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tv   Politics and Public Policy Today  CSPAN  March 2, 2016 9:00am-11:01am EST

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had an office where that powder was sent to multiple government offices that were receiving it which terrified that employee who opened to mail not knowing if it was anthrax or just a powder. i have to tell you i thought not to resume federal service. it is a world map and a blueprint. it is in part on the basis of which congresswoman and i introduce 3299, the strength and public emergency response after 2015. i want to talk about that
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because i really appreciate all of these recommendations. i encourage my colleagues throughout congress to read this book because you as experts talk to experts around the country as well. it's not just the people on the panel. a lot of work went into this. i commend your work. can you contract the merit and can you talk about the importance of that and what has happened and why we're not able to get vaccines and our medical counter measures through the pipeline as fast as we need them? >> thank you. orangeally, the contract authority was rebarted and changed. it was moved to the office and office called the the acquisitions management and contracts office. the problem is the technical experts are not there. they are in fact at barta.
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in fact, because of certain regulations there's a firewall between the two and sometimes they can actually not speak to one another. imagine how frustrating it is for a accompany trying to get a contract and talking to folks who know a lot about contracts but not the issue, about the medical counter measures. i think it makes all the sense in the world to eliminate that level of brou bureaucracy. >> thank you. with respect to the companies trying to get zac seens into our stockpiles, can you and doctor talk about the fact that we don't have a sufficient coordinating mechanism in our national strategic stockpile also identified. we don't even have if i'm not mistaken the right coordination between cdc and barta to have
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the right zac seens in our stockpile. can you talk about that? >> yes. we made recommendations in that record because the system is weak now. thank you for your leadership on this issue as well. >> thank you. mr. greenwood, any comments back to the stockpile? >> it goes to the essential point which is that we are not organized as a government to effectively and quickly respond to either pandemics or bio terror because the authorities are diffused and don't talk to one another and that is exactly what a central unified plan, sta teej rancic plan, essential budget and giving the authority to the vice president makes all the sense. >> i think citizens believe and know we have these stockpiles and believe that they are adequately filled with the
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proper rights of types of vaccines. would anyone else like to comment on our national strategic stockpile? >> i'm the share on the spock pile for now and they've made tremendous progress. the problem with the stockpile is the new drugs going into it are largely biologicals and they're very expensive and expire in two or three years. there's a pipeline of new counter measures that come in and increases the cost of the stockpile and everybody's budget is staying flat. so the limitations on the measures we have in the stockpile first of all are budgetary limitations. this is an expensive proposition. the stock holds the stuff. we're talking about having to cover multiple cities with these
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sometimes very expensive drugs and vaccines. we need a cheaper way to do it. you're never going to be able to create a stockpile that has everything you want in it against every contingency. we have to move to a strategy of being able to quickly design and manufacture its scale, what we need. >> thank you chairman and thank you for the witnesses for being here. i first want to thank you for this report. i'll you the more i learn the more i wish i wouldn't read it. it looks very troubling when you understand the false security we
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have even from something sympathy and dangerous like the through to the most serious threats we're facing today. in particularly the weaknesses we have there. following miss brooks here, i want to get more indepth about what you see is some of the recommendations. don't get into it too deep. just one or two we can work on in the committee here. >> i think dr. otool is the one with the stockpile. it doesn't cover everything.
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it was a good idea at the time but constantly having to renew it is our biggest challenge i think most of us think there's other issues we could address and certainly scientific issues that would give us a longer life in some of these areas and i think on the production side tara, our ability to produce something faster and not being totally dependent on the stockpile is probably where your iom conditions are. >> yesterday i had a meeting with some bio defense individuals and they're telling me there is something they're looking at that would extend the life of the, the shelf life through maybe a dry freeze, is that correct? and then also they're retesting it too and some of it that was designed will go two or three years and last as long as 15
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years. they're constantly retesting it. how do we dispense it and get it out? having it in a stockpile is okay. >> one of our recommendations was to use the existing community pharmacies. the original idea was to use the v.a.'s because they're spread across the country and do keep a certain amount of supplies. the government has also contracted with fed ex blue pallets around the country. the reason is because the military is not well situations to do that kind of thing. i think the contract was with the fed ex to move pallets around the country when there are outbreaks.
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>> the big problem with the stockpile is traversing the last mile. it's not about the health the presidents. it's about getting it in the hands of people. that dispensing function is very complex. washington state is going through the final six. that won't work in every state. particularly rural states. although, most americans live within reach of a pharmacy. advanced employment is being used in those very few states that can move quickly to dispense such as new york city. one thing that would definitely help is more money for the state and local health departments to do drills on dispensioning. these are value usual and time consuming and expensive. they don't have the money to do them. making it a more viable way to
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practice would i think make a difference. >> that's a great reck menation. i was just discussing this with one of my colleagues yesterday. it seems that work is just disappearing. with centralized leadership focus work on how to solve that last model of dispensing the medical count of measures. we need that. it's one thing to have a stockpile and one thing for fed ex to be able to get it to an urban center. actually getting it into people's hands is a huge unsolved problem.
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>> thank you, i'm out of time. appreciate it. >> good morning and thank you to the panel for your terrific work on this important subject. the folks at the university of miami were so appreciatiive and everyone across the country for your service. i know they misyou there. it's great to see you continue on in your service. during the ebola outbreak in 2015 we looked at that time preparedness and the important roll at biological dispense. the president requested emergency supplemental funding the record ebola. the congress responded now with zika we're having to do that
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again. this doesn't seem to be the most efficient way to prepare for emergencies. i would like to ask a few questions about what we can do to assist the hospitals throughout the country and their response. we had some very well prepared. emory university, what a terrific job they did. nih was at the forefront in the ebola response. some did not do quiet as well and there's no mystery that if that had been more serious that a lot of hospitals is cross the country would have struggled. what lessons do you think we learned from this? from the ebola outbreak in africa and the few cases that came to the u.s.? i would like to ask maybe. >> hospital preparedness is
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important. i think between 2002 and 2008 it did improve for two reasons. first of all, disaster response drills are required by the hospital crediting facility. it's expensive and difficult. there also was a cdc, hhs. in my city, 2001, baltimore, the mayor for the first time got all of the ceo's of the hospital together in one room.
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that funding has been cut in half since 2010. that makes a big difference. >> the panels report mentions that the disease preparedness funding is the most efficient and costly manner to fund preparedness. what are the alternatives to disease specific programs especially since many states have frayed their public health infrastructure. how can we respond better and give the hospitals and our local communities the tools we need? >> we have specific recommendations of this area including a steady stream of funding. we recommend it be done through the creditation system.
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every hospital cannot be prepared for every complex disease. both the regional coordination but more importantly identifying those hospitals that can have special rooms set aside. in florida, for example, all of us looked at particularly at the great public hospital in miami whether we could build separate rooms with separate access to handle ebola patients and went through an exercise to make at that possible. creating a tiered system that would have the capacity and separation to be able to handle these diseases is certainly the way to go. we have some specific
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recommendations both on funding, on the acreditation process and in particular on creating a tiered system in this country that would give us coverage across the country. >> thank you very much. >> thank you. >> mr. cramer for five minutes. >> thank you mr. chairman. thanks to the panelist and i'm going to, i want to focus on this incentive issue congressman that you've raised and i will admit right up front what i'm about to do is dangerous. i want to think out loud for a bit and also admit you're not going to adequately inform and educate me in five minutes. you're going to have to come to my office and help me work through this idea. you've all done a great job as has the blue ribbon ponl anel i scaring me to death.
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i'm add kwatly prepar-- adequat prepared to understand the threat. part of why i think you don't see congress acting or the government acting proactively is because we respond to the people we represent and they will blame us when we're not prepared and they'll blame us when we spend money foolishly and of course, we're talking about finding a way to invest in something that we hope is never needed. so that's our political dilemma. congress greenwood and others if you want to weigh in, elaborate more on the prb how we could help pharmaceuticals and the private sector feel comfortable with the investment and innovation and we've talked a bit about it but if there's a
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way we could elaborate more to better understand. i may sals emphasize is there a way to put a cost benefit analysis on this? for example, talking about emergency responder, that's a cost takd be avoided, perhaps if we're better prepared. has there been work done in the arena to help. >> thank you for admitting we frightened you and obviously, our con stitch waits are not clammering for this. i think to some extend
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leadership involves inl forming your con stitch waits and this threat is real. i calculate when it comes to bio terrorism over time that's going to happen. you have to believe that. you have to believe that's the threat is real. in terms of what works to be prepared, we talked about the conflict reform which is a minor thing and important thing and brooks is the leader on that. we've talked about the need for there to be sufficient funding to actually procure these mcm's when they're developed.
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when it comes to actually developing the product and manufacturing the product, private sector is the only place that's done. to invest money in that, the companies are willing to take the risks that maybe they'll fail at the science but the investors are not willing to take their risks that if they succeed the federal government is not going to be reward them by precuring the product. that's critical and you need enough money and money over time to be certain so there's a certainty that when you get to the end of the road and you get your product approved that congress hasn't moved the money around and it's no longer there. >> i appreciate your national defense analogy. i was thinking a lot about we spend billions of dollars on weapons we hope we never use. there's a benefit of being a deterrent understandably but it
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isn't dissimilar. we have to constantly make this case. i thank you for that and the centralized leadership as well. i'm still struggling with the whole vice president thing myself. the more you talk about it, the more sense it makes. i appreciate that. is there anything else anybody would add to what i said. >> i would like to add a little bit. we heard many of the companies contributing to the defense and those bringing the more innovative collusions are stug ling themselves. >> i've been encouraged with announcements to use authorities they have.
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>> i think looking at other things and contracting that could make it more readily assessable that the innovative bio tech companies would do business with us and the government is something to look at. >> thank you very much. if we could solve it in this that would be a bonus. >> thank you. >> we could probably have them aud at this timed if we could solve the d.o.t. contracting. the blue ribbon study highlighted penalties and emerging and reemerging effected diseases which could cause catastroph catastrophic. many people died of.
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the market forces worked. in 2012 this committee passed and congress passed the gain act and again, this current session in the 21st century we work to remove the financial and regulatory barriers and antibiotics and drug development. secretary, can you elaborate these recommendations are insent vising for emerging infectious diseases. specifically, please explain why there's a need for the government leadership to play a roll in this space.
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>> it's the private sector market for these particular biologicals. jim can explain this better. these are relatively small companies often with a small number of products. we've known a lot about the industry. they're fragile. so unless they know they're going to be reimbursed for the cost of development, unless there are financial incentives, i don't know how we're going to move very quickly in this area.
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we've had experience. congressman in the orphan drug act, we had a lot of diseases in which they were very small markets at least initially. and the congress in its was passed legislation to encourage companies in creating drugs and treatments for vontae small part of the population. our problem here is we start small and then huge by the end of the day. i don't know how to do it without financial insent evidences. i think everything we've learned, it's not just that i'm a capitolist. it's from our point of view and a public policy issue when the market is going to be the government there's no other way to get up a very small number of
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industry people to invest unless they know there's going to be a market at the end of the day. >> jim, welcome back to your committee. >> one of the proposals we have is the priority review voucher. these diseases that occur in places like africa, the countries are so poor they can't afford to buy the products. investors start putting their money there. what it does is says to the accompany if i can get a drug approved, even if i don't make enough return on my investment from the procurement of that product, another maybe a large pharmaceutical accompany will pay me and these things are
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going only two or three of them sold but they go for 200 million, $400 million. that doesn't cost the taxpayers money either. by the way, it goes off patton sooner anyway. it still doesn't have a cost to society. >> thank you mr. chairman. >> that would be nice. recognize the.
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>> that woman from tennessee, i'm so happy to see an aggy on the panel. i've got aggy's in my family and they always bring good common sense seasoned wisdom. just a couple of things i want to touch base on. in talking with some of my research centers and in tennessee we have such an agrease i have bio technology
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group. they have a good underpinning. they talk to me a good bit about the right balance between government and regulatory oversite and then the ability to insent. mr. greenwood, i'm so pleased that you just mentioned the priority review voucher for this mcm's. i just think this is when you look at these medical counter measures, that is just so important that we have that. it's a threat, something like ziak, we have to have a way to go about this. basically, her point is you move tracts to a scale of ability.
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then if you need something you're ready to move with it. and can push that scale blt quickly. so let's go back to that voucher. mr. greenwood, and if you'll continue that conversation and kind of build that the importance of that, how you would address these for something that is a taerl threat let's go back to the importance of having this assessment for this type of occurrence. >> there's great uncertainty for a accompany. we've seen our companies and proudly jumping into this zika
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issue and trying to do reserchl on it quickly to review products. i remember a accompany, the member accompany of bio that was involved in trying to, it looked like it was close to having something on ebola and they almost didn't want to talk about it. the priority review takes away the uncertainties. it doesn't take away the uncertainty of can we make this product and will it be safe and effective? that's always a risk. i will tell you that doing that is harder. most companies fail and most projects fail.
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it's hugely risky to even bother trying. if you do try and you do succ d succeed, the only reason your investors are giving you the leadway to go and do that is because they think that somehow they'll get a return, fair return on that investment. one way is to have enough money in the reserve fund and have it there not just year by year but multiple years so the companies can know and the investors can know if we succeed here they'll buy the product and we'll get investment back. the priority review is an entirely different way to do that. because they have become so valuable. it is a huge driver. it's a huge incentive. if you can succeed, let's say right now, we had a priority review voucher. companies would know if they could succeed and if they not only would they have the great satisfaction of being able to spare people from this disease and god for bid more people born
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with a disease, they would have this voucher voucher that could take the marketplace and sell it at a nice return and use that money to invest in the next counter measures. so i think it's a no brainer to me. i know that there's some that provides nothing but benefit. >> we now recognize dr. burgess of texas for five minutes. >> thanks to our panelist for being here today. i apologize for missing part of the hearing. we're having our budget season. you'll remember what that is like. never a dull moment here today. i want to ask you because we've had several hearings over the
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past several years. now, just for context, my congressional career goes to zika long enough for people back home to say term limits but on the other hand there may be some value seen with some of this stuff over a continuum. but you reference in our testimony about the wonderful tests. the zika, it comes in at focus because okay, you got a chain reaction and only a few places can do it. it's pretty valuable and accurate. it's hard to get. you got to go through the health department to get it. there's an igm anti body but it will cross react with some other viruss so you're not really sure if your result is accurate. would you just speak to the regulatory hurdles you describe in your testimony. we in this committee have been
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studying that. there is a movement as you may be aware to move the regulation of laboratory development test from the lab improvement amendment which basically with the terms over into the food and drug administration and requires the basically the licensing of laboratory development test just as if they were a new drug or device and we know the problems with the time line of those things. so could you just speak to that briefly? >> yes. thank you for the question. first of all, the reason fda is so concerned about the diagnostic is because they have have consequences. we might want to think about the standar
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standards. >> it took me three years to get from doctor a list of the problems he was worried about with the development of laborato laboratory test. to his credit, the last time he was in here a few months ago he produced a list of 20 tests. every day of the week in a clinic's office. excuse me. >> let me narrow the problem down to tests that we need for infectious disease and in particular epidemics. we need a variety of different kinds of test. as you know, a very sensitive test when you have a low prevalence but you don't want that same test when you're in the middle of an epidemic.
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so it gets tricky. however, here's the problem. it's difficult to validate a new diagnostic against ebola or zika if you don't have those diseases. in my view, the government can put this in d.o.t., hhs or fda. the government should develop a procure rated bank of diseases about what they worry so that companies, especially these small fraj jill companies could come and test their diagnostics against them so that they could much more rapidly give fda usable data on how well their tests works. that's one. secondly, they have these during public health emergencies. we ought to think about emergency schools for diagnostics, which i think we can actually create rather rapidly and manufacture quickly during public. >> i will just tell you last
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year or 18 months ago during the peak of the ebola outbreak, i went to a hearing where we heard that the fda put a clinical hold on a drug called tk ebola that was at use and treated patients with ebola. i wanted to hear about clinical trials. it releaked and seemed like they were an obstacle. i want to ask you a quick question on your end and i appreciate your listing up the recommendations of blue ribbon tasks for us. it was street level, of course. i was sort of told you do three things to produce a list of 33 things. i hope it's not static because one of the things that we've worked on on the 21st century
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bill is a whole issue of electronic health records and if we do not address that fact in the recommendations you have, i think that's going to stop the ability for researchers and clinicians to communicate rapidly and respect patient privacy rights and at the same time we need the ability for rapid learning within the system whatever develops. we have actually staggered the recommendations to identify those we think congress should do immediately we very carefully
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laid out a strategy that would be workable for congress and the federal agencies at the same time. these are not just recommendations for congress. >> thank you, gentleman. >> thank you for allowing me to sit in on this important hearing. the communication subcommittee for homeland security, i recognize a need for the country to be proactive. i appreciate the ability to sit in on this subcommittee. they're the first in line of defense against outbreaks and attacks. you also said much of their
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funding through blog programs has been weakened. what should we do to make sure state and local entities respond to outbreaks and attacks? is there enough foe kicus on mel research and capacity for capabiliti capabilities? >> the states are really unfu
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unfunded. >> could you turn your microphone on, please? >>. >> we've lost about a thousand public health and state employees. that has to be properly funded. the tradition has been to have almost a block that goes from cdc to the states. i believe in that tradition and the relationship between the cdc and states and local governments to build an infrastructure because the cdc is not a lined agency. they are responsible for the identification for all of us in this country. we have to make sure
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infrastructure is beefed up and stays in place. >> thank you. >> next question. we all said the need for centralized leadership. what if any protocol is in place now in various state agencies when there's a disease outbreak and what exists in coordinating efforts between agencies. what makes coordination? >> well, i think earlier i talked about multiple agencies involved with an outbreak like this. while hhs has very strong responsibilities and has the scientific and public health expertise, homeland and the vice
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president to be the on going coordinator in this country because the lead agency concept no longer works when you have various jurisdictions involved and in particular when you need to work with the private sector with state and local governments unlike fema which basically can order people around. it's very difficult for one agency and i say this reluctantly because as a former hhs secretary i wanted to own the world. when you don't have proper jurisdiction to elevate the responsibility and we're much more sophisticated about the roll of private sector and the development of diagnostics and this all has to be part of our overall strategy in this country.
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>> i just want to add to that they want to exercise their own authorities. there are gaps between them. this will transcend all the way down to the state, local, private sector level. it's only if you have centralized leadership coming from the white house. however that's done is going to help break that and transcend that leadership. >> it's going to be more logisti logistics. public health, that's really why it's so important, this centralized leadership concept is so critical. everything comes back to it. the federal, state, local,
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private sector levels to close the gaps we've had between the local disciplines and agencies that have to contribute. thank you. >> thank you. i'll yield back. thank you. >> thank you very much. thank you all for being here today. dr., during the ebola outbreak there were weaknesses identified in our system we're now witnessing again. overall, how would improved surveillance strengthen our human disease outbreaks and make us better prepared for dealing with the epidemics? >> well, the majority of emerging infectious diseases come from animals. they're diseases that effect both humans and animals. we definitely need to do a better job looking at those hot spots where we are likely to see spill over from one species to humans. most of those hot spots are in tropical zones and in the junk
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ls of south america and asia and africa. most of our surveillance in the zones for starters. we have tools such as high speed genomics that would dwif us a much better handle. we ought to think about the surveillance. with the systems for starters. secondly, we ought to find much more rigorously the sda's existing program looking at agricultural animals. you know, modern methods of agriculture put sometimes tens of thousands of animals together creating our own industrial hot spots for spill over and we've seen that with the flu and the loss of turkeys and chickens in the past year. for humans, we have to have an approach to surveillance. we've spent billions, literally billions on surveillance in the
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past 15 years. we've done a terrible job at lessons learned. we ought to go back and figure out what really has made a difference. part of that is again we sound like broken records funding state health departments. that's where rubber meets the road. we have to help state health departments do a better job. diagnostics again critical, critical, critical, critical. clinical disease is vague. you're going to have a hard time figuring out what's going on at the beginning and ending of an epidemic. i would be very careful about investing large amounts of money in particular surveillance programs unless you know exactly what they're suppose to do and whether they work. >> next question was going to be are we doing an add kwat job of
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innovating animal health. secretary, how can we improve the components to dwrop more comp rehencive strategy to make sure we're prepared for whatever's next? >> i think our major recommendation is we put this responsibility in the office of the vice president, that we really need a national leader with a cloud to integrate all these pieces and help us. the innovation will have to be done by agencies and others. the strategies for keeping people accountable, we've all recommended we elevate that to the office of vice president. >> appreciate that. dr., lots of concerns being raised about zika and our athletes competing this summer in the olympics and all the spe
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spectators that will go down. spectators and coaches and family members who go to the olympics this year? >> well, i understand the deep concern that zika has raised. whenever children are affected, grown-ups get deeply, deeply worried. that's what's happening here. i will say that there are dozens of very dangerous mosquito and even tick-born diseases that have been with us for millennia. and you can, to some extent, protect yourself from mosquito bites by using deet and dressing well and sleeping in places with screens and so forth.
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that's not a perfect protection. it's not a zero risk. we have to wait and see more information about what is going on. we have known there's been more or less an epidemic of denghi and chicken gungha. and denghi is a serious disease. in south america, for a few years, that hasn't stopped people from going down there. i think we have to wait until there's more scientific data about zika. i know nih is working on a vaccine. i wish we had one. i think if i were a young woman who is pregnant or getting pregnant, i would think twice about going to south america right now. but i think for most people, there are ways to at least mitigate the risk. >> would you indulge me 30
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seconds on the zika question? >> yes. >> thank you. i want to point out, aside from medical countermeasures on zika, there's a whole field of looking at how to bioengineer mosquitos, which we already know how to do. so they are actually -- they're all males, they don't bite, and they mate with the females and the progeny don't survive. it's a fascinating new technology that may be part of the solution to this problem. >> i know we have votes in a few minutes. but if you have one quick follow-up question. >> one quick follow-up question, thank you, mr. chairman. to mr. greenwood with respect to the priority review voucher program. can you share with us existing prv programs for rare pediatric disease or neglected tropical diseases, increasing the biotech investments in this area.
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can you give us some examples where you've seen that already happen? >> i probably have that in my notes. if i had time i'd be whispered to behind. i would just say -- >> and if you would like to submit it for the record, that would be fine. >> i will submit that for the record. suffice it to say that it is working, it has created both in the area of pediatrics and the area of neglected tropical diseases, it has generated a tremendous amount of interest and investment, and it is working perfectly well. just as congress intended. i have no doubts that it would work well in this field as well. >> do you believe that we added dhs's material threats to the fda's prv program, it would spur additional development of the medical countermeasures? >> i think that's precisely what needs to be done. i have no doubt whatsoever that it will be successful in
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inspiring investment in this very dangerous field. >> thank you. i'll yield back. >> a quick follow-up question? >> yes. secretary shalala, you've spoken about the vice president as the overseer of all 0 of this and i appreciate the fact that there are too many agencies and too many people involved. and when too many people are in charge, no one is in charge. and i get that. >> and too many committees of jurisdiction. >> and i'm not -- i don't quite share your enthusiasm for putting this into the executive branch. perhaps it should be a speaker's position, but nevertheless, i will just tell you, i was down
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at the border, the little rio grande border, last weekend and realize you've got cdc map that shows mexico and central america being purple with zika. in my states, the other side of a relatively narrow river. it just seems to me we don't pay enough attention to border control. i know you can't stop mosquitos at the border, but really, the issue is stopping people who are infected or potentially infected. and right now, we are undergoing another surge of unaccompanied minors and family units. and, to the best of my ability to detect, we're not looking. and that is a point of great concern to me. so all of the other things we talked about are extremely important, but let us not forget border control, because that's an issue as well. >> well, i'll leave that to your comments, but i would say that we also have to beef up global health. this is part of the world health organization. we can't stop mosquitoes from
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coming across borders, whether it's in people or they're justify flying across. but it's not only beefing up our own infrastructure, one of the things we learned with ebola is the world health organization doesn't have the kind of authorities it needs. it doesn't have the resources they need. and so it's not just a state and local issue or a federal issue, it's also an international issue. and i think your point about border security is also, but i would put it in the context of international health security and looking at the agencies that we have now, the international agencies that we have now. and we know that they're weak,
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we learned that during ebola and previously. and this committee also might have a hearing because there have been recent reports on the international health organizations to take a look at those relationships as well. >> thank you. >> i know you're going to call votes any moment. i would follow up with two quick questions. if you can't answer here, get back to us. i would like an answer to each of you. if you know countries who model programs of the very thing you're describing, we would love to know about that. any of us know any offhand or would you like to get back to us on that? >> my only comment is if we don't have it, i would be very surprised if anyone else in the world had it. >> to be fair, there are centralized health systems in smaller places that may be more integrated. but i think that we have
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different levels of government, different levels of responsibility. we need to put -- we can't use their models. we'll have to put our own system together. >> thank you. >> another question, just hope you can get information to us for the record. based upon -- given the recent geo report on the failings of bio watch programs, including the lack of valid performance data, should we continue to fund it? do you have an answerer to want to get back to us >> i'm sorry, would you repeat the question. >> should the federal government repeat the biowatch program given the recent gao report on its failings and problems including the lack of valid perform 'data? >> i think we probably will get back to you on the record with that. >> ms. o'toole, can you answer that? >> i'm a long-time critic of bio watch, but i think you should continue to fund the current program for a defined period of time until we have a strategy for what we're going to go do next. i think the notion that bio watch, or even the next gen bio watch, a series of environmental sensors, can protect the country is wrong headed. the technology just isn't good enough. the cost effect in this ratio is just not advantageous. we need a new generation of technology. it's not there yet.
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again, diagnostics would make a big difference. you do need these sorts of sensors to protect high-risk targets and national security events and so forth. the problem with biowatch right now is that it is not characterized, as gao points out very graphically, and i think accurately, we don't know that it works. it's not clear that it doesn't work. it has a very limited range of bugs that it looks for. to really cover an area of a city, you need a lot of those machines. it would be very expensive. >> i want the committee to -- >> can i just say something? thank you. first of all, with all due respect to my friend from texas, i don't think any kind of border control, even building a wall is going to stop these vector-born diseases from coming over. i know that's not what you mean. but what it does really highlight is how we are an international community. it's not just the mosquitos coming. we even had ebola cases come here because of international travel. that's why it's so unbelievably critical that we take this report seriously and work hard as a committee. mr. chairman, i just want to commend you again for calling this hearing. i know you're planning to have a classified briefing when we come back from the february recess. i think that's a good other step. and i would just offer my input
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and of the minority staff and members to help come up with a robust hearing schedule for the rest of the year. i think if there's nothing else we do, spend time on this report and recommendations, trying to get our arms around it and get that sense of urgency to our respective leaderships and it will have been successful. and i want to thank everybody again from the commission for doing this deep dive. this really is important. >> and let me announce on march 2nd, we will have a hearing on the zika virus where many of these issues will come up. we'll take a deep dive as well as what my friend said about getting into classified briefing and some of the bio defense issues critically important and should be a wake-up call for america. but as you said a couple of times, mr. greenwood, we may not do these things until after the fact and that would be a tragedy. so we'll get moving on that. >> we'll go live now to capitol
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hill for a hearing on bioethical yishs around fetal tissue research. the select investigative panel on infant lives. this is just getting under way. >> the last decade has produced tremendous change in medical research and therapies. we are in the middle of a biotechnology revolution. certainly in my home state of tennessee this is ef dent and even today we have members of biotennessee who are on the hill. the cures for diseases and afflictions that cause untold pain and suffering. new words have entered our vocabulary. three-parent children.
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chimeras, crispr gene editing and bio informat ticks. words like tissue regeneration and transplant seem like history in favor of regenerative medicine that could reconstitute entire organs from adult stem cells. in a word, things are moving quickly. eth call questions and moral challenges can lag behind but the new information and knowledgele in medical science raises important questions. what does it mean? what are the historic principles of do no harm? promoting disinterested decisions by medical professionals and importantly addressing the question of human dignity and personhood. ours is not the first era to face such questions. the nurmberg code produced an ethics statement after horrible information was revealed about
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experimenting on humans without permission. we learned years after it was under way about prisoners in china forced to donate organs or killed for organs. we learned about the horrors of forced abortion and testing drugs on the poor and unaware after it had happened. we all remember the horrible reports about the syphilis studies on african-americans or forced sterilization of the mentally challenged years or decades after it happened. last summer's videos revealed something troubling is going on related to fetal tissue and research. the weak, vulnerable, those with no voice harvested and sol. something is going on that deserves investigating and demands our best moral and ethicalle thinking. the first hearing on ethics focuses our attention on procuring answer transferring baby body parts and related matters. we'll hear from professors,
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medical prak technicianers, from those who do biomedical research from those within america's faith traditions so we as legislators might be informed about the ethical implications and issues for the womanle who terminates the pregnancy. for the person who needs a cure and for the baby. this is about bioethics. we didn't invite our guests here to debate election year politics or journalism ethics or whether this select panel should be funded. i ask my colleagues to join me in focusing on bioethics so we could hear the best testimony our witnesses have to offer. i welcome each and every one of you and i look forward to hearing from you. at this time, i yield five minutes to the yanking member of illinois. >> thank you, madam chair. i want to make two key points.
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first, fetal tissue research has saved millions of lives and has the potential for saving millions more. that's why many republicans have long supported and should continue to support the use of fetal tissue for research purposes. second, today's hearing is not part of a serious investigation into fetal tissue research or anything else. a grand jury in texas has already investigated and found no evidence that planned parenthood is seeking to profit from the sale of fe tall tissue. indeed, the only criminal acts uncovered in the course of these investigations have been those of anti-abortion extremists david deliden who is under indictment for his role in manufacturing the deceptively edited videos that fuelled the republicans' latest attackses on women and their doctors. faced with the facts the select panel should have disbanded.
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instead the chair embarked on a partisan and dangerous witch hunt. the actions are putting the privacy and safety of americans at risk. over the repeated objection of the democratic members of the panelle the chair sent dozens of document requests to academic institutions, medical schools and health care providers across the country. she has issued three subpoenas demanding the names of individual researchers, graduate students, medical students, doctors and clinic personnel and is threatening to issue more. there are no rules in place to protect the names from public disclosure. in fact, the chair staff has made it clear any name turned over to the panel may be released to the public. there is no reason to create such a database. the chair's abuse of position as chair to compel this information is frankly reminiscent of senator joe mccarthy's abusive tactics. we live in a world where
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researchers who use fetal tissue are compared to nazi war criminals and extremists tried to burn clinics to the ground. we live in a world where women face a gauntlet of harassment to get the health care -- to get health care and where there are threatening websites that identify reproductive health care providers, their families and maps of the location to their clinics and homes. on the day after thanksgiving, a gunman drove 60 miles to a planned parenthood clinic in colorado springs, killed three people, injured nine others and terrorized doctors and patients. when arrested, he uttered the words, quote, no more baby parts, unquote. a phrase that many of my republican colleagues invoked both before and after the murders and in connection with this panel's investigation. linking individual names to an investigation described as examining, quote, the
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harvesting, unquote, of, quote, baby body parts, unquote. and the quote, horrific, unquote, practice of abortion providers, puts people in danger. our words and our actions matter. the chair refused to explain why she needs a database of names. as the washington post editorial board asked, quote, how is the name of a graduate student five years ago was an intern at a lab relevant to anything? unquote. there is no apparent reason for this other than harassment and intimidation. republicans may not like the fact that abortion is legal and therefore safe for women in this country, but that's no excuse for puttinging students, researchers, women and doctors at risk. the democratic members of the committee have repeatedly asked the chair to stop demanding the information. we have proposed reasonable rules that would prevent collection of certain information and otherwise protect the information that we
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do receive . so far the chair ignored our requests. i want to make this very clear to the entities that are under threat of subpoena or contempt from the chair. and to every researcher, doctor and woman in america. democrats will continue to fight to keep them safe. the unfortunate truth is that this partisan pursuit of the manufactured false allegations of anti-abortion extremists is putting americans in harm's way. it must stop. it is time to turn our attention to ensuring that attacking critical medical research and women's access to health care. with that i request unanimous consent to ent er into the record the february 21, 2015, washington post editorial. quote, the planned parenthood witch hunt. i yield back the balance of my time. >> your entry is made without objection. >> madam chair?
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>> the gentleman is recognized. >> i have a parliamentary inquiry. >> state your inquiry. >> madam chair, my colleaguing the ranking member noted in her opening remarks our concerns about your dangerous and sweeping demands for the names of individual researchers, graduate, medical students, doctors and clinic personnel. can you explain what rules govern these demands? >> the answer to your inquiry, we are entitled to the information and we are -- >> under what rules are you entitled to the information is my question. >> we are under the jurisdiction of the rules of the house of representatives and the rules of the committee on the energy and commerce. >> very well. furtherle parliamentary inquiry. >> the gentleman will state his inquiry. >> if we are under the rules of the committee on energy and
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commerce, rule 16 of the rules of the energy and commerce committee requires that, quote, the chair shall notify the ranking minority member prior to issuing any subpoena under such authority. to the extent practicable the chair shall consult with the ranking minority member at least 72 hours in advance of a subpoena being issued under such authority. the chairman shall report to the members of the committee on the issuance of a subpoena as soon as practicable. but in no event later than one week after issuance of such subpoena. unquote. those rules required three things, madam chair. they require you to notify the ranking member in advance. they require you to consult with the ranking member and to do so 72 hours before issuing a subpoena. they require you to report within a week to the committee. on friday, february 12 you told the ranking member you would be issuing subpoenas the next week. we immediately asked for a meeting to discuss this and for
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a copy of the subpoena to see what you were requesting. those requesting were refused. you then issued subpoenas on the 16th of february, four days after the conversation. and have yet to report on their issuance. madam chair, can you explain what constitutes consultation and reporting within the meaning of energy & commerce rule 16? >> energy & commerce committeele requires a conversation on the committee's plans which i did. and i will remind the gentleman the resolution establishing this panel, house resolution 461 stated that rule 11 in the house of representatives, the rules of the committee apply to this panel. further, the rules of the committee on energy and commerce do not require subcommittees and the panel the functional equivalent of a subcommittee are not required to first meet or organize before conducting business.
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>> madam chair, further parliamentary inquiry. >> state your inquiry. >> whether what you have described is long standing practice the fact is we made a -- the ranking member made a direct request to discuss these particular subpoenas and have a copy of them. the flat refusal even to communicate with democratic members is unfortunately common place since the outset of the investigation and violates the duty under the rule to consult. with regard to reporting we have yet to receive any report on the issuance of the subcommittees including -- and this is critically important -- exactlile what information entities are refusing to produce and how that information is pertinent to this investigation. contrary to your public claim that is the entities didn't cooperate with the panel they have done so. they turned over hundreds of documents and to the extent there is disagreement it appears to be over your command that they turn over the names of students, researchers, doctors and clinic personnel. to date, you have refused to
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explain how this information is pertinent to the investigation. the recipients of your demands are entitled to the information as are your democratic and republican colleagues. it is incumbent on you, certainly prior to moving to issue or enforce a subpoena to show how the information you demand is pertinent to the matters we are investigating. madam chair, explain how the names of individual medical, graduate students, health care providers and clinic personnel are pertinent to this investigation, please. >> no, sir. i am not going to do that. but i will let you know that copies of all the document requests have been made available to the minority. copies of the subpoenas have been made available and the requirements have been met. at this point we are going to move on -- >> madam chair, i have one further parliamentary inquiry which -- >> state your inquiry. >> i disagree with the assertion we need to compile a database of
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names to get answers we can easily get from institutional. witnesses under the federal rules of civil procedure. you refused to inform the subcommittee to consult. you should drop the names and adopt the rules to ensure balance in the investigation. if not, if you will not change the rules we should at least obey the current rules. we cannot proceed in violation of the rules nor should we proceed with dangerous subpoenas that en danger the lives and physical safety of patients, providers and researchers in a way that could make the committee complicit with any physical assault on these people railroad ou or murders of the people. i move to quarterback the subpoena.
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>> madam chair -- >> there is a motion -- >> the gentleman is recognized. >> i move to quarterback the request. quash the request. >> the gentleman from pennsylvania moves to table the motion. the gentleman from pennsylvania moved to table the motion. the question is on approve ing the motion to table. all those in favor of signifying to table the motion will say aye. those opposed say no. >> roll call. >> call roll call is requested. mr. pits. >> ai. >> mr. pits. >> aye. >> ms. black?
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aye. mr. bujon aye. mr. duffy, aye. mr. harris. aye. ms. hartslur. >> aye. >> ms. love. >> aye. >> ms. jutowski. >> no. >> mr. nadler. >> no. >> mr. get. >> no. >> ms. spire. >> no. >> ms. dobene. >> no. >> ms. watts man-cole man. >> no. >> ms. black burn. >> aye. >> report.
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>> ms. chairman, on that vote this were eight ayes and six nays. >> the motion is tabled. at this time we will introduce our first panel. i will ask that our panelists please move to the table as they are. -- called forward. first, ms. page come stock-cunningham, the executive director of the center for bioethics and human dignity, ale fellow at the institute for biotechnology and the human future and a trustee of taylor university. dr. gerald donovan. senior clinical scholar at the kennedy institute of ethics at
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georgetown university. he is also director of the pelegrino center for clinical bioethics and professor at georgele township. professor alta sharo. professor sharo is the warren p. knowles, professor of bioethics at university of wisconsin madison where she is on the faculty of the law school and bioethics at the medical school. i want to welcome each of you. at this point, i would like to make certain that as you are here, you are aware that the selective investigative panel is holding an investigative hearing and will take testimony under oath. do you have an objection to testifying under oath? the chair advises you that under the rules of the house committee on energy and commerce you are
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entitled to be advised by counsel. do you desire to be advised by counsel during your testimony today? thank you. if each of you will stand to be sworn in for your testimony. [ sworn in ] >> thank you. you are now under oath and subject to the penalties set forth in title 18, section 1001 of the u.s. code. you will have eight minutes to make a written summary to provide a statement summary of your written testimony and we thank each of you for providing that. i'm going to ask that you make sure your mike is on before you give your testimony and then
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that you will turn the mike off when you finish. and you will turn it back on when we move to the question portion. dr. donovan, we will begin with you for your testimony. >> well, thank you chairman blackburn and members of the panel. i'm pleased to present testimony regarding the bioethical considerations in the harvesting, transfer and use of fetal tissue and organs. i'm a physician, trained in both pediatrics and clinical bioethics. i spent my entire professional career caring for infants and children. it was this interest and concern that led me to a further study in bioethics. i have always been concerned about the most vulnerable patients, those who need others to speak up for them. both at the beginning and at the end of life. i have significant familiarity with research ethics having spent 17 years as the chair of an irb.
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although i myself am not a research scientist. the irb is the board that monitor it is rightness and wrongness of medical research to protect human subjects. we took this aspect of our duties so seriously i renamed our irb, the institutional research board. four years ago i was called by dr. ed monday pellegrino to take his part at georgetown university. our duties include ethics edgele indication and resident physicians. consultation for dock tors and patients at the hospital and the promulgation of scholarly papers and public speaking. we focus on clinical ethics which directly involves the good of patients and addressing normative questions which involve right and wrong. this is what we want young physicians to know. medicine is a moral enterprise. our actions have consequences that can be good or bad for patients. we must always focus on the patient's good and avoid doing
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harm. what does this mean for the topic at hand? we are talking about bioethics in the fetus. in order to make moral judgments we would have to be clear on the moral status of the fetus. obviously this is an area in which society has not reached consensus. that doesn't mean we cannot make sound judgments on the topic. in a question of biomedical ethics it's good to start with solid science. what do we know about the phoenix with certainty? it's alive. it represents growing developing cells, tissues and/ organs whic develop increasing complexity and sophistication resulting in an i intact organism, a human baby. of course this growth and development doesn't cease with the production of the baby. but continues for years afterwards. as can be seen by this description the fetus is not only alive but is human. i'm not talking about a potential human in the way some parents talk about their
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teenagers as potential adults. i am refer ing to the scientific fact that a fetus constitutes a live human, typically 46 xx or 46 xy fully and genetically human. in fact, it is the i are refutable humanness of the tissues and organs that made them be of interest to research rs and scientists. if a fetus is clearly alive and human can we justify taking the tissues and organs for scientific experimentation? if so under what sort of consent or authorization should be required? in the past century, medicine has made incredible progress resulting from scientific studies involving human tissues and organs resulting in the development of medications, vaccines and the entire field of transplantation medicine. is there a difference between these accomplishments and those that would require the harvesting of body parts and tissues from the fe us the? first we have to a mitt not all scientific ex-peer men tags has
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been praise worry think. studies done in germany and by american researchers in guatemala and tuskeegee were morally abhorrent. any knowledge gained from these would be tainted. no one wants studies with such egregious breaches of research ethics. all it takes to avoid such a comparison is a consensus on the moral status of the fetus. those who proceeded with experimentation and research on fe tall cells, tissues and organs typically obtained them as a result of an abortion. it is this stark fact that makes such scientific endeavors controversial because they proceeded without the aforementioned consensus on the moral status of the fe us the. we know the fetus is alive and human. we must find an explanation for why it should not be treated with the same dignity with which
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we accorded all human lives. although it is a human life, it is not a human person. various criteria are offered for a definition of personhood. but none have been found universally acceptable. we thus have a stand-off between those who wouldle protect this early el vulnerable human life and those that would deny that it deserves protection. in order to resolve anneth call dilemma the guiding principle is this. one is morally permitted to take such a life once you can demonstrate with moral certainty that the life is not fully human. it is a concept that can be exemplified by the situation faced by a hunter when he sees a bush shaking. he may believe it is a deer in the bush. if he kills it prior to determining with certainty what it is he's killing he will be morally responsible as well as legally if he has, in fact,
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killed the farmer's cow or worse yet, the farmer. as we can see two deeply held but opposinging viewpoints need not be resolved unless someone intends to act upon them. then the one who intends to take the action resulting in the death of the disputed entity must not do so unless they can first show with moral certainty that their perception of the moral worth is irrefutable. those who would not disturb the normal progression of life bear no such burden. it is my contention such proof doesn't exist and deliver it to fe tall destruction for scientific purposes should not proceed until it does. without disputing the arguable necessity of research on fe tall tissues and arguable necessity, i would also point out harvesting it in such a way is unnecessary. not only to cell lines already produced in such a fashion but new cell lines from spontaneous
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miscarriage. this is not a theoreticalle alternative. georgetown university has a professor with a method of isolating, processing and cryo preserving fetal cells from 16 to 20-week gestation miscarriages. these have been obtained and are stored in georgetown freezers. more over the present practices of obtaining fe tall tissues and organs seems to go against procedures approved for other who is harvest organs and tissues donated. first we follow the dead donor rule. vital unpaired organs cannot be obtain unless the owner died a natural death. this is not the case in induced abortion. such tissues and organs cannot be harvested without consent. in pediatrics parents are the normal proper surrogate but this internship tags rests on the presumption that the parent is acting in the best interest of
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the individual child. it is difficult to sustain that interpretation when the same parent has just consented to the aborted destruction of the individual fetus from whom those tissues and organs would be obtained. finally, we are at a difficult time in our nation's history. we demonstrate much moral ambiguity in our approach to the human fetus. we can legally abort the same fetus that might be a candidate for fe tall surgery even the same justification for acts that are opposed. we call it the fetus if it is to be aborted and the tissues and organs transported to a lab. we call it the baby even at the same stage of gestation when someone plans to keep it and bring it into their home. language has consequences. it can also reflect our conflicts. we are a nation justly proud of the achievements of the biomedical research. life saving research cannot and
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should not require the destruction of life for it to go forward. if we cannot act with moral certainty regarding the appropriate respect and dignity of the fetus we cannot justify its destruction. alternatives clearly exist that are less controversial an moral arguments exist that support our natural abhorrence of the trafficking of human fetal parts. surely we can and must find a better way. >> ms. cunningham, you are recognized. >> madam chair black burn, members of the select investigative panel. thank you for the opportunity to speak about the ethics surrounding the use of fe tall tissue for research. my argument which ises expanded in my written testimony el is threefold. first respect the fetus. it is a human being entitled to the protections of guidelines
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for medical research. the foundation principles of respect for persons should apply to unborn children without distinction. second, you cannot take a life and then give away the body. participants in elective abortion including the mother are disequalle identified from consenting to donating the body, organs or tissue of the now dead fetus for research purposes and third there are better more ethical options. first at the core of concern is the important question, who are what is the fetus? the biological facts are clear. the fetus is an organism in charge of her own integral organic functioning, enduring over time through the stages of human existence. first embryo, fetus, infant, adolescent and adult. rather than being a distinct and lesser form of human life, the fe us the is a distinct human
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being at a particular stage of development. she is not a potential human being but an actual human being. no one has the right to take her life by force. those who are responsible for her death have failed to recognize the fund mental principle of human dignity. they have no moral claim to donate or assign her body, organs or tissues to others. even more, others should not profit from this wrongful act whether for monetary gain, scientific reputation, better health or even to claim these cures are so wonderful. how can anyone oppose this research? the regulatory seem of protection for human subjects of medical research has continued to expand protection for research subjects to ensure that their participation is voluntary and fully informed and that the research is for their benefit or, if not, causes no more than minimal harm and that they may have access to the benefits of the research.
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protections have been explicitly extended to most vulnerable populations but not to the fetus to be aborted. if she were being treated in utero for her own benefit the hhs policy for protection of human subjects provides heightened protection for her well-being. that same hhs policile also provides special protections for prisoners, but not for the fetus to be aborted. some argued that we all share a moral onlile investigation to contribute our organs or bodies after death for the good of society. others claim the principle of proximity. the view we would want to help those most like us. in her analysis of fe tall tissue transplantation, kathleen nolan elaborates on a problem with this view. i quote, in the setting of elective abortion a cruel irony emerges. fetuses excluded from membership in the human community by a
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societally sanctioned maternal decision to abort now have ligations to the same community because of membership in it. end quote. we reject thisle cruel irony. le federal law attempts to erect a barrier between the decision oh abort and the decision to donate. for example, the procedure must not be altered in any way to accommodate researchers' needs and elements of informed consent for tissue donations should include telling the donor's family if the tissue will be used outside the u.s., whether it will be modified into a commercial product, the distinction between the for-profit and nonprofit entities involved and that she be given a copy of the form she signed. is the woman made aware of the specific body parts to be harvested? the request may be for the child's eyes, brain, kidneys that might be transplanted into a rat, his thymus or pancreas.
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the greatest demand might be for his liver. women might find this factual informational relevant to their decision. how is effective informed consent accomplished in a setting where there is no established institutional oversight to ensure compliance with the regulation. as the vast majority of abortions take place in clinics outside the ordinary system of health care and the requirements that exist in hospitals and ambulatory surgical centers. further, abortion clinic owners resist health standards imposed on all surgical standards. the history of the use of bodies and parts in education and research reveals a disturbing pattern of first seeking from the most disadvantaged in society. one national commission noted there were instances of abuse in the area of fetal research and that the poor and minority groups may bear an inequitable
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burden as research subjects, close quote. it would be enlightening to know whether that abuse continues. and the demographic profiles of women solicited to donate. there is another reason to oppose the current practices of fetal research. it is unnecessary. alternative ethically derived sources of a cell exist and they are working. my written testimony addresses this more fully and i will defer to other witnesses to speak to this more directly. a just society has no moral or other claim on fetal bodies, organs or tissues. unborn children scheduled for termination by induced abortion are among if not the most vulnerable members of the human family. as has been said by many leaders in many ways a society will be judge bid how we treat our
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wewea weakest members. curbing current practices of fe tall research would be a small but significant step toward honoring the dignity of our members. thank you. >> thank you, ms. cunningham. professor charo, you are recognized for eight minutes. >> thank you, madam chairman, ranking membership shikowski and members of the investigative panel, for allowing me to address you on question of fetal tissue research. i am a member of the national academy of medicine. i was a member of the national bioethics advisory commission from 1996 to 2001. at present i am the warren p. kno knowles professor of ethics at the university of wisconsin. i would like to note for the record i am not here to represent the university of wisconsin or any of its units
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and i have used my own personal funds to attend this hearing. madam chairman, fe tall tissue has been used in research since the 1920s. nih funded it since the 1950s. it has been deem eed ethical an has been specifically authorized by congress. in my view supporting this research represents a commitment to helping today's patients and tomorrow's infants. i say this for three reasons. first the research serves a compelling purpose. second it operates within a framework of state and federal law. third, support for it need not depend on one's views about abortion. first, any discussion about fetal tissue must begin with unimpeachable claims to have
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saved the lives and improve the health of millions of people. indeed, almost every american has benefitted from this research in the form of vaccines for whooping cough, tetanus, chickenpox and german measles. diseases do not discriminate and the beneficiaries of this research come from every place on the political, religious, geographic and economic spectrum. you yourselves and those whom you love are undoubtedly among those who have benefitted from this research and whose lives have been made better. when work began a century ago no one knew where the research would lead. over time it led to a nobel prize for a polio vaccine using cell lines from fetal tissue. scientists cannot say precisely which disease will benefit or when. hhs says fe tall tissue continues to be a critical resource for developing vaccines against hiv and e bola and research on diseases such as
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alzheimer's and huntington's. zika virus is now on the growing list. i would note for your attention that the cdc posted information on its website on how to provide fetal tissue including neurological tissue, prove rememberly with the structure intact specifically for the purpose of stietding and managing the zika virus to prevent delaware stating birth defects in tomorrow's infants. some people may find the dispassionate technical language used by professionals to be startling but one should never mistake that for callousness when talking about men and women who devoted their lives to improving our lives through medicine and science. the use of the tissue and organs to fetal tissue can make people uncomfortable about benefitting from material whose origins lie in complex situations. it doesn't prevent us from accepting this life-saving gift. critics have partaken of the vaccines and treatments derived
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from fetal tissues and give no indication they will forswear further benefits. they should support the work or at least not thwart it. second, the use of fe tall tissue in research has been specifically protected under american law for over 50 years beginning in the 1960s with the uniform anatomical gift act which was drafted specifically to include a provision allowing fetal tissue to be donated just as oh tissue is donated. in 1974 president ford had a commission look specifically at fe tall tissue research and that commission also found it is ethical. in the 1980s president reagan created the human tissue research panel. chaired by the late arlen adams, a republican, a retired federal judge. an opponent of abortion rights and the author of a book entitled a nation dedicated to religious liberty. like the earlier ford commission the reagan panel found if research to be ethical, declared
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there was no evidence that fetuses were killed for the purpose of obtaining tissue and no evidence that it ever had the effect -- any effect on decision making or the number of abortions performed in this country. to guard against the hypothetical possibility current practice follows the recommendations and discussion about donation takes place after a woman has definitively decided to terminate her pregnancy. the reagan panel can have considered the question of whether the woman should be the one to give consent and concluded that she was the party most interested in the topic and in this outcome and therefore retained the moral authority to make this decision. they viewed any alternative to be more problematic. fetal tissue research is subject to local over sight committee, tissue bank regulations and federal laws addressing everything from the consent process to collection and storage to confidentiality of records. two separate gao investigations have found no violations and
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found no sale of tissue, but only legally permitted reimbursement of expenses and no violations have been found in current investigations at either the federal or state level. third, support for fe tall tissue transcend it is debate about abortion rights. federal review repeatedly found that the option to donate tissue has no effect on whether a woman will choose to have an abortion. that's one reason why the congress passed by overwhelming bipartisan legislation, bipartisan margins that codify the recommendations of the committee's authorization to fund the research in particular. some of the most passionate supporters of the research recognize the difference between opposition to abortion rights and opposition to research using fe tall tissue. senator john mccain was quoted as saying my abhorrence for the practice of abortion is unquestionable but my abhorrence for these diseases is as strong.
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women have a constitutionally protected right to safe and legal abortion services. they make those decisions for their own reasons. and after that, some of them choose to donate the cadaveric fetal tissue to research. we gain nothing when we turn our back on the benefits of the research for people who are sick today or will be sick tomorrow, to say nothing of the irony of halting research that improves our chance of prevent ing miscarriages, preventing bit defects and saving infant lives. thank you very much for your attention. >> thank you, professor. i will note that both of our female panelists came in with time to spare. i think that's off to a great start. i yield myself five minutes for questions as we begin our question round. again, i thank you all. i'm going to do a lightning
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round on questions, if you will. dr. donovan, we'll begin with you in responses and go right down the line. first question, do you think any business or clinic should sell fe tall tissue for a profit? >> no. >> i do not. >> keep your mikes on, please. >> i do not. >> okay. >> it's against the law. >> thank you all. number two. do you think fetal organs should be grown and harvested for transplant? >> no. >> if they can be grown ethically, but not from the fetus itself. >> okay. >> i apologize. i'm not sure i understand exactly what you mean by "grown." are you talking about getting pregnant deliberately in order to donate tissue? no. i would not think that's appropriate. in fact, the reagan panel specifically worried about
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so-called directed donation and recommended it be forbidden and it is under the law. if you are talking about the creation of synthetic organs which is currently under investigation and is something i believe my colleague dr. goldstein might be talking about in the next panel, that's something that needs a closer look and without further information i couldn't say. but it is probably a goodell alternative. >> thank you. question three. do you think fetal tissue should be used for cosmetics,le cell lines for taste tesing for food or experiments that combine human and animal dna? >> no matter how they are obtained i would find these distastefulle. no. >> i agree with dr. donovan. >> okay. >> i think fetal tissue should be used in the same ways we use tissue from adult who is have died. that includes a wide range of uses. some of the ones you mentioned are not the ones that are the most compelling but they are within the law at this time.
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>> okay. number four. if an alternative source of tissue to form cell lines exists such as spontaneous miscarriages, do you think that's a more ethical approach? >> it does exist. it is more ethical. >> yes. and panels have found that to be the case. >> it can be used but it was found to be insufficient as a substitute for tissue from fetuses that were electively aborted that were specifically considered by the reagan panel and has been the subject of investigation since then due to the kinds of causes that change the nature of the tissue. certainly it would be less controversial if one could find tissue that doesn't raise questions about the abortion debate and avoiding controversy is possible but not simply in order to avoid controversy at the expense of public health. >> the fifth question.
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if vaccines exist that don't rely upon fetal tissue or cell lines should consumers be given a choice? >> actually for the most part those vaccines do exist. there are a few still left over from the cell lines started in the '60s to which there is no alternative. many people asked that an alternative be developed. that wasn't a yes or a no, was it? >> it's an answer. that's perfectly fine. >> thank you. >> i appreciate that. i will take that elaboration. >> i think parents and patients should be aware of the source of the vaccines they are using. at least it should be available for their information for them to make their own choice about using one that's derived ethically or unethically. >> the information is available on the internet. i have no problem with the idea of saying people have the right to have as much information as possible and make choices for themselves. i would note in passing with regard to the vaccines that have
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no current alternative it is vatican said specifically that they would wish there were other alternatives available that parents that wish to protect their children using vaccines derived using fetal tissuele should feel free to do so and put their children's interests ahead of all other concerns >> could i offer a correction to that one? i hesitate to have ms. charo corrected on the statement. that isn't what the vatican said. they actually said because the danger to pregnant women would be so great and their fetuses that children could be immunized with this. not so much for the protection of the children themselves but from spreading it to pregnant women and their babies. >> okay. professor charo, did you have anything else to add? >> no. i'm happy to accept the notion that the concern wasn't for the child getting vaccinated but for
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the future children when women get infected from the unvaccinated child. >> dr. donovan? >> it wasn't a lack of concern for children getting vaccinated. all pediatricians vaccines are things and everybody ought to get lots of them. but in fact the reason that such a moral change could occur, such an exception could be offered, was because it was truly life or death for the pregnant woman's baby. and that's who needed the protection and therefore, the exception could be made. they still are quite in favor of other vaccinations. >> my time has expired. at this time i yield five minutes for questions for miss shakowski. >> thank you. the "los angeles times" reporter and columnist michael hillsic wrote in september of last year that it quote would be an moral outrage, unquote if fetal tissue research became collateral
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damage in the campaign against planned parenthood, unquote. he also quotes, professor charro, as saying quote, we have a duty to use fetal tissue for research and therapy and that duty includes taking advantage of avenues of hope, for current and future patients, particularly if those avenues are being threatened by a purely political fight. so let me ask you, can you explain, dr. charro, the view that there are actually is an affirmative duty to use available avenues of research? and if you could please address how this might come into play with the zika virus, and research to understand and find a solution to what the world health organization has classified as a quote public health emergency of international concern unquote. >> thank you miss schakowsky for
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the question. the united states health policy is directed at improving the quality of public health. it's considered a compelling purpose under every possible regime of both law, legislative and judicial. and in this particular instance, this research has proven itself capable of preventing millions of diseases. and has shown tremendous promise across a range of illnesses. for my perspective, if we are dedicated to improving the health and welfare of our population, this means pursuing avenues of research that might improve our resistance to disease or our ability to manage or even cure diseases. now that is always balanced against other interests. and i understand and appreciate the depth of concerns about abortion that are expressed here at this table and by many other americans. but because this research in no way affects the number of abortions, it seems to me that we are balancing a compelling
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public health need, against what is simply a gesture of sentiment, respect, political position, or other kind of nonconcrete effect against the possible cure for diseases. now with regard to zika, i think it brings really into focus. because right now, we are struggling to understand exactly how the zika virus operates, how it is that it can be transmitted through the placenta to the fetus. how it is it can affect fetal development at different stages of gestation and how we can understand what kind of outcomes it can have. for that we need to actually look at the tissue available, after every stage of gestation, where there actually has been a termination of pregnancy. whether through miscarriage or through elective abortion. if we don't do that, we are facing, as you said, a global emergency in which pregnant women will be forced to choose -- between risking the birth of a child with
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devastating effects, or in fact terminating her pregnancy. irony being that the absence of this fetal tissue research might lead to more pregnancy terminations than anybody has ever contemplated up until now. i think we need to look very hard at the unintended effects of restricting this research. >> so are you saying then, that without fetal tissue research, we can't really understand the effect on fetuses? >> because i'm not a research scientist, i don't want to answer definitively. but i can say that looking at the nih website, the cdc website and looking at the information put out by other international governments, it seems clear that there's a global consensus, it is very important to study exactly how the virus operates, both at the earliest and latest stages of pregnancy, in order to understand how we might either stop it or treat it. >> let me also ask you, if that, the remains of the fetus are not used for fetal tissue research,
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what happens to it? >> the tissue is discarded. there are a variety of methods, some involve burial, others involve cremation, there are a few states that have very specific legislation about the management of fetal remains. but they are not used in any way that is helpful to anybody outside of the possibility of using them for this research. >> and let me ask you a question, since we're talking about ethics, does the fact that fetal tissue research is now under attack and at risk of being shut down warrant our moral outrage? >> i am outraged at the idea that we would sacrifice valuable research and that we would gamble with the lives of patients today and tomorrow, gamble with our own lives and gamble with the lives of the people in our family and our communities, because we are trying to fight a deeper battle, about our common view on the moral and legal status of the fetus. again, i can only say again and again, the number of abortions in the united states will be
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unaffected by the outcome of this discussion about whether to use the remains for research. the only thing we know, is that we will lose the benefit of the research for people who do in fact get sick. >> i thank you so much. and madam chair, i seek unanimous consent to enter into the record the "los angeles times" article that i've been discussing titled "planned parenthood and the cynical attack on fetal tissue research." >> so ordered. >> thank you. >> gentlelady yields back. i recognize chairman pitts. five minutes. >> thank you, madam chairman. first of all, dr. charro's written statement that the success of fetal tissue is quote unimpea unimpeachable, end quote, is not completely accurate. the nobel prize given to enders, weller and robbins in 1954 was for showing that polio virus
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could be grown in fetal tissue. in the laboratory. not for developing the polio vaccine. in fact, the original salk and sabin vaccines were raised in monkey tissues. not human fetal tissue. and she conflates the use of fresh aborted fetal tissue with the use of fetal cell lines. and while a few cell lines, which did originate from an abortion, or used in the path for production of some vaccines, only a few modern vaccines utilize these old fetal cell lines. and none use fresh aborted fetal tissue. in fact, the cdc and other leading medical authorities have noted that quote no new fetal tissue is needed to produce cell lines to make these vaccines.
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now or in the future. end quote. the new successful vaccine against ebola virus announced last summer was made using monkey tissue. not fetal tissue. or fetal cell lines. so dr. donovan, looking at modern vaccines, do you see any need for use of fresh aborted fetal tissue for vaccine production? >> i think your statement was absolutely accurate. that yes, these have been of use in the past. there are other cell lines, there are other means of producing vaccines. and so there is no need to use fetal tissue to produce new cell lines. for vaccine production. >> moreover, i think it may be a bit disingenuous to say that millions of lives have been saved because these vaccines were produced in the past. millions of doses have been
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given. and millions of infections have been prevented. most of those would not have resulted in serious injury to the person immunized or death, certainly. that doesn't mean we shouldn't still be immunizing. >> thank you. >> thank you. >> at what point -- and you can continue, dr. donovan, what point in human development does science show one is a human being? and why is this? >> well we really have to go back to one's definition. you know, if we're talking about is it human in terms of having a full complement of cells, you know, that develop continually into you know, fully-grown adults that happens at the zygote stage. >> let me go a little further. is there a point in the baby's gestation at which researchers most want fetal tissue for research? and why is this? >> and that, i'm not sure that i
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can answer accurately, so i won't. >> all right. is there any scientific evidence that unborn babies at this, at a later stage feel pain? and should the knowledge of a baby's ability to feel pain by certain points in development affect the ethics surrounding fetal tissue collection from induced abortion? >> i think the evidence for fetal pain is very strong. and we're seeing good evidence at 18 to 20 weeks of gestation, that fetuses can respond with pain responses. and i think no matter how you feel about a fetus, you know you can accept its humanity, you can reject its humanity. but we wouldn't allow kittens and puppies to be harmed or put to sleep without keeping them out of pain. i don't think we should do that for fetuses, either. >> miss cunningham, did you want to add something to that?


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