Event ID: 1492521
Event Started: 2/5/2010 7:25:35 AM ET
Please stand by for real-time captioning.
Good morning, everyone employ thank you for your forbearance yesterday for a long day. And for starting again early this morning. We will spare all of you more time in Washington than you bar gained for and get everybody be out before too late today. Thanks, everyone, for that.
We have several agenda items we need to cover this morning. [Audio has lots of echo.] >
A fair bit to do. I am -- Rochelle, are you on the phone?
I am.
I think we have a good quorum and will get going.
So we will begin with a discussion of the gene patent licensing reports. This was sent out to committee on January so all of you good get a chance to review it. Before we get into that I wanted to well had the all of you know that we had a opportunity to brief the office of the secretary, the U.S. trademark office announced the [indiscernible] on the conclusions, recommendations on the revised report.
At our last meeting in October we voted -- one ab absent yon. We were advised to form a small subcommittee to work on the report to work on a number of important issues.
The subcommittee itself was myself, Jim Evans, Gwen dar yen, Rochelle, Sheila and Paul. I think I got even. That's the group. And this group did an incredible amount of work since the October meeting. You will see the report was substantially revised and a dissent was incorporate since we couldn't get to all the -- the rationale, conclusions, Paul advised us somehow we had a lot of material in there but had not pulled it altogether as strongly as we did, the conclusions and rages rationale has been added. Paul advised the [indiscernible] wasn't as tight and coherent, so thanks to Paul W who undertook the task of making sure we got that framed properly. That was then done.
The body of the report was changed substantially, too. At the October meeting and throughout the process we knew there were substantial differences of opinion and we needed to incorporate as many of those perspectives as possible in the report, and so this report was substantially revised to do that. I have to say that was a product of the subcommittee, but the subcommittee could not have done this without the unbelievable writing, re-writing and re-writing again of Darren, [indiscernible] and the staff. The report you have all had a chance to review is substantially changed, and I think personally, substantially better than the report you saw in October.
So that's where we are. I must say, although there's dissent here, people who worked on that [indiscernible] cent did us all a service. The points that remain, we could not bridge all the differences, dissent is there. We should recognize without that prompting and prodding and pushing, we would not have the report we have today. So I want to express thanks to the dissenters, particularly Sheila and Paul, but I also want to acknowledge the incredible work the other members of the subcommittee, particularly Gwen, Jim and Rochelle did. I cannot tell you the number of calls, e-mails, nightmares that we have had over the last, couple three months to get all this together. So, the report's complete, it's here, our task this morning is to move it forward to the Secretary. With that, I will open it up for comments, motions, on the draft report.
I wanted to point out that you are, the only one, as I can see, that has a chocolate heart in front of you. It certainly wasn't lost on me, the rest of the folks who worked on this years before I got here and certainly in the last few months and thank my colleagues on the committee for doing such a good job. It was an interesting process, but one that is at a better place now, and if I am the only commenter, you can eat your chocolate, I will move to close the report and move it forward.
This is Mara. I am going to [indiscernible] while I was involved in the second part of the report, the [indiscernible] more intensively, than the first part, the initial piece, I believe the process was one that we came to, was appropriate, effective, and we should move on to more important -- the additional new work from the committee that will be important in the future and look to have this as now a representative report of the majority of the committee and to have the dissenting opinions. I am very much -- appropriately, want to thank Steve and Jim and Sheila and Paul, everyone for the opportunity to have in there representation of the other perspective, but I think the process itself was one that was critical to acknowledge.
I want to second in this atmosphere, this love-fest. I upon want to second what everybody just said. I think while difficult at times, the dissent and the emergence of some degree of controversy really did sharpen all of our thinking about this. I think it shows how good the process can work, how well it can work, and I also do want to second what Sheila said, and really give an incredible thanks to Steve, who remained incredibly calm during all of this and was able to keep everybody's passions channeled. Thank you. And I want to thank Darren, who was unbelievable.
Dr. Teutsch: It was a group process, for sure. So we have a motion on the table, a motion to move the, basically to approve the report as it is so we can move forward to the Secretary. Is there any further discussion on that?
there will be more chock hat chocolate hearts at the end for everybody.
All those in favor of moving the report forward, please raise your hand.
hand aye.
That's Mara.
I think we have a unanimous votes of all those here. So we will -- we have approved the report to move forward. I want to grain again express my gratitude, it's been a long process, we learned an incredible amount about the patent and licensing process, more than I imagined I would ever learn, ormented to know really. And I thank the task force again, for all of you who spent an enormous amount of time and energy and really high-level thinking to bring this to completion. So thanks again to everyone.
Thank you.
All right; terrific. I am going to move to some public comments. Let me just say, the process from here on, the report. Staff will now do a copy edit. Because there's been a lot of interest, Sarah will post on the website. But if any of you have edits, not substantive -- get them to Sarah by February 10.
Let's move, then, to public comments, and we do this at each meeting. I am delighted we can do it this morning. We have one, possibly a second person who expressed interest in speaking to us. The first individual is Ashley Stevens with the Association of University Technology Managers. Dr. Stevens.
Thank you for this time of public comment. I am Ashley Stevens, represent the 500 members of ATM, I am executive director of the office of technology transfer at Boston university. Before entering the technology transfer -- I was a member of Gen map, the first -- Eli Lilly, funding the cloning of the brack a 1 gene and the genetics spun ought of my company to perform that work. While I was at the [indiscernible] cancer institute immediately afterwards I managed the HMPCC genes cloned by Dana fasher -- and the health and sciences university, the non-exclusive -- I have been on both sides of this issue. AUTM -- licenses from academic and nonprofit research, we are strongly committed to the advancement of science and to ensuring the public funded innovations benefit the public. I also remind the committee AUTM, some of the individual members submitted comments to the Secretary's Advisory Committee on Genetics, SACGHS report continue to stand by these comments. I would like to reit rite reit rate -- development, others sited in it. Having been so intimately involved in all aspects for -- breast and colon cancer, I can personally attest to its accuracy, however as scientists we find it alarming there is no connection between the [indiscernible] and the options offered in the report. The policy options address potential problems that -- show are no longer issues.
With regard to the recommendations made at this committee's 2009 meeting I will spend my remaining time on one issue in particular. Our primary concern lies with supporting the creation of exemptions from infringement liability. Intellectual property protection has been a crucial no vision of American -- since the drafting of the Constitution in which the rights of copyright and patents are enshrined. Novel technologies are protectedded. When corporations license technologies from universities, truly nascent, making significant investments in clinical trials, getting close to final production only to have the product fail. Time and again corporations suffer this risk. If we [indiscernible] weaken the potential for commercial development of those technologies. This results in significant delays, fewer -- in the companies providing these products employ the danger in the -- the success our universities have had partnering with corporations to get innovations to market. Remember, neither universities nor scientists commercialize work, companies do, whether through established or start-up companies, protection from infringement is vital to develop new technologies. Without this protection companies can't and won't take that risk. The United States cannot afford to take this either. Without strong patent protection jobs won't -- new start-up companies won't be formed to commercialize these technologies. This recommendation will decrease the amount of taxpayer support and science that reaches the public. Since the goal of this committee is to improve, not impede the delivery science to the public we ask you to consider the unintended qens cons fences, and [indiscernible] will sit on the shelf much as in the -- when academics were only licensed nonexclusively. [indiscernible] patent laws as they apply to human genes, the infamous 200-word statement issued by President Clinton and prime minister Blair, at the successful conclusion of the genome in sight, started a secular decline in the biotechnology's capital markets that has not been recovered today, despite their retraction of the statement -- the advisory board on health impact of gene patenting and license practices, AUTM remains committed to partnering with the American college of genetics and the colleges developing successful practices that reflect our collective learnings from the 20 years of the genetics revolution. AUTM would be pleased to participate in advisory committees or anything -- necessary by the Secretary. Thank you for your time.
We really appreciate AUTM's input and know this has been an area of controversy, but we very much appreciate the input of AUTM and various members of your organization. Thank you.
Dr. Albert Trampage, the other name I had, anyone who would like to make -- yes, ma'am?
Mime name is Christina -- Duke University, ethics, we worked on the case studies. I would like to say point two of the nine points -- all address diagnostic licensing, the nine points are most explicit and precise. [indiscernible] reserved for when they promote getting a test available. In our case studies there were seven clinical conditions in which exclusive or restrictive -- licensing came -- [indiscernible] and hearing loss. It was not reported as a problem for colon cancer, cystic fibrosis or Tay Sachs, all of which were -- but none exclusively license. Of those -- academic institutions, brack a, assignedded to university, NIH and Myriad. In HFE the patent to Merck [indiscernible] and -- of those academic institutions doing exclusive licensing, only one, Duke, for APE, has signed on to the nonslewsive license as to one month ago. Baylor, Hopkins and [indiscernible] have not signed on, excusive licensed sequence identified to shut down testing labs. In no case do the excusive licensee introduce a genetic test not already available, exclusive rights did not lead to new availability of testing for any condition we studied. For [indiscernible] and brack a it is quite clear others were already on the market when the exclusive license entered it.
In case of long QT there is a year and a half period where there was no test available for my CLIA certified lab because [indiscernible] sent cease and desist letters, led to market withdrawal, but never got the test on the market. In the overall study in genetics there were blocking patents in 15 of 22 clinical conditions. Two-thirds of the patents they studied were from academic institutions, the two largest being bay lor and Hopkins who have not signed on to nine points. Exclusive lrnsing has not stopped. Hopkins and Myriad announcedded -- for fame I familial pancreatic cancer, and after AUTM's public comment that -- based on practices no longer prevalent, moreover, [indiscernible] already offered full gene sequencing that would include the relevant mutations the day the deal was announced. So it simply cannot be the cases that scutes excusive rights were needed to get the -- on the market. The [indiscernible] deviation from the nine points. In sum, it appears most of the academic institutions that exclusive license for diagnostics have not endorsed nine points. Exclusive licensing is continuing and several papers have pointed out in the majority of clinical conditions studied these are problems with exclusive licensing that will only get worse with a multi-allele testing and full genome sequencing. Thank you for your time.
Thank you very much. Are there other public comments?
If not, I would like to move on to one of the sadder parts of this task, and that is the time we have to say good-bye to dear friends. So first, Sylvia -- who has been -- preceded me here on the panel. She has been a sunny part of this group all along. She has provided us wise counsel, involved in -- I can't imagine, virtually all of the panels along the way. She missed gene patents, I think. Oh, you were in that too. She chaired the task force on DTC, genetic testing,y patents, genetics education, clinical utility, and comparative effectiveness, and the policy issues surrounding the large population study -- of genes, environment and disease. So, you have been there. And you are not escaping now. As she knows, we will continue to call on her as we do call on former members. We also won't forget she initiated -- the well-appreciated practice of bringing macadamia nuts covered with chocolate to each of the meetings. I understand you have passed the baton and Adam is taking on that task, for which I want you to know we are also appreciative. Sylvia, we bid you adieu, and have a certificate for you, of appreciation. > [Applause ]
The other member of the committee who we'll be losing is not here today. I hope he's watching over the Webinar, because this meeting is actually occurring at a good time for him. He's in Melbourne, Australia, that's Julio Play sinio. Julio has moved to Australia, not here today, provided us wise gyreddance all the way along, a researcher, teacher, author and clinician extraordinary. Down to Earth, practical, always been a voice of reason in our discussions. He served on task forces on policy issues, large population study cohort, and pharmacogenomics, as well as DTC testing. If you are listening we wish you well, we will call on you as well, and thank you for all your service. We have a certificate for you, but that will be coming by mail. Unfortunately they did not allow me to deliver that in person. Thank you, Julio, all the best.
All right. We have a couple other reports.
Dr. Howell, we would like to proceed with that, Dr. Rodney Howell chairs -- had the pleasure be of has visit on prior O cationses. O occasions.
Rod, thank you very much.
Dr. Rodney Howell: Thank you very much. I have two areas cocomment about, but I will be mercifully brief and answer any questions you have. I think most of the people in the room are aware of the fact there's been considerable discussion in recent months, during the past year, about what happens to the drieded blood spots once newborn screen suggest completed. We won't go into the details, but suffice it to say most states retain these tried blood spots, some indefinitely, some states, such as California, literally millions of these on hand. They have historically been used for quality assurance programs and used when a new test is to be developed. A new enzyme developed, historically those spotses stored and on hand, anonymized, run through the lab so you can get the test work before you introduce it.
In view of the fact there has not been any national policy on the testing and storaging of blood spots our committee has been looking at this, drafted a document, still very much in preparation. I will comment to you about what our committee thought about it.
Our recommendations, feel all states should have -- appropriate legal authority addressing the disposition of these dried blood spots remaining after newborn screening. Some of these recommendations you will say, gosh, that seems like a very simple recommendation, but let me point out, very few states have these recommendations.
We also feel the state newborn screening program should have a policy in place reviewed by the state attorney general or other legal authority that specifies who may access these dried blood spot and once they arrive at the state newborn screening laboratory, and further access as the newborn ing is completed.
We feel the program should work to ensure families are educated about newborn screening. Although it's done on 4.3 million babies in this country, it is amazing how few parents understand about newborn screening and it's not uncommon to find families that do not know their baby has been screened. We think the program should maintain, distribute culturally appropriate information that contains basic information about the potential use of drieded blood spots.
One of the issues that has come up, the families learn after the fact that certain things have been done, such as QA things they didn't know were going on. Informing the families is important.
If the spots are to be used for any purpose other than the legally required purposes the parent's willingness should be in compliance with federal research. If for true original research, we feel that should not be done unless the person is A warp of that and have agreed.
We also feel the Secretary of HHS should provide administrative support for state funding to develop model consent procedures for the residual dried blood spots, national data on the utility of the consent or dissent process, education for the public and for the use of such program with facts about potential use of residual newborn screening for consumers and prenatal providers.
It is very important when one is doing newborn screening to have a process in place that will permit normal newborn screening to go forward and you don't have to be encumbered with an informed consent process that will impair the newborn screening.
This drafts report has been sent around fairly broadly, and the committee has gotten a variety of comments back, and we would anticipate your committee would want to comment about this formally in the future. The NIH group made a variety of comments that our group felt were very worthwhile. Urged the committee to become an advocate for research on these spots, setting forth recommendations for the states to consider, and the committee proposed voluntary national standards for broad research use that each state could consider. Again, recommend the Secretary provide resources to promote a national dialogue with stakeholders, and discuss education in the two audiences. Consider the potential benefit of suggesting the creation of a national repository for blood spots into which parents could voluntarily opt their children. Assume you live in a state that does not retain the spots at all. After the immediate newborn screening program is done the states will voluntarily discard all the samples. Some states do that simply because they don't want to deal with the legal aspects that have to do with retention. The NIH suggested, and I certainly personally agree, there ought to be a mechanism whereby you could say I would like my baby's spot to be retained. There are a variety of issues we won't go into today, but the spots have be extremely valuable in a variety of circumstances; sometimes many years later. Some families who are well-informed would want their baby's spot saved and we believe there's a place that can be done. There was a discussion that some of the recommendations that were actually incorporated into the document that was reviewed, and that added ethical, legal issues. The ownership of the these spots, who owns these spots, and simply case law was added, as far as privacy concerns, we accepted the formal comments from the office of civil rights that commented on the document.
We also added already awareness and education, the role of providing education to parents, and so forth in the prenatal setting was added.
We are working with the office of research policy to put comments into the paper and add text boxes explaining what anonymizedded and [indiscernible] but fundamentally I simply wanted to appraise you of the fact the draft paper is coming along. We have gotten a variety of comments back on the paper and look forward to hearing from this group.
The public controversy over the retention of these spots we think is a very critical area, because if parents and so forth become extremely concerned about how the spots are handles, the newborn screening program could be jeopardized. Folks could be concerned about how the spots are retained and opt-out procedures could be a major problem in that area. I am glad to answer questions, or comments, I have gone over this hastily, you may have more questions than I have --
Yes?
Rodney, is the committee going to take a position on, given the fact some of the collected samples that have been retained were not consented in a traditional sense, whether the currently savedded samples should be retained under some exemption from go-forward rules, about how you will consent going forward?
Dr. Howell: Let me say at the current time there are very few samples that have been stored that have been stored with consent. Very, very few state vs a consent process. Virtually all states have an opt-out, but not all, so the samples on hand have not been consented and so forth. I think the committee will make a recommendation about what might happen, what would be appropriate for those spots to be used for; will basically point out they have a variety of uses, so forth, but if you use them for research, the committee will make a recommendation that would not an appropriate use for non-consent sample. I won't go into great details, but for those not in this business, what are some of the things that have been done with these tried blood spots. One of the more common uses that provide a great deal of value is with children who die suddenly, without a known cause, the so-called metabolic autopsy has been done with some frequency. In other words, the dried blood spot would be sent to a laboratory after the child dies at age 3 or 4, and find that the child had medium stage -- a metabolic autopsy. Also for identification of children who have been lost in fires, things of that nature, so forth. They have routinely not been used in any legal thing. I would assume you understand that lots of people are interested in these spots. For example, the police would like to get them, things of that nature. They historically have not been available at all. However, a court can order a spot to be released, but that's a legal issue, et cetera.
Question: This is Mara. I have a quick question about that. Does that mean despite the fact in this repository they will be deidentified, an individual family has a need to retrieve the information from their spot in the future to make a health-related decision for the child, they will indeed be able to do that more effectively? I know there have been many discussions in several states today, while that, in theory exists, has not been practical in reality.
The spots, by and large are identified when stored in the state. The identification is only known to the state laboratory, et cetera, but they are identified at the state level. However, they are not released to anybody in an identified fashion. Let me point out, the public, interestingly enough, the public is very concerned about these spots for reason that's come down to lack of information about genetics. There's one advocate for destroying these spots who is convinced that you can do something quite remarkable with it, that you could take a dried blood spot and out of the blue identify someone, and of course you can't do that. The second thing they are concerned about, if you have my DNA you can do evil things, ranging from cloning on down. The perception of what you can do with these is really a very interesting problem.
Question: We sent the draft report to all members of the committee, would obviously be interested in -- you are sending out for public comment, revision.
Yes, we would greatly appreciate people's commentses, this is an extremely important document about recommendations to the states, the states do have some organized method of handling.
Dr. Teutsch: Do you know the time frame when that will be out? We didn't convene -- hard to get a group --
Dr. Howell: We will probably have modifications from the previous meeting, taking into account the comments, and should be out certainly within the month.
Dr. Teutsch: You are talking about between March and April?
Should be, and we will provide that to Sarah to distribute, if you would like.
Dr. Teutsch: I am thinking more about the process we have because we will not be convening over that time frame, but we will get it out to individuals.
Dr. Howell: This is process is not going to be an immediate one, you probably will have time to be very thoughtful in your comments.
Dr. Toimp: Dr. Teutsch. If we discuss in June that will be timely?
Yes. These non-consented spots have in virtually no circumstances I am aware of and I am aware of most venues for research; has to do with what people consider research. For example, if I run a laboratory, set up a new test and use the anonymized blood spots we consider that laboratory quality quality assurance, not research, you are simply establishing a technology to use the spots. That's the overwhelming use of these spots are made much.
Dr. Teutsch: much. Will the [indiscernible] the use of the -- for the screening program you commented on?
I think we will certainly try to incorporate that. The reason newborn screening is mandated, and does not require consent, that's the history we come against. Increasingly states are asking people if they would be interested in having their sample be used for certain kinds of research. I think we will have model documents of that, so they can be available for things that come to the table.
What I am hearing from rod, we will have a chance to comment. I would like to form a little group that can take the report that should be out here in the next month or so, comment on it so that we can then discuss it in June and decide collectively how to respond. Obviously people can do that individually as well. Who would be interested in doing that? Everybody!
Mara: I will
Mara, Paul, Janice, Alberto, Paul, Andrea, David -- wow. I tell you, folks.
Rod, do you want to take over this committee?
Wait until we get to the next --
We have Charmaine, Paul, David, Andrea, Alberto, Janice, Paul, Mara.
That your definition, Steve? Of small?
Dr. Teutsch: I was going to say -- Rod, why don't you tell us about the carrier screen --
Dr. Howell: One final comment, there have been a variety of studies about parent's perception of these studies, when folks are concerned, they are concerned because of what they didn't understand what might be done. If you explain the spots are saved, retapedded for quality assurance the vast majority are perfectly comfortable. If you are doing straight out research on the spots people are going to be asked, that's appropriate, and the situation that's really a problem is one of information.
I will talk just briefly about carrier screening with you. Our committee has focused very heavily on newborn screening, but the charge to our committee is broader than that, includes genetic testing in children for other purposes. There's been a considerable discussion among members of our group at the NIH and otherwise about carrier screening in recent times. I think that many of you are aware of the fact that carrier screening has been going on a very long time with certain genetic conditions among Ashkenazi Jewish community, cystic fibrosis as a recommendation, be made available as NIH -- about a decade ago, and considerable interest among certain people that carrier screening be adopted for spinal muscular atrophy, sponsored by several institutes in the past year, looking at carrier screening broadly, but more specifically a spinal muscular atrophy.
Our committee has been interested in looking at some of the issues and there's been a very specific issue brought to our committee that I would like to tell you about very briefly that has to do with carrier screening for Sickle Cell disease. In newborn screening all states for many years screened for the hemoglobin Op thees, one identifies carriers for Sickle Cell disease. Routinely identified. States handle this in a very different way. Some states do nothing with it. Some states have a rather formal mex mechanism of informing that an infant is a carrier. I don't know if it's changed, but one of the more interesting systems, that which used to exist in Georgia. They send a letter out saying we have information that might interest you, and if you are interested, call us. About half the people do call and say what do you know that I would like to know, has to do with carrier.
In our recent meeting we had a very nice presentation by Lynette a Jordan, I am using her slide this is morning, she's the chief medical officer of the Sickle Cell disease association of America. The question she addressed brought to our committee had to do with carrier screening for Sickle Cell. One might say my goodness you already screen all people for Sickle Cell. Number one, most people don't know about it and if they know they forget. By the time you get to the the young adult we will talk about this morning, you don't know.
I might point out virtually all babies have been screened for hemoglobin Op thees, and this is a very effective program. You identify a baby with Sickle Cell disease you can be very effective with life-saving vaccinations against bacterial meningitis, so forth. States have been very variable in how they report carrier status. There's been lack of agreement about clinical evidence of health risk of being a carrier for Sickle Cell. This is a timeline, in 2007 there was discussion among athletic groups about the fact that carriers for Sickle Cell disease might be at increased risk for certain sudden death in extreme exercise. The Sickle Cell disease of America group met in June of 2008 and did not support the recommendation that athletes screened. In 2009, the NCAA, a very important athletic organization, made a specific recommendation that institutions test student athletes for carrier state for Sickle Cell disease. That particular problem came to our committee. In a variety of people have been asked to comment about that. There was a commentary in AAP news and in December of 2009 the Sickle Cell disease association and HERSA had a meeting on the public health implications of Sickle Cell --
Let me tell you, there fortunately is a considerable amount of data about relative risk of having carrier state of Sickle Cell disease and the big data come from the military. They did a retrospective analysis of 2 million military recruits, a big number, needless to say, and they discovered African-American recruits with hemoglobin in S trait, there were 13 deaths during that period of time, African-Americans and others with no state had five deaths, indicating a considerable risk in the differences in the group. However, there was an intervention period brought to bear, again with 1.8 million troops going forth. What was done, they developed a strict protocol to prevent exercise health injury and illness, and so forth, and interesting, discouring that period of time simply by having -- again, I don't remember the details of this, but basically a specific requirement about fluids and exercise, so forth. During that period of time not one of the 13 predicted deaths occurred. Basically, the prevention of exercise related death did not require identification of circle cell trait, such as prevention, et cetera. They concludedded quite properly, heat illness is a preventible, related to sudden death in persons with Sickle Cell.
So fundamentally, the evidence does support the Sickle Cell trait is increased trait for exertional health risk, but does not exclude military personnel in any of the branches listed, very simple preventive methods can be used to prevent this illness. What would be the implications of the NCAA -- there are 400,000 college athletes, 8 million high school athletes, sickle DACS is not reliable, you would need to do hemoglobin -- and it would cost -- a recommendation of this nature if carried out is a big and expensive procedure.
That was a presentation we had from Dr. Jordan. It would appear, obviously, there's tremendous concern about screening listing screening high school athletes, old identify persons with the condition and single out carriers. I might point out, as this group knows, you are looking at a very significant portion of African-American athletes who would be ear-marked as having a special problem and being in a special program. In our group, just in the early parts of discussing this, it would seem prudent to say this is probably not a very good recommendation and what you should do is come up with a very sensible program as far as high school athletes.
I had two reasons for wanting to present that. As we think about carrier screening, so forth, and we are in the very early phases, I talked with Steve and Sarah briefly, we think it would be profitable for members, a group from our committee to work with a group from your committee because there are very broad implications as far as legal, ethical issues when you look at carrier screerning of a population of this nature. So I would really invite your interest in considering some of the issues as we go forth, and we are really, literally just starting. In order to get you out of the snow this morning, I had other slides you will be glad I deleted, but one thing I assume many of you have known, while we were starting to consider this issue the announcement by counsel, a group in redwood city, California, offering direct to consumer a test with 100 conditions, carrier screening is emerging as a very big deal. If you look at the diseases on the counsel carrier screening list it will give you hives. I don't know, some of the conditions are breathtakingly rare, but if you have not seen the website I urnal you to look at it, it's CONSYL. I urnal you to look at the conditions on the screening panel. Offering it direct to public, you get the information yourself. We think the carrier screerning issue is becoming a big issue and we would invite you to -- I hope you would have interest in having a group work with, some group from our committee to think about these issues. Thank you.
Question: Those are fascinating data about Sickle Cell. I want to be clear. In the venges, applied across the board?
Yes.
You said the 13 expected deaths were prevented. Were the five expected deaths prevented in the nonSickle Cell --
I don't know. But the -- I think one of the problems in the data that's been presented is that high school athletes -- and you read in the paper all the time a very attractive high school athlete dieded suddenly, you see this all the time. One of the things we don't know, and they tend to identify an African-American who is a carrier or something, but we don't know about someone else who died who did not carry the traits.
Like you say, across the board, sensible enter interventions could benefit everyone.
These are not remarkable interventions, simply simplicitying exercise when the temperature is above 120 and providing adequate water.
Only in thank Tucson --
I wanted to support the importance, at Duke I work with the Sickle Cell center there, they have been approached by the athletic department about this recommendation by the NCAA and the issues that it raises, so it's something they are talking about as well.
Dr. Howell: So many people, the Sickle Cell disease, other people are being contacted around the country, and we think such a policy has enormous implications and we think we should move fairly bris kly to comment about that.
I might point out this is a matter of public record, but one of our distinguished members of our committee happens to be a distinguished pediatric hematologist, and he was to be on the olympic team for Ghana when a student at Yale university, since the olympic games were in Mexico city at the time they screened him because of altitude issues for the presence of carrier state of Sickle Cell and he learned at that time he is a carrier of Sickle Cell disease. Turned out he was not barredded from the games because he carried Sickle Cell because Ghana dropped games because of the participation of the apartheid state of South Africa. Our committee benefits from somebody who not only is an expert hematologist, but has a very personal stake in this game.
What I would like to do, get a sense of this group. Rod and his colleagues are going to try to move the agenda forward, come up with a pr posal. I would like to get a sense as to whether folks here would like to be part of that process so that we can take this out in some joint way, yet to be determined, along withEd rod's committee. I say that because I can never remember all the initials.
I see -- so Rod, my sense is you and your colleagues will look at how that might proceed and in June we will have a chance to -- we won't form a group now. We will wait. Rod will come up with a proposal, we will hear about it in June, and then proceed, discuss that, proceed, form form iewment a group.
Dr. Howell: I think it's a very practical discussion.
Practical and -- overlaps clearly with both groups. Thank you so much.
We appreciate your interest.
Terrific. I believe Dr. Hunt is here now?
Dr. Hunt is here from the office of the National Coordinator for health information technology. He's in the office of the health information technology adoption. As you know, we heard from Dr. Blumenthal last June and we provided comments at that time. Since then, the proposed regulations on the meaningful use of electronic health records have been disseminated and we are going to hear an update about the process from Dr. Hunt and then what we will need from this group is to see how we might respond, so Dr. Hunt, thank you very much for joining us. If you had been here yesterday you would have heard keen interest in this topic. It has continued to be -- has been a topic of high interest for many years. So thank you for joining us.
Dr. Hunt: Oh, thank you. I have to give my sincere apologies for running late. As most of you in the area, and some not from the area know, the mid Atlantic region, we are the official weather weenies of the entire country, the red line of the metro was having their pre-apocalyptic A pop Lexy this morning, later than I expected.
Dr. Howell has been extraordinary to adapt to our weather and other challenges.
Dr. Hunt: I bring you greetings, Dr. Blum that will spoker earlier, sends his greetings. I am thrilled to be here, the exciting issues you are discussing are coincident with one of the most transformative moments in American medicine. 2010 will be among the most interesting years we have seen, we hope. Our office, office of national cooer Nateor is charged to describe what can make this year and the next five or six here after more meaningful with regards to health IT. Dr. Blumenthal referenced this, a reasonable assumption is that I am here to talk about health IT, but you are wrong. That's not the primary focus of our office at all. Sounds like I con tray directed tray directed myself, but associated with information technology, more prompt way to describe our mandate from the president and Congress is to say the office of the national coordinator has been be given unpress dented resource and authority to effect an improvement in the value and the efficiency of healthcare services through the meaningful use of information technology.
The need for that improvement is pretty clear. In 1998 Sigh riel Chant ler pointed it out, medicine used to be safe -- now it can be very effective but almost everything about the practice is more complex, and potentially dangerous. Understanding that ONC, we have a firm conviction that properly applied information technology, properly applied tools can help me as a sur Jon be more mindful of my patients and the quality of care I provide. I spend a lot of time managing expectations to make sure we are careful not to fall into the trap of thinking everything will be just fine when we get the guys at Google and eBay to apply their skills to our domain.
I think you all better than most perhaps appreciate the fact that health IT or technology is really just one piece of a much much larger solution. The compelling solution for 2010 and beyond pivots around the simple question: Can we use information technology as a vehicle to change our culture and in turn our methods in 21st strch American healthcare. I mentioned earlier our Congress gave Dr. Blumenthal and the Secretary the mandate. To look at the text of the mandate, I have highlighted key words and phrases. It starts with security. Goes on, quality and cost. Further along you see we have a clear direction to facilitate the meaningful use of electronic records nationwide.
We also see throughout that the overarching subtext is to improve the quality of care while making sure the information remains secure and supports our institutions of public health.
So, we are talking about improve, ensure, reduce, protect, facilitate, promote. It's a pretty formidable list of challenges, but I ask you to take note the trance centent goal is not to acquire cool hardware, have the latest software. The infrastructure is a means to an end or it is nothing at all. Don't let me get too far ahead of myself. I have it on very good authority that I have to bottom line you. I always recount the public speaking advice my daughter once gave me, she z dad, don't take this the wrong way, but you have to tell your audience very early on, within five or ten minutes, what you are going to talk about, because after that time you have become very boring and tedious.
Who could take that wrong at all? I don't know.
The first thing I want to tell you to take home is that this moment is time, possibly more than any other is the time for clinical leadership. Next, while we lead, I think the essence of this conference and this group actually points to the fact that we must be the very first to acknowledge this work is a team sport and any success we have is wholly dependent on the strength of our partnerships. You see, our current circumstance is not due to a lack of technology, and therefore technology alone cannot be the entire solution. Above and beyond all else, we must form strong partnerships in that regard.
That brings me to my final point, and I always tell my audiences to rest assured that no direction beyond this point will be easy. While I can't stand up here and promise only blood, sweat, toil and tears, you have to understand the path forward requires a system, tremendous resources and no small amounts of courage. With those acknowledgments and looking at all the promise health IT holds, I will say that at ONC our first and steepest challenge is spurring the adoption of electronic health record and clinical practice. Here you will see pretty newly published and preliminary numbers on the state of adoption. This came out a little less than a month ago from the CDC, looking at practicing physicians we see in 2008 only 4% were using an electronic health record that can do the work we need. Handle progress notes, labs and -- we may have increased today by 2 points, still leaves us a long way to go. Why is that? Why are we still in single digits for adoption? The answer is pretty clear.
Here we see the top six barriers to adopting electronic health record. In short, for many it has not been worth it. Collectively, we in the clinical community have been very clearly saying that to embrace electronic health records our needs have to be met. I use this slide everywhere I go because I find it such a wonderful construct to frame our challenge as well as our solutions. This is a diagram from the work of Abraham Maslow, who described the theory of human motivation, dividing need into's growth needs and deficiency needs. Deficiency needs are physiologic, have to be met first. Once met the individual seeks to satisfy the needs of growth.
We can apply Maslow's hierarchy to our current circumstance and the foundational need is privacy and security. Beyond that, moving up the needs of growth the components of usability, basic functions, a strong business case, and finally, at the top, a most fulfilling achievement. One that many of us often gather to discuss, information exchange. Now, let's look at how the requirements will translate into action from our office. I mentioned earlier that privacy in the foundation for moving forward. The reason is obvious and you probably better than virtually any group understand this. The tenets of privacy are old in my profession, the Recovery Act clearly speaks to this point. To help us build the infrastructure the that would support that fabric of trust and all our other programs, Congress provided we have more than a policy of good intentions.
I point this you out to say this is a serious endeavor and our intent at HHS is to durable, measurable, reliable improvement in healthcare. One of the first issues is how to help providers choose and effectively implement this technology. Our department releasedded a framework regarding how to give technical assistance to health IT regional extension centers and within the next few weeks I anticipate we will be able to announce the first of those organization that will be out of the chute to provide that assistance. The goal of these centers will be to provide hands-on technical assistance in implementing the technology.
They will do this for more than 100,000 physicians. Our office is dedicating over $600 million on this assistance. That assistance will be specifically directed at providers that are least likely to be able to do this on their own.
Here you can see those awarded grants must prioritize assistance to those in historically underserved areas with the ultimate goal of reducing health disparities. Reducing disparity you is a primary goal and explain this is recent head line. There is becoming evermore evidence of a growing digital divide. You see, if we believe that information at the point of care can make a difference in the quality and value and safety of that care, and this information can go on to support institutions of public health and social priorities, then the imperative of these findings become much more critical crit and are easily understood. This begs the question, what is the meaningful use of information technology?
Well, I have to give a little bit of a disclaimer here. Right now we just published the rules, a little more than a month old, proposed rule for the meaningful use of health IT. Because of that, we have officially entered the comment period for that propose which means I can't provide interpretations other than what's published. The greatest import is that we are collecting comments. Clearly we believe the proposal meets the requirements established by Congress in the statute. That statute gives pretty clear contours for the meaningful use. For example, the EHR must be certified, must be on a trajectory that includes exchange of information of real value to the patient such as care coordination.
Let me get back to the most important thing I can offer, namely, that as a published proposed rule we are desperately asking everyone and anyone who has thought about us moving forward, to please submit a comment. I invite everyone on this panel to submit a comment. Let me say that again. We are begging everyone to submit a comment; because you will see that for many groups, many -- particularly very interested groups, the proposed rule landed sort of flat. We took a tremendous amount of testimony, and obviously we are working on a very, very aggressive timeline, and some were a little disappointed some of the thought and ideas within their testimony weren't fully fleshed out within the proposed rule. There are a Jean-Bertrand a number of reasons for that -- the aggressive timeline not the least. The thought was if we can put up a reasonable proposal, we definitely can per nect rule with comments. The comment period lasts from now, ends can March 13. The gift of this tiewp the to speak to you really has the price that this is a brief presentation, doesn't provide a opportunity to provide more than a cursory acknowledgment of a lot of the other programs launched for information exchange, workforce development and beacon communities.
Beacon communities are quite interesting, hold the greatest promise because in those communities we are look being to see the full flower of what this technology can achieve. We are providing grants to about 15 communities, the grants can range from 10 to 20 million-dollars and the thought is that these grants will go to communities a little further along, advanced in terms of health IT, particularly that they probably have higher adoption numbers already, much higher than the 4% national average we have, and the thought is that they will provide a way for them to fill in the gaps and really, really demonstrate the full potential of what health information technology can do in one complete community.
We all recognize the essence of that is to see real exchange. Finally, I would be remiss if I don't highlight one other area, not involved in the high tech act at all, but I think this is, along with the beacon community program, probably one of the most exciting areas of all. That is comparative effectiveness research. This investment will obviously benefit all Americans, but it is clear that some of the greatest value will be in commune uponnities and groups not traditional used in research protocols.
I will wind up answering questions you have, just by restating my central thesis, namely, our current circumstance is not solely due to a lack of technology, and therefore it can't be solvedded by technology alone. It is no small matter that two of the stat criteria for meaningful use involve information moving, information exchange. The whole point is to provide a means to facilitate communication, and the transfer of information, and possibly even the transfer of knowledge. In the right hands at the right time, information can be transformative. The full, complete rapid and regular exchange of medical information will represent a singular change in our culture and I can think of no better way to increase the value of our services than to make their provision fully informed.
The alternative is equally remarkable. To continue, each of us in our own silo, putting one new innovation on top of another with no real consideration of how one piece of information informs, supports or confounds another means we will keep our haphazard and -- care of patients. Means we will recreate the experience of babe babeel. I hope you understand [indiscernible] are not the whole answer. The question is not how much technology do we need. The question is how do we improve the quality of care for all Americans, and in turn effect that elusive, yet supposedly self-evident truth that among our unal yenable rights are life, liberty and the pursuit of happiness.
While I am frequently prone to exaggeration, in this case I am not being hyperbolic. Preventible cancers separated far too many of our people their right to life, and life and liberty is not apparent to those who rise every morning with a disability, Alzheimer's or HIV. A computer won't make that right, but information technology can assure that a pediatrician sees a list over morning of the patients coming that day that aren't up to date on immunizations, as well as the names of their brothers and sisters who will probably pow in to with mom. Can ask and answer the questions, what treatments work best for a 48-year-old Latino with cancer, or an African-American with prostate cancer, what are the portfolio of services to effective implement that treatment. A computer won't rid the world of AIDS, but will afford well-meaning people the liberty of having their care coordinated in it such a way that every one of their doctors knows the results of all of their tests.
Nine years ago the Institute of Medicine got it right. Quality care is efficient, effective, safe, patient-centered, equitable and timely. But just saying that won't make it real, and it only begins to describe NASUA we need to do to reform healthcare. With information systems we can see the true choices and the balance that must be preserved. That balance is highlighted in my reality as a 21st Century American surgeon. That reality stands in indeed juxtaposition that no country, no national enterprise has fully and successfully implemented what we are attempting to deliver. Now, I used to end my implementation presentations with a quote from Voltaire that basically said doubt is unseveral, but certainty is ridiculous. While that is very true, and while we stand on the cusp of this new year I appreciate Mr. Twain's observation more. We in the office of the national coordinator are willfully, purposefully grabbing this cat by the daily. And in doing so we are about to understand things that can be learned in no other way. Essentially, every where I go, I want to point out we are here to ask -- for that result.
Appreciate it. Marc?
Thank you very much for that presentation. I would have two comments. One is that our committee certainly was active in providing comments on the first go around of meaningful use, and I anticipate that we probably should involved in the second. I would propose that.
Please. Please.
The second thing that struck me as you were going through the presentation and the things you referenced, so much of what you are doing intersects with things we talked about here. I am interested in the possibility, and I have been told by Sarah this is not out of bounds, would it be -- it would seem reasonable to have a liaison from your office that would be an ad hoc attendee of this committee.
I think that will be fantastic and I can't step over my bounds, have to clear through leadership, but I believe we will be very receptive to that.
I propose invitation be made officially.
We can do that. We will figure out what the channels are.
If you send a note with me I can forward to Dr. Blumenthal, he will take it under consideration and I am almost sure it will be favorably -- we are low maintenance, bring our own water.
I am sure we have our own bureaucracy too, we will figure out what it is and move it forward. That would be very constructive.
I do want to respond, though, to the -- some logistical challenge similar to what we discussed with Rod. This is out for a 60-day period
Comment period ends on May 13.
That's before our next meeting --
March 13, sorry.
It's before our next meeting, but we would like to get comments there. Mark, you drafted the -- right? The comments sent in before.
Yes, I can do that.
Can you send those, scan to be specific to that. I don't know if othersment to specifically work -- but we can share with the committee here --
Sarah is suggesting we take what we did, expand with what we have already done, more complete, responsive to needs, and move it forward. We aren't going to reconvene. We can share with all of you. Obviously everybody can respond individually, and obviously we have an open invitation to do that.
Please, please.
That we can do on behalf of the committee.
Dr. Hunt: Two things. First, the NIH -- there is competition in HHS, and the NIH have been Crowing around for I don't know how long that they got 50,000 comments for their stem cell research rule. We are aiming to top that, okay. Individually and collectively we really want you to provide comment and I am not stepping out of bounds. This is not an interpretation ever the rule, but in the proposal we have three basic periods of development in the meaningful use. 2011 is first, individual practices will be able to qualify for meaningful use incentive payments. And as many of you know, 2011, in terms of the federal government is like next Wednesday. Our thoughts are to have just, to start this off. The next period begins in 2013, and we are actively thinking on how to really ramp up. In the statute it was very clear there's the expectation meaningful use will progress in terms of requirements. In 2013 there are tremendous more process things for meaningful use incentives. 2015, that's the peak, literally and figuratively, where we are seeing the full flower again of what we can achieve in terms of meaningful use. That's the peak because after that period you can incur, the statute incurs penalties for Medicare providers that don't meaningfully use electronic health records. I hope that will help frame some of your comments.
That's triferric. These are of keen interest to us. A flood of information in genomics, information needs to get out and get used well.
We realize it's not going to happen without an organized system of care that can get the information out in a imaginable and intelligible way.
Dr. Hunt: Clearly very few groups would have a sensibility about the privacy issues around the exchange of information, and so I am sure that thoughts around -- because you have grappled with this external to any discussion of health information exchange for are a while and have a tremendous amount of -- I know well considered thought on the issues of privacy, and that will be very, very welcome.
Indeed.
It remains a topic of keen interest. Thank you very much for joining and particularly for your eloquent comments. They were delightful.
[Captioner transition.] > >
I think that brings us to the end
I think that brings us to the end of our agenda so let me recap a little bit about what we managed. While they are putting it on the screen are the any other items anyone would like to bring up.
Are we in some formal way following up on the GINA regulations?
We will get some updates -- I did get some brief updates but you'll be hearing more. The agencies are all moving forward to get them done. As we know there are some residual consequences that were not necessarily happily anticipated.
Okay, to recap we began yesterday's talking of the affordable genome and hopefully have a session at third June meeting that will begin to begin that process so we can decide what our next steps might be. We heard from Mark arm clinical utility and Barbara Landis to a review of the draft recommendations on genetics education and training. We agreed to post those and we look froward to doing that -- forward to doing that. We did not see the Mets receive any additional comments on the paper -- we did not receive any additional comments on the paper and Sylvia, it happened and your watch. Charmaine leather is the route a good discussion on June oh data sharing. Charmaine let us on a good discussion on genetic data sharing the Lewin Group and talk at our June meeting about how we might proceed.
The gene patents report. Thank you everyone. We got unanimous vote to approve a motion to close it and move it forward. So within the Gulf and a copy editing it will be on its way to the Secretary.
I do not know what I will do with all of my free time now.
We heard from Rod this morning about the newborn screening and advisory committee and a group to comment on residual dried blood spot and we will hear from them in June. His committee will be looking at new carrier screening and if they will have a proposal for us also to review. A proposal about collaboration with them on a way to assess and make recommendations concerning carrier screening. And then finally we heard from David Hunt in regard to the office of the national coordinator and meaningful use delighted to hear that there is interest in having them have some representation on this committee and Marc is going to health craft a response to the regs out from public comment. Lastly we did hear from our federal partners and all of the great activities going on there. I am sure I missed a few things. The practice a lot, we did it and we could not have done it with all -- it is a lot, we did it did we could have not done it with all of you.
The commenter, if anybody has any comments --
We will be able to incorporate suggestions and we are going to send that. Anything else I missed? If not, save troubles and we look for to see me soon -- safe travels and we look forward to seeing you soon.
Thanks again to the wonderful staff for doing this.
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