It does, although, looking over the report we were really focusing on the recommendations yesterday. Whether that belongs in the beginning and some a little bit more substantial weight because the document does not say why you are compelled to spend five years of your life doing this study. In other words, it jumps into scope and definition but does not say at all why this came to our attention and why it's so important that this rose to the surface and demanded familiarization.
I want to completely support the sentiment by Paul. Not only because he is a great man but that is a great spot.
I will take great man.
This goes to what Steve said at the beginning of the discussion and that the document currently does not make the argument for this particular remedy, the primary remedy that we have proposed. And why it is so important at all. At least not adequately from my point of view. And what Paul is suggesting is part of the change in the document to do that.
Are you talking about this type of thing at the start of the report or are you talking about something quite different?
It's the same point I'm trying to make but it's a question of format. I think it's fine to keep this in as a reminder and Sam mentioned it as part of the recommendation.
Yeah. It could be smaller and you may not want to go into all of the prior things. But if you look at the introduction, it's very hard to see what the goal of this whole exercise was.
Right.
It also does not make any case -- it almost looks gratuitous and I think you are basically putting up your dukes a little bit because it's a huge burden on the specifics of a recommendation by not having the initial offering been, look, there's a potential problem here. This field is exploding.
There is controversy, right.
Right. As the committee we have long been concerned about the rapid evidence based implementation equitable provision of genetic and genomic capabilities. And then reference to prior reports and say, it's time that we look at this as a complicated issue. We know its controversial but we have been forced into doing our best to address this in a fair and open way.
No, that is good and we can couch it in terms, and I don't think we do it up front in obvious a way that you are advocating that other bodies are looking at this that have not focused on the patient access problem and trying to get that front and center.
The second paragraph page three in the middle varies.
Okay.
And the goal of this study or exercise was boom, boom, boom, and then the justification of why this came to this committee at this time and then reference the prior things. But it's a theory different premium than just saying, you know, we are going off to this issue regardless of whether anybody thought there was a real problem.
Right.
It puts the burden on the critics somewhat.
Right.
We will work on that.
I have always thought that, too, that the beginning does not say what this is about and we should add production to health care costs because it's not just about equal access. It's also about the problems --
This all in the end relates back to our basic charge.
-- So why do think that needs to be in there, too.
All right.
So I was just reflecting on this. It should not be in the recommendation because I don't think it's something that the secretary can specifically take ownership of. But as I re-read that first paragraph over and over again I don't think it reflects the idea of the disparity issues that one of our country today mentioned. That there are issues beyond insurance that impact access. So it's not to say that we should go overboard, but I would like to see something in the rationale that does reflect the fact that, you know, we are not trying to solve the health-care system.
I think that we can say in here that, you know, we recognize that problems in access have many drivers.
What we're missing here is what they said yesterday, that we need a process whereby those that do not have coverage are active. And the secretary did take the step to identify and remove obstacles. A simple process can be used between patients, providers, and the industry.
So that should be added to.
Right.
I had forgotten that.
That should be in the recommendation.
-- And that processes be explored which would facilitate these new barriers [ Speaker unclear due to low audio ] to enable those who cannot afford.
In a way, what we are really seeing here is that we need to reform the health-care system.
Isn't the point here, then, what we think we can infect and what we can not? And then shoot we also suggest that we have some way of measuring the impact of our remedy? Including potential adverse outcomes from our remedy?
Again, taking those one at a time I really worry about having something like this in there. It's like okay, thanks, we are supposed to reform the health-care system. Yeah, that is true but that is a little bit outside of the scope of patents.
He is talking about specific ways to access.
And what they talked about a lot are unable in the programs that the companies have come to the diagnostic therapeutics to comfort or provide free testing. We have had a lot of conversation about this, a viable way of having an impact. So I do not really want to in the last, you know, the 11th hour at a recommendation that the whole committee has thoroughly thought out and discussed.
I mean, that is what we are doing.
The point I would meet here is that I think the criticism in as much as we criticize the common to yesterday relating to the story about the fact that they were distributing form of genetic -- pharmacogenetic testing was that there may be solutions other than operations to patent law that may affect this. I think its a germane to put this in here at this point.
Here is my suggestion that we've framed this so that it's about getting access to tests, period. And then you can talk about insurance policy, removing barriers.
Isn't that what this says?
No.
Its about the insurer's.
Covered by government and non-governmental payers.
So I think what this is really saying is that remember the purpose of these recommendations are to affect changes that are with and the secretaries per view that could familiar rate some of the problems independent of the statutory changes that have been recommended. So this is germane.
Give me some wording so that its narrow enough so it's not the whole health care system. Because I am all for reforming the health-care system, believe me, but that would be jarringly inconsistent to prove that any recommendation. So give me some defined language.
I think we have at it.
Say that again.
they are available and accessible.
Fine.
And then in the rationale you can talk about the uniformity of coverage and that sort of thing. You can talk about how that can be done.
I would point equally accessible to patients.
Okay.
Are equally available and accessible -- equitably available? Then in the discussion we would talk about --
Uniformity and access with the insurers instead of uniformity in coverage.
Okay.
Right?
Right. Discuss uniformity of coverage, alternative mechanisms.
The specific point that she mentioned was the reduction of burden.
Alternative mechanisms, reduction and we can ask Mara for some wording to do. I don't want to put words in her mouth.
Burden when implementing plans. Okay. I don't want to say coverage plans, payment plans for those uncovered. Something like that. We can wordsmith this.
I don't know how you are going to end up wordsmith the its, I would say in the end it's really critical that -- wordsmithing it, I would say in the end it's really critical that they were talking about copayment coverage. And the test is $5,000. Somebody cannot afford -- if they pay 80% they cannot afford $1,000 or whatever it is. So that it does not end up being, it sent up not being that solution -- that solution is not put forth as the solution.
Right. Reduction and preventing on -- preventing undue burdens, financial burdens. So it sounds to me like we have worked our way through the recommendations. I think we are there. Before we vote on this, I want to reiterate, what I would like to see going full word. We know that this is going to be a report that gets a lot of attention and some of it is not going to be hard to be endorsing it. It's incumbent upon us to make it really clear why we think the solutions we are recommending are the best ones. So there will be some wordsmithing in here to make sure that they are as close as they can be and also we acknowledge all of the other perspectives that need to be in here and the positions that we heard about in the last day or so. What we absolutely have to have is that we need some words from you, paragraphs so that they can get incorporated into the next draft.
Where to go, and I know that Jim has been trying to get this to route the process but has not received them. We need to get those so that they can be incorporated and I would like to see them here by the end of next week so that we can complete the draft and get it out back to this committee for one more look-through.
Are you including the long response that you got yesterday from the exificio who wrote us the long response?
That was a response.
We will go back to that although it was not specific --
We are voting before we see all of these changes?
You have seen the recommendations, that is now we're seeing.
To the whole report? We will not have a look at it as all of these things have gone in? I hate to say that.
If we do not do that it means it would be delayed until February.
From my perspective I have been thinking about this. I have heard the comments, I have read the comments and I know where they go. I know what they are reflecting. It does not change the substantive recommendations that we will potentially be voting on and approving. I don't need to sign off on the full report and most of us agreed that it probably will not be read anyway. But if we set that snarky comment aside comment to me I am comfortable with the rationale -- to me I am comfortable with the rationale. The recommendations are the ones that I think we will vote on.
I would also see since I think it is -- you might get a more favorable vote. You know who will vote for because they have been voting for them all the way along. NDP of time to address some of the descent and it will become more of a full committee report.
I think it has been a good full committee report and the descent was three individuals.
I was one of those three.
I know.
What would you like to see in here.
I want to see how everything has been in because I think we have made some substantial changes to it. If we can hardly keep track of everything --
[ Overlapping/Multiple Speakers ]
There has not been substantial changes. These were the changes that we decided upon and voted upon. It's just that they have now been incorporated and formatted. The changes that we made today I would say are not substantial changes.
I think they do change the tone and I think that is something --
But if home were four months.
[ Overlapping/Multiple Speakers ]
Gwen and then Paul.
Can I just ask a process question? Since the vast majority has accepted the report, read the report, studied the report. The So you are asking -- So you're asking, the suggestion is that we accept the report as it is and if people give the sense look at the report carefully and give the words that describe their descent and indicate the place where that this and goes so that is reflected in the final report. Is that the process you are discussing?
Yes.
I think that is definitely there.
I would add that this goes on in almost every report that we do, on the last day there are only some changes that occur.
Is every report as contentious as this one, though?
Not every report. But to delay the --
[ Overlapping/Multiple Speakers ]
-- for being minor changes.
First of all, I will review Mike vote. I could very easily vote in favor of this option. Depending on how the argument is made in the particular remedy, the primary recommendation, we are recommending a change in patent enforcement around health-related in forcing. That is the primary recommendation that we have adopted how that argument is made, with the balance of risks and benefits of adopting that, how that is portrayed in the report. That is all essential in my view to making a good report. And frankly, I feel is sufficient currently. But --
As you expressed yesterday.
-- so the changes that Steve has suggested as the chairman of this committee might actually change my vote.
The question is -- let let me make this suggestion be one of the things we could do offline. We could go through the process to approve the recommendations and to the revisions that we were just talking about. Once the final draft is available to all of you we could have a teleconference and vote. It would have to be public but we could do some such thing for the purpose of just taking a final vote.
I think I agree. I think it will be kind of what happened with my report. Where we have a chance, you will get the comments from the people who do not think their voices were incorporated adequately in the report. Give people one more chance to look at it with a defined time line. I think we can go ahead and approve the recommendations because I don't think that will substantiate changes.
I think the vote is on the recommendations and now what we are talking about is the body of the report.
What we will do is basically --
[ Overlapping/Multiple Speakers ]
Even if we did that same process is delaying its I guess.
It will not delay it until the next meeting.
Twenty-eight in some kind of time reasonable way. I am -- do it in some kind of time reasonable way.
So we need comments on specific issues by the end of next week. They will be re-crafted as a complete report with recommendations. You will have a chance to see that. We will vote on that report at that time. Today we are basically going to say that we are generally correct, the recommendations are okay so that we have that buy-in.
[ Speaker unclear due to low audio ]
That is why you get to review it.
That is my point, if you agree with the report, you're absolutely fine and then it is changed, can you do a dissent from the [ Indiscernible ]?
I would advocate. I would just put in one more plug for this idea. We went over this for eight hours yesterday. We voted on every recommendation. We made a few changes. I would move that we approve or not approve this report. And as we have done with many of the reports there can be wodsmithing to try to change some of the text -- wordsmithing to try to change some of the text but it would not be insubstantial ways to change the recommendations.
Paul?
Is the descent going to be clearly marked as --
No.
That will be part of the considerations and part of the decision.
Are we going to say there was not agreement around this issue?
There is dissent, okay about some of these points. That I'm sorry is not going to change. We can change this report and the people from bio would absolutely love it and then there would be descend from other people. I am not sure what we will accomplish by dragging this out.
Somebody who was not identified as the dissenter, I am quite worried of pushing this through without adequate time. One is I am not sure what the rush is. Is there any particular reason after five years or so that a few weeks away money one way or another will make a difference?
Right people what I am talking about that is we could go for a meeting to meeting every four months and had this same discussion. If we had a mechanism where we could deal with some of this stuff, remote control, I am fine with that. I would ask both pursuant for example -- do we really have that mechanism to do that? Let me finish my point that this is not only controversial, we have dealt with other controversial issues -- But this is particularly lethal to the committee when things are unstable I would say in terms of how the committee its into pediatrics policy considerations and the new advisory role. So to get this done, get this done efficiently, it respect the hard work that has a ready been done to make this work. At the same time if there is not some reason to do it immediately like today, that we respect to these requests which I think are actually quite worthwhile and legitimate. We will do the best we can to integrate the wording that will come within the next week about this and put out the reports that we can all look at it again. And then get the true feeling of the committee give in that conversation that we have just had. Unless there is a really compelling time focused reason why we can get to that, my suggestion is that we do this right.
I am all for doing it right as long as we have a mechanism for which we can do it.
Mark and then David.
So what I would propose is that we obviously are a going to be getting comments into the revision of the report. That report can be sent out for review and then final comments. And then when we meet it is essentially it is a non discussion thumbs-up comes down.
I think that Steve is running this part of the meeting, if I am not mistaken. So I just wanted to be -- the problem that I see is again this could be a beach ball that is hit back-and-forth and we need to have some closure. We do have recommendations that the committee has agreed on. I am in favor if we could present this information, I advocated for that yesterday, we have to have a defined process with an end point.
I agree with what Paul is saying. The deadlines are ours and we need to bring it to closure. Having gone to these processes that we just described we will have a public teleconference to vote up or down on that final report. We owe it to ourselves and everyone else to make sure that this report reflects as broadly as we can and completely as he can our rationale and the different perspectives that we had in getting to that decision.
I'm sorry, David, I'm sorry.
We will do this before Christmas. And we will have a mechanism if anyone cannot participation that they could vote.
That is a challenge.
We need to look into that I don't know if you could give a proxy, I hope it's an up or down vote.
It is awfully hard to get everybody on a call on us to have multiple calls. But you don't want to have the option of eight votes.
If this is a technical issue, we have these two pieces on parallel sides.
[ Speaker unclear due to low audio ]
That is approved.
We are talking just about [ Indiscernible ]
I would advocate for a time to do it before Christmas.
I understand that people have other commitments. We will find out what mechanism you have to get your vote if you cannot be on the phone but hopefully we will be able to get that. What I need now is in agreement that the recommendations are agreed to, and that directionally we are on track so that we can proceed with them.
All in favor?
So this is -- just to be clear -- this is not a vote to approve. This is an endorsement of what we currently have and the procedure that has been outlined.
The recommendations in the process.
Yes.
So this is a vote on the recommendations.
Let's bridge to vote on the recommendations -- let's first vote of the recommendations.
We went through them all. We voted on every one of them.
The ones we just did this afternoon.
All in favor of approving the recommendations.
1, 2, 3, 4, 5, - 12.
Opposed?
One.
Abstention?
One.
And Mara are you on the phone?
I'm sorry.
And the process.
All in favor of a process that we outlined for by the revisions will occur and we will have a teleconference on the final report presumably in December sometime.
All in favor?
Fourteen.
All opposed?
Okay. Thank you all. And Jim, thank you.
What do we have to do?
[ Speaker unclear due to low audio ]
I am just delighted. Jim, a thank you for all of your leadership on this.
My pleasure.
Before we break up there are several issues and I would be interested in getting some of your suggestions. They were about -- three issues, one is incorporating devalue, economic value of technological innovations and the cost utility cost effectiveness task force activity. The second was about addressing the implications in the affordable genome and the third was publishing a paper with prior recommendations. I will take them in the opposite order. How do you feel about trying to get more visibility by our recommendations by writing a paper, highlighting the recommendation something like a commentary or something of that ilk.
I am seeing several nods here. To any people feel this is not a good idea? The people that will write it probably. So given that we want to move in that direction do I have volunteers that want to help write this paper?
Dr. Gayle, Dr. -- what is your name? Evans. Julio, and staff.
I am not volunteering but I would like to think carefully about who we aim it at and not necessarily a clinical medical journal because we can get to narrow with one discipline. I think what we were suggesting is that we need to get a. Broad audience, policy audience so it could be in Health Affairs but that type of a journal as opposed to a specialty journals.
Gwen?
So after finishing [ inaudible ] I will help.
That would be great. If this could be adapted for different audiences, that would be great.
All right. The second issue and this is sort of targeted towards Mark and he has not been forewarned about incorporating the economic value of technological innovations and the responsibilities taskforce. Or is it already there?
I think that we are already certainly -- we are not certainly ruling out the cost effective legislation at least for some of the money indicated that there are certain places where research would have to exclude consideration of cost from the effectiveness. But I think any rational view of comparative effectiveness has to include issues around cost including cost effectiveness in the traditional sense. Opportunity cost doing this.
Something else, comparative costs, etc., etc. So we have reviewed what currently has gone out from the different agencies and there are a number of other people who have written on this that I have not had a chance to review with including the new NIH studies. So we will definitely try to capture that as a piece of what it is we're doing.
And we will talk about this in February.
Correct.
The thing that we have been waiting on is the one thing the secretary has direct control over is the money that was designated to the office of the Secretary of pilot comparative effectiveness research. And that is still in the Office of Management and Budget and I don't know what else they're doing. That was a joke. I think that will give us a much better direction on how we want to target where we think we need to go since we are responsive to the Secretary as opposed to AHRQ and we want to be responsive to the secretary's role in the realm of compare to the effectiveness -- comparative effectiveness.
The last item is considering the implications of an affordable genome as the topic to take up. We need to be a forward looking. We're talking about an affordable genome in the foreseeable future. What are the implications for health and health care systems? It's not that we have not discussed it. It has come up in other reports as well as some of the ones that we are doing but its re-framing with a focus on that critical technology to change -- destructive technology that could really change the landscape. I don't want to get to a decision today but I would be interested in your thoughts on whether that is something we should be focused on.
I think, yeah, I think this is a very important topic as we see the technology exploding and starting to be developed. When you talk about the forseeable future I think in the very near future we will be able to have these tools. We just don't know what it means, but we have movement on that [ Indiscernible ]
I was just going to add that I do think it's an interesting topic in particular with the work that we had just done because there was a recent article this week about testing two of the most popular companies and how is that affected and is there still a discussion [ Indiscernible ] and does that relate to the new way we are conducting research in the traditional research so I would be interested in that.
Sylvia?
I think that this will throw our whole concept of genetic held here upside down because somebody will have genome and then you will have to take the family history to help you figure out some of the Syrians, what is going on in the family. So instead -- some of the family history, what is going on the family. So instead you might have to figure out how the sequence is interpreted and it will have massive impact in the public health arena if we're doing this with newborn screening, you know.
We're talking about the whole genome.
Oh, absolutely. You'll know about things that have been later in white and will it make -- in life and will it make health care disparity even ores because they will not have coverage for treatment.
Mark and then Barbara.
I would propose as I think about the work of the committee going board it seems to me that barring some recommendations or requests that we will probably have a fair amount of available time in our second meeting in 2010. I would suggest that we do in educational, probably a full day educational program about this particular issue. I think that would be highly useful.
Okay.
Barbara?
I was thinking of -- I like the idiom of an educational session and whole bodies scans come along and they may go nowhere and this is an important committee and we should think hard about where we put our priorities and how genetics can help society. I think the great step is to bring educational sessions and not go down that route and [ Indiscernible ] other issues.
I am hearing in the interest that we can put something together with its net educational session or whenever. We will have a little bit more discussion in February. Folks, we have done an enormous amount in the last two days. I don't know about you but I am pretty exhausted. Just to run through a few of the things that we did. I have to look at all of my notes. It basically we heard about this is being implemented from the various federal agencies and what is happening people we heard about some issues that will need to continue -- that we will need to continue to monitor going forward. Some of the unintended consequences of all of this. Then -- okay. Then, Of course, we reviewed the patent report. We made an enormous number of very thoughtful comments, a lively discussion. But as you know we have made a number of changes speed we basically approved the recommendations, we have a report that is going to go through some final revisions and then we will review it in December and looked bored to getting that out we had some reports this morning -- look forward to kick in that out and we had some reports this morning and will hear more about that and are meeting in February. We we viewed the education and training recommendations that Barbara put forward and we look for to getting those finalized and February as well. One thing that I want to [ Indiscernible ] and get back to me -- to Myriad to let them know of the concern's. We looked at the reports that Sylvia has been working on and we will emphasize some of the oversight and basically get that report completed and out and that will be great. I think that is a real accomplishment. Let's see. And then we're going to be preparing a paper highlighting our recommendations and then we will be moving on to discuss where we want to go with this affordable genome at one of our upcoming meetings.
[ Speaker unclear due to low audio ]
That is what Mark is incorporating into the utility report on economic evaluations, and we will hear about that in February as well. I think we have done an enormous demount. Congratulations to everybody and thanks particularly to Jim on the patents. We have come a huge way and they can for all of the work on getting the DCC completed and you all, thank you very much and have safe travels.
[ event concluded ]