Skip to main content

tv   Key Capitol Hill Hearings  CSPAN  September 4, 2015 4:00am-6:01am EDT

4:00 am
go to the moon and we went to the moon. we want to integrate and we integrated. we want to win world war i and world war ii and we won. we want to take care of our vets when they came out, and we did it. we built housing in hospitals and everything that we wanted to do. unfortunately, today people have to come to certain places. they are too used to being told we cannot do anything. we are getting that again from even the republican party when they talk against trump. it is too expensive. how dare he think of a dream. how dare he have a dream to make america great again. this is exactly what the american heart wants. we want america again. we want to be able to be proud. we want to not make excuses for what we do. donald trump embodies everything that the american
4:01 am
spirit is. i am so proud to be supporting him. i voted i am ashamed and embarrassed to say that i voted for obama. i do not vote already people. i vote for the person. i vote for the issue. at that time, i was blind and i thought we needed obama to straighten out the bush problems. host: thank you for the call. we will respond. guest: the sad truth is the policies of the clintons and bushes and obamas are identical. i have come to the conclusion that after many years as a republican and a former republican national chairman, i had the privilege of working for three republican presidents, but the truth is the two parties have morphed into one party. it is a big government party. it is a big war party. it is the erosion of civil liberties party. it is the big debt party.
4:02 am
it is the big spending party. , they try to rhetorically sound different, but they are jointly responsible for the decline of america. personally, i always wanted donald trump to run as an independent candidate so he can criticize both parties. i am happy he is running now as a republican, although he is running against the republican establishment. he is still the outsider in this race.he puts his finger on it when he says our leaders are weak. we are in the position we are in because our leaders have been weak. they have made bad deals for the united states. they bought into the idea that we are a country in decline and things can only get worse. things cannot get better. no president has disagreed with that since the ronald reagan. i appreciate the caller's sentiments. i think she is typical of americans who are fed up and want this country to be great again. host: do think he has staying power moving into the fall and winter? caller: i do --
4:03 am
guest: i do. i think that is up to him. that it's been for the discussion of his economic plan. i am very optimistic about that. he will have to ultimately talk about his worldview. he has only laid out one set of policy and that is on immigration, and that has dominated the political debate so far. the great thing about trump is he is always interesting. you never know what he is going to say. he is not scripted. as long as he is interesting to the voters, as long as he is engaging the voters in a way otherf the candidates can, he has staying power. this is a $100 million endeavor at a minimum in my opinion. when he files his financial disclosure form with the federal election commission, he shows he
4:04 am
had a net worth south of $10 billion. more importantly, he had very little debt and $358 million worth of cash or cash equivalents. he has the money to do what is necessary. it is money with no strings on it. jeb bush has $100 million, but that is wall street money. every dollar in that account as a string on it. donald trump is exactly right about that. host: as you might imagine, a lot of political junkies watch this network and work here. one of the questions everybody asked before we sat down to talk with you this morning is your tattoo. i want to ask you because you tweeted it out. is it real. if so, when did you get it? i actually have a tattoo of richard nixon on my back about the size of a pineapple. is equal distance between my shoulders. here is why i did it.
4:05 am
is not an ideological statement. they said was a pragmatist. it is a dealer might or that in life when you have setbacks, when you get knocked down, when you face disappointment, when bleak, youhings are have to get back in the game. he was an introvert and and at an extrovert's business. he opened the door to china and segregated public schools, reached arms-control agreements with the soviets, put money into the african-american community to develop black capitalism, the first real environmental protection that we needed. he was in many ways a great president despite his many problems and failures. it is a personal reminder. i got the tattoo, which is a
4:06 am
good likeness of him, in california from a tattoo artist there at the ink monkey. i did a lot of research before i chose somebody to do the work. i saw a tattoo this particular artist had done for someone else.it was a tattoo of general patton . it was a great likeness. i knew i found my man. it was very painful. it is a daily reminder that you need to have the same kind of resilience, the same kind of indestructibility as richard nixon. philosophically, i am more of a reagan republican. what i admire about nixon is his tenacity. to a very different and long career, he got knocked down repeatedly but he got back up. host: was richard nixon alive when you had the tattoo put on your back? it?o, did he see
4:07 am
guest: unfortunately, he had already passed by the time i got the tattoo. i did it in remembrance of him. he was a good friend and mentor of mine. it was president nixon who introduced me to the reagan people and got me my job with president reagan. i worked on governor reagan's andpaigns in 1976, 1980, 1984. richard nixon gave me my start in politics, for which i will always be grateful. host: mr.
4:08 am
>> with the sudden death of president harding, vice president coolidge takes office. grace coolidge was an enormously popular first lady. although she married a man known as silent cal she never spoke to the press but used her office to bring attention to the issues she cared about.
4:09 am
>> i think we need a different model of education that includes one-year programs for people doing routine work, two-year programs is an option for people who want to do something specialized in the third year, and three full years for people who want a full general practice legal education that we now have. but it's crazy to train in the same way somebody who is doing routine divorces in a small town in the midwest and somebody whose doing mergers and acquisitions on wall street. we have this one size fits all model of legal education that is extremely expensive. the average debt level is $100,000. and that assumed that you can
4:10 am
train everybody to do everything in the same way. i'm licensed to practice in two states and i wouldn't trust myself to do a routine divorce. >> former british defense secretary liam fox spoke at the heritage foundation about why he opposes the iran nuclear agreement. this is an hour. >> liam has been a frequent ood morning. during which time he has worked tirelessly between the united states and grapet. throughout his political career,
4:11 am
dr. fox has been a conservative, dedicated to the principles of limited government, a strong national defense, and a robust transatlantic alliance. he has been a member of and cochairman of the conservative party. his most recent book discusses rising tides facing the challenges of a new era. today, he will address the greatest threat posed to the united states and its allies by the nuclear ambitions of iran. it is the largest exporter of
4:12 am
state-sponsored terrorism. he will discuss the implication for the free world, following the agreement between the p5 plus 1 and iran indiana. please woke me -- please help me in welcoming liam fox. liam fox: does a pleasure to be back here at heritage and particularly, to be talking about a subject that is dominant in the american idiot, but is most -- in the american media, but is almost absent in the u.k. media. for the sake of clarity, let me say on the outset that i think any deal that genuinely put the acquisitions beyond the reach of iran would be a good thing. it would be good for the region, global security. if iran were ever to achieve a
4:13 am
objective it would start a destabilizing arms race in the region. before i turned to the deal itself, let me briefly talk about the background. the election of the iranian president in june of 2013, was heralded by certain sections of a landmark moment. there was a government who we would be able to do business with, a government that would bring iran in from the cold. it called for caution from season iran observers were lost. wishful thinking prevails over political analysis. fast-forward to 2015.
4:14 am
this become clear that the country has not changed direction. it was never going to and those who expect to change, fundamentally misunderstood the structure of iranian power. rouhani was destined to only ever have a limited influence in a state tom and aided by the supreme leader and revolutionary guard. we've seen an amazing ability for consistency that western politicians can only dream of. he has never wavered in his contempt for the existence of the state of israel, for the united states, or his belief of the parity of the islamic revolution. critics are only half joking with they say he is more afraid of mcdonald's . nor has his administration brought any relief for the iranian people. in 2014, i read was the world leader in executions per capita.
4:15 am
persecution of those who supported the green movement and their families continues relentlessly. the western media is curiously detached from, or even indifferent to, the plight of their repressed iranian colleagues. iran remains a sponsor of state terrorism, providing financial, logistical, and material support to islamic terrorist groups across the region, including those who targeted british and american forces while they were in afghanistan. it is just not possible, nor is it responsible, to see the nuclear ambitions outside the context of its support for terror proxies. arguably, the defining element of its foreign policy. and, anxieties over the nuclear intentions are not in the realms of paranoia or fantasy.
4:16 am
they are well-placed. iran's extensive nuclear program features many of the key components required to facilitate a domestic production of a nuclear weapon. possession of large quantities of enrich materials, knowledge to convert enriched materials into a weaponize to form, and the plans to develop a delivery mechanism in the form of ballistic missiles. i hear many voices in washington say iran should be given the benefit of the doubt. let me say this. the country has a long history of clandestine nuclear work. two of the nuclear facilities, which are the center of the international community's concerns, were constructed secretly in a clear breach of the spirit and letter of their obligations under the npt. for years, they have used facilities to enrich uranium
4:17 am
levels and quantities beyond those required for a legitimate and peaceful civil nuclear program. iran routinely neglects its obligations to cooperate with the iaea, including repeatedly denying inspectors access to contentious nuclear related facilities. this facility is suspected of having undertaking tests related to triggers of nuclear weapons. it is logical to assume their intentions have been to develop nuclear weapons capability and some point in the future. anyone who claims the intentions are peaceful should not be regarded as credible. let's turn to the deal that has been agreed upon. in particular, let's measure it against the timescale set, the
4:18 am
issue of sanctions and assets, and perhaps, their vacation. -- and verification. the original aim of the international community was to make sure they never have the ability to possess a nuclear weapon. these original aims have morphed into a agreement with iran that merely puts the nuclear ambitions on hold in suspended ambitions on hold in suspended animation for 10 years. this all seems to be predicated on the belief that in this timeframe, internal change in iran will produce a government that will ultimately, laid the nation's nuclear ambitions to rest. with me give you two reasons why believe this is a dangerous gamble. the first is that there is no guarantee that there will be a change in their internal
4:19 am
political position that produces a government more aligned with western, liberal values for politics. the second is that even amongst reformers, there is a belief that iran is not entitled to just a civil nuclear program, but to a nuclear deterrent. they will argue. the reality of the arguments is not going to change. let's look at some of the other issues. on verification, anything other than totally unrestricted and unfettered access is unacceptable. we all know in the light of the iranian behavior of the past how they will manipulate any weakness in the terms of the iae a's access. yet, instead of a clear and unambiguous commitment to unfettered access, we have in this agreement, a bizarre
4:20 am
committee structure. you can only get access to the committee when the iaea declares this as i -- declares a site as suspicious. this seems to me, the greatest surrender by the international community and the one we will play a -- pay a very high price for. then we come to the listing of sanctions and the unfreezing of iranian assets. rather than a graduated lifting of sanctions as a reward for full cooperation on the implementation of the agreement, the p5 plus one has caved in completely to the supreme leader's demand that sanctions be lifted completely and immediately. likewise, the unfreezing of iranian assets seems to be a surrender to the demands of the regime.
4:21 am
one of the more ridiculous arguments i have heard is that the money will not necessarily be available to iran because a substantial portion will be used to pay off the debts it already has. in other words, it is not real money. if someone paid off my bank overdraft, i would think it was real money. i would be able to spend other money on something other than the debt repayment. the same holds i am afraid, for iran. we have also been told the money will not exacerbate the problem of hezbollah and their other proxies because they are alrea dy able to fund them with sanctions in place. my interpretation would be the exact opposite. if we regard them as a priority for funding one they are already tightly squeezed by financial sanctions, then they are likely to see them as prime candidates for extra funding when the synonymy of unfrozen assets -- when the tsunami of unfrozen
4:22 am
assets hits them in the future. then, we go to the lifting of the arms embargo and the is to of -- and the issue of arms technology. the iranian supplied arms have been used against our armed forces directly in afghanistan and against our allies in the violent proxies supported by iran. to make such a concession without any guarantees about any change of behavior by the region seems extraordinary to the point of being incomprehensible. likewise, the change in policy towards ballistic missile development in terms of ballistic missile technology, why would you want to develop a capability when you claim you have nothing to wish to deliver by such a system in the first place? all of these, taken together, seem to be the fulfillment of the iranian wishlist, rather than a negotiation to improve
4:23 am
regional and global security. that does beg the question, why did such a deal take so long to negotiate? what congressional is given for this approach? we are told these measures will help iran become embedded in the international and economic order in a well they -- in a way that will encourage reform. i would just like to point out that bringing russia into the g8 did not exactly make it less aggressive or expansionist. if anything, it said putin's pretensions. there is no guarantee that economic independence with the state will produce the desired promoter. -- desired behavior. after 1945, europe became much more economically interdependent and look how it has led to a prolonged.
4:24 am
-- a prolonged time of peace. >> russia has taught us an example of that. iran is another. the supreme leader has already said that while he supports the deal, he reiterates that the iranian government, is 180 degrees different. we are told that this deal had to be accepted because there was no other approach available. i simply do not believe this to be true. iran came to the table because sanctions were becoming an enormous burden economically to the extent that it was beginning to threaten political stability.
4:25 am
maintaining sections until such time as i ran was willing to accept a tougher deal, more suitable to the p5 plus one, was certainly an option. it was not the option that was chosen. likewise, we are told that the snap back sanction is a solution to any flaws that might be contained within the agreement. this merits at the least, extreme skepticism. once iranian assets are unfrozen and ancient lifted, iran will be able to make very rapid progress in seeking the partners needed to repair and update their infrastructure in both the civil and military fields. not only will the effectiveness be 10 chile of any subsequent sanctions be diminished with time, but western governments will faced increased pressure from their own interests once contracts have been signed, projects have been started and profits have been put at risk.
4:26 am
we know that and the iranians know that. perhaps those of us who do not believe all of this are just being cynical. maybe there will be genuine logical change in iran by the time the 10 year envelope has passed. maybe any change will make them into a constructive partner in the region and beyond. maybe iran will offer free and open access to international inspectors. maybe, they will be completely honest and transparent with us. maybe, they will follow their own religious scriptures that say developing a nuclear weapon is unacceptable. maybe they will not use the unfrozen assets to fund the proxies in the region in the way they have in the past. maybe, they will not try to manipulate the terms in the treaty. maybe they want some -- they won't utilize for breakouts.
4:27 am
it is a lot of navies. -- it is a lot of mabye's. wishful thinking has prevailed over political analysis. we need to make the assessments based upon how the world really is, not how they wanted to be. wishful thinking is a dangerous foreign policy and a potentially catastrophic security policy. let us hope that those of us who have these reservations and belief this is simply pushing a difficult problem down the line in order to gain political promise today, let us hope that we are wrong. i would not put much money on it. thank you. [applause] nigel: thank you very much for your terrific remarks. i would like to open the floor
4:28 am
for questions. i would like to take the liberty of asking the first question. it is regarding the perception of the iran deal and the united kingdom. the obama administration has given the impression that outside of washington and outside of israel that their is opposition to the deal. what is the situation on the ground in london at the moment? will the british government back the deal. i understand there are a number of mp's who are opposed to the deal. is there a prospect of a parliamentary debate taking place in the house of commons on the iran agreement? liam fox: it is rather extraordinary. i was aching to the excellence qqq it last night -- the
4:29 am
excellence hewitt last night. there is a great deal of anxiety in the united kingdom and other european countries about the deal. it is quite wrong to portray it as having the full support across the political spectrum. before the deal was announced, there was a debate in parliament. a very large number of my colleagues attended and spoke forcibly about the potential problems that it might create. we have had, because of the -- we have had little opportunity to discuss it. i would find it unlikely that there would be no parliamentary debate on the subject. it could also have been during our back benches time. our parliamentary timetable is not entirely determined by the executive.
4:30 am
again, i just made the point that i am open with that it is extremely disappointing that this issue has had so little coverage in the british media. arriving in the united states, it is on every political program. it is virtually absent from the political debate in the u.k.. that is something i intend to help put right. nigel: first question from the audience. >> i am a doctor of geography. my question is, if you compare this issue in the usa and the european union, do you find any
4:31 am
difference? number one, number two. in this negotiation, do you think iran singularly outsmarted all of the other five layers? -- five players? what for the other options? liam fox: i think there is this court over the agreement politically and europe. i think it has left more partisan that it has in the united states. that brings greater focus of it here as an issue. i think that the iranians, let's put it this way. look at the agreement itself and compare it to the initial demands and the iranian initial demand. look at who it ends up closer to.
4:32 am
that to me, since the iranians managed to get a great deal of what they wanted. i am not sure we got what we wanted. i go back to the point that our original name was that iran would never develop a nuclear weapon. there is nothing to ensure that at the end of the 10 years, with the money they will have gained from the sale of oil and gas, getting back into the global economy with the unfreezing of their assets and breakout capabilities, that they will not turn around and say, we have done the 10 year suspension. now we will build the weapon. at that point, we have left our self with nothing, except the reimplementation of sanctions. at that point, that will be much less of a threat to them than a is today. i think they have got more than we have, frankly. >> the third point is.
4:33 am
what is the other option? liam fox: the other option is to continue with sanctions until i ran was willing to accept an agreement that is more foolproof. this idea that we had to somehow, in the summer of 2015 accept an agreement that we thought was at best, below expectations, let's put it that way, that we had to accept it right now, rather than can can you sanctions and seek we can get a deal from then later on the top why did have to be right now? why did we accept a deal well below what we initially asked for? i think the answer is that this was about politics more than it was about security. that is generally, in the longer term, not a good way to set
4:34 am
priorities. liam fox: -- >> yes, hi. i want to complement you on saying it is about politics. i was at an unclassified briefing about the iran deal. we were talking about how the mainstream media has cap information away from the general public and even more so, in the u.k. it was declassified a few years ago. that they did play a role in the bombing. if people knew that, they might be against the deal. i have heard that the mainstream media reviewed the report and are embarrassed. i don't know if what i heard was correct, but i would like to know, especially in the u.k., they are not having the dialogue. at least in america we are having the dialogue. i have heard that the deal is going to be pushed through. the issue is, it was monitoring the enrichment? people need to be educated and
4:35 am
they cannot understand it because of the complexity. any comment you have, and i believe like you said, it is the mainstream media not reporting it and not educating the people. it is politics. thank you. liam fox: the book i wrote, which contains a large section on iran, and part of the problem is that contemporary politics and political discussion as you rightly say, often has very little historical context around it. you would be hard-pressed to hear anyone talking about iran, pre-1979, it did not have any history. not a political circles. iran has a very sophisticated diplomatic capability. it always has. it has been very well known for running rings around over time. it has a very long record of
4:36 am
involvement in all sorts of terror groups. and proxies in the region and beyond. you could get a copy of it. i do think that we need to educate our public much more. i kind of liked it when i was practicing medicine, i was with say, when i had a real job. you do not simply come in and look at the blood, and make a diagnosis. you want to ask the patient about past history and family history. you want to know context. too much of our politics is discussed in two dimensions, rather than three. we need to put that right is one of the duties of politicians to educate, as well as make policy. >> thank you so much.
4:37 am
thank you for the excellent talk. here, in the united states, some promote its of the deal have making -- have been making a lot of the 24 snapback. . it is no gradual way to address the potential cheating. what is your take on, could you take, flesh out a little more how the provision is not particularly effective in bringing iran back to compliance with the terms of the agreement? liam fox: i think you put it very well because what happened in the agreement is, iran gets all of the rewards immediately. we are left with fewer and fewer potential sanctions. sure they not stick by the agreement. they get the unfreezing of the assets and sanctions very early on in the process. after that, when they have access to money, when they have
4:38 am
access to western contracts and capabilities, to be able to bring their economy back up to shape and to repair their damaged infrastructure, what a sanctions are we going to be able to apply? if we are able to apply them , how effective will they be. then we have the second problem that i mentioned. once the sanctions are lifted, once you have got western companies going into iran and doing business, it will be more and more difficult for democratic governments in the west to reapply sanctions, even if they are justified. i think we are making this very difficult for ourselves. we are loading this deal very heavily. on the iranian side, that is. we are leading -- leaving ourselves with too few options should iran go back to its old behavior of trying to manipulate
4:39 am
the agreement and behaving in what i can most accurately described as an utterly un-transparent way. i think we should have done something quite different. iran against rewarded for maintaining clear if limitation of the deal and unfettered access. they have to have a graduated process of having assets unfrozen and sanctions lifted. that, seems to me, to have been a much more sensible approach. it seems we have given everything away at the outset and it is all predicated on hope. we hope they will change. >> the gentleman here in the front. if you can identify your affiliation, that would be incredible. >> [inaudible]
4:40 am
iran has to answer to the iaea, but there is no deadline for that. in other words, all they have to do is to track of the time about an undeclared facilities. the 24 days will turn into years.
4:41 am
[indiscernible] liam fox: yes, and this as you say in the news, a developing story. the news becomes more substantial about the picture and the details. there will be greater public anxiety about this deal. that is why i think we need to start a genuine public debate, not about how iran is bad and the west is good, but focus on what it says and what the implications of it will be. and how we will operate under the most adverse circumstances, not the most optimal circumstances. that is the debate we need to get into. the points you have made are extremely valid in that.
4:42 am
>> thank you for a excellent speech. i am an associate of the middle east forum. i have a very personal interest. if we do not have america, i would have perished. i am looking at the situation from the perspective of the iranians and the islamic people i had to study for years. i am not muslim, i do not adhere to it in any way. this treaty satisfies every single role, and according to the jurisprudence of treaties,
4:43 am
this treaty is a temporary truce. limitations of it in 10 years. after the 10 years, a muslim ruler is obligated, and limited to, a violent attack and raging war against the nation. either the nation they have the treaty with, or its allies, that is what it explicit the says -- it explicitly says. otherwise, the ruler would not be legitimate anymore. i don't think it satisfies every law --i don't think they would sacrifice their will to satisfy the united states or the west. my question is, is this taken into consideration of the political discourse in europe, or in the united states of america, how the iranians are
4:44 am
looking at it and the implications of it if iran does in fact, act upon his promise of "death to america and, just to israel?" liam fox: i will not even attempt to get into issues of iranian politics. i think what is very clear is that the mindset from the west, and coming to the agreement is, chances are with a young population it will become much more liberal. the regime we we know -- the region we know will be fundamentally altered.
4:45 am
the whole agreement is predicated on the fact that at the 10 year mark, iran will not be the same threat regionally or globally that we see it as being today. i can see, circumstances in which the successor is actually more fundamentalist than he is. i don't think there is anything at all that suggest that any change will necessarily be more liberal and more pro-western. i think this is a dangerous gamble. i think, to try to guess what the world will look like, what any country will look like in a decade's time, and base a security policy on it is really, placing too much value on hope over experience. >> what about israel?
4:46 am
what about the threat to israel? because of the deal. liam fox: clearly, iran as a nuclear state poses an existential threat to israel. i think we need to understand the implications for regional security as a whole and global implications as well. it is extremely important, it is of great importance to see the threat it poses to israel in particular, we should understand the implications for more widely of iran the able to get a nuclear weapon capability. it is not simply iran getting a nuclear weapon capability and the threat it poses to israel. it is what it would trigger. in no time at all you can bet he will be in an arms race.
4:47 am
saudi will want a nuclear weapon, egypt will want a nuclear weapon, turkey would want to get a nuclear weapon will sto. all that we did at the end of the cold war to prevent proliferation, we don't want to leave to the next generation a new nuclear arms race in the most unstable region of the world. we want something more than that. i am the first to say, any agreements that stops iran from getting a nuclear we been, -- nuclear weapon, generally stops them, i am for. i don't think this agreement gives us the guarantees that we need. i am almost sent to not be supporting it. i think, you have to be realistic and policy. as i said, which will thinking is not a good basis for national security, or the security of our allies.
4:48 am
>> hello, andrew overton. i work at the british embassy, i know i do not sound like it. i appreciate your comments greatly. i wanted to push back a bit on a couple points you made about sanctions full u. the deal says they will only be lifted after the iaea have verified certain restrictions. the british secretary is very clear that he will snap back pensions -- snap back sanctions. the alternative would be more sanctions to presumably get iran back to the negotiating table. do you really think china, russia, and the other p5, will sign up for more sanctions? do you think they would return to the negotiating table? liam fox: my point was that we
4:49 am
did not have to have an agreement now. iran was becoming more complaint because of the sanctions we were already having. weeden option to continue with the sanctions until such time iran was willing to accept an agreement to our liking. we decided not to do that will stop it will leave that open for debate. i think that, if you look at the difficulty that there often is, when sanctions are being applied, in the timescale ahead, i think i made the point. will sanctions have equal impact once iran has had a lifting of the restrictions to the present time and the everything of the financial assets? will sanctions be as effective in the future? and secondly, will western, and
4:50 am
other governments, be willing to reapply sanctions when we have large financial investments that we do not have at the present time? democratic governments come under pressure so that the chinese government comes under. when you have large industrial interests, able to make profits from an open top iran, there will be a will not to close it down again. that is a reality of what happens in western politics. we need to accept that. the snap back argument, that it will happen very quickly or easily, we have to question that will stop i do not believe it to be true. >> it is hard to imagine the russians and chinese supporting the real position of the un security council sanctions. at least with the russians supplying weapons.
4:51 am
in a very close relationship between moscow and them. liam fox: i think it has been overplayed because i do think there is a real danger that some of the players that are required to make sanctions, would be a lot more unwilling in the future than they have been in the past. added to that, the point i made to the gentleman from the british embassy is that the democratic western government will have different pressures of life to them because of their industrial and commercial interest. it is not as clear, as it is being portrayed.
4:52 am
liam fox: at the moment, i do not think it's likely. you can never will anything out. if you at instability into an already unstable region, who knows what the final outcome and implication will be. it is impossible to say, but i think it would be unwise for anyone to rule out that there might be a potential military response at some point in the future by israel due to what they perceive as an increasing risk to their national security. >> thank you for your speech. recent polls show that americans do not approve of the treaty. another recent poll shows that
4:53 am
british people have been more enthusiastic towards the treaty. what is it that this disapproval towards the treaty on these polls is not out in the media? liam fox: one of the things i am never answering for is the behavior of the media. i am internally grateful for that. it is interesting however, first of all there is the death -- the discrepancy between the two. the american population are less inclined to support the deal that the british population. i've not seen these polls, but i have no reason to doubt what to say. what is the difference between the two? there has been more debate about it in the united states. that to me, sounds a great deal like, the more people know about it, the less they like it. the answer to the conundrum in the united kingdom is to open up the debate.
4:54 am
try to get articles into the british press on this is extremely difficult. the of session in europe is very different. the of session in the middle east is the migrant crisis, and not iran. it is part of a continuum and does need to be debated in greater detail. one of the reasons i am here today is to try and get the debate opened up in the united kingdom. it is extremely department -- it is extremely important that we do so. just because people do not want to hear something, does not mean politicians should not say it. >> could you comment on the migrant crisis in europe? the number one political issue across the mid-atlantic. how is that related to the current situation in the middle east with syria? could you address how europe is
4:55 am
responding to this crisis, and what needs to be done for the big picture? liam fox: first of all, i would differentiate between economic migrants coming from all over the region to try and get work and better living conditions by being in europe. that is understandable, but we are not simply there to be the recipient for everybody who was a better life. i draw distinctions between those people and those poor souls who are fleeing one of the most cruel and vicious organizations, isis, that we have seen in a long time. it is pitiful to watch them trying to bring their children, not just to a place where they can get for money, but to a place where they can be safe will stop our failure to act in syria is coming home to roost.
4:56 am
we need to set up a safe zone. the needs to be secure zone in syria where people can live without fear of beheadings and crucifixions and cruelty and gang rape and the other things we have seen from isis. that'll require, at some point, if you want to stem the flow of these poor people trying to escape this, we will need to have military action, a no-fly zone, and a protected element inside syria will stop otherwise, the flow will continue. there is no point in simply saying we will not allow people to cross the borders. we need to deal with the cause of the problem, and not simply the symptoms. the longer we wait, the longer the cost, in terms of human suffering, will rise. >> let me add this one thought. not acting is a policy.
4:57 am
not acting is a choice. not acting brings its own consequences. you have do with the cost of action -- you have to weigh the cost of action against the cost of inaction. her many people across the political spectrum, the cost of inaction is rising too high. >> could you comment on how you see the debate moving about british military action in syria. what needs to be done exactly, with regards to military action, against isis? liam fox: there is been confusion between the response to the use of chemical weapons by syria and military action
4:58 am
against isis. it seems absurd to me that we accept that it is ok to carry out military strikes against isis in iran, but not in syria. they are either a threat to your national security or not. and if they are, you have to deal with it. a nonexistent border in the sand should be an extraction -- should be an obstruction. it just leaves me speechless. what we require to do is something else.
4:59 am
discussion i had in the palace. why was it -- during the cold war, that we were willing to use the word better. that democracy was better. that freedom was better. i happen to believe that religious tolerance is better than forced orthodoxy. i believe treating women as equal citizens is better than second-class. i believe that the values we hold our better than the alternatives put forward by the
5:00 am
islamists. when i made the argument, the answer was this -- i don't think we can say better. just a different. if we only believe that what we stand for is different, and not better than the alternatives, we ourselves will not have the moral courage to do what we believe is right, and we will not have the moral authority internationally to do so. it is time in the west, that we stop using different, and started using better. we can start seeing the information revolution not as a threat, but as an opportunity to propagate those values that made us what we are. it is time to say that countries like the united states, the united kingdom, australia, canada -- we are not who we are by accident, we are by design. it is time to get back to the
5:01 am
values argument. that values argument is just as important in the long term in al-shabaab,is, or or whatever the subsequent threat might be. over the all too easy military response. this requires a fight by our whole society and not just the military. for youryou very much excellent speech, and for bringing us up to date. my big concern is that this document is just peace at any price. the peace we get is a piece of blank paper, and the price we pay is our future. it seems to me that, what we really need is to go back to peace through strength. we need a lesson in history, that in 1979, the hostages were
5:02 am
released when the political side was going along and going along. will move when they think they have the best deal. when did they let them go? right at the inaugural. when the former president took off, and ronald reagan, with whom they were not sure what he would do as the cowboy. that is when we got peace through strength. that is what we need today. peace through strength. in addition, i have another concern. is this going to get full diplomatic authority? or are we going to have limitations? re: getting back there and the sea here -- are we going to give back there embassy here too? it is a very crucial location. 1979, been vacant since
5:03 am
except when it was used by the state department. bridgeust across the from the italians, resilience and all of the other embassies brazilians, and all of the other embassies. that would be a perfect center for mischief. i don't know if anyone has brought that up. >> i guess the aim is to see greater and greater normalization in relations with iran. that is not a bad thing, but it has to be earned. to give all of these things, at the beginning of the process, before they have been earned, before they have shown they are willing to implement the agreement themselves, seems a touch naive. >> [inaudible]
5:04 am
mr. fox: as i described it, the west have a policy where wishful thinking trumps political analysis. russia launched a cyber attack on estonia, we didn't do anything. the invaded georgia. they are still there. and our response was minimal. the last time i was here in washington, one of the u.s. senators, i will not name them, said i am worried that putin is misreading the signals from the west. i said -- putin is perfectly reading the signals from the west. he acts, we don't respond. what is difficult to read about that?
5:05 am
>> thank you again for your remarks, dr. fox. it seems like the democrats and the u.s. are going to filibuster, and the deal will be implanted. what are the steps -- will be implemented. what are the steps going forward ? fox: it looks like the agreement will go ahead. with its termsck and all of the risks that are inherent in it. what we will have to do is to ensure that the rights of access by the iaea are fully upheld, and that these stalling
5:06 am
techniques that we have seen in the past, are not allowed to buy them extra time. is not anreakout accurate figure. i think it is more like 7-8 months. there are so many risks in this process, that i generally find it hard to be optimistic. i think we will be sadly limited with what levers we have to pull, if our anxieties grow over the years ahead. this was brought out in the house of commons. -- hereign secretary said thought it had the potential to be a historic agreement. but he said, with all due respect, history will determine if it is an historic agreement. a generic lesson for all politicians in that moment.
5:07 am
>> on the if you -- issue of refugees, the vast majority in syria were not caused by isis, assad. shouldn't thes, kind of action you propose be brought against isis and syria? fox: i'm not going to get into the complexities of syria, except to say this -- it has been the movement of isis, that has caused in recent times, this mass movement of refugees. you are quite right that the civil war was already causing instability, and this is
5:08 am
instability upon instability. it is not just the refugees coming to europe, i was recently in turkey. no one seems to be mentioning that the turks have seen potentially 2 million people crossing the reporter as refugees. that is a huge problem for any country. we know what isis are capable of. we have seen what they have been doing. we have seen their animal behavior toward fellow human beings in the name of so-called religion. at some point we have to raise our game. isis is notikes on going to be enough. it is not giving the civilian population the safety that they require. i go back to my early point. achieve we were able to no-fly zones, zones of safety so that people could live without
5:09 am
fear in their own country. we will have to do something similar again. i know that we do not want to do it, and i know that public opinion may not be in favor of doing it, but if we only want to have the policies that are already accepted by the public, what we give up and let the pollsters run the country. politics is about leading, not just reflecting public opinion. >> the last two questions. from this gentleman here. you touched the base a little bit, where can we go from here? what can we do about it? be approved byo the senate. a 34th senator has
5:10 am
agreed to the deal. not much the senate can do. deal, i the iranian think it is going through. that's it. this deal is going to be a reality, and we are going to have to work out what maneuver we have within the terms of this agreement. we have to hope that people like me are wrong, and very wrong. if we are right, even half right, we have not got a lot of levers to pull should iran change its behavior. in a direction that does not shoot -- suit security interests. thank you very much. , [indiscernible]
5:11 am
if they were allowed to continue still, they were getting close to developing a nuclear weapon. -- better to stall the process. what is your view? fox: i understand the desire to get an agreement. as i said at the beginning, any agreement that stopped iran getting access to a nuclear weapon capability, would have to be welcomed the cause it would reduce the threats to the region and beyond. to go back to, your earlier question, who got
5:12 am
the most of what they wanted? is it closer to the iranians starting position or our starting position? one,is, one -- in the this the winner is pretty clear. >> i would like to thank liam fox for a terrific presentation today. a very engaging q&a session. been a huge number of questions remaining with regard to the a ran nuclear deal -- iran nuclear deal. think it is an extremely dangerous deal that will undercut the security of america, britain and its allies across the world. we hope that you will join us in the coming months, and we wish you all the best as well with the reconvening of the house of commons next week. [applause]
5:13 am
[captions copyright national cable satellite corp. 2014] [captioning performed by the national captioning institute, which is responsible for its capt
5:14 am
during world war ii itself it was of extreme value. and also contains uranium and uranium as we know is one of the best sources of atomic power and weapons. >> he fought the battle to reserve water for western colorado by making sure that we got our fair share. how did he do that? well, beginning in his state
5:15 am
then going on to his federal career he climbed up the ladder of seniority and was able to exercise i think more power than you might normally have certainly in the united states congress where he was able to make sure colorado and western colorado would be treated fairly in any divisions of water. his first major success was the passage of the colorado river 56.age project in 1950 --
5:16 am
this is an hour and 15 minutes. >> hi, everybody. we will go ahead and get started. thanks to all of you for being here today. i'm the senior fellow at the manhattan institute and the new editor at forbes. we are here to discuss bridging the gap between precision medicine and the fda. i know a lot of you know me as the obamacare entitlement reform guy and that's what i worked on in my time at the manhattan institute. what you may not know is before i came to manhattan, i spent a dozen years on wall street as
5:17 am
an investor where i looked at clinical trial data and fda regulatory actions to figure out which companies we should invest in based on development in medicine and science. this is an area i have long been interested in. i am glad to have this opportunity to help moderate this discussion today. we talk about how to pay for health care and how much it costs. we don't spend enough time talking about how innovation is transforming the quality of life for millions if not hundreds of millions of people in america and around the world. the manhattan institute has been a leader in this area. we have this: to to and called roject fda which is centered around fda reforms. that has probably been one of the most productive areas at the manhattan institute in the around fda reforms. other think tank doing the kind of work the manhattan institute sense that i don't know of any is doing on this issue. the question we will talk about today is one of the most
5:18 am
interesting areas in terms of how we think about how to reform the fda. people always complain that the fda is too slow in approving innovative, new treatments. ne of the issues that has come up recently is this area of precision medicine. there are these things called biomarkers. when you go get your cholesterol checked at the precision medicine. there are these things called biomarkers. doctor's office, that is a biomarker. that's what we mean. a biomarker is a lab test. it is something we use to correlate something going on your body with a particular utcome of disease. in the case of cholesterol, there is decades of research that indicate the high cholesterol levels, particularly a low density level protein or ldl, high levels are highly correlated to heart disease and heart attacks nd other problems.
5:19 am
that is a biomarker. 50 years ago, maybe we had a couple of dozen biomarkers. because of advances in genetic science and all things we are learning about how different genes in our body regulate and produce different proteins with regulating the biochemical science and all things we are learning about how different process in the medical processes and diseases, we on the verge of having hundreds of thousands of these kind of lab tests were biomarkers. they can help us determine many things. they can help us advance more quickly drugs to market that affect certain i'm tests or biomarkers. they can help us design clinical trials. for example, there are many people with lung cancer but it is not all the same. different people have different
5:20 am
kinds. it might be responsive to different treatments. the fda and drug companies are trying to figure out how to different people have different tailor their investigation into the individual patient and the individual patient's clinical and biogenetic position. these are the kinds of things that are going on scientifically in the world in the private sector. is the fda doing what it can do to take this scientific knowledge into account in the ay it regulates this evelopment of new drugs? in that light, peter huber and paul howard have put out a new paper which you have in your folders there. it argues that the fda is a little behind the curve in addressing how these new developments, these new scientific developments can help accelerate the discovery and development approval and marketing of new treatments for disease. we will hear from both peter
5:21 am
nd paul today and what brought to additional panelists with those who i think can illuminate a lot of this discussion. we will hear fromemile kackus who is the ceo of ultra-genex who specializes in the in that light, peter huber and development of treatments for ultra-rare diseases. before he was there, he was with another company that specialized in this area calledbio-marin. ultra-genex has had some success. it went public last january and has a market cap of two point $3 billion which 10 years ago was unheard of but has become more common as companies have gotten more sophisticated at how to develop these drugs. e will talk about the trials
5:22 am
and tribulations he has had in this field. we will also hear from lynn matresian from the pancreatic action network. she will tell us at the patient level what some of the challenges have been in trying to work with companies and work with people doing critical trials of your eight -- doing clinical trials if you are a patient to develop new treatments. with that introduction, i think we will go ahead and start and maybe get the ball rolling. i want to go through that each trials of your eight -- doing clinical trials if you are a patient to develop new treatments. with that introduction, i think we will go ahead and start and maybe get the ball rolling. i want to go through that each of you based on your expertise -- maybe we will start with lynn -- you have had experience in the pancreatic cancer world. from the patient point of view, what are the challenges? how do you think about cancer varies between patients and trials of your eight -- doing clinical trials if you are a what are the challenges in getting the fda and drug companies to respond to the unique characteristics of individual patients? >>. thank you very much
5:23 am
yes, i will tell you about that through a story. marjorie called our call center, the patient central at the pancreatic action network ecause her husband was diagnosed with pancreatic cancer. our associates at the call center gave her lots of information about the disease and physicians who saw a lot of pancreatic cancer and nutritional information and that type of thing. and they offered her and charlie the opportunity to get his tumor molecularly tested and do a biopsy and do something about a test that will tell us something about what was causing his particular cancer and therefore how we might treat it. that made marjorie pretty happy because she read the statistics and she knew that only 76% of
5:24 am
people were not going to be alive in one year and only 7% were going to be alive after five years. she said this is something i can try. the current standards of care are pretty crummy. hey agreed to do this. about a month later, they got back a report and it has mutations and alterations in jeans that are underlying charlie's cancer. e has been luckier than 55% of pancreatic cancer patients based on this molecular profile. there are some options that his pancreatic cancer patients position would never have thought of before. some of those are off label treatments so they are drugs that have been developed and other cancers that are for a
5:25 am
mutation that charlie has in his cancer. some of them are clinical trials. here is where they were faced with not really medical problems but system problems and problems with how does he get access to these drugs and how does he decide what is working for him? there are no real clinical trials in pancreatic cancer for any of these drugs. there are 50,000 patients per year of which 4.5% of them go on to clinical trials. then this mutation is only in 2% or 3% of those 50,000 patients. 3% of that going to clinical rials so how do we learn about
5:26 am
what to treat charlie with human that we have this molecular information? what happens is that even if he can get on a clinical trial or get off label treatment and there is all sorts of insurance issues and being out of network and those kinds of challenges that he will face -- even if he can, what usually happens in these clinical trials is that he is treated with the drug and then three or four month later, they take a radiological scan and they look at the tumor if it has grown are shrunk. the overall result is whether charlie lives or dies and how long he lives. in the meantime, they are checking what's called a biomarker in his blood calledca-19-9 which if it goes up, the tumor is probably growing but we are not 100% sure that is always true but there is good data that says that is often the case. if it goes down, that's a good ign.
5:27 am
you cannot act on that information. there has not in the proper studies to know whether the drug is doing charlie any good or not. if it's not, he could go on another treatment. i think that is two examples where we do not have the information to determine what treatment we should give charlie and we are not able to act fast enough i biomarker to determine whether we should change that treatment or not. i think those are both opportunities for the fda to pay attention to a disease that is life-threatening. charlie does not have a lot of time. survival is measured in months and weeks and this disease. when he to act faster and we
5:28 am
need to change the system so people like charlie can benefit from the science that we have around cancer treatment these days. >> let me introduce peter. he is the senior fellow but i like to call them the resident genius of the manhattan institute. he has a phd in mechanical engineering from m.i.t. and a law degree in harvard and writes about energy policy and legal policy and tech policy and is the author of the cure and the coding of 20th-century law is undermining 21st-century medicine so he is equipped to talk about this topic today. how do we take that every day patient example and translate that into better policy? >> the first thing to understand is the example that lynn went through. there will be a test for a device that will check for these oscillations in a patient's bloodstream and what it tells us about the drug. it does not get to the market without the fda say so. i have a number of oncologists that tell me if they were not allowed to describe off label which they do, oncology would shut down. guest: >> explain what that is. >> that means the drug has been up for something but not for
5:29 am
what you are prescribing it for. i don't know what the off label drug was in your case. the fda is not capturing every possible use of every drug. your life depends on people who do not believe that. there is hope for a lot of off label work because it is happening all over the place. it can look different in different parts of the body and have the same underlying mechanisms and repurpose the drug and prescribing drugs based on their molecular different parts of the body and effects and the ideology -- the etiology of the cancer is widespread in this area. it has been used in other areas but this is where it would be most effective. if a drug company walks run and says it does this for pancreatic cancer and if the owner of the drug tells you, they will probably get
5:30 am
prosecuted. they will certainly face a civil suit. these are billion-dollar issues for drug companies. they known off awful lot about this and are interested in their drugs. they are compiling the data. doctors who share this can and the fda has not gone after them but they very well may. the fda questions these uses. it has not certified it to be true so it wasn't true and they had to shut down half of their business in the state. the fda has plenary power over how much of this biomarker information you use in a drug in the approval process print you have to persuade them that this biomarker is good and valid and can be used. this is especially painful
5:31 am
because the best people at the fda and i would start with dr. woodcock who is the head of the agency, they know exactly what is right here. there are excellent presentations that were given 10 years ago. biomarkers are the foundation of evidence-based medicine. they determine what happens and what we should prescribe to home and outcomes happen to people not populations. there is an indictment of what the fda has been doing for 50 years. the fda clinical trials are population-based trials and are overwhelmingly based and looking for imperial cult -- or empirical correlations. if what you have defined as the disease is 25 different diseases, the drug does not get through. there is a core problem with the fda and their existing trial protocols which statisticians call the
5:32 am
reference class problem. if each of you represents 1000 patients, let's do pancreatic ancer, this row here, if i round you up, 15,000 or so and i test the drug in all of you, who is to say you are predictive of the rest of the people in this room? it think we had a cancerous dentical disease, then that is pretty good sample. we know today that june on the have shown in august amounts of variations in genes and the proteins that they code for. the saddest part to my mind is the fda issued its first guidance, as they call it, for data in 2003 or possibly early
5:33 am
2004, ok? the nih is one of the agencies in washington that does a lot of genomic research. they said, well, nice work. please tell us what the hell you mean by validating a biomarker. by the way, folks, we have set that internal standards for what we accept as good funds. as far as i can tell, it is without a trace, ok? when you later, the fda did issue its critical path report saying that biomarkers are something that we really have to do and they said that an institution called -- what is it called? cpac, the critical path nstitute which got private funding to research this. meanwhile, we have an enormous amount of taxpayer and health care money going into sequencing tumors.
5:34 am
every time doctors are treating patients like us, we are getting new sequences. they are firing clinical data at the same time which made your developing huge databases that they receive these molecular profiles and are associated with these effects and you can basically do epidemiology for these biomarkers. this is how we isolate between microbes and many diseases. you can begin working out molecules. molecules are way more complex, there is not one-to-one correlations, they work in very complicated networks. we have fantastic competing powers today and they have decreed and stated publicly and he is right and google knows this and that is why they're getting into business and apple knows this and that is why they're getting into business and all of silicon valleyand has not reached washington you. the have incredible computing tools. you give them enough an update and they can unravel pathways. it is too good not to say, why would darfur, then advanced research projects agency, suddenly be interested in cancer?
5:35 am
they actually issued a big mechanism notice a couple of beers ago saying that if we give you a really complex data set, get some ingenious technology working out mechanisms within that data set, and vitally, signaling systems, too, the nsa has this uge database if i blow up this person, we will stop having terrorist incidents, i'm quite sure the nsa would not want to share its database of every risk of the country.
5:36 am
same goes for cancer, and we
5:37 am
have terrific oncology and they haven't exactly right. the fda has the lead analysis and affiliated to the nsa, we would be in really good shape. this is what it is all about. >> i think you found a political platform for the next
5:38 am
5:39 am
5:40 am
5:41 am
5:42 am
haven't exactly right. the fda has the lead analysis and affiliated to the nsa, we would be in really good shape. this is what it is all about. >> i think you found a political platform for the next president. put the nsa in charge of drug development. peter: just validating power. acquisition. >> let me ask you, i think what i have taken away from both of these discussions, from lynn's point, which i think is interesting is that there are these patients, two to three per -- 2% to 3%, small populations within a large population of people of cancer who may have a unique genetic signature, but that is a tiny number of patients. it is hard to show statistically in a tiny number of patients that the drug is actually having an effect and not just a noise, a placebo effect, so how was the drug company feel ortho biotech company navigate that scientific problem of genuine -- of generating genuinely statistical evidence that you found a correlation between your drug's ability to target this particular genetic subpopulation? and then to peter's point, how do you take this big data idea that is revolutionary -- revolutionizing the rest of the economy, and had to convince that the a to adapt some of that technology into their own thought process? >> we don't, but we would like to. the challenge i think in that we deal with rare diseases every day are these small subsets and we have been struggling for a long time. these biomarkers are the most important ways to gain power in understanding what is going on in a precise and accurate way that allow you to actually determine what you are doing in a small population. the challenge has been, and there are thousands of diseases -- where diseases, thousands of
5:43 am
which you do not know how to spell, save them, or never have heard of them, but 10% of the american population is affected with the rare disease and probably all of the miss some of the rare disease and 25% have treatments. we should be doing more translating and being able to get the power to determine what is going on in these patients at time markers is one of the critical things that we believe. i am the president of a foundation that is focused on where diseases and we focus on how to use biotech -- biomarkers and we believe that is one of the key pieces that will help her diseases as well as patients of pancreatic cancer, and the stories that peter has been talking about, so i can say this, the facts are that since the beginning of approval in 1992 after the hiv and aids crisis, when it was first -- in that time, in the rare disease genetic area, only to diseases where new biomarker has occurred has been used in those whatever 23 years. i was involved in one of them and the other one was have her son. -- all of them have been ones that were approved and drive and in the early 1990's, so there hasn't been anything new. the question is with all the genetic information we had and all the bread diseases out there and the science that has been done, that we know and understand what has been going on. how can it be that there are no biomarkers based approvals for more diseases that could require them? i know doctors had them because i working on a program for disease and it -- type seven, that disease is a slight disease. only 20 patients in the united states perhaps with this disease. yet, we have a treatment that has been around for 20 years. it works beautifully and not translated because we cannot detect or do a study with 10 patients and prove it is working. if you used the biomarker, how much material they have in their bodies, we could do it immediately. we have got bma to a great and fda has not agreed at this point. with a biomarker, we can run the study with 12 patients and get the study to work. based on all the signs we have, showed that is a reasonable treatment and get these kids treatment. what is the point of all the nadh research we have been funding? the billions of dollars we have been spending and if we find the treatment, we do not turn them into products for someone to get? that has been a tragedy for nps seven. to show why it should be done and how it should be better. we continue to work on access
5:44 am
and policy and legislation. it has been challenging and i think my manhattan students are tied to the got away to make some financial happen on the biomarker front. >> a meal, even if the case with their company, altered genex, trying to study disease with clinical trials is physically impossible because you cannot ethically do a study in where you let the patients died. you have to treat them in the way that you know how to treat them. the only way to measure progress is through the biomarker or lab test. the broader problem is if janet woodcock were here or representative of the fda, she or he would say, well, it is great that you have all these biomarkers, these test that may correlate to better clinical outcomes, better performance on disease or measurement of disease, then they probably would have otherwise had, but we do not necessarily have that. we do not necessarily have a inclusive proof that the biomarker is correlated to better disease all caps and longer lives in statistical situations, so push back on that. tell me why the fda should not be cautious, should not be scientifically conservative and say, you know what? yeah, this biomarker sounds like it is a good thing to test, but there is no definitive evidence that it actually means a patient who does bad on a lab actually going to have a longer life or do better on a disease. >> i think one dimension of that problem, if the industry would say, it doesn't make it easy, you can make it hard, but tell us exactly what the standard is invalidating a particular biomarker for the context of use. we would go out and we would develop these weapons states or find studies that do that. i think the agency is concerned to something like this -- funded researcher runs a study, discovers a biomarker for cancer of the diseases, publishes an article in science, declares victory and moves on -- the agency would look at that and say, gosh, that is not a biomarker, it has not been reproduced, how do we know that is good science? how do we know it has been validated? what is the reference class control that would prove he would hit something that is really important for that particular disease or indication of how abuse question mark that -- that ndication? i think one year or two years ago, researchers out at stanford, what they did was to achieve expression profile, looked at classes of drugs that were already approved by the fda and then compared them to cancer expression profiles across a number of different
5:45 am
tumor types. what they found was a match between the genes that were hit by a 50-year-old class of drugs of antidepressants, some of the first i came online, and a very rare class of lung cancer called small cell lung cancer, about 20% of cancers. i think it was called the endocrine tumors, a small class of pancreatic tumors. they said this was interesting. the pathway that these drugs inhibit, it seems they are implicated for this class, particularly in small cell lung cancer but other cancers we know about that are endocrine. let's do the science, so they ran and looked at tumor cell lines, they looked at knaus models where they grew tumors in mice and then they hit them with the drugs, they hit them with other drugs. it was a neat experiment, and they said, you know what? we are to launch a clinical trial. so now 15-year-old drugs are in testing for small cell lung cancer and face to be trial cells for efficacy. as a really interesting things, but unfortunately, these rugs are 50 years old and have not been used very much. this is a more recent class of drugs. we have lots of data on observational data, so we will look at these positions and see how many patients have been taken lithium or other classes with rates of brain cancer slowing or a better response or no endocrine tumors for lung cancer or other cancers and do they have good response rates? there is a range of other dad is taken years to valid -- there is a range of other dad as they can use. it is observational data. they can be used to enrich a clinical trial for a particular class. if you can get down to a little of knowing and what it is xactly that is causing those cells to self-destruct, billy
5:46 am
can use that as a circuit in point. i think what we are asking the fda to do is hand out that evidence of development which they have said they are not equipped to do, or have been reluctant to do, to the people who are capable of doing it, which is the research community. >> would that be a particular professional society over that the -- or what they deputized certain academics? how that process go? computer: how about getting it to the people who are spending billions a year on taxpayer money? the nih has characterized them as characterizing genomic variations that have medical impacts. not just say to anybody who would like and send it in. one database that i know that they monitor is where they invite people from all of the country descendent reports of adverse affects on drugs. it is important to monitor and i googled this and i kid you not, they tested that they have done vaccines that transformed into incredible hulk, so that is the one you should be worrying about an apparently
5:47 am
got a call sometime later saying, oh, that is strong. anyway, look, first of all, people talk about drugs doing a biomarker. certain endpoints are not drugs pointing toward a biomarker, they are drugs changing the level of some biomarker, ok? certain endpoints are about understanding. if you're going to do a collective, it is understanding the pathway which will often be a whole series of interactions and alzheimer's is probably dozens or hundreds of proteins in a chain. it can be any number of them and each one will have the same effect because it is a chain effect and the weakest link is what causes the lead. you have to understand these mechanisms, that is why i am glad dartmouth is looking, they deserve a nobel or something. you are talking about mechanisms of action. if you contact those down in
5:48 am
much smaller data sets, in fact, you don't really have to use of statistics at all. you can simply wake up and this is leading to that, leading to that and these are a lot of experience. i would also add that the tumor typically for the more common effects you can find 10,000 mutations in a cancerous and they can go crazy. they mutate in every possible direction. hey just do it wildly. these analyses are sophisticated methods. these tumors have -- they call it days and network analysis, i these analyses are have some of them in my book, they look like this huge spidery web with links between them and you can quantify the links and it is important to note that these are hierarchical networks. they're clearly important almost all variations and others are playing alongside try they map our system systematically and for a long time, they have four major categories, depending -- i think there are four major but
5:49 am
more recently become of the database is but nonpatent statistics -- that non-basics as his six, they do have these large databases and it does it very well. the drugs are developed to be oriented and homework. i mean, nobody can with the number that is collectible from a molecular perspective. very rare diseases associated and the effects that are often ne to one. sometimes you have to double up get better effects. once you have it narrowed down, you can do very good studies on the mechanism and it is a very long chain reaction and more difficult. that is of modern computing s.
5:50 am
>> i think two takeaways from your paper, actually, that i thought were very interesting was one, first call, the fda is very restrictive in the ability to talk to drug companies and biotech companies because of conflict of interest that prevent them from talking. even the national institute of health, which is the major governing agency that runs a good -- academic biomedical research, even nih does not have a lot of cross channel medication with the fda about some of these advances and maybe as you said, that they could work with nih and use nih as the intermediary to help develop some of these standards. the second thing that you talked about in the paper that was very interesting was the fact that their european medicines agency, the em ea, european equivalent of that day, actually spent more orward thinking on some of
5:51 am
these issues relative to the u.s. fda i thought, paul, maybe could talk about a little bit and, emil, the reason we have this $2.3 billion market cap is because the em ea has been more orward thinking on some of these issues relative to the hese issues than the fda has first paul and then emil. paul: just a look at one of them and say, there is a foundation for the nih. there's biomarkers consortium which is a private profit foundation that works because academic researchers and are companies have an interesting partnership that we talk about called the advancing medicine's partnership looking up for diseases or five diseases. they do exactly what we are talking about, you go through, validate biomarkers, and debunked evidence. i think it is a big step forward.
5:52 am
and then i think the emea has something called innovative medicine initiative which is making biomarkers one of the key projects and sending hundreds of millions of dollars compared to a few tens of millions of dollars a year and that could be doubt they, too, but i think the key is getting this outside expertise that the agency is usually walled off from, involving critical standards so that people like lynn and emil and academic medical community and the drug companies can say, this is all the evidence we have. this is how it can validated and we should go about validating so we can affect and check things off the list. emil: i think what i would like to say about the market is it is not all based on biomarker -- biomarkers. and i do not own it all, to the clear.
5:53 am
i think in general what we can say about the ema and the gency, the last few years, they have been more scientifically based in less regulatory precedent base. they're willing to look at what you've got to make intelligent decisions about it. in the case of mps-7, we showed them the plan and how we present the data and that is based on false the kitchen criteria that we just published for qualified biomarkers. we create a very thorough, thoughtful set of on how to qualify a biomarker and we present it in that format to them. they were convinced we have a lot of cash and updated pieces put together to explain that it would be impossible that the marker is not correlated with disease activity in the patient and would not predict, as i said to them, and there is also the drug approval that made sense.
5:54 am
what they told us is that this is the only way you can do this study, that is what he said, the only way to do the study in the disease is of the urinary substrate measurement and there is other way to do it, so their view is this is the only way forward and we will accept your plan because we think it is reasonable to do given the rarity of this disease. i think that is the basic fact, at some point in the rule and regulation policy in the country, we have to make it practical realistic. otherwise, things will not get done. to say that i want a clinical driven and i went walking test than this test and that test, unit 100 patients or something to do this study and there are only 20 in the united states, you're basically saying that i igured out a way that we are never going to find the science for the patients to retreat and that we want them all to dive
5:55 am
rather than risk getting treated with a biomarker endpoint. that fundamentally is no one us been, so maybe you could touch on that as a. never going to find the science for the patients to retreat and would agree with that. that is sort of the ultimate outcome of that decision and that is what we need to change. i think there are ways to do this in a the way and we proposed them. some of the low group of industry, academic and foundation people, developed the criteria and wrote a paper on it. it is not trivial, it is not quick and dirty, it is there a, comprehensive, and the key thing is it does not require things that are impossible. there is little to require you to know the cardiovascular outcome in the disease that has less than 100 patients 10 years from now. you're never going to get that data. what about the data you do and how good is that? what the law said, and this is important to member, they had a piece on approval that said it was to include ways to qualify a biomarker endpoint by using pathological and pharmacological criteria were other types of data, in other words, outcome data, was impossible or impractical to
5:56 am
collect. so it really struck me that you are hearing your choices. you are not creating unrealistic and if possible barriers that will cause the disease is not to get treated. i think that is where the differences. you may see the practical and scientific side and i don't think that they did -- theft is a can of precedent and concerns. i think their concerns come from the fact that a couple of drugs and the harder area and circuits did not play on people were hurt by that. there are these big fancy cases of drugs in the big market area that did not play out. it is causing them to flinch and move away from diseases where we know a lot more about what is going on with a specific biomarker and the clear genetic condition. it is just not the same situation where biomarkers have failed in the past. we need to get over that
5:57 am
story. i love bob temple, he is a great guy, he keeps telling that story and needs to stop telling that story. needs to get on with, you know, new science and where we're going now which i think is much ore soundly based. >> when i introduced lynn, i neglected to mention that you are president of the national cessation of cancer research which is the most important academic society in cancer research and the country and she also worked at the national cancer and the national institute of health as a phd in molecular biology from the university of arizona. please, talk about and it is obvious points that you have been hearing. lynn: well, there are lots of ways that i could do that, but what occurs to me is that what we are duly saying is that the fda looks like one of those human resource departments that
5:58 am
you roll your eyes at that says, one-size-fits-all. you've got to do it, these are the standards, everybody has got to fit into these groups. you know -- and for those of you who have been in that position where you just say, come on, we have a mission here and there is something we need to complex and there needs to be some flexibility around, so i think for historical purposes, the fda has this one-size-fits-all. i am not -- not a real big government agency and in order to gain efficiency, everything has to fit in the individual little silos. i think that is what has to change. this idea that not all diseases are the same, they have a very important role in protecting our society. and protecting us around drugs that are out there that thousands and thousands of people take who are relatively healthy. blood pressure controlled
5:59 am
medicine, those types of things, that is a very different story than rare diseases or deadly cancers. it is that ability to be flexible enough and yet stick to the principals of some sort of scientific validation and overlaying exactly, as you are saying, emil, the principality of it. what is really required here. in a population that we are addressing, what is their risk tolerance? i confided that pancreatic cancer patients are, in general, much more willing to take risks with their treatment because what they are facing is really virtually certain death otherwise. it is overlaying all of that into the decision-making that goes into what is approved and what is the level of validation that we need for those biomarkers that seems to be the
6:00 am
-- roy: how good is the science or, lynn? a paper came out of johns hopkins, suggesting or indicating that sometimes when we do these profiles and a tumor in a particular patient that we are not actually getting good data because if you do not benchmark that to the baseline genetic profile of that patient, maybe you are not getting accurate information about how that tumor is distinctive. there is a lot of commentary out there that, ok, yes, it sounds great in theory to do this genomic work and biomarker work, but at the very basic analytical level, are we at the right level? are we mature enough with those analytical tools that we can actually say, ok, we are actually measuring accurately the genetic profile of the patient and being able to make the decisions on that basis? lynn: it comes down to don't throw the baby out with the bathwater. it comes down to the research component of it and the practical patient treatment

14 Views

info Stream Only

Uploaded by TV Archive on