mr. chairman it is clear in west virginia that the harm is already occurring. and in fact as we were preparing for the lawsuit we filed last year against the epa one of the principal arguments we made is unlike many of the other traditional rules subject to notice and comment, this proposed rule is causing real tangible harm in the states and also effecting power plant operations if you look at litigation, we have at least eight declarations from experienced environmental regulators who talk about the cost of trying to comply with the rule. the other point i raise is that time frames associated with the proposal are hyperaggressive. you have proposed rule issued june of 2014 final rule scheduled to be should sometime this summer. while regulators are suggesting they may need many years to try to come up with a plan, they've

been given one year, that's a very real problem. but there are real costs being expended by the states and also i believe this administration is not interested whether the rule is finalized so long as the marketplace moves away from them. if coal fired power plants have to be retired quicker than baseline, then they're going to accomplish the goal, even if this regulation never is upheld in courts. >> thank you i want to follow up on this. i'll wait until the second round. >> senator markey. >> thank you madam chair. i ask that two articles by jed ee freedman and richard lazarus be included they provide thorough analysis of that clean power rule. >> so ordered. >> pope frances is about to issue on climate change.

they named the jesuit who taught chemistry as the pope. pope frances believes science is the answer to our prayers, we have to look at modest ways to look at this to reduce the danger that growing greenhouse gases will impose to god's creation of the planet. i think it is important for us to find ways to accomplish that goal. back in 1990 we worked on the clean air act. i was on the committee that drafted and put that law on the books. i added an energy efficiency section to give more flexibility to the administrator at the epa. and there were ways utilities could comply with their acid rain requirements by undertaking activities beyond what was occurring at the power plants.

and i can assure you my intent and that of my congressional colleagues was to encourage utilities to look at the energy system in total and find ways to reduce sulphur pollution. so ms . heinzerling, in addition to the acid rain program that i just mentioned, are there other examples of using energy efficiency renewable in the clean air act? >> yes. very early on, some 35 years ago, they included washing of coal before burned as compliance mechanism for dealing with the clean air act. it was something that wasn't within the source, wasn't a typical into the pipe kind of measure.

in regulating interstate conventional air pollutant, eepz included renewables and energy efficiency as potential compliance if you look at section 202 to regulate mobile sources, you might if you looked at that quickly, you may think that's a classic end of the pipe measure. and yet if you look at epa's most recent rules on greenhouse gas emissions from mobile sources, epa has in terms used today gone i think beyond the fence line. they included flexibilities in their rule that made the rule a marvel of modernization. they included the air conditioning refrig. rants used in the vehicle, flex fuel

vehicles, and so if you look not just at the pollution regulation that we have been talking about stationary sources, but beyond that it has i think become standard. >> that was the intent of the '90 act, to give more flexibility, use a different model. i think that's what this proposed rule will do. say to each state move in a way that accomplishes the goal, but you know we're going to be very flexible. so let me ask this question. the constitutionality of epa approach to setting public health standards has been challenged before. supreme court upheld an 9-0 opinion whitman versus american trucking in 2001. in 2011, supreme court ruled that epa has the authority to set standards for carbon pollution under section 111 d in an 8-0 opinion. and during the oral arguments in

that case, counsel said to the court we believe the epa can consider as it is undertaking to do regulating existing nonmodified sources under section 111 of the clean air act. miss heinzerling, is there any constitutional question about epa's approach on their legal authority to regulate carbon pollution under section 111 of the clean air act? >> no, i don't think so. i think constitutional issues have been a distraction. i think they have been used to make people worry that maybe there's lurking a constitutional issue, so we better interpret this narrowly but i think constitutional arguments i think are flimsy and the statutory authority under the clean air act as i said i think is clear. >> beautiful. thank you. thank you, madam chair. >> thank you very much, madam chairman. attorney general pruitt, good to see you. oklahoma is a fossil fuel energy producing state. attorney general morris see

state of west virginia like wyoming is a coal state. all our states are hit by the slew of proposed epa rules aimed squarely at the fossil fuel industry and folks that work in that industry. i would like to highlight a letter from the governor of wyoming to the epa administrator on april 28th i ask that letter be entered into the record, madam chairman. in this letter the governor highlights a study by the center for energy economics and public policy at university of wyoming entitled impact of the coal economy on wyoming published february of this year. i would ask that this study be entered into the record. >> without objection. >> thank you. the governor states about the study that it determined the single largest threat to wyoming's coal industry is epa's clean power rule. in fact, the study says that 111 d climate regulation has

potential to drastically reduce wyoming coal production. coal output under favorable circumstances decreases by 32% of the 2012 production by the year 2025. study goes on to say even the best case of impact modeling of that 111 d scenario suggests loss of 7,000 jobs by 2025, relative to unemployment in 2012. it says overall proposed carbon regulations result in predicted decline in the state's combined coal and natural gas revenues, between 36% and 46% by 2030. so our state is finding this rule will cost thousands of good paying jobs, will drastically slash state revenue that pays for college scholarships, schools, medical emergency services, road safety programs environmental protection programs, water quality services veteran services, other vital services. wyoming children, seniors, veterans, fish and wildlife don't deserve this dramatic cut

in revenue by the epa. so i find this is recklessly irresponsible, where costs are so clear and devastating and benefits are theoretical or unknown. my question to the two of you is this. are these statistics similar to what you're seeing and concerned about in your states and how will essential services for children seniors and the environment be impacted in oklahoma as well as in west virginia? >> sure. so i think you raise a number of important issues. we obviously received a great deal of feedback from coal operators, from power plants, from coal miners in the state of west virginia about the devastating impact of these rules. but there are a couple of other implications as well. for instance west virginia as its tax base relies heavily on coal severance revenues. if you were to look at a chart and examine some revenues that come to each of the counties

from 2011 to now, you'll start to see a rapid decline. recently seen news publications about people laid off in counties because coal severance tax revenue had declined. the regulations have far reaching implications well beyond coal operators. the fact is for every job you have related to coal in west virginia, there are probably seven jobs that tie indirectly. it has fundamental impact on the economy. that's just one of many reasons why our office has been focused so much on this, because it would be an absolute travesty to finalize a rule that ultimately has a real likelihood of being struck down in the courts. >> so regulations have direct impact on the people and quality of life of the people of your state? >> without a doubt. as you're looking at the issues there are always a wide variety of reasons that give rise to a

particular decision by a power plant operator or mine operator to change unemployment status, but regulatory burdens is always very high on that list. >> if i could add to general morrissey's comments though we don't have a robust coal economy, we have coal in the state of oklahoma we are vertical. i think what's lost in the debate is the impact on consumers, those consuming electricity in the future in the state of oklahoma between coal and natural gas, 78% of electricity is generated. as i indicated in opening comment, 15% of our electricity is generated through wind. the choice is available to the state of oklahoma to comply with this mandate from the epa of reducing co 2 by over 30%. puts us in position of having to make decisions about shuttering of coal generation which makes up over 40% of electricity

generation. that will increase costs substantially to consumers. one rule to give an example. in the clean air act something called regional haze section of the clean air act. that one rule alone, between pso, and og and e have seen 15 to 20% increases in their generation of electricity, with just one rule. when we combine all of the others, it is going to be obviously substantially more than that in the future for consumers in the state of oklahoma. >> these regulations would directly hurt, hurt the people of oklahoma. >> some of the folks that can least afford it. >> thank you, madam chairman. >> senator whitehouse. >> thank you very much madam chairman. this is an interesting hearing because the questioners on the republican side and attorneys general present are all from states that have the characteristic that attorney general pruitt just described, they have a robust coal economy. and clearly we have a practical

problem in that coal, burning of coal for electric generation creates some very dangerous consequences, but they're not fairly distributed. so where there is a robust coal economy, this creates one kind of problem. in rhode island where the oceans are up ten inches against the shore, where our fishermen are seeing fisheries disappear where houses that have been there for generations are falling into the ocean we have a very different set of problems. and i think it is important if we're going to address this that we on one hand recognize that there may very well be economic effects within coal economies from trying to unburden ourselves of the environmental consequences of coal burning and we are i think very willing to work with you to mitigate those consequences. but we can't allow those consequences to take us to a point where we deny the problem

exists. that's just irresponsible and factually wrong and ultimately i think potentially quite disgraceful to the institutions that we all serve. so let me ask you first attorney general pruitt, you said one of the problems with epa regulation was that this issue should be left to the local level. please tell me what oklahoma is doing at the local level to address carbon pollution and climate change. >> senator if i could in response to your question also say i did not make reference to the coal economy in the state of oklahoma. we don't have a robust coal economy. in fact, our percentage of generation of electricity attributed to coal is 40%, less than maryland. >> i wrote it down as you said robust coal economy. if that's not correct i stand corrected. the record is what it is. >> i think what oklahoma that done is engage in very much a

balancing effort between diverse fuel sources from renewable at 15% of generating electricity to 40% in coal. >> how does climate change roll into that calculation? >> our focus through public utility corporation decision making as well as my focus as attorney general is not to engage in policy debate about whether climate action is occurring or not. >> why not. >> to look at the statute to determine if epa is engaging in a process consistent with authority you have given the epa. >> why would you be willing to look at the consequences of the regulation on, for instance the coal economy but not be willing to look at the consequences of the regulation on environmental protection? why is that the debate you think you need to stay out of when you're willing actively to get into the debate on the other side? that seems imbalanced. >> my comments referring to decision making and discretion that the state is engaged in

balancing generational electricity between coal and fossil fuels. i would also say to you it is congress that should be jealous about protecting its role and what it has told agencies what they can and cannot do. it is congress that has set up the framework we are talking about this morning between 111 and section 112. >> i am comfortable that they're following it i am not jealous at all. i think they're doing exactly what congress intended. so i am very comfortable with that. what i am concerned about, we heard from the senator from wyoming, an important coal state that the benefits of the rule are theoretical or unknown. they're not theoretical or unknown. they're very clear they're very specific. they're people very knowledgeable about it. if i could use the remainder of my time to quote one very well known scientist on this who says we know precisely how fast co 2

is going into the atmosphere. we made daily measurement of it since 1957. we have ice core data before that. it has increased by 40% since the industrial revolution and that that increase is due to human activity primarily fossil fuel burning. second daryl, bad use in agriculture. there's no debate about that. he continues there are lots of scientific eve sees, the facts that it is increasing in the atmosphere and increases in the atmosphere due to humans about those things, there's no debate. and that is a statement of doctor barion moore iii who is the dean of the university of oklahoma's college of atmospheric and geographic sciences. i think we need to be fairer about the hearings if we're going to get to a suitable result.

my time has expired. i yield back. >> thank you. i would like to ask another question, make another statement. i believe the chairman of the full committee and senator certainly if you're here we will go through another round. i would just react to some comments made in terms of the constitutionality and legal authority that we are looking at here. i think we all need to be mindful that this can swing both ways in different administrations. just because this time i think the constitutional overreach is too much and it's something that bears terrific scrutiny it is not to say another ten years another administration that senator whitehouse would be thinking the same thing because of the direction it is going. so i think this is extremely important to look at the legal implications and also the comment was made that there was tremendous outreach to the state regulators, and i would

reinforce that what i said in my opening statement, that i said before the committee before and testimony was in front of the committee that the primary administrator in charge of this at the epa wouldn't even come into the state our state to hear about seniors whose prices of electricity are going out. the miners who lost their jobs, the manufacturers who are going out of business or are concerned about price. i think you know maybe there's been outreach, but hasn't been enough outreach in my opinion with regular folks that are being heavily impacted in those states where i live. i am going to ask quickly a question to mr. martella. we heard a lot about whether -- getting back into legal authority on four building blocks. what legal authority if any does the epa have under the clean air act to impose dispatch requirements on natural gas-fired power plants? because that's one of their building blocks. >> so thank you for asking that question, and the question about the building blocks two three,

and four. >> i am going to ask the same question on all of them. >> maybe i can give you the same answer to all of them. they synch up with the question about cooperative federalism and relationship we are hearing from all witnesses between the federal government and states. i would like to answer in this one way, and it is something that professor heinzerling said in her testimony. a lot of people, a lot of people make analogy to esps and naks program. people say epa has been able to implement naks program. professor heinzerling said this is not materially different than that, but it is materially different. i think this is the answer to your question. in the naks program, congress authorized epa to regulate naks pollutants and authorized epa to delegate that to states. two things are different. at the outset no doubt congress delegated this authority to epa

congress said you can give it to states or take it back. the fundamental distinction with the clean power plan you talk about blocks two, three four epa is saying we want states to implement renewable forward, or dispatch system or energy efficient system. the distinction there's no debate congress never authorized epa to run a new standard in west virginia or dispatching system in oklahoma or energy efficiency program in rhode island. congress has never given that to epa, epa therefore can't delegate that further to the states. that's a summary way that brings together themes of federalism, constitutionality questions and questions that have come up. >> you're saying in the area of naks there's specific legs late i have authority to go into the direction they have gone. >> that's correct. that's well settled the supreme court addressed it several

times, it is very clear what congress set up this cooperative federalism system there. if a state decides if my colleague from oklahoma decides not to implement the epa naks congress said epa has the authority in the first instance. if oklahoma decides not to implement renewable portfolio standard, congress never authorized epa to implement that renewable portfolio standard. >> thank you. attorney general morrissey how many states were adjoined in the case you recently -- >> right now we have 15 states, which includes attorney generals and governors. in the d.c. circuit there were three cases that came together and were consolidated. we led the state effort and there were other industry efforts as well. >> would you characterize the 18 states as ones similar to west virginia, wyoming, oklahoma, energy producing states or heavily reliant on coal or is it all over the board? >> my sense, these are strong energy producing states.

this is a bipartisan coalition. the state of kentucky is on board with the lawsuit as well. we have been reaching out to more states. we believe that even noncoal producing states or energy producing states should care fundamentally about whether this rule is finalized because of legal implications. >> thank you. >> senator whitehouse. >> thank you very much chairman. attorney general morrissey is climate change a problem anywhere in the world? >> well, senator, my role is to serve as chief legal officer of the state of west virginia. i am not going to make an argument today about climate change and whether the temperature is evolving because regardless of the policy merits of anyone's proposal, policies have to be implemented in a lawful manner. that's one of my main obligations as attorney general of the state of west virginia. >> and well, let me just ask

attorney general pruitt is climate change a problem anywhere in the world? >> senator i think that the process matters that the epa engages in, to address the issues. >> i get that. i didn't ask a process question i asked if climate change is a problem anywhere in the world. >> the question about climate action plan of the president, climate change is something that's a policy consideration of this congress. if you want epa to address that in a direct way, you can amend the clean air act to provide that authority and statutory power to do so so states can no how to conduct themselves in a way that's consistent with statutory construction. >> so to be clear, neither of the attorney generals present will concede that climate change is a real problem anywhere in the world. >> senator i think the material discussion is the legal framework of the clean air act. >> material or not, i get to ask questions. so it is material to my

question. all right. let's go on to something else. we talked about kilowatt per hour cost. i would like to make a point which is that the price of electricity in rhode island was 15.2 cents per kilowatt hour compared to 9.67 cents per kilowatt hour in oklahoma and compares to 9.52 cents per kilowatt hour in west virginia. however, because of rhode island's investment in efficiency and whole variety of programs particularly through rggi mentioned earlier that have been able to bring usage down, rhode islands paid only $91.48 a month for electricity compared to $110.47 in oklahoma and

$106.44 in west virginia. will both of the attorneys general from west virginia and oklahoma concede that the real impact to a consumer is the dollar amount they have to write on the check that pays the bill. >> well senator i think where you're going now, some of the details in terms of how electricity prices may vary across the state is a policy question. and in west virginia we heard deep concern from power plant operators, from coal operators about what the impact will be on electricity pricing. i have seen that in the context of other proposed regulations that have gone through. it is important to reiterate right now, to choose a policy objective and try to advance it through unlawful means is something everyone in this body should reject. >> can i go back to the question

i actually asked? isn't the economic effect of the policy made real in a consumer's life by the amount of the check that they actually write rather than a per kilowatt hour cost? >> i think, senator, most people look at the amount they're paying when they get in the bill. >> attorney general pruitt you agree? >> i think senator what is important for utility companies across the country is to have choices, flexibility and diversity of the portfolio to produce electricity. >> my question was quite self. that is when you're a utility consumer in terms of the economic effect on you, what really matters is the amount of the check you write, correct? >> in a long term economic effect shuttering coal generation, long term will be substantial on consumers. >> you didn't answer the question. you segued into your lobbying on behalf of coal. the answer is yes or no, the

real difference is made by what the bill is? >> senator, i maintain that the state of oklahoma is experiencing an increase in cost to consumers because of the epa heavy hand of eliminating fossil fuels from the energy mix. >> i suggest that you try what rhode island did. our costs are higher than you but bills are lower because we took trouble to invest in a significant way in energy reduction and efficiency and with that my time e expired. >> thank you, madam chairman. we have been talking about this since '02. i remember down on the senate floor, tried to pass a similar thing that this regulation would do, but pass it by legislation. i saw what happened. that first bill was the mccain lieberman bill. mccain was a republican. we decisively defeated that bill and every bill since that time, senator markey is not here now, he had a bill up also. now, that's happened. and this discussion about the science is settled, the science is settled, the science is

settled, every time something comes up about the science isn't settled, they come up with the science is settled. they don't want to elaborate on it. i want to make part of the record an article in "the wall street journal" called the myth of climate change, 97%. this whole thing they say 97% of scientists, this totally diffuses that. it will take too long to read. i will put it into the record. >> without objection. >> and talk about some of the scientists. i know richard lynn sen, i talked to him, he was upset when al gore was using this politically for his career. he is an professor in climate and people ask the question why is it that people are so concerned about regulating the co 2. he said it is a power grab.

he said these are his words regulation of carbon is a bureaucrat's dream. if you regulate carbon, you regulate life. this idea that the science is settled, the science is settled it is just flat not true. i know that people who have 12 years of their life wrapped up in this issue as the only issue of our time, they don't like to recognize this but nonetheless -- in fact, i will do this from memory i have said it so many times. you go back you see these cycles that take place in the world. 1895, we went into the first cold spell that has been really talked about, about 30 year cold spell. that's when they first said another ice age is coming, all of that, try to get people alarmed, the world is always coming to an end when this happens. 1918, we went into a warm spell lasted about 30 years.

then the first time you heard global warming. that was 1918. then 1945, they change and started going into a cold spell. this is the interesting thing about the 30 year cycles. and it goes right up until today. the year that we had the greatest surge in emissions of co2 was after the second world war, 1945. that precipitated not a warming period but a cooling period. these things, these are reality realities realities. i remember speeches i made in response to things that my good friend from rhode island said when i talked about what is the reality of what's going on today. now, so we're going to hear more of this. i know there's an effort now to have this bureaucratic thing that in my opinion doesn't have what it is supposed to have. the only thing i am going to get back and get the response from

both attorneys general is a matter of what we have been talking about in flexibility. miss heinzerling talked about it, the epa often talks about flexibility and would say the epa is simply hiding behind flexibility while in reality forcing states to make the least economically devastating decisions. i would ask the two of you, does the clean power plan provide states with any real flexibility? every witness talked about flexibility. >> i think if you look at the concept of flexibility, this is a false concept. the reality is that states are having an enormous amount of pressure applied to them to develop a state implementation plan within one year based upon the declarations we receive from many of the states, people don't think that's possible that the goals of this proposal are so

severe that states are not going to be able to come into compliance. when you look at the proposal the way it is constituted i don't think it is fair to say it is flexible, but our argument has always been regardless of whether people think that's desirable from a policy perspective, the law actually doesn't even allow the epa to go outside the fence to develop that kind of flexible approach. the final point i would make, if you look at the predicate rule required before finalizing the 111 d rule that's for new source performance standards, that obviously does not rely on outside defense technology. when they developed the best system of emission reductions, it is much more narrow. >> general pruitt? >> i think my fellow panelist addressed it earlier. flexibility with respect to how plans are adopted is something the states endeavor to possess and have but flexibility with respect to performance standards inside the fence versus outside the fence that's what we are

facing here. the epa is taking approach of forcing performance standards on the state of oklahoma that are outside the fence. they're providing less options in the future as far as how to comply. >> thank you. senator carper. >> i am not a lawyer either. studied economics, got an mba but not a lawyer. i don't understand all of this, some of this discussion when we get into technicalities, but i do know this, i have seen us pass legislation when i was in the house with senator inhoff and in the senate where we put in the same bill conflicting approaches to the same issue. and in some cases we were unable to resolve differences, so we put both in say somebody else will figure this out. i think in a way when i saw

discussion on section 111 d of the clean air act, it reminded me of that kind of behavior, and i am looking at your testimony lisa, where you say based on the text of section 111 d alone, epa has perfect sidewaysively defended its proposed view that the statute is ambiguous interpretation is reasonable. these are the criteria for the chevron deference. explain it so i can understand. i think do i, but we have two amendments, one dropped out in the code, i am told it lives in another life. explain this to us. >> congress in 1990 passed two amendments to section 111 d. one seemed to look to pollutants, one seemed to look to sources. as epa has explained as i note there, they're not entirely clear, either one of them standing alone and the combination is not entirely

clear coming together. so what epa tried to do is try to take from each amendment something, and what it said is you cannot regulate the same pollutant from the same sources under both programs, section 111 and 112. that's the kind of judgment as you're suggesting that agencies make all the time. there are many times when statutes aren't entirely clear, they may contain provisions that are in tension with each other and agencies resolve them. this usually is a straightforward application of what i call chevron deference, which is the case in which the supreme court said if a statute is not clear, if policy judgments are left to the agency to make, then the agency gets deference to a reasonable interpretation of the statute. and here i think the text allows epa's interpretation and also say in light of the comments

earlier about the problem of global warming, just imagine if the epa said no, we'll take the interpretation that does not allow us to regulate the sources of greenhouse gases that are -- the most greenhouse gases in this country and to attack the problem of climate change by doing that, that we are going to pick the interpretation that does not permit us to do that. that would be quite strange. >> yes, it would. question if i could, miss backman, please. i want to go back to the issue of whether science of climate change is settled. very briefly do you think it is, do you think it is not? the question on whether or not the science of climate change is indeed settled law do you believe it is? do you believe it is not? >> senator -- >> microphone. microphone. >> i am sorry. i thought you were asking me. >> i am.

i am asking you to use your microphone. >> is this better? >> that's good. >> thank you. i am also not a lawyer. i am not a climate scientist but i choose to believe the overwhelming majority of climate scientists that say it is real and say it is caused by humans. so now we need to act and i can tell you also that there is a cost to action but there's also a cost to inaction. and i can tell you as one who is responsible to consumers electricity consumers who depend on reliable affordable energy that certain ways to help the system include renewable energy include energy efficiency, include demand reduction to help with reliability issues and help with resiliency of the system. >> that's fine. hold it right there. one last question if i could for lisa. are epa's proposed carbon

standards supported by three supreme court decisions in massachusetts versus epa american electric power versus connecticut and regulatory air group and epa thanks very much. >> yes. >> tell us more. >> massachusetts versus epa of course held greenhouse gases are pollutants within the clean air act. much of which we here is attempt to relitigate that, tell us carbon dioxide is not dirty somehow. so therefore it is not regular ulable. that case holds they are. american electric power is interesting because it relied on regulation under section 111 d in holding that there was no so-called federal common law, court made law of global warming pollution. that's significant because if this regulation goes by the boards, then all of the reasons for the common law come back to force.

and the last thing that the utility air regulatory group seems to me that case can be understood generally as a victory for most of epa's greenhouse gas program that was at issue there and secondly it asked epa to look section by section and make sure that regulation under the particular provision of the clean air act made sense for particular pollutants. that's exactly what epa has done here. >> i would say this is a good panel. i commend you and the staff for pulling it together. thank you all for coming. if i ever go to law school i want you to be my professor. >> thank you very much. i would like to thank the panel and senators. >> will there be questions for the record allowed? >> yes, we will leave the record open for two weeks you can submit questions for the record. >> very well. >> thank you very much. appreciate your patience when we had to leave.

on the next washington journal, debate on ways to reduce poverty in urban areas.

later, colonel commander of the war fare group discusses training needed for u.s. troops in international urban combat zones. as always we welcome your thoughts by phone, facebook twitter. it airs live every morning 7:00 a.m. eastern on cspan. sunday on cspan q and a, kate anderson brour on the world of the white house through the eyes of people that work there from the kennedys through the obamas. >> who are the thicklands? >> they're an incredible family, nine members of the family worked at the white house. i interviewed james jeffries the only current part time butler who i did get to interview. he's still there, might be there now. he works every week at the white house. and nine members of his family

worked there. his uncles, john and charles were mater ds the head butler. he told me my uncles ran the white house. they brought him in when he was 17 years old in 1959 during the eisenhower administration, he is still working there. he describes how he used to work in the kitchen, was a skinny guy, they kept giving him ice cream to eat. they were great. it is incredible he remembers what the eisenhowers were like, that's a dying breed of person and he remembers that. that's what i wanted to do is to pay tribute to these people. >> sunday night at 8:00 eastern and pacific on cspan q and a. the head of the national institutes of health testified at a senate hearing about president obama's precision health initiative. a research program intended to improve medical treatments by tailoring them for individual patients. this hearing of health, labor

pensions committee is an hour and 40 minutes. >> the senate committee will come to order. this morning, holding hearing on the promise of precision medicine for patients. senator murray and i each have an opening statement then we will introduce the panel of witnesses who are getting to be very familiar to us. we are grateful for you for coming. after that we will have time to ask five minute rounds of questions or two, depending how many senators are here. we are here today to discuss exciting new direction in our health care called precision medicine. what does that mean? well, those of us in the room a good representation of the population, they estimate one in

ten of us would have diabetes. if doctors could use precision medicine, that is if they could look at our individual dna and genetic, molecular makeup of disease, perhaps they could tailor treatments to each individual rather than to more general category of diabetes. i was visited this morning by the head of philadelphia children's hospital who talked about their work in identifying a defective gene, mutated genetic defect that causes blindness, and how they have developed a therapy that restores the sight in a child because of the therapy directed for that specific genetic defect. this is happening with cancer treatment. doctors can look at the cancer cell and assess how to treat it. news week reports genetic

testing on tumors is starting to become the norm in the big cancer hospitals like sloan keterring, all incoming patients have their tumors sequenced. this is all possible because of extraordinary achievement by a great many individuals on sequencing the human gee gnome, none more important than dr. collins who is here today. we are grateful for that. today we want to discuss what national institutes of health and private industry are doing in precision medicine how the food and drug administration will regulate those innovations how electronic health records can effect the ability to innovate and what this means for the american patient in the health care system. it is one of the most exciting new frontiers in medicine. senator murray and i are working on initiative to ensure our federal agencies are equipped to review medical products and processes produced by this kind of cutting edge medicine so

american patients aren't waiting on the sidelines because regulatory science can't keep up. our innovation initiative is not just about precision medicine but precision medicine is an important part of our initiative. president obama announced a precision medicine initiative in the state of the union this year, he detailed his plans at the white house and i attended that to demonstrate my support. the president proposed mapping gee gnomes of 100 individuals and making it available to medical researchers across the country. look forward to hearing more from our witnesses. there are similar private efforts under way. i am interested in hearing about that competition and about possible collaboration, for example, children's hospital of philadelphia that i mentioned has 250,000 individual children gee noems sequenced there. i wonder how useful that would be to the one million dr.

collins is putting together, how these scientific entrepreneurs, dr. vent ner in california philadelphia other places how that relates to the president's proposal for a million individuals. i look forward to hearing the cost. the cost to the human gee gnome have been reduced in the last two decades. dr. collins testified i believe that he said 15 years ago would cost about 400 million to sequence the first human gee gnome, whereas today it is about $1,000. very often in health care innovation initially increases costs, doesn't mean we shouldn't innovate. they can increase costs but in the long term decrease health care costs. take alzheimer's which according to alzheimer's association will cost $226 billion this year along with other dementia. we could use precision medicine to delay onset or cure of the disease. save precious dollars in health

care systems and alleviate some grief and pain associated with it. the committee has spent time and will spend more on improving electronic electronic health records. the federal government has spent $28 billion to drive the adoption of these record systems and the results is that doctors don't like the systems. they interrupt the doctor-patient relationship and haven't been worth the effort. senator murray and i begun a working group to identify the five or six thing we can do to help make the failed promise of electronic records that something that physicians and providers look guard to. instead of something nay ensure. desalvo, we look forward to working with you on that. and looking forward to results that you take administratively or we do legislatively. we have to get to a place where the systems can talk to one

another and smaller physician's offices want to adopt the systems, can't afford the cost can be confident their investment will be of value. dr. collins told us that a properly functioning electronic medical records system is tremendously important to the president's precision medicine initiative. it can help to assemble the genomes of the one million individuals. and second if we want to make genetic information useful, this is complex stuff. it's going to take computers that operate easily and with a click of the house to help make it possible for doctors to actually prescribe prescriptions for individual patients. also would like to hear if we know dr. desalvo, at some point how the $11 billion effort by the defense department on electronic medical records would

relate to the $28 billion we've already spent, and whether those will be compatible and whether you'll be working with them. there's a lot to talk about today. this is a tremendously interesting and important effort. and i look guard to the witnesses' comments. senator murray. >> thank you very much, mr. chairman and thank you to the witnesses for being here today. each of your agencies plays a critical role in the topic we're talking about and i'm grateful to have you here to share your expertise. i've approached our bipartisan effort to advance medical innovation focused on one question in particular, and that is what can congress do to help all patients and families get the safest most effective treatments and cure more quickly. our conversation today is about the promise of precision medicine and it's a crucial and truly exciting piece of the puzzle. there's in question we're at a critical moment in the medical

field. researchers and medical experts are increasingly finding ways to treat patient, not just as the average patient but instead based on their own unique characteristics and history. this is the different in getting eyeglasses based on the average prescription and getting eyeglasses based on your own prescription. it's huge, especially for families across the country waiting and hoping for better cures. i'm proud that nay home state of washington is home to several institutions that have been pioneer in this area, the university of washington which is using this precision medicine technology to tackle breast cancer, eye disease and alzheimer's disease. i'm glad we have to opportunity today to discuss the ways in which fre sigs medicine is changing and improving lives and how congress with help advance the new frontier. the president has proposed

making significant investments in precision medicine. his physical year 2016 budget has a budget to advance the ge nomices and data management to shift away from the one size fits all medicine to treat tailored to specific individuals. this proposal could accelerate the advancement of precision medicine. as i discussed with dr. collins last week i'm deeply troubled with the nih's purchasing power. they were able to come together to replace the harmful sequestration cuts to nih and fda and other critical priorities like education, infrastructure and defense. i'm am hopeful that we will be able to work across the aisle and find a wie to prevent these

short sided cuts in kicking in again. this is absolutely critical to the kinds of investments we need to keep our -- make our families -- to help our families and grow our economy, including precision medicine. one of my top priorities on this committee is to look for ways to continue improving the quality of care patients receive and supporting precision medicine is essential to that goal. by offering patients and provider misare and much better health information patients in consultation with their doctors will be empowered to make informed decisions about their care. and our health care system will be better equipped to put their needs first. protecting privacy will be an fornt challenge throughout this process. in the last few months we've seen serious security breaches impacting families' health information. that is unacceptable. as researchers, providers and

patients gather together we need to be aware that data is being created that cyber criminals will want to exploit. that means we'll need to develop strategy to protect privacy that meet today's challenges. chairman alexander and i are investigating the current state of cybersecurity in the health sector and this needs to be an all hands on deck effort with providers, insurance and government working together. thank you to all of our witnesses for being here today and i want to thank chairman alexander for holding this meeting. and i look forward to working together with you, mr. chairman and other members of the committee to support this important initiative mgs thanks, senator murray top the underscore what senator murray said, this specific topic is an issue with the president which the committee in a bipartisan way is interested. we have three witnesses and i'll

ask senator cassidy if he would like to introduce the fist one rmts yeah dr. karen desalvo and i know each other from way back when i was full time with lsu and she with tulane. i told her that we made the spread tulane green today. she's at the office of the national coordinator of health information technology. onc is the lead agency charged with formulating the federal government's i.t. strategy. i've been impressed. dr. desalvo has come to me personally. there's a friend back home who's having a lot of problems with her medical record and adapting to it. she clearly recognizes interop ability is key. she's listening to the physicians and developers of this product. he was a health commissioner for

the city of new orleans including and after hurricane katrina. >> we look forward to you testimony. we expect to get to know you pretty well here because all of us are interested in fixing the electronic medical records system. and you're on the point for that according to secretary burwell. we look guard to that. our other two witnesses, dr. collins, the director of the national institutes of health who oversees the work of the largest supporter of biomedical research in the world. he's been the director since 2009. and of course he's known among other things for his leadership of the international human genome project. completely sequencing the human genome in 2003. dr. jeff shuren was here last week. he's at the food and drug administration for more than five years. they're responsible for sharing the safety effectiveness and

quality of medical devices, and fostering device innovation. we welcome him back. if the witnesses would summarize their remarks in about five minutes, we would appreciate it. we have senators here who want to have a conversation with you. so let's start with dr. collins. >> well, good afternoon, chairman alexander ranking member murray and distinguished committee members. it's an honor to appear before you to discuss how we can advanced americans' health. earlier this year the administration unveiled the precision medicine effort a bold new initiative. we believe the time is right for this ambitious initiative and the nih and our partners will

work hard to achieve the initiative. we've had to make decisions based on the expected response of the patient. this one size fits all works for some patients in some conditions but not e others. precision medicine takes into account individual differences in patient's genes, vief styles. blood typing for example with has been used to guide blood transfusions for almost a century. the identification of the brca one and 2 genes has made it possible to provide options for women at high risk of breast or ovarian cancer. and the gene discovered in my own laboratory 25 years ago has led to wide spread ability of targeting therapeutics. but the concept of applying the concept broadly has been dramatically approved by the

development of affordable methods for characterizing biological information. that includes genomics the recent revolution in mobile health technologies and the emergence of tools for analyzing large biomedical data sets. patients are increasingly interested in taking part in research. all of these developments will help make possible the dream of processing a wide range of health applications. we're thrilled to take a lead role in the multi-agency precision medicine initiative. this initiative will focus on cancer accelerating efforts. this component will include the molecular analysis of large numbers of individual tumor to see what gene mutations are driving the malignancy and matching that information with available targeted therapeutics

provided by pharmaceutical industry partners. simple blood test will be developed that can detect early response or resistance to drug therapy. and a combination of drugs will be tested to see how best to achieve not just a remission but a cure. to put a human face on this i would like to paint you a forward looking picture of what the precision medicine can deliver for cancer in a few years. consider the hypothetical case of lily, a 52-year-old woman of asian decent. in 2018 after battling bronchitis and a persistent kof were lily goes to her doctor ordering a lung screen along with a new blooz test to look for dna and other biomarkers serk lating in her blood. the ct scan detects a tiny spot that could be inflammation from

cancer. not clear. but it's revealed a genetic mutation that occurs with patients only with cancer. her prognosis from this cancer today would be pretty grim. but in 2018 that could all change. lily is treated with surgery to remove the tumor and the tumor dna undergoes molecular analysis. and she was treated for a target drug that was originally developed for skin cancer but has the right therapies for her tumor. with this treatment a decade later, lily remains cancer free. that's a hypothetical but quite realistic of what the cancer component of this initiative could achieve. as a longer term goal, nih will launch a national research cohort of one million volunteers who play an active role in how

their medical information is used to manage a broad array of diseases. the participants will be centrally involved in the design and implementation of this process. they will be true partners with appropriate privacy protections they will be able to share genomic data, lifestyle information and samples linked to their records. participants will be able to have access to their own health related information. new approaches for detects and analyzing a wide array of variables will be tested in small pilot studies. ultimately the most proms will be used over time to collect valuable data. let me quickly give you an example of how this can benefit a specific person but also provide evidence for a new

strategy for health maintenance that could be extended across the nation. consider the case of 38-year-old precision medicine initiative participant carla. it's 2020. carla feels healthy. she welcomed a chance to try out a wearable sensor that monitors her pulse blood pressure and medical activity. but discovers that her blood pressure runs 150 over 200 too high increasing her chance of stroke and kidney failure. carla is not alone. nationwide 78 million americans have high blood pressure. many like carla don't know it. what's worse nearly 50% of those diagnosed with hypertension do not have it under control. carla consults with her doctor who confirms the need for treatment, suggests she takes an inexpensive diuretic drug. carla on tans a smart bottle that sends a note to her phone

if a dose is missed. so the precision medicine initiative will also bring many types of health care monitoring into this new century. current evidence suggests that the physical exam and the associated lab tests may not be as useful as one would help. but new opportunities to incorporate specific indicators of individual health are emerging. this national research cohort will provide a powerful opportunity to ape says such strategies rigorously to see if they provide clinical valuable information and better health outcomes for the american people. in closing let me emphasize that the impact of the precision medicine will extend far beyond the individuals who volunteered to participate. it will push the frontiers of discovery across the entire spectrum from basic science to translation tall science.

given the size of the project and its real world nature, evidence of um proved health outcomes derived from this initiative will be attractive for immediate application across u.s. medical care. with sufficient resources and a strong sustained commitment of time, energy and ingenuity from the scientific medical and participant communities, the future of precision medicine appears really bright. we look forward to torquing toto make stories like lily and carla a reality. that concludes my testimony. i look forward to answering your questions. >> thank you, dr. collins. dr. desalvo, welcome. >> thank you, senator alexander and ranking member murray and to the other distinguished senators. thank you for the opportunity to be here today with my colleagues. i'm karen desalvo were the national coordinate at the department of health and human services. when i was a medical student at

tulane i could never imagine that in my career i would see me sin on the such a track. we are on the cusp of being able to customize treatment for the patient in front of me based on key information instead of having to treat them as a average patient. what is more exciting is that precision medicine is not just a theory. it's already changing practice and saving lives in the u.s. we wouldn't be on this cusp but for health information technology which is foundational to the president's precision med sip initiative. the office of the national coordinator is the federal lead for health information technology. and onc's responsibility is to advance the health i.t. infrastructure for what is six of the u.s. economy health care. we do this work through a mix of programs, meetings and technical asis tan tans aimed at cattizing the marketplace.

we seek to spur and support innovation to support advancements like precision medicine. onc has responsibility to ensure that all consumers are engaged and their interests are protected. congress created significant momentum in 2009. the act provided funding of the support of adoption of electronic medical records on the front lines as they made the transition to use them. as the result, we're bringing health care into the digital age and we have reached a tipping point. this strong foundation of health information technology makes it possible to bring to the bedside personalized treatment through precision medicine. the data and electronic health records married with advanced and lytics and other sources of data including patient preferences will provide the picture of a person's health and needs.

this comprehensive data picture is necessary to identify the right prevention and treatment that is not only the most effective but also the most desired by the patient. this is a reality already in places like tennessee, maryland, nebraska, florida. thanks to the tools bimt into the electronic health record, doctors are able to taylor treatment today. i spoke to folks at the university of florida health where a patient's card yolgs can order a test to see if they carry a particular variant of a gene. this test will held. cardiologist know if they're using the best medicine to prevent a clot in a patient eats heart. a doctor is choosing the right life saving blood thinner tailored and specific for them. and though this kind of treatment is exciting, it is indeed only the beginning. we have much work to do ahead. see that this is available to everyone in this country. as part of routine care.

and onc stands ready to undertake this work. to get there we'll need to stay the course in adoption to see that every american has an electronic health record. we also need to go beyond the pockets of data exchange and achieve true interoperaability. we'll need to establish new data necessary, environmental exposures and patient generated information. we will build a trust framework that respects individual privacy and establishes strong security protections. we will work with the private sector to establish openly available apis which are doorways to unlock data. in all of this work we'll remember what i hear consistently from consume ares who are our principle customer. they want to be able to access and share their health information, including the scientists if they wish without blocking or delay. the president's precision

medicine initiative is one of the most exciting ways that we can bring the right care, the right prevention to the right patient. only imagined a few years ago. it's because of advances like this and the underlying technology to support it that we are on the cusp of realizing better care and health for everyone. onc stands ready with our colleagues at hhs and with congress. thank you and we look forward to your questions. >> thank you, dr. desalvo. dr. shuren. >> chairman alexander, ranking members murray and distinguished members of this committee. thank you for the opportunity to testify regarding fda's role in the precision medicine initiative. the success of precision medicine depends on having accurate, reliable and clinically meaningful tests. it's the results of the tests that determine which patients get which drugs or treatments and whether or not they get

them. inprecise medicine results from bad tests misdiagnosis you get the wrong treatment or you get no treatment at all when you should. and as a result patients get harmed and health care costs go up. fda's role in the initiative is in a technology called next generation sequences. ngs can sequence long segments of a person's dna or the entire genome. we're moving away from the model of one test one disease. but a test that can identify one of many different diseases or the risk of developing that disease. but today there are significant barriers in place for advancing that technology. it affects the research, affects the development and the ability to use this optimally in health care. let me tell kwlau the barriers are and what we're doing about it. if you're making a test an you want to know is it accurate, two

of the things you need to know are the following. does it accurately measure what you're trying to mesh hur. do you identify the right variance. we call that analytical validity. and secondly you want to know is there a good relationship between what you measure and the particular disease. if you say it's a test for breast cancer is that variant associated with breast cancer. we call that clinical validity. that's difficult to do for next generation sequencing. here's why. you have about 3 million variants and your genes are made up of components called base pairs. there are 3 billion of them. now you want to know how accurate is the test to measure all of that. normally you would look at each of the variants. you can't do that for 3 million variants. people are struggling to make

sure are their tests accurate. then if you want to know is it clinically meaningful you need data for that. it's hard to get a lot of clinical data. it's difficult to do clinical studies and the data tends to be siloed in the institutions that are doing the testing. so in december we propose an entirely different work on the tests. we and the developers have struggled on what to do with it. so for analytical validity we need to have reference standards, essentially sub sets of genetic variance that if you can show accuracy in measuring those, it's reasonable inferred that you're good at measuring the other variance. we gave $2 million to the national institute of standards and technology the work with the scientific community to come up with the very first reference standard if the genome and they just released that last week. under this initiative and with

additional funding support, we'll continue to work with nis t and the scientific community. as a result the developers wouldn't have to come to the fda. just meet the standard. we need to lench databases where we get all of the genetic information and then make sureardized and. the cure yags activity. and then working with them and the scientific community develop standards and best practices for having these databases for doing the occur ration and then have clinical interpretation. you know what happens today. you can send your blood to different genetic tests labs and get different results. that's what happened it may be because you missed the variance

or you interpret it differently. with the standards in place we can have consistent accuracy in testing and consistent interpretation and reduce the time and cost to spur research, advance technology development and ultimately to achieve better health outcomes. thank you. >> thank you dr. shuren. we'll snow have a round of five minutes questioning dr. da so vo, when i was the governor of tennessee, i had the idea that all student would become computer e lit rate. so i bought enough mac computers to put in all of the middle schools. it was a great idea. sounded good. forget something. i forgot teacher training so nobody really knew how to do it. i didn't think it all the way through to the end. i think we have something of the same problem with our electronic health care system.

we spent $28 billion. it's a great idea. holds great promise but it's not working the way it's supposed to. the current standards for meaningful use aren't clear upgrades are expensive, the systems don't work well enough to share the data. we hear it's expensive to share the data because of the relationships between vendors and doctors. some of the doctors call this data blocking. you just released a report on data blocking describing these concerns. senator murray and i have set up a group, working group to work on this because of the large amount of interest in our committee on the subject. my question is, will you work with us, this committee, to identify the five or six steps we could take to get our electronic medical records system functioning well enough so that it supports not just the precision medicine effort that we have but so that it functions and it's something that physicians and providers can

look guard to using instead of enduring? >> yes, senator, i look forward to working with you all in identifying ways that we can make this work for doctors and others on the ground, on the front lines. that's where it really matters, where the work flows are sometimes not the way they ought to be. we look forward to that. you can count on our participation very actively. we have some efforts underway as the senator is likely aware. we've been working through our rules for meaningful use for certification. but we know there's more work to be done and belook forward to that. >> what i'm talking about is actually beginning to get some results. identifying the five or six steps we should take. you should know them better than we really. although dr. cassidy has some personal experience in this he'll give us i'm sure. and going step by step to get them done. and if you can do them by

administrative order, great. we'll include them as the administration initiative and begin to do what we ought to do. dr. collins 1 million genomes i mention i was is iz haved by the children's hospitals they have 250,000 sequenced genomes. one question how many how many of these are already out there? i mean you want to assemble a million, they've got 250,000 in philadelphia. dr. vent ner want to assemble a million. can you get those by going to the philadelphia children's hospital and using some of theirs? >> that's a great question. and we're trying to come up with every possible way to assemble that million strong cohort by taking advantage of things that have already been done. we'll have a may jr. meeting in your state on may 27, 28 with a number of those who have been

managing these large scale cohorts gathering together to see if there is a way to put them together -- >> can you estimate the number of genomes that have been sequenced? >> i should be clear. when you say genome sequences, some people are referring to a sampling, a gee know type. a snip chip is the term that's used. some are talking about sequencing just the parts of the genome that code for protein we call that the exome. to do the whole gee know is becoming quite affordable. most of the cohorts have not yet done whole genome sequences. the group in philadelphia is doing it with some of their patients. dr. vent ner has the sbrengs. we believe that to get the maximum information you want that. >> let me ask you quickly.

senator murray has emphasized the importance of making sure everyone or a representative group of everyone is included in this. what about children? i mean the suggestion was made this morning that sequencing the genome of a child for a genetic defect leading up to a particular disease can be less complicated than for an older person who may have a more complex disease. will you include children and the single gene therapy treatment as part of what you do? >> that is an active area of investigation by our working group. let me explain we assembled a group of public and private experts on this whole question of of this million strong cohorts. they've met once last week and wie they're meeting again to talk about what should be the constitution of the cohort.

should children be included. we want to be sure that covers diversity of the population as well. and some of the cohorts out there may not be as diverse as what we need. we'll figure this out. there is a desire to have this be something that representing the broad swath of our country. there will be a strong motivation for many people to include children. >> thank you. senator murray. >> thank you for being with us. dr. collins we've heard a lot about how precision medicine is revolutionizing the practice, allowing for the development of targeted cures for individuals. but i'm also interested in the economic impact of this work. we know that precision medicine is not only about treatment but about prevention when' have a lot to do about how factors like environment, nutrition impact individual health outcomes. how might these discoveries impact health care costs?

>> well i do appreciate that question because we all agree that health care costs need to be brought under control. a lot of concern about the current system is it is a sick care system than it is a health care system. and if we had the opportunity focus on prevention instead of waiting for illness to strike we would improve the health of the nation and save money. the precision health initiative aims to focus very intensively on prevention and to find out what actually works. i mentioned in my opening statement something about the fact that our annual physicals probably don't collect the kind of data that ultimately you'd like to have that might be a tip off to something sma needs attention. and the opportunity to begin to use the new tools as well as the wearable sensors reporting on the environmental exposures should put us in a much better situation to monitor individual health before an illness strikes. i don't want to overpromise the

value a that this will result in as far as cutting health care costs and bending the curve that we want to see start downward again. but i would think over the course of time this is one of the best opportunities we will have to cut our health care costs. >> you know, one of the exciting things about precision medicine is it's empowering patients and people to participate and be full partners in discovery of new treatments. you mentioned the new mobile and wearable health technologies that are out there that allow researchers to collect data on how participant behaviors affect their outcome. i know all of the agencies are working to find new ways to engage patients in their own health and sustain participation among people involved in research studies. what are the best practices in patient engagement to ensure sustained participation

throughout the medicine studies? >> another great question. there are a number of cohorts that are engaged a lot of patients that we're going to be consults with about what their experience has been the mayo clinic, marsh field has one. all of these have done a lot of work to figure out what it is that people are looking for if they're going to participate. i think an important part of what we're trying to do with this initiative is not to think of the individuals who take part as patients. they're partners. we want to have them at table. we're going to have a workshop that is focused to try to get information from the individuals, what they're looking for. people expect if they're going to be part of this that their information is going to help people. but they also would like to get information back about themselves in terms of what has been learned about their own state of health. and what has this study led to in terms of broader discoveries

that might not have happened otherwise. they want to be included, informed and at the table. we promise that is the attitude we will bring to this. >> let me ask you, dr. desalvo we've seen several high profile sophisticated attacks on health care organizations in the last few months. americans expect that health care providers and researchers are taking the necessary precaution to protect their data. that's why i mentioned working with senator alexander on the current state of cybersecurity in the health care industry. can you tell us what steps onc is taking to help researchers keep the large amount of genetic and other information that they're collecting secure? >> thank you for the question senator. we agree it's a major issue. it's on top of our mind every day. the steps we've taken most recently are to require in the electronic health records that day the is encrypted at rest and in motion.

so as you move and data is moving across systems it also needs to be secure and encrypted. we're working with the department of homeland security with the national security council and others to ramp up the additional security expectations. but as data begins to move and be liquid there's more opportunity for there to be security issues. it's a top priority. we've taken some actions and we have some additional ones underway. >> what is nih doing to protect the patient privacy? >> we've already initiated a genome data sharing policy which has been in place for several years because we've been conducting studies to try to understand genetic contribution to diseases like alzheimer's or schizophrenia or heart disease. qualified researchers can apply to see that information. but it has to be overseen to

make sure that the individuals who are looking at the data are appropriately signing on to various restrictions, such as not sharing it with third parties and acknowledging where it came from. and that's been very successful over several years. i think we have a good framework there. we think there are things needed in order to protect genetic privacy to make sure it is not acquired by individuals who do not have the right to do so. there ought to be something to avoid surreptitious genetic tests of individuals without their consent. >> thank you. senator cassidy has deferred to senator hatch and then senator franken. >> thank you mr. chairman. we've been following your work for years. we have a database too and i wonder if that could be part of the million person cohort. we have, as i recall, -- it's the

largest repository of computerized family histories and it's linked with 22 million public health and clinical records. and the scientists at the university of utah has been able to use the noncommercial resource to identify dozens of genes responsible for diseases. now the utah genome project is harnessing the power of utah's large family. discover new disease causing genes in underlying conditions such as diabetes, heart disease 0 pieceobeseity and cancer. they mall fie our ability to identified disease causing genes. by harnesses these advantages, it seems to me you know, using these large families and large cohorts. i think our folks in utah can make significant contributions to what you're trying to do

here. and i would like to know if you think they would be useful and if i can play a role in getting the university of utah and you -- i think you're already working together but i think you need to work with that group as well. >> we are indeed. senator thank you for the question. utah has been in a wonderful place as far as the ability to do remarkable research in human genetics over many decades. research i've personally benefitted with collaborating over decades of my own research clear. you have an unprecedented level of depth in terms of family collections. one of the things that we are going to be wrestling with a bit in terms of this cohort is exactly what ought to be the involvement of multigenerational pedigrees. it brings considerable strength to the effort and that will be a topic of discussion also at this workshop later this month in nashville. i would say that inner mountain health care system, i should

have mentioned it early. they have a strong presence in this as well. so i'm quite sure when the dust all settles this prevision medicine initiative will have a utah connection. i saw a wonderful piece this morning in the news talking about some of this. and i think there's a lot of excitement across the scientific community and across the country in what this might lead to and i appreciate you volunteering to help us. >> we do want to help you. university of utah has a genetics department as good as anybody can have. we've irritated harvard to death by enticing a number of very top researchers out there to utah. i think they like the mountains and the skis as much as anything. they won't leave once they get there. we'd love to be of great assistance to you. i personally appreciate all three of you. i have take an great interest in what you do other these many years, as i've been chairman of the finance committee. i haven't had as much time to

spend in this committee, which i used to chair. i want to campment the distinguished chairman and vice chairman here for the good work that they're doing. they're terrific leaders in the united states senate. thank you. i appreciate you all three being here an i appreciate the work you're doing. >> thank you, senator. >> excuse me go ahead. >> thank you, senator hatch. almost had to get senator warren equal time there. the order i'm calling on senators is based on who was here at the time the gavel went down and based on that, on the republican sides cassidy and collins are next. and on the democratic side it's franken, bennett warren and murphy are next. senator franken. >> thank you, mr. chairman. thank you to the ranking member for holding this hearing.

precision medicine is extremely exciting. those of us in minnesota thank you, dr. collins. because mayo and the university of minnesota have been doing genomics project that funded by you. very smart on your part. this is exciting because this's really been a paradigm shift in the way we think of health care in this country in some part due to the health care reform law, health care providers and insurers are moving more toward person centered care. i'm talking about coordinated care medical homes, acos provide incentives and information that help doctors taylor their practice their treatments, their therapies to meet the needs of individual patients. and that's of course what

precision medicine is all about making sure the right patients get the right treatment. and the right treatment doesn't as wu were saying, dr. collins, doesn't necessarily mean -- it isn't treating people when they're sick. it's about health care not sick care. and using personalized medicine should improve prevention and so we are doing health care and not sick care. dr. desalvo, i do want to talk about what you said. we're at a tipping point in the adoption of medical health records. and electronic health records. and i want to talk about that for a second. because we had a hearing on that not so long ago. and this -- there are some -- been some barriers to adoption

by certain medical providers, some resistance. some people of doctors who feel like i got 20 minutes with this patient and i don't want to spend eight of it inputting data. but on the other hand, we have -- this is where we're going. so what are you doing to address that open what are some good models. i've heard of something like having a scribe whose job -- a medical student who is there with you who is taking down the information. we need to get there. what are we going to get there? >> well, senator thank you for raising the voice of a lot of doctors in this country. i hear similar things when i travel and talk from my own family members, including my husband, that it's been a great advancement, we're going forward, folks want to go there. however the systems are not a part of the work flow in the way that we want or expect in incall

practice. the opportunities there include giving more time for providers to be able to implement the systems on the front line. so the senator may be aware that in the last year we've put forward some rules with cms to provide additional flexibility in timing of the adoption of records or upgrading to new ones. and also to propose in this last set of rules, giving doctors the option of a more stream lined approach to the kinds of ways that they have to report. so reducing the burden or the expectation on the amount of clicks that they must do to show that they're furngs nally using the records. we're working towards a goal of a shared expectation that this is going to be an inabler and really support them. i'm committed to continue in that path. your point about successes on the ground and tools doctors have used anywhere that office practice. is it really important. we collect those through our

fellows program as an example and share those. it is -- it varies by doc and by office what is going to work for them. sometimes using a dictation system and having assistants tribe over it, sometimes it's a scribe. sometimes working with the electronic health record they've had so much time that they're able to make the system seamless. so state like minnesota is so far advanced as i'm sure you're aware. >> thank you. i don't mean to interrupt you. we can talk about this for a long time. i just want to -- i want to get one quick question to dr. shuren. i have a question about how the tests at fda -- the tests that the fda is going to be assessing. one thing that concerns me is some tests may get quite expensive and i want to make

sure that i understand how they and the highly personalized care that precision medicine can provide will benefit everyone. and won't contribute to health disparities in our country. so my questions are, will these tests be considered diagnostic tests or preventive tests and who is going to be paying for them. >> well, in the case of next generation sequencing, they can be used potentially for diagnosis and for predicting. and therefore prevention purposes. it all depends on do you have the data to show that that particular test can perform in such a way. in terms of reducing costs there's the funt for reducing costs for those technologies to be developed. if we have the standards i talked about and we have those databases of information it will be a lot less expensive to have the science. so in the past you do a clinical study to show does your test

actually predict or diagnose that disease. but now with the databases you might be able to point to that data. essentially it's the clinical community is crowd sourcing the evidence. and we just did that recently with -- two years ago with a test for cystic fibrosis where first we approved the test based upon a subset of variance. and secondly they were able to use data in a database at johns hopkins that was support bid the cystic fibrosis foundation and didn't have to do a clinical study. dramatically reduced the cost of bringing that test to market. who pays for it. hopefully the insurers will pay for it at the end of the day. if you have good technology it's of no value to patients if they don't have access to it. and if they can't afford it, they won't have access. >> there's no question that precision medicine can bring down our costs in certain ways. i don't worry about a brave new world where certain people have

sk says to certain things. i'm out of time. i'm asking for consent to san mateo a statement to the hearing record. >> of course it will be done. thank you, senator frank. senator cassidy. >> dr. desalvo we've had a gao report in the past. the va and the dod need to do much better to coordinate their records. clearly electronic medical records are critical to precision medicine. now i hear that there's an $11 billion dod contract going out and i'm not quite sure that it's coordinating with the va. and we have testimony recently about how there's a lack of interoperateability. so i feel like we're in a thicket here and we can't get

out. but all we know, we're about to spend $11 billion on something that the va system is not interoperable with. please tell me that i'm absolutely wrong. >> senator, that is -- the dod's acquisition of a new electronic health record you with correct. we're intimately involved in that. the department of defense has embedded staff with us at onc to see that we're communicating. the department of defense has agreed to lead the way to pointing to the standard. if i could for a second -- >> i nl have three and a half minutes. >> one of the important things is to move away from proprietary -- >> there's open source budders. epic is one of them. >> those vendors will have to agree to use the standards that the department of defense wants to use, which are the ones that

onc has published. we're very pleased that we're all moving in a direction to have a core set of standards that everyone will agree to so we don't have run into a problem -- >> you're telling us that the va will be able to share records or that the local hospital will be able to share records with the dod? >> so the va and the dod is a separate issues because they have a different kind of technology. but the request goal is that becomes exchange but also interoperateability. >> when you mentioned the goal, i accept that it is the goal. but how likely is it to happen. it seems like you left some wiggle room that indeed the va has a separate system and it may not yet communicate with the dod. >> they've found a solution to exchange information. so if you're at the bedside with the patients, you can see the records from the va and the dod. the integrating of the data requires having the same core

data elements. there's a technology issue which is solvable. there's also a policy issue which is generally the harder one, like information blocking, which is one of the things getting in the way in the broader community. >> you spoke of the open source. that seems by definition not to include information blocking. so who is blocking the info? >> so information blocking can happen sometimes from technology. but what we're seeing commonly is that the vendor systems will charge -- >> i accept that. we've had the hearings about how the vendors are blocking. let's take it back where we start pd. my fear is the unvendors blocking bidding. ic i'm not cliesh, with the final $11 billion project be something that i at in baton rouge can access data or will there be a problem with vendor

blocking. >> i would need the dod to confirm the answer. however, what i would share with you is that since we described blocking and since we put out that report, the vendors have been able to pull down the fees to make the problem start to go away. >> i apologize. i'm almost out of time. i guess is it part of the initial rfp that they cannot block and that the va has to be able to share as does the community hospital? >> that is the intention of the dod, yes, that is correct. >> it is the intention but is it part of the rfp. >> yes, that's where they're going. that is what i understand from -- what we have recommended as onc to the dod. >> can you? i sometimes find that recommendations are not adopted. >> we can certainly get back with you on that. >> i'm almost out of time.

i yield back. >> thank you. >> thank you senator cassidy. senator bennet. >> thank you mr. chairman. i thank you, the witnesses for your testimony. dr. shuren as i'm sure you know, there is a thriving movement of innovation of molecular diagnostics underway. thanks to the human genome project investment over the past decade. a number of colorado companies which are developing remarkable new advanced diagnoses. and there is like ebola, cardiovascular disease and lung cancer. the fda released a draft framework to regulate lab developed tests. as i wrote in a letter to you a couple of weeks ago, as always we need to balance both innovation and safety to be sure we create a fair and workable process. there's some concern that the

draft framework would improve thousands of labs or at minimum thousands 0 tests. i'm wondering if you can speak to. this given the size and scope of the issue, do you intend to more formal actions? are you open to congressional action? would that be useful? how do we get a handle on this? >> first let me say that laboratory developed tests play an important role in our health care system today and our goal here is not shutting down laboratory developed tests but in fact making sure we're facilitating inno ration and that those vest tests are accurate, reliable and clinically meaningful. we tried to strike that balance and i don't know that we'll actually receive thousands of tests. because what we've heard from the lab community is that a lot of the tests they make are to address unmet needs. one of the things we put out in our proposal is to say you're making a laboratory developed

test you're a health care facility and treating patients and there isn't a test like that that fda has approved or cleared. you don't come in the door for premarket review. we'll address that unmet need. now subsequently if someone has the test and sends us the data we know the test works then our expectation is other people who are making the test should do the same because we have data that the test is accurate, reliable and clinically meaningful. i don't know that we'll actually receive thousands. that said we received a lot of comments on the proposal, we're working on it and we will be making changes before we have the final policy. >> if there is legislative work that needs to be done around this, i hope you'll let the committee know. i wanted to turn to one other topic around innovation. dr. collins mentioned earlier how important mobile technologies have become here. really in the blink of an eye this is all changing the way

doctors practice medicine and patients monitor their own well-being. and as you know probably senator hatch and i reintroduced the med-tec act yesterday to ensure that the mobile apps are not regulated by the fda. i think we share the same goals on this and i want to thank you team for giving us technical advice all the way through. can you talk a little bit about fda's think in this area? >> well, first let me thank you and senator hatch and your staffs for the opportunity to work together on the med-tec act. we agree as we looked at the space, we were looking at functions, device functions that we had been regulating for a long time and now some of them are being put on mobile platforms. and what we found as we looked at it is that some of these lower risk functions we may better serve by no longerly activating

them. instead focus on higher risk medical device functions in this space. that is kind of a nice balance on the facilitate innovation good patient safety. >> thank you. i don't know if you have anything to add? >> well, only that i think that your point about mobile house technologies is well taken. proliferation of exciting opportunities is happening around us and we certainly see the precision medicine initiative as an opportunity to test those out. you not only want an application that's cool gives you interesting information, but you want to know if that improves health, change outcome, and if we have a million individuals excited about participating in research essentially volunteering to become users of these kinds of technologies, whether it's the next version of a watch that measures all kinds of aspects of your body's physiology or something detecting in the air around you

what exposures you're having, this would be a great opportunity to find out what works, what actually improves health care, and what ought to then be extrainlated and use liezed for the country. >> thank you, thank you, mr. chairman. >> thank you. senator collins? >> thank you very much mr. chairman. dr. collins, just this morning, i met with samantha kits from main who is pushing for more research into brain cancers such as plastomas. you mentioned thatton oncology is the clear choice for impacting precision medicine and important advances have been made in the area, and so i very much look forward to sharing your testimony with this group of people from maine who are concerned about such devastated brain cancers as these.

i'm wondering if you also see a role for precision medicine for alzheimer's, parkinson's, and als? our investments in these important areas also being considered as part of the precision medicinecollins, for the question. absolutely. we are learning that disorders like parkinson's and other nerve conditions do, in fact have multiple contributions to whether they happen or not to a given individual. for alzheimer's disease we know of 35 individual places in the genome where variations place an individual at higher risk, and we know about one or two where individual variations actually are protected, which is an even more potentially actionable

finding because you'd like to understand that in order to develop the next generation of preventative strategies for people who were not so lucky as to inherent that preventative genetic variation, so there's especially for any disease that is common enough that you're going to have thousands of individuals in your one million strong cohort and opportunity to study those at a scale that's not previously been processed and to try to put together all of the things we can learn about their genetic inharns using the genome sequencings and exposures to learn everything we can about the health record experience and using mobile health. are there ways we could have better detection systems of early trouble in terms of cognitive changes? that's very much an intention of this. i think one of the exciting aspects of having this very large cohort is that it does not have to be just about heart disease or just about diabetes or just about alzheimer's disease. it can be about all of those

things because it will have the scale to do so. we have waited a long time to reach the point where the technology would make that possible and the time is now. we've really reached a remarkable reflection appointment, i think, in the potential of medical research, and we should not let this moment past. >> i could not agree more. i think, truly, it's so excite ing ing. doctor despite the federal support that you mentioned in your testimony i continue to hear from small erer health care providers about barriers they face with electronic health record implementation. just yesterday i met with a physician from bangor maine, who shared with me that putting in place a comprehensive electronic data collection system for his small practice was going to cost in excess of

$230,000. this was just for the software not for the hardware. that's no small amount particularly for a smaller independent practice that is not hospital owned. to access information about individuals to improve diagnosis, treatment, and prevention of diseases you discuss the important role, the absolutely essential role of health information technology and interoperateability including standards and technology needed. as you you to build these health i.t. systems for precision med sip, how can we ensure we're not leaving out rural america, smaller practices, rural hospitals, health clinics

because of the cost? >> senator collins, thank you for the question and for particularly spotlighting the challenge of small practices and rural. as the center was aware that was a particular focus we had early on in the high-tech funding prior to rejoining the administration, and that team wanted to see rural america was not left behind, and there was great success in the adoption in many of the communities across the country in partnership with the usda as an example. they are facing challenges now in upgrading technology, and challenges because of last year, challenges they had to put out the flexibility rule to give out more time to advance the cause you're described for that physician sounds exorbitant and i'm happy to follow up with your staff and that physician to see what's happening there and perhaps the regional extension centers in your communities to follow up. you are exactly correct. it's critical we get this and that nobody's left behind and we

find a way to make it successful for everyone. >> thank you very much. i'll take you up on that offer. thank you. thank you, mr. chairman. >> thank you, senator collins. senator warren. >> thank you, mr. chairman. president's precision medicine initiative could be a big step guard for targeted therapies for any number of conditions, and i think it's a great idea. we should have started years ago. dr. collins, you first advocated for a national genetic study to see how people's genes and environments contribute to diseases over a decade ago 2004, is that correct? >> in fact, that is exactly right. that landed with a thud at that point. that's the article on the screen that i published in 2004. i, in retrospect this was ahead of its time because we did not have the technology at the point where this would have been affordable or practical, but it is now. >> well, i'm glad to hear that

it is now, although, if we started pushing and fund back then we could only wonder how much further we would be ahead right now. you know congress did not make those investments, and, in fact, over the past decade, nih funding has not kept pace with inflation inflation, and that means we are years behind in doing this work. if we are serious about speeding up innovation, reducing long term cost, we have to start by investing in nih. the house has a proposal called 21st century cures that's supposed to accelerate medication and when first released months ago it did not include a single dime of new nih funding for congress, and last week's new bipartisan draft of the bill very much seems to be moving in the right direction.

there's $2 billion in new mandatory funding for the nih every year for five years. and i applaud house republicans for acknowledging what so many of us including newt gingrich and the industry said for years that nih is critical to accelerate. let's be clear this will not solve a decade of neglect much less build the future that we need. so dr. collins, in the late 1990s, congress doubled the budget of nih, and then agency funding was left to shrink back down. if congress had never doubled the budget of nih and had simply kept pace with prior investments, where would the nih budget be today? >> senator i keep a graph in front of me all the time about this very question, and i'll put it up on the screen because this is a documentation of the problems that we are now facing. >> yep.

>> what you're seeing on that screen there, the yellow line is basically what nih has had as far as our purchasing power for research. it's the appropriation, but as adjusted di the eded by the effects of inflation inflation. the dotted green line was the projection going back to 1970 until 1998 with the wonderful doubling and we have been getting up doubled ever sense. follow the dotted green line, and we stayed on that trajectory, we would be higher up in the neighborhood of over $40 billion. >> so just to get back on track, and to reverse damage of the last decade, nih, if i'm right, needs more than $12 billion in just the first year? the house proposal does not even put that much in over the space of five years? so let me just ask based on what you've got here, in your expert judgment, what's annual rate