decision that must be defined as radical activism. >> larry gold represents the aolcio. they were not covered by austin in 1990. >> this case is about independence speech. actually, it is about a relatively small slice of speech. the express advocacy, the austin case, and what is called the functional equivalent of express said the keadvocates say, that a relatively interpreted as nothing by an exhortation to vote for or against them. this is not a contributions case. .

anybody to actually give money for people to use as they wish. but this case does implicate what kind of first amendment we have. consider some of the government's propositions in the case. there has a lot that has been said about what extreme results thermite be if things -- if thermite be if things -- if anything is ither of the two cases is overruled. but cyclical key propositions year. one is -- let's take a look at you proposition's here. one is that it is available for video-on-demand, for people to call it home on their television. and the government says the issue in the case is whether or not it can be constitutionally made a crime to do that sort of thing. secondly, as alluded to earlier, there was an oral argument that,

for example, the union subsidized a writer to write a book, that is the explicit message of voting for or against the candidate, and a rep fuel publisher decided to publish the book and did so, it will be a crime for the union to have subsidized that. finally, and even more broadly, the government's decision in this case is that it is constitutional to criminalize speech merely because an officeholder or candidate are aware of were feel indebted to those seeing what is favorable to them. and it is considered that a speaker is trying to curry favor with or influence officeholders by what they say in public. speech could be prohibited,

independence speech could be rejected in various cases, tried by the government, the sec, and there's a restriction from six years ago not accepted by the court that is now the centerpiece of a government argument. when you think about it, the notion that any speech can be prohibited merely because candidates might hear in react to it in some way has no limiting principle. it is not limited to the elections were legislation, and it is a pretty extreme proposition in itself. and that is why it weighed in at the second stage of focus. so really, one reason we ought to be focusing on this, it has been all lost, looking at the context of this case and seeing

what truly bears examination, is who gets to have a say about candidates and officeholders in america. who gets to use express advocacy and who does not. so very quickly, who can do this? individuals can do this, with their own money, no matter how wealthy they are or regardless of the fact that corporations have sources of wealth. people could spend their billions even though they derive directly from companies they control. media companies have absolute freedom to use their resources to talk about candidates, editorialize about elections, and have things be relayed by candidates as delegations. and in corporate associations can use advocacy and delight --

the likes. and so-called corporations, nonprofit groups the to do's to corporate money, can say anything bit more in any circumstance. so can bloggers, an individual with the website canst do it, and a federal package. so there is a broader array could can now speak freely on these matters. kucan not? business corporations cannot. regardless of their size, state, expertise, or even if they have control over them. secondly, nonprofit groups cannot do it if they take a penny of corporate money. advocacy organizations, the sierra club, the national rifle association -- they are prohibited, regardless of

whether they have expertise or people want to cure what they have to say. -- hear what they have to say. and people have been swept up and involved in uncomfortable legal situation of corporations in many years. our subject is that even though our subject has never identified the standard, it was never one to justify in the speech, except in french fleet. the austin decision distinguished unions, that was the one that said it was constitutional to prohibit corporations from the express advocacy. they say that distinctions do not apply, and the supreme court seemed to have forgotten that when they issued a mcconnell decision. but consider this. uniquely among the organizations

mentioned, unions have the following characteristics. there are formed by individual workers, often under arrest. -- underdress. membership is voluntary. by law and culture, they vote on other policies, there are boards like non-profit corporations, business corporations. the center's in unions can utilize the democratic process of reorganization, or they can resigned membership, not pay for political activities, and still be entitled bylaw to complete and total and fair representation. yet the law disfavors unions in the same way that it does

corporations. in this case, it is not directly concerned about a union plan. but in our view, it does implicate the rights of unions and all organizations, rebels of how the court comes out or what rationale it uses. i think it is really important looking at this case that we consider what is, and we have some serious rethinking about what the first amendment is and who is a entitled to it, who should be disfavored, and why. i have to think that the principal ones of argument in this case in part directly deal with unions, simply not comporting with what i think a thoughtful analysis would say. >> we have gotten word that bob bauer is on his way, so i will stall for a minute on those defending the provision and

asked jim and larry to address directly the idea of the wealth that could be unleashed in elections in 2010, 2012, if the supreme court does strike down this provision and reverse austin. i think everybody knows that people like senators mccain and find gold talk about the special nature of corporations, that they have this artificial distinction, they're not persons, and individual people should be deciding elections. do you want to address that first? >> the argument they're making now is completely novel. so while they rely on the long history and so forth, their actual arguments completely new. it is that austin was based on the idea, and you're alluding to it, that because of the corporate form, the ability of corporations to amass very well that their participation in our electoral process who be

distorted by their mere participation, that basically is the government and the reformers throwing it in the trash can because it seems so indefensible. now that they're talking about quid pro quo corruption, that is -- look at this money corporations have, they can use it to try and essentially bribed officers. the first thing is, quid pro quo corruption is dealt with by contribution lists. the supreme court had a whole series of cases on contribution limits and they said the way to deal with people who want to curry favor or get quid pro quo favors with officeholders is through a contribution limit. certainly, any corporate spending that would be the result of the decision in this case will still be subject to corporate limits. the only way i can get around that is to say that, well, it is

stored to be the general spending, the independent spending that will be corrupted. here they run against a whole series of cases that specifically rejected their claim. so sure they are, talking about science and history, while the arguments are, number one, one that was never considered by the court as it relates specifically and particularly to corporations, and the second argument is why the supreme court has routinely rejected support for corporate prohibitions. and honestly, if fred and his cohorts actually believed what they were saying, they would tell you they are simply a mouthpiece for the richest people in our country. in the last 10 years and 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 hold bond by grants from the largest corporations, the largest individuals, and the largest foundations in our nation. but they never say that. they never say they are just a mouthpiece, because they are not. i do not believe they are. i believe that they are sincere in their advocacy for the position. it is, of course, true that the wealthiest people benefit by the restrictions on corporations. because after all, george soros has spent 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 the

corporate ban targets them. they cannot go out and spend their own money like george soros or rich people can. they have to pool their resources, they invariably do that in corporations and labour unions, so it is people of average means who are targeted. >> first of all, last i checked, i have never received a contribution since created. corporations are not usually used to describe foundations. secondly, if i'm a mouthpiece for the second richest people in america, they haven't told me so, and nor has he.

i want to make two quick points. i firmly established the that congress' simple in trust affects cass corruption, curbing the occurrence of such influence, and i would submit to you that that is exactly what massive expenditures in campaigns do. 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

that showed that expenditures, expenditures were used, being used to attempt to buy influence, the standard test of the supreme court. secondly, in terms of larry's. about no unifying principle, there is a unifying principle. it has been that individuals who vote and individuals who provide the private financing to elect our officials. labor unions participate in this process through their pacts, which get voluntary contributions from individuals. , given for the purpose of being used in corporations.

so the unifying principle curious that for over a century , we have individuals, citizens, people choosing to represent, 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. in the economic marketplace, we're talking by business corporations, and doing so in the context of their economic interests.

>> we're going to let you have some opening remarks for about seven minutes. >> talking abut the indiscriminate nature of some of these rules, he says some foundation supporting his organization are not the corporations we would be concerned with, but the law does take all corporations and treat them the same, whether it is a nonprofit organization controlled by members that is wholly dedicated to a particular member or a huge mega- corporation, whether it is general motors or general electric, with special privileges. the question earlier was, what would happen if both of these cases were overturned, and i think it is difficult to predict what would happen.

corporations and unions now, even though they are disfavored under law, and do have a broad range ability to speak without prohibition on legislative and political manners and talk about candidates, and we have not witnessed the dedication of resources that i think are predicted if some of the last lines of speech categories were eliminated as far as descriptions go. i am not sanguine about corporate power. we deal with it every day in the media. but the notion that unions are subject to these restrictions or have special characteristics that justify faber, a think ignores everything i said about them. the fact is that again, unions, voluntary groups and the like --

this is freedom of association. we protect associational rights with the first amendment, not just individual rights. >> thank you for a comedy me on this schedule cure. -- schedule here. there was no basis in the case for speaking out, no record to support it. the court would have to go out of their way to decide so momentous a change in campaign finance causes. there are other alternative ways of reaching a decision in this case, whichever way it turns out, without unsettling these core principles of constitutional law.

we are also a point where, over many years, campaign finance laws have been in development. it has been around for a long time. we're seeing some equilibrium which has worked in the last couple of years in favor, and with very great deal about it and other panels have mentioned it, that for a variety of reasons, including developments on the internet and other incentives for fund-raising that may have accelerated in recent years, political act shares have found ways of reaching small donors where it was difficult to

mobilize before, and once they're on list, there also asked to participate in other ways, looking at participants in the political process for this development so long coming to be unsettled by a violent change in constitutional rules in favor of corporate spending rights, certainly a very destabilizing potential, and it is something that this court is not required to do. there is nothing but compels the court to destabilize the campaign finance regulatory situation or balance, his

starkly destroying excess long coming. now we're seeing a maturing under this regulatory scheme. the last point i would make -- and i'm looking at fred's notes -- i want to stress that there's a myth out there, the austin case, which the court has asked to your arguments on, were somehow one-out liner, wondering if kim fame finance doctrine, it should be -- wandering around a campaign finance doctrine -- it simply isn't true. allston may be a case that was not very clear exposition, but that certainly would not

distinguish it from other campaign finance precedent. in that respect, i think it is not an out liar in a disreputable cents. but in many other respects, if you look at what the allston court tried to say, the majority of the deeply doubt and analysis of where the constitutional law has rested for many, many, many years. so while austin may have been a somewhat opening presentation and open to criticism, i did not see a departure from precedent. and the notion that somehow we deserved the circumstances with no record before the court to support it and no requirement that the court address it, it nonetheless deserves to be reconsidered. i think it is an unsustainable proposition true for those reasons -- an unsustainable

proposition. for those reasons, it will visit and revisit issues of constitutional law, and be a fairly extraordinary step for the court to take, and i think that is generally recognized. >> i just want to ask a practical question. he talked about too fast, too soon for any kind of reversal. but it strikes me as a journalist that it is interesting that the dnc has come in and not the rnc, where to make of that. i think, fred at one point, you said that the interests are already spoken for there. do you think, looking at 2010, 2012, you would speculate on how there could be a shift in the character of elections, if this could particularly hurt democratic candidates? >> anybody who has hazard a guess on the impact of law on political behavior has been wrong. so i am being invited to be wrong publicly, and i will

decline that invitation. i will say about the rnc, there is, and this probably has also been mentioned, there is a pending case. the republican national committee is looking to mccain- feingold-of of political parties. to permit political parties to collapse soft money. if you look at the rnc as a whole, it is positioning itself, and i think its position each year is quite clear. >> would you respond to that? >> i would respond not by agreeing. the rnc has adopted a resolution i sponsored, i am a member, putting them in favor of deregulation, and in particular,

got them off their two-year detour where they were supporting the adoption of further restrictions on 527. so there are definitely in favor, as a matter of policy, in favor of the first amendment, and that has to be juxtaposed with the dnc which is in favor of the status quo. >> i just have one more question before i open it up. we're planning to open it up first to reporters, anybody who wants to oust the question of the panelists. but just in the context of the supreme court broadening these cases so dramatically with the june order, we saw in another case of last term, the voting rights act case, were justices at one point seemed to be looking at a very broad ruling and then pulled back in the and, as we all know, for the texas utility district voting rights

case and decided not go further. does anybody feel like there might be a sense, even without hearing oral arguments, that the justices might not go as broadly as they're looking right now? any sense of speculation as to 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 john roberts and justice samuel sli -- alito? >> they have to set up a situation, i think, where they are giving themselves options as a matter of good sense. and the appellate said in their brief that we do not believe this case is necessary. it is appropriate for them to reach mcconnell and overrule it, not necessarily to reach austin.

there is an interesting subtext of this case having to do with the supreme court as an institution, and how it deals with cases and issues before it, which is interesting and important across the board, with all kinds of cases and issues. but if it does not reach either of the questions that opposed, it is inevitable it will, and that is at least for this panel the more important focus, because it deals with these first amendment issues i described. and there will be a case next time, but if they do not do it at this time we will not have any of these institutional questions working, as well. >> anyone else? rep. we would start with reporters first, and there's a woman with a microphone here. if you could just read either side with questions.

>> hello prepare -- hello. tomorrow, national law journal. ted olson took a different approach from your perch. why didn't you take that approach, and are you pleased with how this developed by? you did not make a frontal attack, and now it is being framed that way. do you think that is wise? >> our approach was based on two considerations. number one was that i believe a president is of course, the government is asking that austin be applied.

it is a justification for the corporate prohibition on the movie and the requirements of the reports and disclaimers that mccain-fine gold applied. it seems like every time there is a liberal precedents under challenge, the liberals get antsy about broad rulings, even though in my experience, they love broad rulings that say -- that go in their direction. i did a law review article when roe v wade was argued at that time. it is always implicated if you are asked to apply it. what do you expect the supreme court to do? you expect them to sit there. if they decide austin is wrongly decided and makes criminals of a wide variety of individuals who want to simply engage in a democratic free speech, that they should apply that precedent, even though they

think it is wrong? niceties that the plaintiffs did not ask for it to be understood and overturned? that is irresponsible, in my judgment. so if the validity is always subject to reconsideration if somebody asks the supreme court to apply it. the second reason was -- is that we believe that the supreme court tossed explicit recognition in this case of the unambiguously campaign related principle, kind of a threshold issue that taps the power of government to only those things are regarded as a campaign speech. we have campaign disclosure requirements applied, and unless

it is like davis, saying that if reports go down, the court will have to look at these specific justifications for the disclosure provisions. so this has obviously been more dramatic, and the supreme court, it seems to me, in asking for arguments, and given all the possible options and niceties been, the reformers are of concern about them, like of which is principles, narrow rulings, and the plaintiff asking for things -- that has all gone by the board down. so they have a full array of options. i've argued in the re-hearing on behalf of eight former commissioners of the fcc, seven of whom are former chairman, that while it is not necessary

to overturn austin or mcconnell, that the court should do so and do so because of the established fact that all of this has become unworkable, and these eight commissioners that were asked to apply, to administer the act, are uniquely situated to explain to the court about how utterly complex and unworkable this team is. >> let me just mention to the audience that ted olson is in the unusual position of being a challenger to this provision. >> i do not tend to look at a crucial principles as niceties. but let me just wuote and justice roberts view of processed precedent. he said, "i do think it is a

jolt to the legal system when you overruling precedent. precedent plays an important role in promoting stability and evenhandedness. it is not enough, and the court emphasized this on several occasions, not enough that you may think the prior decision was wrongly decided." . . and seeing how this is played out in practice. i wonder, if the court rules in this case in an adverse way, if

you could talk about what the implications would be for the president and his reelection campaign, would he be put at a disadvantage? >> as i mentioned, i said, i am disinclined because of the history of completely mistaken assumptions about the fact and the change in the law. i will not speculate about what the effects of the decision could be. the court could decide this case in a number of ways. the court could also decide the case in a way that it never occurred to anyone in this room before. for that reason, for me to say what the effect would be would be beyond speculation. i would be engaged in a hallucinatory exercise that would add to your view that campaign finance law has limited interest outside the beltway. >> i agree with bob on that.

we have seen that historically. republicans come after the 2004 election, thought they wanted to prohibit 527's. i would argue that the swift boats had more facts than all of the money of george soros. it is difficult to predict. the swift boats had more effect. it is difficult to predict. incumbent politicians do act on what they think to be their partisan interests. the dnc likes the status quo. the rnc does not. they want to change it. i think that is consistent with the rnc's positions in the past. it is in form to a certain extent by the perception of whether the current situation benefits us or not.

congressman tillman of the tillman act that reformers like to lionize, he was a notorious segregationist to have a problem. his problem was that corporations in his district were lining up in favor of the republicans to throw him out. he wanted to do something about it. as incumbent politicians will inevitably do, they used their political power to pass laws to disable their opponents. we have seen this historically. mccain fine gold, there is not one word or paragraph, not even one sentence that adversely affects incumbent politicians. 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 rewrite the rules for their own election.

we have seen over and over again that they would write them to benefit themselves. >> fred, you said the argument about the results to power to regulate books was a red herring. what you say that? the think it influences the justices' decision to widen the case, and how you think the solicitor general will adapt the argument? >> i will not predict that. i do not know the answer to that. predicting the supreme court is something that i leave to other people to do. why do i think it is a red herring? in the 62 year history of this provision, i know of no example where it has been enforced against a book. leaving out the fact that books are not involved in this case.

the campaign finance rules have a broad exemption for commercial and activities, which means the whole book publishing world is exempt from the campaign finance laws if they are involved in campaign practices, in commercial practices. i do not believe that a 500 page book with a single sentence of expressed advocacy in it is covered by this provision or would be treated as covered by this provision. i know that the assistant review what the assistant solicitor general said, but i do not agree with that position. i think it is unrelated to the specifics of this case. >> larry, you do not think it is

a red herring, do you? >> none of the solicitor general says explicitly that a book could be banned under the circumstances that i described in my opening remarks, a position that has not been repudiated in the to briefs that do solicitor general said. i would be surprised if knowno e asked if the government still adheres to that position and how it applies to this case. >> would you be surprised if that is not the first question? [laughter] >> one of the things that has been raised 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 do not allow

it. as experts in the field, what do you see as the differences in areas where the contributions are allowed as opposed to other areas? >> i do not know the answer to that question, but i do know there is no record and there was no opportunity in the record to examine what the record is in states with the band and without the ban. it is also true that this is a federalism system, and of some states think they do not need the ban, they are free to do it. that should not prevent other states who feel the need for it to be able to have the ban, but i do not think there is any really strong documentation one where the other about the impact in states that do not have it. >> we have over 20 states that

have no corporate bands. --. bans for more than 200 years. you would expect them to say look how horrible it is. look how corrupt the public officials are. look at all the massive spending trying to influence the governor and the state legislature and the city council. isn't that telling? that means they have no case. that means 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. >> let's let larry go next. >> i think fred's point is right. there has not been developed a substantial record on some of these things. everybody was surprised with the

argument, and it was just a 30 day period for all these briefs to come in. this is an expenditures case, and the supreme court still does not adhere to what i think is an appropriate, fundamental difference between contributions and expenditures. just looking at the union experience, most states impose no restrictions on the ability of the union using its regular treasury money to say anything it wants publicly about candidates and elections. the reality of that is that some unions do and some do not. there are all sorts of considerations that go into that, but there is hardly any record there, any claim out there, any proof that somehow this has been a corrupting influence at the state level.

>> there is no track record at the federal level, because fort 62 or 102 years, depending on how you want to count it, these expenditures have been prohibited. >> one thing about the contribution expenditure distinction. there are circumstances across the body of campaign finance law with there is no question that has been very significant. very recently justice kennedy blue right past it and completely ignored it because he believed that it was not stated x -- stated clearly. huge expenditures have the potential -- it was alleged to be the effect of dominating a particular race.

the contributor could have claimed to be the author of the victory. some thought he was. in those circumstances, the contribution expenditures dissolved. with restrictions, talking about corporations, a similar question is raised about whether you can really distinguished contributions from expenditures where vast sums of money, and that is the phrase the court typically uses to describe the threat, the use of the immense wealth, has the effect of achieving a dominant hold on the political process. i think the contribution distinction does not have quite the same magic or automatic application that it might in other more routine cases of finance. >> can i ask you about another issue regarding austin?

in kennedy's dissent in holliston, he regards nonprofit organizations differently. how do defend the fact that the government should have at least accounted for the distinction between profit and non-profit corporations, and if we are talking about the corruptive power of them, explain why there was no reason to have that distinction, in your mind? >> one of the panelists and pointed out a few minutes ago, there is built into the long some distinction already between corporations and that are profit-making and non profit making. one of the possibilities of the case is that the court may

decide that that particular exception for a certain class of nonprofits is too narrowly drawn. it is too restrictive and that more nonprofits should be able to make a broad constitutional claim a speech that other corporations would be denied. that is certainly a possibility. a lot in this area, and it is hard for me to speculate on what was in the mind of congressional sponsors or hell congress looked at the statute when it was passed. i do not know the answer specifically -- how congress looked at the statute when it was passed. it is clear that the claims of non-profit corporations have occupied more space in this debate. though congress may not have anticipated this debate, the court is now confronted with it and will have to address it.

>> this is a question for fred. gm previously characterized the position espoused by the opponents of the citizens united reeve as concerned with quid pro quo corruption as compared to the undue influence. i would like to reorient the discussion to the undue influence aspect of this case. larry gold also mentioned that this is not a contributions case. as law students are aware, the corporate free-speech adoption originally emerged and corporations are not awarded the same free-speech rights as individuals. i also want to mention something that has not been addressed. james identify the fact that the bill gateses of the world would be negatively affected by it

reform, and that makes a strong case for this zero sum game that we have with campaign finance reform. if this is not a contributions case, could you please explain the potential distorting effect of unbridled expenditures being released into the market? could you elaborate on the undue influence argument, which i think has received not as much of an explication in this discussion as the judicial principles which are also being threatened by citizens united? >> there seem to be many questions there. i will try to grab a couple of them. first of all, let's look at belotti. here is what it says. our consideration of a corporation's right to speak on issues of general public

interest implies no comparable right in the quite different context of participation in the lit -- political campaign for election to public office. that decision takes itself out of the game of whether there is any precedent there for corporate centers. 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 that an obligation for those expenditures that were made. i would submit to you that if you look at a situation where

you have a house member who is going to spend $2 million in a campaign and is facing -- faced with a corporation or series of corporations who are prepared to spend $20 million to defeat that member if he 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 is that is applied to independence speech. there really is no limit in principle. and what is happening with the health-care debate right now. tens of millions of dollars are being spent in order to influence their conduct, and will have some collateral effect on the election next year, intended or not. that is what speech is.

it is unpredictable in its impact. the problem, if you take undue influence itself, the notion that officeholders are candidates will react in some way to a speaker and use that as a justification to prohibit an even criminalize that speech, it is very difficult to draw lines of where that stops. right now, well the individuals do not have any of these constraints and can spend as much as they want to do so. unions cannot, non-profit corporations cannot, a small nonprofit groups cannot. why did congress do some of the things it did? let's not forget that when congress enacted this restriction of these broadcasts, it did so very explicitly. there are many statements by members in the debates about how much they hated the fact that unions and organizations were referring to them, talking about

them, putting public pressure on the legislatively. they call that nightmares, they call it trash. these were their words. the prohibited -- a prohibited -- they prohibited it. they almost eviscerated in the wisconsin plot -- right to life case two years ago. i am hoping this case will end of that. >> i was interested in hearing from you whether you think that the courts have already significantly chipped away at mccain-feingold and could ruling in this case be used to further challenge the law?

>> there are two parts to mccain-feingold. the first part is a ban on soft money going to political parties. that is not been touched. jim is presently in court trying to touch it. [laughter] i think wisconsin right to life substantially cut back on the communication provisions but did not eliminate them. i think they still have force. i think they still will be treated seriously by corporations and labour unions. i think one has to keep in mind here in terms of what larry just said that when you switch from issues to direct campaign

activity, corporations and labour unions are being asked to speak through their tax. they are not being told not to speak -- to speak through their pacs. they are being told that you need to use money voluntarily given by individuals for this purpose in order to speak directly in campaigns. i continue to believe that there is going to be a major difference if all of a sudden a constitutional right is the established -- is established to make expenditures to directly elect or defeat candidates, in terms of what the potential impact of that money is on government decision making. >> one important irony in all this is that the predictions of

some cascade of money being applied to this kind of express speech that is not the functional equivalent, whatever that means, is that the whole rationale for imposing these greater restrictions on broadcasts is that the -- it was socially meaningless. it did not matter, so it had to be extended much more broadly. now it seems that this line, whoever is going to be able to do it, has some kind of important point of no return. with respect to the pac point, i do not see why unions and other organizations ought to be restricted when they are democratically controlled, democratically a rise -- why they should be restricted in using their own treasuries in speaking out on issues and

candidates. >> a guess we have time for one quick question. >> of raised the possibility that the court might get out of this by somehow -- bob raised the possibility that they might get out by allowing a broader class of corporations. i wonder if the panel could try to illuminate us what types of non-profit corporations or other divisions among the corporate world might be appropriate for the court to go to to get out of this case without sweeping aside austin entirely. >> to say that they might look at the question of whether or not an organization that is clearly organized for ecological or political purposes that is not engaged in commercial like

to be, and that is receiving only the minimus amounts of funds, ought not to have the same right to participate. it might loosen up some of the rigorous restrictions that the court imposed in the ncfl case. that is only one possibility. >> the federal election commission has maintained since 1986 that you can have no corporate contributions in order to qualify for the not-for- profit exemption from being prohibited from doing independent expenditures. they have even done a regulation that says that, but now we have the solicitor's supplemental reply saying that citizens united has argued that the vast majority of their spending for the movie is not corporate, so maybe we could open that up a

little bit and allow groups that just have a little bit of corporate funding to run things like "hillary, the movie." if the court does not spend the -- expand the exemption, they will have to address austin. i am not in favor of that approach. one reason 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 a the minimus amount of corporate contributions -- 8 de minimis sees that as inhibiting their

activity, which is the best majority, then it will not be a practical or useful expansion of mcfl. >> thank you very much to our panelists. we have some final words. thank you all for attending. >> i just wanted to thank you for attending this a very lively panel. there is a wide range of opinions on this case and what the court might or might not do. i want to mention a couple of upcoming events. . ust want to mention a couple of upcoming acs events. on the 24th we will do our 2009- 2010 supreme court review. it will be here from 12:00 to 2:00. the moderator will become a gold steen, who is the founder of a blood. blood. on september 16 would be nationwide simulcast

particularly the arguments in the new book of an " keeping faith with the constitution." i welcome you to tune in for that event and it will be available on our website. and we had another even coming up on the 29th, which will also be here on "don't ask, don't tell." and that should be very stimulating with a wide range of viewpoints expressed. thank you very much and we look forward to looking at -- seen you at our next event. ♪ dollars the supreme court will hear oral arguments on this case citizens united v. of the federal elections commission this coming monday.

you can see more about this from our web site. in tunis for america and the courts saturday evenings at 7 eastern on c-span. c-span is a public service of america's cable companies. coming up, a panel discussion on the growing practice of private genetic testing. that will be followed by president obama weekly address and a response by jonathan moreno -- john kline. and in a discussion on how a bill becomes a law. sunday on "washington journal," a look at the british health- care system. our guest is a british ambassador for health and life sciences.

and then release of a report showing that civilian contractors in afghanistan now outnumber u.s. troops. and later an author on his book "polluted and dangerous." abandoned properties in what cities are doing to help that. "washington journal" opens with your phone calls and e-mails live every morning at 7:00 a.m. eastern here on c-span. tomorrow on "newsmakers," the secretary of the smithsonian institution. he talks about his first year of overseeing the smithsonian and the future of the institution. see that it sunday at 10:00 a.m. and 6:00 p.m. eastern here on c- span. and now, a forum on direct consumer genetic testing. the practice of private companies providing test directly to purchasers instead of to the health care providers. issues include substantial

privacy concerns and future research opportunities. the national academy of sciences is the host of this event. it is about two hours in 20 minutes. our next cluster of topics is around social responsibilities, the regulatory framework, different models of social oversight, and our first speaker, or speakers, should i say, andrea and timothy, will address the existing oversight mechanisms for genetic testing, those in the united states and the united kingdom. we do not know who is going first, but we would share the time in some equitable fashion.

>> good morning. can everyone hear me well? i liked it thank the committee to talk about oversight of genetics testing in this country. i am going to be covering today, while kiefer some of the findings that we have -- some observations that we have made, that in 2007 the secretary of health and human services

charged our committee to actually investigate different questions related to the adequacy and transparency of the current oversight genetic -- system for genetic test to see -- testing. we got together with experts in the field and drafted a report of oversight testing in this country that was released to the public in november 2007, and we were able to incorporate an extensive amount of public comment and to the report. and then it was finalized and released to the secretary in april 2007. as part of the charge to our committee, the secretary requested that we develop a comprehensive map of the genetic testing in this country. in order to do that, we got help

from the low-income group, a significant amount of help with the oversight models. we looked at the genetic testing in this country and it became apparent that there were five major components, and there are all interrelated among themselves. and that is how we see the five different components here, with the research and development that feeds into different areas, ever the fda, the clia, reimbursement, and others. you can see the lines going through all the different areas. this is been sent to bat -- signifies -- simplified significantly by the bosses. i hope that you remember that

this is coming back and forth between the different areas. we start to look at the oversight of genetic testing, when do we start developing the tests? this is the area of research and development. in that area, there is federal funding, or a private research, that identifies the ginny's -- the disease, which can be used for the particular diseases. and the identification of genomes from the basic research, it allows us to gain more information in hard numbers on the association of the genetic variation with the disease and perhaps part noses. from the second round of basic research, one can develop a prototype or design test that

actually can be used for preclinical development. at this point, it can take different routes. it can move to a laboratory develop test, ldt's, developed in clinical laboratories by professionals that are trained in these particular areas. the other route is being reviewed by the fda, and a number of different diagnostic manufacturers go through this route to have the fda review their product. there are a number of different gaps identified in the process of developing this map. you can see them listed with dave g1 or a g2 here. all how like the ones relevant to the discussion today.

the gap that we found in the -- to preclinical development, is the lack of control of materials that were available to the research and the clinical community that can be used to validate these assets and for further practice down the road. the second gap that we found is that the laboratory developed the test, it can be offered to the public without an independent review. and we will go through some a bit further regulatory issues necessary for these to be offered by specific laboratories. 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 getting ready to be moved into practice -- not practice, but move into consumers that can start 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 developed 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 applications of the drug 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 it to different clinical laboratories and manufacturing practices. the of the type of testing, majority of class two and class

three actually have to go 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 when 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 application 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 new 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 these can actually be classified into an area where they are actually lower risks, even though there is not comparable diagnostic testing

the market -- test in the market, they can go through an approval. we've had some genetic test going through this sequence that are currently available for certified laboratories. we sent these products for review for the fda, and the differences are very significant. it will be clear -- it claims are comparable to the predicate device. [unintelligible] so with regard to to were the laboratories are offering that clinical tests, clinical tests in this country are regulated by the clinical laboratories and improvement act of 1988.

laboratories have to meet a set of standards, very rigorous standards, to be able to meet clia standards. able to meet clia standards. personnel from the laboratory to supervisors, consultants, and so forth that need to be that cannot 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 have 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 inspections. 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 then 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. there are a number of different positions that we tested by providers. but there are a number of different tests that go through these alternative 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, that 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

state 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 continue 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. this 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 interrelated overset of genetic testing. you can see the work on our community that has been extensive and trying to really get a handle on the current oversite a genetic testing and point out some of the gaps 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. this is a very exciting time for genetics, because of the very rapid 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 tend to be applied to health care, which is the major topic for this meeting.

ashton and the slide here, -- as shown on this live here, i have three roles relevant to this workshop. i'm a chairman of genetic " -- genetic clinics, and i'm the commissioner of they human genetics commission, and i was the adviser for a madison inquiry for the house of lords. i am representing the first of these and i am not representing my role as specialist adviser here. the views that i are giving are my personal views. there have been several reports and much activity over the past six or seven years in the u.k. -- the humans -- the human genetic commission consider this question in 2003. this is about the same time as the government produced a white paper which had a major impact on the way the genetics was

viewed by the department of health services. much more recently, the commission report in the present calendar year, a consultation initially by the human genetics commission on the direct consumer testing, and a consultation -- a public consultation is about to start for this tomorrow and some of it is already available in the workshops. the gentleman madison inquiry -- the genomic madison inquiry was quite recent. it sought -- it showed how it could be applied to clinical practice. one perfect your -- one particular chapter referred to direct a consumer testing. 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 utility and 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 tend to 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 cloning. the dramatic changes did not occur until 2005. so this knowledge is really very fresh. in some ways it is not surprising. opinions and the ways in which this knowledge could be used.

now, the reason for drawing this distinction here is that the diagnostics for a single gene disorder, a very well established protocol under 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 applied to the second and third of these.

and although it is knowledge that could be of benefit to the direct report felt that if there were benefits that were useful and needed 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 consumer they 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 not be as statutory ban. i think that the debate for this in the united states and some of the states have 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 genetic 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 second apart from the funding, the second most i do not know whether there is a similar statute in the u.s.a.,

but this is covering all of our thinking about genetics testing since it was introduced in 2004. the statute under which it is considered is the human tissue act of 2004, and it's defined as non consensual analysis of dna iwhen a person is thought to hae committed oan offense. this is coming into parlance as dna test, to protect people -- some high-profile individuals. taking a coffee cup that had been drawn from bite your president and then being able to assign personality traits or other trades to that dna that could be a -- extracted from a coffee cup. dick be punishable with a fine or within prison and up to three

years. 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 to be just lifestyle. this is very relevant to whether one considers this the practice of medicine or whether this is about 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 essentially 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 certification 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 to be 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 considered as the framework for international cooperation on direct to consumer testing as something we would like to have feedback on. so addressed this major problem of the international nature of the director of consumer testing market. the human genetics commission 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 support 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 development of the common framework principles which a move on to now. the consultation is about the at the end. it will be available on the web site, i hope, tomorrow. there is the time to go into all of 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 international 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 process 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 provider has to make sure they are happy. and finally, this is almost an exception, 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.

the web 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 evidence held a wide range of views about the value of direct to consumer tests. 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 business.

the executive director of the public health genomics foundation for many years regardless of the authority on public health 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 other side of the corn was really presented by peter donnelly, the director of the trust's center for human genetics. 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 intervention 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 the 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 reaction from cholesterol is very comparable. for breast cancer -- and we heard this earlier for prostate cancer. the study 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 for women at 50. in the right hand column if if you consider the age, they would achieve i'd 2.3% risk. in the lowest percentiles, they would not achieve it at any stage in their lives. and high as 5%, they would achieve it at age 41. perhaps they should receive it -- receive a mammography considerably before they are receiving and. they favor of voluntary code of practice for direct consumer testing, which would offer safeguards to the consumer by encouraging test providers to be open about the test and enabling consumers to make

informed decisions. the house of lords inquiry -- there was no particular conflict there, and rather than going for a voluntary code of practice, they would recommend the principles i referred to earlier. and with regards to education, the committee regarded it as very important that the department of health should set up a website contending up-to- date information like the condition of the barn door is -- laboratories, so that public's would have information about the direct consumer testing. in conclusion, there's apparently no one in the u.k. that has responsibility for oversight of direct consumer testing. -- direct to consumer testing. quality assurance should follow -- follow international standards such as those set down

by the oecd, which i have not had time to go through, and the principles for regulation should include consensus on the major issues such as consent, accuracy of information, market counseling, and that a sampling. and now will stop there. >> i thank you, timothy. thank you, andrea and timothy both. we have some time now for questions. i am just intrigued, timothy, by your explanation of the dna theft. it is a little bit of a departure from the core of what we are addressing here, but i used to be a law professor, and we were fascinated by the

absence of a right to privacy and u.k. law. 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 of interesting questions that come out of this. >> 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 issues 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 lowering 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 family 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 promotion. 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 say 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, usually 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 before. 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 are 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 relevant. whether it is. 1% of the population for a

particular disease or one or two or 5% it doesn't mean that we should rule it out as an eventual public health measure. the second question of 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 i 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 the various aspects of laboratory 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 materials 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 the clia regulation that takes over that. >> and what does 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 test? >> 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 that 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 now commercially 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 in the 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 were specific concerns. their is a difference between clinical test ban of the human specimen done for diagnoses common clinical assessment, or prediction and clia regulation. in the laboratory during even research testing 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 through 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 not only understanding what the testing does, but actually how the air going to react. so those are some of the major concerns that the community has. >> okay. i'm going to take questions from the floor also in addition to persons around the table. i we will be able to make the powerpoint is available by no later than men week, perhaps sooner. -- midweek, perhaps sooner. and perhaps there will be three

documents by the end of the month from the u.k., simply because they might otherwise be unavailable to you. yes? >> i month run -- i am from the fda. i want to commend the night's presentation. i think she went into debt to try to shut it was how complicated regulation and oversight in this area is. i wanted to let a few things. first i wanted to reiterate what was already said in the morning and is on your agenda, dr. courtney harper will give a presentation on fda oversight past and present. that is tomorrow morning during the breakfast. also, about the performance of the tests, i want add to what andrea said, actually fda does look at the performance of the

test, either in a free-market or in the post market her renown -- are renown -- arena. if our lab developed kids, the fda has applied for oversight of lab developed tests so far. courtney will vibrate -- elaborate on the someone. >> i had a question for andrea as well. i wonder if the secretaries advisory committee is thinking about converging the legislation, particularly in the state of california, senate bill 482, which has been co- sponsored by some other companies. .

the comedy is concerned about this legislation. we cannot, -- the committee is concerned about this legislation, we cannot comment on this one in particular.

>> i would just like to follow- up on that. add pathway -- at pathways' navigenics, in general, we do not think the separation of the analytical and the post- analytical analysis should be accomplished in that it should still be maintained under clea and not develop a new body to regulate something that we do not really for many people may not understand. i think it is our responsibility to help train clea, teach clea more about the analytical process, how it works, and engaged overall regulatory

process. if you look across the board, the difference spaces have all kinds of regulation. we are doing our best. the goal for us is to eventually have all of the appropriate -- meet everybody's standards and have the appropriate standards across all states. states. so pathway would definitely join in getting a common frame. >> i didn't mean to give the impression that this was an exclusive framework to the u.k. in fact, the u.k. would very

much welcome, tampa dissipation by any other jurisdictions. i think the initial idea was that a code of practice would apply to the u.k. and other european states as well. and it was realized that actually it couldn't happen partly because the dna theft that is on the statute both in the u.k., meant that there was an protection in the u.k. that might only be present in our jurisdictions. at them rather than trying to produce a code of practice, which could be signed up to voluntarily by the dtc companies, a framework of principle should be universally applicable. and i think it over a three-month period it may be too short of a time to develop those two away that it is globally applicable. and certainly any comments from corporations or legislator or academic institutions would be very welcome.

and the website will be up and running i hope for tomorrow. >> good. anyone? >> yes. >> go ahead, patricia. >> i don't know if there are any consumers in the audience, but i am a clinician. and just begin to having seen some of these reports and seen how patients perceive these organizations that do the direct consumer testing, they have no idea that they are nonregulated. they think it is a laboratory test and a result just as if i would give them their printout from the labs that i just did. they don't even know how regular clinical care laboratories are standardized and regulated and so forth. so i test is a test as far as they are concerned. and it is just a blank slate, not whether there is regulation are not. so i think in addition to all of the public and clinical education that needs to on for professionals as well as

patients, i think the real -- reliability, validity, accuracy and interpretation of every test in medicine or any direct to consumer arena needs to be addressed and this needs to be discussed publicly. and i think that's one of the challenges that we have is that people will believe what they get from the health food store because someone has made a claim for whatever it is that they are looking at. and they believe this. and for many people in the public, they are one and the same. >> i guess i kind of resonate to the common. i think it seems to me, first of all, the industries thriving and will continue to drive, which is fine. i do think they are engaging in a practice that is getting very, very close to a clinical laboratory. and i think that there ought to be a uniform system of standards

that are applied both to the commercial sector and to the health care sector so that the people who received the information have the same level of confidence or whatever word you want to use in the results. and i think that's one of the issues that i have been trying to get my hands -- my head around in understanding exactly what fda does and doesn't do and what clia does and doesn't do in that regard. look for the companies to work together to get uniform standards, which i think doctor becker mentioned might be happening, i think it's okay. but i don't think that's the solution because their standards ought not to be different from the standards of any clinical

laboratory that is offering comparables services. because i don't think consumers can tell the difference in general. and i don't see any reason why they would think there was a difference, based on the promotional stuff going on by the companies. so i'm not being negative about this at all, but i'm just trying to think of a way out of the dilemma so that asks the industry thrives and would move forward, there is some consistent level of quality assurance that all of these entities that are performing these tasks and delivering results to people must meet. and i think that would be a good goal, and how to do it i don't know. >> david, what you're driving at bill goes beyond what the data are that the microarray

produces. in other words, how far will the standards go? is it just to the quality of the test as run on a sample, or does it go all the way through to regulations or standards for announcing the results, displaying the results that presenting them to customers, clients? >> i don't know. i think that is a very legitimate question. and i don't pretend to have the answers to them. >> but your focus was on the testing a sample, right? >> yeah, but i mean i actually agree with you that it is the testing, and in what you do with the information. >> i think what david is expressing a is a certain level of malaise, anxiety, in terms of the potential sort of, i guess misuse of the information that

could come out both in the context of people on their own as well as the impact on the health care delivery system. i think one of the things that the workshop that we just had last year, which didn't have much time to go over all the accommodation, it takes all of these things into account and ask a person in the context of the inadequate that they have uncovered. i think as a consumer, as a provider, we need assurance that the full gamut and clinical mobility, the allegations are taken care of. is not sufficient to say that this is a test that can, you know, has a good analytical validity. even that long takes, you know, half of the oversight chart to cover that between clia and the

fda. i mean, if we are confused between is this a prime example or a human sample right now, i mean there are issues that have to be addressed. but on the clinical side the clinical validity, that's what i was asking about all these evolving markers for heart disease, etc. we are generally in a state of flux and confusion about what these numbers mean. i mean, based on the slides that he showed and the slides that i should, i don't think providers know what to do with this information. and it is not sufficient to say we need to educate providers, because providers can be educated but we need to go collect the data that actually shows the validity and utility. and then display it, display it in a prominent way for the providers and consumers so that they can make the right decisions. so the amount of oversight that is needed to assure that process is what we are talking about,

whether it's new regulation or using the existing regulations, it doesn't matter. but i think as a society and as a health care system, we need that information. i think one of the recommendations that they made is this mandate a genetic test registry, which you didn't talk about, andrea, but i think it is one of those things that the test developers will put out their best guess of what that information means. the other thing, independent panels can actually take a hard look at the evidence, say okay, is there more on average but more harms or benefits than harms to the not only the individual tester, but to the system. i think we're dealing with a disruptive technology that may or may not affect everything we do. it may lead to truly revolutionizing the way we practice medicine that could also break it and could break the health care system and could add additional unwarranted

costs. i mean, think about all these various risk estimates for various diseases and think about how many follow-up tests that could be done to rule in or out these kinds of increased risks and whether or not we end up getting people more drugs because they have these steps where people have colorectal cancer screening at an earlier age or prostate surgery at an earlier age. i mean, these things have to be somehow considered as an outcome of these things. and right now if i was selling a biomarker, that hasn't rate of one point he. that is not going to do it. forget about genetics. genetics has sort of this mystique about it but think about biomarkers in general that are supposed to be providing tools for risk assessment. we are not there yet. i think the evolving literature, as you heard both of us but didn't, we may be there next

year. i think the clinical validity will involve more quickly. for clinical utility there has to be some randomized clinical trials at some point to evaluate whether or not if you add that additional information to the system, whether you do more good than harm. and of those things will take you two timing, i@@@@@@@ @ @ @ we need enough oversight to ensure that the providers are getting the right information at any point in time, which could be different tomorrow or the day after. how you put it all together is a

challenge. >> you may be a lot of points there. i don't know that i can respond to the mall. you made the anecdotal case of whether a particular sample came from a human or someone else. and all of occasions, we make errors. there has to be quality assurance schemes in place, which there are in the u.k. o be quality assurance schemes in place which they are in the u.k. and i think that we have as i understood it in the u.s.a. has them as well. and in the u.k. the genetics lab which makes single gene disorder diagnoses they are well in place. i would put the analytical validity once i because i think it's much easier to deal with. there are, whether the test are accurate reporting in the labs and licensed registered with the right afterwards, that is a much easier thing to do. the thing that you raised, the next thing you raise is whether these snips are really of any

validity at all. whether they are utility. and i agree that the evidence is not really there. but i think that in terms of diabetes and coronary disease, the arguments are much less clear because for diabetes we've been telling people they should take a good diet and lots of exercise for years and it either do or don't take the advice. and this is likely to particularly help, and i agree. it could even stop people from doing it if they think they are at risk. and it is a potential. but i think the case for me at least is much clear for cancer. if you knew that you had a 203 form. for individual steps may be one point threefold, for the concert at risk may be two or three fold which i think may be much more clinically relevant. if there is a clinical intervention for some cancers there could be, there could be done by earlier screenings. that isn't something we want to deny people there and i think it comes a question in the u.k. for

example should it be in the nhs or should it be by direct consumer testing or private health. i think in the u.s.a., it's probably a question of whether you get reimbursement for it. and at the present time i would guess that the statistics and evidence is not going to get reimbursement and that this will stay in the director consumer market. so i think what the house of lords committee recommended, and you refer to the national institute of health clinic of excellence, is that at the moment they upraised drugs and they're not particularly a problem with the promise pharmacological industry. the genomic inquiry proposed that there should be a new program established which is specifically appraised the clinical effectiveness and clinical utility of these studies. and although peter donnelly i think consciously said that he thought he would come into

routine practice and he is talking about the nhs within 10 years, my guess is that for some diseases, it will be sure that the models that include snips will be more and there will be a public health case. for introducing these in models for screening well before tenures. but i would like to predict exactly. >> we're going to move on at this point, and before we create a genetic accountability office here from the government accountability office, there will be plenty of time to discuss these issues as the remaining afternoon and morning, the program continues.

>> thank you very much for inviting me today. i think this will be different than somebody of the discussion to. i suddenly don't have the medical and background at all if you have. at my staff would laugh at that and say that is an understatement that we did do an investigation into thousands based on the last 45 minute or so i've been in the room it seems like it is very relevant to your discussion and should enlighten some of the talk here. so i'm going to get background quickly up my good. at gao, and i'm going to talk about the investigation we did in 2006 and give you a little bit of the objectives, methodology results from that, and i was really anticipating questions and discussions here for as long as you would like me to. a little bit of the background on my good, we do mostly anti-fraud work and the special investigations and a little bit of security vulnerability assessment. we do some of the motherhood

apple pie kind of things looking at challenges facing our nation which is an understatement, if you will, at this point. i can spend hours talking about that alone. ethics, stewardship, intro controls and and a little bit of online and national security issues. relevant to the discussion today we have the authority and oftentimes to undercover testing which really enlightens people about what exactly going on out there. and that will be very low but to what i'm talking about here. we look at the nutragenetics test, the director consumer marketing of them. getting into issues where they were going to recommend certain lifestyles based upon your genetic profile, and so that is what scrubbable we did, the nutragenetics, it is a very broad set of test out there's so we limited it to those types of test which i assume are still out there today. we did this work for the senate special committee on aging related validate the legitimacy of the claims that were being made by these companies.

we did that do a statistical sample so we could not project our results sorted to all the companies out there that are doing this on the internet. probably no one could possibly identify all of the companies that are asked out of. it is probably a moving target. on a daily basis or weekly or monthly basis, but we selected for website that we are doing these mutagenic test. and all claimed to look at a limited number of genes, and specifically for you, and i don't know which genes, but it was between four and 19 genes that were being looked at for the various test. and then they would create a personalized lifestyle and dietary recommendation. they all stated that the product would not test for predisposition or provide diagnoses of actual diseases and your aptitude for getting those types of diseases. so we have 14 of the zombies for sites leading leading to a variety of result when we look at this, i assume these prices have changed over time, but the prices were between $89 almost $400 per kit.

the methodology, what we did was we created fictitious consumers, or bogus individuals, we're going to send the information in on. ashley had real people who provided the dna and the way they did it was a little cheek swab. it's almost like a q-tip thing that you schwab and she. i can it was. added to each time we did two samples. we used a nine month old female and a 48 year old male and just to let you know that the, it was my daughter. and we did consent. i don't know if we would break the law today by doing that, but that is in fact what we did. we did the questionnaires with these additions are providing dna samples. each company had a specific questionnaire that you fill out. is a weave about these questioners with 14 different individuals of different ages, sexes, different types of dietary practices, smokers, non-smokers etc., and we turn these into.

and we certainly can salted with experts because we did i'd anas expertise to fully evaluate these results. this shows the profiles of people, our 14 fake people. it's a wide range of ages from the '20s to the '70s, males, females. what you don't see in specifics where some of the people spoke, some were overweight and some were underweight. some drink excessive amounts of caffeine, some didn't. so we put a variety of profiles out there. and again, this was $0.14, 12 of these were with my daughter and the other two were one of our special agent, the male who was 48 at the time. this is what we got. it's kind of interesting. i mentioned that the websites claim that they were going to make any diagnoses, but in fact they really did. and what they predicted here for us would be the various types of increased risk, if you will, these various types of conditions. some very serious. i heard some discussion your diabetes is one of them,

osteoporosis, cancer, reduced ability to clear toxins, high blood pressure, heart disease, and in brain aging which i believe i am getting at this point. this is some of the specific from the actual results we received, and again there's a lot of detail behind that. but just a couple of things and you can all read through them about issues related to the ability to metabolize cholesterol, mineral absorption. you that issues related cardiac, brain aging, cancer, and then age-related conditions associated with elevated level of dna damage. so there was discussion of damage to dna. at the time we did this, and it sounds like probably still, the experts that we can salted said that the predictions did not have a basis in fact. there was not enough evidence out there for these predictions to have a scientific basis, if you will. and really there are two parts

of this. one proven at the time, but also ambiguous. the way they were written was you are at increased risk or you may be at increased risk of these various conditions. so it was very strange wording, if you will. something like the weatherman predicting 50% chance of rain. you know, just anybody in the world could have met the criteria you may be at increased risk of getting certain types of cancer. that was really the result we received with respect to that. on the lifestyle piece of this, and this is very, very interesting. again, they claim that the lifestyle recommendations you going to get was based on your unique dna. and so as we build is out, that's why we did a variety of actual people with various lifestyles. and what we found those who depend on what we said, they said the opposite. if we said we spoke, they said don't go. if we said drink excessive alcohol, don't drink at all.

if we ate at a good, stop eating type of. on the other side if we didn't go, they said keep up the good work. that anything. really commonsense lifestyle, but they link it to the genetic testing in your unique genes. another piece of this, i don't know if you talk about the supplement piece of this, but certainly several of the websites were also marketing supplement at the same time they were giving you the results and you are at increased risk of these diseases. very clever how common you, linked together a little bit to say if you took the supplement, well then maybe you would be at decreased risk of actually getting the serious conditions. and they also said the pills were unique. well, the two people we had, my daughter, and the special agent are two different people, unrelated. they both got the same exact same supplement. exactly the same. said both got the same unique supplement. and we saw that throughout. and the supplements were almost always the same. in fact, they were multi-vitamin

that you could buy. goes another one and claimed there was that repair damaged by dna by taking this pill. based on the experts we spoke to, there was at that time no such bill that could repair damaged dna. the next chart shows the cost. knows really what i thought this was kind of a consumer fraud scam, in my view. we had them look at this and it was exactly the same ingredients, vitamins versus what we got in the supplements. you see the various types of vitamins. the only difference is there was a little more for the supplements on the left of i think some b-6 iron and various other things. some of the stuff could be dangerous if you got too much iron. out of the difference myself. the fact of the matter is look at the cost at $0.10 a day versus $3.20 a day for basically multivitamin. so that was really another piece

of this in the end. there was another set of vitamins. i mentioned i think was $1800 a year for that product. so there were various products marketed and this is quite marketed for this is really the investigation, and i'm going to just say the purpose of this was to give congress an inside look at what was going on in this direct to consumer marketing over the internet at the time, although we did see some of these in grocery stores and pharmacies and other thi we certainly did not intend to cast any doubt on the clear medical evidence out there and they promise in this field. that was never our intent. thank you. >> sorry. excuse me, lee. we will hear next from the

center for biomedical ethics. >> ok, can you hear me? first, i would like to think the organizers for inviting me to this workshop. it is obviously an important and timely topic. i am an anthropologist and my work is born out of an interest and understanding how emerging technologies and the information it produces is taken up by the population. we look at the dominant socialize -- social ideas about defense and social identity. i think it would be important to think about what i labeled here as the traditional paradigms to genetic testing. let's see how it has shifted in the last several years.

these are based on basic tenets about how people feel about genetics. first, the traditional approach would be that genetic tests justified for * individuals for actionable conditions with available options. test should really only be ordered by those or for those who have shown through medical history and the history, a reason for taking a genetic test. and that they should really be done only for conditions that are action in the sense that you can actually do something about them. another kind of basic approach to genetic testing has been oversight by trained health care professional, the idea that these tests should only be ordered by position or another type of trained health care professional. and that they should be a requirement for pre-and post test genetic counseling that we should have high standards for quality assurance deliverable you and the liability and that there should be mechanism for ensuring confidentiality and

privacy, all of which are built on this idea fundamentally that genetic information is special. i put this up but not to say that we have somehow departed completely from this paradigm, but just to show you how we have shifted somewhat at least in the ways in which we think about direct to consumer to know what in particular. the first is that there are a lot of messages out there in terms of some of the information produced by direct to consumer genomic companies that individuals will have a right to information without being at risk. to the idea that you have to somehow prove that you need a genetics test is really been kind of secluded by some of the companies at least in some of their messages. that there is a diminished role of the health care provider, health care provider and the broader category of genetic experts. so the idea that the longer do you necessarily need a health care provider to have a genetic test, and that genetic expertise

can come from different types of sources, namely companies now can provide much of the information on genetic information to the public. a proliferation of genetic or not conditions, really this category of action ability is under contention now about which test we should be allowed the public have access to in terms of diseases and traits. and a medical genetic testing is only part of the picture. so the idea that we've been close to sing here mainly on medical genetic test but there is this other broader category of tests that we might not want to distinguish from in terms of a bright light. light. sign of the term recreates a genetics has been bandied about. my own opinion is that perhaps a dichotomy does a disservice in thinking about the rate of progression that we should be putting in place in anticipation of how these tests might broaden in the future. genetic research is a catalyst

for public advocacy and activism. we're going to talk a little bit more about that in the afternoon, but to really think about companies as being a site for genetic research and a catalyst for public interest in that type of research. and incorporate guardians of the personal genetic information. so who owns, who takes care of one's personal genetic information. increase in the company are taking up that role. what remains the same inc. and what we see is a shifting landscape is this idea that genetic information is indeed special. i want to do is just immature time i have is to think about some of the social issues that are emerging from this shifting landscape you to have a think about or anticipate somebody challenges, and i picked for different topics. i could have picked more, but these are for areas that i think deserves some scrutiny in terms of how we are approaching regulation and guidelines.

the first is the social networking, and in particular privacy protections. for those who have chosen to share their information online, the second is company-sponsored research, consumer, have the consumer has often been recast as a human subject. ancestry testing in terms of finding common language in describing genetic ancestry. and finally behavioral genetics, the testing of normal traits. him some of you will recognize this from the website of 23 meet. had been a front runner in terms of providing sharing architecture online. this is a compared gene stool that is available for 23 and the customer. and with it if you are a member of the 23 and the community you can share or at least compare i should take your genetic results with another individual who is part of that 23andme community.

and you will see your individuals, and how they may be similar according to these various traits and diseases. in addition, this particular company allows an individual to create, if you will, your own family or group of friends in which you can compare and share your genetic information in terms of increasing or decreasing similarity. and again, another tool that is available now, at least by one company from the social networking, social networking genome. another set of tools that are available are the sort of virtual communities that are given space on the website to convene and to talk to each other through blogs about different genetic information

that might be of interest to them. this is from the 23andme website with a talk about an instant circle of friends. here is the pregnancy community really trying to congregate individuals who might be most interested in certain issues dealing with pregnancy and genetics. now we have gone into more detail about social networking and its possible uses through direct to consumer genomics. and we talk about this in a recent article in the american journal of isle at exhibit focusing on this concept and it is a concept that has been brought up by anthropologist in thinking about how we are starting to use much more kind of genetic information, biological information and creating our cultural and social identities. and here we talk about direct to consumer companies is emerging as new regimes of sociology

where personal genetic information constitutes human identity that build on relationships. social networking around a personal genetic information has the potential to buyout groups which overcome the nature, culture split. and i think it is important to think about how companies may serve as that locus for bringing together individuals who have similar genetic profiles with other groups that may not have existed prior to the coalescence on the website. so this is kind of a quick summary. social networks, we have an expanding infrastructure, commercial infrastructure for networking. and not only on the site of the various counties, but also in terms of collaboration with different social networking platforms like facebook and myspace.com, and we maybe behooved to think about or anticipate how the travel of

personal genetic information may be a medium for connections but also an important site for scrutiny in terms of protections and privacy of those privacy. this is not to say that direct to consumer genomics is the first area, industrial area that has tried to bring together individuals, patients online. and this is from the website patients like me, which is an online company that tries to bring together patients who have been diagnosed with various conditions to talk about their experiences, to share ideas around therapeutic. really as a way of creating virtual online communities. and what they have done in terms of their approach to privacy is interesting, i think that i think it is emblematic of what we might see very soon with

these other companies. but it is called an open philosophy, and the idea is that the internet, and this is directory taken from places like patients like me website. it can accelerate research like never before. furthermore, we believe data belongs to you the patient to share with other patients, caregivers, physicians, three searchers, pharmaceutical and medical devices companies and anyone else that can help make patients lives better. an example of the type of transparency that we may be seeing in terms of social networking and sharing of information online. now, we all know that the genetic information was passed a little over a year ago, and it does provide important legislation in terms of the prohibition of discrimination by employers and insurers. however, there is some question about how this relates to online sharing of data, and whether or not the same type of protections will be extended to information

that has been gleaned from publicly available sites. as well as kind of the inadvertent taking of genetic information. and one of the questions that i think has yet to be resolved is whether or not this type of online sharing of personal genetic information is indeed protected by g.i.n.a and whether or not we need additional protection for those who do decide to share their information online. the second area i want to bring up, and again, this is perhaps a segue to the afternoon session about research, but the expanding use of company in thinking about personal genomic research. and so here again this is from 23andme. unlike other company, research where they enroll some of their community members into various

research efforts. and the justification for this is the scaling up. the idea that companies can somehow take the place, or at least supplement what we see done with traditional academic research and really speedily along genetic research. and here they say 23andwe is the new efficient way to do genetic research even though the technologies have made it possible traits and conditions more effectively than ever before, collecting the data for this research can be a costly, time-consuming and logistically difficult process. progress is entered by the fact that these studies require both genetic and personal information from thousands, sometimes tens of thousands, of people. so the idea here is that companies may be taking the role of really scaling up. and that through collaboration, again from 23andme, one becomes

empowered. another quote 23andwe intends to create another kind of collaboration. by connecting consenting 23andme users who are interested in producing in research and/or genotype data with the research community, we eliminate the need for an efficient recruitment procedures and distribute the cost of genotyping. we believe connecting people with a scientist and powers everyone to accelerate the pace of research. a powerful public message, and this is a translator to the most recent effort by the company unveiled this summer called the research revolution, where consumers can sign up for the services at a cut rate can be part of i think in now have 10 different research projects. so i think this begs some fundamental questions about how we as a society want to approach oversight of these different projects that are emerging out

of direct human genome is. i list for different questions. there are many more, but to start with, what does democratization of the genome mean for the future of large-scale population-based biomedical research? what are the implementations of the blurring boundaries between consumer and research participants? wind as an individual who signed up for these services become a human subject? and it is at transparent to the consumer when they are signing up for the services, how will consumer genetic information travel, given that samples and data are stored with the company? how will questions in terms of the questions being asked of the genetic information travel, and will the consumer had any control what are their rights and responsibilities of the companies and consumers as these types of research efforts move forward.

i want to bring it to other issues that may be important in anticipating a regulatory oversight. this is the area of genetic ancestry. we will talk more about this. with the desire -- much of the desire around consumers genomics has been in the area -- the question of whether or not i can answer where we come from. there was an article recently in that talk about the need for regulatory oversight for these services. the question was how do we find common knowledge about the times of information being offered to the public? there is the definition for

origin, for example. how can we start to think about what we are conveying to the public in a more unified fashion. a first step may be the joint creation of a vernacular that characterizes things i probability, association, and so forth. and how it crosses the atomic unit and governmental and community with a different vantage point and i would argue that this is certainly not confined to genetic ancestry, but to the broader field of direct consumer genomics. finally, the texting, i think in thinking about regulatory oversight we should be mindful of the expansion of normal trait testing. this is just a quick list at what seems to be out there now. and you'll see it really runs the gamut in terms of testing

for memory, food preference, height, intelligence. and i would just end with this. i don't know if many of you have seen this article about a summer camp in china where parents for $880 could sign up for a week of summer camp, starting with and you'll see on the bottom page where a young girl is being swapped for her genetic sample. and this is a quote from one of the parents. is that nowadays, competition in the world is about who has the most talented at an early age. and sell these tests are being used as a way of providing information on these children in terms of musical talent, athleticism, management skills. and in the summer camp would try to hone in on some of these early predictions of their natural talents. so i only put this up there to kind of help us think about where it is this testing going? and to really give us this idea

that there is medical testing and then there is everything else that is recreational because i think really those kind of boundaries do not serve us well in terms of the radio to oversight. thank you. >> thank you very much, both of you, for interesting presentations. as i listened, sandra, to the first two of you are for topics, social networking and company research, mentioning 23andme and you are from stanford. i started to think only in california. but on the other hand, this is a global phenomenon as was pointed out. the floor is open for questions. we have someone, david, you will come next. >> a recent speaker brought up a very, very important point, and he stole some of my thunder for

tomorrow morning. because i'm speaking on some of the same issues, although i'm going to speak on them in the economist point of view. and she spoke added more on the other point of view. but the issue she brought up that i think it's so important that i have not really heard this this morning. is the idea that these companies have a research purpose as well as a services purpose. i'm not particular familiar with the companies. i work more in euro signs generally. about my understanding is that these companies, their business model is to build a research database, that they are really focusing on that database as their long-term business objective. and so we need to think about what are the pros and cons and the costs and the benefits of that side of things, as well as the provision of direct services to consumers. because otherwise it seems to me we are missing an entire purpose of what these companies are

trying to do. but i would be interested in hearing, particularly because we have some people from the company here, whether that's really true, and what they see as the applications of that. >> this is definitely part of what i'm going to be speaking tours in the afternoon. but i have to say that as one of the things we constantly hear about in terms of these genetic association studies is obviously the power of the study, the number of people involved. and so as we can start to expand the number of individuals who have been tested for whom we have genotypes, for whom we have been a tip or family history did i think think is obvious and natural resource in terms of further discoveries. so i know from the other perspective on the one of the absolute gold is for us to be able to utilize our patient, our client base to be able to better

learn how to refine all of these risk associations, whether it be for ancestral groups or whether it be based on phenotypic groups and such. >> right. sandor, did you have -- >> i did have a question actually. sodas navigenics then see itself as the guardian of that data, or does it leave open the idea that you can sell that data set at some point to another entity? and is that made transparent to consumers when they sign up for this? >> essentially, we think that every individual owned their own dna and on information. and that is something we are very transparent about. one of the things i'm going to discuss this afternoon is also about the specific language around opting in to donate your dna to any kind of research endeavors. which is something that unlike some of the other companies that are out there is an option. is not a required component of our testing service. >> we have three or four people

who are looking to speak. patricia, david, and someone standing back here, and joseph, and david. [laughter] spec anyone not wanting to speak? >> and let me turn to david, i think -- >> muin khoury is very eager to speak. >> i am very interested in learning more about the research use and how that is envisioned, and whether -- i think, given again the incredible hopes that academic institutions and teaching hospitals have to go through with consent forms to do anything with patient materials, i am really interested in seeing your informed consent processes. so i will look forward to you this afternoon. the other thing i wanted to throw out that, not to distract

us, is that genetic information is the right age is the property of an individual, but the genetic information actually has a kinship relating, relatedness to it. that is, you genome is unique in some ways, but it is shared with many, many other ways. and the issue of how far one goes with making one's genetic information available for democratization for socialization, or whatever else, there is an issue here about whether you are close kin are also being dragged into this society without even knowing it, let alone consenting to it. and i wondered whether anybody is thinking about that. >> i am glad you asked that question, david, and your next. i would just like to make three

comments. first, greg's talk about the gao study from 2006. i think the field has evolved since then and would be nice if you guys could repeat the study in the current landscape here and i think some of the early companies that you have probably said he had ceased to exist. second comment with respect to the research endeavor, i think people who join these kinds of research efforts are truly not representative of the underlying population. they're going to do well no matter what. i mean, we have done a clinical trial where we analyze people into receiving personalized information on the basis of their family history, versus receiving genetic public health messages. and guess what? both groups did well by talking

to people alone, i think you cannot attribute, if people do well on the basis of being called that because they are not motivated enough and going to do more of the right things. and you can only attribute that to the intervention, which is the genome. it could be self-motivated and you need to subject these kinds of studies to the rigor of randomized clinical talk, which i hope and sincerely hope that the business model of these companies would involve the. the third question directed to sandra, talked about, and i'm not an anthropologist. i play one on tv but i am curious that a networking that is now clustering around genetic information can bridge the genetic culture divide rather than create new that are involved in more like this around genetics and forgetting the role of environmental factors in disease and general. i am curious to see how the anthropology of the nature and

nurture, or nature and culture might evolve as we all cluster around saint genetic traits. and we create, you know new racial ethnic or other based on our genome profiles. and so too much stuff you. i don't people want to -- >> sander, if you'd like to make a brief response and they would go to professor and into the microphone. >> so we are just typing some work with a company on networking. so we don't have the data yet, but i think that your question about how genetic information can trump other sources of information, is something that we have seen in the arena of genetic ancestry, in the sense that people who may have lived, you know, their lives identify with a particular ethnic or racial group may receive results and all of a sudden that challenge is how they see themselves. and so i think it's important to

do empirical work on how this is being taken up by the individuals. >> i also, the research hot button got to me as well, and i think one of the issues that i see is whether there's going to be public or private funding of research. and this is a little like what's happened to our clinical trials in oncology which is largely funded by pharmaceutical companies now instead of by the government. because the government doesn't have the resources to do that, but they would get files that are really directed toward the question of the pharmaceutical company wants answered and noble we really have as a major scientific question. and so on the backend when you're sharing your specimens with whoever comment is that going to be peer-reviewed research, is it going to be for the public good? and again, the confusion for the doney, or the altar restricted volunteer is they are just, it is research but what is the quality of that research? are the specimens being used for

a cause that has gone through a peer review process, through an irb, that says that the research is scientifically valid, that the benefits outweigh the harms, etc. etc.? we have this experience with pharmacy database is being sold to the pharmaceutical companies. there are electronic health companies that could have a viable financial model, and instead gave the electronic records free to the doctors to use. and then on the backend, sold by prescribing practices to those doctors. so i think it's not to say that you don't have good intentions, but i think it's an issue of what kind of research are the specimens going to be used for, and what is the quality of the data, it's a volunteer populace and it is not population-based. what would be able to learn from them. >> i'm going to go to the floor for the next two questions, and ask each person who speaks as they were just briefly identify

themselves. this is a fascinating material we are dealing. on the one hand, the medical community is being cut out, and unwilling, potentially unwilling members of groups and families are being dragged into. there is a lot of shifting and shifting going on here. >> i am from an rh. santer, could you elaborate some more on your idea of creating a common language of gamma knowledge, the concept in dade which can be transmitted across various as you know, we're still struggling with the old issue of two cultures. it has become very hard to communicate across borders. what can we do to id