>> presidents, prime minister, excellencies, distinguished guests, ladies and gentlemen, 70 years ago today we saw the outbreak of a storm, a storm that ravaged our continent and spread throughout the world, world war ii began. it was 4:45 in the morning right here in westerplatte, the battleship suddenly opened fire on the polish garrison. in the years that followed we saw nations fall, democracies tumble and people enslaved. we saw the destruction of invaluable cultural heritage. we saw cities engulfed by fire. we saw killing that we still find hard to understand.

over 60 million peoples lost their lives, the majority of them civilians. this makes the second world war the deadliest, bloodiest conflict in human history. ..

gathered here today, we call for the remembrance of one of the darkest hours in the history of mankind. and remembrae is necessary. it is necessary because if not remembered, history may repeat itself. world war ii changed not only europe, but the entire world and in europe, we learned the lesson that we must build a common future, not on conflict, but on cooperation. it was a painful lesson and that makes it even more important to remember. never again. these were the words that rose to the sky from the survivors in

the ruins left by the war. never again war. that was the founding pillar of the european project that we now know today as the european union. the european cooperation that followed the end of world war ii was not only created as an escape from the extreme forms of nationalism, which has devastated our continent. it was also founded in order to give the people of europe a chance to build a common future. based on values such as tolerance, democracy, market economy, and rule of law. from this point of view, this year is also a year of celebration. and remembrance of european cooperation, integration, democracy, and freedom. 60 years ago, the council of

europe was founded and just two years later, the european coal and steel community was established. 30 years ago, the first direct elections of the european parliament was held, and 20 years ago, we saw the fall of the berlin wall and the birth of a new and free europe. certainly, we have reason to celebrate, yet these celebrations are worth nothing if we dootemember the war that 70 years ago ravaged our continen if we do not remember the victims, the survivors and people who gave their lives to save the others, if we do not remember and honor those that sacrificed their les to respect for human dignity. our collective memory becomes weaker and weaker, and the older generation, those who survived,

disappear and can no longer be a witness. but here today, we must say, we will never let this memory escape. we must remember, we must show that we have learned the lesson. today, tomorrow, and in the days to come. and we must do so to ensure that two words, will have genuine meaning as we build our common future. the words, never again. thank you. [applause] >> our celebrations have come to an end. i hope that the message of this assembly will stay in your memories for a long time, and will be delegations.

please turn to the exit on the right and the public will be so kind as to leave by the entrance through which they came. thank you. ♪

>> coming up next, a discussion on the citizens united versus fec. the ruling in that case could have a major impact on corporations to spend money on political campaign. it will also be the first case heard by justice sonia sotomayor. discussion should get underway shortly. live coverage here on c-span2. on the supreme court, the associated press is reporting this morning that supreme court justice john paul stevens has hired two more law clerks than usual, generating speculation that the leader of the court's libels will retire next year. if stevens does step down, he would give president barack

obama his second high court nomination in two years. the a.p. rights that souter failure to hire clerks was the first signal that he was contemplating leaving the court. they also write that justice stevens, age 89, joined the court in 1975. he's the second oldest justice in t court's history after oliver wendell helms and the seven longest serving justice with more than 37 years and 8 months on the court. again, waiting for the discussion on next week's case here at the american constitution society. [inaudible conversations]

[inaudible conversations] [inaudible conversations]

[inaible conversations]

>> here we're rating for a discussion on the saturday of the case, citizens united the ruling could have a mainly i remember packet on the ability of corporations to spend money on political campaigns. might be a couple of minutes here before it gets underway. the associated press reporting today, president obama and his family heading for a couple of days up at camp david, reports indicate also the president is

likely to give a speech befor congss when they return next week, a speech focusing on health care and health care we have a web site for you, c-span health care hub, where you can sendúus your videos if you've attended town hall meetings and upload video there to c-span.org/citizen video. >> one of the participants in the discussion which we now understand will get underway at 9:30 a.m., so about 15 minutes from now. moments ago, we were reminding you about our health care hub and among the health care coverage that we're bringing you, some folks here in missouri

at a recent health care coverage of a recent town hall. here's from our health care hub. a look. >> i'm john from rich land, missouri and i'm really concerned that there's a lot of scare tactics going on on both sides, that we're not getting a lot of the truth and it's really hard to make a good decision or choose your sides, because of that. did you see senator mccaskill's town hall and if so, what did you think of it? >> no, i did not. >> what do you think of any of your representatives here from missouri and their opinion on the matter? >> well, i've been trying to keep up with what hour representatives are saying and right now, it almost seems like we're leaning strong toward a reform, but i'm not sure how good that reform is going to be for missouri people. >> mr. swkrao: i'm janet, i'm from springfield missouri and i'm totally against the health care issue that we have today. we have to stop what we are doing right now, and we cannot let this program go through any

farther. obama's way of thinking is not the way that the united states -- people of the united ates are thinking. congress is not listening to us, and we as people have to open our mouths and say time to stop, time to listen to the people. >> senator mccaskill here from missouri had a town hall republic sently. did you see that and what were your thoughts on that? >> i wasn't at the town hall meet, but i did see some of it on television. i thought she did a rather good job, but i didn't know why she didn't understand why the people were so vocal. the people are vocal because it means so much to us. this is very important for the young people in our community, babies, for old people, for everyone. we need health care and we need good health care, not what is being proposed today and they must vote for the way the people want us to vote. that's why we elected them. >> my thoughts on health care, i wish that president obama would give us real true health care. i wish he'd look at the france

system, i wish we'd look at the british system, even canada, i've been to canada, i've been to france, i've been to britain and i've just seen that those people, no matter what the hangups are, they have good health insurance. >> did you see claire mccaskil mccaskill's town hall, and if so, what did you think of it. >> yes i did. i thought it was sad but also necessary for everybody to have the right to say whatever they want to say about health care. it is a challenging situation for everyone and there are a lot of people without work right now and they need health care, and they need the right kind of health care, not expensive. and not for people who are else's expenses. >> my john is john, i'm from maryville, missouri, and i think the health care could be a good thing here in america, if it's done in a certain way that would help the elderly and the -- but give the people freedom of doctors, choices that they want,

and the freedom to go to their own doctors. >> what do you think about the town halls and how they've been going? >> they're not getting much accomplished, i think. theyúsay it's a war out there. and that's what i think. >> have you been to one yourself? >> no, i have not. >> would you like to goo one? >> i think so, if it was close enough to my area. >> my name is janet, i'm from missouri and my thoughts on the health care is i realize there are a lot of people who need help with their insurance. on the other hand, i don't like the government trying to come in hand give us something. i think it needs to be private industry, that's what america is all about. >> now claire mccaskill, the senator here from missouri, she had a town hall republic centsly, did you see that and at were your thoughts? >> i did not see it but i heard all about it where the people were outraged, upset, rude, i heard on the news. >> right now do you have health coverage and if so, where did you get that from? >> yes i do. from whdre my husband works at

the at a time. >> a few a -- at the state. >> if you attended a town hall in your town, you can share them with us on video at c-span.org/citizen video. >> coming in october, c-span's original documentary on the nation's highest court. part of supreme court week. here's some of what you'll see. >> mr. chief justice and may it please the court, the government can see that the destruction of documents in anticipation of a proceeding was not a crime in the fall of 2001. >> something different is going on here, than what goes on in the capitol building or in the white house, and you need to appreciate how important it is to our system of government. >> this is the highest court in the land, and the framers created it of after studying the great law givers inúhistory, and

taking a look at what they thought worldwide was important for their judicialúbranch to . >> i put in as much blood, sweat and tears on the little cases as i do on the big ones. we don't sit here to make the law, to decide who ought to win. we decide who wins upped the law that the people have adopted. >> you wille surprised by the high level of collegiality here. >> we're here to decide things, the job is to decide, we decide. >> why is it that we have an elegance, astonishingly beautiful imposing, impressive structure? it's to remind us that we have an important function. and to remind the public, when it sees the building, of the importance and the centrality of the law. >> i think the danger is that sometimes you come into a

building like this and think it's all about you or that you're important. and that is something that i don't think works well with this job. >> supreme court week, starting october 4, on c-span. >> the supreme court actually returns a week from today to take up a case dealing with the federal election commission, citizens united versus the federal election commission. they'll rehear that case a week from today. this morning, a discussion hosted by the american constitution society on the decision the court will make in t%at case. the discussion expected to get underway now in about ten minutes. 9:30 a.m. eastern. so in the meantime, we're going to show you an event from earlier this week with attorney general ken salazar. the construction of the fght 93 memorial will begin in

november. this half agreement with the landowners whose property surrounds the flight 93 se. thisuns about 15 minutes. >> are you ready? matt, kendra. thank you all for coming this afternoon. in less than two weeks from today, our nation will observe the eighth anniversary of september 11, 2001. we will join again to remember the friends, family members and day. we will remember the sacrifices of firefighters, police officers, first responders, and all those who rushed into the buildings in new york, and here in washington, d.c. and we will remember the heroes of flight 93. the people who gave their lives to bring down a plane in a

pennsylvania field. one of our own employees at interior nationalildlife refuge manager rich was on that flight. our memories of that day are still fresh today. the pain is still near. and we as a nation are right live committed to properly honoring and memorializing the lives of those we lost. that is why i am proud today to announce we have taken a major the heroes of flight 93. thanks to the good, collaborative work of many people, the united states, through the national park service, has signed agreements with all the land owners for all the properties needed to build the flight 93 memorial. this is a critical milestone. these agreements will allow us to break ground on the memorial this fall, and stay on schedule to complete the memorial by the 10th anniversary of the september 11 attacks. today's agreements are the results of herculessan work by

many people over the last several months, including the national park service, the families of flight 93, local land owners, senator specter and senator casey and others. i have been to the site twice in the last sex months, join in these -- 6 months, join in these conversations and to try to find a way forward that rks for all the parties involved. our goal has been to reach agreements for the local land owners for the property needed for the local memorial, to ensure that they receive fair compensation for their land and to stay on kid for completing the memial by september 11, 2011. the agreemes we are announcing today meet these goals, they protect private property rights and they keep us on the time. that we wap -- time line that we wanted. with seven of the eight property own he is, the park service has reached negotiated settlements. the closing on these properties will be complete by mid october. that will allow construction to begin immediately after the

memorial ground breaking in november. the park service will acquire and eighth parcel owned by the bonevic incorporated as well. the owners of this property have agreed with the park service to allow the courts to establish a fair compensation for that property. today's agreements are the product of good faith collaboration at many levels. and particularly, i want to thank dan, leader of the national park service and all of his staff, and i want to phank senator specter and senator casey, who have been tireless champions of this memorial. the fields of western pennsylvania are hallowed ground for a nation that is eternal live grateful for the passengers of flight 93. they are heroes and today is a milestonin commemorating their contribution to our country. i could not be more proud that the flight 93 memorial will soon stand if their on homplet -- in their on o. i -- their honor.

want to have dan wenk to make a couple of comments. >> i would also like to acknowledge the leadership of secretary salazar for bringing an emphasis to this with the families and with the land owners, that we were able to complete these negotiations and also to acknowledge the families and the lan land owners to come together with the national park service to complete these successful negotiations. thank you. t% thank you uan. and as part of the negotiating team that we had on the field working tirelessly on this, steve led that effort, one of our leaders also at national parks and also dan mcclay, who was very instrumental if helping us get the deals down. but i would be happy to take questions. yes. >> these are the entire parcels needed or the individual properties which you can reveal? >> the price tag -- i know i had

written that down somewhere. the price m- the way that this will proceed, there is phase one for the establishment of the memorial. that will be a little over $20 million for the lands@ acquisition and the construction of phase one. that is essentially the heart of what will be the memorial for flight 93. now the land that will be acquired in these agreements, the total amount is in the neighborhood of $9.5 million. that amount is reflective of the appraised fair market value f those properties. >> that doesn't include then obviously the court settlement that is yet to be determined. >> the $9.5 million is included within the appraised value. >> but not for the eighth property. >> it is included. >> oh, it is included. >> if the courts determine more, the price will go up. >> in that range. >> other questions?

are there questions on the line? >> finance you'd general knight. >> go ahead. >> hi, secretary. i was wondering, what exactly happened with negotiations wit with -- going to the courts and that route to get the land? >> i'm soak sorry, the question again? >> guggenheim to the route of using basically eminent domain to get the land from that one land owner. >> there was an agreement that was reached that the acquisition was in fact going to go forward. the agreement also said that we needed to have a determination of fair market value and the agreement was that the court would make that determination.

and so there will be the park service appraisals that will be presented, there will be the salvonik appraisal that will be presented and the court will determine the value. that's what happens when you have an agreed-upon proces of moving forward. it's an agreement that to us makes sense and tend of the day, we will honor the principle that land owners will receive, the constitutional requirement of fair market value. >> so negotiations just weren't going well with just doing it without the courts? >> no, the negotiations had actually, on that particular parcel, had actually reached agreement since back if january. that was when the determination was made to get to the fair market value would be to have an outside party determine it, in this case, the courts and that's essentially what will happen with this property. >> other questions?

thank you all for being here. one more question. >> can you talk a littl bit more, go if depth about some of the conversations you had during the negotiations with the land owners, what stood out to you, what was the most important thing to them that they needed to make this happen? >> i think first and foremost, it was the recognition among the land owners themselves that they also were victims of what happened from the tragic events of flight 93. yes, the heroes who we honor here were very much victims, as were their families, but so too was the community of summer set and the land owners who are affected by what's happening in the creation of this memorial and i think they wanted that recognition and that's very consistent with us honoring the private property rights of those land owners, which we have done and will do, so that stood out for me. i had also, you know, as part of that, that there was a sense from the land owners that this was hallowed ground, sacred

site, a place that was appropriate for a memorial, and a sse that they wanted to get to done being and they also i tk wanted to get it done in a way that sometimes these things end up in endless litigation, that's very costly for everybody. but that everybody would walk away saying we've done it for the right reasons, andúwe are going to move toward with a good neighbor policy. i was moved frankly by the people in somerset, pennsylvania, the last two times i went up there, about them wanting to be a good neighbor to this memorial. we are in the department of if tieror, the -- interior, the national parks, will forever have a presence in somerset and that presence will be one, our hope is, that we'll have the kind of good neighbor policy and support that we've had with so many of our other national parks around the country.

>> have the plans for the memorial changed at all? >> the plans and designs have been already to move forward, phase one, that's approximately $23 million effort that will be underway as soon as we start construction very, very soon. and there will be other phases of this memorial over time. but the plans have not changed. >> construction should start in november? >> yes. >> ok. >> thank you all very much for coming today. [inaudible conversations]

>> taking you now to a live look at the nation's capitol. a week away from congress coming back. they return next tuesday, september 8. we're waiting for the start of a conversation on the supreme court case that will be heard, reheard a week from today. the case, rehearing the court rehearing a case on citizens united versus the federal election commission. ruling on that case could have a major impact on the ability of corporations to spend money on political campaigns, discussion this morning from the american constitution society should get underway in just a couple of minutes and we'll have it for you live.

>> we are having a few technical issues in bringing you live coverage of our conversation this morning of the american constitution society on next week's supreme court case. we hope to resolve those issues and have live coverage shortly. in the meantime, comments from yesterday. president obama got a briefing yesterday from a number of cabinet agencies and department heads on the h1n1 swine flu virus. and u.s. government preparations. here's what he had to say yesterday. >>

>> good afternoon everybody. before i say a few words about the meeting we just had, i'd like to mention some good news that came out today about our economy. for the first time in 18 months, our manufacturing sector has expanded. and the statistics used to measure manufacturing output is the highest it's been in over two years. this means greater production of transportation equipment, like cars a electronic equipment like computers and aliances and it means these companies are starting to invest more and produce more. and it is a sign that we're on the path to economic recovery. there's no doubt that we have a long way to go and i and the other members of this administration will not let up until those americans who are looking for jobs can find them. but this is another important sign that we're heading in the right direction and that the steps we've taken to bring our economy back from the brink are

working. nowl we just had a good meeting about our ongoing efforts to prepare this country for the h1n1 flu virus this fall. and i want to thank john brennan, our cdc director tom freeden and secretary sebelius, napolitano, duncan and locke for all the good work they've been doing to get us to today. when i first saw the first cases of h1n1 in spring, i don't want anybody to be alarmed, but i want everyone to be prepar. response plans have been put in place across all levels of government. our plans and decisions are based on the best scientific information available and as the situation changes, we will continue to update the public. we're also making steady progress on developing a safe and effective h1n1 flu vaccine. and we expect a flu shot program

will begin soon. this program will be completely voluntary. but it will be strongly recommended. for all that we do in the federal government however, every american has a role to play in responding to this virus. we need state and local governments on the front lines to make anti-viral medications and vaccines available 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 to ensure that they have plans in place, if a family member, a child, or a co-worker contracts the flu, and needs to stay hoavment -- home and most importantly, we need everyone to get informed about individual risk factors and we need everyone to take the common sense steps that we know can make a difference. stay home if you're sick.

wash your hands frequently, cover your sneezes with your sleeve, not your hands, and take all the necessary precautions to stay healthy. i know it sounds simple, but it's 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've done an we anticipate that there will be some issues coming up over the next several months. the way it's moving is still somewhat unpredictable. but what i'm absolutely confidejt about is that our team, that's assembled here, has done an extraordinary job in preping for whatever may happen, so we appreciate all of

you for being here and i want to publicly again thank you for all your extraordinarily hard work. all right. >> mr. president, -- >> the president from yesterday. we're going to take you live now to a disssion on the supreme court case citizens versus -- citizens united versus the feddal election commission. the supreme court reporter moderating this discussion on the case that the supreme court will hear a week from today, just getting underway, live here on c-span2. >> -- their filings and since then, three times as many have come in for the rearguments that are so much more important to constitutional free speech. we're going to hear from our panelists today and then after their initial opening remarks, we're going to do some q & a up here and then take questions from you all, so please, be read difficult with any kind of queries thatou might have for our gup. immediately to my left is jim,

who is general counsel for the james madison center forree speech. to his left is larry gold, associe general counsel for the afl-cio and next to him is fred wertheimer, president and c.e.o. of democracy 21. joining us a little bit later in the program will be bob bauer, who is the general counsel for the democratic national committee, and all four of these gentlemen have been crucial players on campaign finance law for decades, literally. we're going to have each of them start with opening remarks about seven minutes, just to lay out where they stand on the case, and then we'll have some questions and then go to the audience. we're going to start with jimbility who will talk a little bit about the history of the provision at issue and the history of the case which he started in his challenge to be able to sell -- to offer hillary, the movie, on video on demand. jim? >> thank you. my job is to tell you how we got

here from there. and many of the things that i will discuss, i've been involved in. i was one of the lawyers challenging mccain-feingold d mcconnell, i repsented 26 plaintiffs in that litigation. i was lead counsel in wisconsin right to life, which took a big whack out of the lexry communication corporate prohibition, that the supreme court had upheld on its face in mcconnell and then i was counsel for citizens united in the lower court and in the pleadings that got the case accepted by the united states supreme court. well, if you want to start from the beginning, you'd start with the first amendment. and of course, the first amendment says that congress shall make no law abridging the freedom of speech or of the press or of the right of the people to peaceably assemble and to petition the government for a redress of grievances.

now, of course i am aware that t%e supreme court has had trouble with the word no, similar to my daughters as they were growing up. and that is no, often meant to them, well, it's ok, at least for this time,nd the court in austin and mcconnell and in upholding contribution limits in buckley and shrink certainly viewed the first amendment's prohibition on congress making any laws abridging the freedom of speech as well at least those restrictions are ok this time. the result of these three decisions has been an incredibly complex series of statutes and regulations. the federal election campaign act itself is 24 4 pages in the federal statutes and there are

568 pages of regulations that the fec has promulgated. of course, the courts have been very active in interpreting what all those laws and words mean, and there have been 13 major court decisions interpreting the fec. 366 other cases doing the same thing. and there are 17 cases currently pending. if you needed for information about what federal law was, you could consult the 1,278 pages in the federal register, providing the explanation and justification these regulations, or you could look at the 10 policy statements, or the 1,771 advisory opinions that the fec has issued since 194. now -- 1974. now i would submit that this body of extremely complex and difficult regulation is the

antithesis of the notion that congress shall make no law. now, the next principal case beyond -- would of course be buckley versus valeo, which in striking down regulations on issue advocacy, striking down lits on campaign snding by candidates a parties and pac's established two principles. and of course,hese principles were explained by the -- to the u.s. supreme court by john mccain and russ feingold in their brief authored by all of the luminaries in the campaign reform movement, including fre wertheimer, who is on the panel today. and that is that buckley stood for two propositions. one, that a law must be clear rather than vague. and secondly, that the law -- that campaign finance laws could be only -- could be -- must be directed precisely to that spending that is unambiguously

related to the campaign of a particular federal candidate. now, the result was the adoption of a series of tests by the supreme court in campaign finance laws to only that -- to only campaign financing, and to positively protect issue advocacy. now certainly mccain-feingold went beyond express advocacy and we would -- an many of us would argue the proper limits of the authority that congress has on regulating campaign finance, and the principle one was the electionry and communication prohibition, which established a blackout period before federal elections, where you go to federal prison if you mention the name of a candidate in a

broadcast ad. now, mcconnell upheld this provision on its face, and as you could hear, the proponents of the electionry and communication did not try to overturn buckley, but tried to argue under buckley that the electionry and communication prohibition was unambiguously related to campaigns for federal office because studies indicated that the -- that the ads run during these blackout periods were the functional equivalent of express advocacy. now, after the case in mcconnell upheld the prohibition -- corporate prohibition on its face, wisconsin right to life challenged the provision as applied. and as we know, a statute can be constitutional on its face, but has certain unconstitutional applications that the court will

prevent the government from particular circumstances. and here, wisconsin right to life argued the grassroots lobby was the type of issue ad that the corporate prohibition could not be constitutimnally applied to. even though its application generally was upheld. the result of that case was a cision carving back the electionry and communication blackout periods, application to broadcast ads, to only those ads that had an appeal to vote, that is, where the only reasonable interpretation of the ad is that it urged people to vote for or against a particular candidate. well, the problem that faced citizens united after that case was that while their movie, hillary the movie, a 90-minute

documentary that they wanted to run on tv, mentioned the name of a federal candidate during the -- and would have mentioned it during the blackout period. they also wanted to do ads to promote the sale of the movie and they had 10 second and 30 second ads to do that. the problem was the disclose you're requirements were not challenged in wisconsin right to life and a 4.2 second disclaimer pretty well eats up a 10-second ad and you really can't run a meaningful 10-second ad with a 4.2 second disclaimer, and the -- you know, and the -- and as to the movie and the ads, they would have to report their contributors and those of us who represent advocacy groups understand that disclosing your contributors to federal office holders in the wake of nixon's enemies list and clinton having a thousand -- illegally having a thousand f.b.i. files or obama

asking you to out your friend and neighbors who are criticizing his health care reform, understand that revealinthe identity of people that criticize federal office holders and federal candidates are setting themselves up for retribution, and as a result, disclosing contributors is as chilling as a prohibition. so they challenged -- so when we put this case together, our main focus was on the disclaimer and disclosure requirements that remained after wisconsin right to life and we believe that consistent with the unambiguous campaign related principle, if a particular communication does not meet with wisconsin's appeal to vote test and can't be prohibited, well, then it can't be regulated at all. well, of course we also challenge the prohibition on the

movie, which the fec said it could be prohibited, because it did not have an appeal to vote. there was no call to action in the ad but we also argued that the -- that this has become so complicated and that it has been so difficult to apply the appeal to vote test, and the fec has been so recalcitrant in adoption of its regulation and applying the appeal to vote test that it has become unworkable and the supreme court should go back to first principles and overturn the upholding of the law. now, once we got to the supreme court, ted olson took over the representation, and he took a different approach. number one, he basically did not pursue the unambiguously campaign related argument but did pursue two lines of argument, one is more broadly, he specifically raised the

constitutionality of both austin and mcconnell, which were not raised in the district court, but he also made narrower arguments saying that well, this is a video on demand, and after all, video on demand, somebody has go pay for it, and maybe the movie ought to get that exception for that circumstances and furthermore, that citizens united is kind of like the mcfl type corporation that cannot be prohibited from engaging in this kind of activity, and of course, the oral argument on those arguments of course resulted in a stunning, for many people, revelataon that the federal election commission actually believed that corporations could be pro hinted from doing books, which of course has been the long-standing position of the federal election commission and was no news to those of us that practice in that area, but to

actually be said in public, in front ofveryone, that this could happen. i think triggered the supreme court in saying, well, it's time for us to take a relook at the principal cases that support this sort of regulation, austinc and mcconnell, and that takes us to where we are today. >> great. and as he said -- >> three more words. >> that's ok. we want to make sure we get in some of the others quick for this opening round, as jim mentioned, the assistant solicitor general did make the point during oral arguments back in martha this could extend to books and we'll have to see what new solicitor general says during the arguments next week. coming next is fred wertheimer, who comes from the opposite side on this case, and will talk a little bitbout the provision itself and its history and why congress enacted it. fred? >> thank you. i think the book's argument is a

red herring, we'll get to that later on in the discussion. i want to talk about -- i want to focus my opening remarks on the ban on corporate campaign expenditures. and the austin decision. although, a good deal of the remarks also apply to the issues volved here, dealing with mccain-feingold. what we're dealing here with is a polic federal policy that dates back for more than a century. a line of cases that have upheld the constitutionality of that policy. long-standing court principles that stare decisis means we give respect and adherence to past decisions unless there are exceptional circumstances. the constitutional doctrine of constitutional avoidance that says we don't decide cases on

broad grounds with they can be decided on narrow grounds. in a ce where the issue of whether the decision upholding the ban on corporate campaign expenditures was never raised below, therefore, there was no opportunity to create a factual record, which has been very important in campaign finance cases. and where we have now had the court on its own, announce that it wants to examine the question of whether this constitutional doctrine and long-standing policy is constitutional. whether in 2009, we're going to discover that corporations have a constitutional right to spend their immense aggregate wealth in campaigns and in doing so, to

create a system of potential influence buying the likes of which we've never seen before. the first ban on corporate campaign expenditures goes back to 1891, when kentucky enacted a ban. there were four or five states that enacted it in 1890's. in 1907, congress following majoscandals enacted a ban on corporate contributions. this was in the era when senators were not known by their states. they were known as the senator from standard oil, the senator from u.s. steel and that was certainly in the forefront of the minds of congress and president roosevelt, when the ban on corporate contributions was enacted. 1947, in the taft hartley act, the ban on corporate contributions is expanded to expenditures. at the time, senator taft says

all we're doing here is affirming what we've always understood that ban to mean. that it covers indirect contributions or expenditures as well as contributions. he then -- that act also extended both the ban on corporate contributions and expenditures to labor unions. so that you also had a ban on labor unions using their treasury funds for contributions and expenditures. in the mcconnell decision, which affirms the ausn decision, here's what the court said. since our decision in buckley, that's a 1976 decision, congress's power to prohibit corporations and unions from using funds in their treasuries to finance, advertisements expressly advocate being the election of defeat of candidates

in federal elections has been firmly embedded in hour law, so the supreme court in 2003 says this power has upheld by the supreme court is firmly embedded the mcconnell case is followed by the wisconsin right to life case, that jim was talking about. application of restrictions on corporate and labor union expend tears and then reaffirms them again and that was just two years ago. we look at the consequences that we face here if the ban on corporate campaign expenditures is orturned. let's start out maybe with the universe of corporate wealth. in 2005, the i.r.s. estimated that corporations had total net worth of $23.5 trillion.

$23.5 trillion. now, no one is arguing $23.5 trillion is going to end up being spent if campaigns, but that's the universe we're dealing with here. if you unleash that, you provide corporations with the capacity to use untold wealth to en directly to elect or defeat campaigns and in doing so, to clearly create the opportunity to buy influence with elected officials, or to create the appearance of influence buying. and if you just look at the health care fight going on right now, you can get a sense of this. the economic stakes in government decisio are enormous. if in the mid early this battle the drug companies -- middle of

this battle, the dru companies, for example, were free to make these kinds of expenditures and you had a member of congress sitting there trying to decide what to do on health care, and facing 5 or 10 or $20 million in direct expenditures to defeat th member of congress, dependingn how that member votes, you're facing a clear situation of potential influence buying. and you multiply that across the board on issues across the board we will see a campaign finance system, an electoral system, a government decisio making system, the likes of which we have never seen before in terms of the capacity of corporations to dominate that. now, i would submit that if you look at the history of this policy, if you look at the history of court decisions, the

doctrines of stare decisis and constitutional avoidance, the absence of any factual record in this case,f the supre court chooses this case to overturn austin and declare that corporations are free to unleash their immense wealth on campaigns and government decisions, you will have a decision that must be defined as radical packet very much. -- activism. >> larry gold represents the afcio and unions have an unusual role here, because they're swept if by the new laws. they weren't covered by austin in 1990, but larry, why don't you address the consequences for unions and why you're part of the challenge. >> sure. thank you. you know, this case is about independent speech and actually, it's about a relatively small slice of speech. express advocacy, which is explicitly calling for the election or defeat of a candidate in any medium, that's the austin case, as corporations

and what's called the functional equivalence, which is certain broadcasts that refer to candidates with elections paid for by unions or corporations, and that can be reasonably interpreted the supreme court says as fog but a an ex xortatin to vote for or against them. it's nothing to give money to candidates downpour them to use as they wish, but this case really does implicate what kind of a first amenment we have. consider some of the government's propositions in the case. there's a lot been said about this case about, you know, what an extreme -- what extreme results there might be, if things -- if anything is either of the two cases is overruled, but let's look at some of the government's key propositions here. one is what's really at issue in this case is an organization that has a documentary available

through video on demand for at home on their television and of the government says, and the issue in the case is whether or not it can be constitutionally made a crime to do that sort of thing. secondly, as was alluded to earlier, the government has taken the position, this was in the oral argument, that for example, if a union subsidized a writer to write a book about something, and a few lines in a 600 page book contained express advocacy, that is the explicit message about voting for or against a candidate and a publisher, a repute publisher like random house then decided to publish the book and did so, it would be a crime for the union to have subsidized that right in preparing i and then finally and i think even more broadly, the government's position if this case is that it's constitutional to criminalize speech merely because an office holder or a candidate in the government's words are aware of and feel

indebted to those who finance an ad that is favorable to them, or becae the -- it is considered that speakers are trying to curry favor with and attempting to influence office holders by what they say in public. :

>> we ought to be focusing on this and i think it's a little lost its looking at the context of this case, and what truly bear some reason exanation and consideration is who gets to say things in america about candidates and officeholders. who gets to use express advocacy, you're dysfunctial equipment, and who doesn't. so just very quickly, who can do this? individuals can do it with their own money and no matter how wealthy they are and regardless of the fact that corporations are really the source of their wealth. bill gates as an individual can spend their billions even though they drive rectally from companies that they control. media corporations of course

have absolute freedom to use their resources to talk about candidates, editorialized about elections, and editorials that are coveted by candidates and relayed by candidates as validations of their worth to unincorporated associations can use express advocacy, even though they have comparable liability protections in many states, the district of columbia, as corporations do. and in so-called mcfl corporation, not-for-profit groups that don't take union or corporate money, they can say anything they want in any circumstance. token partnership, so can bloggers, and corporate bloggers. any individual who has a website they can do it and of course federal tax can. so there is a broad array of organizations without any defined theme among them really who can now speak freely on these matters. who can't? well, first of course the folks of this case as business

corporations can regardless of their size, the state, their expertise or even whether or not shareholders have any actual practical control over them. secondly, nonprofit corporations can't do it if they take up any of corporate or union money. nonprofit groups, advocacy organizations, the sierra club, the national rifle association, they are prohibited regardless again of their size, whether or not they are membership organization, whether or not they operate democratically, whether or not they have some expertise and whether or not people want to hear what they have to say. finally, unions who have been kind of swept up and involved in an uncomfortable legal marriage with corporations for many, many years. even though th supme court is actually never identified a compelling governmental interest, and that's the standard, never identified one to justify any restriction on using independent speech except perhaps inferentially in the

mcconnell case. now joan biskupic mention the austin decision, that's what it said it was constitutional to prohibit corporations from doing express advocacy distinguished unions, and said the same justifications really don't apply to unions. supreme court seem to have forgotten that when it issued the mccoell decision. but in fact, consider this. uniquely among all the kinds of organizations that i've mentioned, unions have the following characteristics. first of all, they are formed by individual workers, often under duress in order to advance their individual causes. they are membership organizations, every single one of them. membership is completely voluntary. by law and by culture, members elect officers by secret ballot to determine the finances of the organization and vote on other policies. they have no self-perpetuating boards like nonprofit corporations. dissente andnions utilize

the democratic process on the organization, or they can we sign their membership, not pay for any of the union's political activities, and still be entitled by law to complete and tol and fair representation. that also has been the law for a ry long time. yet the law disfavors unions in the same way that it does corporations. now in this case does not directly concern a union plaintiff. but in o view, it does implicate the rights of unions and all organizations, and regardless of how the court comes out, comes out of a rationale it induces, i think it's really important in looking at this case that we consider what it is that has some serious rethinking about what the first amendment is and who is entitled to it and which speakers should be disfavored and why. and have to say that the incipal lines of argument that the government has used in this case, in part, directly and the

mcconnell portion of it simply i think and not purport to what i think our are thoughtful analysis would say does serve the first amendment doctrine. >> thank you, later we've gotten word that bob bauer is actually on his way. so i'm going to stall for a minute on those who are defending the pvision, and ask both jim and larry to address just directly the idea of the wealth that could be unleashed in elections in 2010, 2012, if the supreme court does strike down this provision in reverse austin. i think everybody knows that people like senators mccain and feingold have talked about the special nature of corporations, that they have been artificial distinction, they are not persons and individual people who should be deciding election. do you want to address that first, and then larry? >> the argument they're making out is completely novel, so while they rely upon stare

decisis and a long history and yak, yak, yak, their actual argument is completely new. that is, austin was based on the idea and you are alluding to that, that because of the corporate form and the ability of corporations to amass great wealth, that their participation in our electoral process would be distorted by their mere participation. well, that basically the government and the reformers, have thrown in the trash can. because it seems so indefensible, and larry alluded to some reason that i will allude to others. and now that they are talking about quid pro quo corruption. that is, look at all this money that corporations have, and they can use it to try to essentially bribe officeholder. well, of course, the first thing is quid pro quo corruption is built by contribution limits. i mean, the supreme court has had a whole series of cases on contribution limits and they

have said that the way to deal with evil that want to curry favor or gift quidro quo favors with officeholders is the contribution limit. and certainly any corporate spending that would result from a decision in this case will still be subject to corporate limits. now, the only way they can get around that is to say that, well, it's going to be the general spinney, the independent spending that is going to be corruptive. here's a run up against a whole series of cases that it specifically rejected their claim. so here they are talking about stare decisis and a long history while their two arguments are, number one, one that was never considered by the court as it relates specifically and in particular to corporations. in their second art is one that the supreme court has routinely rejected as support for a corporate prohibition. and if honestly, if fred and his

cohorts actually believe what they were saying, then they would tell you that they are simply a mouthpiece for the richest people in our country. in the last 10 years, the pew foundation, george soros and other corporations through a concerted effort have spent $140 million subsidizing the reform movement. in fact, democracy 21 was created on a whole cloth by grants from the largest corporations, the largest indiduals, and the largest foundations in our nation. but you know, they never say that, do they? they never say we will just a mouthpiece f george sor, because they are not. i don't believe that they are. i believe that there is our sincere in their advocacy for their positions. but it is of course true that the wealthiest people benefit by

the restrictions on corporations. because after all, george soros can spend his own money. bill gates can spend his own money, as an individual, that they derive from the corporations. but those of average means have to pool their resources in a corporation or a labor union in order to participate. and of course the corporate ban targets them. they can't go out andpend their own money like george soros or rich people can. they must pool their resources. they invariably do that and corporations and labor unions. so it's the people of average means that are targeted and pushed out a system. >> why don't you respond. and then larry can go. >> first of all, the last i checked we'd never received a contribution from a corporation since we've been created.

[inaudible] >> that's a foundation if you want to call it a corporation, five. corporations usually are not used to describe foundations. secondly, if i'm a mouthpiece for the richest peopl in americ they haven't told me so. nor did mr. soros say so when i attacked him and the 2004 presidential campaign for all the money he was putting into 527 groups. but i want to make two quick points. because jim likes to describe the tests for the supreme court in terms of quid pro quo corruption. i just want to read one thing from a supreme court decision. our cases have firmly established that congress is legitimate interest eon prevent simple cash for book russian to curbing undue influence on officeholders judgment and the

appearance of such influence and i would submit to you that that is exactly what is at stake and massive corporate expenditures and campaigns. and i would also point out from the time of the austin decision to the time of the mcconnell decision, we had clear evidence inserted in the record in the mcconnell case that showed that expenditures, expenditures were used, being used to attempt to buy influence the standard test ofhe supreme court. and secondly in terms of larry's point about no unifying principle. there is a unifying principle. and a unifying principle s been for over a century. that is as individuals who vote and individuals who provide the private financing to elect our

officials. labor unions participate in this process through their trenches which give voluntary contributions from individuals. given for the purpose of being used in elections. corporations do the samehing. nonprofit groups that do not accept corporate or labor union money and therefore cannot be used as a conduit for that money also have the same right of participation fr the maachusetts citizens for life case. so the unifying principle here is for over a century, we have individuals, citizens, people who are choosing the representatives, also financing those cases. and we do not have groups with special characteristics doing so that give them -- in the end,

have been gathering money and the economic marketpla if you're talking about business corporation, which is what it is taken in austin. and doing so in the context of the economic interests. spirit maybe have larry respond, and then first though i want to welcome bob our. thank you for coming. we're just going to finish up with the respons with larry here and let you have som opening remarks were about seven minutes. >> i think there is a change between jim and bread point some of the indiscriminate nature of the roulette talked about earlier. fred says that foundations that support his organization are not generally viewed as a kind of corporation that we might be concerned with what the law does treat that all corporations except thatarrow group of mcfl's phe same whether it is a nonprofit organization controlled by its members, wholly dedicated to particular unsolvable ideas and social ideas, or a huge

megacoorations whether it's general motors or general electric, which controls nbc and the like, and has its special privileges. you know, the question earlier was what happened if both these cases were overturned. and i think is difficult to predict that it really truly is difficult what would happen. i mean, the fact is corporations and unions now even though they are disfavored under the law, can have -- do have a broad range of ability to speak without prohibition on legislative and political matters and to talk about candidates and certain media and the like. and we haven't witnessed the kind of dedication of resources that i think are predicted if some of the last lines of speech categories were eliminated, as far as restrictions go. i'm not saying certainty trattoria singlet about corporate carpet we deal with it

everyday and meaning media. but the notion that unions ought to be subject to these restrictions or have some kind of special characteristics that justifies their disfavor, i think it ignores everything i said about them. i mean, theact is that incoming unions and other organizations voluntary membership groups controlled by members and unions case, universally democratically operated through electns and the like. this is the freedom of association, and the first amendment attacks association rights and not just individual rights. >> .com if you'd like to take a ment to express that whitey emc is supporting a provision. >> and think you are accommodating me on this. the democratic national committee did file a brief and it is great for. this is not the time nor the occasion to reach out and reconsider a corporis of the on corporate spending rights. there was no basis in the case

for it, there is no record to support it. the corporate would have to go out of the way to decide so momentous a change in the campaign-finance laws. and there are and i'mure other speakers have said so before, the other alternative ways to reach a decision in this case, whichever way it turned out, without unsettling these corpses constitutional law, were also at a point where over many years in the campaign-finance laws have been in development. congress has been at it for quite some time, mccain-feingold, the modern campaign has sort of settled if yowill in many respects not to say there has been controversy, but we nov have a body of law and rules that have put us where we are today. and where are today is we are seeing some equilibrium which has worked in the last several years in favor of the small

donor. and we've all heard a great deal about this and i'm sure other panelists had mentioned it up for a variety of reasons, including development of the internet and other incentives for fundraising, which i think always exist that may have accelerated in recent years, political actors have found ways of reaching through technology and very cost efficiently small donors very difficult to reach in the same way before to mobilize in the same way before. and they are being brought into the system not nearly as donors but as participants in other ways. that is to say once they are on the list, they may be solicited for contributions, but they are also asked to participate in other ways, both in their person and in their online participant in the political process. for this development so long in coming. to be unsettled by a violent change in the constitutional rules in the road in favor of corporate spending rights, even if characterize as independent

corporate comment is a very destabilizing potential. and it is something that this court is not required to do. there is nothing that tells the court in the face of these particular circumstances to destabilize the campaign-finance derelatory situation, or bound in such a fashion as to seriously disturbed access to small donors and access block incoming and now we are seeing entering and i think contributing to some form of general equilibrium here under this campaign-finance regulatory scheme. the last point that i would make has to do, and i fear that i may be speaking, i look at fred's notes i think i may be repeating what has been said before, but i do want to stress, there is a myth out there, and it is a myth, that the austin case, which asks the court has heard the argument on it somehow a

quote outlier. that is it is wanted in the dark borderlands of campaign-finance doctrine a it deserved to be reconsidered because it was sort of uniquely weak as precedent and out othe mainstream of constitutional thinking. and that simply is not true. austin maybe a case that was not very clear in its exposition, but asserted would distinguish it from other campaign-finance president. and so in that respect i think it is not an outlier and disreputable slip since. but in many other respects, if you looked into and what they often cortright to say, the majority opinion and the concurrence by justice brennan, lay out an analysis of where the constitutional law has rested on matters of corporate spending rights for many, many years. so while austin may have been somewhat notable in presentatio and open to criticism on presentation, i don't believe it represents a sharp darture

from mainstream constitution president. and i think therefore the notion that somehow we deserve even under these extreme circumstances with no record before the court to support it and no requirement that the court address it, but it nonetheless deserve because of its unique weakness to be reconsidered. i think it is actually an unsustainable proposition. so for those reasons this is going to be i think for the record a telling moment and how it chooses to visit and revisit issues of the constitutional law. this would be a fairly extraordinary step for the court to take and i think that's generally recognized. >> thanks, bob. i want to ask a very practical question to follow up with you. you talk about too fast, too soon for any kind of reversal here. but it just like me as a journalist that it is kind of interesting that the dnc has come in and not the rnc and what to make of that, i think tha one point has said that maybe the rnc just believes its interest are already spoken for there.

do you think looking at 2010, 2012, do you just want to speculate on how there could be a shift in any kind of character of eleion if this could particularly hurt democratic candidates? >> everybody who is ever hazard a guess about the impact on law amitabh law on public behavior have been wrong. at the ib inved to the wrong publicly and i will decline the invitation. i will say one thing about the rnc, however. there is and is probably has alsoeen mentioned, there are other cases currently pending, and was in fact argued only a week ago and the court of appeals against the democratic national committee is also present as aarty in which the rnc is looking to lift the soft-money funding restrictions for the mccain-feingold off of the legal parties. in other words, permit the legal parties for circumcised in five and a wide range of references to collect soft money. so if you look at the rnc as a whole and sor of where it is positioning itself in these very legal controversy, i think his

position on this case here is quite clear. >> do you want to respond to that? sure. i will respond to that by agreeing in fact, the rnc has adopted a resolution that i spotted that i am a member of the rnc, whic put the rnc a favor of deregulation. and in particular, got it f gets to hear detour when it was supporti the adoption of further restrictions on 527. so the rnc is definitely in favor as a matter of policy, in favor of deregulation, in favor of the first amendment, and that is to be of cool juxtaposed with the dnc which is in favor of the status quo. >> i just have one other question before we open it up, and i think what we are planning to do is open it up first for journalist reported from anybody who wants to ask a question of any of the panelists.

but just to get the context of the supreme court broadening these cases so dramatically with its june order your we saw in another case of last term the voting rights act case where t justices at one point seemed to looking at a very broad ruling and then pull back in and as we all know for the texas utility district voting rights case and decided not to go further. does anybody feel like there might be any sense, you, again without having even heard the oral argument and the kind of questions we'll hear from the bench, that the justices might not go as broadly as they are looking at now? any sense of just speculation as we go into this of what they might already be signaling, and given the new makeup of the court, what you might anticipate from people like chief justice john roberts and justice samuel alito? go ahead, very. >> i mean, who knows, you know, any and.

embodies a set of the situation situation i thi where given themselves optio that they didn't have before as a matter i think that since. we have said, in a brief that we don't belie it is surely not necessary to reach often. i think it is appropriate for them to reach a calm -- mcconnell. sohere is th ieresting i think the subtext to this case having to do with the supreme court as an institution and how it deals with cases and issues that come before it, which is interesting and important across the board for all kinds of cases and all kinds of issues. but if it doesn't reach either of the questions that have post was reargued in this case, it is inevitable that it will and i think that it's at least for the spam more important focus because it deals with issues, the first amendment issues that i described and next time there will be a case next time if they

don't address it this time are we won't have any of these institutional questions working as well. >> anyone else? i thought we would start with reporters first, and there is a room with a microphone here. also if you just raise your hand on either side with questions. tony. >> tony, we identifier? >> tony mauro, national law journal. you said that ted olson took a different approach from your approach. why didn't you take that proach and are you please with how this developed? in other words, you didn't make it as much of a frontal attack on austin and mcconnell, and now it's being framed that way. do you think that is unwise?

,. >> well, we will see in the end. trul communal, our approach was based on two considerations in addition to the one i mentioned. number one was that i believe that a president is always implicated and always subject to reconsideration if it is being asked to apply, to be applied. and of course the government is asking that often be applied and as a justification for both the corporate prohibition on the movie and the requirements of the reports and disclaimers that mccain-feingold applies. in fact, you know, it seemed like every time there is a liberal president, serves as challenge the liberals get real antsy about broad rulings, even though in my experience they love broad rulings if they go in their direction. and i did a law review article in the early '90s when roe v. wade was under challenge and argued that that time that rb

wade after all, what you expect the supre court to do? do you expect them to sit there if they believe that austin is wronghy decided and that makes criminals of a wide variety of individuals who want to simply engage idemocratic free speech, that they should apply that precedent even though they think it is wrongly decided, because of the niceties of what, the plaintiff didn't ask for it, to be overturned? by me, that is irresponsible in my judgment. so the precedent as always, it's validity is always subject to reconsideration if somebody asks the supreme court to applied. the second reason was, is that we believe that the supreme court's explicit recnition in this case of the unambiguously campaign related printable kind of as a threshold issue that cabins the power of government

to only those things that are regarding campaign speech, would be a basis to decide this case. and also has to be reached in any event. we still have a disclaimer a the disclosure requirements that are being applied, and unless they apply something like they did in david saint well if the prohibition goes down, the reports go down, then the court is going to have to say lk at the specific justifications for the disclosure pvisions. so you know, this is obviously been more dramatic. and the supreme court seems to me and asking for reargumen, as well as that, given at all the possible options, all the niceties that the reformers are suddenly all concerned about like avoidance principles and narrow rulings and the plain of

asking for things, have all gone by the board of. so they have the full array of options. and i have argued in the rehearing on behalf of eight former commissioners of the fec, seven who are former chairman, that while it's not necessary to overturn austin or mcconnell, that the court should do so. and they should do so because of the established facts that all of this has become unworkable, and of course these eight commissioners that were asked to apply and administerhe federal election campaign act are uniquely situated to explain to the court how orderly complex and unworkable this scheme is. >> lete make io the audience that ted olson's name has been raised is in the unusual position of being a challenger to this provision that just a

few years earlier as the u.s. solicitor general he was defending. go ahead. >> i don't intend to look judicial principles as little niceties. but let me just quote from justice robert view about past precedent in light of jim's abused their care is what he said at the confirmation hearings. i do think that it is a jolt to the legal system when overrule a precedent. president plays an important role in promoting stability and even handiness that it is not enough and the court has emphasized this on several occasions, it is not enough that you may think the prior decision was wrongly decided. also says people expect that the law is going to be what the court has told them the law is goin to be, and that's an important consideration. >> thank you. yes? >> i am not with the "washington

times." i had a question for bob. the discussion of campaign finance can be sort of esoteric and a limited interest inside the beltway, but bob, you have been on the frontlines and seeing how ts is played out in practice. and i wonder if the court rules in this case in an adverse way to your position, if you could talk about what the implications would be for the president a his reelection campaign, would he be put as it disadvantaged? >> as i mentioned to john, i said i am very disinclined because of the history that completely mistaken substance about the effect of a change in the law and the very disinclined to speculate abouthat the effects of the decision would be, as i'm sur a number of the panelists said before i got here. the court can decide this case in a number of ways. in fact, the court could also let's not forget this, decide the case in a way that it never

occurred to anybody in this room before. and so for that reason, for me to say what the effect would be would be, i think, beyond speculation. i would be sort of engaged in sort of a hallucinatory exercise that would add to your view of the campaign that would have limited interest outside the belly. >> jim, you said you wanted to mment on the. >> i agree on bob on that and we have seen that have skurka, the republicans after the 24 election thought they wanted to prohibit 520 sevens, and of course i would argue that the swift boats as 527 had more effect than all of george courses many. so it is very difficult to predict but incumbent politicians do act on what they think to be their partisan interest. i mean, the dnc has shellacked republicans now to election in a row. they like the status quo. the rnc does appear they want to

change it. i think that's consistent with the rnc's past positions, but it's probably informed to make certain consent by the perception of whether the current situation benefits us or not, or benefits the dnc or not. you know, as a matter fact, congressman tillman of the tillman act that the rormers like to lionize, he was a notorious segregationist who had a problem. and his problem was a corporations in his district were lining up in favor of the republicans to throw him out, and he wanted to do something about it. so as an incomof politicians will inevitably do, as they use their political power to pass laws to disable their opponents. and we have seen this historically. mccain-feingod, there is not one word, not o paragraph, not even one sentence that adversely affects an incumbent politician.

so that is why the very sophisticated politicians that wrote the bill of rights to our constitution wanted congress not to be able incumbent politicians, not to be able to write the rules for the own election because they knew as we have seen over and over again and that they would write them to benefit themselves. >> thanks. >> can with juicy press. fred, you said the argument about the presumptive power to regulate books was red herring. why do you say that? do you think whether or not it was a red herring, do you think it influenced the justices decision to widen the case and have the you think solicitor general kagan will adapt your argument? >> i'm not going to predict solicitor general kagan. it may well have been influenced in. i don't know the answer to that, protecting the supreme court is

something that i lead to other people to do or why do i think it is a red herring? in the 62 year history of is provision, i know of no example where it has been enforced against the book. leaving out the fact that books are not involved in this case. the campaign-finance rules have a broad exemption for commercial activities, which means the whole book publishing world is exempt from the campaign-finance laws if they are involved in campaign practices. , and commercial practices. i do not believe that a 500 page book wh a single stence of express advocacy is covered by this provision, or would be treated as covered by this provision. and i know the assistant

solicitor general said, but i don't agree with that position and i just think it is unrelated to the specifics of this case. >> larry, you don't think it is a red herring, to use the? not in the repeated questioning an oral argument between the supreme court says explicitly that a book could be banned under the circumstances that he described and that i described in my opening remarks. a decision that has not been repudiated in the two previous that the solicitor general has filed. i wod be surprised if no justice aks solicitor general kagan if the argument whether the government still adheres to that position and how it applies to these. >> would you be surprised if that's not the first question? [laughter] >> another question? yes.

>> i encanto. one of the things that haveeen raised with some of the breeze is the fact that some of the states already allow corporate union direct contributions. and whether there is a difference between those states that do and don't allow for the deral system. is expert in the field what you see as the diffences in areas where corporate contributions, corporate direct contributions are allowed as other areas? >> i don't know the answer to that question, but i do know is there is no record, there was an opportunity in the record to examine what the record is in states with the van and without the band. it is also true that this is a federalism system. and in some states think they don't need a band, they are free to do it. that shouldn't prevent other states who feel a need for this

kind of ban to be able to have the ban. but i don't think there is any really strong documentation, one way or the other, about the impact in states that don't have the ban. >> isn't that telling, oh, my gosh, we have over 20 states that have no corporate bands. they've not had corporate bands from now for more than 200 years. and those with experience of this, you cannot say. as you would expect them to say, look out warble it is. locale corrupter public officials are. look at all that massive spending by these corporations trying to influence, you know, the governor and the state legislature and the city council. isn't that telling? that means they have no case. that means that this has all been theoretical, in the abstract, that they have no empirical justification for all of their scare tactics and

alarmist rhetoric. they have nothing. >> wait a second. les let larry was sitting between the two of you go next. >> i think fred's int is right that in this case there has not been developed a substantial record on some of these things. everybody was surprised i think with the order for reargument that it was just a 30 day period for all of these beds, and not a breathes, but not a lot of time to come in. but kendall asked about contributions but this is an expenditures case and the sueme court still doesn't adhere to what i think is inappropriate what they call a fundamental constitutional difference between contributions and expenditures, and just looking at the union experience, again, the fact that most states, three quarters of the states impose no restrictions on the ability of the union to use its regular treasury money to say anything it wants publicly about candidates and elections and i think the reality of that

is that some unions do, some unions don't tre are all sorts of political considerations that go into that, but there is haly to my knowledge, any record there, any claim out there, any proof that somehow this has been a corrupting influence at the state level and something has to be done with that. >> i would just pot out there is no trackwork at the federal level because 462 or 102 years, depending on how you want to count it, these expenditures have been prohibited. >> bob, did you want to add something? >> i wanted to mention one thing about the contribution expenditure distinction. and that is there are circumstances across the body of campaign-finance law where there is no question that distinction has been very significant, but very recently and apologize again if i'm tracking something somebody else said, in the maffei case of the supreme court decide which was a case about judicial campaign-finance,

justice kennedy wrote the majority opinion blew right past that, completely ignored it becausee believed that it wasn't stated explicitly that under the circumstances of the case, huge expenditures for the potential fact that it was alleged the affect of dominating a particular race such that the contributor could literally claim the author of the particular justice who claim to be the author, not that he did. some thought he was. that in those circumstances under that kind of spending, but contribution expenditure distinction is often significant. and soap resource significance now talking specifically about corporations, spending issue in austin, a very similar question is raised about whether you can really distinguish contributions from expenditures were vast sums of money, and that is by the way th phrase the court has typically used to describe a threat, the use of immense wealth, they put the word

eminence in quotes, has the effect of achieving a dominant hole on the political process. in those cases i think the distinction does not have quite the same magic, the connotation that it might another more routine cases of campaign-finance. bob, can i ask you about another small dissension that you reminded me of him invoking kennedy. in kennedy's dissent in austin he certainly regarded the corporation especially non-proper corporation and muc different way than we think of to date because of how they have been so much in the news. how do you defend the fact that the government at minimum suld have at least accounted for the distinction between profit and nonprofit corpations, and if we're talking about the corruptive powder of them, just explain why there was no reason to have that distinction in your mind for what he did. >> you mean the congrs and cracking? >> yes. >> well, as i think one of the

panelists pointed out just a few minutes ago, i mean, there is built into the law as a result of the supreme court's jurisprudence some dtinction already between corporations d profit-making and those of a nonprofit making major. massachusetts citizens for life and wthe possibilities in this case is that the court may decide that that particular exception for it certain class of nonprofit is too narrowly drawn to it is too restricted and that more nonprofit should be able to make a broad constitutional claim in speech that of the corporations would be denied. and so that is certainly a possibility. the law in this area, and it' hard for me by the way to speculate on sort of what within the mind of congressional sponsors or have congress look at the statute when it was pastor i don't know the answer to your question specifically, but as the law has developed over time, it islear that ai of nonprofit organizations have occupied a much, much more spaces debate, and though congress may not have

anticipated this turn in the debate, the court is now confronted with it and will have to address it. >> thank you. any other questions? yes. >> hi. this is a question for fred. i am with the stanford journal of civil rights and civil liberties. my question is this. jim previously characterized the position of taste as fast by the opponent of the citizens united brief as concerned with quid pro quo corruption as compared to the undue influence. if i could, i would like to reorient the discussion toward the undue influence aspect of this case. larry gold also mentioned that this is not a contributions case, as law student are well aware of free speech doctrine, the animal originally emerged with the equal latte decision and corporations are not afforded the same free speech

rights say as individual but are afforded us by so we can have a free marketplace where all ideas are expressed. i also want to mention somethi that hasn't been addressed. jim also identified the fact that the bill gates of the world would be negatively affected by reform, and i think that may face strong case for the zero-sum that the zero-sum game that we have with campaign-finance reform. so if this is not in fact a contributions case, -- excusing, could very invite, could you please explain the potential distorting fact of unbridled expenditures being released into the market, and could you elaborate on the undue influence argument, which i think has received not as much oan explanation in this discussion as, say, the judicial principles which are also being threatened

by citizens united. >> there seems to be many questions there. i will try to grab a couple of them. but i don't know. first of all, let's look at the lobby. here what bilotti says quote our consideration of a corporation's right to speak on issues of general public interest implies no comparable right and a quite different complex and a political campaign for election to public office. so that decision takes itself out of the game of whether there is any precedent there. for corporate expenditures. the record in the mcconnell case shows that expenditures can be used for the purpose of obtaining undue influence,

improper influence over elected officials. and that elected officials, in fact, did feel debt and obligation for those expenditures that were being made. i wod submit to you that if you look at a situation where you have a house member who is going to spend $2 million a campaign, and is faced with a corporation or series of corporations who are prepared to spend $20 million to defeat a member, if the member does not vote the way they would like to see it, that that has the capacity to influence the member of congress. and to have undue influence over the member of congress. >> i think the problem with this undue influence argument when it's applied to independent

speech is that there really is no limiting principle. look what is happening with the health care debate now. tensf billions of dollars are being spent focus on individual memberof congress, house and senate, in order to influence their official conduct. and unquestionably will have some colteral effect on the election next year, intent on not. that is what speech is that it is indiscriminate in its effect and undebatab. and its impact. but the problem, if you take undue influence is felt, the notion that officeholders or candidates are going to react in some way to a speaker and use that as a justification to prohibit a even criminalize that speech, it's very difficult to draw lin on where that stops. the fact is right now that wealthy individuals don't have any of these constraints, and can spend as much as they want to do so. unions can't. business corporations can't. nonprofit corporations can't. small non-profit groups can't. one thing that was matagorda,

why did congress do some of the things at the. let's not forget that in taste when congress enacted these restrictions on these broadcast, it did so very exquisitely and there are many, many statements by members into debates about how much they hated the fact that unions and organizations were referring to them, talking about them, putting public pressure on them legislatively. and a cast dish they called a dynastic they called trash. this is their words. and a prohibited it. and the court upheld it and i think the apogee of campaign-finance regulation of the supreme court and mcconnell and almost eviscerated in the wisconsin righto life case two years ago and i think rightfully so. and i am hoping that this case at the very least will be, will end up in. >> i think w had a question in the back. we have time for maybe one or two more pics that i am diana with the milwaukee journal, and i was interested in hearing from

you whether you think that the courts have already significantly to the way it mccain-feingold, and put a ruling in this case be used to further challenge the law? >> bob or fred. >> well, there are two parts to it mccain-feingold. the first part is a ban on soft money going for political parties. and that has not been touched. although jim has presently in court trying to touch it. [applause] >> more than just touch it. >> i think wisconsin right to life substantially cut back on the eltioneering communications revisions, but did not eliminate them. i think they still have forced.

i think they still will be treated seriously by corporations and labor unions. i think one has to keep in mind here in tes of what maryust said, that when you switch from issues to direct campaign activity, corporations and labor unions are being asked to speak through their pac is. there being told not to speak. they're being told that you need to use money, voluntarily given by individuals for the purpose in order to speak directly and campaigns. and i continueo believe that there is going to be a major difference if all of us on a constitutional right is established to directly, to make

expenditures to directly to defeat candidates in terms of what the potential impact of that money is on government decision-making. >> one of porton irony in all this is that the predictions of some cascade of money being applied to this kind of express speech, broadcast age, that is not the advocacy, whatever that means, is that the whole rationale for imposing these great research and on the broadcast in mccain-feingo was that the it was functionally meaningless that it didn't matter. and so it have to be extended much more broadly. and yet, now it seems that this light, whoever is going to be able to do it as some kind of, you know, a important comic it is an al important point of no return. and that is not at all clear. with respect to the pack pointer

to very quickly again, i don't see why unions and other organizations sort of membership organizations ought to be restricted when they are democratically controlled democratically arise, why they should be restricted in using their own treasuries in speaking out on issues and candidates. >> thank you. i guess we have time for one very quickly because i know caroline would like to make some final remarks. if you don't mind. think it's the next i am an attorney with harman current. bob raised the possibility that the court might get out of this i somehow doing mcfl more extensively in allowing a broader class of corporations whether that includes the pew folks i don't know. and i wonder whether the panel could try and illuminate as i think larry did a bit what types of nonprofit corporations or other sort of divisions among the corporate world might be appropriate for the court to go to to get out of this case without sweeping aside often

entily. >> i don't know what it would be appropriate for courts to. i will go that far, but toay that they might look at the question of whether or not an organization that is clearly organid for the theological or political purposes that is not engage in commercial activity and that is receiving, receiving only small amounts on not to have the same right to participate. it could be cast quite nearly and maybe loosen up some of the really sort of rigorous restrictions the court imposed in the mcfl case. that asserting one possibility. >> go ahead. >> of course, the federal election commission has maintained since 1986 in the mass citizens case that you could have no corporate contributions in order to qualify for the not-for-profit exemption from being prohibited from doing independent expenditures.

and they they have even done a regulation that says that. but now we have the solicitors supplemental reply saying that, well, the citizens unitedas argued that the vast majority of their spending for the movie is not corporate and so maybe we could, you know, open that up a little bit and allow groups that just have a lile bit of corporate funding to run things like "hillary: the movie." in fact, ted olson, in his briefing, has made the offer as well. well, if the course doesn't expand the mcfl exemption extension, then they will have to address often. i'm not in favor of that approach for many reasons. but one reason i'm not in favor of that approach is that still an organization is going to be subject to a very intrusive investigation by the federal election commission to see

whether or not you really are getting eight dominion is amount of corporate contributions. whatever dominion is means. so for those organizions, and it is the vast majority that see an investigation by the federal election commission and evitable complaints by the reformers, for every organization that tries to take advantage of it, sees that as inhibiting their activity, which is the vast majority. and it's not going to be a practical orseful expansion of mcfl. >> thank you to much to our panelists, and caroline edericton has some final words. thank you all for attending. >> i just want to thank you once again for attending this very, very slightly panel. you can see there is a wide range of opinions on this case and what the court may or may not do. i do want to just mention a couple of upcoming ac at the events. on the 24th were going to do

our 2009, 2010 supreme court preview. it will be here again from 12 to two. and the moderator of that panel will be tommy goldstein, who is the founder of scotusblog it should be very exciting. concept of a 16, were also doing a nationwide simulcast with all of our student chapters of an event which will feature pam karlin, and john easement debating constitutional interpretation. and particularly the arguments of the pam and goodwin and her new book, keeping faith with the constitution, debugging original is in and asserting an interpretation of the constitution in a progressive way. so i welcome you to tune in for that event. it will be available on our website if you want to watch it. and we have another event coming up on the 29th which will also be here on don't ask, don't tell. am i getting that right on the date and that should also be very

stimulating debate with a wide range of viewpoints expressed. and so thank you again, look forward to seeing you at our next event. and thank you to a very fine panel. [applause] [inaudible conversations]

>> all thisweek on c-span2 and 8:00 p.m. eastern book tv. tonight's the story of a former death row inmate who spent four years in prison. then cadillac man talks about his book land of the lostouls.

from a middle-class background to life on the streets. all this week on c-span2. >> as the debate over health care continues c-span's health care coverage is a key resource. go on line. watch the latest events including town hall meetings and you're share your thoughts including video from down hot technology. here is mark on the project. >> what we are doing, one of our final days of shooting hour documentary. we have been in there for about

two months. talking with nine of the justices about their job. how the court operates, the processes of the court and humanizing it. what we are doing is scrapping a couple files shots shots today. >> supreme court week starting october 4th on c-span. next, a discussion on the practice of private companies providing genetic tests directly to purchasers instead of through their health ca providers. issues include the regulation of testing, potential privacy concerns, and future research opportunities. held by the national academy of sciences. two hours and 20 minutes. >> responsibility r regulatory framework. different models of social oversight. our first speaker or speakers, should i say, andrea timothy,

will address the existing oversight mechanisms for genetic testing. both in the united states and the united kingdom. i don't know who is going first, but we will share the time, i assume, in equitable fashion. >> well, good morning. can everybody hear me well? i would like to thank the work shift oversight committee for viting me here today to talk about oversights of testing in this country. i am going t be covering today or walking through some of the

findings that we have. the secretary of the advisory committee on health. in 2007 the secretary of health and human services charged for our committee to actually investigatspecific questions related to the adequac and transparency of oversight of genetic testing in this country. so the committee, rather a group of 33 different members drafted a report of the oversight of genetic testing in this country that was actually released to the public november 2007, and we were able to continue some ostensive amount of public ckmment. afte that it was finalized by the the senate committee and released to the secretary in

april 2007. as part of the charge to our committee or questions to our committee the secretariat requested that we develop a comprehensive map of the genetic testing in sting in this countr and in order to do that we got help. actually helped us out significantly. and as we became looking at oversight and genetic testing it became apparent to us that there were five major components. of these five major components or all interrelated. and that is how you see the five different components here with the research and development with two different areas, either the fda, clia, availability and

reimbursement. as you can see, these white lines coming back and forth from all the different areas. this is an extremely comex method of testing oversight that we have simplified significantly by the process what i am going today is walking through each of the different process. so for us to start to look at the oversight of the genetic testing we need to start with when do we start developing? this is an area for research and development. so in the area of research and development to allow federal funding or private organizations were this industry funded research that and identified the needs and the violations that can be used for a particular disease. for this identification there might be a second round of research that allows us to gain

more information into the more hard numbers of the acquisition of the genetic variation with this disease and its disposition and prognosis. from these second rounds of research one can develop a design test that actually can be used f clinical development. at this point once there is a clinical development of a test you either move to a laboratory that is going to test and this has become an acronym for ldp. laboratory that's going to test. developing clinical laboratories that are trading these particular areas. this has become available. the other through the review. a number of different diagnostic manufacturers going through this rout to have the fda review of their products. so a number of different gaps identified through the process

of developing this map. and as you can see, this gap is going to be listed here. and we find many different. i'm going to only highlight some of those. the gap that we found in that development of the test is the lack of control of reference material available to the research and clinical community that comes in used to validate these type for clinical practice down the road. this second is the laboratory that will test can be open to the public without independent review. and we are going to some of the further regulatory issues that we will cover, some of the standards for these cuts laboratory tests to be offered by specific types of

laboratories. with regard to the particular map that we go through, the review of these tests, we talked about already different kinds of review, fda, the manufacturers that develop kids that are actually, when they are gettg ready to be moved into practice -- not practice, but move into consumers that can art with the appropriate research. diagnostic manufacturers actually have 30 days to that the fda know that they are intending to do these. this is part of the registration. in addition the average product that we showed earlier -- let me see if i go back. in here. so this will be the first week of development of test kits. actually going to go through the fda review. their is a registration, and then you can have an

application. then also the review. this is a type of lab developdd test that has guidance from the fda. there are a couple of differences using this particular draft guidance, and there is the diagnostic for therapeutic that also goes when we do combine applicationsf the dr verses the continue diagnosis. so once we get to the fda, when we get to the fta, all of the after registration and listings the fda does an assessment of risk of that particular test. and there are usually three categories of glasses of risk. class one, too, and three. class one is considered very low risk. a number of different class two's also have very low risk and we will only have to go through the fda registration,

exempt from a further review and could actually be offered ito different clinical laboratories and manufacturing practices. the of the type of testi, majority of class two and class three actually have to g through the approval. and there are different routes for these different applications. and it can be divided in two or three, actually costs are about that. the dna process and the humanitarian. and this is en there is specific need for that particular test for humanitarian purposes that actually will go at different types. sometimes they do some of this review. when the manufacturer comes for the appcation for approval if there is a predicate device already in the market that has been approved or cleared by the fda and the new device has

comparable characteristics to the currently in the market, this new device or comparable device can receive approval and go for the review and approval back to the laboratory services the other route, premarket approval, mainly class three, which are higher risk and for w technology, for example. they will go through a pre-market approval were there is not only premarket review of the application, but also preapproved along the section of the areas of the manufacturing facilities and it goes through the application review and back to the use of the laboratory. faugh first the number that did not mean actually the ecifications, andhere might be of of high risk. so these can actually be

accessed and some of this can be declassified. these actually lower risk. even though there is not a comparable diagnostic test on the market that can actually not pose as much risk to theublic, we have had some genetic tests that have been going through that are currently available. so as we go through this process there is an extensive review of some of these products to the fda for clearance and approval. theifferences between clear and approv of a very significant. if i take a product it will be cleared. sof it's called clear. the tee and a process actually approved. they have full review of the test bed is going to be used.

so with regard to the army where the laboratories are offering the clinical tests, the clinical tests in these countries are regulated by regulation called the clinical laratory improvement of 1998. so as we go through these laboratories have to meet and is then didst toe ab to meet clia standards. personnel from the laboratory to supervisors, consultants, and so forth that need to be that cann be able to qualify that person. there is quality assurance and the quality control, and a validity. so a laboratory that wants to start offering all of the little tests of services needs to hav

a clia certificate meaning that they would comply with clia regulations. so the clia laboratory support a submitted an application to be inspected or reviewed by cms, which is the center for medicare services for other approval. one of those are very commonly used. laboratories of american policy that actually we will allow you after"  you have gotten the register that you want to get a certificate. you can come and do the inspection and be able to -- the timing that you have meet the requirements. this is not a one time deal. this goes back into the circle. we have biannual ipections. we also have, every other year we have inspections for an outside inspector. during these inspections their

is a review of the validation, analytical validation for all the tests that has to be proffered within the last three years, and en as you can see here we go back. our laboratory -- our community found the gaps in different areas but of the oversight. one of them was about laboratory testing that is actually offered for use without independent review unless there is biannual inspection and then there is a review of that particular date when the inspector comes. the other, more important, the current regulation requires only 82 and lives. none of those are for genetic testing. the reason the regulation,

assessment. ther are a number of different positions that we tested by providers. but there are a number of different tests that go through these alrnative assessments. nobody has shown what is the benefit or not of these alternative assessments in a systematic way. but washington and new york state. and the reason they have clia extensions is that their program for oversight of the laboratory testing meets or exceeds the clia regulation. so they receive their status. the only difference between the exempt stage and that not exempt test is that the clinical laboratory program, the core program, tt is analytical and clerical review of the test

before it's available for use. so that will be the primary difference. they still have issues and now of efficiency testing like the rest of the laboratory. as we continue to move forward in the genetic testing the other forms of regulation become a ste regulation, actually professional organizations that provide different kinds of guidance. all these laboratories we actually looked at to be bringing into. but so as the different testing does into the offering of the different individuals, the location of the laboratories, independent, other laboratories that there is another form. non regulatory specific for the laboratories that we have to

file bones. as we ctinue the offer available for use, this testing and only for fda related tests in. there is also the development of outcome research and clinical review. this has become very important. the services task force, evidence for ergonomic application and practice, government agencies that actually independent groups. groups that actually do independent reviews of the clinical validity and utility that actually are going to be used for outcome research and also can be used by professional organizations, for example, or even the same group to provide recommendations of the guidance on how to use these tests. these can actually be used or

not used by third-party payers to pay for the test. th has become of factor regulator. so it is very important that we bring these things. and this provides feedback. so we can actually finish riley said of genetic testing. as you can see, this has evolved over the years. the complicated and interrelad overset of genetic testing. you can see the workn our community that has been extensive and trying to really get a handle onthe current oversite a genetic testing and point out some of the gs that the treaty is very concerned about. you can find of report on our particular web site. i invite you all to read the

report. >> thank you. a decree will we will go straign to dr. aikmen and then we will take questions from both. >> as i'm su you have all gathered, this is a very exciting time for genetics, we are giving the stock not only because of the interest, nterest

because of the very recent some advances in genetics that have already been referred to by one or two of the speakers and the fact that this knowledge and the technologies have the potential to be applied to health care, which is a major topic for this meeting. so as shown on this slide here i have three roles. i clinical genetics. i am a commissioner for that u.k. genetics commission. ifs i shod just like to say that i am representing the first. the views that i am giving are not my personal views. there have been several reports

and much activity over the past six or seven years in the u.k. the human geneticsuestion initially considered the question directed consumer testing in 2003, and this was at about the same time as the government produced but said a major impact on the way that genetics was used. much more recently there was an update on the human genetics report. and the present caldar has been back consultation, initially an internal consultation by the human genetics condition directs and the consultion, the public consultation for this. it will be ublicly available. that genomic medicine was quite

far reaching. it dealt with the w in which all the genome technology and genome knowledge could be applied to clinical practice. one particular chapter referred to direct consumer testing specialists. so in an area as complex as this we have had already the fda. there are a number of regulated reports which are this did here. including the u.k. genetic testing network which is the single gene disorder, national institute for health which is the body that advises on the clinical utilitynd effectiveness, mainly of drugs that become available and the human genetics commission which is the u.k. government advisory body on genetic testing. now, a couple of relevant statutes which i will refer to shortly. in vitro diagnostic medical devices which was initially enacted by the european union in

1998 has undergone a number of revisions since then. now, i don't need to remind this audience that genetic diseases are important, and they could properly be separated into a single gene disorder, which are generally rare and present in the 1,000 of the population and have usually got up fairly clear relationship between the gene and the disease and the genetically complex disorders where they have a complicated factorial in theology. they are very common. many of us are protected by some of these are tento be protected by some of these. now, into dozens to. already referred to t his. we thought that there were eight diseases that had been

positioned for cning. the dramatic changes did not occur until 2005. so this knowledge is really very fresh. in some ways it is not surprising. opinions and theays in which this knowledge could be used. now, the reason for drawing this distinction here is thathe diagnostics for a single gene disorder, a very well established protocol unr the auspices of the u.k. genetic testing which has a protocol on the gene dossier for approving new diagnostics for common diseases. as yet there is no formal body. so i would like just to briefly summarize what the various reports i alluded to earlier have noted and suggested. and the genes direct report in two dozen three recognized three parts of access to genetic test through the national health

service or private. through nonmedical such as therapists, and it through direct testing. and direct to consumers test our really apped to the second and third of these. and although it is knowledge that could be of benefit to the direct repor felt that if there were benefits that were useful andeeded to be mechanisms to ensure that only high-quality was marketed. then it was important to make sure that they don't miss use the power of modern genetics as a marketing tool, something we have already come across. there were possible harm to the consumerhey needed to be identified and prevented. so there was some recommendations that came out of the direct report. firstly there should be stricter controls on direct genetic testing. but there should n be as

statutory ban. i think that the debate for this in the unite states and some of the states ha taken a different view on this. they needed to be well-founded tests to the national health service, and one would be results of this report. 50 million pounds to improve the genetic services. this was to dramatically improve the infrastructure, the managing is a genetic disorder that really only apply to single gene disorder. recommended that most netic tests which provide predicted health affirmation -- and i think one has to now reappraise what predictive health information is. in the context of this report it has been a single gene disorder. and they discourage the use of home testing or home cycling. now, i think the seconapart from the funding, the second

most important recommention was the introduction of a newer and the misuse of genetic information. i don't know whether this was the similar statute in the usa, t this has really covered the whole of our thinking about genetic testing since it was introduced in 2004. so the statute under which it is considered, 2004. it is defined as not consentual analysis of dna when a person is thought to have committed an offense if he or she has any materials intending that any human dna is analyzed without qualifying consent. and this race here is what has commonly come into problems with dna that to protect some people with very high-profile individuals. taking a coffee cup and being

able to assign personality traits. it is quite a serious offense. can be punishable with a fine or with imprisonment, but the years. as it i'm not aware that it has been tested. now, that genes direct report also commented on the regulations for genetic testing, which were prevalent at the time. as i mentioned, the relevant directive is the european union directive called in vitro diagnostic devices, and this has been revised and number of times. but essentially this is a statute. this has to be regulated in member states by a nominee to the authority or in the uk this

authority is the product regulation agency. so any product that is brought in for commercial or other use has to meet the requirements of the directive. now, it is fair to say that in 2003 there was a lot of uncertainty over the faces of genetic testing and whether these were covered because they could be thought t be just lifestyle. this is very relevant to whether one considers this the practice of medicine or whether this is abou life style. and at that time this distinction was not clear. now, in a more genes direct which is the update on the first report published in 2003 the human genetics commission came down more firmly on their view about where genetic testing stood in relation to the

directive. and sentially it felt that most genetic tests were considered to be of low risk, and therefore the implications of this, the manufacturers are not required to submit to the national notified body. this means that no pre-market assessment is required. and self certication is sufficient. now, at the present time the other component of this is the market. and the office of fair trading has the authority to regulate. this brings up a big issue. direct consumer testing is an international market. how does one regulates at market? and should up did this by saying at the present time they still

regard genetic testing as being of low risk. the human genetics testing has revised their opinion and feels that this should be reclassified as being immediate risk. there may have toe some classifications. those have not been specified. cesta genetic testing is considered to be of low risk. so the last is the one i have just alluded to which is the genetic tests cannot be easily regulated. in order to promote high standards for human genetics we expressed the desire to regulate other countries. this is why it is a privilege for me to be here. by the consultation could be important which could be consideped as the framework for international cooperation on direct to consumer testing as something we would like to have

feedba on. so addressed this major problem of the international nature of the director of consumer testing market. the human genetics commsion held a seminar in june 2008 where there was a wide range of stakeholders' represented including decoding in napa jennings. and one of the conclusions which was strongly supported was that they would like to pport a code of practice, the this was voluntary or based on a free-market principles. and the reason for that, the companies felt that if they were doing could practice that they would be protected by having a set of a framework or principles that they could adhere to. and so this led to the developmt of the common

framework principles which a move on to now. the consultations about the at the end. it will be available on the web site, i hope, tomorrow. there is the time to go into all these principles, but i'll highlight what i think are the most important principles. so the first thing is, i have alluded to it, an intertional market that crosses national borders and jurisdictions. the common framework across all of these jurisdictions. the first principle was able to provide a high-quality service. that needed to meet the customer expectations. so this is what i did dr. carey would have said. the test for disorders and the definition of what is inherent

and lifestyle needs to be defined. and part of the pross of marketing is the local legislation or national guidelines or international guidelines. the second set of principles is the promotional claims should describe the characteristic accurately and avoid. the providers should supply easily information. the outcomes of the tests as we discussed earlier, and the genetic tests should only be paired out after the person concerned has been given free and informed consent. part of that relates to the dna that because then the private provid has to make sure they are happy. and finally, this is almost an exceion, but a very important exception. where these genetic tests relate to children in general genetic

tests should be delayed until the age of consent, and tell the child can give consent themselves unless there is a clinically important reason why that test should be carried out before the test reses reaches the age of consent. thweb site is there. a i think we will circulate the details. so i would just like to and, if i have three or four more minutes. my personal views about the direct to consumers test which was part of the materials during the process. so an area of science as suppose it is inevitable that witnesses to give evence held a wide range of views about the value of direct to consumerests. we have various eminent people who give us evidence of the report. share of genetics, and he was

looking at the website. and he felt that it is scientifically valid. medically relevant and very much a question of if you want. that is your businers. the executive director of the public health genomics foundation for many years regardless of t authority on public heah in the u.k. he could not see anything in a free society to suggest that we should stop people having their own direct to consumers test. for example, they have a 2 percent higher risk war of 4 percent lower risk of heart disease. derived from direct to consumer testing. and of course that phrase is taking a of a lot of our major national newspapers. we are aware that we have to be very careful. now, the oth side of the corn was really presented by peter

donnelly, the director of the trust's center for human netics. he would be an enthusiastic. sir peter said that he believes that direct to consumer tests, and likely to o happen in the commercial environment. a concern raised by public health. these are the steps of a service that would eventually be incorporated. maybe examples of when these tests can screen for 40 diseases, even if only one or 2 percent of things seem to be high risk. that then starts to account for large portions of the population if each of them accounts for a high risk of one or 2 percent of the individuals. so if there are a whole range of diseases let me focus on the lifestyle changes are as essential in a moment, the medical inteenti that could make a difference to those.

he said it was difficult for the time scale. but he said he would be very surprised if it took as long as ten years. he thought it would probably be much sooner. i'm going to give two examples of where i think these things might make a difference. the first one is in the context of coronary heart disease affecting up to the 30 or 45% of the population at some stage in their life. and according to the latest results from nine of the validated steps if you separate the population into quintiles, that is five people groups and treat the lowest quintile because they don't have any of the steps are only a few of the steps they have of reference ratio. but if you look at the fifth quintile, 20 percent of the population. they have a ratio of 2.2.

more than double the risk compared to the lower percentile. is that important? well, to fold is important in the context of public health. if you look at t early studies for coronary heart disease we would all except, prevent, or delay the onset of coronary heart disease. either secondary prevention or primary prevention. and so if you look at those studies that have the largest effect it changed from a risk of around 22 or 23% to a risk of around 15%. that is less than that to fold reduction. so the reactn from cholesterol is very comparable. for breast cancer -- and we heard this earlier for prostate cancer. the sty which was published in the new england journal last

june, the percentile of the population that would achieve a certain risk that would be considered to be the threshold for screening ban. often at the age of 50. that is based on a risk of 23 percent over two years. now, at the present time it is also f women at 50. in the right hand column if you consider, what is the age at which they would achieve it to 3% risk? in the lowest percentiles they wouldn't achieve it at any stage during their life. in the highest 5% they would achieve it at age 41. that would suggest that perhaps these inviduals should receive mammography considerably before. but so i will conclude with the

conclusions of the generic dicine inquiry which hold that for a voluntary code of practice which would safeguard the consumer by encouraging test providers to be open abo the limitations of the test and enabling consumers to make an informed decision about purchasing direct. the house of wallace which is a good thing. rather than going for a voluntary code of practice that would never recommend the principles. and finally with regard to medication the committee regarded as very important. should set up a web site that would contain the most up-to-date information on such things as the accreditation of the laborories and other things so that the public would have access to information about the use of direct to consumer testing. so in conclusion there is currently nobody in the u.k.

that has responsibility f direct to consumer testing. the advisory board has recommended a voluntary code of practice based on a free-market principles. quality assurance should follow international standard which i haven't had time to refer to and the principals were directed consumer testing and regulation should include consensus of the major issues such as accuracy of information, pre and post counseling, and data protection >> thank you. thank you both. we have some time now for qutions. i am just intrigued by your explain to us about the in a

theft. is a little bit of a departure from t core of what we are addressing here, but used to be a law professor. those years ago we were fascinated by the absence of privacy law. the explanation was the british didn't invade each other's privacy. what is interesting is we don't have a concept of dna theft. but in your society one might not have expected that you do. my question goes to, can you elaborate a note holidays hands you have u have the statutory criminalization of dna

that? as i think about this as a lawyer a think the lawyers and companies are elsewhere concerned about knowledgeable, informed consent and to triple and redouble their efforts if the failure of informed consent is to criminalize the subsequent analysis of dna. there are all kinds o interesting questions that come out ofhis. >> well, i'm not a lawyer and don't know the history. i note that the popular press was very keen and has been but for several years interested in how new technologies can be used and abused. one of the popular items in the press was with the high-profile individuals could have their paternity tested without their knowing it. of course that would be of great interest to some of the popular press. a think that was one of the stimuli, but quite apart from that i think it was recognition

that the new technology had considerable power to detect disease susceptibility are the traits that might not have been easily possible previously. and when you can do this sort of tests on just a single hair or coffee cup i think that that led the human genetics commission and others to advise that there needs to be statutory protection. >> okay. your analysis of reclassification isss for heart disease risk as well as breast cancer. the affair article. i mean, this is really an interesting both clinical and public health issue with respect to health care services and screening and the use of cholesterol loring drugs.

two questions. one, do you think the evidence we have so far -- and it's the kind of targeted action both for breast cancer screening as well as cholesterol lowering targets on the basis of 20 or 25 steps we have for heart disease. the second question i have relates to faly history. family history is a risk factor by itself. it takes 20 steps to get to ed to fold increase whereas family history, you know, does more than that. their is a significant fraction of the population that has that. last week there was an nih scientist consensus on the use of family history as of risk assessment tool for comment disease prevention and health promion. i was one of the speakers. the panel concluded there wasn't enough evidence to evaluate the

clinical utility. so i'm curious to see what you think about family history the city the steps. i think the first thing i would y is that the danger is very fresh. most of the geneticists believe that the scientific evidence in favor of the association has been adequately replicated. now, for many of them to show that they do have a small, uslly a small impact on risks susceptibility for these common diseases. that is completely different from saying there is sufficient evidence for clinical utility. the house of genetic madison inquiry concluded that there needed to be more research fore. that is different from saying

that individuals will have a direct to consumers test. it's possible that some individuals will recognize that they have a very high risk for individual diseases. now, i would say that i take the view of peter donnelly. at some point in the next ten years these will be shown to be of clinical utility, and the health services will want to introduce them into routine clinical practice. i don't think we a at that point now. i do believe the companies that offer direct to consumer testing have a lot to offer. they are the people who will be offering the test and have the most access to data. they are probably going to be the ones to accumulate the day to to show their clinical utility. but that does this stop the fact that there should be public funding of large studies to show whether these new are currently predicted. my belief is that some of them

are. my belief is that if you accumulate the snips that are available now federally coming in some of those will be shown to be clinically revant. whether it is. 1% o the population for a particular disease or one or two or 5% it doesn't mean that we should rule it out as an eventu public health measure. the second questionf family history is going back to the discussion we had earlier. family history is a crucial risk factor. if we are talking about single gene disorders it is a different matter, and don't think that is what we're talking about. if we are talking about common diseases but we need to do is develop models to take into account gender, family history. and when that is done at think we will probably find that we have a better prediction than if we didn't. >> yeah, i wanted to dank both of

of the speakers. i have a question. i'm going to direct it to you. you concluded with this bewildering slide that horrified everybody about all of the actors that are involved in overseeing thearious aspects of labatory testing. but two points in particular. with of the fda it is my understanding, and i hope you'll correct me if i'm wrong. the fda does not oversee the performance of tests. it only overseas the commercial marketing of merials were kids or whenever. >> well, the fda has decided not to enforce that. there are a number of different tests. >> can you put that cluster? >> their is is a very narrow nur

of tests called the diagnostic that has gone through a review by the fda. the fda has not oversight on the continuous evaluations on the performance of the test and so forth. this is thelia regulation that takes over that. >> and whatoes clia actually know about the proficiency in any lab, not just directing this at anybody in particular, in the lab, about the proficiency with which genetic jean best tests were performed. what do they do to assess the quality of the performance of the tes >> well, laboratories which are clearly certified and required by law to perform proficiency testing for assessment,

proficiency testing is required by law for only 82. there is no genetic testing that is part of the '82 and lights. the second component of tt is that we are required to do alternative assessment. and the alternative assessment could be done by using a proficiency testing materials from an approved organization like the quality of american pathology that has genetic testing out there. and if there is nowommercially available approved provisions to testing survey panel that we can purchase then we have to do other, alternative assessments for the proficiency testing through a simple exchange with another laboratory which is certified or through the test -- previously tested laboratory assessment. so that is for the performance of the test.

in addition all testing personnel has to be evaluated on a yearly basis to determine that they are competent inhe testing that they do and can produce quality results. we have to give them and those for all the testing that they do. >> can i follow up with a question? you had, i'd think, 29 cats in the final slide. did you have specific recommendations for how to address the steps? >> yes. >> and did you, in the and, proposed regulatory oversight as in other genetic testing? >> well, there wer specific concerns. their is a difference between clinical test ban of the human specimen done for diagnoses common clinical assessme, or

prediction and clia regulation. in the laboratory during even research tting with there is a chemical change should be done in a clia laboratory. there is need for more enforcement to make sure the laboratories that are performing clinical testing under that definition actually are clia certified and follow the regulations. secondly there is a number of bell laboratories that claim to have been during testing on lifestyles are health-related testing. some of those -- now some of these regulations. the issues of proficiency testing. how these companies are doing that. and then there are issues of -- there is current regulation on advertisement throug the -- >> ftc. >> we have regulation today that we need to make sure informs.

misleading information. so those need to be -- there is current regulation. we need to make sure it is enforced. we are recommending that those are actually enforced. with regard to direct to consumer testing we have in the process of developing a report. we pull information that we have done over the years. you have a copy of the draft report. at this point we don't have final recommendations, but you have a copy of the report that you can use. the other concern that we as a community have is on the education of the conditions and health care providers to t only understanding what the testing does, but actually how the air going to react. so those are some of the major concerns tt the community has. >> okay. i'm going to take questions from the floor also in addition to persons around the table. i wanted to note first, though

that we will be able to make power points available from presentations by no later than mid week. and we wil also make available to are three documents -- three by the end of the month. maybe it is the end of the month. from the uk. does might otherwise be available to you. >> i am drawn the fda. i just wanted to commend and theresa for bringing that presentation. at think she went into debt of trying to show to us how complicate regulation and oversight in this area is. i just wanted tat add a few things. first i want to reiterate what was already said and what was on