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tv   Key Capitol Hill Hearings  CSPAN  March 28, 2015 4:00am-6:01am EDT

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t -- we got to make a difference. i'm blessed i have a great partner, but i also am blessed that because of the opportunities we've been afforded to to try to give back. thank you. to what happens to us, but we do choose what we do with it and you guys have made a really good choice and trying to be a beacon of hope the situation that can seem hopeless. senator kaine: i have learned one thing in life. you play the hand you are dealt with and you play to win. sender: -- senator. : tell me about how it's different or are we dealing -- is it the same medical condition as later onset or is it different in significant ways
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that we understand? >> early onset disease is defined by the age of onset, but we have learned in recent years that it is probably the same underlying disease process. having said that, a person who was affected with alzheimer's disease in his armor 50's versus somebody in the 80's may have different contributions to the clinical picture. they look the same. they are forgetful and they develop problems with thinking and activities with daily living, but in the older person, there is that tangles and some other pathologies and vascular disease. in the younger onset person, it is more likely to be a few are -- a pure form of the disease i think both of them are comparable.
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treatment that are likely to be used for onset early on can be used for later on. there might be a slight predilection toward a genetic as with most diseases. when they occur earlier in life they are more genetically noted that later in life. the biology of the disease is quite comparable with early onset and late onset. senator kaine: how about the caregiver side. we have folks representing organizations that do a lot of work with caregivers. i'm certain you have testified a good pick about recommendations a you might have for us. this year numbers of caregivers in my state and i am sure in all of our states are staggering. what are the kinds we have to be considering form a policy level to make caregiving test not an easy one but a little bit -- but lighten the load a little bit?
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ms. kimberly: thank you. i am here on behalf of many caregivers and there are many with different stories. many of the stories i have heard this week. they are all different. we share very similar things about. we share the same sorrow, the same and paying. we also share the same hope. -- we share the same pain. we also share the same hope and we will fight until we see the end. one of the things we are here and that we are collectively coming together as one faith is asking for what we need and we need the hope act to the past. we needed to be passed in this congress and we need it because it is going to improve care planning services for individuals like myself, for
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families, for those living with dementia. once they receive that diagnosis, they walk out of their doctors offices, receiving a diagnosis, and not knowing what the next steps are. that that alzheimer's disease will follow them and go with them wherever they live me take them, whether they then begin to develop diabetes or anything else. they will know that this doctor will know they have alzheimer's. there is an intricate need that i need to provide for this individual to give the best possible care that i can. and so we need this act to be passed in this congress. we needed now -- we needed it it now. my situation is different because i'm five, six years down the road. caregiving and care planning services did not happen for me
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exactly the way i would have wanted it to. but you can help a lot of other people. it can help millions of people and we need that help to make this vote easier because it is hard and we need help to carry this burden because we are carrying it the best what we can, but we are asking for help. senator kaine: thank you very much. and thank you madam chair. [applause] madam chair: senator tillis is on his way back and that means i can ask another question. my question is for both dr. peterson and dr. wierman. dr. weirman mentioned that you look at delirium as well. i am wondering if there is research that shows that do. in older people after surgery where a general anesthetic has
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been involved which i have seen cases of can be a trigger. i see dr. haut is nodding also so maybe i will start with them. is there a link? can that be a trigger about summers? -- cannot be a trigger for alzheimer's? is there a link when you see something in older people after an operation that involves a general anesthetic and dementia? dr. hodes: good point. the room can be succeeded or followed by decreasing the cognitive function and so also for general anesthesia, even if there is not delirium so that is after general anesthetics, there
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can be a short-term decline. most people recover fine, but the recovering quickly is also predicted of long-term. both of these insoles, whatever that means to the brain as a result of deep anesthesia or delirium, do seem to be capable of a celebrating that functional decline -- of accelerating the functional decline. madam chairman: dr. peterson? dr. peterson: if the brain is injured, how much resilience doesn't have to respond? sometimes people who are developing dementia and undergo anesthesia may have a lower threshold for becoming delirious in that context. it may contribute to the downward decline, but it also may just be a stress test on a system that is starting to gradually fail and consequently be a harbinger of what could be
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dementia in the future. difficult to figure out the effect there, but it is common. madam chair: dr. wierman, i have been discussing this issue with many anesthesiologists from maine med where you work and others on whether they should be doing more with older patients to be careful about what kind of anesthetic they use only use a general one if necessary could you illuminate us on this as well? dr. wierman i think it gets as to why we are here. we need more research. clinically, i certainly see people who are functioning quite well before surgery and that are not doing so well after. i think as we have more research now where we can identify there are changes happening before it is evident in day-to-day life. my suspicion is that it is those
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people that have a decline after and it is like a stress test you fail. that is how i thought of it as well. i just -- i think we just don't know. definitely an older population and in doing more assessment prior to major surgeries if it is a planned process so you can at least understand what the risks are going into it. so people can incorporate that into their decision-making. i think it is really important. as outlined, we need more research into what anesthesia is best and how to focus and do the right thing for them and not put them down this path that we can't stop. madam chairman: dr. peterson and dr. dodoshodos? dr. peterson: this is a hot
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topic with regard to bring resilience and cognitive function. and its role in the development of dementia. so it is a good question. madam chair: i was not aware of that. dr. hodes: an extremely good and important question. research directed at this actively now includes approaches into using eeg measurements of brain function during anesthesia with an attempt to monitor the lead -- the level of anesthetic with an eye toward brain activity and to look at the effect of that monitoring on cognitive outcome. that is one area where we could develop rather quick answers i can make a difference. madam chair: interesting. senator tillis, we are delighted you made the effort to come back. senator tillis: if i'm out of breath, i am. i was running back and i apologize i had a conflicting committee. i would like to thank the chair and their ranking for the leadership.
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i have been a caregiver. so i just want to let you know that we not only need to focus on the research -- excuse me -- the research, but we also need to make sure we have the right funding, madam chair, excuse me. to make sure the caregivers -- they have the resources and the education that they need to the best job they have because of my personal experience, i was the grandson of a grandmother who got alzheimer's at a relatively early age. i wasn't quite sure what i needed to do to help my grandmother, but i was pretty certain my mother and her two sisters were not doing it the right way and other family members, so that is why i went back and took some college courses to actually better prepared me to help my mother and my two aunts who were the primary caregivers to be a better caregiver.
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i am not going to ask you questions because i know you have been questioned to death and i will read that to the record, but i wanted to communicate, first, how important it is for something like this. another area where i have a lot of passion is around autism. this is a classic example of where i think the head and the heart meet because with the investment of resources, we do the right fiscal thing, but we determined this desperately to tremendous impact for those with alzheimer's. we need to invest in the right research and identify some of the most promising research. some i read earlier this week about potential promising treatments and they should we put those on the front burner because in a state like north carolina over the next 10 years i will see the population of 65 and over go up about 30%, those suffering from alzheimer's. in a state that is going increasingly large in age population.
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we do educate our members in the house and senate on the compelling fiscal reasons to do something that produces a transformational outcome. i want to thank you all for being here and i want to thank all the folks in purple. my. it would love this because it is her favorite color. i want to thank you all for being here and advocating and i encourage you to reach out and explain the transformational opportunity we have to make this a priority. thank you, madam chair. madam chair: thank you mr. senator. well said. we were talking earlier that will be spent $226 billion as a society on a disease that is going to bankrupt our medicare and medicaid programs that if the suffering of families and does not move you, the economics ought to move congress to do the investments that are necessary. and your focus on caregivers is absolutely appropriate, too. i want to thank our witness
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today for the extraordinary testimony. each of you has brought so much to the debate and discussion today. i think you have given us some very comprehensive look at a devastating disease. i want to assure you as the cochair of the alzheimer's task force in the senate, that i will continue to work with my colleagues like senator tillis and senator mccaskill to make sure we are keeping a focus on the disease. that we are educating our colleagues and that we are increasing the funding. we can't do it without your help . as i have said, i have an amendment that i will ask your help on the budget to have essentially get the senate on record for increasing the funding level that nih get for alzheimer's research.
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i hope as you do your office visits that you will urge your senators to support that amendment. you may not have time, but this afternoon, text messages work to. i want to thank all of you for traveling from all over the country to come to washington to tell your personal stories and to help advance the fight against alzheimer's. as we have said today, the color purple represents the alzheimer's movement. it is my hope that someday soon the color purple will also represent those who survive alzheimer's. [applause]
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madam chair: we will keep the hearing record open until friday, april 3. there may be additional testimony or questions for the record, but again, my sincere thanks to this wonderful panel and to all of the advocates who are here today. and everyone who participated in today's hearing, including my staff and senator mccaskill's staff, which has worked very hard and also shares a real commitment to the cause. this concludes the hearing. thank you for being here. [applause]
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>> next, fda commissioner dr. margaret hamburg, outlining the agencies, schmitz during her tenure. after that, the discussion on iran's nuclear program. live at 7:00 a.m., your calls and comments on "washington journal." >> barbara bush, daughter of george w. bush joins other governmental tonight to discuss issues that motivate their generation. they explore new ways so-called millennials are engaging in the communities. here is a portion of that at the roosevelt institute. barbara bush: i agree that there are problems with our generation. we are looking at new ways to do things and we are not
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necessarily trusting or in favor of the establishment are constitution. there is a research poll saying that our generation trust political institutions far less than generations before us. that can be really is concerning to folks. there has to be a change in the status quo in order to engage young people. think about this past election. a lot of folks talking about how millennial's did not turn out to vote, but we turned out in the same level of 2010. the problem is people do not hard to reach us. they were using old campaign tactics for a new generation by using old ways. i don't check my mail box, but if you were to contact me via text message, maybe i would see it. i think that is a weight we can engage millennials in a different way and that is not happening as much as it should be. >> the discussion with the adults concerning the issues with motivating their generation
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is tonight at 8:00 p.m. eastern on c-span. >> now, food and drug administration commissioner margaret hamburg at the national press co-op -- press club. she discusses regulatory science and the impact of globalization on drug products and the food supply. dr. hamburg recently announced her retirement from the agency as an expected to step down at the end of the month. dr. steven ostroff will serve as acting commissioner until a successor is named. this is one hour. >> good afternoon and welcome.
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my name is john hughes and i am an editor for bloomberg first word. that is our breaking news desk in washington. i'm the president of the national press club. the leading professional organization for journalists. we are committed to our profession's future through programs like this. we work for a free press worldwide. for more information about the club, visit our website to donate to programs, offer to our journalism's institute, visit on behalf of our members worldwide, i would like to welcome our speaker and those of you attending today's event. our head table includes guest of the speaker as well as working journalists who are club members. members of the public attend our lunches so it is not necessarily
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evidence that journalistic objectivity is lacking. i would also like to welcome our c-span and public radio audiences. in can follow the action on twitter using #npclunch. after our guest speaks, we will have a question and answer period. i will ask as many questions as time permits. it is time to introduce the head table. i ask each of our guests to stand briefly as names are announced. from the audience possibly as wright, dr. charles snyderman health and science correspondent for audiovisual news. health reporter or the gray sheet. paula dillow, president of politics low and associates and former executive of nasw preess. news editor at fears medical
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matthew perrone, health reporter for associated press. dr. beatrix hamburg, guest and mother of our speaker. jerry risky, chair of the npc and former national press club president. skipping over our speaker, doris margolis president of editorial associates health and science communication and the npc member who arranged the day's program. thank you, doris. dr. david hamburg, guest and father of our speaker. susan heavey, correspondent for writers news. sarah riordan biomedical research and policy reporter for nature magazine. anthony shot, a member of the national press club board of governors and chief strategy officer and cofounder for social drive. [applause]
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keeping consumers save when they take prescription drugs or eat food or use medical devices or consume tobacco products or wear cosmetics or get vaccinated. these are not small tasks. and these tasks fall to the food and drug administration. these products are important to consumers and to companies and the economy. so of course there can be controversy when the da plays the role of a referee. for instance, we have heard questions such as, our products safe enough? is the fda taking too long to approve a new drug or device? well, for nearly six years, dr.
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margaret hamburg has led the fda as its 21st commissioner. no surprise the agency has been the target of both criticism and commendation as it has touched a broad range of issues during dr. hamburg's leadership. for example, three years ago an outbreak of functional -- fungal meningitis traced to a pharmacy and resulted in criticism that the fda had not provided adequate oversight. on the other hand, the agency'ws accelerated process which has led drugs to the markets faster have been welcomed by patients and families, as well as the pharmaceutical industry. dr. hamburg is a graduate of harvard. she has a background in infectious disease bioterrorism, nero science neuropharmacology, and health policy.
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before her appointment as fda commissioner, she was the senior scientist at the nuclear threat initiative, a nonprofit dedicated to reducing the risk of nuclear chemical and biological weapons. dr. hamburg will retire next week as one of the longest serving commissioners in fda history. please give a warm national press club welcome to dr. margaret hamburg. [applause] commissioner hamburg: thank you. i am pleased to be here. i'm delighted to be joined by my parents and many of my friends and colleagues. this is probably my last formal address as commissioner.
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i thought it would be a nice opportunity for me to reflect a bit on what i have learned about this agency, and what i really want to communicate to you is how firmly i believe, now more than ever, that this is an agency that is absolutely essential to the lives and health of every american, every day. i think it's hard to overstate, really, the unique and vital importance of this agency for all of us. i confess i didn't arrive at the fda with a fully formed perspective. i said yes to the job a little early. i didn't appreciate the vast scope of fda until i was actually ensconced in the job. it still amazes me that the products that we regulate account for somewhere between $.20 and $.25 of every dollar the consumers spend in this country. the fda is responsible for promoting and protecting the public health by ensuring the safety, efficacy, and security
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of human and veterinary drugs, vaccines, biological products. medical devices, the safety of most of the food supply, the blood supply, and other tissue products, cosmetics, and products that emit radiation. most recently, fda is responsible for regulating the manufacturing marketing and distribution of tobacco products. some things might surprise you about some of the products that we regulate. ranging from things like bionic eyes and replacement body parts that are made by 3-d printers. to the use of medicinal leeches, that was one that surprised me. we oversee the safety of the food the dignitaries needs at government events, like the state of the union, i just learned last week that we are responsible for regulating the waste that is discarded from moving trains.
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so you can see that wherever you are, the fda is working for you. but is not just the diversity of the products that we oversee that someone might find surprising. it's the way that we bring our enormous expertise to bear. in this age of skepticism about government, it's easy to imagine fda regulators simply as bureaucrats focused on a narrow set of responsibilities. yet nothing could be farther from the truth. what a remarkable group of physicians, scientists, lawyers, policy analysts, and other professionals and support staff committed to helping people get the products that they need and count on. i am so happy that some of those fda employees are here with us today. i also was really very struck by the fact that fda employees do far more than just use their knowledge and expertise to review applications or investigate safety concerns.
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they also undertake vital research to advance medical product innovation and improve food safety. for example, scientists made a crucial contribution to the meningitis vaccine by developing a needed conjugation technology. this vaccine has now protected more than 217 million people from what was a deadly killer across the so-called meningitis belt in sub-saharan africa. fda's food scientists help develop sophisticated genome sequencing technologies to more rapidly identify and stop foodborne outbreaks. during the gulf oil spill, i was surprised but very grateful when another team of fda scientists developed a new laboratory technique that significantly accelerated the testing process that was necessary for detecting certain oil related chemicals in
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the seafood itself. that enabled the fda and the state to open up the gulf waters to fishing much more rapidly, it also meant that the rather agitated congressional gulf delegation stopped calling me all the time. [laughter] commissioner hamburg so that was : really a worthy undertaking. it was also a surprise to me as the commissioner that during that time, i was ordered by the white house twice to go to new orleans and and eat seafood it to show that it was safe. there are some hardship duties in this job. [laughter] commissioner hamburg: i want to focus on a few key issues today, issues that i have really been intent to work on since i began, and i believe have really made an important difference in strengthening and reaffirming fda's critical role in american society. i think that most would probably
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agree that i came to fda at a time when the agency faced considerable difficulties and uncertainties. a series of visible foodborne outbreaks that resulted in disease, nationwide anxiety, and economic disruption. several drug safety crises had eroded public confidence. at the same time, fda was facing serious threats, budgets were tightening with economic crisis. a chronic underfunding had already stretched the agency thin in many critical areas and jeopardized our ability to keep up with inspectional demand, product reviews, and the evolving science and cutting-edge biomedical products, at the very time that scientific and technological discoveries were revolutionizing medical products. fda's challenges were exacerbated by the increasingly global marketplace for the products that we regulate. the imports of fda related products were growing
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dramatically. there was a series of serious episodes associated with adulterated products coming from overseas, most notably the imports from china obtained -- of tainted heffron, and the melamine laced dairy products and pet foods that cause deaths and serious illness. these effects, and a constant negative drumbeat from our friends in the media combined with the congressional criticism took a toll. , public trust was flagging. it was clear there was so much good work going on. as i took stock of the agency, its vast responsibilities and it's enormously talented and committed workforce, it was clear that fda was at a crossroads. decisions made then would matter in fundamental ways and for a very long time. if fda was truly to fill its mission in the modern era, this was a critical time to reposition in several fairly fundamental ways. to do this, i focused on three priority areas.
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increasing public engagement accountability, and partnership, reinvigorating our scientific base by advancing regulatory science, and underscoring the need for science-based decision-making, and scientific integrity as the foundation for all that we do. lastly, addressing the challenges of globalization, and it's huge implications for health, safety, and security in the products we regulate. six years later, thanks to an extraordinary leadership team at the fda and all of the dedicated employees, i think we've seen enormous progress and really important advances. we renewed, expanded, and refined our mission and activities, in important and powerful ways. notably as well, congress has given us important new authorities to regulate cigarettes and other tobacco products, to transform our nation's food safety system with
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a new focus on prevention, and to use more flexible and streamlined approach is bring exciting new medical products to patients in record time. to be effective, fda must do its vital work with input from stakeholders and with the trust and confidence of the public. that is why it was imperative to increase transparency, enhance stakeholder engagement, and strengthen partnerships across sectors, disciplines, and components of government. i really think we have. soon after i arrived at fda, we launched an agencywide effort to make useful, understandable information about the fda more readily available to our stakeholders. this transparency initiative brought greater clarity and understanding as to what we do how we do it, and why for the general public, for industry for patient and consumer groups, and for other key stakeholders. we also worked to increase collaborative efforts, including establishing many important public private partnerships.
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we enhance our communications, including listening sessions leaders, experts, and advocates seeking ideas and feedback as well as a focus on patient centered medicine. which involves holding dozens of public meeting with patient advocacy groups for input on specific diseases. with stronger stakeholder engagement, there has been much better information sharing, more predictability and ultimately a , better process and product for the people we serve. my second priority, science, really builds on and reinforces the efforts just mentioned. as a science-based revelatory agency, our credibility and success depends on our ability to deliver on the promise of science through smart, data-driven decisions that benefit patients and consumers. smart regulation also requires the ability to respond to changing situations, new information, and new challenges. we cannot have a
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one-size-fits-all approach, but we always must bring the best science to bear. it requires that we advance regulatory science. the knowledge and tools necessary for the meaningful and timely review of products for safety, efficacy, quality, and performance. and it to a form a -- and to inform a more efficient product of element process as well. building on greater understanding of the underlying mechanisms of disease and human biology, a robust field of migratory science can help us leverage opportunities for innovation and more quickly bridge the gap between scientific discovery in the real-world products that will make a difference in people's lives. advancing regulatory science has been a huge priority, not just within the walls of fda, but as an active, dynamic field of scientific research, we are continually working to find new and better ways of doing things. to seize the opportunities of
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existing science and technology, and to work with industry and our scientific partners in academia and government in a collaborative way to discover and apply new regulatory tools. but what does this really mean? in the food area using regulatory science we've taken , critical actions that will improve the safety of food americans consume for years to come. importantly, the development of science-based standards to create a food safety system focus on preventing foodborne illness has been key, thanks to the passage of the food safety modernization act as well as new tools to help us in the detection and rapid response to outbreaks, as i mentioned earlier. we've taken significant steps to make americans make more informed and helpful food choices, including working to reduce trans fats in processed foods, more clearly defining when baked goods and other foods
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can be labeled gluten-free updating nutrition labels based on current science, and finalizing the rules to make calorie information available on chain restaurant menus and vending machines. some of you may be asking where is the science there? believe me, and my deputy for foods knows these areas are , based on sound and current nutrition science, and involve some very complicated analyses. turning now to the medical product domain, we are pursuing such things as enhancing the use of pharmaceuticals and qualified biomarkers, developing innovative critical trial designs which enable clinical studies to be more effective. and to effectively mine large databases to learn more about the issues. as well as such things as how can we identify populations of
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responders to a given treatment based on certain indicators. these efforts matter in our ability to swiftly and shortly -- and surely review product applications that come before us. they are also essential for reducing the time and cost and increasing the likelihood of success in the product development process itself. in the ecosystem for biomedical product development, fda plays a critical role. because we more fully understand what it takes to translate a good idea into a product with demonstrated safety, efficacy, and quality. and a product that can be scaled up and reliably manufactured. simply waiting until we see what comes through our doors cannot be the going model. fda is uniquely situated to examine important unmet medical and public health needs, and how they match up with what's actually in the development
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pipeline. indeed, a growing part of our focus in recent years has been to try and identify what is in the development pipeline provide guidance and incentives to address gaps and to accelerate progress, and to foster the kind of innovation that will make a real difference for patients. also, we've seen how early in continuing engagement between the fda and researchers in the product development plan makes a huge difference in streamlining the process and making sure that the right questions get asked and answered from the very beginning. as you may know, we have now in place a number of expedited review programs that help to speed the development and availability of medical products that treat serious diseases. for prescription drugs, we have fast-track, priority review, accelerated approval, and now thanks to recent legislation, we have the breakthrough therapy designation. we are seeing both development
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and review times increased -- decreased significantly with exciting new therapies entering the marketplace much sooner for the patients who need them. last year, we approved the most new drugs in almost 20 years. and more orphan drugs than ever before. 41% of these new drugs were first in class products, resulting in a breathtaking array of truly innovative new therapies for patients, and the majority of these new drugs were approved using some kind of expedited pathway. today, contrary to what many would say, fda approved drugs faster on average than all other advanced nations, and the vast majority of the time, the u.s. is the first country in the world to approve important and novel medicines. and substantial improvements are being made in the efficiency of medical devices used as well. -- device reviews as well.
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moreover, we have accomplished this while remaining the world's gold standard for safety and effectiveness. yet we all recognize that despite the successes, too many diseases still await treatments and cures. serious public health needs, such as treatments for alzheimer disease are not being met. in response, people suggest that fda's authority and procedures be fundamentally reconsidered. i strongly disagree. in actuality, regulation, when done right, is not a roadblock. it's the actual pathway to achieve meaningful and lasting innovation. smart, science-based regulation instills consumer confidence in products and treatments, it levels the playing field for businesses. it decreases the threat of litigation. it prevents recalls that threaten industry reputation and consumer trust.
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not to mention levying huge preventable costs on individual companies and in fact, entire industries. and it spurs industry to excellence. the fact is, when done right smart regulation allows us to deliver on the promise of science in the service of patients, consumers, and yes even industry. it is foolish and dangerous to believe that reducing regulatory standards will make new treatment intervention appear if the science is not there. alzheimer's disease is a good example. i've heard comments that something must be wrong at fda because we are not approving as many drugs for alzheimer's disease as we are as cancer. and we certainly are not doing it as quickly. the reality is not the problem of unnecessary hurdles, but rather for the need of medical research to increase our understanding of the underlying disease process, and natural
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history of the disease, and where are the best targets for therapeutic development. we are working closely with the alzheimer's research community groups to do everything we can. i hope that in fact we will see meaningful progress soon. of course, there are sometimes tensions between moving new, potentially promising products quickly out into the marketplace and making sure that they have adequately studied. as fda commissioner, i have been surprised by how many people ask whether i favor safety or innovation. in fact, mi confirmation hearing, now quite a while back, i was really, i guess a bit of an unknown commodity to both the consumer and patient groups, and industry. they were trying to figure out what perspective i would bring to this new position.
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i was surprised to learn that someone supposedly went through and counted how many times during the course of the hearing i said safety and how many times i said innovation. this was supposed to be a measure of whether i was going to be consumer friendly, or industry friendly. i'm told it was actually about equal. i never went back to actually check. i certainly don't believe that the two are mutually exclusive. why should we have to choose protecting the public health while encouraging, not discouraging, innovation must be the goal? for us at fda, it is. innovation is only meaningful as it makes a real difference, a positive difference in the lives of patients and consumers. that's why we must have standards and science to assess the benefit and risks. when it comes to the treatment of disease, we must understand the broader context of use, the
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nature of that specific disease or condition, the other treatment options, and such things. we must also better understand the patient's experience of the disease and its treatment, their perception of the risks and benefits, and of course, their willingness to accept risk. the balancing of risks and benefits is absolutely fundamental to the fda's role. it's always a challenge. we joke at the fda that we have only two approval speeds, too fast and too slow. we are perceived to approve -- we are perceived as too quick to approve a drug or device when a significant safety is identified once the product is in widespread use. on the other hand, we are to o slow when a drug that has undergone a lengthy development and review is finally approved and provide the real therapeutic benefits. it's a hard task, but the challenge for fda scientists is to strike the right regulatory
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balance. i also want to speak briefly about the importance of striking the right balance between fact access and good science. in a race for the newest treatment, we must remember that innovation doesn't matter if the product doesn't work. i can't emphasize enough the critical need to maintain the standards of safety and effectiveness for medical products in this country. it wasn't that long ago that companies were allowed to market drugs without proving that they were effective. we've only got to look back at that time to see the devastating consequences for patients and for medicine. drugs were marketed for thousands of unproven uses. most of them unsupported by adequate research. -- inadequate research. in the mid-1950's, congress gave fda authority to require
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evidence of effectiveness, i 80% of the drug uses the companies were promoting turned out to be ineffective. many of them were also dangerous for example, before companies , had to show that their drugs worked, drug companies widely promoted powerful toxic antipsychotics like thorazine for low-level anxiety. and there was little or no incentive to conduct those research is necessary to find out what were true medical advances. most promotion was based on unscientific studies, or no studies at all. it's important, i think, to understand that fda strongly supports responsible to -- responsible communication of scientific information. but we do not support an approach that will harm patients or undercut the incentives for the necessary studies to be done to prove that a specific use of a drug product is both safe and effective. history has shown that patients have been harmed from physician
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reliance on preliminary or incomplete scientific information regarding unproven uses. history has also shown the enormous patient benefits that results when i sponsor conducts rigorous clinical studies and demonstrates that a promising medical products is in fact safe and effective in treating a serious disease or condition. fda's objectives, to strike the right balance between respecting the usefulness of communicating scientific data in certain circumstances on the one hand, and preventing harm to the public on the other. we must not forget that the great leaps forward with evidence-based methods after a series of disasters involving unsafe and ineffective medical products. those standards have boosted the confidence that americans place on medical products, the world places on the american medical
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byproduct industry. we must move forward, not backward as a nation. and embrace the opportunities of cutting-edge medical advances and the promises they hold for public health. i want to talk about one other important issue, it's been a priority, globalization. when fda was first established our regulated industries were predominantly local and the volume of imported products was very low. today, however, other nations increasingly produce in whole or in part, the food and medical products that american consumers and patients use in their daily lives. nearly 40% of finish drugs americans consume today are made elsewhere, and 80% of the active pharmaceuticals in those drugs are manufactured outside our borders. for the food supply, the numbers are equally startling. more than 85% of seafood that
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is eaten here comes from other countries. about 50% of our fresh food and 20% of our fresh vegetables, and these changing dynamics obviously introduce new complexities, new risks for american consumers, as these products follow increasingly complex global supply chains to get to your table. and your kitchen cupboard. we can no longer rely on simple inspections at the border to track the products that are coming through. the volume has quadrupled over the last decade. we have introduced new high-tech risk-based screening systems of the borders to allow us to target on the most vulnerable commodities, the ones with the highest risk. we really have to step beyond our borders to the places where these products are being manufactured. processed, distributed. that has caused us to have to undertake a whole new shift in how we do business.
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we now have foreign outposts around the world to be a hub for inspections and for collaboration. with industry counterpart regulators, and other stakeholders. we are working closely with counterpart regulatory authorities to harmonize standards, to share information, and in fact, to share the workload of inspections and assessments. of the products that we are all struggling to regulate in a globalized world. we are working together with other organizations, and nations, to try and actually build regulatory capacity in many of these countries with very immature systems, but where an increasing volume of products are coming. and being consumed by americans who expect the same standards in the products they are taking wherever they had come from in the world. so that has been a major focus of time and attention.
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i think it represents a huge and underrecognized area that challenges health safety and security in our nation. so i think that, though i got lots more that i want to talk about, i think that i have gotten the indication that i ought to be winding down. so with that, let me just make a couple of points. one is that fda is a unique and essential agency. that has a set of roles and responsibilities that are not done by anyone else. if we can't do her job and do it -- do our job and do it well, there is nobody else to backstop behind it. moreover, we are regulating products that are so important to each and every one of us every day and to the health of our nation, our nation's economy, and in fact, our global economic competitiveness.
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as i look forward, i worry, fda has constantly been underfunded with responsibilities that outstrip the resources we get to do our job. if you look at what cost every american in this country to support the services of fda, believe it or not, it's eight dollars for americans for a year. i suspect some of you may spend more than that starbucks later this afternoon, and yes, we regulate starbucks. [laughter] commissioner hamburg as i stand : here, not only concluding my remarks, but concluding my tenure very soon as fda commissioner, i really am proud to be able to tell you that fda is a stronger, more engaged, more effective agency, better positioned for the challenges of the 21st century. we are an organization that embraces smart science driven regulation, we are an
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organization that understands in the modern world the importance of partnership, we have a wonderful mission and an extraordinary group of employees. we have the challenges before us, and we do need your help and support so, while i will not be present any longer, i do want to leave you with this fact that the fda as a public health agency essential to the health of all of you, we need to strengthen it, rather than we can or undermine it. and to do so will require support and partnership of all of our stakeholders, and every american who uses fda regulate products is a stakeholder. i look forward to watching that vital collaboration amongst all of the stakeholders, just seeing the work of this relatively small in size, but truly mighty
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in purpose agency, be both appreciated and supported. thank you. [applause] moderator: thank you dr. hamburg. you mention striking the right balance. when it comes to approval of products and devices, and from the experience of your tenure what percentage of the time would you say that fda got it right, and what percentage of the time did you realize that we didn't do our job there, and maybe we should not have let that one out? commissioner hamburg: that is a very hard question to answer and to quantify would be dangerous task. one of the things that's important to understand is that we are always having to make
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decisions with partial information. because when you are doing the study before it drugs actually approved, you can learn a lot. and if the drug really works and really reflects a good match between the target of the drug and the underlying mechanism of the disease, you will know it quickly as the decision would be obvious. with many things that don't work quite as well, it would be almost impossible to know everything about the drug. and even the things that actually are extremely effective, you still can't know everything about them. in the context of a preapproval developments. it's when they go out into the marketplace and they are used by many more people and are used by people with other coexisting diseases and taking other medications etc.
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that you begin to learn a whole lot more. that's why fda has a lifespan approach to the regulation of drugs. we continue to monitor drugs after they have been approved, both through what we call post-market surveillance and sometimes by requiring those post-market studies to collect more information. in my view, people are quick to jump on us if a safety issue emerges, in the post-market setting. they think it's a failure of the system, someone had to admit a -- someone had made a mistake, but i think we know that everything has risks, and that the nature of the process is that some of those risks will emerge when many more people are taking the drug, and it's more complex settings. so i think that when we can detect it early, and make the determination about how to address it, whether we need to change the indications for use whether we need to actually recall it from the market, or
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whether we need to provide additional warnings, all of those things are possible. and all of those things are part of the comprehensive regulatory process. moderator: you mention several things that you are proud of about the agency, what would you consider the number one contribution that you have been able to make to public health in your tenure? what is the one thing he would talk about couple years down the road when you're talking about your service, that one thing you are most excited about. commissioner hamburg: that's an impossible question, number one. there many things in many different arenas given the scope of our responsibilities, it's unfair to even ask. [laughter] you think about the many different ways that you can answer the question also. if you mean in terms of potential impact on burden of
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disease, i would say we hadn't realize the potential yet. but the new authority we had to regulate tobacco clearly is historic and transformative. tobacco products remain the leading cause of preventable death in the country. and frankly around the world. and with the new tools we have over time, we will be able to make a profound impact on health and well-being in this country. and as regulatory authority, a fairly unique regulatory responsibility over tobacco, we also i think are showing the way for many other countries around the world. and the global burden of tobacco-related disease. moderator: a couple of different questions on what you think of the 21st century cures initiative in congress to overhaul health care industry regulations? commissioner hamburg: i think we all can agree that this is a critical time to really look at
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what can be done to really leverage the opportunities in science and technology today to ensure that we are developing the safest, best, most innovative and effective medical products for people who need them. that's the goal of 21st century cures. we are sort of in a golden age for this undertaking. we want to make sure that all of the parts of the biomedical products ecosystem are aligned towards that goal. i do think it needs to be approached in a very thoughtful and careful way. because many of the things that need to be done perhaps are not best achieved through legislation.
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i think for us, there certainly concerns about issues that i touched on in my remarks, of the misperception that you might be able to speed innovation by lowering standards for safety and efficacy. we think that would be a terrible mistake and ultimately would not just damage patients but would damage industry as well. we also are concerned that through this process, we might be given what we call in washington unfunded mandates, or we would be asked to take on a set of new tasks, but there wouldn't be adequate resources to go with it. that i think would not only be difficult for that specific activity, but would have ripple effects on other important regulatory activities are really matter to patients and consumers. moderator: what if any steps is
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fda taking to ensure truth in labeling of nutrition in vitamins and nutritional supplements given recent findings on walmart shelves? commissioner hamburg: we have authority to regulate dietary supplements in a limited set of activities. many people in this country think that the fda regulates dietary supplements in the same way that we regulate prescription drugs, there's a preapproval process. but we do not. we oversee and have the authority to ensure good manufacturing practices at their plants, there's a requirement that they report serious adverse events to us, and we do regulate
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claims that they make, and when we find a product that has unapproved drugs, for example, that shouldn't be there, steroid or a viagra like compound, the frequency show up in dietary supplements. then we will take action. i'm not familiar with the specific walmart case, i will have to defer. moderator: there have been concerned that the medical device approval process is too lax. how do you feel about the process now, and have you felt political pressure to accelerate product approvals, and what changes need to happen to that product approval process? commissioner hamburg: medical devices have a different regulatory pathway than drugs. for some of the points i was talking about, in terms of the different perspectives that people have on fda, too fast or too slow, too lax or too stringent, applies with medical devices. the majority of medical devices that fda oversees are what are
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called 5-10 kay's, not the highest risk devices with the middle category of devices. there are very limited requirements for new data to be generated as a part of that approval process. you need to demonstrate that your product is similar to an existing product in the marketplace, using a predicate mechanism and some people find that just totally lax and inadequate. to assess a changing device array over time. others think it's more than enough, they would like to see even the standard that currently exists relaxed a bit. it's one i have been fascinated with during my tenure as commissioner to see the differing responses and i think that we need to continue to look at how we regulate devices
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because the world of devices is getting increasingly complex on one end and then there's a set of other devices that really don't need much attention. i think this is an area where i don't know that the u.s. has gotten it completely right, i do not know that the european union has gotten it completely right i think it's an area that we need to continue to learn more about and i think that we are encouraged by some of the activities, partly through public-private partnerships that have developed, to look at innovative strategies to do research that's necessary to better assess devices through a
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recent new requirement for unique device identifiers on devices, so we would be able to track devices and their use in the post-market setting more efficiently. and learn a lot more about risks and benefits. i think it's a dynamic area. moderator: had a few questions come in on the relationship between the agency and those it regulates. this questioner says that within the ranks of the fda, there are many scientists and administrators who have served at the agency for decades, and one of the criticisms is that the leaders become too cozy with industry after working for years with the same officials, while fda obviously strives to retain its best staffers, is the risk that staffers can overstay their welcome and this problem creeps in? commissioner hamburg: again, this is one of those areas where different people have very
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different perspectives. some people believe that there are lifers at the fda that have no use for industry, and are always skeptical. and then there are others who worry about the issue you were describing. what i would say is my experience at the fda, which is now almost six years, is that the employees who work there have just remarkable commitment to their jobs, and the highest integrity, scientific and personal integrity, we obviously operate in a framework where there are very clear conflict of interest rules. very clear requirements about how certain kinds of interactions are structured, and i think that we need to work in partnership with industry because we are regulating the product that they make, and we need to understand those products.
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we need to have a full and open exchange of information. in many instances, there is great value in having industry academia, and government actually work together in shaping research in critical areas. i think people sometimes get worried about that. but we do it in a way that clearly defines us as free -- pre-competitive research, not a collaboration where there is a particular product that's being developed where an fda scientist might be working in the partnership. but it's where information is being developed that can be applied across a whole category of products and help us to advance our knowledge and
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develop the regulatory tools that are needed to advance our ability to do adequate and full reviews of the products. and to enhance product development. moderator: you have been a champion of advocating sodium reduction. the majority of your statements reference blood pressure benefits of lower sodium consumption. however, some recent studies cited by this questioner including one by the iom have suggested that low sodium consumption for healthy individuals can lead to significant health problems. another article found that for healthy people, there is no or very minimal blood pressure impact from sodium reduction. the questioner is saying that the agency needs to reevaluate what it says on sodium and is there any examination of shifting the view? commissioner hamburg: this has
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been a topic of ongoing discussion, i think that clearly there have been some recent studies that have raised some questions, there have been individuals who have obviously been representing that position over time. i think the body of evidence does really demonstrate a linkage between sodium in the diet and negative health consequences. and that americans' diets on average contain a very large amount of sodium. most of that sodium is in processed foods where we as
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individual consumers really can't control our exposures in terms of what is in that food, it's not the salt shaker where you can control it, it's what you are eating. so we feel that we are providing very important information to consumers through things like the nutrition facts label, which enables you to know what is in the product that you are eating. and we do things that there is clearly, a very positive health benefit by trying to bring down sodium levels in the american public. moderator: got a couple of questions on biosimilars. i will try to combine them because we are running short on time. one questioner wants to know how
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you envision this new area of copycat versions of biotechnology drugs playing out in the u.s. marketplace, the other wants to know if devices such as generics in biosimilars may actually discourage the development of lower-cost options for the public? commissioner hamburg: bio similars are biological molecules that are similar to existing biological therapeutics that are innovative drugs in the marketplace. they have a parallel relationship to generic drugs and innovative drugs. they are much more complicated molecules in terms of their size and how you make them. in the human response to them. it's a much more complex process than just generic chemical tablets. we've only just recently approved our first bio similar which was an exciting event for us. the pathway for bio similars actually is relatively new at the fda. it was part of the health care reform act, the aca actually.
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one of a few things for fda that was embedded in that larger piece of legislation. we imagine that these drugs will be available to the public at much lower cost than the innovative biologics, which are very, very important drugs in medical practice, they make huge difference in the lives of many patients, but very very costly. it remains to be seen whether some of the most optimistic estimates of cost savings will really be true, but if we can help make important therapeutics available in a more accessible way, i think overall in terms of the american health care system, that would be a huge benefit and the fda role is to assure that these bio similars can be used in these patients in a manner that is safe and effective. moderator: could you update us on the current listeria problem? we are interested in any specific foods or brands involved in recalls.
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commissioner hamburg: we have a couple of listeria problems. we have listeria in bluebell creamery ice cream, which in resulted in several deaths in a kansas hospital. and there was a listeria outbreak in spinach but when companies did a voluntary recall after finding listeria. i don't know that there's much more it i can say other than it's a powerful reminder that foodborne illness is very real in this country, and it can be low-grade, where you get sick and have a few days off from work, one in six americans suffer from foodborne illness every year. but it also does results in many, many hospitalizations and deaths each year in this country. we are in the midst of implement
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ing the food safety modernization act, which is a historic opportunity to transform our food safety system from one that is reactive, where you respond after outbreak occurs, to one that puts the emphasis on prevention, and understanding where the points of vulnerability in the lifespan of the product are, and how can you shore up those risks so we can prevent problems from occurring in the first place. i hope that we will come as we implement the food safety modernization act, be able to report fewer listeria and other foodborne illnesses, but in the meantime, i think one of the other things that striking about listeria outbreak so we've been seeing is that we are seeing listeria in certain food products where we hadn't seen it before. so it also is a reminder that microbes can be unpredictable, they can take up new homes, and
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that we have to always come back to the best strategies for food handling and hygiene, and the implementation of the food safety modernization act to prevent problems from occurring. moderator: i will ask you one more question. i wanted to remind our audience of our upcoming speakers. on tuesday, the irs comissioner will speak to us. on april 7, a best-selling author and outspoken critic of radical islam will address a luncheon. on april 16, ban ki-moon secretary general of the united nations will speak. second, i would like to present you with your national press club mug, which is perfect for enjoying fda approved liquids in. [laughter] commissioner hamburg: we do regulate some forms of ceramics as well. [laughter]
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moderator: wouldn't you know it. the final question, dr. hamburg, you were named one of the world's 100 most powerful women by forbes in 2014. what do you think our country can do to encourage more young women to pursue careers in science, technology, engineering, and math? in other words, to follow in your own footsteps. you have less than two minutes to answer. commissioner hamburg: i think it's really important, we need to start early, we need to have exciting, engaged, knowledgeable teachers in our children's schools. have to help with mentoring, career pathways, and we have to make sure that there are good jobs for women at the fda. we have a very strong representation of women in our scientific and leadership teams. i have been proud to be at the helm. moderator: ladies and gentlemen, join me in thanking dr.
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margaret hamburg. [applause] moderator: i would also like to thank the national press club staff, including its journalism institute and broadcast center for organizing today's event. if you would like a copy of today's program, or to learn more about the national press club, go to our website, thank you very much. we're adjourned. [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. visit] [captions copyright national cable satellite corp. 2015]
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>> some of our future programs this weekend on the c-span networks. on book tv, peter wallace and says that government housing policies caused the 2008 financial crisis and could happen again. sunday afternoon at 5:00 p.m., the director of the earth institute on a development plan to tackle global issues. and on c-span3, a discussion on the last speeches by abraham lincoln and martin luther king jr. find out the television schedule at let us know what you thinking -- think about the
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programming we are showing. during the season conversation -- joining the c-span conversation. senate minority leader harry reid has announced he will not run for reelection. he said he do not want to soak up campaign resources when he could be focusing on putting democrats back in power. he has two more years in his current term. in exercising accident has left him struggling to regain sight in his right eye. it has given him time to think. here is his statement. senator reid: these bruises i have on my face are an inconvenience, but they are nothing compared to some of the bruises i got when i was fighting in the ring.
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when i was a boy, i dreamed of being an athlete. i listened to those games on the radio, baseball games, and i envisioned me as a man out in center field in yankee stadium or fenway park in boston, but the joy i've gotten with the work that i've done to the people of the state of nevada have been just as the filling as if i had played center field at yankee stadium. the job of minority leader, and the united states senate and is just a support as being majority leader. it gives you so much opportunity to good things for this country and that's what i am focused on. but this accident has caused us for the first time to have a little downtime. i have had time to ponder and to think. we've got to be more concerned about the country, the senate, the state of nevada, than us. and as a result of that, i am not going to run for reelection. my friend senator mcconnell, don't be too elated.
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i am going to be here for 22 months, and you know what i'm going to be doing? the same thing i've done since i first came to the senate. we have to make sure that the democrats take control of the senate again. and i feel it is inappropriate for me to soak up all those resources on me and i can be devoting those resources to the caucus, and that's what i intend to do. the decision that i've made has absolutely nothing to do with my injury. it has nothing to do with my being minority leader, and it certainly has nothing to do with my ability to be reelected because the path to reelection is much easier than it probably has been for anytime i have run for reelection. mrs. reid: i get a little upset sometimes when i hear politicians say that they're going to go and spend time with their family after they decide
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that they are not going to be in politics anymore. he's a wonderful husband and a wonderful father. so that's been more important than the other things that he's done with his life. senator reid: someone with my background, my upbringing, to have the experience i've had is really a miracle, i want people in the state of nevada to know that i am so grateful, and i have done my best. i haven't been perfect but it really tried my hardest to represent the people of the state of nevada. ♪
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>> with tle years left in his term, he said he was endorsing new york senator chuck schumer to succeed him. he issued a statement saying in part i think harry reid for his friendship to my counsel, and steadfast leadership of our caucus over the last 10 years. i look forward to our caucus continuing to fight for the middle class. president obama had this to say about the announcement --during
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my time in office harry has become not only an ally, but a friend. i'm out of all we have accomplished together, and it of the same without him. majority leader mitch mcconnell issued a statement saying he has gone through many challenges and they make him a formidable opponent today. >> this sunday, eric larson on his new book that way, the last crossing of the lusitania. >> the story gets complicated when the western arises as to what ultimately happened to the lusitania. why was the lusitania allowed to enter the irish sea without escort? without the kind of detail that could have been provided to captain william thomas turner, but was not? this has led to some interesting speculation as to if it was
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essentially set up by attack for someone in the admiralty. i found no smoking memo, and i would have found it if it existed. there is nothing from church role -- churchill to anyone else saying let's let the lusitania go into the irish did because we wanted to get sunk. nothing like that exists. >> sunday night on c-span q&a. >> next, and negotiation about iran's nuclear program. after that, your calls and comments on washington journal. >> now a discussion on how iran and other politics collide.
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here is a portion of their remarks. >> hi, i am jacob, the editor of the national interest magazine and i am moderating today on behalf of the center of national interest, which hss invited that -- has invited two guests to
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speak about iran and american politics. on my right is david rothkopf, the ceo and editor of foreign policy magazine and managing director of kissinger associates and has held several high-level positions in the clinton and administration and is also the author of several books on international relations. to my left, dov zakheim, a longtime friend and also the vice president of the center of national interest -- vice chairman. he is also the comptroller at the pentagon during the george w. bush administration and is the author of a quite provocative memoir about his years at the pentagon, called, "vulcan's tale." dealing with how he believes the administration mismanaged for policy in afghanistan -- foreign policy afghanistan. and today, we will talk about iran, it could hardly be more timely.
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the middle east is always in ferment. today, defense department officials were quoted in the wall street journal asking, "who is going to be the person who shoots the archduke of the middle east, igniting a new world war one." with negotiations in geneva and the events in yemen, i think it is hardly a better time to discuss the role that the middle east and iran are playing in american politics. i will go to david first. david rothkopf: thank you, it is a pleasure to be here. the observation i have heard most frequently since i arrived, that the center of national
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interest has the best lunch of any place in town. i have to agree with that. i do also want to make a brief side comment, before i dive in. several weeks ago, i made a pledge not to appear on any panels that did not include women. unfortunately, i see that there is not one woman at this table. i think we can do a lot to enrich -- well, yes. it is true. move closer to the table. i hope you are not diminishing my point, which is, i think there must be more women out there interested in this subject to enrich the conversation. in any event, you know, i think it is apposite in a discussion of it is apposite in a discussion of the middle east that we focus on iran, because it is central to the situation.
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before we get into the iranian facts, we should jump off of jacob's point a moment ago there has never been a situation in our lifetime, such as that that we see in the middle east right now. every single country in the region is involved in a military conflict, with the exception of one. every single country. the analogy to the balkans is not over the top. it may not turn into world war but we already see it fueling unrest in africa and parts of asia. we already know it has potential conflict or consequences for
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extremism and terror attacks in europe and north america. clearly has global consequences economically. it is clear, we cannot afford to walk away from it and i think that our impulse and the impulses of some administrations to do that is a contributing factor to problems we have here. but since the topic is iran and american politics, i want to zero in on that and then we can open it back to the rest of the region. during the 2008 presidential election, when barack obama was trying to differentiate himself from hillary clinton, in a debate when he said the approach ought to be engagement, the questioner he faced said, with whom would you engage? his first reaction was iran. in fact, hillary clinton responded with some skepticism. i do not believe that our
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interaction with iran over the course of the ensuing six years is therefore an accident. if you look at the chaos that followed in the wake of the arab spring and the changes that have come to the middle east, one country has benefited. that is iran. iran has benefited with greater influence in the yemen, with greater influence in iraq, by very considerable amounts, it has benefited in syria, with its man assad now looking likely to outlast obama in office. it clearly looks to benefit from the upcoming nuclear deals, in some important ways, in terms of sanctions relief and increased stature.
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at the same time, i think one cannot help but objectively conclude that u.s. relations with virtually every key ally we have in the region have deteriorated and the only country with which there has been a substantial improvement or potential for improvement, or thawing with our relations, is iran. not only is it that the case but our allies who feel shunned aside or neglected or distrustful, feel that way for a reason. we did not respond to their concerns about growing problems
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in syria. they feel that way because they saw us embrace too quickly the more regime, not criticize it in egypt and embrace too slowly the possibility of the cc era in egypt and what it meant. while egypt is the anchor in the arab world. our relationship with israel is at its worst, in terms of the leader to leader relationship. and our relationship with golf
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ulf states who feel we have been in the midst of a slow -- with iran, even as they have had growing concerns, has also deteriorated. although everyone is trying to put a brave face on it. this situation does not look like it will improve, despite some optical sleight of hand this week that included general austin saying he would never have american troops coordinate with shia militias, which is preposterous. we are flying air support for the iranians in iraq and everybody knows it. if you do not collect coordination, come up with another word, but look it up in the dictionary and the word will mean coordination. we are playing telephone with the iraqis or doing it through back channels. but, that was sleight of hand, having the ship militias pull out. and our so-called support for the saudis going into yemen, which creates the confusing situation of opposing an iranian backed group in yemen while fighting alongside them in iraq. also that does not take away from this, particularly since the big looming issue on the horizon is an iranian nuclear deal.
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and that nuclear deal looks very likely not to be anything like the nuclear deal we thought in -- we sought in yemen. the primary purpose of the deal has to be, are we going to reduce the risk of proliferation in the region? secondary, are we going to reduce the risk of threat from iran? the reason i put them in the at order, if iran is it going to have this firepower offshore the deterred effect would work. the concern is that iran gets nuclear weapons and other countries seek to counter that and that increases the risk that weapons fall in the wrong hands. if you have a nuclear agreement tjathat creates the
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possibility that iran could go from the day it ceases to comply with the agreement to having a nuclear weapon within a year or a few months, then every state that is concerned about iranian nuclear power gets put in the position of having to defend itself and thus the proliferation risk remains. that is what we went from. we went from seeking zero situation to seeking a one-year buffer, from not wanting centrifuges to now accepting thousands of centrifuges, those placed in bunkers, we went from what i think was much more gradual expectations regarding sanctions to i think you will end up with us getting into some pressure for greater sanctions relief. and we are going to do this in a way that will improve iranians standing ultimately with a lot of countries that want to deal with them.
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even if the united states congress blocks this, in terms of the places it has power to do so setting sanctions that requires congressional involvement. and so, you will end up with a less than ideal arrangement that will survive, will get from an interim agreement to a permanent agreement. the congress will not be able to block the agreement. the president will veto efforts to block it. a lot of it will go through the u.n. and iran will have additional cash. and as iran hasn't additional -- has additional cash, that will give it additional opportunities. clearly it has economic problems at home. but iraq has economic problems. the government of iraq is broke. it is unable to operate the
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oilfield property in the southern part of the country. and the iranians have put themselves in a sponsorship position with the baghdad government that is a shocking reversal of what was in the past. the posters of the supreme leader in downtown baghdad. sulamani is hailed throughout iraq as the leader of the pushback against isis. and if the iranians have the ability to help the iraqi further and we are disinclined to do so, which we are, imagine what that will pine in terms of further iranian influence there or syria or places like yemen or places like western afghanistan. i think it is highly likely that we will come into the 2016 election cycle with iran being the big middle east winner from the obama administration, with the middle east being in the most precarious shape it has ever been in. that the approaches of the obama
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administration to the middle east, being seen as egregious failures, even among those who would argue that the bush administration had more egregious failures in its term. and by that i mean significant parts of the democratic party. it is pretty dark. and perhaps in our ensuing discussion we will be able to find some rays of light. but i wanted, because i know dove's sunny frame of mind to provide -- you know, a useful counterpoint so that he can now assume his role, which is to defend it what the obama administration has done. [laughter] jason: for the c-span viewers, i would like to say that these remarks are coming from someone who served in the clinton
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administration and may not be sympathetic, but the situation is very stark. >> i am extremely sympathetic, ask any of my daughters. david rothkopf: i will now turn to dov. dov zakheim: i am afraid i will disappoint people here and the viewers and i will not defend the obama administration, i will take a perspective that is pretty much the same as david's but expand on it in a variety of ways. first, this guy used to sit at the far corner of this room, named arnold deborgraff, and he was a leading journalist analyst, a brilliant thinker quite a character and we will miss him. i wanted to mention that because
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he really was a regular here. and he contributed tremendously to the conversations that we had. i wanted to give you some context that goes beyond in some ways what david talked about. you have to begin not just with the debate with hillary, you have to begin with the fact that the president as a candidate and pretty consistently since then wanted to focus on nation building at home. that was his priority. do stuff at home and try to keep the world at a distance if at all possible. so what are his big legacy items? obamacare is one he hopes to preserve, he is still trying to do something on immigration, he clearly has a predelection for wishing thepushing the envelope on
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environmental issues, even if it means alienating canada. you start from there and you look at, ok, what has been his approach to the world? it has been one, if i can keep out of it, i will keep out of it. pull out of afghanistan, pull out of iraq, no ground troops in libya, even if the country falls apart. withdraw two brigades from europe, and not restore them even as mr. putin flexes his muscles. we sent a company to each baltic states, that is not a lot of people. and it is not a major deterrant. only arm the kurds with baghdad's approval, and without more forces in asia, and so you see a pattern. how does iran fit into this
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pattern? what i see essentially going on is an attempt to on the one hand, create nixon's condominium with the iranians in the region. more than that. nixon handed it off. he handed off to the shah, and in some ways i think mr. obama thinks the way to deal with this region is to let the iranians handle it. part of that, and sort of an outcome of that, is to downgrade the relationship with the israelis. treat them as a secondary power, revert back to the relationship israel had with the u.s. prior to the mid-1960's. i think that is where he is headed. if you look at all the things that have been going on, they kind of all hang together. for example, in the case of afghanistan, everybody is
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noticing that they had a terrific visit here and we are keeping troops in there until the end of the year. one thing it does is help the iranians. the last people they need back in kabul are the taliban. they almost went to war with them. that favors the iranians. not providing support for the kurds favors the iranians. because if you give the kurds too much military equipment, and they really feel they can go independent, and they have talked about it in a way that they hadn't as long as two years ago, but because of the collapse in iraq, they are now talking about it. if you do that, everybody notices that well, the turks will be upset, but so will the iranians. because the iranians have their kurds. so they don't want a stronger kurdistan.
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i was in kurdistan for a conference and i came away convinced that we are working hand in glove with the iranians. i had a panel that included the national security adviser of iraq, the vice president of iraq, bret mcgirk who is our emissary to writing -- fighting isis and thed viceor -- the advisor foyting isis and and chief of staff to the president of kurdistan and i asked the panel four times talk to me about iran. nobody really wanted to. i can understand why the iraqis don't want to, because they want us to help and they want the iranians to help. i can understand why the kurds don't want to. they don't want to inflame the
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iranians. but why didn't mcgurk say a word? nothing, zero. that tells you something. so, it is true obama has a dilemma right now in yemen. no question about it. he is supporting the guys that are fighting the iranians. but by and large that is -- iran is the direction in which he is headed. look at this deal. everybody is arguing for ages over how many centrifuges we will allow the iranians. it turns out, it is not just a matter of allowing the iranians to have centrifuges to which they give nobody access. they were supposed to close them down. that was the original part of the deal and close down iraq. they are not doing that. we are giving way on the whole question of what they have done until now. which the iaea has been pushing. we are giving way on this.
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and for an ancient empire, what is 10 years, what is 15 years, what is 100 years in the middle east? nothing. and then what. and then david rightly said, look at the reaction in the rest of the region. on the part of people who are supposed to be our friends. okay? i am not as worried about an iranian strike on israel, as some people are for the very simple reason if the iranians try it, work the analysis. the missile has to go off. the target has to work. none of the four layers of israeli missile defense works and only then might something come through. if it comes through, of course you are destroying jordan and saudi arabia and a lot of other countries. lebanon. syria as well as israel. but guess what? with the percentage, the likely percentage that an iranian missile can actually make it
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through, well, if you run the percents, less than 1%. the likelihood that the israelis can retaliate and wipe iran off the map is 100%. if i am an iranian general, i will not recommend that. but if the iranians have a nuclear capability, as david said, nobody is going to sit on their hands. if you are sitting in riyadh you are seeing groups that want to overthrow the regime next door. the iranians are playing in the eastern province which is mostly shia-dominated. you see the houthis taking over yemen. it's the nightmare being surrounded by iranian puppets and supporters. add on top of that an iranian nuclear capability. there is no way the saudis won't go nuclear. i heard from one gulf foreign
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minister who told me i think about a month ago, he said why do you think the saudi's have in supporting the pakistanis all these years? what to you think is the quid pro quo? it is that they will give the saudis the nuclear capability they need and they will give it to them very quickly. do you think the saudis go nuclear, the u.a.e. and the egyptians won't? the turks aren't sitting quietly either, they're nervous not about the arabs going nuclear what about the turks going nuclear. there you have it. everybody goes nuclear. you have a chain of nuclear powers running from the pacific ocean all the way to europe and all it takes is one mistake. one mistake and then you have got worse than world war i. so this is what the iranian deal is going to get us.
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but again, the way the administration is going about it it's as if none of this matters. now the one person who has actually helped the administration more than any other is mr. netanyahu. mr. netanyahu should not have come to congress. he should not have ticked off the president of the united states. his behavior during the election made the president of the united states feel absolutely justified in ignoring everything he says. and his subsequent backtracking hasn't cut any ice with anybody. now, what did he really do? if there is no override of an obama veto of new sanctions because of this deal, you can thank mr. netanyahu for that because the democrats were certainly going to override, but now they're in a very tough position.
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the only reason an override may happen right now is more and more is coming out about this kind of fuzzy deal that gets fuzzier by the day, but it's going to be much harder thanks to mr. netanyahu. finally, i would point out that if iran were the number one concern of mr. netanyahu, then by definition, a deal with the palestinians isn't the number one concern. and if you want to worry about your number one concern, you offer something to the palestinians and tell mr. obama, hey, look, i'm giving you x, you give me y. he hasn't done that. so he hasn't helped his cause at all, in my view. but objectively, the deal is terrible. the behavior in the region is all of a pattern even as i say with respect to afghanistan and the pattern is simply some kind of condominium or less, some kind of off shoring american influence, prestige in the
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region and just simply handing it to tehran. i will stop there. >> a quick response and we'll take questions after that. david rothkopf: i never said the word quick, but i'll make an effort to be brief. first of all, i think we need to look at the response of the saudis and the g.c.c. states to the houthi gains in yemen, not just in the political context of yemen nor in the traditional shia-sunni terms. it's also a response to the sense that there are no other stabilizing forces in the region right now. and that iran is gaining.
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it is a message from them that they are unwilling to tolerate a further deterioration with regard to iran's regional position. and, therefore, it's a broader consequence than it's typically described to be. now, so far, dov and i haven't disagreed on any point. i am now about to say something he may disagree with, but i want to throw it out there if only to validate your assertion that i was in the clinton administration and that, in fact, i'm a democrat. i am not one of those people that believes that, you know anything other than a good deal shouldn't be done. i think we should get the best possible deal we can
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. i think we should embrace the gains that deal gives, but i think that for that to be effective, it needs to be in the context of a strategy. and the strategy needs to work with regional allies to allay their concerns and to rebuild a regional alliance that extends from the gulf to egypt and includes all of those who are concerned by the iranians and gives them the assurance that we are standing with them and we will tolerate no deviation from this. it requires a kind of balanced approach and a long-term view and a strategic framework that we have not seen. i think one bit of absence of a strategic framework is to the degree the iran deal itself has been overemphasized in the context of iran policy. not only when we're worried about iran gaining nuclear weapons is iran gaining ground in the middle east which is a greater threat to the stability
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of the middle east, but in other areas, there are other disturbing patterns. we're in the midst of a cyber war with the iranians. they are, as snowden documents and others have demonstrated regularly attacking private sector targets in the united states. we are willing to negotiate a deal on the technologies of the 20th century and give them sanctions relief while we are exploring the risks associated with the technologies of 21st century conflict at the same time. so we may end up rewarding them even as they are attacking us in other ways, even as they're attacking our allies in other ways, even as they're destabilizing the region in other ways. this does not suggest strategy. it suggests a very narrow gauge focus on deliverables, a campaign-oriented approach to
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how to deal with geopolitics. let's get a win. let's get something out there that we can show for it without putting it into any kind of broader context. the final thing that i would like to say and this, again, may confirm your suspicions that i'm a democrat, is that i don't think it's been all bad. during the first term of the obama administration when they were getting some good advice from hillary clinton, leon panetta, bob gates, they were pretty good at imposing tough sanctions on iran. they were squeezing iran. they were gaining benefit from iran from those sanctions. they were getting themselves in a position to negotiate a good deal. but what's happened since then? not only have those people left, but i have talked to people inside the negotiating process who will say they reach an impasse and then there