>> clearly there are multiple barrs to antimicrobial resistance. i do agree that the streamlining of clinical trials for resistant organism will stimulate development in that area. why? partly because developers have told me that, two, because we know from experience that if we have a clear path to market and people understand that, they're willing to put their money down on a, you know, on a kind of bet that they will have a molecule that can get through. but this is clearly not sufficient. number one, we're only talking about the most resistant organisms here in a small cadre of drugs to treat them.

we also need a robust pipeline of discovery that'll lead to new drug candidates for all different kinds of infections. so the limited population idea and the streamlining of clinical trials which wouldn't just decrease the time frame, it also decreases the cost and the, you know, the number of people needed, so it would do a number of things, that is one thing that we can do at fda that we think would be beneficial and would be beneficial for patients, but it's not going to fix this problem we have of investment. >> thank you, mr. chairman. i yield back. >> i think that concludes this round of questioning. we'll have follow-up questions, i'm sure, from members. we'll send them to you and ask that you please respond. but, again, dr. woodcock, you are a terrific witness. thank you for your being so

forthright, clear in your answers, and we will now take a three minute recess as we set up for the second panel. >> thank you. >> the subcommittee willw reconvene on our second panel. today we have, and i'll them in the order that they will make theirey w presentations. first, dr. kenneth hillen, chief executive officer of -- [inaudible] dr. barbara murray, president, infectious disease society oft america. third, dr. adrian thomas, vicein chairman -- or vice president of the global market access and global public health, jansend global services. and then mr. kevin adderson,mr professor of. law, boston university school of law.

mr. allan coukell, senior director, drugs and medical devices of the pew charitable trust. and dr. john powers, assistant clinical professor of medicine,t george washington universityrs school of medicine. thank you all for coming. your written statements will be made a part of the record. you'll each have five minutes to summarize your testimony, andvef we'll begin with dr. hillen. you're recognized five minutes to make your opening statement.r >> hi, thank you. good morning and thankem you, m. chairman and members of the committee, for inviting me to testify today. it was also heartening to hearin the recognition ofg the work of alexander fleming, my fellowre countryman. of course, not only did he discover pencillen, but, actually, when he received hishr nobel prize, he also spoke of s the danger of the ignorant man who may expose the microbes and make them resistant. that was back in 1945. i'm the chief executive officer

of cajun, of noble antibiotics for multidrug-resistantall infections. it is based in the san francisc bay area.em we're a memberpl of antimicrobia innovational lines, a coalition created to address the uniquetin challenges we've heard about today. as we've already heard, antibacterial resistance is one of the most significant medical challenges our country facesca today, and we're committed to trying to find solutions. our lead product candidate, which has been engineered specifically for multireus dances, is currently being evaluated in clinical trial, an the meds are considered to be our last line of antibiotic offense. the trial utilizes a superiority design to demonstrate a reduced number of deaths in patients with therapy versus the best available standard of care which, unfortunately, is not

very good today.a we've also developed thewe a diagnostic -- [inaudible] that's been used in the trial to measure blood levels to try to help individualize dosing for patients which we believe willth improve outcomes. he sign requie consultation and coordination with both the drug and diagnostic agency to be extremely collaborative and believe the approach has a model for how they can help to facilitate companies with development to antibiotics and the unmet medical need. the program has also been benefited by receiving the first contract awarded the broad spectrum of the program from the biomedical advanced research and this is the signed through the approval to provide over $100 million in total funding. however, even with the groundbreaking study the team with the exciting pipeline has a

successful idea of the significant support if significant barriers for the companies developing antibodies and we can work together to address these obstacles to have effective antibodies that will always be available for patients. we would like to propose significant changes in the four key areas. first we believe in in a new economic incentives are the key for the need of the reform of the antibiotic. the economics of developing new antibiotics is not attractive to the pharmaceutical industry and many companies of antibiotic space. this has led to a decline in the number of antibiotic approvals and has heralded to increase in antibiotic resistance. commercial returns for the antibodies are limited by the fact that generic antibodies are cheap, new antibiotics are used sparingly to preserve their use their use for reimbursement of hospitals is limited to six payment system that is intended to cover the total cost of patient care and because longer-term trends are awarded by the unavoidable development

of resistance. furthermore, other therapeutic areas such as oncology or diabetes or by the pharmaceutical companies with much more attractive opportunities for the return on their investment. we believe that the act sponsored by the congressman has been proposed for the qualifying products and and bbv this would provide a powerful incentive as the payment to the hospital is the same regardless of the antibiotic. so the hospitals are incentivized to use the cheapest is not always the best and most effective antibiotic. but by providing the reimbursement for the qualifying antibiotics it eliminates the important barriers. the passage of the act would like to see the reimbursement for the antibiotics extended beyond medicaid and medicare patients covered by private insurance. second, the fda needs the authorization for the greater flexibility for the approval of

antibiotics antibiotic space limited clinical basis of the rationale today. it is the streamlined development program however for the mortality plan and be infection times in the enrollment period in the study is expected to take three years to read and contrast in europe the guidance extends more flexibility in the scenario of the unmet clinical need and doesn't require inferential statistical testing for the antibiotic approvals. in order for the new drugs to be available ahead of the emergence of unacceptably large numbers of infections from the congress must enact legislation that authorizes the fda to approve new antibiotics for the limited patient population spaced on smaller clinical trial data sets that the technology of the available evidence supports the risk profile financed antibiotic. while the technology and reflecting greater uncertainty associated with the testing and product of the product label. occasional support passages

provided the fda with an increased flexibility that we believe it needs. third, there is a need for the more rapid test and streamlined approval path of the diagnostics. for those in the administration of antibiotic by just one significantly increasing patient mortality. the traditional diagnostic tests as we have heard they take 72 hours to complete and we believe the federal government could make a significant impact providing support and incentives for the development of the the cost effective point of care diagnostics that have the clinical care. there is also an opportunity to streamline the process for the development and the approval of the companion diagnostic tests. there is the need for an expedited approach to the diagnostic development and approval through the regulations that are anchored in the consideration of the urgency of the unmet medical need and the overall benefit risk for patients. the regulation should provide

flexibility to streamline the required analytical studies as well as the testing related to the quality manufacturing software and the documentation for the diagnostic advice. for then finally, we need to sustain funding for antibiotic research and development. we must be prepared to take a long-term perspective to fully realize the public health benefits will be derived from increasing funding for antibiotic research and development. the funding that is received have been a sensual and we believe that it illustrates how about public-private partnerships are successfully advanced. on an unpredictable basis for the broad-spectrum program and the expansion of the mission to allow them designed to address public health records by the antibacterial resistance. we also support continued funding through the antibacterial discovery development. we appreciate the opportunity to contribute to the discussions

and to strongly encourage congress to take measures to mitigate the significant public health threat posed by the bacteria. >> we now recognize doctor murray. five minutes for an opening statement. >> thank you very much, mr. tran. thank you for inviting me to testify on behalf of the infectious diseases society of america on the public health crisis of the antibiotic resistance and the need for antibiotics and diagnostics. we are grateful for the subcommittee's continued leadership on these critical issues. the position of seeing more and more patients with serious infections resistant to all or almost all antibiotics for example i recently saw a young woman with lupus and autoimmune disease who developed a very painful infection that persisted despite topical antibiotics into surgical interventions. the infecting criteria and they did her bloodstream and developed resistance to every antibiotic available including that of last resort.

finally, we sent her to hospice for comfort care while she waited for the infection to claim her life after a very prolonged and expensive stay in the hospital. a colleague of mine recently took care of an active patient in his 60s following a prosthetic knee replacement he developed a and an affection that despite the removal of the joint into the antibiotics it couldn't be controlled and he have to have an above the knee amputation. this summer but i think women with urinary tract infections had to be admitted to the hospital not because they were so seriously ill but for the therapy because they are accepting organisms resistant to all of the oral antibiotics. for anyone that has had eight utis which is going to be most of the women in this room and some of them and having to be hospitalized for a common infection is inconvenient, decreases productivity and increases healthcare costs. antibiotic r&d as you have heard of faces a significant barrier and the discovery is hard. scientific challenges lead to

development costs and economically antibiotics have a very poor return on investment because they are typically priced flow can be used a short duration and held and reserved by us to try to control the antibiotic resistance. we thank the subcommittee and especially represent the leadership in an acting the act of 2012 which is beginning to address some of the economic barriers we hope you can build on the efforts to address current regulatory barriers specifically extensive resistant bacteria currently relatively small number of patients making its not virtually impossible it's not virtually impossible to populate the traditional large comical trials between the two develop new drugs before there is an epidemic. think of how the fear for able would be less if there was already effective their feet. it represents the act that would address the regulatory conundrum by allowing the fda to improve certain antibiotics with smaller trials and this approach would only be for antibiotics to treat serious infections where there

is an unmet medical need. adapt would make trials of highly resistant bacteria feasible, less costly and allow the fda to assess the risk of the new antibiotics relative to its potential benefit to this limited population. we are deeply concerned that without adapt most of the urgently needed antibiotics wouldn't be brought to the market. the strategy of the limited population pathway was also suggested in the report that you heard yesterday. adapting to the safeguards to help ensure that the drugs are used appropriately also contains multiple important provisions to ensure that the susceptibility and interpretive creek here you breakpoints predict whether a patient will have a good response to an antibiotic or quickly updated to make publicly available up to date information is crucial for kroc all care and to ensure that antibiotics are not misused or overused. they urge the subcommittee to markup the act swiftly. as also mentioned in the addition earlier today additional economic incentives

are required such as public-private partnerships, support for federal agencies to invest in antibiotic research, improved reimbursement, and or tax credits. ernst and young estimated that the idea proposal targeting the r. and d. for these needed antibiotics would result in an additional five to seven new antibiotics in the pipeline every year. the new antibiotics are critical. they've also committed to a multi-pronged response to antibiotic resistance including a well coordinated federal leadership as mentioned in the report. sustained involvement of the non- governmental takeover is coming antibiotic stewardship programs in every healthcare facility enhanced surveillance event of bionic use and resistance patterns and research on the novel strategies to prevent and control antibiotic resistant organisms. these steps are critical for the patient public health and the federal investment data due antibiotics. you have heard it is extremely important to promote the development and the plentiful integration of the new diagnostics. the rapid point of care

diagnostics can reduce inappropriate antibiotic view that the drive is resistance by lessening the need for the shotgun therapy. ideas recommended grace diagnostic research, pathways, strengthening and reimbursement and supporting outcomes research to demonstrate the impact of diagnostics on patient care. thank you again for allowing me to justify here. and for your continuing effort in this very important area. the stomach hispanic the chair thanks the gentle idiot recognizes doctor thomas. >> for this opportunity to come before you today i am doctor adrian thomas the president of the global market access and head of the global health pharmaceutical business of johnson & johnson. i applaud you and commend all of the leaders in the room that have given voice to the situation and antibiotic resistance. we also recognized as the committees and the leadership as well as the leadership of president obama on this

important issue and offer our support to the national strategy announced yesterday. from my early career in the service to my current role as a portfolio product service the disease of high public-health impact which include tuberculosis and also more recently ebola. i'm a clinical pharmacologist and physician by training with expertise in a variety of areas in the healthcare industry. the majority of my 17 years in the private sector has been with johnson and johnson. as many of you know johnson and johnson is the largest most broadly based healthcare that it also includes diagnostic devices as well as the consumer products. we are an innovation-based business and as critical as you think about the issue that we address incentives that apply in the relevant different stakeholders in the area of innovation not just large companies but the discovery of

academic research, biotechnical startup into the public sector. reaching across that ecosystem allows the unique visibility in the number and the status of the projects underway in the areas including antibiotics. it also as commented that we consider incentives for antimicrobial resistance we should also consider incentives incentives into vaccines and other preventative mechanisms and diagnostics if we are going today to progress against this terror will issue. we also bring this into the proximity of the patients facing life-threatening illnesses including patients with these infectious diseases and the stories affirm what we've heard today that we must do all we can to meet the needs. first and foremost we must work together and think differently to bring forward these new therapies. we have heard in some detail today that despite the need of the legislative efforts the innovation climate and antibiotics and other remains suboptimal. that is a large part because the basic science in the field

continues to be very difficult with the highly. if the failure is no longer an option given this critical global health security crisis that we need to take different measures we can learn the lessons of the crisis which is also neglected and which now we have companies scrambling including our own to try to provide new vaccines in a short timeframe and unfunded mechanisms. for the better stewardship of antibiotics on the market in the fight against resistance to current demand that we need a framework for innovation that antibiotics are indeed. we have to track them all best and brightest including the private sector. the u.s. can and should lead the world in creating the conditions we cannot wait for the europeans medicines initiatives to old problems for us. it is our hope the committee and the congress will give serious

consideration to the new legislative proposals. beyond this we believe there remains a need to put forward a comprehensive set of options specific to antibiotics that address the needs across the stakeholders. we must create a broad set of highly attractive although financially manageable incentives to engage the different biomedical innovative companies including academic networks. the policies can and should be able to take into consideration the view of the costs and risks of this and also the cost and risk of developing and introducing and supporting the products worldwide and how those risks are different for different state coders and the incentives to address the different stakeholder perspectives. i would like to talk a little bit about the exclusivity. we've heard different perspectives on the topic. as the companies undertake its own in depth analysis of the different incentive proposals for antibiotic r&d it is apparent that many existing

proposals only offer marginally valuations. in addition to being a physician i serve on the committee of the pharmaceutical business and i balance the difficult choices we have to make about is ebola and drug-resistant tuberculosis, cancer and more public health question and is it financially feasible to balance our research in this area. spending almost $5 billion annually on research and pharmaceuticals and these decisions are not easy and often have timeframe is a ten to 15 years. thinking about the exclusivity, the notion of exclusivity that can be applied towards another product, not only gives the investments to be made in very high-risk areas, but also this incentivize activities that might otherwise undermine both the public-health stewardship and the protection of the products and assets against emerging and developing antibiotic resistance to encourage appropriate use. the bottom line to the proposals as we believe we have to have more basic research, more

discovery, biotechnical startup's and academic partnerships, more companies companies investing in the in-house facilities to recognize and to take up new assets and to conduct the expensive research necessary to deliver and develop the products in the marketplace. in conclusion we welcome the changes in the public policy to stimulate the new antibodies and thank you very much for your time today. >> we now recognize mr. anderson >> good morning mr. chair. thank you for inviting me to testify today. i'm a professor at boston university and serve on the centers for disease control prevention and resistance working group. at the institute for international visiting fellow my remarks today are my own but the work that we've been doing the past year is focused on the linkage. i think today we need to focus and act decisively because the business model for antibiotics is broken. not only for antibiotics but other things that treat and

prevent diseases such as diagnostics and other devices. so i have a couple of slides to look at the business model and this is based on the study stunned study stunned by the eastern research group by which i was a part for the department of health and human services. the first slide no one in the committee needs to see this. we know this is a huge problem. the number of deaths on the assessment was 37,000 per year. it's a huge problem. let's look at the business model. we are looking at the present value from the private perspective. this is a company looking to make a decision about whether to invest in a molecule in an early stage. this is a typical decision tree that tries to analyze what is the chance of failure at each stage and how much it will cost to advance.

every company uses a model like this. everyone might use slightly different assumptions and members and this is a typical thing done in industry affect in england right now the office of health economic there's another study almost completed that comes out with much gloomier numbers then we present here today. the first thing we looked at is the six bacteria were indications. it's hard to read and i'm sorry for that. what you need to see is that the companies were hoping for 100 million-dollar net present value that was the money they would get in return and you see here that for several of these indications they have a negative net present value they are going to lose money after they build built a factory to make this drug and for others there was a positive one but nowhere near the threshold that was necessary

for the companies to move forward. the 90% interval for every single indication that confidence interval included a negative number so it's difficult for companies to commit to research programs in that sort of space. the second thing is that social net value. how valuable are the drugs to society? we didn't have speculative numbers, we didn't look at the effect of reducing resistance and we didn't model how it would keep us all working, the kind of ancillary effects but just the direct cost and the numbers we came up with were huge. these numbers are in the billions. so the social net present value was the two orders of magnitude higher. several million dollars for several of these drugs. in other words, society would be having -- would be getting a

tremendous bargain if it was able to procure one of the drugs for even a fraction of that amount. as a comparison, ie compared for each of the six indications the social and the private. if you look carefully, you can't even see the private on the same scale because it is in blue. it's so small it's almost impossible to see. there is a huge gap. so, i did this one and try to stretch it off across the slide. what i did here is truncated everything at 100 million. those bars would literally go up another 15 feet on the wall if i am out of them and that is the gap between the social into the private value. it's another way of saying that we are tremendously under reimbursing for the antibiotics. we also looked at incentives and given that i have 30 seconds, i will get down to the key chart in which we modeled which

incentives could be changed in order to solve this on hundred million dollar benchmark. we looked at every incentive ever published and then put them in the different categories. the short answer is that if you do something that affects the cost of capital, it has to be fairly significant in order for it to work. so if we have to we have to draw the funding it better be significant in order to kick and. something on the range of a billion dollars for the module molecule. yesterday's proposal from the president from 800 million they are hoping for more. i think it is a reasonable number. things that don't seem to work based on the model we even had unlimited perpetual's that still didn't get the companies anywhere near the 100 million-dollar threshold. to reduce the clinical trial times you would have to reduce it by 75%. so, at apt could be useful to

ring the new drug to market for the people who need it today. but it shouldn't be viewed as a powerful economic incentive for a company early to decide now is the moment to greenlight this drug. it doesn't have that sort of effect. what the companies need is money, not the promises of early approval. thank you. >> the chair thanks the gentleman and recognizes for five minutes for an opening statement. >> mr. chairman, i would like to think you added the ranking member for the opportunity to be here today. i directed the medical device food program at the pew charitable trust. we are an independent research organization with a long-standing focus on the urgent need for new antibiotics. as you've already heard some of the pipeline of the antibiotics as a potential public health tries health crisis and everyone of us will need those in our

lifetime and already probably know somebody that had a resistance to infection. children and seniors are particularly vulnerable. as the members of the military one third of those injured in iraq and afghanistan came back with an infection. some of them resistant to almost all of the drugs and among the broader population, 23,000 americans die every year from a system to infections. for the the company has a response requires infection prevention and surveillance and reducing the unnecessary use of the better diagnostics. but my focus today is the steps to reinvigorate the pipeline. the state of the pipeline is not good and included in my statements and 38 drugs antibiotics now in clinical testing. five of them them and advanced development have some potential to treat a negative switch are probably the most serious and immediate threat. that may sound encouraging but let's recognize based on the general trends come about 80% of those won't reach market and will fail because of reasons of

toxicity or lack of effectiveness. very few of the drugs now in development have novel mechanisms of action that would significantly delay the onset of resistance. so what can be done? passing the act the committee has already taken a leadership role and getting introduced in the extended market exclusivity for antibiotics gives companies a better chance of a positive return on investment and also ensures swift review of the drugs. that was an important first step and more is needed especially for those that are the hardest to treat. it trials of antibiotics are hard because only a small portion of the population would say pneumonia has a resistance bug at any given time suitable to dress the challenges a long list of bipartisan cosponsors have introduced the adapt act. at apt would create an fda approval path for antibiotics to treat patients with few or no other options.

it's also limited population antibacterial drugs with the public health goal and help streamline development. so what may make it concrete with the different scenarios. it's they range up to real pneumonia some treated in some resistance. when fda approves it has to consider that universal people who might get it. some of them have lots of treatment options and won't be willing to accept the greater uncertainty. now a second drug which is the l. pad is caused by a resistant organism. the patient with this infection would die if they don't take drugs be for the benefit might be greater against the uncertainty command of the fda making the benefit risk calculation only for patients like our patient can accept less data and approving the drug. that reduces the development cost. to be clear this doesn't change the standard of approval.

it targets the specific population that's different than the general population. for l. pad it to work as intended, providers have to know and understand the drug is approved for the population based on limited data. the drugs special status has to be clearly communicated in drug labeling and any marketing materials. to that concept, pew has worked with the infectious disease society can antibiotics per file, drug companies, health insurers, the fta and others into the legislation has the support of numerous and diverse stakeholders. yesterday the president's council of advisors on the science and technology also called for the subsequent. this committee has long understood the antibiotic resistance and has done much to bring into the national stage and we appreciate the leadership and continued commitment. what we conclude with the observation that we face. many problems and many diseases that seem intractable, this is not one of them. bacterial infection is a solvable problem.

in the heyday of the drugs that have effectively conquered the bacterial illness for a time, and we can get back there if we commit and ensure that we do it again. thank you. and i welcome your questions. >> the chair now recognizes doctor powers for five minutes for an opening statement. >> thank you very much mr. chairman. thank you for inviting me to testify. i am a practicing internal medicine physician and medical researcher that actively cares for patients. i was a scientist for almost a decade and a cochair of the task force on antimicrobial resistance and i'm a member of the who advisory group on antimicrobial resistance speaking on behalf of the national physicians alliance. npa is a professional home to physicians and more than 40 specialties. we share a commitment to patient centered healthcare, evidence-based policy and integrity. we do not accept pharmaceutical company funding. we believe in the advancement of knowledge to research that is

free of financial conflicts of interest, financial and peer-reviewed. the task force was established to support the work and defense of a strong scientifically rigorous fda. as numbers of the committee pointed out, studies of infectious disease when there were no effective therapies for the first used for the trials that are a part of wall today. investigators in the have congress realized appropriate methods are critical to separate the harmful from the helpful for patients. the problems of antibiotic resistance in the responses to it are also not new. the doctor in the recent book the antibiotic era recounts during the rise of the infections of the 1950s, drug companies marketed numerous ineffective antibiotics based on supposedly superiority in the test. doctor maxwell the first president of the infectious disease society of america with other infectious disease clinicians pointed out the need for adequate well-controlled studies have patients and said properly conducted clinical studies may support the claims and justify the enthusiasm for these antimicrobial agents but it is incumbent upon those of us

intimately concerned in the welfare of our patients to wait until the data is presented before we accept any agent or recommend them for general review. in 1962 doctor finland made the same planes that resulted in adding the the requirement for effectiveness for new drugs based on evidence from adequate well-controlled studies showing that like other drugs antibiotics effectiveness can't be consumed a summer tests come animal studies or mathematical modeling but can only be verified by studies that ask the right questions with the right outcomes and patient who might benefit from experimental drugs. the problem of antibiotic resistance today is the same as it was in the years past. a medical need exists with no effective therapies. the need for treatment is for treatment of improved effectiveness compared to older treatments on the outcomes of decreasing death or irreversible disability. not alternative outcomes. the program described focuses on this addition of these outcomes. the drug market and life savings should actually be shown to save

lives and adequately well-controlled studies using appropriate diagnostics such as those we discussed this morning and advocated in yesterday's report. to select the patient that would receive added benefit from those drugs and susceptibility criteria should be based on patient outcomes, not mathematical modeling from the sources without conflict of interest. drugs that are highly effective in a few patients to show those effects and adequate well-controlled studies therefore the sample size is related to how effective the drug actually is. it is ethically questionable to expose patients to have any current effective options to the most effective treatment in order to have a robust pipeline of or economic stimulus to companies. it is invalid to test the drugs and patients in the susceptible organisms and assume effectiveness in older patients with disease resistant pathogens based on assumptions from the modeling of individual anecdotes. ..

>> ongoing clinical research studies as was done in the early years of the hiv epidemic to allow new access to therapies while drugs are continuing to be activated prior to widespreadthe marketing. the types of patients whoo benefit, how clinicians shouldd select those patients and the information used for approval. our written testimony provides npa's plan for a comprehensive approach to development, disease

prevention and reimbursement strategies for improved therapies of infectious diseases inline with the -- in line with the p cast report issued yesterday. investigators and authors of medical and scientific publications have the duty to protect the medical profession and the public against the abuse of eliminate scientific information and against improper and richer exploitation of conclusions based on inadequate data. thank you very much for the opportunity to testify. >> the chair thanks the gentleman, thanks all the presenters for their testimony. we will begin questioning and i will recognize oneself five minutes for that purpose. dr. thomas, you mentioned in your testimony that a multi-pronged strategy is needed that includes both stewardship and antibiotic innovation incentives. these you think about the path to cure as being three faces, discovery, development, and delivery, do you believe that we

need incentives in all three phases to have an effective incentive strategy? >> thank you for the question, mr. chairman, yesterday. because i think often the players or the stakeholders were conducting that research at those different stages are different. what it instead of ice is academic or biotech startup might be different for instant fires of multinational corporations, johnson and johnson different organizations that are involved in health care delivery. one incented is not, since we've seen since the incentives introduced, we still have an empty pipeline. one incented will not solve the problem. it may well be that larg larger grants or so-called prizes will attract academic researchers and startups get a very different incented needs to encourage venture capitalists to go and back start companies with a higher level of risk. johnson & johnson, we look up a portfolio of investment opportunities to understand

which of those is most important medically, but also which is widely able to be conducted and finally which enables us to bounce our risk and our return. >> all right. let's look at each phase. first of all, what types of discovery or are in the incentives do you believe would encourage companies to develop -- r&d -- to develop new antibiotics. >> look at the discovery incentives not just her and her buttocks but for all animatics and adjacent technology. it is critical we focus on point of care diagnostics, new capabilities be able to diagnose and also to advance clinical research in this field. this endeavor, this is where larger grants, funding, prices would make the most sense because that will encourage broad-based academic research as well as broad-based technology company research that's often

shorter in duration and is able to diminish in a different way. as we think about the incentives for development, development and the pharmaceutical process is most expensive piece. we recently brought a new product, an indicator for multi-drug-resistant tuberculosis, 13 years of r&d and early development. we had proof of concept that was compelling and leadership agencies like fda and european medical agency in the world health organization had a conditional approval on early phases to resolve. we still have more than 15 years of clinical trials, evidence generation showing safety and effectiveness in children, showing safety and effectiveness to other drugs in the field, improving out the hope we saw in phase two studies to harry spent well over $209 today with no

commercial return for siebel for this product nor nusra should it be we're now looking at a for the 15 years of investment in the hundreds of millions more. tax credits are not enough to spur that sort of asset on a broad-based across the industry. i think for drug developers we need to make sure there's an incentive for two things. one is, how can they justify maintaining the infrastructure in house, the confidence he to understand what is a good asset and how to develop not they have one of those assets themselves. and that's critical because lightning doesn't always strike were headquarters is. lightning strikes all over and went to understand when it hits what that technology is worth. the second thing is we have to build a encourage companies to invest in a long range risk associate with a large dollars of drug development. the way to do this as not to hope that they have a certain expertise in one drug.

the way to do this is to say we want as many shots on goal is of possible bias the large players as possible so that we can see a sustainable and continual pipeline to revolve. this is where the concept of exclusivity comes in. what you're not doing is incentivizing people, saying we have to understand you to go and profit making path in some of your business and we've tried -- trade off against these activities. in the area of delivery side, this is problematic. by the nature of these with research we conduct to get products approved for at the micro the resistance, we are looking at studies. from a payments perspective that means in most countries in the world that you get price parity despite the fact your price parity is with what's on the market, with the costs that were achieved many, many years ago and may not, no longer be relevant and that's why they're usually negative. so the notion of a price premium our reimbursement incentives are

attractive in that area. i would posit, however, and use as an example our own experts and multi-drug-resistant tuberculosis but when you talk about highly resistant bugs, highly transmissible blogs, you want the drugs used only in the people who need them, only for the bugs that need and other people who understand how to treat and use those products in an appropriate way. that's not a very strong economic model to understand how your product even with the reimbursement incentives is going to be successful. it's probably a negative commercial model in most areas. >> the chair thanks the gentleman, no recognizes mr. waxman for five minutes. >> thank you, mr. chairman. last congress we passed that gain act to provide new incentives for the development of important antibiotics. and under that act, antimicrobials and antifungals

intended to treat serious or life-threatening infections can be designated as qualified infectious disease products, or q. -- q. idp, these received a priority review. that's hopeful. if they're approved they get an additional i've years of protection from generic competition. that's a strong incentive. fda has already granted q. idp designation to almost three dozen different antibiotics to companies clearly are interested in this program. major -- for today's hearing there's a need for new and biotic seeing the growing number of life-threatening pathogens. that are resistant to all or the chew and biotic. however, in your testimony, you know there's nothing in the law that requires qidp designation's the only given to antibiotics

intended to treat resistant pathogens. as result you assert that essentially every and biotic ever approved by the fda will qualify as a qidp. some of us during the fda safety and innovation act negotiations try to limit it, that designation to this antibiotics that would fulfill an unmet medical need. however, we were unsuccessful. can you tell us how many or what percentage of the qidp's are for antimicrobials entity to treat highly resistant pathogens? on their public health impacts we should be concerned about as a result of the failure to prioritize drugs to resistant pathogens, and how can we better incentivize the development of the drugs we most need? >> thank you for your question. the definition of qualified product is built on the previous

definition of a qualified pathogen, and that list does not require any of the pathogens to be resistant. it includes most species known to cause any disease in human. that was done because it's difficult sometimes in these trials to run them are historically have been done to run them on people only with resistant pathogens. so you are correct in saying that the qualified infectious disease product will apply probably to every antibiotic that will be approved in the next decade or two. which is a question about whether the incentives are properly targeted. on the incidents themselves when i talk to companies privately, ma large countries as well as small they all say that incentives in game with the correct direction but there's a quiet walk when what we should be doing is running. that the economic value to them of these incidents is really

very small. they will take them and register, but it's 1% of the way to where we need to go to change the economic model. it's a small change and we should be doing something about it. >> tell us how to change the economic model. you talked about that. how much do we have to keep giving in order to give the right incentives? and we have to know how much this is going to cost the american people and whether it's going to be successful spent to use of the three steps, stages the chairman mentioned, on the discover side our budgets need to be dramatically increased. we need basic science. it was in the pcast report yesterday. >> and we've been cutting back on that. >> it has been flat line or slightly negative to the best of my knowledge. on antibacterial research, nih. the second piece on developing, i think tax credits are a piece of that. i think barnett is a huge piece of the. some of the best brand negative

malik is not have a lot of money in them -- >> we want to shorten the time that fda to get this review done as quick as possible to get the drug out there. we want to help companies decide if it's in their economic interest to do this. what do we need to do a? >> the last pieces one that was delivered to the public and i would agree with dr. thomas there's a reimbursement problem. i don't particularly like the solution. at the chatham house work were looking at the linkage which is using the companies will be generously rewarded on something that has nothing to do with molly. i think everyone would agree we don't want but i $100,000 prize on a drug into the company a reason to over promote it. so there needs to be significant price type or bardic rant type reward for companies -- barda,

which is what glaxosmithkline has suggested. to give significant rewards to the companies after they delivered a drug to the market. >> i would suggest that we may be better off with much more money in biomedical research at nih at the universities around the country. because they don't have the profit motive and what they do helps the companies because science use for these products, but if the governments are having too difficult a time without if incentives to make a lot of money, let's make sure we get the work being done at the public expense because otherwise we're going to be a lot of money and we may not see the results that we need. do you agree the? >> i completely agree. if we do not have enough basic

science, the pipeline that flows to venture capital and into the larger companies runs dry. >> i.t. thank you, mr. chairman. >> chair recognizes the gentleman from georgia, dr. gingrey. >> that was a very interesting line of questioning from the distinguished ranking member of the committee. and your response was not unexpected, but there is something to say for the profit motive as well. you get more and more and more money, taxpayer money to nih or whatever the basic research is being done and you don't have this profit motive you're talking about in the wrong instead of misguided incentive. but if you don't have somebody with a profit motive, a pharmaceutical company, big or

small, you can sit there doing basic research for 100 years, and maybe some brilliant scientist, many of them could be very comfortable in their labs, you know, and joy that fairly well. i think i would. but you never really get to where you need to be in regard to drugs that treat patients that q. are these -- that q. are these terrible bugs that are killing them. so i'm going to shift my question to doctor murray as president of the american society of infectious diseases to basically ask you the same question, dr. murray. the business model by antibiotics, diagnostic and vaccines is broken. i think we will all sort of agree with that. that's what we learned this morning, this rather long to panel hearing, but it's been good.

but it's a broken model. what specific steps do you think congress should take to address this crisis works do you agree with mr. outterson, or do you agree with mr. waxman? what do you think? >> well, i could take dr. woodcock's approach is that i'm not an economist, but i will try to address that. i think basic research input is an important component. i am biased. 90 basic research in my in the laboratory but i agree also there has to be a reward at the end. the suggestion i've heard from others, and they're not my own, including taking certain drugs out of the drg so they're not part of the total hospital budget which means everybody is trying to attack on antibiotics as one place to decrease costs. that, the other model is buying up a certain number of doses at the end of a product so it is, there bought up, i think that's what you meant by the insurance

model. so you hope you never have to use them. they would be there but it guarantees the industry some return on their dollar. so those are the to come in addition in the development phase the tax credit but at the end product, i mean, i've heard it for many years there has to be, the interest, the answer to talks -- consular, the answer to stockholders, they don't answer to taxpayers. tom pernice cannot just be motivated by the greater good. >> it's kind of like when we talk on this committee about energy. the energy policy we should have have, and all of the above policy is the one that i like the best. and i think really in regard to this. because as mr. waxman said, talking about tax credits. you're talking about what you just said, dr. murray, buying

back a certain volume that's not used because you don't want to just incentivize based on sales. and more grants to the nih. all of the above really. i think that's what got to look at it. i've got a less than a minute left and want to shift to dr. hillan. you mentioned in your testimony that half of the investment costs necessary to support your drug -- will be required. half of investment costs necessary to support it, that drug come will be required after the point of united states regulatory approval. what drives the cost of these investments post fda approval? >> it's a big -- what's the big cost drivers? >> i'm not sure what you mean but i am certainly happy to

answer. there's an ongoing process after drug is approved so you actually understand the significance of use of the product in the real world. there are additional pediatric studies which are important, we believe -- >> let me shift just, i've got no time left but trying to come if you'll bear with me because i really -- and think you dr. hillan. i really wanted to address this question to dr. thomas. so if you could quickly respond, mr. chairman, if you'll bear with me. >> sure, and thank you for the question. getting approval is a start of a long process of paying for regulatory approval all over the world on a sequential basis of maybe over 100 countries. there's completion of commitments, unknown questions about basically that is 15 years of pediatric research. so if antibiotics that sometimes, started in a 15 year-old, proving that, drug

safety reporting requirements. when you have a commercial product these are all cost of doing business. we have a product with the aim is not to use it unless your absolute have to, it's just a tremendous overhead that you can't really get out of the way. it's the right thing to do and the way we do it today, but it's significant overhead. >> and i think both of you for your response to the question. thank you very much, mr. chairman to i yield back. >> the chair thanks the gentleman and now recognizes ranking member, mr. pallone. >> mr. pallone, would you yield me one minute? >> surely. >> i think you for yielding. i would want anyone to believe that we thought you don't need a profit. you don't need a private enterprise, and to argue we need to put much more in the research of scientific. but we do need a business model that system the company, if you do this work, you're going to make a profit.

you've got to make a profit otherwise they're not going to do it. had to make a profit we don't want them to sell more antibiotics. we want to be sure they get a profit so that we want to guarantee -- we could take their investment, guarantee a certain percentage and say that's a much the government will pay you. that's what i did. i don't think it's the only ideas but it's a different kind of incentive that we have in other areas. i thought dr. gingrey was right when he said all of the above. we've got to do everything we can under the a lot more public investment. because the pharmaceutical industry will not make a lot of investment in this area when the research investments can be result in a blockbuster drug. this is a social need and they've got to do what we need them to do but they're not going to do it without making a profit. so thank you for getting the chance to add an additional thought.

>> thank you. thank you, mr. waxman. i wanted to ask dr. murray and mr. coukell, i know that you have worked very closely with the adopters of the death act and are strong supporters but i like to get your views on a few aspect of this legislation. first unconcern is truly drafted fda may not have adequate authority to require an untapped antibiotic labeling the way the calls attention to the fact that it's intended only for special populations. i don't think in clean secretary of state in the prescribing information is adequate and i'm concerned if those drugs are used more widely at appropriate that we could in that both harming patients and losing the effectiveness of the drugs to antibiotic resistance. what are your views about the accuracy of the language in the bill? do you agree it's critical to be a strong and prominent labeling statement to settle to find they should use the drug only in circumscribe situations? i guess we could start with dr. murray and then go to mr. coukell.

>> i think it is important to have some label there. in a practical sense what we do in the hospital to prevent overuse of certain drugs is we already have stewardship in place. in our county hospital, whatever reason have to go through an infectious disease approval. that's already in place. another thing we sometimes do is we don't report on the chart of the report that goes to the patient's chart, the susceptibility certain antibiotics. if you're in infectious diseases or are smart enough to know 's g on .. that. usually is done because there's certain combinations that even though the antibiotic is susceptible you wouldn't use it alone. the third way with electronic records that might be possible that i was speaking about last night was that when this drug is

written for there's an automatic pop-up. with all sorts of automatic pop-ups now an automatic pop-up could say this has been approved in a limited population. i think in many ways that may not be as much of a problem as people are imagining. these infections occur in -- their complicated. are uly invved ine physicis they are complicated. infectious disease physicians are usually involved in these patients. for someone to try to use this drug or a special drug that isn't approved in this fashion for an ordinary e. coli infection, there is not a need to do that. the companies are not going to be out there marketing for that purpose. fda will be overseen what goes into the promotional materials. i'm not sure the ordinary physicians can assert they won in the about using it. i think there's some inherent safeguards. >> okay. mr. coukell. you want to respond?

>> we've worked very closely on this bill and we think this is the one place we really would like to see improvement. as i said in my testimony, it is important to convey to the provider for special status and nature of the struts unless recognized the labeling is not affect it when someone looks at the fine print, but the start of the process of how information about the drug is promulgated in the community through the medical record, marketing materials and so on. we have called for a logo to distinguish drugs. as long as it is communicated clearly that the strokes are different and that is part of what congress is doing by creating this designation. >> all right. thanks a lot. >> one rethink some of the other thing in the bill that we think it's important how to monitor the drug sobieski tackett know their indication is working as intended. >> all right. they experience the next chair thanks the gentleman. the shuttle and from illinois, mr. shimkus. >> thank you, mr. chairman.

this has been a tremendous. and i am glad i stayed. i think you see the importance that this subcommittee puts on these issues. you all of the panel turnaround and see dr. woodcock was right there appeared brief terror. i want to make sure everybody knows she is stay and i applaud her for doing that. would you consider you while facebook friends with the fda or in a relationship? [laughter] anyone want to answer? are your friends are not even? had a friend notification and they didn't even accept? >> maybe i could speak to that because obviously it is important the industry is regulated in terms of drugs and also diagnostics. i don't know whether we callers of friends, the third the colleagues that work together. >> the point is this only gets

solved with the people in this room. it gets solved with you, the pml. it gets solved with the fda and it gets solved with the public-policy folks here. so we have to have that communication. we have to be in a relationship. that is what i'm taking from this. you know, i couldn't believe it. i was also looking at stuff. the pentagon is -- the groundbreaking of september 11, 1941. the dedication of january 15, 1943. so in this issue, these are timelines. her teen years to get the 1.15 years down the road. we've got it. we've got to switch this timelines. there are people willing to accept some risk. we've heard in numerous testimonies on the 21st entry carries debate and how do we do

that effectively? the question i have been listening to the testimony is government has historically bureaucratic and not flexible and we are very rigid. in this process, you are the experts. you are the doctors, the scientists and staff. can there be -- how do we ride into legislation the flexibility to incentivize while protecting public health clinics and can we do that? that is what we are going to move fun legislatively. am i right in that analysis into you think we can get there? i only have two minutes left, so why don't we go down and let everybody way into that if you'd like. >> so it obviously has to be done appropriately. a lot of this is building trust. we're working towards the goal of antibiotics to patients. we have interacted with the fda and i can say the fda has

facilitated the development. they came up with really good ideas. the company has been incredibly supportive and brings technical expertise to the table as well. we can work effectively together as well and we are working towards the same goals. i hope they continue to do that. it does need to be flexible. we need to trust people to use good judgment and we can look after patients. >> i think one of the benefits of the p. cast report in the structure that will include external stakeholders be included and i certainly agree with that external to the government and the input is needed and that may help keep driving the process. >> i think it's absolutely possible and impossible. i would also like to say we want to be part of that discussion. we believe it does take a different way of thinking and we have to link the testing that

doesn't necessarily seem palatable. it is no accident breast cancer is almost a curable disease. many bone marrow treatment. the incentive for a runner to innovate in those areas. if you don't want this to be an accident, we need to design the right incentives. >> we need a billion dollars incentive enough for companies. it is hard to write what you'll need in 10 years and legislation when we don't know what the diseases will actually look like. barta is a wonderful model. one of the most encouraging things i took yesterday was a significant funding proposed for part because they can contract given flexibility based on what is happening now. the only other person is not in this room are the payers, so i'd like to see blue cross and blue shield insurance companies, medicare pay for performance, pay for value.

let's pay more to keep it valuable. >> is no single solution here there are things that congress can do now and do quick way. there are places where there needs to be continued collaboration. i think we seen that with fda and companies in stakeholders in the pcast calls for more of it. they're a basic questions that are not academic questions, the question software i have been effectively working together. not just with our money, the smarter science. very things we can do to move this along. >> i think we've talked a lot today about the history of resistance and how we got to this point. there's already tremendous or flexibility built into fda's regulations already. when fda cannot in 1971 when adequate study was from other pharmaceutical companies immediately sued. one of into the courts, the courts found the regulation allow tremendous flexibility for

fda and how the studies can be designed. what we are trying to say this morning and dr. evers then has brought this up several times. really what we are trying to say is that they give perks for companies, not to be for performance, not perks for potential, that the study should show as stock religion showed in his decided that if it flies in the people we need to use them in. >> i want to end on this. the mackinac one additional comment? >> yes, you may. >> i want to get back to the point of art i've been a good model. in a i.d. could serve the parallel role of helping to develop drugs for things that part is not applicable to. they do have an antibiotic resistance leadership group whose task is to help design trials for antibiotic resistant organisms. but the model is a good one. it does not necessarily carry it

out. >> and i appreciate that. i obviously say that he is, then he is -- this raises my eye every now and then ,-com,-com ma too. these are perks. , these guys raise capital, suber is, employ thousands of people and pay taxes. so they are the ones who are raising the capital and assuming the risk. if we go down the route of trying to beat up corporate america in the process, we are not going to be friends. we will be de-friended and we can't hear but got we can't hear but got to be a to be a nest to be in this together and without a yield back my time. >> the chair thanks the gentleman from georgia to make a point of clarification. >> mr. chairman, thank you. and i don't disagree. in fact, i do agree with the comments from my collie, the gentleman from illinois,

mr. shimkus. but i also want to let you know that the concerns you expressed in your testimony are not lost on me at all. i don't think other members that committee. and also, the ranking member of this house subcommittee, mr. pallone and his concerns about labeling. that is not lost on me either. and staff is working almost as we speak on this issue to try to get that right and laid those concerns. mr. chairman, this has been great. those panels. dr. woodcock, we are so grateful to you and i like the other members that stayed over and didn't get an early flight back to atlanta, i am grateful that i stayed because this has been most informative and we are deeply appreciative. thank you very much. the mac to chair thanks the gentleman. i would like to say it's good to

hear the collaboration that is occurring between the public and private sectors. that is so important. i might mention dr. woodcock has been before this committee many times that she is one administrator that always stays through the whole hearing and you should be commended for that. we thank you for your responsiveness. other members will have questions and we will send those to you. we ask you please respond promptly. i remind members that they have 10 business days to submit questions for the record. that means they should submit their questions by the close of business on friday, october october 3rd. very good hearing. exciting, very informative. thank you for your participation. without objection, this subcommittee is adjourned.

[inaudible conversations] >> arkansas' two-term democratic governor is term limited and two former commerce men, mike ross and republican asa hutchinson are running for governor this year. they have debated in little rock. here's a few minutes of that debate. >> let me just come back to what mr. ross is speaking now. you know, he is talking about an ad for an out-of-state group that we don't have control over. the ad in which mr. ross himself attacked my character. whenever i look at that happening, is this encouraging 18-year-olds to vote? doesn't encourage people to participate in the political process? we have an obligation as candidates to make sure we encourage people to say public

services good and negative advertising doesn't work that way. so i can't control the senate rate. i can control my own message and that is what i want to do. mike is right. i mean, it is about our vision for what we'll do for middle-class tax cuts, veterans will want to do. >> wait a minute, you want to say for me. he says you can't control ads being run by the governors association unfairly, untruthfully attacking me. when he came out with this sad, my wife is a pharmacist who she's been 14 years going to work everyday building a successful business. she would get up at midnight and get medicine for sick kids. it is america. she sold her business for profit in america. imagine that. he attacked her for that. for him to say that it's not me, the republican governors association, you know when that began airing? from the chair of the association of denmark are raising money for the campaign.

he could've said this is not fair. the democrat gazette has done to editorials. the committee has reviewed this like seven years ago and said there's no truth to it, but he didn't. he let them continue to go ahead and go after my wife and i think he is my wife an apology right here right now. >> mr. ross, do you control the democratic governors association attacking me? you know better than not. of course i have no control over those ads. i don't know anything about the facts. i'll let you answer those questions. i have never, ever attacked on that issue. if you remember me attacking remember me attack remember me attacking the one that point anyway come you saw me right now because i have not. >> that debate from the arkansas governor's race was one of her than 100 campaign debate c-span is airing this election year. thursday at the bay from nebraska's acting congressional district.

incumbent republican retailer is being challenged by brad ashford. you can see that live thursday night on our companion opera, c-span. >> last night the u.s. launched airstrikes against fighters in syria and today the bipartisan policy center hosted a discussion on the threat from isis and other terrorist groups. we will hear from a former state department and national security council officials as well as terrorism analyst peter bergen. this is an hour and 15 minutes.

>> thank you. i am catherine herridge. thank you for being here this morning and be invested in our nation's security. you were all very familiar with our panelists, but i am going to give you a brief thumbnail sketch of each of their backgrounds and then we will launch into today's discussion and there could not be a better come as there was a tv news that they pay for this discussion will be seen overnight with the targeted strikes in syria and not only the targeting of isis, but also a group which has been very focused on lodging plots against the united states and specifically the aviation sector. immediately to my left is peter bergen. peter bergen is the director of the international security program at new america. he is a cnn national security analyst and as many of us now, peter is bit more best-selling books about al qaeda than anyone else. thank you for being here today, peter. mary habeck is immediately to peter's left.

she is a lecture and strategic study at the johns hopkins school of advanced international studies. thank you for being here as well. and then here is that the islamic world project at the brookings institution. i would like to begin with you. one will look at the overnight strikes, was specifically caught my attention was the degree to which we have information about a specific group within the area. for a layperson, what is the correspondent group and how does that reflect the current predicate the u.s. domestically and also western targets overseas. >> thank you, kathryn for the invitation to write this report. i want to acknowledge my co-authors in the audience, emily schneider, david cahill for your question. so the group i think u.s. intelligence groups have been tracking a group of guys and a

lengthy history in terrorism in history are prettier from the tribal region in pakistan. to syria who were sort of an over generation. the word was actually used, we mentioned the group in this report, which this report we had to finish up some time ago because the publication schedule. it of course is the nation word for the area now in afghanistan so this is moving into this area conflict. if you think of isis has been not qaeda and iraq has never had not qaeda target outside of iraq

since 2005 when they attacked the free american hotels. so in terms of a group that actually has a real desirability track record to attack the united states, the cordon is that group. we had an audiotape inciting people in the west to do lone wolf attacks within the last 24 hours. >> the concrete threat to the u.s. in the aviation sector in a way that isis is not christ on train across the threshold. >> so would've been nine years since al qaeda anorak launched the attack on the free america. it was a spectacular failure for them because almost all the victims were attending a wedding. zarqawi, the leader in iraq have released an usual statement which was almost like an apology. it wasn't a real apology.

so, yeah, that is exactly right. this is the group that has the record and of course there are indications they link up with people of al qaeda in the arabian peninsula and sharing on making expertise so that explains the strike. >> one of the things i've learned through my reporting is there is a bomb major in yemen. this is the person who is an expert with nonmetallic explosives. he was behind the underwear bomb in 2009 over detroit, also these cargo printer cartridge bombs the following year. i think my panelists would agree u.s. intelligence community believes he has been very persistent in trying to develop or evolve the technology to circumvent the new security put in place. so my question to you is given that we understand our theory

has trained some apprentice is to go into syria. what is their intent? is it to develop the bombs further? to find meals to carry the bomb. in layman's term, how would you experience that? >> to understand the nature of the threat we are facing from this group and also somehow involved with the corson group, we need to see that this is one of the few times where we have watched different affiliates within the greater al qaeda network work with each other in order to carry out a specific kind of threat against the united states. so, we have other sorts of places we can lock in my day have been cooperating or coordinating with each other on local issues. so there's also reports of

shabbat members around africa or even over in yemen helping out with the fights they are. you have also reports that a few i had pretty much all over north africa coordinating with all sorts of different groups. but this is the first time we've seen a specific plot, specific threat against the united states were two different affiliates are coordinating with each other. so it's very purposeful. but this is not the only place right now we are seeing this. we have also had a threat from both a q. i am together against the united states for their attacks on isis. this is again unprecedented that we have these huge groupings of affiliates that call themselves are called a s. affiliates. call themselves branches, threatening to carry out attacks

against the united states. >> i want to bring you in. how do you make the distinction if there is a distinction between a group like corson, which has members which i would call traditional al qaeda or ties to the old guard of al qaeda and the news throughout france, which is in syria and is a group that at least shares the same goal as the united states and its allies, which is to topple the regime of us thought. >> so i have a very minor minority report compared to my colleagues here and i'm sure they will correct me as soon as i say what i'm going to say. >> will jump in first and then bring the rain, mary. go ahead. >> so, the corson group, the

name we've been told of this group, i don't know if it is what they call themselves are not is part of the news throughout organization in syria, which is a direct affiliate of al qaeda for the past year or so. previously it wise to remember a part of the islamic state in iraq and broke away so it answers now directly to al qaeda. or what i have read in the media and i think a lot of us are just getting up to speed on this group is that it is part of the old guard. many members for the al qaeda branch that is camped out in iran. this branch is fascinating. we don't know a lot about them. we know from private al qaeda memos that have come out over the years that they did 18 a major logistics hub in near ran. it has been set in the past that a lot of these guys were under house arrest in iran. i don't know if that is exactly

the case. they seem to have had a lot more freehand than we've understood previously. they're often a direct indication that al qaeda leadership inside pakistan and afghanistan. it seems like a number of these members are the ones who went from easterner ran over into syria are coordinating with al qaeda. so these are folks who are used to taking direct orders from al qaeda in carrying out its bidding. and it is interesting to see to your question the united states government in the few statements they've made about the corson group has downplayed the fact that it is embedded inside the nusra find. i don't know exactly what make of that, but they seem to be making a conscious decision about these extra operatives focused on attacking the united

states and nusra itself, which seems to be almost exclusively focused on toppling the assad regime. i don't know why that the sanction is being made. i only know that it is fair. >> go ahead. >> so actually, i am finding myself in agreement with will on this issue. or is a very tight connection between nusra and that was a rare group. the fact that there are press reports, that the airstrikes being carried out are not just against isis, but against nusra specifically to get the group i think is telling. i also agree with will that this is a group used to taking direct orders from al qaeda central. in fact, one could make an argument that they are al qaeda central members who have relocated themselves to syria. it is very troubling, but it's also not the first time we've

seen al qaeda central leadership in places other than afghanistan and pakistan. for instance in yemen or the arabian peninsula. we've also seen some of these members. so i think that this is a problem of our definitions really. between what is nusra and what is al qaeda central leadership. the two are co-located and working together, what is the distinction between them? >> peter, i want to bring the same care what does this tell us about the reach or the influence of what remains of the al qaeda core? >> well, it probably tells us the american drone program in the tribal regions was pretty effective. i mean, if you take the same documents that will refer to that i think is very ambiguous relationship to al qaeda and iran had with the irani regime,

the same documents made it clear that bin laden was very concerned about the program, so much show that he was urging al qaeda to move to eastern afghanistan, which is heavily wooded and therefore far for american drone's to be effective. so, one of the themes of this report is al qaeda has sorted effused and i think that's good news and bad news story they are. al qaeda or its affiliates are present in more countries. they were present in syria until more recently. for instance, 16 countries that we find in this report compared to eight in 2008. but it is a question for everybody on the panel, including you. institution of itself an issue that we should be concerned about? the concern -- the commonsense

answer is yes. if you think about it more carefully, the time al qaeda was the least if used in the history basically existed one country, which is afghanistan. so diffusion doesn't necessarily mean a greater threat to the united states. many of these al qaeda affiliates are preoccupied with what is going on locally. i mean, as mary just said, you know, is nusra is more focused on the assad regime, is that focused on the united states. as corson is focused on the united states, that is a problem. it's an interesting question. does the existence of or affiliate has a greater or less threat to the homeland? >> i was going to take a question as moderator, which i will dangerously i would add that i think peter has hit on an excellent point because the

issue becomes the al qaeda core to me that based on my research and reporting is much more of a movement or a set of ideas, which can be adopted by regional groups who may not share the same end goal as the enemy ussr enemy. at what point does across the threshold and then become a strategic threat to the united states. i think they stunned the data and the open source reporting, it should cross that threshold when as mary has pointed out, you see in syria are these groups from different regional organizations have made a decision at some level to work together with the focus eating class against the united states.

so for example, you can same argument of poker run has identified itself with the al qaeda ideology, but at least based on the reporting available now has not taken it that additional staff to target the united states proper, the homeland. but we see this distinction now in serious specifically with a q. a p., which is kind of become one of the driving engines of the organization now in terms of and power and training. like if you've got the well, we have got the people to help you execute it. that seems to be where a piece of my reporting where the two intersect. ..

you still have an al qaeda central which is still trying to carry out plots against our

allies in the united states. this is an example of what they want to do. then, you have their affiliates who are also locally focused but some of them will also take their action to go international. so a.q. a p. both locally focused and willing to carry out attacks against the united states. then you have a splinter group like say the islamic state whose broken away from al qaeda, has the ideology that is much more focused unless we poke them with a stick. then, you have what i call the little helpers, all of the groups that have popped up everywhere. they have the ideology that they don't take any direction direct commands from al qaeda but the willingness to share resources and personnel. then you have a number of militia who don't have the al qaeda global jihad ideology but share a lot in common theologically with al qaeda but are more nationally focused and willing to take in specific al qaeda members into the ranks.

the u.s. policy community has to disentangle all of these and not all of them are covered. so it is clear it is uncontroversial that the unbeaten authorization for the military force and the attack on the group that is well within the ambit and the wall is basically the group that attacked us on 9/11. it is a little bit less clear it was interesting to me that the strikes there were on the u.s. strikes against and then the five arab countries also engaged against isis. it seems there is clearing going on in the national security council and i'm sure she knows

the kinds of lawyers that work in the white house and how clever they are but is it really legitimate? in this authorization is not a nato authorization and there is no arab league authorization. this is a coalition and not a very large coalition although it has a lot of arabs. >> one of the things that has been pointed out as there is a definition here. what precisely are we dealing with when we say al qaeda? it has been my assumption all along that this administration is backed up by public statements and follows to the letter of the law. that group of people who carried out 9/11 so if it is limited for

the people that belong to al qaeda we have a serious problem with definitions. if you don't redefine what you mean by al qaeda, then under the ams we have no right to carry strikes against them. there is a separate authority that you have to carry out attacks against eminem threats and this could fall under that eminem threats to the united states, but i'll qaeda itself is defined as a tiny little group that we basically wiped out and it leads to language like the strategic defeat when many people around the world say that it looks like we are not talking about strategic defeat so that needs to be dealt with. >> just on that point when you look at a group if you want to be creative in your interpretation of this original or foundational group of al qaeda, what you can see is that there are connections. after all, he who was tending to bin laden is now within aqap

who's been the the course on the group, so if you want to really sort of pull the thread i think you could make the argument that there is a connection although the third cousin once removed by marriage or however you want to look at it but there still is that connection. and then when you look at this is someone and correct me if i'm wrong his connections to al qaeda predate 9/11. this is part of the facilitation and now he has been in this area. but the larger question here is a question of definitions and distinctions and whether we are putting ourselves into this vicious circle of trying to find

the definition when we look at the thread asked your report has found out it is more diffuse and it is under this broad under allah, but it doesn't have that kind of top-down fortune 500 leadership anymore. >> i want to return to this question because, okay, so we are at war with isis just devoted itself from al qaeda and amiri said that his administration who uses a narrow definition on the list, so it seems to me that when we did the first strikes there were two arguments being made by the administration one of which was the imminent threat or argument and the other was the genocide argument, so the question is what -- the president on the article to authority as the commander-in-chief is a very reasonable standard.

now we have all agreed that isis, the administration has said repeatedly j. johnson, matt olson, there is no evidence they are planning an attack on the united states and you can't use the imminent threat argument with isis. what is the argument that has been used? the question hasn't really been either asked or resolved. >> i don't and i don't know why congress is impressing the administration more. when they come back from the recess they are going to be saying wait a minute. >> there is a legal justification for this. we have seen about 150,000 kurds

and other inhabitants as we head across the border into turkey. and we have to wonder if there has been a serious threat against that group in northern. isis wants to control the borders because then they control the flow of the foreign fighters and all sorts of resources. so i can imagine that there is a threat out there. people do not flee in the hundreds of thousands unless there is a serious threat. >> i want to focus a bit on the homeland in light of what has happened overnight. do any of you anticipate that homeland security they would put out a bulletin warning that there could be retaliation for the strikes is that one of the issues that has to be considered or factored in, and if so does isis really have that capability

and at what level plaques >> i don't think they have the capability just by virtue of the fact that they came out with a lone wolf attack and that is the sort of last play of the desperate terrorist organization that doesn't have a lot of cards to play while they develop the capability over time? probably so. particularly any of the other factions that are favorable towards the islamic state but i don't think they have the capability in the near-term to do anything in the american homeland. i would be more worried if i were a european country. >> now, why does that, just because they are closer and they have more fighters? >> exactly there are thousands of europeans that are fighting inside of serious and it's much easier for them to get home and have an ocean between us. we have far fewer people that have gone over. >> but when you look at the data

you see to me what is a remarkably low number of incidents so far of individuals to travel to serious and then come back to their home country and launched attacks. is that because we are at the beginning of the conflict? we don't know what the unintended consequences may be of the current actions or do you belief that there is something at play in the psyche of these individuals so that they are going to carry out versus coming back to their home country. >> i think that you've identified three possibilities one of which are true. for a lot of these guys we've seen them try and to join isis. for many this is a one-way ticket. there are people going to serious from the countries with

no battlefield experience and some of them have a small meeting so we sold it to the floridians from very elysian florida. we saw the two americans died from isis and the colleague. so this is a very dangerous work. if you look at the numbers that are being killed in the iraqi civil war into this eerie and civil war it is 200,000. that is the same number that took ten years of the iraqi civil war which is about three times more dangerous than the afghan civil war. is it 12 times more dangerous per capita. so it's a very dangerous place to be. people are going over there and they are dying. and they want to die for the people who were going over there. that is one factor. another factor is we are aware of this problem and this is an incredibly important -- al qaeda had a branch office on atlantic

avenue in the early '90s. it was called the services office which is the same name that bin laden called the service office and so they just didn't know that they were going to be a problem. we are very conscious of that now and it's very interesting. i wrote a piece in the foreign affairs in 2005 but said there was going to be blowback because the firefighters were going in. it just didn't happen. another is a big difference between serious and iraq. according to the british government assessment that was provided to me for cnn, there were at least 2600 europeans. it's very detailed account. there are 25 times more birds if you address the population that has gone to serious and americans and only a dozen have joined isis. if you drive to damascus in a few hours you can -- it is

doable. we are all over this like a wet blanket right now as is every european government. i will add one other point. what we are talking about is a very obvious one. all of this happened on the obama administration watch. you cannot assign -- i think that is one of many reasons why the obama administration is very upset about this. you can't say this eerie and civil war happened under president george w. bush and so there is a huge government a letter to -- effort and the only way they can succeed is what we will mention which is encouraging the lone wolf attack by somebody that thinks isis is not somebody that's gone into serious about this guy that was arrested in rochester new york and by the way he was an

informant so it wasn't a real plot it was some degree. >> if one of the avenues is to inspire people here in the united states who hasn't made the trip to serious and iraq that brings me i think to me into the next important plank of the discussion which is the youth of the social media. when i first wrote about this four years ago i talked about it as the lifeblood of the new digital jihad because my information has been anecdotal, but before 9/11 you have to had to have this kind of one-on-one contact to cross the threshold but it now seems that if you had grown up in social media and you are able to establish a much more intimate contact in the virtual way that allows you to cross the threshold for there that means you make contact to

get your self to turkey and then to serious or to take action at home. major test on whose held out the ultimate case at home grown terrorism to me is really an anomaly. he had internet contact with the clerk and and lara lucky which is well-documented, but if my memory serves me correctly he was 39 at the time of the attack and he also met at his mother's funeral so he had some kind of personal connection but when you look at the home-grown cases almost everybody is under 30. and if the majority are under 25, so to me there is something really going on here a fundamental level in terms of how this message is able to reach people. so, peter based on your observations, is this a way that isis has been able to show that it's part of a new generation of

jihad versus al qaeda that seems to take so long to respond to the current events? >> it was the first social media war and i think that it was an important point to be made. one of the reasons that the social media gave the illusion we understood what was happening in serious, you know, conventional journalism wasn't really happening so there were exceptions. it's very dangerous to get in and we in the media were overreliant, the social media is incomplete so from the journalistic point of view i think that it is a crutch that we've over relied on and from the isis plaintiff view when he

released the 55 minute tape that al qaeda was going to establish itself in total nonsense, it was the most boring 55 minutes lecture with static camera shots. it couldn't be worse tv. one of the reasons it is very good tv and that's why that cable news networks are showing a lot of their material. i think that cnn has made a very good decision to not air this appalling lecture by the british hostage. that social media is very aggressive. >> my feeling is the same as

peter. it might be because first of all the appeal to the they appeal to the younger generation who is sort of amherst but the second thing is that al qaeda central or the al qaeda leadership has a vision of themselves as the doers. so his name for himself or the name that people have given him is the wise man and he is maybe not the most charismatic but he is the smartest guy in the room and so the formation of the all qaeda comment is an interesting example of this. it's very poorly done. but immediately the group claiming to be connected to carry out an assault against the pakistani port and managed al

qaeda then put out a statement that is full of all kinds of policies claiming credit for this and saying this is the first of what they hope will be many attacks so i agree they don't know how to do this anymore. they used to be on the cutting edge in the 1990s with cassette tapes and things like that but today they have fallen behind but that hasn't stopped them from being infected. >> affected in what way? being able to insert people they had historical relationships with within the groups that advocate of the body to attack the united states, so i'm thinking about the arabian peninsula and the group that's

now in a serious. >> they call it unifying the rank. there is no doubt that a lot of these groups once had simply local kinds of grievances and local objectives and had no reason to be attacking other countries with the countries with whom they don't have some sort of a personal beef with alone the united states. since the 19 '90s they spend a lot of time figuring out how to make appeals to other groups and talk about the envoys that went off to algeria during the 1990s is interesting for the later development which became an al qaeda affiliate in 2000. so you know, when you're talking about al qaeda in the subcontinent tonight we are talking about a lot of groups that have local grievances but somehow they've been talking to joining up with all qaeda with

the more regional vision. >> it seems to me that it's been almost a decade that we've been talking about al-shabaab and somalia and many of them are naturalized american citizens but the young men man from the minneapolis-st. paul traveling over to somalia joining al-shabaab yet we haven't seen the reverse and to me it seemed and i don't know if he would agree that it seemed to take a long time to reach the point where they launched the attack that is a western target. people have been talking about this country for ever since 9/11 so there does still seem to be that the disconnect.

>> for lots of the kids whether you think there are 40 or 30 it was a one-way ticket. we've had three or four american suicide attackers some of them just got killed in the war and it was also a very dangerous war. some of them got arrested in african countries or western countries as they try to come back and none of them had conducted or even tried to conduct any kind of terrorist attack in the united states. a number of them are still missing. they may be dead. we don't know. so, there was a lot of concern if you go back to 2007 about this cohort and nothing happened. it's not a precise analog because the difference is that they were overwhelming the somali americans. it is much more of a religious

sectarian battle but the fact is nothing happened and so far in this union civil war we've only had one attack in the west which was on may 24 of the at the jewish museum in brussels which killed four people. so the war can go on for a long time. but we have only seen one attack so far. that goes to the fact that every government is very concerned about this and they have tried their best to get a handle on this problem. >> i want to open it up for questions. if you have a question, raise your hand and identify yourself. and as my old journalism professor used to say, eight words or less. bottom line up front. they they're in the back please.

>> [inaudible] >> there's a microphone right up there so we can all hear you. my quick question, comments on lebanon and how it's impacting the current fight. he just did an article by hezbollah which i thought was interesting. there is a small contingent of the militants have made some noise for many years but there are not a lot of them. there were fears early on but a lot of this contingency was going to be activated by the war in and that the whole society.

and the more that increases but i've been really surprised at lebanon's resiliency. in the islamic states they tried to keep the hornets nest and stir things up. so far, so good. >> just a comment on the attack over the weekend it was reported by the government news agency that hezbollah deployed to drown against the base on the syrian borders and in fact we are not sure how it is legitimate or if it is legitimate or not on the

attack. of them on state has used the drug in the combat successfully, and i think it raises some pretty big issues for this discussion because this is not the end of this and if you are a western country with the advanced system the drones are not a problem and in fact the air force could have shut down the drugs if they chose not to. however, if you are let say some kind of a western target somewhere around the world in the country without those things and the militant organization requires the armed drown, we are in a whole different set of scenarios and the number of relative organizations have been using sophisticated surveillance drones. isis used one last month and it is a base in 93 that they

surveyed running against qaddafi for the canadian company and hezbollah and hamas have been using surveillance drones. .. this is before the airstrikes in syria. i would like everyone to give me their assessment as to the efficacy of drums