Transcripts For CSPAN2 Key Capitol Hill Hearings 20151223

We intend to keep working with Council Members to acknowledge and respond appropriately to this serious incident. We dont so how members can cast doubt on this violation. I dont see that permissiveness. There was a letter sent by the president to senator coons where he says quote robust enforcement of sanctions related to irans nonnuclear activity will continue to be a critical, a critical, element of our policy. I will maintain powerful u. S. Sanctions under a host of Domestic Authority countering irans support for terrorism, human rights abuse, and the elicit sale or transfer of iranian weapons. I ask to place this in the record without objections. Powers and this letter because we know we have sanctions if you counter irans support for terrorism, human rights abuse, missile proliferation, elicit sale or transfer of iranian weapons. Those sanctions havent been changed. They will still continue. So i just, i just dont like this narrative that is coming out of here. I think it sends a bad message to iran. I think our messages. We are united on this. We are not divided. Maybe divided on giving them a chance. But we are not divided at all on standing together to enforce those kind of sanctions. And i feel anyway, i will move on. Is there anything in this agreement, ambassador mull, that would prevent the United States from taking action for the iranians violate the Nuclear Agreement . No, maam, absolutely nothing. Everything is on the table and i think that is important. I want to switch to questions about the iaea because i think they are important in this. I guess i would ask Lieutenant General in your testimony you mentioned coordination and cooperation we know the iaea and the department of energy. With regard to the training, how would you describe the quality and capability of iaea personal . Thank you very much for that question, senator. I rate the quality, professionalism, seriousness of iaea including those who work at the head quarter and inspectors to be high. We support the training of the inspectors. In fact, every single iaea inspector takes a course on Nuclear Material management at Las Alamos National lab in new mexico. Other inspectors and members of the staff we see continuing professional information or g d graduate levels at other National Laboratories here in the United States. We also provide, at the request of the iaea, a number of people to support their safeguard staff. There is about 800 people in the safeguard staff at iaea. 10 of those, 80, are american citizens, many who came to the National Structures across the United States. We also provide about 15 costfree experts to serve on the staff on short term bases. The other thing we do besides training, if i might take a little more time on this, our National Laboratories are developing a lot of the processes and technologies which are part of the process for them kercar carr, ying carrying out inspection inspections. I have visited some laboratories that are developing the fields and monitor and cameras we will use in iran and other countries that have agreed to safeguard agreement or Additional Protocol with the iaea. It is a professional organization. It ought to be. We have been working with them closely since the late 1950s. Thank you. I will close with saying i think the iaea is critical to all of us. If you see anyone changing your view of the iaea we need to know because they are key to this whole agreement. Thank you very much. If i could, i do want to say this permissiveness issue is one that has been felt strongly on both sides of the aisle. As i understand it there is a strong ladder that went from a large group of democrats yesterday to the administration. I think the concern is that we have known of the violation, we have had multiple, i think ben and i met with the Security Council patience and Samantha Power and we know russia and china will block. We see this break neck thing happening where likely at the end of january all of the sanctions are going to be relieved. Yet potentially no push back on this issue. I would like to engage in a i never said it was partisan. I said, you know, a narrative being written on both sides of the aisle. You look at who voted against this Nuclear Agreement. Both sides of the aisle. There is a disagreement. It is in part of that. I didnt mean to suggest it. I never said it. I disagree with it. You can write it a hundred ways. I just read Samantha Powers and the president of the United States. Does it hurt . No, it probably emboldens the people. But i dont agree with it. For the record we never got to vote on this agreement. If i my interject myself for a moment may and that is there is, i think, unanimous support in the United States senate for zero tolerance of violations by iran. I think there is a 100 support to work as hard as we can to prevent iran from becoming a Nuclear Weapon power. We are committed to that. I think there is pride that the engagement of congress is giving us a better opportunity to achieve those objectives. I think that is where we have together. I know that we can continue to work together. Senator flake . Thank you. And thank you for the testimony. I apologize if i am plowing old ground here. With regard to, and let niasia ellis me say, i supported the agreement but it was a difficult call. You never want to be on the other side of all of your allies. But my concern and what tipped the balance for me is the concern that our ability or our desire for iran to stick to the nuclear side of the agreement might prevent us from challenging iran or punishing iran on their nonnuclear behavior. But what other remedy to be had outside of the saturday counsel for this breach . A couple of points. One, it shouldnt be taken but it launched october 10 as a mediumrange Ballistic Missile. We do have by the way a general concern about the proliferation of the mediumrange Ballistic Missiles by a number of countries in the middle east but of course the number one concern and the number one target for action is the program. Now, the authorities that we have, we have used aggressively and creatively and we will continue to do so. But they are the Authorities Congress has given in to the president has established under executive order in order to designate specific entities and entities outside of iran. To propose a genuine Economic Cost upon the entity and the program of development of the Ballistic Missile technologies. When those sanctions and designations touched the companies outside of iran coming , it is a matter of significant commercial arm to those companies and those countries that allow the countries to participate in that kind of behavior. Thats what we have the authority to do very aggressively on the diplomatic side i think the ambassador already described what we can do in the United Nations the of course reached well beyond the United Nations. Last friday i was in brussels with meetings for all 28 of the counterparts from the European Union states where i emphasized again the necessity to stand strong on preventing the shipment of technology and Ballistic Missiles to iran. So, those are the authorities he had come and i sincerely Welcome Ideas on how to use them more effectively. By concerned is a government stated over and over that it will consider any implementation going back to the sanctions we have in the books for the violation of the agreement. If iran were to take action outside of the Nuclear Agreement that we thought to be egregious enough to justify implementing sanctions in particular the ones that we can do on a unilateral basis in the Capital Market sanctions will we hesitate to use that if we need to because thats been the difference we have said yes we will. The administration has said if you do that violates and we are out of our obligations. What is your sense of a willingness willingness to use those that we have . The administration has been clear publicly and throughout the entire negotiating process that if the deal is exclusively about the nuclear question, and we will not hesitate to use other authorities to address other threats to the interest outside of the nuclear deal. Even if it is the same sanctions that we imposed on the nuclear side and in particular the sanctions on the central bank . We have a wealth of authorities available to confront all of these threats to the interest whether it is on human rights, to Missile Launches that we talked about, the regional destabilization activities for terrorism. We have a wide variety that target any number of aspects of iran. I was prepared to vote against the agreement as we got to devote. I hope it works. I hope the committee and the congress ensures that it does work. Its important i think that we not count even from the beginning of the violation of the agreement on the site if we do then its all gone. So thank you mr. Chairman. Thank you mr. Chairman. Much. Secretary, last spring the Committee Held a hearing on the new u. S. China cooperation agreement. During the hearing we discussed very credible allegations against the liberty or as i suggested, unwillingness for its commitment to prevent bad actors from selling Ballistic Missile technologies to iran and other countries of concern. Theyve conducted to Ballistic Missile tests in violation of un Security Council resolution 1929. Which countries did you do you believe are providing Ballistic Missile technologies to iran. My assessment is the same as it was this spring that the primary source of the advanced Missile Technology for the Ballistic Missile program are companies in china. I believe the Chinese Government has stepped up its efforts to enforce its own wall and un sanctions however i cannot say they have reached a satisfactory point of enforcement. Its been a Nuclear Agreement without conditions attached to it that i do not have to support on the committee and the senate to attach the conditions but the conditions would have imposed the requirements to put in place safeguards against others transferring the Ballistic Missiles into iran and north korea and other countries. We essentially have the equivalent of the Nuclear Materials which i think now under the bullets but the missiles are the guns and we are in a guncontrol discussion here today. Ballistic missiles they can deliver the Nuclear Bullets to other countries in the world. And china is the gun manufacturer. So from my perspective, we missed a great opportunity here to condition that agreement. I think we should have. Because this whole discussion on Ballistic Missiles now goes back to that agreement since they are from the administrations perspective the most likely source of the Ballistic Missile technology. And we had a lot of leverage at that point and i argued we should condition it at that time. But again i think there that was a great historical missed opportunity to draw the line on the Nuclear Proliferation issues and create the linkages so that we could have put stuff safeguards on the Nuclear Material program in on the gun program. It will be clandestine and as long as people are able to move about without impunity i think that we are going to continue to have a very serious problem. And we might as well just have a hearing on the subject because that is the Ballistic Missile discussion in iran and its going to be other countries like china that belief notwithstanding their public support for gun control that they find their own way around relatively poorly enforced restrictions because we dont step up and use our leverage when the historical opportunity arrives arrives at his china civilian Nuclear Agreement. Its what china was looking for at that point to have the discussion. It didnt happen. So, going forward,. What do we have is a tool to let china know about how we dont intend on the convention of an International Agreement in the entire world at least ostensibly since they believe its very important to the longterm global stability. I will be in beijing again next month. I cant predict and cant forecast at this moment what additional actions we will take against chinese entities that are complicit in providing the Ballistic Missile technology. I will only say as we said earlier that under active consideration now is additional effective measures in response to the october contest. I appreciate that. I think its inadequate. I dont think that its going to have the kind of weight force behind it. It continues to raise the question of the nuclear 123 agreement at the very high hypocrisy coalition that had been as a message to the rest of the world, and i would hope that next year we take up once again the 123 agreement of climate that we have created around the world that we supply ourselves and we unfortunately turn a blind eye to often to the other suppliers who are out there who do not believe that theres going to be a sufficiently well enforced International Response when its clear that there are violations taking place and i dont think there is any question that he is the gun dealer, the Ballistic Missile together, one of them anyway but at the top it still is not sufficient chinese response and i dont think theres response from our own countrys perspective i just think we have to take a line on it and there is really no point trying to convince people that iran is sincere if they are engaging in an ongoing clandestine Ballistic Missile program with supplies coming in from china. That leaves the impression that we are in a temporary period of advance before the attach the bullets to the top and that is a cynical approach they are taking at the chinese are taking and we have an opportunity that i think we have to focus on this next year so that we can come back to this question once again. Thank you for your continued vigilance. I know that we shared concerns and we both realized where the issues stood in the senate as a whole but i think you for your efforts in that regard. I get back. This is a joke. It has been for months and years now. Im going to answer the rhetorical question. Do you think that this is the soft stuff . Yes. Are they standing up shaking their fist and saying death to america and we are going to prove it. We have prohibitions against us but we will continue to develop them and continue to test them into your absolutely right in your statement that it doesnt matter they will continue to do that regardless of consequences. So, the only hope that we have into generally agree he talks about going to spotlight the violations. They love a spotlight and their violations. They just love that. They say look at us. The report of the Ballistic Missile firing we had to wait. We didnt have to wait. Everybody in the world menu when they fired at those Ballistic Missiles but that was a violation of the agreement. You think this is soft stuff, it is tremendously soft stuff and we will keep their own tony toughen up. A 200 days from now when we inaugurate a new leader that leader is going to convince the iranians that indeed we are going to do something about this and we are going to protect the American People and we are going to stop them from testing Ballistic Missiles into doing what we all know that they are going to continue to do in this agreement. Thank you mr. Chairman. Appreciate you being here today. I want to try to put a fine point on senator boxers comments. I appreciate some of the namecalling here today. I support the agreement not because im an apologist for the administration that because i think that its the right thing to do for the National Security and i think that she and senator corker are right and correct there is a broad agreement here that we need to take definitive steps to respond and we take the ambassador at his word that this is the start of the consideration of options and this is a predicate of action and there is an agreement but that is an absolute necessity. The disagreement is over this broad labeling of the culture that may exist with respect to the actions that iran is taking and frankly the report that was issued by the iaea describes a culture of purpose of this dot allows them up to 2003 and in some respects after 2003 to conduct a military scale Nuclear Weapons research program. There was a culture created by the lack of International Consensus that in the years after 2003, allowed for the iranians to stockpile of 8,000 kilograms of enriched material to get up to 19,000 centrifuges, and in many ways, this agreement ends the culture of pervasiveness that has allowed for the iranians to conduct a program that was unprecedented in scope. From 18,000 to 6,000, and with respect to the Ballistic Missile program again, we are united in the idea that there should be a response. But whether whether we like it or not, this isnt new. They are engaged in a Ballistic Missile Program Sends the war with iraq, and there have been regular tests under republican and democratic administrations. So if you want to argue that there has been a culture relative to the Ballistic Missile program you can make that argument, but i would maybe ask this question to the ambassador because you know the history of the Program Better than i come i think that we had used strong words but i would imagine we used strong words in the past. This has been a longstanding commitment to building the Ballistic Missile program that the clearly tried to build International Consensus to stop but it predates the Nuclear Agreement, and i write . Spend your absolutely correct the Program Perspective time of the iran iraq war in the 1980s and that it preceded the active Nuclear Weapons program in iran and i think that it goes back a little bit to your question mr. Chairman. It is multiple reasons for iran to engage in this program. Including the desire ultimately to have a Nuclear Weapon also including the fact that there is a proliferation of such systems throughout the region region and to the enemies of their neighbors, so they are building a whole bunch of them but it also includes an element of National Pride as it has been in other countries and indigenously produced Ballistic Missile technology that becomes something both military and politicians boast about as well as other motives. The chairman and point is the inability or the refusal to act this time they have greater consequences because now we are in business with them at a different level than we were before and i get that. But having a scope of the full program is important as well. Two specific questions on other points. I want to followup on the question that the senator asked you come ambassador, about what happens to the material being sent and i know that he wasnt satisfied in the fact that there wasnt an agreement, but let me just clarify a russia has obligations to safeguard the material and the iaea has ability i assume to assure they live up to the safeguards in the agreement you may be negotiating today. I would be happy to have you take that question. Away the safeguard system works is for existing non Nuclear Weapons states. If they are going to have a secret agreement in the iaea has to be voluntary. Thats the case for us and its the case for russia. It will depend of course at the end of the day where the material actually goes in as ambassador said, but its still a discussion thats going on as to whether or not the safeguards exist. But let me go back to the point i made earlier if i could. You know the russians have been in this business for a long time. They know how to package, store, ship, safeguard account for Nuclear Materials. We have collaborated and worked with them in terms of improving the capability of doing it under years in the cooperative Threat Reduction so we are very confident that this will be done in a professional manner. Thank you, general. I dont want to leave any room for doubt that that it concerns the material by ultimately arrives at russia will not be subject to safeguards. We are in the process of negotiating very closely with discussing very closely the ie ea and russia will look like but there are 27 Nuclear Storage facilities in russia that are subject to safeguards. And this material will end up at a safeguard facility. One last question we are about to pass a reform of the Visa Waiver Program that will include in it than naming of iran are such that individuals have traveled to iran will no longer be eligible for the the visa weve are program. There has been a suggestion that because there is an element of the agreement that obligates us not to take steps that would stop the economic relations between other countries and iran that we could perhaps be in jeopardy of breaching the agreement. The reform proposal including how it affects the nationals that have the europeans raised concerns to you or others raised concerns to you about specific provision as something we should be thinking about in the wake of its imminent passage . I have heard from very senior and secretary kerry has as well from very senior officials from european allies of ours that it could have a very negative impact on the deal. Something for the committee to consider. Thank you esther turn in. And if i could on that note i think because the lady on the skin together there were some concerns about some of the technicalities being looked at and my sense is that down the road they will be but a thinking member thank you mr. Chairman i appreciate that. Thank you senator murphy. I do think senator corker this is an issue that we need to take a look at. Obviously there has been a great deal of congressional interest in the program and that refugees since the paris attacks and into the attacks in their own countries and included in the omnibus wasnt the right venue. We should have had an opportunity to debate the issue and look at the consequences far beyond just the Immediate Impact on individuals who wish to come to the United States so i thank senator murphy for raising that issue and i hope we have an opportunity to take a look at this from the point of view of the Senate Foreign Relations Committee to the agreement oversight is in the committee and the connection the senator made to that issue is very much in the committee jurisdiction. As they have said consistently throughout this, the iranian activities in regard to Human Rights Violations in regard to Ballistic Missiles, supported terrorism that our response has not been at all hampered by the iran agreement, which is focused on one issue. I appreciate all of those matters. So let me take my 1st question to deal with not a direct issue that has been talked about by most members of the committee, the iranian violations of the un Security Council. My question is pretty specific. Yes the United States will respond. That is clear. We have a mechanism under the iran agreement where an individual country that is a participant can take direct action unilaterally. But we are depending upon the coalition with our European Partners to have a daytoday strict compliance with the iran agreement. It seemed to me this is the 1st test of our unity. And i just hope command i will ask the question that we are trying to coordinate a response with the European Partners because it seems to me they also understand the importance of the coalition to the successful implementation of the iran agreement. Yes, i completely agree. We havewe have a really powerful toolbox that we can use unilaterally. To the extent we can get others to join us, that substantially increases the impact of these sorts of numbers. Confronting these threats over the past several decades. The compliance within the agreement, yes, we want to get International Support but it is important we have the numbers that will be important and enforcing the iranian agreement. In response to your specific question about this Missile Launch we have the full support of the Security Council in reporting the violation from france, the uk, and germany who joined with us and bring it to the attention. We will be watching their actions to the Un Resolution as violation because to me it is telling whether we will have zero tolerance for the compliance with the iran agreement. We can take unilateral actions but a lot of this depends on a ran understanding we have the support of Coalition Partners in europe. Let me move on to a 2nd issue that has me concerned and get your response. Throughout the iran review of the agreement itself, the estimate from all of the administration witnesses was that iran would most likely be eligible for sanctions relief in the spring. That was the date given. Many of the specific estimates had so much to do that it would take at least until the spring. Now it is likely that iran will be in compliance and entitled to sanction relief as early as january. So i guess my point is and obviously we want them to comply as quickly as possible. But are we underestimating irans participation in this agreement that could affect other aspects as well . And why did we miss judge so badly the date which was likely for compliance . I think the agreement is clear that implementation day comes, the sanctions relief comes only when iran has completed every single step that it must in terms of reducing the capacity of its Nuclear Program for weaponization. I dont mean to interrupt, but i want to focus on this. Based upon Technical Information as to how long it would take to dismantle the centrifuges and shift the equipment, there was a thought that it would be spring. Now it is december. Is that of concern . I assume there was assumptions that some members of our administration did speculate at how long it would take. What ultimately guys the answer is has iran done everything it is supposed to do . So the pacing of that is fully and irans hands. We have been very firm and clear in delivering a message that they must do this right. In fact, beginning with adoption day they moved swiftly to begin dismantling there centrifuge operation. We are not there yet. We are working closely to make sure that they have a fulla full insight into be able to verify everything that iran is done. We will get implementation day only when iran has completed the steps. I dont think anyone in the us is able to predict when that will be. The responsibility lies with iran. The shipment of enriched uranium outside to russia and cause extent, there are also considerations that some material may end up and cause extent. From a legal point of you will we know whether iran after the time period on restrictions of the stockpile has lapsed, whether they will have the legal right to reclaim this material and have it shipped back . According to paragraph 60 of annex one iran before the agreement ends is eligible to receive a five kilogram increments those bits of fuel for its research reactor. That can only receive those increments as the iaea verifies the preceding amount of fuel has been used. That will be under tight control. After the end years from now in the future there is no restriction on irans enrichment activities. They have committedthey have committed that they will develop an Enrichment Program consistent with these purposes whether we have this agreement or not. That will be a constant focus of the us government. My question is, we will we know whether the legal agreement entered into between iran and russia and perhaps iran and cause extent today will give them the right to reclaim this material after the jcp away restrictions are eliminated . Only that the only exception for that is getting the fuel increments. Whether or not they will have the ability to get the stockpile that will be moved from russia back is not addressed in the agreement. They must keep below 300 kg. We will not know legally whether they have the right to reclaim. That is not something that is required to be disclosed until brady is with the arrangements being made . Whenever they ship out. Sir, that is just not addressed within the agreement. The agreement only requires in the stable of 300 kilograms. Thank you. We talked earlier before he arrived relative to your efforts to secure his brother and get back into the country. Would you want to address that one more time briefly . Yes, sir. This is a subject of great concern for the administration. Secretary kerry replete it repeatedly raises the plight, and the other detainees in a ran. As well as asking for help and cooperation in finding out what has happened others who have disappeared last seen in a ran. I am not in every meeting that the secretary has. But everyone in which i have been. This book eloquently that in spite of this agreement these issues of these four people not being addressed caused a lot of consternation. That cannot be resolved much more easily than it is. Thank you for the courtesy. I appreciate your testimony. It is not the 1st time you have been before this committee and may not be the last. I want to make two comments. I want to applaud the Ranking Member and chairman. And i have used this word before. More nonpartisan, about National Security, global security. I use the word naive earlier and stick by it. Mr. Secretary, you mentioned something before. We did not talk about it. I am a business guy. I know how seriously sanctions effort them and we could double down and talk about it as an alternative. I want to come back to the word naive, but before i do that, let me set the record straight. This committee unanimously passed a bill recommending it was an act that gave us a look at this agreement. Otherwise no one would know. I give you guys full credit for that. But we never got to vote on it. We could not even get it to the floor of the senate to have a vote. That is what drives my people back home absolutely apoplectic. This process is all talk. Fiftyeight to 42, four democrats voted. The rest of them unanimously almost argue at 42 votes voted to not even move this to the floor to have a debate. The last thing i would say, i did not use that word lightly. Not just this administration, others. We dont have a great record dealing with rogue nations. In 1993 another administration said trust us,us, this will preclude the potential of ever having a Nuclear Weapon on a peninsula with korea. We know how that worked out. The United Nations has no ability right now in my view except to taunt because the vetoes that are part of the Security Council situation. We were faced with a false choice. I wanted to set the record straight, but, but i want to commend this committee for the approach to the topic and for the leadership and what you guys are trying to do to make sure the implementation goes properly. Could i just 25 sen. Perdue is one of the most effective members of not only this committee but the United States senate and i deeply appreciate the comments. I want to put on record the negotiations took place including senator cain and menendez and corker and other members of the committee. It was always envisioned we would not have an xmen process for the consideration. Interpreted in laymans language itlaymans language it was always anticipated that there would be a 60 vote threshold so that it had to be a bipartisan action considering that we have divided government between congress and the white house. That was always envisioned in the agreement. And i know there is a different interpretation among the democrats and republicans as to whether we had a vote on the substance are not. I understand, but the American People no 58 senators oppose the agreement and 42 supported. And it did not hit the 6060 vote threshold that was the ground rules on which the legislation was negotiated. That got the broad support, unanimous support of this committee. I just want to put that on the record because there was a difference among parties as to how that was to be handled and i respect it, but clearly there was anticipation that it would take 60 votes. I think i am just going to refrain. I thank you both for your comment. I want to thank you for the tremendous role you have played as a new member. I am so glad that things worked out a we could have two senators from georgia. Thank you so much for digging into the issues the way that you have. I want to just mention a couple of things. The snapback provision for what it is worth, if we cannot get the un Security Council to act relative to the issues i dont think any of us believe the snapback itself israel. We can call for it but the other countries have to implement. And if they are not willing to implement it has no effect. So i think if the un Security Council and i understand what the senator was saying. Much of the discussion is to try to shame the administration and the un Security Council and the takinginto taking action. It is what people want to see happen. Much of our comments about russia and china are to push them and to be willing to address this issue. Again, if they are not willing to do that it renders the snapback provision totally useless. Sure, we can call for it to happen, but the other countries do not have to follow suit and call those sanctions to snap back into place. It is just not real. That is a concern. We are not talking at you. We are talking with you. There are others that will be taking these actions. The only issue that is left hanging, is there any pressure . I realize thei realize the reason that iran is doing what it is doing relative to moving quickly which again is what we want them to do, but we understand there are political issues that are current with in the country, there is an election that will be taking place, and we understand that the people who negotiated this agreement want those sanctions lifted prior to the election. That way it will affect the outcome. We understand that. I dont think you would question that. My question to you is, are we dragging, is there any pressure within the administration to drag, is that one of the reasons you dont want us to implement the sanctions that are going to be expiring exterior right now, or is there pressure relative to this agreement to somehow call in action to have again an effect within the Parliament Elections that are taking place in march . Mr. Chairman,mr. Chairman,mrn , i agree with your analysis of the political situation in iran. In the same breath i hasten to stress that what happens internally politically is not part of my brief in terms of implementing this agreement. We have a specific roadmap. On the 1st day that my office in the state department was created pres. Obama stopped by the state department to congratulate the negotiating team, and he pulled me aside and said you know what you have to do in making sure this agreement is fully implemented. You cannot make a single mistake. It was a pretty impressive way to start work, but it has been clear that we are fully focused. There is politics in every country,country, but we have a deal that we need to implement and that iran is to implement regardless of the internal political situation. I understand you are not the enforcer. Outside of your purview there others within the administration that have the ability to put in place sanctions. Countrymen can call for them, but there are others. Have you sensed any issues relative to, you know, enforcing, punishing relative to the elections that are coming up in the spring . Senator, secretary, as recently as yesterday they have all said that we need to follow up, we need to make sure there are consequences for violations of international sanctions, international prohibitions on such things as the reason Missile Launches. We are fully committed is an administration that exercising when warranted. No one has asked me to modulate, accelerate, or slowdown the implementation of the steps we are considering to to considerations of an electoral calendar on. I think all the soap if we are unsuccessful the ability that the administration has will take place. The procurement channel, when do you think that process will be fully agree to and in the place where we begin implementation . At the last meeting of the joint commission that i attended last week in vienna we reached agreement on how the channel would work within the joint commission and this week we are doing a test run of the process. The personnel managing the process will be next tuesday they will scrub how we did and make necessary improvements. A piece of it that has yet to be agreed upon is how the process interacts with the Security Council. Ultimately the Security Council has to give his blessing for the transfer of technology. Youre close to agreement. Any other questions or comments . We thank you for being here, for your service to our country. We wish you well as you ensure this is implemented. I think you can tell we will be paying attention. Without objection the record will remain open. If eachif each of you would respond fairly promptly we would appreciate it. We wish you a good Holiday Season and with that the meeting is adjourned. [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] [inaudible conversations] this holiday week we have been showing you on course of our q a program. Videos on immigration detention centers. We will start at 8 00 oclock eastern karen carmen. Aei president arthur books discusses his book the conservative heart. The biggest mistake that i think we make on the conservative side a lot the trip people of the most is the one that should be easiest. Examining the life of doctor Martin Luther king jr. In his book the radical came. Martin understood that for any human being who wants to reach a level of integrity, honesty, and decency as a longdistance runner you have to kill something in yourself, fear. You have to kill something in yourself. Followed at 9 00 p. M. , author of the relevance of religion. Religion does. Is beyond ourselves. And for faithful people, what is in it for me, it is not central. At 10 00 p. M. Senator Claire Mccaskill talks about her book. I dont think we do anybody any favors by trying to dress up politicians as if we are not real human beings. Saturday evening a panel discussion. And then 11 00 p. M. His latest book the general. One of the 1st questions i usually ask is why did you choose these three men from the 2nd world war . The answer is they embodied super characteristics of courage, character, and patriotism. Sunday night at 8 00 oclock a turning. In World History in 1932. At 11 15 p. M. The influence machine, the us chamber of commerce and the corporate capture american life. There is aa reason i chose the chamber of commerce as the subject for my book. It is because this organization sums up the story of how we got here. This Holiday Weekend watch book tv on cspan2. The Manhattan Institute put out a paper this year. Joining the reports authors in this discussion was a cancer patient advocate and medical. This is an hour and 15 minutes. And fda regulatory action to figure out which companies to invest based on developments. So this is an area i have long been interested so i am glad to have a chance and to moderate this discussion today. How much Health Care Cost we dont spend enough time talking about how innovation is transforming the quality of life if not for hundreds of millions of people around the world. The Manhattan Institute as you know, we have all whole institution called project fda centered around fda reform. That is one of the most productive areas at the Manhattan Institute. I dont know of any other think tank to bring the kind of work the Manhattan Institutes is doing on this issue. The question we will talk about today is the most interesting area talking about how to reform the fda. Talking about Innovative New treatments and recently precision of a storm. There are a thing as called by markers if you get checked at the Doctors Office that is a by a marker it is a lab test it is something that we use to correlate what is going on in your body with a particular outcome of disease high cholesterol levels or low density or high ldl is correlated to heart problems that is day by a marker. 50 years ago we had a couple dozen by a marker is but the cousin of the the answer is a genetic science and as human genome project how zero different genes in our body regulates different proteins in the chemical process for diseases were on the verge of having hundreds of thousands of these lab test to help us determine a lot of things. Advance more quickly drugs to market. They can help design Clinical Trials many people with long cancer the people have different kinds and could be responsive to different treatments. So the fda and Drug Companies try to figure out how to tailor their investigation to the individual patient and there genetic condition in this is what is going on scientifically in the private sector is the fda doing what i can do in a way that regulates the development of new drugs . So peter huber and paul howard the center for medical progress put out a new paper it is a little behind the curve with these new developments of scientific developments can help accelerate the discovery and development of approval and marketing for their treatment of disease. The ceo of an emerging Biotech Company that specializes in the development of treatments of ultra Rare Diseases before that was with another company with a largest most successful biotech energies in this area they have had success with a market cap of 2. 3 Million Dollars which 10 years ago was unheard of but that is more common as companies have gotten more sophisticated were also going to hear from the Vice President of scientific and medical affairs at the Pancreatic Action Network to tell us that the patients level the challenges to work with companies to take advantage of personalize precision madison medicines might think we will start to get the ball rolling. I just want to have each of you tell us you have had experience in pancreatic cancer world so what are the challenges . How does that very between patients and what are the challenges to the unique characteristics of the individual patients . I will tell you about that through a story. Marjorie called the call center of human segovia because her husband was diagnosed with pancreatic cancer. And our associates gave information about the disease about nutritional information and that type of thing. Then they offered her a and charlie the opportunity to get his Tumor Molecular tested to do a biopsy and learn about the test that would cause his particular cancer and how we might treat that. That made marjorie pretty happy because she was into statistics and you only 76 percent of people were not going to be alive in one year and only 7 would be alive after five years. She said this is something i can try. Because the current standards of care are pretty crummy. So they agreed to do this in one month later they get back a report that has nutations adulterations in the genes better underlying charley cancer. About the 55 is very interesting on this molecular profile. So now there is an option an option the physician never would have thought of before so drugs that are developed and other cancers that with the invitation he has his cancer and some are Clinical Trials. And now not faced with medical problems but problems with how does charlie get access to these drugs a and how does he decide . So there are no real Clinical Trials for any of these drugs there are 50,000 patients per year of which 4. 5 percent of them go on to Clinical Trials but two were 3 percent of that go into Clinical Trials so how do we learn about what to treat even though we have molecular information . And then if he gets clinical treatment or off label then networking and insurance issues and he will face public usually happens is he is treated with a drug and then three or four months later they take their idiological scan and to say has it grown or shrunk . The overall endpoint if he lives or dies and how long. So they are checking a by a marker in the meantime in his blood if it goes up the tueber is probably growing although we are not 100 percent sure that is always true. If it goes down that is a good sign. But you cannot act on that information there hasnt been the proper study to know if that drug is doing charlie any good or not. If not he can go on another treatment. So that is to examples to dont have the information we need a and were not able to act fast enough on the by a marker to determine if we should change that treatment or not and those are both the opportunities for the fda to Pay Attention to a disease that is life threatening. He does not have a lot of time. Survival is measured in months and weeks with this disease. So we need to act faster to change the system so people like charlie can benefit. So peters official title is resident genius. [laughter] the ph. D. In Mechanical Engineering at m. I. T. And a law degree from harvard writing about energy policy, legal policy and is author of the cure and the code out 20thcentury law is undermining 21st century medicine. So how do we take that every day patient example and translate that . With the example there will be a test or a device for the bloodstream and how we get to market without the fda say so. The type oncologist tell me if they could scrape off label. It means you can use it for cancer but not Bladder Cancer you to use it but not what it was approved for so in its drug approval process is not capturing every possible use of every drug. Hopes for a lot of off label working is happening all over the place is completely different in different parts of the body and they can repurchase the drug and to prescribe based on their molecular effects and it is widespread in this area. If the drug company says they do this for pancreatic cancer than that would get them prosecuted probably criminally or face civil suits and off claims suits and shareholder access. It is a pity because they know a lot they are compiling this data. So far they have not gone after them but they may. And not just giving a genetic profile the fda says, says to . That it has not certified to be true so it is not true. The fda has the primary power over how much of this bio marker is approved you have to persuade them that this by a marker is good and valid but it is painful because the best people at the fda ahead of Drug Development and evaluation knows exactly what is right you can still have your power point on the web to say it is the foundation of evidence based madison outcomes happen to people but not populations. Because the fda calculations are overwhelmingly based looking for correlations if you have pancreatic cancer we will throw the drug get you. But what you define as the disease so year after year you fail to cure that. There is the core problem that statisticians call the referenced class problem. In here represent 1,000 patients eyebrow and you rub with the pancreatic cancer and test the drug and food is to say if it is the identical disease then they get a good sample we know modern genomics has shown i moderation for those proteins and the fda issued the first guidance 2003 and 2004 and the Economic Research now please tell us what the hell that you read. Wateree supposed to be gathering . And by the way we have set up internal standards for good by markers. So as far back as i can tell one year later the fda did issue the clinical records to even set up an institution with the Critical Path institute that got public and private funding. Made while we have been nervous of taxpayer money going into sequencing. Firing Clinical Data and add a at the same time. And basically you can do epidemiology for by markers that is how they disturbing between microbes and molecules. They are more complex and we have fantastic Computing Power that has stayed publicly and apple those this all of Silicon Valley business. Said it is not too good to say and why would this project certainly be interested in cancer they said if they give you a complex data set with in that data set is cancer the main killer of the military . No. But the nsa has a huge database they have not confided in me but i am sure there would not want to share its database so now we have terrific news for oncology if we left this to them would be in really good shape. [laughter] i gave you found a political platform. With the private depositions. There are a these patients the two or three persons with those populations food may have a unique genetic signature and it is hard to show statistically that is having an effect. And with the scientific problem of genuine significant evidence but then to peters point and then to adapt some bad technology. And we have been struggling with though long time. The by markers is one of the most important ways to understand what is going on in an accurate way to determine what youre doing with the small population. The challenge has been many but not even know how to spell or how to say but 10 percent of u. S. Population all of you probably know someone with the Rare Diseases and only 5 tax treatment the truth is we should do more translating to get the power to determine the buyer markers and that is focused on how to excel a rate biotechnology and the facts are after the hiv aids crisis and in that disease area only of the nubile marker has occurred for 23 years. I was involved in one of them. So it all that time those five markers used all that are approved for drugs in the early 90s so there hasnt been anything new. With all those diseases that we know and understand what is going on how can there be no by markers . I know the opportunities have happened there is a disease there is only 20 patients in the United States. The treatment has been around 20 years but we cannot do a study that with day by a marker you can do immediately. But with the bile marker we can run a steady with 12 patients based on all the science to get them a treatment and when we finally find the treatment that is a tragedy and make it my mission to get them through the process to make that process better. Im writing and policy and legislation. Rand in the case of your company to study disease work with Clinical Trials and hospitals you cannot do a study and in a way that you know, how to treat them. The broader problem as he or she would say. That may correlate with of lager life with the measurement of diseases then they would otherwise have but we dont know that. Thatd was correlated to the diseases in the typical situation. In to be conservative to say it sound like it is a good thing as the means that does that on a lab test. And you dont make it easy but what that standard is to evaluate that by a marker. We will develop the evidence based so the concern with the nih funded researcher runs a steady to publish an article of the nature of biotechnology that hasnt then reproduce. What is the referenced class control . That is not what your talking about here. But a year or two ago researchers on stanford took a gene expression profile class of drugs that was already approved by the fda then compare them to cancer expression and profile and what they found was a match between the genes that was hit by a class of drugs with the very rare class of lung cancers with the of neuroendocrine termer so to say this is interesting and but is implicated in Small Cell Lung Cancer but theyre also others. So do the science. The human cell lines and a model and use drugs and other drugs and they got a defamation to say we can do a Clinical Trial so right now those 50 role drugs are being tested for lung cancer and a phase three trial for efficacy. But the interesting thing is they have not been used very much. But the more recent class we have day dash a and observational data. You can look back to see how many patients have been taking lithium with debates of brain cancer slowing. To have a better response rates. There is a range of other data they can use with the expression profile data. If there is say but no marker there to reach a trial even down to level of knowing even to selfdestruct, but what were asking the fda to do is they are not equipped to do it or that they are capable of to a the research community. Is that a society to where they deputize certain academics . How about giving it to the People Better spending billions of dollars per year of taxpayers money like that nih to characterize those variations. I might add the of one database that i know that is central from all over the country for the effects of drugs. One reporter tested at it with the incredible hulk. Comes out and wins the competition talking about the mechanisms in the much smaller data sets you dont have to use of statistics at all. You can lookup this is leading to that and a bath. These are experiments in either also add typically for the more common effect you can find 10,000 mutations and they go crazy. They mutate in every possible direction. They are not guided by anybody. They just do it wildly. These are sophisticated methods and they have built out the analysis in the book they look like a huge spider web between them you can quantify the links on the importance. With cancer they are hierarchical networks that use notes that are important in almost all the variations and there are others that are playing alongside. A method of systematically. One of the most studied cancers is pressed cancer. They broke the disease up into four major categories depending on the receptors or combinations in the more recent databases on the statistics it does this stuff with a large database and does it very well. Its oriented towards these therapies and nobody can possibly doubt that a number of them are actually quite simple from the perspective you get these correlations with very rare the defects in the genes it is often one to one and sometimes you have to double up to get a very good effect. Once you have to narrow down it couldnt do very good studies on the mechanism or on whether a drug will go in and block it if it is a Chain Reaction its more difficult but we can know how to deal with complexity. Two takeaways, never one first the fda is very restricted to talk to Drug Companies and Biotech Companies because of the interest rules that prevent them from talking that even the National Institutes of health which is a major Government Agency that funds the Biomedical Research within nih doesnt have a lot of cross Channel Communication with the fda about some of the advances and maybe as you said they could work with the nih as the intermediate develops some of the standards to. The second thing you did talk about in a paper that the paper that was very interesting is the fact that the europeans aged and see the equivalent of the fda has been more forward thinking on some of these issues relative to be u. S. Fda and i thought paul maybe you could talk about that a little bit. The reason you have the market cap is because its been more forward thinking perhaps on some of these issues be in the fda has been and maybe you can talk about that as well. Spec of course just to just what the briefly there are a few other groups that you could put at a table just to look at one. At the nih there is the foundation and there is the switch which is a private notforprofit Foundation Within the nih that can accept and works with academic researchers and Drug Companies and theyve had an Interesting Partnership we talked about what the called the advancing Medicine Partnership looking at four or five but i believe at least a couple are in the movement to do exactly what we are talking about, go through the science, validate the markers and develop the evidence. So i think that is a big step forward and then theres an initiative called the Innovative Medicine initiative, which is the key project in spending hundreds of billions of dollars compared to the few tens of millions of dollars each year. And that can really be a breakthrough but i think the key is getting this outside expertise that the agency is effectively walled off from involving the critical standards so that people like oneill and the community and the Drug Companies would sit at the table and say this is all of the evidence that we have. This is how we can validate it and we should go without validating it so that we can check things off the list and move the sign and forward. But i would like to say first of all is the eugenics isnt based just on the biomarkers and they dont own it all to be clear. We do have one program that is looking at the approval that some of the other programs or using other things but i think in general what we can see about the european agencies in the last few years they have been more scientifically based in a little bit less recovery priced so they are willing to look at what youve got and make an intelligent decision about it. They said there are we have shown them the data and we have a very organized plan and how we present the data and it is based on a qualification. The just published for qualifying the biomarker and we created a very thorough and thoughtful setup criteria on how to qualify the biomarker. We presented the data in the format to them and in the defense beheading of animal mac and mystic beat the pieces put together so that it would be impossible but the marker with the disease activity would end predict to them and there is also those that make sense. So in that basis and what they told the basis of the meeting is this is the only way that you can do the study. The only way that you can do a study of the disease is the measurement there is no other way to do it and so their view is this is the only way forward and we will accept the plan because we think that its reasonable to do given the rarity and i think that is the basic fact is that at some point in the rule in the regulation that weve created as a country, we have to make it practical or realistic otherwise things wont get done and to say i want the walking test and this test and test you need 100 patients were something to do the study is only 20 in the United States, you are basically saying i figured out a way that we are never going to apply science and the patients will not be treated and we want them all to die rather than risk getting treated with another disease approved by the biomarker endpoints, and that fundamentally is no one also agree with that but its sort of the ultimate practical outcome of the decision and that is what we need to change. And i think there are ways to do this in a very thoughtful way and we proposed an. Like the group of industry and academic and Foundation People developed the criteria written. It is not trivial, its not quick, its thorough and comprehensive and the key thing is that it does require things that are impossible. It doesnt require you to know the cardiovascular outcome of the disease that has the stamina and patience ten years from now because the data doesnt exist but what about the data that you do know and how good is that and work off of what we know and what the law said today remember that important. If you have a piece on the approval says that i didnt put out was to include the ways to qualify the biomarker in using the biological and pharmacological criteria where other types of data in other words the clinical outcome data was impossible for a practical to collect so it is really attracting that they need to be practical here in the choices so that we are looking at the signs the best we can and not creating unrealistic impossible barriers that will cards things not to get treated so that is one of the things is to see the scientific site i dont think that they are looking at the pressing concerns and i think the concerns come from the fact that a couple of drugs in the area didnt play out and people were hurt by that and those big, you know, hand the cases of drugs in the big market areas that didnt play out are causing them to, you know, flinch and move away from the disease is where we know a lot more of what is going on and it is a very specific biomarker and they genetic condition. Its not the same situation as the others that feel in the past and they need to get over that story. Hes a great guy and they need to get on with new science and where we are going now which i think is much more familybased and mechanistically sound. That i introduced earlier i neglected to mention he were president of the American Association of research which would be the most important academic professional society of Cancer Research in the country. And also worked at the National Cancer institute of the National Institute has a phd in molecular biology for the university of arizona. So you have come even all of these please talk about addressing all these points that youve inherited. Well, theres lots of ways that i could do that but i what occurs to me is the art really seeing is that the fda looks like one of those Human Resource departments but you roll your eyes at says one size fits all. You know, youve got to do it. These are the standards come everybody has to fit into these groups and you know how far those of you that have been in a that position where you just say, on we have a mission and there is something we need to accomplish and there needs to be flexibility around this comes with the purpose of the fda has this one size fits all and to gain some efficiency everybody has to fit into the little silos and i think that is just have to change. This idea that not all diseases are the same and yes they look very important in protecting us as a society and protecting us from drugs that are out there that thousands and thousands of people take who are relatively healthy. Blood Pressure Control medicine, those types of things. That is a very different story than Rare Diseases or deadly cancer, and it is that the ability to be flexible enough and get to stick to the principles of some sort of a Scientific Validation and overlaying exactly as you are saying the practicality of it. What is the required here and in the population that we are addressing what is the risk tolerance. How are they i can tell you what their treatment its overlaying one that into the decisionmaking that goes into whats approved and what is the level of the validation that he needed by the the we need by the biomarkers that seems to be the mindset. Are doing or suggesting or indicating. We are not getting the data because if we dont benchmark off to the baseline genetic profile of the patient. But duty at the very basic analytical level are we ask that right level and are we mature enough so that we can say we are measuring accurately the genetic profile of the patient and being able to make good decisions on that basis. So it comes down to. Dont throw the baby out with the bathwater. And it comes down to the Research Component as a practical patient treatment component. So right now, yes it is not 100 certain that the mutation means that you will respond to the disease like pancreatic cancer. I have seen at work and others. The patient has very little options and i see no reason to say well it really ought to check their genomic dna to make sure that this is right. You know, what is it is standing in the way of the good and moving forward. Now come in the research a Research Setting yes we should be doing that. Its not understanding what specifics for this tumor versus what is a normal background for that person. That is all absolutely true in the Research Setting. But that will eventually inform the treatment setting. Give us a little bit of time to move things from the research lab into the clinic. But for right now what would scare me about that type of statement is that people would throw up their hands and say we shouldnt be doing any of this because it isnt good enough. But it is a whole lot better than shutting your eyes and treating the patient exactly like you treat every other pancreatic cancer patient and you know you are only giving them a couple months to live. So it is a whole lot better than that. Just to followup on that, once you have the clear standards out there. Up to a level that is needed. There is cancer and hiv and some other drugs that are basically 90 of the accelerated approvals which are. Part of that is the pathway that drives the investment. When you get the microphone make sure that you get the name and affiliation because this is going to be on cspan. Why do we are getting the microphone of ground, to whoever raises their hand, theres something going on in congress right now called the 21st Century Initiative and its through the House Energy Commerce Committee Led by chairman fred upton. This is to develop some of these ideas into the concrete congressional bill that would push in the right direction. Had you already following the Processing Power to you about going . Are there things that you want them to do that they are not currently thinking about . We are very failure with it. My foundation is working on part of it which is the opening act which is the exclusivity provision which allows the companies of the big market to be in the incentive to get more of the science thats already created. The bill is extremely long i think that its 400 pages and a lot of sections. And i said that it was in the middle of it somewhere. It is a very ambitious effort and i think what fred upton was trying to do do the stupidest ideas that he could and put it in and work for them to come up with something that was going to change the way that things get done. And on the house side. Something is being done that would be comparable. I think that there are things on the patient input into the process there is an incentive and a number of other aspects that could improve and i think that it is a good discussion to have as it gets different stakeholders outside of congress and outside of the fda to Start Talking of fixing and improving things as we need to. Its been absolutely. We wouldnt be having this conversation without the chair man and a congresswomans leadership. Weve been most focused on the biomarker piece and i think that is a really good direction because it is recognizing that you are right the evidentiary area stands and the use of the particular biomarker would incentivize bringing in those other expert bodies to convene those groups in making sure the patients were at the table and industries are at the table to develop the standards that sure everybody they do the science correctly the fda is going to recognize it. Do you have any other i might add is quite stunning how bipartisan it has been. The house has equal numbers of democrat and republican and i might also add the to counsel the flies sometimes in technology should report two years ago we get just about all of this right as far as i can tell. Theres an awful lot of people that seem to believe the stuff is science but its pretty hard to delude. Some of us are more skeptical but this is what is politically wonderful about this. The agency works really well on this in the project which we wrote about in an oped weeks ago. This might be a little bit mean the other they are doing a series of richer studies of the clinical drugs but failed on fda standards and they are going back and analyzing the issues and that in fact worked well and i think that this is truly wonderful. Anything else lacks the 21st century cure is another perspective, the devil is in the detail you there will be an awful lot of working through the detail as we go forward. But its certainly delightful to see the efforts being put into that. Lets go to the qanda. Remember your name and affiliation. I am a lawyer here in new york city. I would like to ask the panel, listening to the discussion, i heard compliments about nih but i have to ask to what extent have the outlived its usefulness i heard them say they do some things that remain useful but we are better off at the macro level permitting the market to take this on and move with it. I think that we rely on somebody to determine the things that we can describe for us and we understand what those safety parameters are. In my mind is a matter of dialing into the the flexibility. Flexibility that we need to be able to look at specific situations as opposed to the one step well. Speaking as a wall street investor if you have any of the classic investors that i know pretty much every single one they would tell you that getting rid of the fda would be a disaster because the fact that companies sometimes life sometimes they do studies where they dont disclose what went wrong with the patient or maybe the baseline caret twos were different and the journal of medicine doesnt have the Regulatory Authority to audit of those records. They have to rely on the honesty of the people at the studies where the fda goes through with a fine toothcode but they analyze the Clinical Data that civilian institutions are able to do and so at least for me personally i think a lot of the people say theres an appropriate role for the fda but thats why we are convening the meeting. The data is absolutely necessary. Is doing well. The that reasons why i think they need to help recruit more people that are connected to the academic world as they were when they had more people, which i think that helped them to be more creative and connected to the science than they are now and there are things we can do to help them get better and there is more funding we need to figure out how to better organize and recruit the kind of people that would keep connected with what is going on. We need a political initiatives of the programs where they hire people and we need to get more money into the nuts and bolts of the quality of the people involved in the appropriate and the appropriate standards for things like biomarkers and other things and i definitely wouldnt work well. [inaudible] they are not aware whether or not they are getting it right if the government review is important to them. The rise is progressively moving the power away and i dont know if president obama was aware of this when he endorsed the medicine in the state of the Union Address but if the others can do it the but doctors are going it alone to describe these labels they will not be described off label. The problem is getting them to the market. They have lost their grip on a lot of this. Something the audience might not appreciate is that say other drugs that they have approved for breast cancer. Once the drug actually has been approved for any disease, a doctor has the liberty to prescribe for anything. In theory, the drug has been approved your doctor can prescribe for high cholesterol. That would be stupid. A malpractice but he has the Legal Authority to do that is what is happening is what peter is referring to. They have a certain amount of liberty and what the evidence is out there in the Public Domain is to say once this drug is the drug is out there is evidence that it might work for high cholesterol even or some rare case so when going to the describe prescribed it to you for that so thats where it kind of loses control of the story. Theyve become more conservatives because they are worried about once they are out of the barn they dont have complete control anymore so they are trying to it took some incredible courage as many of you know it was a mystery as to what in the 60s that caused birth defects all across australia and with the largest drug in the United States that they put out a bunch of conditions they have a certain amount of power and limits. I might add even as they filed the lawsuit somehow or another. These are being listed to do the diagnostics on the huge scale with much data and much more specific recommendations. Specifically the federal drug law is that its written so broadly in the database and everything that google sets up is technically a medical device and they treat this or that in the jurisdiction to go after any of them i hope that they hold their fire. If they do actually go after them i think that they will lose on First Amendment grounds. Another question. Recently retired oncologist in new york and i couldnt have practiced for 40 years if i knew what the fda approved and didnt and this goes back to 1969 when we had a combination approved for 60 of the people. We discussed then they never approved the combination of drugs but we went ahead and we did it and we never got bothered for that until years later. Its very well discussed and in the various diseases the key issue that i think has to be addressed is bought and went after in any American Society for clinical oncology. Ted kennedy told us there were some senators that were against it, just get some patients. They cant argue with Cancer Patients and when you come down here they think that you want to make a lot of money for your self and im