shake in life, and a whole range of other important issues. he wasñi passionate,ñi a fighteo the very end. he was also someone who was able to reach across the aisle, to reach out and work with other çópeople to get things done. that is whyñi he has a long recd of accomplishments. i just -- we passed in the united states congress and presidentñw)z obamañiñr signed e service to america act. to encourage and make sure more young people have the >n#opportunity to help particie in the great democracy by workin an fields of public service. . . course, one of the things senator kennedy said was that health care was the fight of his life, and in fact he was successful. he was the leader in the effort

to expand health care in the late 1990s to america's children through the children's health insurance program, the chips legislation. he teamed up with senator orrin hatch and others, and they were able to get that done working with senator clinton in the white house at the time. and that was a great victory. and earlier this year under the leadership of barack obama the congress passed an, tension of that children's health insurance bill. it was the second bill that president obama signed this year because the full promise of that legislation had not been realized. there were still millions of children in america who were not getting access to coverage under the children's health bill that senator kennedy had been a leader on, and so that was the second bill that was signed by our new president. but, of course, in the area of health care there's still a lot of unfinished work, and senator kennedy was working on this

issue, of course, up to his final days, and that brings us to the question of health care reform, our health care system in this country and where do we go from here, and i think that we should recognize at the outset that we have many strengths in our current system. there are many good aspects to our current system. one of them is the engine of innovation. there's lots of incentive in our system to develop new treatments, new cures, new techniques, new drugs to deal with different diseases, and in the process of fixing what's broken we don't want to harm what is good. of course, the doctor's principle is first do not harm and we need to make sure that as we fix what is wrong with the system we preserve what is best with the system, but you have to acknowledge and i think we all recognize that we can have a better health care system. we can strengthen our health care system.

it does have many weaknesses. in our country we spend now 18% of our gross domestic product. i'm not talking now about the federal budget. i'm talking about all our spending, our spending as americans, part of our gross national product, what we spend every year. we spend 18% of our dollars on health care in this country. it is by far the largest expenditure on a percentage basis of any western industrialized country in the world, and so we should be asking ourselves what we're getting for those dollars, and the fact of the matter is despite being by far and away the largest spendser in ter eee of health care dollars we have an estimated 45 million americans who have no health insurance whatsoever and many more who are underinsured who can scrape together some dollars and buy a health insurance policy often only to discover when they need it most that what

they need it for is not covered, so you've got about 45 million americans with no coverage at one point or another during the year. some of them on a regular basis and then again many more who do not have adequate coverage, and the institute of medicine which is a non-partisan organization has estimated that about 85,000 americans die prematurely each year because of lack of coverage, because they didn't get the treatments when they needed them in an -- and in time to reverse the course and catch their illness because for those americans their first line of medicine is the emergency room, and many of them wait, of course, until whatever their health condition is has worsened to the point where sometimes it's irreversible by the time they finally go to get that care, and that's a staggering number and that is rationing. there's not rationing in this health care bill. that is rationing.

now in 1965 as a nation we decided to address one of the big problems with our health care system at that time which was the lack of coverage for seniors. we had millions of seniors in the united states who could not get the health care they needed, and what we did as a nation was enact medicare, and many of you were following that debate at the time. i was relatively young at the time, but i have done my time, but i have done my homework and read the at that time and see how similar it is to some of the language being used against some of the health reform proposals that are being debated today. medicare was attacked viciously as socialized medicine, as a communist plot. people said it was, quote,

german medicine. i encourage all of you to just re-read some of that history of the fight over medicare, and i say that because tid medicare is recognized by most people i think as a successful program, a very successful program in our country. and, again, you've got a little bit of repeat in history in terms of the language being used in the debates. now we need to strengthen medicare. we need to make sure we put it on a sustainable footing and a sustainable basis going forward because i think all of you know that medical inflation in this country, both in terms of public dollars spent on health care meaning medicare and medicaid and in the private insurance market medical inflation is rising at a very rapid rate, much faster than the rate of inflation in the other parts of

the economy. between the year 2000 and the year 2008, insurance premiums jumped by twice. they doubled. during that same period of time insurance company profits also soared. in fact, if you look at the top ten insurance companies during that period, their profits exceeded 400% over that same period of time as premiums were going up. that's not a coincidence, of course. premiums were going up, and profits were going up, but also the underlying health care costs are going up, and so we need to make sure that we tackle that issue through more efficient delivery of medicine, and there are lots of ideas out there for addressing those issues within our overall health care system, and we need to address those issues as well. in addition to having to grapple

with the cost factor there are obviously other major flaws in our current overall system for insurance in this country. i'm not referring now to medicare but in the other insurance market. people are denied, of course, based on pre-existing conditions. we have a system right now that is based entirely on your employer for the most part providing health care because it's very difficult as an individual to go into the insurance market and buy affordable health care which is why most people in this country by far, apart from medicare, and there are about 45 million americans on medicare right now, about 38 million seniors and about 7 million individuals who are disabled who are also covered by medicare, but setting aside the medicare system people primarily, of course, get their coverage through their employer which means if they lose their job and, of course, we're in an economic downturn, a recession now, it means they lose their

health care, and people today are expecting as they start out in their careers to switch jobs four or five times which means that every time they switch jobs they are going to have to make sure that their next employer has adequate coverage, and if they get sick on one job and then lose that job or want to move to another job they are not going to get it on the next job because they will have a pre-existing condition and be denied. there's also a fairly regular use of what we call recisions which is you've been paying your premiums month after month, year after year. finally you need it, and when you need it most, the insurance company goes back and finds some fine print in the contract to try and deny you the care when you need it most. it happens on a regular basis because the fact of the matter is some insurance companies, i mean, that's -- by denying

payment, obviously that increases their bottom line and helps their shareholders and stockholders and these are some of the other major problems in our current system that we are determined to try and fix, and that's what the legislation does, and that's why i believe that while americans may disagree on some of the specifics on the best way forward the overwhelming majority of the american people understand and believe that we need to improve and strengthen our system. now there's been a whole lot of misinformation, a whole lot of misinformation out there about what's in the plan. i should say that there are obviously as in any big debate there are going to be areas of legitimate disagreement, and we should have that debate but we should have it based on facts so this is an opportunity to talk about what the facts are and have a conversation and get your input as to what you think we need to be doing as a country so that when members of congress go back into session we can talk to

our colleagues about the best way forward. before i talk about specifics of the bill let me give you an update on where it stands in the process. president obama has not himself submitted a piece of written legislation to the united states congress. instead, he took the position i think rightly so that he was going to outline a series of principles that he supported and work with the congress to develop specific legislative proposals, so there is no specific bill out there that the president has submitted. in the house of representatives, and it's a great privilege to represent all of you in the house of representatives, in the house of representatives we have three committees that have what we call jurisdiction over this health care bill. three committees where their area of responsibility touches on some part of this debate and have worked to fashion

legislative proposals. the ways and means committee which i serve on, the education and labor committee that deals with a lot of the employer-based coverage issues and the energy and commerce committee. as of today, all three of those house committees have reported bills meaning they have voted in their committees on bills so you now have three bills before the house of representatives, and it will be our job when we come back bases on the input that we get from you and my colleagues get from their constituents to take those three bills and try and bring them together, merge them and make any changes or modifications or additions that we think are appropriate going forward. that bill would then go before the full house of representatives for a vote. now in the senate there are two committees, not three. in the senate there are two committees that have jurisdiction. one of them is the committee

that had been chaired by senator kennedy. it's known as the health committee, health, education, labor and i think pension committee and that committee has also voted out a bill. senator dodd took up the reins? senator kennedy's absence and that committee, too, has voted out a piece of legislation. the other senate committee that has jurisdiction is the senate finance committee chaired by senator backous and the senior republican, the ranking republican member on that committee senator grassley from iowa. and as you probably know they have put together what they call the gang of six, a subset of that committee, three republicans and three democrats and they have been trying to work out an agreement so that that committee can also report out legislation. when the senate finance committee, and we hope they will have a bill, when they have a bill, the two senate bills out

of the help committee and finance committee they will also have to be reconciled and they will come together on the floor of the senate in some form. after that, if all goes according to plan, you will then have a house bill and a senate bill and then they would go to conference where you work out the differences between the two. again, if that all goes smoothly and, you know r, not sure that will go smoothly, but if that all happens, that all happens that combined bill then goes back to the house and back to the senate for one final vote because each body in the legislature has to vote on -- on every detail of the final agreement, and then if it passes the house and the senate, of course, it goes to the president for signature or for a streeto, and that is the process, and that's where it stands today. now i'm going to talk about the house bills because as i said we have bills that have been coming out of three committees, and let

me briefly say what they do not do. they@@@@@@@ @ @ @ @ @ @ @ @ @ @ pqsátñi to end their lives. what they do is to say that doctors can be compensated for advice and counsel they give patients about different treatment options that they have. some doctors already do this. but some do not. why do some doctors not do that? because they get paid for a pretty good operation, not the time they take with you and your family to talk about different treatment options. family to talk about the different treatment options, but there's absolutely nothing in this bill that provides any encouragement or any incentive to any doctor to substitute his or her decision for your decision. your decision will prevail no

matter what, but i think all of us recognize that in order to make informed decisions we need information. i know from our family personal experience is always good to know what the treatment options are and how you can best proceed, but you, the patient, consumer, the individual, of course, will always in consultation with your doctor be able to make whatever decision you think is best for you and your health care. number two, this bill does not provide coverage to people who are in this country illegally. it does not provide coverage to, again, illegal immigrants in this country. in fact, can you go to the bill, and there's a specific provision that says that coverage is not made available. now we have a serious issue and debate in this country with immigration, and we have to address those issues as a

nation, but that debate will take place separately, and there's nothing in this bill that says people here who are here illegally get coverage. number three. this doesn't cut any medicare benefits. it does not cut medicare benefits. in fact, as i'll mention in a minute it expands some medicare benefits, especially with respect to prescription drugs. so those are three areas that have gotten a lot of attention and where there's been a lot of misinformation that at outset i want to get the facts straight, and what does the bill do? it fills in the gaps in our current health insurance system which as you well know as we've talked about is already fairly fragmented. we have medicare for now 45 million americans. we do have the children's health

insurance program for kids in millions of american families. we have the medicaid program for the indigent, but that still leaves, as i said, over 45 million americans during the course of a year who have no health coverage, so we want to work with the current system and fill the gaps which means as the present has said that if like your current coverage, your employer coverage, first of all, i said medicare it's not -- it's not touched except for it's enhanced. i'm going to talk about that in a minute, but for people who are not covered by medicare what it will do is encourage them to keep their employer-cover coverage if they like it and want, it and the employers are going to be encouraged to keep that coverage, but for people who don't have coverage either because their employers don't provide it and increasing numbers of employers in the united states are not providing coverage because the costs are going through the roof and they

have to compete with other companies and businesses from around the world that are not providing health coverage and are not assuming those costs, and, therefore, as time goes on fewer and fewer american businesses are providing coverage. it's still by far -- the majority of big businesses provide it and fewer are and certainly many are not and so for people who do not get coverage through their employer and are self-employed and can't afford coverage, what this bill does is create another option for them. it establishes what we call a health care exchange. now i don't know how many of you were federal employees or on federal -- the federal employees health benefit plan. i don't know if you could raise your hands if you're on the federal health, okay. members of congress are on the federal health employees health benefit plan. just like you every year during open season we get out our booklet and what do you do? there are a whole lost plans out there, and you can compare among

and pick and choose which plan you think is best for yourself and your family. we want to provide that option to millions of americans who don't have coverage, and they will be able to select from among those plans, and from among the plans they will al also -- there will also be a public option. most of the plans will be -- all the plans but one will be private insurance plans that have to meet certain criteria to protect the consumer, yes, just like under the federal health employees benefit plan where the office of personnel and others monitor those insurance companies very carefully to make sure they don't put something in fine print that undermines your care. these will be very transparent, and the insurance companies that are offering plans under this

exchange will be held accountable for what they are offering, but there will be a series of plans, some basic coverage and then for people who want to pay more you can buy another plan, just like under the federal employees health benefit plan and you'll have a public option. the public option is not required. this is another great myth out there, that somehow people are going to be forced into a public option. it is an option. people can choose. there are a lot of people who are opposed, especially the insurance industry, because it creates more competition. there are many places in this country where you may have only one or two insurance carriers. when you only have one or two insurance carriers, they get to dictate price to the providers, okay? and providers also sometimes like that because they are the only guys in town.

now this will provide more choice. if people don't like it, if people don't like the cost or they don't like the care, they can say no. it's also very important to understand that this public option has been circumdescribed, been limited in a way to make sure that there's an even playing field between it and the private insurance companies. what do i mean by that? it has to support itself on its own premiums. the initial startup costs that would be advanced by the federal treasury have to be repaid. it has to operate just like any other entity. it will be a non-profit because the federal government is not in the business of making a profit so it will be a non-profit. it will be like medicare. it will be an option like medicare for those people who choose it. they want to choose the private

plan, they choose the private plan. they want to choose the public option, they choose it. more competition, more choice. that's what it is. now the congressional budget office non-partisan congressional budget office that comes up with projections and estimates in all sorts of areas ve looked at the interaction of all of these elements in the house plan, and they have looked forward to the year 2019 and according to their projection in the year 2019 you'll have more americans than today on employer-covered health insurance. why do i say that, because there's some people who think this is a grand conspiracy to get all these employers to let go of their employees and put them into this other plan. there are penalties for doing that, and then there are other economic reasons employers aren't going to want to do that, but the fact of the matter is the cbo when they looked at this conclude that in 2019 you'll

have more americans on employer-sponsored plans. they estimate that in 2019 30 million americans will now be a part of this exchange. remember, we've got 45 million americans who are not covered today so that sounds like a reasonable estimate of the people who don't have insurance today will now be covered. they figure 30 million americans will be in the exchange, and of those 30 million they are figuring based on all the incentives that 20 million or two-thirds of them will choose the private insurance options within the exchange and that 10 million or one-third of them will opt for the public option, so there's -- so this notion that the public option is designed to swallow up the entire private insurance market is disproven by the analysis of the non-partisan congressional budget office. now, let me say a word about medicare.

medicare as all of you know under part "d" prescription drug program has what we call the doughnut hole, that you pay premiums on a regular basis but after you are covered by a couple thousand dollars you go in a doughnut hole where you're essentially on your own for the cost of drugs until you get to the other end of the doughnut hole at about $5,000 or up where essentially your coverage kicks in again. the white house working with actually in this case the association dealing with the pharmaceutical industry came up with some savings and other parts of the prescription drug coverage and came up with a method which we expanded on in the house to fill the doughnut hole so over a period of time under this bill, the bills in the house, the doughnut hole will be closed. in the short term it will be about halfway closed, but over a period of years it will then be

closed. the house bill also increases the reimbursement rate for providers, for doctors, you know, family physicians as well as other doctors. why is that important, because as many of you know, and i'm sure you hear it from some of your health care providers and doctors, they say that they can't afford to provide health care under current reimbursement rates, so those are increased as part of the overall package here. how is this paid for? it's paid for in two parts. one is these negotiations that took place at the white house looking for areas where you could find savings through efficiencies and other areas within the provider network in the medicare program, and let me give you a very good example, hospitals. hospitals are today provided a

money, especially hospitals in lower income areas for uncompensated care. makes sense because what happens? someone shows up at the hospital room. they can't pay for it. we still want to make sure that they get care. it is, as i say, the last line of defense for most people but it's the first line of defense, of course, for people who don't have coverage, and so there's -- there are funds -- currently some funds in medicare to compensate hospitals for those costs because otherwise they might just turn everybody away at the door or they are actually required not to and we don't want them to have to be providing free care. under the new system those people who are uninsured will now have coverage so that when they come, first of all, they won't come to the hospital as the first line of defense, but when they do come to the hospital they will be paying. they have insurance, and so that means that they are obviously

savings in that part of the system because of changes in the other parts of the system so that's part of it. the other part of this is paid for by increasing and putting the surcharge on families with incomes over $350,000 a year. it is a group that did very well from a tax perspective during the bush years. they had tax cuts that disproportionately benefited people at very high end, and for people earning $3350,000 and up there will be about a 1.5% surcharge on the income that exceeds $350,000. you pay your current rates on your income below $3350,000. for every additional dollar above you pay an additional $1.5% to contribute to to overall national effort. it goes up a little bit for people who have family incomes over $500,000 and up a little

bit more over a million but that's the other component to cover the cost. that's the architecture of this. now i -- i left out one important piece. what that is paying more, what those funds are paying for, as i said, is to fill that big gap in the system. we're going to require -- individuals are required to take some responsibility for their health care, so people are going to have to buy health care in this new system because right now we have a system where we're all paying for those individuals who are not covered. we're just paying for it in a very inefficient way. i mentioned the uncompensated care at hospitals for people. where does that come from? it comes from medicare? where does medicare funding come from? comes from all of us. in the private insurance market when somebody who is not on medicare but doesn't have health insura ows up at the hospital and the hospital gets

on health." careñr, reducing it gets swallowed up? çóthe insurance companies t[ú%ì+ it on. ñiñiçóñrçóñiñion averageçóñr, ps pay onñi average $1,100 per y%ì+ for all of theñr people who are notçó insured an1%9ñ very not getting the preventative care up front. they wait until the problem is worse because they cannot go to kptj÷ñiñrñiñrxd5aymñiñrñi c1çó who pays for it, all of us through our insurance and medicare through the system so we're saying people have to shoulder that responsibility now, but you can't say to somebody who earns $25,000 a year that you've got to pick up the entire tab. in the medicare system, us a all know, it's funded by everybody. people regardless of their age

are paying on their payroll tax for medicare. that's part "a." part "b" 75%, of course, is covered through general revenue so what we're saying for these individuals is you have to put in something based on what you can afford based on your income, but the government will provide what we call affordability credit, almost like a voucher, that you can take depending on your income. it phases out, it phases out of a family of four 88,000. by that time people get nothing. most of that goeso people who are in the most needy income areas. it gets phased out very quickly. it's on a sliding scale. it's not like everybody up to the phase-out point gets the same subsidy. it gets smaller and smaller and smaller as you go up, and that is what some of those funds go for that i talked about in terms of paying for it, and under that

system the idea is finally we will have everybody included. they will be able to get preventive health care. they will be able to call their doctor and when the doctor says do you have a number they can get a number and go and get it checked out. they don't have to wait until they get sick and go to the hospital and cost us a lot more money. it's also the right thing i think to do and also the smart thing to do in a system where costs are increasing dramatically, so that's the overall architecture of this bill. now there are legitimate questions obviously, and we can have a great debate, but there's been a lot of misinformation. i appreciate the opportunity to come here and just talk a little bit about what our intent is and what we hope to do. thank you for being so engaged in this debate, and i would be happy to try and answer any of your questions. >> okay.

we will be taking questions. i want you to please be civil and respectful. we want this to be a productive event, and in order to accommodate as many residents as possible please keep your remarks or questions to one minute so congressman van hollen can answer and go on to the next resident. i think we all should be thoughtful of the other residents that also have questions. okay. does anybody have questions? >> my name is joan guberman and thank you very much for coming here today. i was wondering how are you going to stop cherry picking by the insurance companies, especially because then people will get forced into the public option? public option premiums will go up and it will become another cycle where people can't afford the premiums. i notice that the insurance

companies can discriminate based on geographic location. they can decide everyone in a certain zip code or everyone who lives at leisure world is not eligible for insurance. that's my question. >> that's a very good question. i'll repeat it for those of you who didn't hear it. the fundamental question is how is this reform going to prevent insurance companies from cherry picking where they go out and select people for them to cover who are the healthiest and then deny people who are unhealthy and those people then have to go into some other plan? the bill essentially outlaws cherry picking and it outlaws denying people based on pre-existing conditions. you as an insurance company under this bill cannot deny health coverage to somebody who asks for it under your plan. in other words, you'll have your plan out there. if you're offering that insurance and i come and say i'm going to pay that amount for that benefit and that coverage,

you have to take me, and that is essentially community rating. that, of course, is what inshurns is all about. the whole idea of insurance as we know is we're one big rusk pool and we're sharing our risks. we're paying our insurance premiums to protect ourselves against a time when we will really need the costs, and there are some people, god willing, who will not use up through the health care system the amount they put in through peopleuals. that's the whole idea. the whole idea is to people the risk, and when inshurns companies cherry pick they undermine the fundamental notion behind insurance which is why that's going to be prohibited under this legislation. i should also point out that insurance companies spend a lot of money. people talk about costs to the health care system. insurance companies spend a lot of money trying to figure out who they should insure and who

they shouldn't because they want to find those people who aren't going to need it. that makes sense. for you shareholders what you want to do if you are really good with the insurance company you get all healthy people and take all the premiums and you never have to pay out and your shareholders are happy, so -- but it does undermine the fundamental idea behind insurance so it's a very important part of this bill. >> me name is josh logan. i have a question for you. what is your position on medicare for all, also known as single-payer plan, and if against it why? >> i agree with the president that if we were starting from scratch that that would be a port -- a way to go, if we were starting from scratch. as you know, our system evolved

really into somewhat historically accidental fashion during world war ii when the government put a freeze on wages and to control prices and then employers decided to help compensate their employees in part by providing health insurance. we now have a system where the majority of people would are not on medicare get their insurance through the private market and through their -- excuse me, through their employer and the private market, and i agree with the president that it would be a mistake to -- and too disruptive to change that system, and so i think that what he has proposed and what is being proposed in the congress right now is a practical alternative that is a huge improvement on the current system.

>> thank you. i agree with the notion that nobody should be without health insurance in this country, and i wonder if this isn't already in the bill or if a system like this would work. when a child is born, gets a social security number and at the same time that child is given a government health insurance policy which the parents can decline as they wish to. otherwise every kid that's born gets a social security number and a government health insurance policy which at any time in their life they can opt out of. >> right. well, that is -- that proposal is very similar to the

single-payer proposal and, again, given where our system is today i agree with what the president has said which is that lets build upon the blocks that are already out there. we have medicare that is working well for 45 million americans. yes, we all have our frustrations with part of it, but it is a solid program. we have children's health plan so under the children's health insurance plan children are covered, and there is, again, help, government help for those at the lower income scales, medicaid, so rather than essentially take all that out and substitute a whole new architecture what we're trying to do is design the system to fill in that big hole that does exist in it without reinventing the whole system. there are lots of good

alternative proposals out there, but this is one that we think can work and improve the system and hopefully get a majority vote in the united states congress at some point. >> the lady with the green shirt. >> i'm barbara cassidy. my question deals with the lobbyists. when and how are we going to make it become illegal for the medical and pharmaceutical lobbyists to influence federal senators and representatives in health care plan reform? >> well, let me start by agreeing with the premise of your question which is that -- which is that lobbyists and the

people they represent spend a whole lot of money trying to influence the process and they do it to protect financial interests of their clients, and what many of us -- there are constitutional issues here, first of all, people's right to petition the government so what we've done with respect to lobbying is over a period of time and i've been working very hard on this is to try to increase the transparency and the accountability of lobbying both in terms of the lobbying that they are doing, and they have to file, and anyone can go on the internet and find out who is lobbying for who and what they are paying for which is one of the reasons as we all know right now how much is being spent and we can see what they are doing both in terms of how much money they are spending, the company may be spending to pay their lobbyists and how much they may be spending in terms of campaign finance and contributions, and with need to make sure that that process is totally transparent and my view is when it comes to campaign finance we need to reform the

system, and there are a number of measures that support and are pursuing in order to deal with the campaign finance piece. this, of course, relates not just do -- we're talking about health care now so those -- but within every issue that comes up whether it's energy policy or health care policy or even education policy there are, of course, a whole lot of interests that have a stake in the outcome and it's the job of the members of congress to always keep the public interest in mind knowing that got all these individuals out there who are being paid a lot of money to try to influence the process in a certain way so we need to ensure that kind of transparency, and i think as we go through this debate it is very important that people ask themselves when they see, for example, advertising on tv, and you can't -- you can't say people can't advertise on tv. i mean, there are all sorts of way people can spend their money in order to try to influence the process. sometimes they try and maybe do it directly but a lot of times they try to do it indirectly.

they put an ad on tv an constituents watch and call up a member of congress and my idea is transparents set best policy because if everybody is educated about what's happening and what interests are doing what they can make their own judgments about what's happening here, bu it comes to the health care debate, there are a whole lot of interests that are raised against it. and i mentioned one, with respect to the public option, which is that there are a lot of -- in the insurance industry that don't want the competition. it does provide consumers more choice. there's no doubt about it. it provides more choice. it also provides more competition. so that's just one example. but i think that the best approach, and again, is to try and get the information to the public about which interests are doing what. because there are a whole lot of people that are spending a lot of money in direct lobbying, but also through indirect methods.

they call it astroturf methods. that's different than grass roots. astroturf is like fake grass roots. and so -- but no, there are companies, i just want to [laughter] there are companiesñi that are trying to generateñi at the locl level lv>$# + misrepresenting tho position. ñione of my colleagues in virginia, tom. love was getting his mail from a group of ministers and i believe it was a public interest groups. it turns out they were forgeries. that obviously goes way across the line. i only mention that because qjñthere are people lobbying thr members of congress, but lobbyist techniques have gotten a lot more sophisticated. now they are trying to influence çnbñrññiño'ççr

we all have a respo6s%1%qe to sort through that information to figure out who is giving that to us and where there and go on it might be. >> and sometimes having a built- in microphone. ñiucongressman, what of the mar faults, if not the major fault found with the present health care bill is its size. ñiitçó is over 1000 pages. who can possibly read and comprehend this? and we all know how complex and our other insurance policies are. our home lenders insurance and othwrq. pm$váuñrñi think it wouldçó be a good idea to have someonexlññii of our proposed bill? [applause] reducing the size of our

proposed bill? [ applause ] >> well, there are a number of issues there, right? one is the size of the bill. and the other major issue is whether or not people have taken the time to understand what's in the bill. and i must say that i am pleased that the congress did not -- the house did not take a vote in the full house before we took this break. because i was one of the people who argued that it was important for us to go back and talk to all of our constituents and all of you before we took that step. now, i should say, members of congress are taking this issue extremely seriously. as are their constituents, as evidenced by all of you. and people have taken the time to educate themselves on this bill. now, health care reform obviously is a major issue. it's a comprehensive issue. you could have a narrow -- a smaller bill, but a smaller bill

would also lead to potential huge misunderstandings if you don't take time to make it clear what you mean. and you don't want to have a situation where you pass a law and then subject to multiple interpretations. so sometimes you have to pin down the meanings of things in order to avoid misinterpretation and misunderstanding. and let me give you one example. we're going to put in this bill -- there was a great article in either the "washington post" or norm "times" the other day in using plain english. requiring insurance companies to use plain english. now, i think we should use more plain english in these bills. it's a lot of lawyering in these bills. [ applause ] because what your doing in hess bills is amending different parts of the code. if you can't do it in the bill, what i hope we will put together is a fairly good explanation. we call it the section by section analysis. it's not the legal language

itself, it's an explanation in plain english as to what it's about. so there is going to be a section -- there is a section by section analysis of the bill that comes out of the house. we haven't yet, as i said, brought these three bills together, so there's not a section by section analysis of the unified bill because it's still subject to debate and change. but the plain english language, in order to require plain english, you've got to write that in the bill, too. you're going to ask insurance companies to put these policies out. i can tell you, i mean, i think you can be a ph.d. in linguistics and not understand some of the gobbledygook on your insurance policy. we want to write that in the bill. but again, the more things that you want to put in the bill and would agree would be in the bill, the longer it gets. i wouldn't measure the bill by just the length. i would measure it by what it accomplishes and whether or not you think that it hangs together

and touches the pieces. because anytime you're dealing with a comprehensive issue like health care, it's going to touch multiple parts of the existing law and you're going to have to amend multiple parts of the existing law. but members are taking this very seriously, and they are reading it. i was fortunate in that i serve on the ways and means committee. we spent day after day after day after day going through this bill. and i would encourage all of you to not only look at the bill, which is on the website. i mean, all these bills are available for public examination. as well as the section by section. yes, all of them. it's all on the internet. the internet is a great tool. it's all out there. >> the lady in the orange. >> my name is doris howard. and there's a lot said about this bill being socialized

medicine. could you speak briefly? because a lot of people i don't think understand what socialized medicine is. so could you speak briefly to the difference between the bill that is in congress and socialized medicine? >> yes. i'm glad you asked that question. and i had a book that i was going to bring with me to read from regarding the medicare debate. because as i said, socialized medicine was the charge that was leveled against medicare as a reason to be opposed to medicare. again, it was a communist plot, it was socialized medicine. this bill relies on the -- on private doctors, and private providers to deliver health care. it's not a system, as you do have in some countries, where the government is running health care, and health delivery.

we're not paying the doctors. we're not paying the emergency room. what we are doing is paying the -- under the private plans, we're not paying the salaries of the doctors. what we're providing is the care to the -- first of all, under the employer network, the employer sponsored network, that remains the same. but with respect to the exchange, going back to the federal employee health benefit plan model, you have private insurers out there that are going to be offering their plans that you can buy into. then you would have a public option that is the same sort of thing that medicare. where -- and so that's -- and people will charge fee for service, or under whatever other paying arrangement they have. it's a fee for service type arrangement, not a government

salary type arrangement. >> we're going to take a few more questions, because it's after 11:00. okay? >> it's up to you. but i can do another. >> baseball cap. >> i'd like to raise a question. you mentioned the numbers of -- [ inaudible ] i think studies have shown many of those 20 million -- [ inaudible ]. you did not mention illegal aliens. will it provide for any kind of protection against people coming in, getting health care, who are an illegal alien. number two, you talk about the medicare bill of 1965. part of that argument was it [ inaudible ]. that bill was estimated to be

$11 billion by 1990. in fact, in 1990, it was $117 billion. right now medicare and social security have unfunded pub lib indications of $48 trillion. i am more upset about what all these bills are doing to the fiscal stability of this nation from here on out. to what extent is the congress, are you looking at this issue from the long range, and also considering all the other bills that are in the hopper, stimulus bill and all these. thank you. [ applause ] >> now, that's a very, very good question. and as you know, the congressional budget office has been looking at this, and they came out with some estimates on the cost which we're going to have to take into account and make revisions. and some revisions have already been made. and other revisions will have to be made to address the cost issues that you just raised.

let me start with the illegal immigrant issue. again, there is a -- we're going to have a big debate in this country about how to deal with illegal immigration. this bill is not a forum for it in the sense there's nothing in this bill that changes that one way or another. and we're going to have that debate. i don't know when. we're going to have it in the country. we have a lot of big issues on the plate. but i just want to make it clear that i don't know, within the 45 million, there are estimated to be about 11 million people in this country who are here illegally. to what extent that number's included in the 45 million, i don't know. but whatever it is, there are a lot of american citizens who are not -- do not have health care coverage today. even if you back that tout, still have, you know, you would have 32 million. so whatever it is, they're included. but this does not, as i say, it's written in the bill. it's not -- does not provide health coverage to those who are

not here legally. with respect to medicare, that's a very good point. you're right, in 1965, when medicare was passed, people had certain cost projections for it. it turned out it was a lot more expensive than originally projected. and so the congress has had to come back now twice to make revisions to medicare to keep it solid. and we're going to have to address that as part of this reform. because as i mentioned, both in the government insurance area, which is medicare and medicaid, as well as the private insurance area, medical inflation is going through the roof. and as the president has rightly said, it is the number one driver of the deficit in the out years. social security is a piece of it. but it's about a fifth of what medicare is. and we have to fix both. but within the health care debate context, we're going to

have to bend that cost curve. and i think that some of the initial bills that came out of the congress, you work on these bills and the cbo gives you an estimate. clearly the cost piece has got to be dealt with better than in some of the original proposals out there. now, the house bill -- the house bill, during the, you know, the ten-year window that is projected under our budget, is paid for through the means i talked about. it's paid for by taking some savings through efficiencies in the medicare under the other part of the plan. that means you don't have to pay, as i said, the grants for uncompensated care to hospitals, because they'll be compensated on the other part. and we're going to debate about it, but we have a revenue thing. it is paid for. it is paid for by -- in the house bill. i'm not talking about the senate

bill. the senate does not -- one of the reasons, you know, the senate has two committees. former senator kennedy's committee, and the finance committee. it's the finance committee that has to come up with the method of paying for it. which is one of the reasons they're still working. seriously. that's their job. they have to figure out how to pay for it. in the house we bit the bullet. we can have an argument about how to pay for it. but we did pay for it, during that ten-year window. now, there is still an issue beyond that ten-year window in the trends of medical inflation, which are there today, and while they're bent slightly, i don't think they're bent enough. you know, bending the cost curve is the dry term. but i agree with you that that has to be part of it. but again, the house bill is deficit-neutral, as scored by the cbo. the current house bill,

there's -- there is another provision -- there's the provision with respect to doctors' compensation that is part of the carryover from the bush days that's already built into the budget. and i will agree with you that we have to deal with that and pay for as well. you're absolutely right that the deficit issues have got to be dealt with. we can have a longer conversation about the economic recovery bill, and i think the number one priority of the president had to be to get the economy out of total free-fall and turned around. because in addition to throwing millions of americans out of work when you have a fast dropping economy headed toward depression, in addition to the problems of, you know, in the economy, obviously you also have less revenue generated. the fastest way you can deal with the deficit in the short term is to try and get things

back on track. but you need to have a long-term plan in place. and i agree with you on that. yeah. >> in the back with the glasses. >> good morning. i think it is still morning. i have a question about long-term health care policies. >> yeah. >> will these are scrutinized at all, addressed at all as part of health reform? >> yeah. this is, of course, a big issue, long-term health care policies in the country. and there are issues in the bill regarding payment structures for long-term care facilities, nursing facilities. it has not been the central part of this bill.

but it is something that we are going to be looking at as part -- in other words, as you know, medicare right now covers certain things, but it does not cover the long-term costs, which is why we're really going to have to focus as a country on a couple things, including increasing our personal savings, as well as i think creating some more incentives for people to save. because while the government can pick up some of the costs as it currently does under the system, going back to the previous question from the gentleman, there's obviously a limit to how much we can ask the treasury to pay in a fiscally disciplined way. so there are some provisions here regarding long-term care. but again, it is not the -- certainly not the focus of the bill.

>> i had a question about what president obama meant when he said to the woman that talked about 100-year-old grandmother, saying just give her a pill. and i would like to know what pill he meant and what he was talking about. [ applause ] >> i'd have to go back. this was, i believe, a part of a statement at a press -- >> it was in a conference. >> a conference? there have been a lot of town hall meetings. i've been trying to follow them. i, frankly -- there was a question in the press conference where the president made an analogy regarding choices. and how you would be given choices under this bill for different insurance coverage plans under the exchange.

and you'd be able to make decisions based on information. so i'm sorry, i'm just not familiar with it. i can't speak for him. >> back there. >> one of the fastest growing costs is associated with pharmaceuticals. i believe the va has the power to negotiate pharmaceuticals. there's a rumor that that will not be in the bill when it's finally presented. do you know where we stand so that some of these exorbitant costs compared to what other countries pay for the same pharmaceuticals produced in this country, so that it could be negotiated? i know they argue that the preparation, et cetera, is to be paid for. but i think that the profit motive has exceeded the

necessary costs for being in the forefront of development. >> yes. i mean, it's another -- the question had to do with giving the federal government negotiating authority with respect to prescription drugs. in other words, when part "d" was passed, the prescription drug bill was passed, there was a provision written into the bill, and i should say i opposed having the provision in the bill. the provision in the bill actually prohibited the federal government from negotiating a price with the drug companies. it said that had to be done entirely through a private sector structure, and that the government would not be able to negotiate a price, even though the government as a big purchaser, just like a large insurer, obviously has some bargaining power, because it has lots of members. as the gentleman pointed out in

the veterans administration, the veterans administration does have the power to negotiate prices. and that's one of the reasons for veterans that the price of drugs is lower than it is for so many others. and so many of us believe that we could now, now. the short answer is, this is an issue that will continue to be debated as part of the bill. as i said, the bill's got a long way to go. and there may be some things that are added to it, and that is something that is certainly in the mix to give -- again, this is under part "d" prescription drug -- to give the government the ability to negotiate directly for price in order to help bring down the costs. obviously the pharmaceutical companies oppose this. i should say that the drug prices under part "d" are lower

than the cbo originally projected. that there has been more negotiation and competition among some of the private covers through these pdms and others, that have driven down the costs. so that the actual costs of prescription drug part "d" is lower than the cbo projected. now, we're going to -- we under our rules live by the cbo numbers. and i -- and they're a nonpartisan organization. they do good work. it's very difficult for people to project into the future on some of these costs. i grant that. so all of us know, you get ten economists in the room and you're going to get ten different opinions. there was an article in "the new york times" the other day that indicated that the cbo takes a very conservative approach, conservative little c, not a political sense, they take a conservative approach, as they should, and that in -- with

respect to medicare part "d" as well as the two other revisions that we talked about in medicare, because medicare costs were going up and changes were made, that the savings generated to the taxpayer to the treasury from changes that were made, the savings were dramatically underestimated by cbo. in other words, cbo in those cases projected much higher costs than ultimately occurred. that having been said, we operate with the cbo analysis. and i'm not saying they're wrong, and that's under our rules. we in the house have adopted what we call a pay-for rule. meaning that we have to pay as you go. and this bill will come up subject to those rules. and we will live with the cbo analysis. but i got a little bit off on a tangent. but the prescription drug part "d," yes, i think we can get more savings from, if you give the government the negotiating power, but it may not be as much

as the people had previously thought. >> we're going to be taking the last question. over here. >> good morning. i'm richard cornell. and we want to welcome you here. >> thank you. >> hello? got it. yes. the press has reported over the last two or three months that there's a division among members of the democratic majority in the house over certain provisions in the bill. and as i recall, the politico democrats have some resistance to the public option. and i wonder if you could talk a

little bit about this -- these differences, and to what extent they may affect passage of a bill in the house that includes a public auction? thank you. >> i don't know if everybody heard the question. it related to the discussion within the democratic party. we were talking specifically about on the house side with the blue dog democrats, who are democrats who -- let me back up a little bit. in the house, there are lots of different caucuses. you have the blue dog democrats, you've got the progressive democrats, you've got the new democrats. in the interest of full confession, i didn't sign up for any caucus. i'm a democrat. so i'm not part of any one of these groups. now, the blue dog democrats are more conservative, moderate democrats, and have been concerned about a number of issues in the bill.

and they raised concerns, as you say, about the public option. and one of the issues they raised is something actually i think many of us agreed with, which is, you need to make sure -- there are some people opposed to the public option. but for those who agreed we should have some public option but were concerned about how it was structured, we did make some changes in the combinations. because you want to make sure that there's an even playing field. you're not trying to, as i said, create a system where the public option swallows up all the other privately offered plans. and so there are limitations on how the public option can operate. for example, you can't go to the federal government, if it's premiums are running too low, and it can't cover its costs, it can't go get a loan that nobody else is allowed to get to cover it. and they have to repay the initial moneys advanced from the treasury, just like a private insurance company would have to

deal with the loans that it took out when it set itself up. and it has to go out and negotiate with providers. now, the major issue that came up, one of the big issues that came up was the rate of reimbursement that would be offered to providers by the public option. the original proposal said that the public option would propose to reimburse providers' doctors at a medicare rate plus five. and apparently a lot of people didn't like that. they wanted -- a lot of the folks in the provider community didn't like that, even though as i mentioned now, in order to deal with some of their concerns host: calle[captioning performey

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and secretary of sibelius, napolitano, locke for all the good wosk they are doing. phase of the spires and$spring, i do not want any"ódy to be armed but i0want everyboly to be prepared for it we know we usually get a8second, larger wave of these flu viruses in the fall. the response plans have been put in place across all levels of based on the best sign to the commission available and as the situation changes, we will continue to update the public for it we are also making steady will begin soon.oping a safe this program will be completely voluntary. it will be strongly rmcom-6n%ed. federal government, every american has a role to play in

responding to this virus. we need state and local ront linesate and local to make anti-virus medications and be ready to take whatever steps are necessary to support the health care system. we need hospitals and health- care providers to continue preparing for an increased patient load and to take steps to protect health-care workers. we need families and businesses nsure that txey have plaísesses in place if a family member, a child, or a co-worker contracts be flu virus and needs to stay home. most important, we need everyone to get informed about individual risk factors. we need everyone to take the common-sense steps that to make a difference. stay home, if you are sick. wash your hands frequently. cover your sneezes which your sleeve, not your hands, and take all the necessary precautions to stay healthy. i know it sounds simple but it is important and it works.

finally, for people who want to learn more about this virus, please go to www.flu.gov or talk to your doctor. i want to commend every member of our team. i think we have done an extraordinary job in preparing for this flu outbreak. we anticipate that there will be some issues coming up over the next several months. the way is moving is somewhat unpredictable i am absolutely confident that our team that is assembled here has done an extraordinary job in preparing for whatever may happen we appreciate all of you for being here and i want to publicly thank you for your extry hard work. >> do you have any comments on afghanistan?

[no audio] >> as the debate over health care continues, cspan's healthcare hub a key resource. go on line and follow all the what's the latest events, including town hall meetings and share your thoughts on the issue with your own citizen of video. including video from any town hall meetings you have gone too. both tv and primetime continues all this week on c-span 2. tonight's lineup includes former democratic national committee chairman howard dean on his book," howard dean's prescription for a real health care reform."

then we have the book, ecocatastrophe." after that, peter carlson, author of "k blows top." book tv beginning tonight. that is on c-span 2. >> in more than a dozen works, national book award winner jonathan kozol has critiqued the american public education system. he will take you -- your questions live on book tv. >> next, a discussion on genetic testing and the practice of private companies providing such medical tests directly to purchasers instead of through health-care providers. issues discussed include the regulation of testing, potential privacy concerns, and future research opportunities for it is

held by the national academy of sciences and it is to an half hours. >> good morning, everyone. you see members of the planning group who, over the past several months, have organized the discussion that you will participate in this week. barbara bierer and i will moderate the discussion which is to say way out of the

way. we will follow a format that may be familiar to you, presentations according to an agenda which has been distributed to everyone in the audience and around the table, then a bit of the interaction among the planning group and speakers with prompt opening up of the floorh to everyone here who has taken the trouble to attend and i am sure is interested in the subject matter. our co-sponsors and collaborators in this includes our colleagues in the institute of medicine. everyone knows that the national academy is a complex of the national academy of

sciences, the national academy of engineering, and the attitude of the madison -- at and the institute of medicine. the national research council came into existence during the presidency of woodrow wilson. the board, life sciences within the national research council joins us as well in the planning and execution of our program. we want to welcome all members of the planning committee, panelists, and our audience and we will encourage analy;qm j analysts -- panelists to cover their subjects. you will mostly seek power point

presentation so we have about 20 minutes for discussion. when the audience participates, notice that there are a couple of microphones in the room and you will need to go to those microphones in order to be heard and make sure your words exist for posterity. we will issue a report. it will not be a series of recommendations. it will not afford a platform for subsequent policy making, as some academy results do. the report will be available to you and you can access it through the committee on science and technology website. some time will elapse while the editing process he lapses.

we think it would be a good idea to run around the table and in panelists briefly introducepj themselvew. it is not our intention to introduce eac("p%mqe5hpì(lc@&c+ length when the panelists speak áfpj!msñ no you'll know wu ?i am the onl] lawyer who has

survived through the tree gush -- the triage and i know that is deliberate. in the committee, we are pretty balanced betwcq' lawyer[ and scientists.+ for this particular program, we heavily on the science and science policy involved for direct consumer testing so that explains the formation of our panel. i practice law here in washington and them involved in all science issues. kpv3sr'd yotúto press the button your various electronic reminders. i am a professor of medicine at harvard medical school.

>> good morning, my name is patricia ganns, from the university of california los and public help in the johnson ik i direct a division of cancer prevention. that is that the johnson cancer center. i too am an attorney. u'til very recently, i was at the genetics and public policy center at johns hopkins with a gocus ongenetic informatrjz, gocus ongenetic informatrjz, di+crimination, and quality and 3poversight. starting tom/rrow, i will be the policy director for the

the generations ahead. >> i am tem bateman, -- i am a clinical let elegist. my research has been a to the genetics of common diseases. most recentlyi have been the specialist adviser for the u.k. parliament inquiry into genetic medicine and i am a commissioner. i have had of the interest in this area for a little while. >>!i am dick merrill, a retired member at the university of virginia. i am also the co-chair, with donald kennedy, on the panel on

science technology and law that is sponsoring this event. >> i am scott woodward. i have beq' working with the foundation for abuíkejuáákq ì(+ my background is in molecular genetics. my work as mainly focused on human genetic variation research and human genomics. 1ñ the i0ao in san diego, california.4+ ge7tics. >> jonathan >reino.

i was trained in genetic involved in genetics education for one population or another for abóut three decades. >> i am katrina doddere#. i am an epidemiologist in portland oregon. >> i am allen guttmacher. i'm a pediatrician and geneticist. >> i am wayne coury the director of the cdc division of to genomics. i have a part-time appointment i r'stitute. >> i am david corn. for the past nine months, i have unr+ersityv and i am also a member of the committee.

>> anne marie mazza. ñl thank you all and welcome. before we begin officrp&l=< i want to thank and murray and steve kendall for an unbelievable job putting this panel together including last minute changes and an enormous amount of organizational ability. david corn will introduce thet+ õscope of the workshop ane the fizst p9ut(v  >> thank you again and welcome to all of you. i want to give a special note because one of them travelled

the furthest and that is tim aikman who is sitting right here who is a professor in clinical and molecusmr genetics at consultant position aton and a- hammersmith. imperial academic health science center is the first and only academic health science center in the u.k. and maybe in western europe, for that matter. it is a you could neatly american institution. i had the pleasure of dining with the vice chancellor. i am a member of the committee

on science technology and i want to acknowledged di-ujr&l who committee and fred anderson and a couple of othq)s were th# is about 10 years old, or 11t+ perhaps for the committee is an interesting one. xbased in the environment at the interface of science and law and they look for interesting problems or interestiñg challenge ye). such scanning, the genetic

testing caught our attention and we decided that it was worth putting together this workshop. the reasons for interest in this are many. the american public is very concerned in general about privacy. particularly the privacy of medicad informatio& which is a they are particularly coícerned especially about genetic information for a whole host of reasons, many of the misconceived such as genetics is the diary of a person's fuuure which a professor of broke -- wrote.

but given all that and the amount of political activity and federal mevelk in ÷hisd medical information antúnmc offering to provide genetic informatyon to individuals. no one gáh#obcing t! to spit get the information. dhev are amassing a fair amount of information about people. it is contributed voluntarily by the persons who are seeking these services. what we don't know and what we hope this meeting will eliminate for all of us is are a number of

questions that have to do with how the testing is done, what indicators of quality and validity, both analytic and clini[al, are not inherent in the system, what sort of oversight is there of the activities of these companies, from either a legal or tomorrow morning who i hope wl what happens to the information that the companies collect and whose is it? who does it belong to? "'e people who do the analyses? what protections are there for those who contribute this information? you may say i am being picky but taját(u is, i have many scars

to show for battles for exactly and genetic information and when it could be accessed and who will use it. i speak with some humility about this matter. as a pathologist who has many tissue samples, those are also at the center of a lot of actions as to who owns tissue fragments this is unresolved in the united states. there have been at least three court cases that have ruled that an individual no longer owns or controls the disposition of a piece of tissue removed from his or her body. on a national level, there is no consensus on this matter at all. another factor to consider today

is that, for a long time, in the history of the evolution of genetics, became familiar with simple-gene disorders where if you have a particular genetic defect or absence or whatever, you had a clinical presentation for0it was not any doubt about we are now dealing with a whole family of significant chronic, major diseases of humans where the information that is rapidly accumulating suggests very strongly that there may be no dominant gene that will be the clue to these diseases, rather one finds associations with dozens or hundreds of other factors. the contribution of each to congestive heart failure or emphysema or whatever disease, is entirely unclear at this

point. we know the contribution is very small. it might be 1% or less. clearly, there's a lot more going on in these diseases then simply finding one or two genes that will give us the magic bullet. with all of this activity, the rise of the gene industry has been significant. some people want to send their samples in because they want to know about their ancestry or relational kinships or things of that sort some of them may be interested to know about their pre-election to various diseases and whether they ought to be advised to change their lifestyles. yet, one wonders what real value some of these findings

have since i am not sure that anybody can really answer that question this is a very rich agenda of topics, both scientific, legal, public policy, and i am hoping very much that during the day we will learn a lot about this and see where we go from here. thank you all very much for participating. >> feel free to move if you cannot say.

-- if you cannot see. >> i would like to ask the organizers -- i would like to thank the organizers for asking me to be here. this will be a 30,000-book look at -- 30,000-foot look at where we are and where we are headed in terms of economics and other kinds of things that we are dealing with. where are we? it depends who you ask for it to 7, cover from"science. " this certainly set the stage for the kinds of things we will be talking about today. if you look more recently, their end of the year issue in " science"it was no longer the

cover story for it in terms of sequencing bonanza number 10 and cancer genes that number 3, these applications of genomics were talked about as well as technology moving forward and they were the breakers of the year. if you do not like this side of the pond, the british thought there was really something here is so the end of the year issue of "nature" they are talking about genomics going mainstream. they give several examples of that. the fact that direct consumer availability for genetic testing is getting attention in the public but also from scientists themselves in fact, they talk about california

offering personalized genetic  for $399. "nature" in 2008. you don't have to look at the side of it literature. you can look at "time"magazine . they call it the best. how did we get here? we got here in several ways. one way by the -- one way was by the sequencing of the human genome. the one thing that is interesting to keep in mind is that in 50 years, we went from the sequencing of the description of the dna double helix in 50 years.

now the applications of that knowledge are moving. technology moves more quickly each year than the year before. some of the applications and genetic testing we are seeing 5itzj*q moving áery quickly. i think there was a genome bubble back from the time tha(ì+ the genome project itself ended that things would happen the next day. like every new technology, whether it be rail route, telegraph, or whatever, people tend to overestimate the immediate impact of new technologies. they also underestimate the long-term impact which i think is what we are dealing with here today. are now in the genome era.

that is where i would fall. other people talk about how we are in the post-genome era. we know we were in the pre- genome era until 2003 when the sequence was finished. this was suggested the genome qu)obonds from april 14, 2003. the important point is that we are just now at the beginning of this. that is why we are having these how we will use this new technology, this new kind of information. if that is where we are, what is next? we faced this question as we were coming to the end of the genome project. this is the slide that moved me the most in the number of people.

this shows the graph for the number of human traits and disorders for which we know the genes involved. it was very interesting. there is some good news if you look at the pink line. there are 1700 or so human were involved. that is good until you realize there are probably 5000-6000 uruój)e only halfway there. -aan use the scale at#u$e zight. 9r'ds of conditions. schizophrenia, etc. but the news is worsgbñceuse you look at humans, it is aligned only goes up to eight.

we are in single digits in 200" in terms of the number of genes we actually knjp)e involved in that seemed like a proflem we did a calculation in 2002. we keep using these candid jean it turns out that the genome is more complex than our ability to deal wráh it. ñwe thought we need#d to take n if you took 1000 people with a condition and 1000 people who differed between these tw/ find genes that were involved. it seemed like a nice idea. we did a calculation and we knew there were these p

polymorphisms. this would give you a pretty good approximation by looking at these 10 million snips. that was a short cut. that is present for that means you have to do 20 billion genotypes and it wa[ 50 cents to a single genotype in 2002. that was a $10 billion study. the budget in 2002 was something like $25 billion. it did not seem like we would get far. we thought we might spend 40% of this budget doing this for one disorder. which is kept the calculations to ourselves. the international hat map was

a genetic study of populations across the world. this looked at human variations in the genome which is responsible for the differences we see biologically. it told us something about the structure of the genome ann our inheritance of the pri it demonstrated something that many of us in washington, d.c. had long suspected which was that we were -- we are a young species and have not evolved very far. because of that, it means we have inherited our genome in large chunks. i you tell me that someone has an a rather than c, i can tell you with great accuracy exactly what vhey're genome sequence will be for maybe 1000 base

pairs on either side of that. that allowed us to recalculate the same problem. instead of having to do the 10 million snips we could take about five moderate thousand. -- 500,000. that is only 1 billion gino types. we had new technologies that reduce the price of doing 80 now type from 50 cents to 1/tel -- 1/12 of a penny. this meant that it took less than $1 million to do each disease. if you had a budget by more than $25 billion, this begins to be something you might do very people thought of doing it. this is what led to gen+átywiì+ association studies.

the first of vhese was this one that was completed before the hat map was done. it looked at macular degeneration. it affected vision loss. this was interesting because we use less than 1000 cases per this group was able to note three different genes involved in amd. these genes contribute to something over 50% of the attributable risk for the disease. this was for a disease that we did not think was genetic before. ñthese are fairly common variations. that offer the possibility for people to begin to test individuals to see who was at a higher risk for developing this disease. that is where many people focused on the power of the genome-wide associations.

i think that is less important than something else that this study showed us over and over and that is, it tells us something about the fundamental biology of disease. all three of the genes that were involved in a different pathway nobody thought that amd had a large inflammatory component. information is very important to the process. one might think%jáoáññ using anti-ionlammatory to treat the disease. >trials are on going. looking across the human genome,

starting in 2005, you will see one finding for amd and things started to pick up in 2006 end you have edit a few more. by the first quarter of 2007, we double the numbers of the original grant. the second quarter of 2007, by the end of the first quarter hundreds of genes implicated for scores of diseases and most of these have been validated and shown in other studies to be accurate. there are some others we have not put up there because we have questions. this is our best tabulation of what we think our real findings. that has completely changed the

way we look at things. you suddenly have this exponential rise in jeans that have been implicated in, this is the technology that we are here to talk about today. just to emxhasize the fact that while we will focus on what this will do in terms of pre- emblematic risk, it tells us a the first thing to say is the genome-wide studies are wonderful but they do not explain the most ability. ifyo]1do testing that is purely based on genome-wide service, you will not tell anybody about most of their inheritable risk for disease. by definition, it will be incomplete information.

i think it is more of these other mechanisms that re elucidate and understand those will take somc tmke to be able to provide information equal to this. ñwhere else are to genomics going? the 1000-genome project is looking at human variation in finer detail. it is getting down to variation that is less common but common enough to be of importance. we are looking up across that in different population groups. how bizarre genome function?

it has been years since we had the idea that we talked to medical students. one gene makes one protein and all the rest of that dna is the junk dna. that job refers to our ability to understand it, not what it is doing. until we understand completely known, we cannot give people complete information or accurate information about what their risks for various diseases are. in terms of genomics, this is the area of chemical genomics which is getting into the question of the kind of drug development we have. if we took all the drugs that we know today, the over-the-counter drugs, under the counter drugs, street corner drugs, what ever drugs, what percentage of the

genome and the proteins that the jeans and code do you think have been targeted with those drugs? it is only 2.5%, about 5147 20,000 that we have come all the drugs we know today -- have a very genome may not be but there is a biological space we have not gone to yet. this is a collaboration of research. they are coming up with new

drugs all the time which are promising. the cancer genome at less which is the idea of trying to find all the genetic variations that and with the uncommon human cancers, as well. this is a publication last fall about glioblastoma. senator kennedy from this. we have the best understanding of this tumor. other things that are happening -- you will see here in the box, $1,000 genome. there are all kinds of stages to the genome project. it mig(t be a couple billion dollars. if it cost that much, ending in 2003, how much will it cost a

few years, we think $1,000. that may seem ludicrous. in fact, we0have reason to believe this is trooper this is the cost of genome sequencing over the last 10 years. the cost of sequencing 89 today is01/14 thousand of what it was 14 years ago. we are at the end of that curve. we are very proud that we drove costs down. it turns out, we were selling ourselves short. we are at the end of this curve. where do we go from here? there is next generation sequencing bat is coming on line now that we think will cause the next curve to fall even more

sharply before it levels off. the idea of being able to completely sequins and wednesday number $1,000 is only a few years away. the discussion is not about what just can be done today but what happens in a few years when you can offer to sequence anyone's entire genome for $1,000. it could get less than that and how do we make that meaningful information. how we use that in health care and how we use that for private individuals? i think that is something to be aware of as we have these discussions. where are we headed? we are headed there. i will stop at that point. i think we have some time for discussion. >> thank you, alan. questions?

>> i really enjoyed the fact that to approach to this with respect to the exponential growth of the knowledge of the decrease in the cost of doing this. last week, i was reading a coup÷e of pieces from someone who pointed out that this thing has 1000 times the computing capacity of the computer he used as an mit graduate student 50 years ago, which took up a building. he makes a more general point that you have felt fully illustrated that this happens in all human knowledge in the last 70 years in every field this is in spite of the inherent evarts as between biology and artificial intelligence. i was going to ask you toa exted that third curve, which you helpfully did. i want you to make up point -- i

want to make that point about the growth of knowledge. i want to challenge you to go back to that 2.5% targeted genes. if it is true and we keep underestimating how quickly these things change, in the last 50 or 60 years, where are we on that curve if you were generous in your ima"ination with respect to how many genes we can target? where willóe be 20 or 30 years from now? is our ability to imagine that limited by the elements on your previous slide? >> that is a very good question, jonathan, thank you. there was probably a footnote in that article that you read that developing new pharmaceuticals is the one thing that has

escaped that occur in human knowledge or the last 50 years. >> i read the footnotes. >> chemical genomics -- it uses happen -- having genome sequence as a map helps. clearly, i think we will uncover 'aqujq)ug(tergets more quickly than before. it has happeneb in the pharmaceutical industry because of the way the industry works with shorter time horizons. it is much more seductive if one is to have a corporation that has stopped to think about tweak$&ááát drugs so they can be used once a day instead of twice a day because of the market share. it is much less up front were t+ come up withúa completely new i think there'll be some issues in terms of new targets being found and transmitting data to

drugs. there is reason to think that some of those steps in the valley of death of drug development can be changed into how one gets for the valley of death. some may know there is a new congressional appropriation for the first time that gives the nih $24 million per year. we hope that grows. it helps you go further down the road in terms of rare and neglected diseases. rare ones are those t at that the definition of occurring in less than 200,000 people in the u.s. and the neglected ones may be more kommon but!they happen in folks who cannot afford pharmaceuticals so they tend to be neglected in drug development. the nih now has some money and a mandate to seeá$rá can do in terms of getting things further down the field to make them more vate entities to pick them up for the final stage of the drug development.(.

.

>> with regards to the accessibility with all of this new information flowing in from the studies. >> that is a very important question trade if someone looks back at the human genome project's 100 years from now or even later and says what was the contribution to back -- to biology, the major contribution was not the sequence. we would have gotten that eventually. the major contribution was the fact that it became a cardinal feature of the genome project international governmental genome project and all of the data would be every 24 hours a bloated and everyone with a computer and paying the bill

could download the entire information. that's part of the age of wikis for sharing information. in coming up with new ways to value the contributions and the worst of what principal investigator said done at the same time, the research data that exists not to be buried with the investigator, but benefit society, there has been a major change over the last -- it's hard to know when it began, but the genome project a visible process for that. it is moving forward and i can tell you that the nih is aware of this and pushing it to some degree more than weçóñi were soe years ago. but it does reach an issue that gets quite complex as you have researchers and others where they can begin to figure out whether someone wasçó in the daa

set. many of the will be aware of the publications about that in the past couple of years. there are a couple ofu lessonso learn from that. one is the abilityñr to come up with new techniques to in a few whether someone was in a data set or not surprises. we don't know in the future how people will be able to use this information. ñ+wñiçóçóthat's the first take. this can be important -- while youñp(articipate in2ááqáqp)ch project about schizophrenia,ñrñr some people could befall someone if it found out they were participating in one research arm of that or what ever you are looking at. what's happening is that now pay gets to be more complicated in how do balance not to, but three important principles. one is free and open access to

research data. ideally, it ought toçkomc=sne researchers ownership to some degree, or lease the rental of that information. that has been done in the past few years by having publication embargoes so that in the data set, someone says we like to have large collections of genotypes. if we say we will make all of the data public, but nobody decides you and your close collaborators can publish and submit for publication on that data for nine months or however long after they're made available -- that has been worked out more less. but now you have a third party involved, the research participant. what is their right to privacy? what is their right in terms of this information?

thereñwiñi are two major divisi- in new studies going forward, clearly people haveñi begun to construct consent and consent process is in a way to foresee this use of the inflammation. many people would say as long as it clearly is spelled out in a way that the person actually understand what is going to happen with their data, that is one thing. the problem is going back to the time when nobody had any idea about this in terms of constructing consent. so what they're doing is to go rigorously back over each one of those consents and see what we think -- i am the co-chair of a

group looking to develop trans- nih policy on sequencing. i think you'll see a notice coming out within a couple of weeks formerly declaring we will be looking at this and we hope to have some principles. there will not be paulist -- there will be one policy that fits all. there'll be some basic underlying principles that set all and then how you do that for each situation, we need to base some of those principles and to some degree to the participants. >> let me press you about research models. if you could summarize the research models you think maybe the most productive five, 10, or more years out. as an attorney, i take the

problem is matching out human experience, medical records with a genetic model. when i think of models, i think of an analogy to physics were a mathematical model exists and experimental data are gathered head ofental data are gathered each other. hear, the genome and the medical records, bringing them into greater congruence. 10 years out, in light of what you just said, what are the most likely research models? ñiwe have the thousand genome project and others,ñi but you ao mentioned the wiki era we live in andñi some direct to consumer companies will be seeking to play a role in research. patient groups gather in

aggregations through the internet. what do you see is the basic research models in this totally different world a decade out? >> i think that's a wonderful question and very difficult to answer. first of all, he said it correctly. he said models and i think we will see a proliferation of worthwhile models. there will be more kinds of models and we're used to. the drivers of those models are going to be somewhat different from the ones we are used to. the idea of the individual investigator will be important for much biological research, but for some of the applications we're talking about, it's going to be multiple centers. it probably will come from the participant community. it's clearly the case in the area of disease where people

aggregate individuals and families with air-conditioned and go to researchers and say here is some research the chicken do now. we will enable you to do that. research -- -- here is some research that you can do now. how that information is used, what happens if drugs are developed based on it, who will have use of the drugs, at what cost, etc. it will be much more of a partnership than it is now. the first change is going to be the availability of sequencing. with the amount of time it takes to get a research project off the ground, the studies done the way we're doing now, it's almost finished. soon it will be complete sequencing. already people are asking should i get to complete exxon sequencing?

when the place -- when the price could slow enough, it's $1,000, why waste time and money when you could just get the inflation? the other implication is we have all that information. more and more of this will be tied to medical records and other kinds of information about individuals. once you have someone's sequence, in the futureñi, once you have identified their sequence,ñiñrñr some of you will remember an interesting piece at time of the election, there was speculation as to whatñi happens in the future election and we have complete genome sequencing available. it's inexpensive and we know with the informational means. presidential candidates will be able to drink coffee anymore because all you need is a coffee cup and you can harvest the dna and then be able to say something about theirñi genetic variants which had to do with impulsive behavior, criminal

intent, all kinds of behavioral traits we have not talkedñi abot at all but its huge important to people. all of those things have a genetic componentçó which coulde exaggerated easily. those kinds of questions, in terms of research and other use of the information is going to be very important. >> how do you think the direct to consumers commercial enterprise can interdigitate with what's happening at nih and elsewhere in the public domain. -- in the public domain? what kind of expectations the anticipate would be appropriate? >> that's something we have been thinking about. i had conversations with that a number of direct consumer marketers because clearly some of them more than others, but

several of them talk about wanting to be old to participate in research. they have the potentialñi againo congregate a lot of individuals. as you wrl hear more directly from some of the purveyors, they come from a tradition out of the world of google and others. e1people have shown that they don't care so much about privacy as we saw. they're willing to give up information willingly as long as they can navigate freely. but some individuals are not as concerned. altruism is alive and more well than we thought. there are many individuals who say i'm going to be sequenced, go ahead and use it. i think it's going to be tricky

and i think part of the question is how you design consent process these that are not just a legal document to help you in court? how you design a process is for these -- for this kind of world in which the participant is truly informed? i say that not just about the direct consumer, but in terms of traditional academic research as well. what are the rights of people to draw simple thing want? to use it only for investigating certain diseases or others? i think it's very complex and there's a potential thereñi for other groups besides the nih to be doing worthwhile research. it's difficult, but also in terms of well-designed research.

you need to think about who these people are and what is the bias of ascertaining if these people happen to have the wherewithal for paying for these services or whatever. that is not to say that as long as one is awful about designing research, that there cannot be applications. >> to take that a little further, did she think significant issue is the annotated phenotype of the samples and least significant part of the true expense of the research in asking the questions is not theçó dna sequencing, but the net at data that attends the sequence? >> that's a key point. as the sequencing cost of going down, and this is happening in some studies where the g a typing staff is -- where theñr keynote typing stuff is penciled. ñiif youñi areñr relying on soft

reported data, one needs to be cognizant of limitations has. ñrsome information is pretty go, for others it is poor. i think that naively people think we have these people who do this wonderful research and we need to see if we need -- we need to look hard at the methodology and see that one to be valid. ñr>> thank you. >> i apologize. i'm going to have to leave because we are having a meeting at 10:00 on spending millions of dollars of stimulus money. i apologize i will bobby brown for the rest of the day. [applause] >> our next speaker is [unintelligible] ñrwith history and scientific

foundation. >> good morning everyone. thank you for the opportunity to speak this morning. a disclaimer -- since i partnered with others to write this speech, i have had some depressed interviews, more than the last 15 years combined. this piece has been labeled by many as two paternalistic or, some would say as a naysayer. i just want to latino on not a naysayer. i am quite excited about the technology but i also public health person and would love for the technology to be used. with that caveat, i would like to give you three things this morning, the status of personal

giono mixed in 2009. let's talk briefly about the scientific foundation for personal genomics. we will end with a synopsis of recommendations that the panel made last year that was published in the august issue of quality genetics and medicine." -- of "genetics and medicine." one of the most called are we there yet? just to summarize the status, people are excited about the studies that are afraid of the in irritability. we have talked about how important these things are for the biology, but if the question is, do we want to use current information for this prediction? i would like to read something from one of the articles -- one

article in favor of using the available genetic protectorsñr s that some information is better than no information that we should not let perfect the enemy of the good by refusing to make use of our knowledge until it is more complete. why not begin testing for common genetic [unintelligible] that is a fair question. i would like to tell you the limits of doing that. we have been waiting for that happen in the last couple of years and we of seen the emergence of the movement including the issue of "time magazine" allen showedñi earlie. i was told we were not ready for prime time. this is not an endorsement of these companies, but i wrote this piece that talked about different types of personal

genome profiles trade you can buy your pu"ujeuiq%j really expensive. it's around $50,000, but [unintelligible] you can also buy selected variants and you can also -- there are some applications for ancestry, for skin treatment, for what some people call recreational genomics. i use this only for risk assessment and disease prevention. part of the discussion from the bloggers and elsewhere, apparently the community out there is certainly interested in this. about 6% of the community -- i

don't know what to call them, the social net workers have used these kinds of testing and people are wondering whether or not you shouldñrçó have -- you shouldn't have access to this çóinformation. i personally have no problem with people buying their genome. it could be fun. i just want to show you the limits of doing it, as long as you know you're getting into, there is no problem there. we have done our own surveys and i think you will hear more about this survey and the general population and health care ñiproviders, the statistics in e u.s. are not as representative as the social not workers, although the awareness is there. very few people have actually used the genomes cans. you would not be surprised to

know that the [unintelligible] ñiçóñiand white etznkcity. among the providers, this was a random sample ofkoñi providersn 2008. almost half of the providers are aware of the services. it is interesting that we have been getting a lot of queries aboutñi this and about 15% of te providers, [unintelligible] the scary thing -- not scary, but it's a fact thatxd about 75% ofñrçó the kids -- of these instances, the providers changed some aspect ofñi practice as óc1 result of this. zvñithis is a general survey tt

had nothing to doñi with genomes ganz. we added a few questions to it. what is a science behind using genome stands for disease prevention? there are few steps in the process for when you want to use any by zero markers for prediction of the future. we look at four components. [unintelligible] how good is a test in telling youçó what the variants are? the validity and utility is what i'm going to focus on. i'm not going to talk with the ethical, legal, and social implications because i don't have that kind of time. over the weekend, one of the companies found glitch in the

analytics software that seems to have mental human and animal mitochondrial dna. some people were wondering if the results were below sapiens or not. there are errors and -- in the lab process and testing process [unintelligible] when you are looking at a million variants in mitochondrial genes, some things can go wrong and in this case did go wrong. but i'm not going to talk about that. in terms of clinical validity, what we're dealing with are essentially the ability -- the ability of these gene variants to predict future disease. we talk about sensitivity, specificity, positive and negative predicted values. usually people who measure the

relationship between genotypes and phenotypes, they use that information to measure for disease protection. there are essential steps in doing that. you have to establish and that -- a successful association to begin with. the second is how certain are the estimations? i have to give you some numbers to show that we have right now is based on shaky ground. last not least, evaluating the clinical relevance of these. this is from a paper we did last year -- it was quite a bit about the subject. will be quoting her a few times. this was from the analysis of

companies that were under market as of 2007. this does not cover some of the new stance, but to make a long story short, you can see at that time we reviewed seven companies selling 56 genes -- 24 of the 56 -- that was a relationship based on studies where there is no attempt to do that analysis and market data from seven studies at the same time. of the 32, 160 various work covered and only 60 of them, when you do the math analysis, it's different from one. even the findings were not significant. if you look at significant findings, most were week to

moderate and it goes back and forth. most of this year has been replicated, so just to put things into perspective, we are dealing with much more applicable associations people are putting on the market. there are a few of those that are predicated. the uncertainty of this estimation, when you find an association between 18 and a disease, it's an association between 18 and a disease. there is músu$at is still hidden and i would like to show ñiyou how to things influence te way you go from an observation to a prediction and mess up the interpretation. the other things are very important, the biological i uój)e (si aboutájju that. i'm only going to talk about two things.

the problem of stability and the variations of epidemiology in theñi disease is trying to predict. peter craft and others have looked at this in the series of articles in the quality new england journal of medicine. -- in the "new england journal of medicine." there is a strong familial packwood -- aggregation. the analysis has somewhere between one-half and threefold increase risk of that disease. what they did in this panel is to evaluate how many steps it would take, which is the root magnitude for which we have these associations. how many explain the relative risk of two or relative risk of three. long story short, the numbers youq,@ñ need to make those predictions are much higher than the ones we have right now.

ñifor most diseases right now, e . it may well be that you have much better genetic variants which requires a much larger sample. ñrthat is the problem -- we have right now does not explainñi the amount of aggregation people see in these diseases. what isñr the implication for te individual predictions? it can be rather severe. the panel on the right shows what happens with distribution and three types of people -- the person [unintelligible] the subject in blue are people with one-third of the medium risk.

theñiñi subject in black are pee at the medium risk. the panels show, depending on the number of undiscovered variants -- if you only have two hundred andñi discovered [unintelligible] xdñithere isçó quite a bit of ñiuncertainty. even people who [unintelligible] there is more misclassification -- with an increasing number, the number of misclassification seems to increase. there is about 7% of people labeled under the median. if you have to hundred as

opposed to 15%. what we are dealing with in a lot of uncertainty -- i'm sorry you cannot see the panel very well, but we would like to look at the [unintelligible] you basically use an external population incident treaty have age specific incidents. stuff in green is the people without the variants. because the association is weak, there is a limited [unintelligible]

women have a one in eight or one in nine lifetime risk. it is only when you assess them throughout the life cycle. on the bottom, use the amount of uncertainty. if you change the epidemiological parameters and change the relative risk, the incidence of that disease, you get so much more variation. if you apply it the ratio is you get john -- drawn from a general population, or have a different distribution of that disease or to risk factors, you could get some much more variation. that sort of cozy tightness is quite uncertain.

evaluating the clinical relevance in terms of sensitivities, specificity, and predictive value and with the offer in terms of added value, there is one way to look at the added value of these kinds of risk profiles in terms of what people call the area under the curve. it is sensitivity against specificity. if you take two people and you try to predict using their genetic profile, one will have the disease and what will not and if you try to put them in play, usually flip a coin and the probability is about 50%. that is what happens when you have the area under the curve and you have something that's not predicting more than chance. what peter kraft has done is for both process -- prostate cancer,

and you look at the ratios, d.c. an increase -- you see an increase in the response relationship. the riskçó isñi onlyçóñr at 1.5d there are very few people at the end of that distribution. it goesñr from 0.5 2.55, meaning there is much more to be explained. çóçópeople have known that for s and this is [unintelligible] l getñr disease and who will not. xdçóñithey have showed clearly t withñiñiñi their ratios,ñiñi se- átñi disease verses to will not is very much overlapping. it is reflected in the area

under the curveñr and there's a much strongerñi relationship in order for the areaçzo toñixdxd7 or 0.8, which is whereçó we are with some ofçóñer theseok-9 rik ñrçóñiñiñiñrñiçóthe limited addn changing landscape to the area under theñr curve for these ÷jfexistingñi types ofñixdñr tee the added valuexd of the genetic disease risk or type 2 diabetes, or prostate cancer. this was from an article published last year. ñiñithis is an importantçó areat

eeds to beñtrñi explored.ó areat çóif you look at the distributin ñi9k factors, it turns outñi that you can specify the population into those response relationships where some people at the end of this tradition have very high risk and some people at the lower end of the distribution have very low risk. most people are somewhere in the middle. the trek around if classification using genetics is that you have to find a way where the upper bound of the risk classification that is different clinical management that you need to do in the case of heart disease for example, whether you put people on çóthe discovery of theñrçó 9p21e

theyñhbyñ usedxdçó the variant n ñiaddition toçó risk reduction models for heartçó úwease -- you çóñie1ñi where the risk of heart disease be -- it's less than 5%. ñiñrçóñfiçóp,ñrñiñrñtrokñiñiñie people move higherçó levels because they have moved from the ui to high risk. this is an interesting way to look at this classification. are three ways to look at this. çóçófirst, your models have to e

calibrated and you have to correctly predict the risk of disease within groups. many of these early papers, the models have not been calibrated. çósecondly, there has to be discrimination. people sometimes say you don't need to change the area. çóñixdi]ñi!u2mmçi÷ñiñrfáçóñiñr

>> at one point, you tell

people that they are at high risk of type 2 diabetes. then you tell them you are a low-risk and u.s. [unintelligible] if you are trying to do risk- management and trying to do disease prevention, you have to be very careful what the interpretation of these things are. it is sort of where everything is closing up and some people think clinical utility is in the eye of the beholder. that's what an industry member told me last year. i happen to think there is more to it than not and i would like to give the to case scenarios to interpret. ñithereñi was a famous case for someone who work for these companies, a 38-year-old white male who was very interested in genomics. he found out his relative risk

for prostate cancer was 1.88. they found prostate cancer and [unintelligible] on the other hand, you have people like dr. oz, appearing on oprah winfrey saying when he appeared in november of 2008 appeared in november of 2008 xdñm/ñrthatñiñ had the risk for prostate cancer was 30% lower than average. on the basis of that,ñi he sayse doesn't have to have a rectal exams anymore. whatñixd is going on here is the rñiw more. ñiçyóñr0biñiñiçóxíkñii/wñrwhat?

are they actionable? çówhat didñiñrxd they tell peop? and imagine the -- what is in the balance for the population at large. at the same time, i was looking at these results, these partial results for long-term credit -- long-term clinical trial on screening for prostate cancer. ñiñiif you findñi ñ1e prostate cancer, the xuy)ak is still on whether or notñrñ1/>çzir>=iñiñy save some lives. 3 ññrñrñixdñiñiñiif you looriñin who take the test and have early prostate cancer discovered, i'm not sure that could be the case or not. n=óñiwwoktálrñ2óñs

old andñi haveñi a lot of reproductive years ahead of the. ñyóçó8hñakt(ñd]ñiçóqçóñiñqu%eje ñichanges works andçó reduces t2 diabetes. now you start with genetic polymorphism. in this case, they datañiñiñrçóe

l have a long way to go. in the last two minutes, i would like to summarize the deliberations and the ñiñrrecommendations of the pane. this is the panel we did last year. from the list of names, you can see there are a number of people from various companies, from academia, from nih, from cdc, etc. that's available in the august issue of "genetics and

medicine." it has to be an industry-wide standard. several companies have gotten together to write up the standards and it is basically about analytical quality and validity. when you get tested using three or fourñi companies, it's not good. it is the same gm andñi you have toeuz a common standard -- it çóñiwe also=)ñjfçóñrñiñr2nged tf multidisciplinaryñi research. how is put together and all of epidemiology needs to happenñrñs i was trying to suggest. ñrclinical evaluation in terms f quantifying the disease risk and reclassification and looking at other risk factors as well. how you -- is very confusing,

even for scientists. last but not least, the health service research, find out what the potential impact on health care delivery system of having these kinds of evolvingçó toolsn the health-care system. ñrñias for a publicñi health perspective, utilization and impact of the levels. in closing, one of the priorities we hear a lot about comparative effectiveness research, is thexd buzzword in washington these days. they recently released their top 100 recommendations. there were three orñiñiw3 four there a particular relevance to this area. ñrñrñiñrñrç'áokthe standardñi:xl outcomes. i hope someçó researchñi dollars

will be expanded on eva'=c%;! tie the evidence toçó factsçóñr. we need to develop the kind of evidence-basedçóçóok [unintelli] ñii am out of time here, so i am jumping over some slides. but there was an independent panel looking at the applications and picking up the personal genome profiles as well and looking at type 2 diabetes. this is from the january issue where they published their methods as well as key evidence [unintelligible] last but not least, we want toñh explore the value of personal utility.

sometimes there is no medical benefits, but there is personal utility for the person from a psychosocial perspective. there are a number of articles that explore what utility means and how you can quantify it. forp me, it has to be quantifid otherwise it could beç(pj good s astrological signs because they people. personal utility for others. my own personal view of personal utility is that we need to look before we leap. thank you very much. i'mñr sorry if iñi took morexd e than i should have. >> çóthank you very much. we have a littleñi time for questions. you are very thorough, but i'm sure there will be a question or two.

>> that was an extraordinarily rich presentation and not sure how much of it everyone can digest in such a short time. but there is a point of like to throw out on the table. with the hope that more discussion will occur during the meeting. you may statement about a group of companies coming together to establish scientific standardsñó for analytical validity. i just want to make clear to the audience that in ordinary diagnostic testing, the sort of thing you get when your doctor takes a blood sample or some other specimens and sends it to a lab. the labs are kcáu11e quite ñiregulated at both federal and

state levels. in addition to the regulation, many of the laboratories are participants in accreditation programs. accreditation programs are not the and all and be all, but they are valuable. they engage in proficiency testing. what that means is that every month, or more frequently, they get on the samples from the efficiency testing organization that they have to analyze and said results to be compared with dozens or hundreds of other labs doing the exact same test in order to determine whether their analysis is valid, whether they have problems in the way they're doing an analysis or whether their answers are way off the scale. one of the questions i would be interested is what equivalent or

oversight protection mechanisms are applied to the direct consumer industry, if any? and, should there be? i leave that for further discussion. >> do you want an answer or is it to you just want to throw out there? >> it's up to the moderator. maybe we could wait for others from industry to have a chance. >> we will have a chance. >> that was a very elegant presentation [inaudible] >> you have to talk louder. >> when you showed some of these

associations and the borderline ratio, they provide the information to individuals that bring to a clinician, i'm concerned about the education need for these conditions, not only to know what the alteration means, but the necessity to add more value or markers in other clinical findings they have at the time. how you go from negative to positive just from we put into the calculations is very revealing to me. >> that is the whole point. when you have week to moderate associations, all of these models tend to be best at. the lack of calibration and sometimes you have minor changes and other risk factors and in an environment interactions. it makes it so much harder to interpret. it's hard enough to tell someone you are at 10% at risk

of a disease whereas the average person has an 8% increase disease risk. they're going from 8% up to 10%, it may or may not mean anything. but if i tell you your risk is 10% and a test tomorrow for something else, it might go back down to 6%, that becomes even harder to digest. that is the state of the science, because of the hidden heritage ability and complicated jean environment and risk factors. what i am saying is that all those risk profiles don't add much to what we currently know. if i was a clinician in my clinic and somebody [unintelligible] i would use those printouts as teachable moments, if you will, to teach people about health promotion into these prevention

i would use the g note type as a way to vote -- i would use the genotype as a way to do that. for the most part, we are dealing with a little bit up and a letdown and a changing landscape. reenforcing general prevention and health promotion messages is where i would go with this. >> we're going to do our best to stay on schedule and take one more question and then moved to our next speaker. >> as a molecular geneticist and physician, i would agree that the effects are very small individually. the data are very recent, so the models are in evolution. i think the types of analysis are very valuable in looking at

the clinical utility, which is a important question. but i would ask to questions -- first, the meta analysis you have shown is the data from before it that era. a lot of it was not replicated by the studies. do you plan to repeat that type of analysis? the second question is i was a little surprised about your reclassification of type 2 diabetes because the reclassification was based on looking at gender and bmi after applying [unintelligible] the models are still in evolution, but generally when we look at diabetes with gender and bmi as one of the first risk predictors, not a secondary one. >> first question first.

i agree with you. [unintelligible] we have been tracking this act cdc and we have about 40 two thousand articles over the past few years. we have about 400 torso -- we have about four hundred or so from this era. there is also meta analysis currently being looked at. the good thing is it's more robust and there's a larger sample size. you could still have some of these analytic biases, we're looking at. 't think we have something to say right now. the secondñiçóñr questionxdñrñit involved with that analysis. she has the data. you have a study in rotterdam

wsere you look at the instances of type 2ñiçó diabetes overtimef five-seven years. i think she's that and i have for paper with me, to show an illustration as toñi in the modl and change. ñiñiyou start with age, gender,d bmiñi t(first before you get toe other vraants. i think you did that in some of the publications, butñr if you don't use these clinical markers at theñi end any just rely on genetics, this is data set. your point is well taken. >> thank you very much. [applause]

>> now we're going to david baker who will speak to us on direct%o consumersñi genetic testing, present and future markets. thank you. >> thank you very much, thank you to theñi organizers for afternoon to give the stock. çó-- to give this talk. i am replacing one of the speakers who could not make it. [unintelligible] is a new company entering into this field with a new approach we're taking. with a general understanding of the limitations of these tests people by the hand and teach them about genetics as well as

áññi:f>x(xw thisime. 3q%~m413 directly goesçó toward howñrokwi shouldçó÷d looku at genetics. w%z, agree would be actionable w?r, talks. ñixdxdstephen pindarç*ár'gs up d genetics. really worryñi about every aspet the#s. w3ñiñiñithere evujtxdokñr thingt give us worry and concern. hopefully, we will have -- the

point is toñr bring this to people and help to teach them. lr9c'g(zb brought and clients? ñiçóhow do we teach these limitations and benefits of these tests? 5?nçokñrñi=/%[hrrñé2hóñi/+ñdñiçd more politicians?k+&h0l3 )-ñdçóxdñ>áqxd. . ñiñiñr

in the future, we think the genetic information will play a role in earlier detection and prevention. these are &=5wez the few limited stories, one of which was already bro+glt up earlier,

that bring us all here today. certainly, there are a lot of success stories about using genetics in madison, including the controversial one at the bottom, whether or not we all realize it. surgery has its limitations. i am not sure that the doctor is being fully serious. i have spoken with him in the past. he is very concerned about the limitations. let me tell you a little bit about pathway. we have our on-site lab. it is in california. we have licenses for high complexity genetic testing. we have a strong team of ph.d.'s, scientists in m

bioschematics. there's also some ancestry content in it as well. where using multiple dino-typing platforms. -- geno-typing platforms. we are engaged in proficiency testing for our particular assay. another aspect of our service is that we integrate family history and life style questionnaires. we think these are extremely important. family history come alive stuff, and things like pmi are often more important than the genetic factors. we tried to present a platform

across which a person can get an indication of their disease risk. we use genetic counselors as well. certain genentech results -- certain genotype results will predict [unintelligible] we have a very strong team of physics folks, as well as jim plant. this is his fifth company. we also have michael nova who is our !% medical officer. we also have the head of the and you cst head of genetics -- the head of the ucsd genetics.

and our advisors are a strong group of individuals. we have published several papers on alzheimer's disease and genetics. [unintelligible] the customer comes on line, gives saliva, comes to the test, comes to our lab, we tested, everything stays in house, the sample stays in house in process on our facility, and we have control of the sample and the

data. genetic counselors are in place. we have a position of record that is reviewing -- we have the physician of record that is reviewing the data. there will be questions in the genetic results and questions in the lifestyle that will be available ahead of receiving the results. the criteria we use is similar, but it is more stringent than some of our competitors. we have validated markers that have been at least concerned in the secondary steady and then preliminary -- secondary study and then preliminary

information. in general, we have developed most of the markers that are directly tested with unknown associations. the secondary study also has had the unique human standards. it must show association in the same direction. i think that leads to some of variability that have been seen in other studies and have been pointed out by at our previous speaker. some allele associations and some representations are with the same allele and not with the same ethnicities. we have a scientific fact that

reviews these papers. we will continue to update our snap pal as well as our scientific data as more as known. we are testing about 25 complex conditions. these are the number of genes. in some cases, they are a very limited number. with others, they are a growing number in type 2 diabetes, for example. an example of the health page and how we show -- we have included harvard health content. we give very detailed information about the condition itself broadly, how that

condition might be treated, things you can discuss with your doctor, and other factors that are involved. our genetic risk is that we have taken the stance that, with all the variability and the issues around individual markers, it is not really appropriate to give an actual percent risk. we use of ratios similar to our competitors. there have been earlier discussions about how to standardize these. those discussions are ongoing. we are very consistent with how others are using on a ratio to calculate risk. but we do not multiplied by five

times risk. we actually give you a number -- but we do not multiplied it by five times risk. -- we do not multiply it by 5 times risk. we actually give you a number. the other message that i would like to point out is that we do try to bring out the information as far as will i get the disease and what i should do about it? we get into the lifestyle factors and the family risk. we give more intermission tlat has been reviewed in the field and written up by our scientific staff and some data on markers themselves and in direct references.

another factor that we do test is some high monogenic disorders. we have come forward and out our -- and picked out our martyrs. for example -- and pick out our markers. for example, cystic fibrosis and await test about 23 -- and we tested but 73 recurrent mutations. we also test for several other genetic markers. several are emerging data and we

tried to discuss how it might be useful for our clients. our ancestry test tests for the two hundred 50 paternal possible -- for about 250 paternal possible y chromosomes. you get an idea of how you fit into human history and whether or not -- well, and also help to define ethnicity. privacy and security are important at pathway. we feel that privacy is important. we have hired a security

officer. we have a detailed consent form that is distilled into a single page so that we give you a highlight view of the most important characteristics in that. there is a typo in theire. sorry. security -- we essentially treating our facility and information with data center level controls. we have worked with for many years. he has the understanding of how to deal with -- we have worked with capital one for many years. whe has the understanding of how to deal with these issues. security and privacy is so important that the protector

would not work. we feel that pathway genomics has a strong scientific team, an onsite laboratory, and we have lower costs than our competitors. we have a test and design chip containing numerous meaningful steps and it is an opportunity to test meaningful associations. we have customer and proprietary assets. we incorporate family history and have highly experienced in our successful management team -- and have highly experhighly

experienced and successful management team. i guess i should have updated that slide. we feel u$at informed patients will accelerate the change in medical practice. i think it is exciting that people are actually approaching their genetics and taking those to their physician. there is certainly a lot of )jju$at we can discuss@e=uq whether or not how useful th is. certainly, some medical changes could be made and could be as simple as alterations in diet and lifestyle. get from getting good information? i think one of the big criticisms is the fact that will

tell it -- that we always tell people to diet and exercise. that is the same message that we get from thousands of web pages and commercials every day. the feeling is that people will take their personal genetic information a little more seriously and may actually uses to motivate themselves to make some specific changes. the data certainly is very new and not expensive in this area. but there are some suggestions in support of that information, that theat may actually be occurring. it'll be interesting to see how the studies will come out. it should be published later this year.

it is very important to actually present limitations on risk and benefits, for the consumer especially. as we have discussed, the $1,000 in chino will be here by 2010. -- the $1,000 genome will be here by 2010. d. no typing -- genotyping will be cheaper. you could have markers as low as $25 in the near future. hold genome sit and say -- home genome sequencing will bring of these issues.

as we have been discussing, many more markers will be clinically validated and useful. now is the time to try to educate and inform people, even if the risks change slightly. i think there is definitely difficultly in trying to explain increased risks and decreasing risks that happen over a month when your genetics do not change, but the analyses do. i think the onus is on us at this point to help make that happen and to inform people more. i would like to bring up the potential at dpc genetics. it has the potential of bringing out information in ways not approached before. it has the assault -- the

possibility to inform and educate and to facilitate the transformation to personalize medicine. that is my talk. thank you very much. >> thank you, david. this presentation is now open for questions. jonathan and then jill. >> that was very helpful. thank you for filling in a big " i want to explore with you, and maybe others -- thank you for filling in. >> what i want to explore with you, and manmay be others, you mentioned the privacy and the form of consent. what does this mean for the therapeutic relationship? when does a client enter into a

therapeutic relationsh)p with you, your company, the agents, the employees of your company? we know you're not in that relationship if you're a dermatologist and your first and let me and they're slapping baby oil on yourself. you cannot go up to them and say that you should not be doing that. understandably, that person on the beach did not go to her and say, you are my doctor, tell me what i need to do. maybe i will do it and maybe i will not. but tell me what you think that ought to do or not to do. the paradigm case of entering that relationship is, when you go to a doctor, you say, take care of me. if there is a non voluntary situation which is, i feel faint flying over the atlantic and the

pilot prevails upon a cardiologist to come to look at me. those seem to be clear cases of a voluntary or non voluntary relationships. let's say that i wanted to know if i was related to barack obama -- and i probably am because everybody is or wants to be around here -- but i go to your company to do this analysis. i am sure that you do a good job find some things that are medical that are of concern to me. at the moment that i signed the form in which i acknowledge that that might happen, is that when i enter into a therapeutic find something and you're council gets in vouch with me?

or is that neither of those cases? i don't put anybody on the spot. i just want to surface the question because it is really hard. maybe it is an anachronistì(lc@+ concept. maybe this is just changing and so it does not apply anymore. we need to develop some basic modification of the idea when i become a patient. >> thank you very much. that is a great question. i think that question relates directly to some of the "1scuss and we had we have all been in and o-- we have opted -in and opt-out options. the client may opt in and say, i

am ok with it. and then they could find a particular damage limitation, in a worst case scenario, and they may be a little aghast. i think that is still the challenge in genetics in general. people may have an expectation up front. more the issue may be pretest education and proteetest handlig of that person. >> i would like to follow-up on that. again, i do not mean to be provocative, although identity sometimes. are you practicing medicine when you provide this information and counseling to a person? i ask that because, if you are, my recollection from a long time in california is in that that

state, at least, has a law against corporate practice in medicine. if you are practicing medicine if you are phoéeicing medicine that goes with being able to get a license and maintain a license to practice medicine. do you think you're practicing medicine? if you do not think so, could you homan understand why you are not practicing medicine? %p&ñháhat we aredicine? practicing medicine. practicing medicine. and we do not intend to try to diagnose and give people specific treatments and work however, we$do feel like we're

giving them useful information that they can take to their physician. >> what happens when your counselor is explaining results to your client. how is that different from a counselor and san francisco general hospital or some other place? >> in general, it is quite close. our counselors are well-trained people with their certifications. they are sitting down with the client and talking about their family history and their overall lifestyle as well, then getting into the genetics and discussing that and how that may affect them. if there is an issue, there will be getting them in touch with their physician.

them in touch with theiretting- physician. >> thank you. >> i wanted to follow-up on the genetic counseling question. >can you tell us a little bit more about the structure of the genetic counseling that you offer? are ,our coun?=imeváup#ford you contract that somewhere else? second, do you offer the opportunity for your clients to talk with a counselor before talk withink he said that befor. >> that is an opportunity that the client can talk to the genetic counselor before ordering the test. the second question -- the first question, actually, is that we do have genetic counselors on staff. but we also contract outside counselors. >> in one of the papers you

referred to, the jáu$at is in the current issue of "genetics and medicine," you elaborated a little bit on the notion of something like 75% of the clinicians said that they actually changed management recommendations on the basis of the information that people were bringing to them. the way you refer to it in the journal is that svrveyóh"ata revealed a disconnect between perceived validitywsv betwee sll%,pr#ctice aídl5he do not know. the survey is limited in scope and the kind of questions we asked and the potential responses. these were a numb%r of questios that were added to an already lengthy survey. it was a shot in the dqrk asking

about this. whether you told them something that you would not tell them otherwiáq we do not have an idea what that is. jt answer that uát require -- it is a tantalizing answer that would require more. you can postulate what rá mean, that people ase looking at this in a positivk way that allowed clinicians to focus on, let's say, heart disease. negative outcome if it ordered a procedure that they should not have ordered. it could happen -- it could be >> let me ask you this. and again, i mentioned that i was an attorney. #ti may have a genetic

polymorphism. [laughter] its is the same theme. have you had a melt down. -- a meltdown? all signed permission forms. while you may have confront your clients with the permission form, they may have signed at of wr&lingly and unthinkingly. then they request everything u very serious disorders and the have you had a meltdown and have iou handled it? does anyone here have any similar examples? >> currently, we have not had a meltdown. people have given us positive

feedback so far. as i have said, we are still a new company, so we probably do not have the birth of some og the others. i am not really sure that heard of meltdowns at other companies. maybe there's someone in the audience who may be able to address that. >> can you define "meltdown?" >> declined becomes a patient and becom]s devastated. th is my definition. >> and he/she feels that they process could mean? >> yes. they simply did not expect the deliver the results that it did. genetic counseling.

we have had a lot of experience in working with a large number of individuals through our i have to say, overwhelmingly, it has been perceived as an in powering and positive we're 'ot currq'tly testing for any monogenic conditions. i think that takes us ut of the scope of some of the more the impact. in our current model, we have to rethink how we present the information very carefully before we will let any information in that scope. in terms of individuals who hae gotten certain results around old-timers, i think this is certainly -- around alzheimer's, i think this is certainly something that people are familiar with and it is a devastating disease. we have had some individuals who have had some heightened anxiety from their test results. é help them identify -- one of

the interesting things thar have come out of this from our standpolnt is that people not only really want the want to get involved in researc+ studies so that, even if it does aybe they caí actually help the community and others down the road. it"really has been a call to action. we have had several people get involved in national efforts based on learning about their own genetic and opinions. i think there are broad ranges to the impact, again, overwhelmingly positive. >> you mentioned alzheimer's. what marker is significantly predictive of alzheimer's to the point where you tell me that i

am likely to get it or however you deliver the information? what kind of markers are they that have that kind of clinical validity, if you will, that you can deliver that information with all its consequences to me?

>> that is a foot. my answer for mike -- for the committee to think about -- that is a footnote to my answer for the committee to think about. >> of the physician has to act on americans and most americans are overweight. the physician has to act on

those senses as well. >> you do not need the genome to act. >> that is true. >> next question could >> some of these questions have danced around my morning a question. that is not leave because i am from maryland. -- that is naive because i am from maryland. what is it that you offer your clients and what is the implied promise in the offer and what are the expectationsñi? all of this is going to affect the therapeutic relationship. it is going to affect the meltdown. it is going to affect all the questions that have been addressed to you. çóçóñithose are things that, to, strike atñi my relationships wih my patients. the intrigue me with the dtv

pharmaceutical thrust -- a tthed tc pharmaceutical thrust. >> we hope that our message is straightforward as best as it can be to bring forth the#% li"u)jjjt these tests and still provide information about ñiyour genome at a level that it has never been before obtainable. i were messaging, not to get into too much of the details, are on the website. we do talk about presenting risk information with the message also about the limitation of those tests. we think that it is about improving your health overall and that, again, going back to our central message, the genetic

information is something people are interested in. it may motivate people to make decisions that would improve their health. does that answer your question? ñiñs changingt( weekly, do you rçó? ñrñ$2wsyxdñrñrñkorif so, howñiñu were basing this on identified snips of literature currently? ñisecond,ñiñiçóñr seeingñiñiñr r california approved,ñiñr!)%a5e regulation in this area? óñyefoe

o that inf. rightçó now, we do notñrñi-9çóa particularw3ñi timing scheduledr how often we do that. ñiñiñibut the goal is to haveñir clients stay with us forñi the long term and try toñi teach thm out. ó=)ññizvtht changeñi their>2ñqññiñrçó or3we theirñi risk. we want to be able toçó inform them about that. ñiçóñi=)ñ

german battleship fired the first shots of world war ii at a small polish military outpost. earlier today, world leaders gathered in poland to remember the beginning of the war and the people who lost their lives.

this is an hour and 25 minutes.

>> i want to welcome everybody to this event. i want to extend a welcome [unintelligible] including people of the bank who have covered here and especially warm words of welcome. i would like to ask everybody to stand up and listen to the anthem of the republic of poland. ñrñr

>> take your seats, please. i want toñi invite the president

to open the ceremony. >> prime minister, madam counselor, prime ministers president, speakers, ladies and gentlemen, today becomes the 70th anniversary of the outbreak of the world of wars, of world war ii. the symbol of her roke resistance over overwhelming

forceçó -- several kilometers fm hereçóñi isçóxd the town that we first to be bombed. of total character of this war. over two generations have passed, butñrñi this warçóxd cos to demandñiñiñrñkó perfectioñir. now the question arises what caused this? i certas and chauvinism. i br

war ii one, the order wasñi the- i, the ordo construct peace on our continent and in the world. the treaty of riversideñversaile road to independence,ñzbutñiçó hungry, finland, czechoslovakia, and then yugoslavia and within yugoslavia, sylvania, croatia, u the protectionñiñiñrzvóii of minori.

it turned outxdçóñ)ñáçó to bexzl least forj/çó theñi]/> reasonst totalitarianism emerged. the breakthrough occurrence was the emergence of the third reich. rxdñr+ydr which livedñ)ó by ideology ofñi revenge9xdt(k>cc ê.ú'÷#@4

as winston churchill rightly said, the powers chosen between disgrace and dishonor or disgrace sandor, they chose war, but they -- they chose a disgrace, but they will have war. in the integrity area of czechoslovakia was stipulated by the munich treaty. it was wrong then and it is wrong today to infringe on a country's territory. it is not only an issue of totalitarianism. it is also something that is

characteristic of countriesñi with imperialistic policies. we witnessed that last year. joining the partition of joining the partition of czechoslovakia was our sinñ çócthi]/j]ñbgxi]qññçó and we do not look for excuses even ifñr suchçó excuses were availa. ófáñiñiçóñeó]/>m/vçómunich cals that are viable today. imperialism's should not beñi bowed to. not even near-imperialists attitudes can be tolerated.

can it out, tolerating imperialism not always as rapid as those that followed a minute -- belling to totalitarians -- tolerating imperialism is not always as rapid as those that fall of munich. it was not simply a non- aggression pact. it was also a pact that stipulated the division of europe into areas of influence. i want to reiterate what i said this morning. poland did receive the proposal

ofb(ájájjtñi dh anti-common 10 pact and there was a proposal for poland to join a march to theñi9 (áñiçóñr. ñiñrñ'ibut poland renounced that proposal and did not join. ñil&z1eíñ%m3;r+=çgr#ñiñiñióñi's çó-- it was adhering to its treaties. the war that broke out lead to ñrñiñiçóñixdçódefeat. there was no other possible outcome. this was followed by the tragic ñioccupation, exceptionally tragic, not only inñixdñr pc nd. ñi5.5 million to çó5.8 million