[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]



 
                  IMPROVING NIH MANAGEMENT AND OPERATION: 
                A LEGISLATIVE HEARING ON THE NIH REFORM ACT 
                                  OF 2006


                                  HEARING

                                BEFORE THE


                          COMMITTEE ON ENERGY AND 
                                 COMMERCE


                         HOUSE OF REPRESENTATIVES


                        ONE HUNDRED NINTH CONGRESS

                              SECOND SESSION


                            SEPTEMBER 19, 2006

                            Serial No. 109-140

        Printed for the use of the Committee on Energy and Commerce


Available via the World Wide Web:  http://www.access.gpo.gov/congress/house

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                     COMMITTEE ON ENERGY AND COMMERCE
                        JOE BARTON, Texas, Chairman
RALPH M. HALL, Texas                      JOHN D. DINGELL, Michigan
MICHAEL BILIRAKIS, Florida                  Ranking Member
  Vice Chairman                           HENRY A. WAXMAN, California
FRED UPTON, Michigan                      EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida                    RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio                     EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia                      FRANK PALLONE, JR., New Jersey
ED WHITFIELD, Kentucky                    SHERROD BROWN, Ohio
CHARLIE NORWOOD, Georgia                  BART GORDON, Tennessee
BARBARA CUBIN, Wyoming                    BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois                    ANNA G. ESHOO, California
HEATHER WILSON, New Mexico                BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona                  ELIOT L. ENGEL, New York
CHARLES W. "CHIP" PICKERING,  Mississippi ALBERT R. WYNN, Maryland
  Vice Chairman                           GENE GREEN, Texas
VITO FOSSELLA, New York                   TED STRICKLAND, Ohio
ROY BLUNT, Missouri                       DIANA DEGETTE, Colorado
STEVE BUYER, Indiana                      LOIS CAPPS, California
GEORGE RADANOVICH, California             MIKE DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire            TOM ALLEN, Maine
JOSEPH R. PITTS, Pennsylvania             JIM DAVIS, Florida
MARY BONO, California                     JAN SCHAKOWSKY, Illinois
GREG WALDEN, Oregon                       HILDA L. SOLIS, California
LEE TERRY, Nebraska                       CHARLES A. GONZALEZ, Texas
MIKE FERGUSON, New Jersey                 JAY INSLEE, Washington
MIKE ROGERS, Michigan                     TAMMY BALDWIN, Wisconsin
C.L. "BUTCH" OTTER, Idaho                 MIKE ROSS, Arkansas                       
SUE MYRICK, North Carolina
JOHN SULLIVAN, Oklahoma
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee


                    BUD ALBRIGHT, Staff Director
                   DAVID CAVICKE, General Counsel
    REID P. F. STUNTZ, Minority Staff Director and Chief Counsel


                                 CONTENTS


                                                                      Page
Testimony of:
     Miller, Edward D., M.D., Chief Executive Officer, Johns 
          Hopkins Medicine	                                        18
     Kirch, Darrell G., M.D., President, Association of 
          American medical Colleges	                                27
     Eckel, Robert H., M.D., Professor, Department of 
          Physiology and Biophysics, University of Colorado 
          Health Sciences Center	                                33
     Furcht, Leo T., M.D., Board of Directors, Federation of 
          American Societies for Experimental Biology	                39
     Zerhouni, Elias A., M.D., Director, National Institutes of 
          Health	                                                64



                IMPROVING NIH MANAGEMENT AND OPERATION: A 
               LEGISLATIVE HEARING ON THE NIH REFORM ACT OF 
                                    2006


                      TUESDAY, SEPTEMBER 19, 2006

                        HOUSE OF REPRESENTATIVES,
                    COMMITTEE ON ENERGY AND COMMERCE,
                              Washington, DC.


        The committee met, pursuant to notice at 2:08 p.m., in Room 
2123 of the Rayburn House Office Building, the Hon. Joe Barton 
[Chairman] presiding.
        Members Present:  Representatives Barton, Upton, Deal, 
Norwood, Shimkus, Terry, Rogers, Murphy, Burgess, Blackburn, 
Dingell, Waxman, Rush, Stupak, Engel, Wynn, Green, and Doyle. 
        Staff Present:  Katherine Martin, Counsel; Ryan Long, 
Counsel; Brandon Clark, Policy Coordinator; Chad Grant, 
Legislative Clerk; John Ford, Minority Counsel; and Jessica 
McNiece, Minority Research Assistant. 
        CHAIRMAN BARTON.  The hearing will come to order.  
        I want to thank our witnesses for being here today to testify 
about the importance of reauthorizing the National Institutes of 
Health.  We are going to hear from a variety of individuals today, 
including the current director, Dr. Zerhouni.  I want to particularly 
thank Dr. Zerhouni for his patience and his generous assistance in 
providing much-needed feedback on the various drafts that we 
have gone through in the last several years, his cooperation at the 
numerous hearings that we have had, and many, many background 
briefings and meetings that he and I have had on this subject. 
        I think it is time to reauthorize the NIH.  When I became 
Chairman of this distinguished committee 3 years ago, I made it 
one of my top priorities to reauthorize this fine institution.  I never 
dreamed it would take 3 years to get to this day.  It is a project that 
is long overdue.  It has been 13 years since we had an authorization 
for the NIH.  It was last reauthorized for the fiscal years 1994 
through 1996, and as we all know, we are now in the year 2006, 
and about to go into fiscal year 2007.  
        During this last decade, science and research have changed 
dramatically.  Congress has recognized that by doubling the budget 
of the NIH.  However, just doubling the money isn't enough.  Our 
job should be to give NIH the tools that it needs to bring 
accountability, transparency, and transformational policies into 
what is now closing in on a $30 billion research agency.  
        The NIH that we know today, with the best of intentions, is a 
hodgepodge of different interests.  I anticipate that we are going to 
hear about some of those interests from our witnesses today.  We 
are also going to hear that they believe, as I believe, that the 
agency needs to be reorganized and revitalized.  The Institute of 
Medicine recently issued a report calling for a number of new 
management tools needed at the NIH.  Under the direction of Dr. 
Zerhouni, many of these recommended are currently being 
implemented, or at least being studied under his roadmap initiative.  
        I think it is incumbent on us as members of the authorizing 
committee to codify these changes into Federal law, and also add 
to the functional organizational structure of the agency.  
        The NIH has a very big job.  It has a great deal of money to do 
that job, and I support both the agency and its mission.  I want to 
reiterate that.  I support the agency of NIH and I support its 
mission.  It, literally, is one of the crown jewels of the Federal 
Government. 
        I do believe, however, that the NIH can do better and it can do 
its part by reporting back to Congress and the public, who provide 
the funding through tax dollars, on how that money is being spent.  
We hear a lot about lack of new funding at the NIH.  I think that 
that is a problem, but we don't have enough transparency.  We 
don't have the systems in place right now, in my opinion, to really 
determine the best uses to put new money, and perhaps even some 
of the current funds that are being spent at the NIH. 
        We have drafted legislation.  I can't tell you the exact number 
of drafts that we have had, but we have had more than one draft 
over the last several years, which we have sent out to the 
stakeholders for their review.  We have looked at these drafts 
legislatively on a bipartisan basis, staff members and members of 
the committee, trying to get exactly the right mix on what we need 
to do to change things at NIH.  The stakeholder community, 
including the entirety of the representatives of our first panel, 
reacted to our very first draft with a number of concerns, 
suggestions--some praise, but very little praise.  
        We have listened and over the course of the past year we have 
worked and reworked various drafts with the stakeholder 
community as well as directors at the NIH to ensure that the bill 
that we hope to mark up tomorrow is as good a product as it is 
possible to have.  
        I believe that while no bill is perfect, the bill that is before us 
today in draft form is a very, very good bill.  The response to this 
latest draft has been overwhelmingly positive.  The bill has 
received widespread endorsement from disease advocacy groups, 
patient advocacy groups, universities, medical colleges, 
researchers, scientists, the list goes on.  After 13 years, we finally 
have legislation that apparently is getting it right.  I am going to 
work very hard at the last stage of this Congress to make this bill 
law or this bill, with some modifications, if it is the wisdom of this 
committee and others in the other body to make some minor 
changes, to help the NIH move forward into the 21st Century with 
the organization, the management and the funding that it needs to 
keep people healthy. 
        I want to commend my Ranking Member, Mr. Dingell.  He and 
his staff have worked hand in glove for the last 2 years providing 
numerous suggestions, numerous alternatives, and when necessary, 
positive constructive criticism of changes that need to be made. 
        It is seldom that the Congress actually does the right thing for 
the right reasons, but in this case, I think that we are doing the right 
thing for the right reason.  If we can have a successful hearing 
today and a successful markup tomorrow and get our friends in the 
other body to work with us, we can put a bill on the President's 
desk in this Congress.  It does revitalize and reform the National 
Institutes of Health, and I think that is an achievement worth 
working hard for in the last few weeks of this Congress. 
        With that, I am going to yield to my distinguished Ranking 
Member, Mr. Dingell, for any opening statement that he wishes to 
make. 
        [Prepared Statement of the Hon. Joe Barton follows:]

PREPARED STATEMENT OF THE HON. JOE BARTON, CHAIRMAN, 
COMMITTEE ON ENERGY AND COMMERCE

        Thank you to all our witnesses today for testifying before our 
Committee on the importance of reauthorizing the National 
Institutes of Health.  Today we are hearing from a variety of 
witnesses who are involved with the NIH.  I would particularly like 
to recognize Dr. Zerhouni for the patience and generous assistance 
he has provided through the numerous hearings and countless 
meetings on this subject during my Chairmanship.

It's time for us to do our job and reauthorize the National Institutes 
of Health.  When I became Chairman of this Committee one of my 
first priorities was to reauthorize the NIH.  It was a project long 
overdue then, and now 13 years have passed since the agency was 
last authorized.  Within this time, science and research have 
changed dramatically and Congress recognized that by doubling 
the budget of NIH.  Just spending double the money on research 
isn't enough, however.  Our job is to give NIH the tools it needs to 
bring the real accountability and transparency needed to efficiently 
run a $30 billion agency.
        
	The NIH that all of us know is a hodge-podge of different 
interests.  I anticipate we will hear from our witnesses that the 
agency is in desperate need of organization.  The Institute of 
Medicine recently issued a report calling for a number of new 
management tools needed by the NIH.  Under the astute direction 
of Dr. Zerhouni, many of these recommendations are currently 
being implemented under the roadmap initiative.  It is now 
incumbent upon us as members of the authorizing committee to 
codify these changes as well as add to the functional organization 
of the agency.
NIH has a big job and a great deal of money to do it, and I 
strongly support both the agency and its mission.  I do, however, 
believe that NIH needs to do its part by reporting back to Congress 
and the public who provide the funding through tax dollars on how 
the money is being spent.  We hear a lot about a lack of funding or 
the need for programs, but with so little transparency in the NIH, 
we cannot properly respond to their concerns.   
	This Committee released draft legislation over a year ago 
proposing changes to the NIH.  The stakeholder community, 
including the entirety of our first panel, reacted to that draft with a 
number of concerns, suggestions, and some praise.  Over the 
course of the past year, I have worked with the community as well 
as the NIH to ensure that the bill we are marking up tomorrow is as 
good a product as we can have.  I believe that this goal has been 
achieved.    
	The response has been overwhelmingly positive.  The bill has 
received widespread endorsement from disease advocacy groups, 
patient advocacy groups, universities, medical colleges, 
researchers, scientists, and the list goes on.  After thirteen years of 
inaction we finally have legislation that gets it right.  This bill 
ensures the NIH will move forward in the 21st century with the 
organization, management, and funding it needs to keep people 
healthy.

        MR. DINGELL.  Mr. Chairman, I thank you for scheduling the 
hearing, and I thank you for recognizing me.  I very much look 
forward to the hearing and to the testimony of our witnesses.  
        Dr. Zerhouni is a fine public servant, and I have great respect 
for the work he has done as Director of our National Institutes of 
Health.  I am particularly pleased that we have another panel of 
witnesses who collectively represent a very distinguished level of 
experience in the area of healthcare and research, and we are 
fortunate to have them here today.  They represent a majority of 
the people and institutions that do much of the extramural research 
that is funded by NIH.  
        And I want to particularly welcome Dr. Kirch, who by most 
happy and interesting circumstances is Executive Vice President 
for Medical Affairs, and CEO of the University of Michigan 
Health Systems.  Doctor, welcome to you. 
        CHAIRMAN BARTON.  Did they play in the football game 
Saturday?  
        MR. DINGELL.  As a matter of fact, and very well, too. 
I am also pleased that we will have the benefit of the 
perspective of a major patient advocacy organization, the 
American Heart Association. 
        The legislation that will be discussed today has its roots in the 
concerns raised by a number of past NIH directors and specifically 
takes into account several recommendations included in the 
Institute of Medicine report entitled "Enhancing the Vitality of the 
National Institutes of Health, Organizational Change to Meet New 
Challenges."  This legislation has been developed in consultation 
not only with the stakeholders, but with the committee democratic 
staff, and I want to express my appreciate to you, Mr. Chairman, 
for that.  
        Mr. Chairman, you have made the reauthorization of NIH one 
of your priorities as Chairman of the committee, and appropriately 
so, because in my view, NIH is one of the crown jewels under this 
committee's jurisdiction.  And it has been more than 13 years, as 
you have observed, since we moved any legislation of this kind. 
        I believe you have proceeded in a manner that shows your 
appreciation for the seriousness of this task, and I want to 
commend you for your leadership and the vigor in which you have 
addressed it.  I do find, and I regret this, Mr. Chairman, the ability 
of our members to review this language at this point in the session 
with the care that it really requires is going to be limited, because 
subcommittee consideration is being skipped altogether, and we 
are now moving to markup in the full committee tomorrow 
morning.  
        I find that that is a situation which creates great peril and 
possibility of misunderstandings, and carries with it the potential 
for mischief being done to what I regard as not only a fine effort by 
you, Mr. Chairman, but also a real necessary piece of legislation. 
        I wish we had more time to address this under a less limited 
process, and I think that more time could be achieved.  I will say 
that the shortage of time and the difficulty of proceeding under the 
stringent circumstances of the kind of proceedings that we proceed 
under poses risk to the legislation and I think threatens your efforts 
to do something which are indeed very important.  
        I will remain anxious to be of assistance to you.  I will observe 
that the substance of the bill in my view is good.  I do remain 
concerned about the adequacy of funding levels, however. 
        The bill has garnered broad support in the stakeholder 
community, and that fact isn't more than a little comfort to me.  
When tomorrow's markup occurs, I will be listening to my 
colleagues and concerns that they would have of this bill.  
        Mr. Chairman, I want to commend you again for embarking 
upon the, what I know is a very important and difficult task.  I 
know that you have tried to address the concerns, but I do note that 
other concerns remain outstanding. 
        Again, Mr. Chairman, I thank you, and I look forward to the 
testimony of our distinguished witnesses. 
        CHAIRMAN BARTON.  We thank the gentleman from Michigan 
and recognize the gentleman from Georgia.  
        MR. NORWOOD.  Thank you very much, Mr. Chairman.  I will 
be brief and submit most of my remarks for the record, but I would 
like to thank you and congratulate you on bringing this bill 
forward.  I know how hard you have worked on this, how 
important it is to you, and, in fact, to all of this committee; 13 
years is a long time, and it is very much time that we got this done.  
And it seems at least at this point that there is great consensus on 
what your work has been.  
        I also want to welcome Dr. Kirch; he is a former dean at the 
Medical College of Georgia.  I am glad to see you out here today.  
And thank you and all of you for your testimony. 
        And lastly, I think it is always appropriate for us to thank Dr. 
Zerhouni, because of his difficult and hard work and great 
leadership over at NIH; we thank him once again for appearing 
before our panel. 
        With that, Mr. Chairman, I will ask the rest be placed in the 
record. 
        CHAIRMAN BARTON.  Without objection, so ordered. 
The distinguished gentleman from California, Mr. Waxman, is 
recognized for an opening statement.  
        MR. WAXMAN.  Mr. Chairman, I welcome the hearing today on 
the proposals recently put forward by you to reauthorize and 
reorganize NIH.  
        We are dealing with one of the most pre-eminent health 
agencies of the Federal Government, recognized for its fine work 
here and around the world. 
        All Members of Congress and most Americans believe that the 
NIH is the crown jewel of government funding, it is an agency that 
we are all very proud of.  Mr. Barton has worked hard to secure 
support for the changes he is interested in making.  He has 
substantially moderated his proposal from last year; it is clearly 
better, and I think the views on the proposal that we will hear from 
witnesses today reflect that.  
        But we are, I think, in a situation where we are dealing with an 
agency that is not broken.  We ought to proceed with caution and 
be sure that what we do improves its function.  We are still making 
substantial changes in the NIH that many in the research and 
patient community have had little time or opportunity to review 
and fully understand.  This bill I think in its final form was 
introduced last week, we are holding our hearing today, we are 
marking it up tomorrow, it is going to the House floor very soon, 
and the Chairman said he would like the Senate to pass it before 
we leave, which is 2 or 3 weeks from now, or maybe when we 
come back for the lame duck session. 
        Is it fully understood, for example, that under this bill, the 
institutes and centers of the NIH will be authorized at a level below 
the traditional levels of the biomedical research development price 
index.  Even if the 5 percent is fully appropriated, with half 
reserved for the Common Fund, there will not be enough funds to 
cover inflation for our research institutes.  I understand there will 
be an amendment to try to increase that funding.  
        Is it fully understood--it is not in the bill now--that the Director 
of the NIH is given the power to eliminate institutes and centers 
established by law after a hearing process and 90-day notification 
to the Congress?  Do people really understand that offices like the 
Office of Women's Health and the Office of AIDS Research, also 
established by law, could be eliminated without Congressional 
notification?  In each case, Congress can stop this only by 
legislation that will have to be subject to a Presidential veto. 
        Further, a Science Management Board could effectuate the 
same changes, removing the process from public accountability.  
This runs contrary to my own basic view that this is the business of 
the Congress.  Recommend changes to us?  Yes.  But Congress is 
the one that should act, and I believe, in fact, this is very much 
what the Institute of Medicine study said, which gave a lot of 
impetus to this legislation.  
        I raise these points partly because they reflect my deep 
concerns with the bill, and partly to demonstrate that we move 
ahead with a full understanding of the impact of the legislation.  
        I look forward to hearing from the witnesses today.  Thank 
you, Mr. Chairman. 
        CHAIRMAN BARTON.  We thank the gentleman.  
        The gentleman from Illinois, Mr. Shimkus.  
        MR. SHIMKUS.  Thank you, Mr. Chairman.  I appreciate your 
effort to move this forward.  And I want to thank the panelists for 
coming.  And this is a time to see what is in the bill, to say what is 
good and raise some concerns, and then we will move forward. 
I appreciate, Mr. Chairman, the issue of the Common Fund and 
the NIH issue because a lot of the research, as we know, works 
cross purposes, and I think that is a very--instead of staying in 
stovepiped areas, that the communication across fields, the more 
you get involved in this, the better it will help all research, and that 
is a very positive change.  
        I also appreciate in section 5 on the report, having 
rehabilitation services included in that what type of benefits that 
occurs to the whole body of health.  And I appreciate this hearing 
and look forward to moving forward, and I yield back my time, 
Mr. Chairman.
        CHAIRMAN BARTON.  I thank the gentleman.  
The other gentleman from Illinois, Mr. Rush, is recognized for 
3 minutes.
        MR. RUSH.  Thank you, Mr. Chairman, for recognizing me.  
And I want to thank our panelists for being here today, and I also 
want to commend you on having this hearing. 
        Mr. Chairman, as we proceed to full committee markup of a 
comprehensive reauthorization of the National Institutes of Health, 
my chief concern is the same as it was in previous hearings on 
NIH.  I am concerned that the committee print before us does not 
do enough to address the persistent evil of racial health disparities 
that continues to plague our Nation.  
        I do not find anything objectionable to the committee print 
itself, and I think it is a good piece of bipartisan cooperation that 
creates accountability and ensures the vitality of the greatest 
research institution in the world.  However, because I regard health 
disparities as one of the most blatant enduring injustices in our 
country today, I simply cannot ignore the fact that the legislation is 
silent on this issue.  I believe that we should be doing more to 
address health disparities, particularly among minorities at NIH; 
indeed, the Institute of Medicine declared likewise in its 
comprehensive study on NIH. 
        Mr. Chairman, this is not merely a special interest issue 
whereby I am advocating specific research on one area over 
another.  I appreciate your desire to avoid a disease battle or an 
institute war when members of this committee start favoring one 
illness over another or one institute over another.  And I agree with 
you, Mr. Chairman, I don't want this bill to become bogged down 
in special interests, but addressing health disparity isn't about that, 
it is about tackling a chronic social problem, ensuring a 
fundamental commitment to basic justice.  
        Racial health disparities is not a specific biological disease, but 
a much larger political and social disease that cuts across a whole 
range of research issues.  The proposed legislation is called the 
NIH Reform Act of 2006.  I think, Mr. Chairman, that if we are 
going to reform NIH, we must reform the organizational 
impediments and attitudes that perpetrate the racial inequality in 
medical research. 
        Mr. Chairman, I look forward to our panelists' testimony, and I 
yield back the balance of my time. 
        CHAIRMAN BARTON.  I thank the gentleman.  
        We are aware of some of Mr. Rush's concerns and are working 
with your staff to try to address those in a manager's amendment.  
I think you are aware of that.  So we are still listening and still 
trying to work on some of those issues that you have just raised. 
        Does the distinguished gentleman from Pennsylvania, Dr. 
Murphy, wish to make an opening statement?  
        MR. MURPHY.  Yes.  Thank you, Mr. Chairman.  
I am pleased you are moving forward with this bill, it is very 
important.  I know it has been a long time coming.  And perhaps 
the good news that comes with this is not only that it is moving 
forward now, but also that we have learned so much in the last 2 
years about healthcare as well.  Some of my interests--actually, the 
committee's interest and yours as well--are on making sure that we 
look at not only how things are done in the laboratory or with any 
disease research, but also how they work together.  
        My assumption is the Common Fund, which is set up here, will 
work on integrating and coordinating a lot of that care together, but 
in particular, some ways that I see as very, very important that I am 
hoping final drafts of this legislation include are knowledge of 
what needs to be done with patient safety, on many, many levels of 
what hospital and primary and secondary care can do for patients 
as we look at those issues of patient safety from infections to some 
of the other things we have dealt with in this committee, but also 
the issue of integrating care, and that each institute is not a separate 
entity.  
        And when you look at things, for example, the Institute of 
Mental Health can combine with some of the other areas, and we 
recognize the impact that mental illness has upon cancer and 
diabetes.  And I am hoping that this is an area that we see more 
growth and research as scientists work together more in 
collaboration to give us answers on how we can deal with these 
diseases by coordinating these researches together.  So I am 
pleased that this bill is moving forward, and I look forward to the 
rest of this hearing.  
        Thank you, Mr. Chairman. 
        CHAIRMAN BARTON.  I thank the gentleman.
        I recognize the distinguished Ranking Member of the 
Oversight Subcommittee from Michigan who has done excellent 
work on oversight of NIH, Mr. Stupak, for an opening statement.  
        MR. STUPAK.  Thank you, Mr. Chairman, and thank you for the 
kind comments.  Thanks for holding this hearing.  I am going to be 
in and out, but I am going to come back during questioning 
because I do have a couple of questions. 
        I want to thank the Chairman and his willingness to work with 
our office to include two provisions in the Reauthorization Act.  
The first one pertains to our Oversight and Investigation hearings 
concerning the NIH human tissue issue and the language that 
would require NIH to report to Congress on the progress of their 
tracking system for human tissue samples.  The second issue 
relates to clinicaltrials.gov, where any language that would require 
NIH to report to the FDA yearly all drug trials added to 
clinicaltrials.gov website.  I believe this is a step in the right 
direction for drug safety.  
        However, I believe NIH still has much to do and much 
progress needs to be made in the area of conflicts of interest in the 
Public Health Service Corps.  Unfortunately, this reauthorization 
does not allow us to address these issues.  In the Oversight and 
Investigations Subcommittee, we have been addressing it for over 
the last 4 years, and hopefully we can come to some conclusion 
and get some strong language in for conflicts of interest, especially 
with the Public Service Corps.  
        So I look forward to hearing from our witnesses.  I look 
forward to continuing to work with the committee and the 
Chairman.  And with that, I will yield back, Mr. Chairman.  Thank 
you. 
        CHAIRMAN BARTON.  We thank the gentleman. 
The distinguished doctor from Denton, Texas, Dr. Burgess is 
recognized for an opening statement.  
        MR. BURGESS.  Thank you, Mr. Chairman.  And let me add my 
name to the long list of people who are offering you 
congratulations for bringing this bill to the floor--to the committee.  
You should be lauded for proposing important improvements in 
how the National Institutes of Health operates and prioritizes 
essential medical research. 
        I have taken the option of making several field trips to the NIH 
in my 3 ï¿½ years in Congress, and I just can't tell you how much I 
am impressed by the researchers, the Institute directors and the 
overall work that is happening at the National Institutes of Health.  
It is truly the crown jewel of the Federal government, and we 
should all be proud of the organization's dedication to improving 
the health of Americans and mankind.  
        I think Dr. Zerhouni shared with me a slide when I first went 
out there that showed 800,000 people between the 1960s and now 
have not died prematurely from heart disease, largely because of 
work done at the NIH; that is an outstanding effort. 
        Advances in cancer care or a greater understanding of the 
human genome--the NIH has a proven record of innovation.  I 
believe that the bill before us represents important improvements 
to achieve the numerous missions that the NIH has undertaken.  
Creation of the Common Fund is especially important to address 
diseases and public health threats that may not fit neatly into one 
single institute's portfolio.  
        The Scientific Management Review Group is also an important 
component designed to evaluate the design of existing institutes 
and centers.  As medical research of the practice of medicine 
evolves, it is important that the NIH is an agile and responsive 
organization.  The Review Group will provide an important 
internal accountability at NIH that is subject to the scientific 
realities and not decisions based on politics. 
        I would also add my voice to that of Mr. Rush from Illinois 
about the needed work to be done on healthcare disparities in this 
country, it is not unique to any one geographic location in the 
country and affects my area of north Texas just as severely as it 
affects Mr. Rush's area of Illinois.  
        But all and all, this is a good bill.  By increasing the 
organization level, the Energy and Commerce Committee has 
produced a bipartisan approach to capitalizing on the gains made 
by the NIH over the last several years.  
        Mr. Chairman, I yield back. 
        CHAIRMAN BARTON.  I thank the gentleman.  
        The gentleman from New York City, Mr. Engel, is recognized 
for an opening statement.  
        MR. ENGEL.  Thank you very much, Mr. Chairman.  And I 
want to thank you for holding this very important hearing on the 
reauthorization of the National Institutes of Health.  
        There are few agencies in the United States government that 
offer as much promise for the future as the NIH.  It is important 
that we strengthen this institution so that it can be better at 
pursuing advance research to truly improve health services. 
        I want to personally commend you, Mr. Chairman, and your 
staff for your willingness to accept changes and revisions 
suggested by the many stakeholders who work with the NIH.  I 
know that there was considerable concern about many of the 
provisions in last year's draft, and I know that many if not all of 
these issues were resolved.  While I appreciate that reauthorization 
for appropriations has been set at 5 percent per year, it is worth 
noting that the appropriators routinely flat fund NIH.  It is 
obviously disgraceful, and it is important that this committee 
strongly signal to our friends on Appropriations that 5 percent 
growth per year should, if anything, be a minimum, be a floor.  
        Many groups like the Elizabeth Glaser Pediatrics AIDS 
Foundation and Foundation for AIDS Research believe that the 
authorization should be much higher, as do I. We could all benefit 
if more money were in this bill. 
        I am pleased that the latest bill has secured the endorsement of 
so many key stakeholders like the Association of American 
Medical Colleges, Association of American Universities, and the 
Federation of American Societies for Experimental Biology.  
        And finally, I would like to thank you again, Mr. Chairman, 
and your staff for working with my office to include report 
language on Charcot Marie Tooth Syndrome.  Charcot Marie 
Tooth Syndrome, or CMT, is the most commonly inherited 
neurological disorder affecting approximately 150,000 Americans.  
A better reporting system by NIH on the research they are doing on 
CMT will strengthen our ability to truly understand and treat this 
disease. 
        Again, I wish there was more money in the bill, but I know that 
you have worked very hard.  And again, I want to thank you and 
appreciate the work that your staff has done with mine.  And I 
yield back, Mr. Chairman. 
        CHAIRMAN BARTON.  Thank you, Mr. Engel.  
        Does Mr. Rogers wish to make an opening statement?  
        MR. ROGERS.  I do not, Mr. Chairman. 
        CHAIRMAN BARTON.  Down in Texas, we had a democratic 
primary about 50 years ago that Lyndon Johnson won by 54 votes 
and he got the nickname "Landslide Lyndon."  We have Mr. Wynn 
next.  He had a little bit of a tussle last week, but he did win, and I 
want to recognize Landslide Wynn for any opening statement. 
        MR. WYNN.  Well, thank you very much, Mr. Chairman.  And, 
in fact, they are still counting, but we are quite optimistic.  And I 
did take a couple of pages out of Lyndon's book, so if I win, it can 
be attributed to Texas know-how. 
        CHAIRMAN BARTON.  I hope not.  I hope you win fair and 
square. 
        MR. WYNN.  A win is a win. 
        MR. GREEN.  Mr. Chairman, we just are real organized in 
Texas, we vote alphabetically. 
        MR. WYNN.  Lyndon Johnson was a great president.  Thank 
you, Mr. Chairman, for your remarks.  And thank you and Ranking 
Member Dingell for holding today's hearing on legislation to 
reauthorize the National Institutes of Health.  NIH is located just 
outside my district, in fact, in Bethesda, Maryland. 
        Currently, it is a cumbersome process for stakeholders and 
researchers--and Congress, even--to identify and pinpoint specific 
research projects and activities being undertaken across the 
agency.  I think today's draft legislation will create an electronic 
agency-wide reporting system, which will increase transparency of 
research activities, accountability of research dollars and 
coordination of research, and I think these are very laudable goals. 
        The draft also seems to provide a permanent funding 
mechanism, the Common Fund, for cross-cutting trans-NIH 
research identified by the Division of Program Coordination 
Planning and Strategic Initiatives.  However, as a member of the 
Congressional Black Caucus, I am concerned that these structures 
may unintentionally undercut the National Center on Minority 
Health and Health Disparities, which serves as a focal point for 
planning and coordinating minority health and health disparities in 
research, truly, a trans-NIH initiative across the NIH.  
        Under the current structure, the center has insufficient authority 
to allocate and control funding for trans-NIH research on health 
disparities.  My concern is this legislation may exacerbate this 
insufficiency.  I hope I can work with you to ensure that this center 
is a key entity for coordinating and funding cross-cutting 
trans-NIH activities that address health disparities, research and 
development.  
        Thank you for your time, I relinquish the balance. 
        [Prepared statement of the Hon. Albert R. Wynn follows:]



PREPARED STATEMENT OF THE HON. ALBERT R. WYNN, A 
REPRESENTATIVE IN CONGRESS FROM THE STATE OF MARYLAND

        Thank you, Chairman Barton and Ranking Member Dingell for 
holding today's hearing on Legislation to Reauthorize the National 
Institutes of Health (NIH).  We have a fellow Marylander 
testifying today, whom I would like to extend a warm welcome: 
Dr. Edward D. Miller, the Chief Executive Officer of Johns 
Hopkins Medicine in Baltimore.  Thank you and we are glad to 
have you today.  
        The NIH, the world's leading biomedical research 
organization, is located just outside my Congressional district in 
Bethesda, Maryland.  It has been 13 years since the NIH has been 
reauthorized and I support this committee for bringing a bipartisan 
piece of legislation before us today.  The retiring baby boomer 
generation will pose a new strain to our healthcare system, making 
it critical that we fast track research on diabetes, cancer, heart 
disease, Alzheimer's, and other diseases and disorders.
        Currently, it is cumbersome for stakeholders, researchers, and 
Congress to pinpoint specific research projects and activities being 
undertaken across the agency.  The draft bill, which will be 
considered during full committee as soon as tomorrow, will 
increase transparency of research activities, accountability of 
research dollars, and coordination of research by creating an 
electronic agency-wide reporting system.  Additionally, the draft 
enacts a number of the Institute of Medicine's (IOM) 
recommendations designed to reduce repetitive research and 
maximize strategic coordination and planning.
        It also seeks to provide a permanent funding mechanism, the 
"Common Fund," for crosscutting trans-NIH research identified by 
the "Division of Program Coordination, Planning and Strategic 
Initiatives."  However, as a member of the Congressional Black 
Caucus, I am concerned that these structures may unintentionally 
undercut the National Center on Minority Health and Health 
Disparities (NCMHD), which serves as the focal point for planning 
and coordinating minority health and health disparities research - 
truly a trans-NIH initiative - across the NIH.  It is my sincere hope 
that the "Common Fund" will supplement and not supplant 
existing and future efforts of the Center. 
        Under the current structure, the Center has insufficient 
authority to allocate and control funding for trans-NIH research on 
health disparities.  This legislation may exacerbate this 
insufficiency. I believe it is certainly time for the National Center 
on Minority Health and Health Disparities to have stronger 
oversight and authority in achieving its mission and the mission of 
the NIH.  
        I intend to work with my colleagues and the Chairman to 
ensure that health disparities research and development are a core 
component of the NIH portfolio and that the Center is the key 
entity for coordinating and funding these crosscutting trans-NIH 
activities.  Furthermore, once enacted, I hope the Center will be 
represented within the proposed "Council of Councils," which will 
review trans-NIH funding proposals and within the proposed 
"Scientific Management Review Group," which will evaluate the 
structural design of existing Institutes and Centers and make 
recommendations for reform.  The Center cannot be underfunded 
or marginalized if we are to make a serious effort at eliminating 
health disparities.  I hope this committee can reassure this Center 
that its work is truly at the heart of the NIH.
        On a positive note, I commend this committee for codifying the 
current role of the Office of Research on Women's Health in 
overseeing and coordinating trans-NIH research through the 
"Division of Program Coordination, Planning, and Strategic 
Initiatives."  The Office of Research on Women's Health ensures 
that research conducted and supported by the NIH adequately 
addresses issues regarding women's health.
        However, it is disappointing to note that no minority health or 
women's health advocacy groups are testifying today, nor have I 
seen any letters of endorsement. I do hope that they will reach out 
to this committee with comment before tomorrow's markup.  
        Thank you and I look forward to hearing from today's 
panelists.
        CHAIRMAN BARTON.  We thank the gentleman.  The gentleman 
from Texas, Mr. Green, is recognized for an opening statement.  
        MR. GREEN.  Thank you, Mr. Chairman, for holding this 
hearing on the draft bill reauthorizing NIH.  We all know what a 
priority this bill is for you, and I want to thank you for your 
willingness to work with the stakeholders and revise the legislative 
text to create a bill that stakeholders can support. 
        As with any bill, there are a few provisions in the current draft 
that could use some clarity.  Specifically, I am interested in the 
Council on Councils established in the bill and want to make sure 
that its establishment and decision making process are as balanced 
as possible.  
        I think my colleagues on the committee would join me in 
calling NIH one of our crown jewels of our committee's 
jurisdiction.  I thank the chairman for actively exerting the 
committee's jurisdiction on NIH, and for the opportunity to get the 
clarification we need to ensure that this bill sets the NIH in the 
right direction for continued success and scientific achievement. 
        And again, I want to thank our witnesses for being here today.  
And Mr. Chairman, I yield back the balance of my time. 
        CHAIRMAN BARTON.  We thank the gentleman for his 
statement. 
        Seeing no other members present, the chair asks unanimous 
consent that all members not present have the requisite number of 
days to put their opening statements in the record.  Without 
objection, so ordered. 
        [Additional statements submitted for the record follow:]

PREPARED STATEMENT OF THE HON. SHERROD BROWN, A 
REPRESENTATIVE IN CONGRESS FROM THE STATE OF OHIO

        Thank you, Mr. Chairman, and thanks to Dr. Zerhouni and our 
other witnesses for joining us today.
        Mr. Chairman, you have worked extremely hard, against 
formidable odds, to craft a reauthorization bill that helps 
maximizes the return on our nation's investment in the National 
Institutes of Health, and I commend your efforts. 
        Ranking Member Dingell's unwavering support for NIH helps 
explain its endurance and its success.  Our nation owes the 
gentleman from Michigan a debt of gratitude for NIH, one of many 
public health institutions that have flourished under his watch. 
        I also want to commend Cheryl Jaeger, John Ford, and the 
other dedicated staff from the Majority and Minority who worked 
on this legislation.  They did an exceptional job.
        Mr. Chairman, I hope your efforts help re-engage Republican 
members of Congress whose support for medical research appears 
to be faltering.
        Following the lead of President Bush, Republicans in Congress 
have taken to passing marginal increases in NIH funding, increases 
that do not even keep up with inflation.  
        In fact, after the across-the board- cut in discretionary 
spending, NIH received an actual budget cut in 2006.
        Medical research is a public priority.  The President and 
Republican leadership are treating it as an afterthought.  That's got 
to change.
        Key provisions of The NIH Reform Act:
         increase the funding available for interdisciplinary, cross-
institute research.  This fund is intended to ensure that the 
"silo" structure of NIH does not inadvertently hinder 
investment in promising avenues of research.
         create a new detailed reporting system.  This new system is 
intended to enable NIH to better assess the strengths and 
weaknesses in its allocation of research funding.
         create a process for reevaluating the structure of NIH.  
This new process is intended to ensure that NIH adapts as 
medical science evolves. 

        I support these provisions, but there are risks involved in 
adopting them.  It's important for each member of the Committee 
to recognize these risks so that we can respond should they become 
a reality.
        The bill increases funding for cross-institute research by 
devoting half of any increase in annual NIH funding to the 
common fund.   
        The idea that any increase we pass in NIH research will 
automatically be split in two, with only half going to the 27 
institutes and centers, is worth considering.  
        If we continue to pass anemic increases in NIH funding, then 
1) we're not going to build up the common fund; and 2) nothing 
from nothing leaves nothing.  The Institutes that would have 
received minimal increases will now receive microscopic ones.
        Before supporting bifurcation of annual NIH increases, 
members of this Committee should decide whether they are willing 
to back healthy annual increases in NIH funding.  I hope it's a no-
brainer.
        Transparency has tremendous benefits, but the new reporting 
system created under this bill could be used to pressure NIH into 
shifting funding away from basic research, the benefits of which 
accrue over time and generally out of the spotlight, and toward 
research perceived as delivering more tangible medical benefits.  
        The report could be used as a tool by policymakers to 
micromanage NIH, picking and choosing which research projects 
should and should not be funded.   
        Stripped of its autonomy, NIH may be able to help 
policymakers win popularity contests, but unable to invest in the 
long-shot project that yields the next major scientific breakthrough.
        Policymakers must be careful to use this reporting tool for the 
good, not for political or ideological purposes.
        I support frequent reevaluation of NIH's structure and 
operations.  Medical science evolves and so should NIH.  
        But this Committee needs to understand that the bill puts into 
place a "guilty unless proven innocent" model for restructuring 
NIH.  
        Unless the Director of NIH opts to -- and can -- justify to 
Congress why the restructuring recommendations should not be 
acted upon, NIH is required to act upon them.
        I support that approach -- I think we have all become too 
complacent about the structure of NIH -- but it carries risk.  
        This Committee and Congress must keep close tabs on the 
evaluation process and weigh in if there is any evidence that the 
path of least resistance is also the path to disaster.
        I support each of these key provisions, but again, Congress 
should recognize that this bill does not let us off the hook.  If 
anything, it magnifies the importance of Congressional oversight, 
Congressional restraint, and Congressional support.
I do not agree with every provision of this bill.  
        For example, I believe there should be an inflation adjustor in 
the authorization levels and I do not agree that there should be a 
statutory prohibition on increasing the number of institutes at NIH.  
That's just as arbitrary as prohibiting a reduction in the number of 
Institutes would be.  It's not good policymaking.
        However, I am generally supportive of the Chairman's efforts 
and hope was can continue to work together to improve the bill.

        We now want to hear from our first distinguished panel.  We 
are going to start with Dr. Edward Miller, who is the Chief 
Executive Officer at Johns Hopkins Medicine in Baltimore, 
Maryland.  We have Dr. Robert Eckel, who is professor of the 
Department of Physiology and Biophysics at the University of 
Colorado Health Sciences Center.  Dr. Darrell G. Kirch, who is the 
President, Association of American Medical Colleges.  We have 
Dr. Furcht, who is Board of Directors, the Federation of American 
Societies for Experimental Biology.

STATEMENTS OF DR. EDWARD MILLER, CHIEF EXECUTIVE OFFICER, JOHNS HOPKINS 
MEDICINE; DR. ROBERT ECKEL, PROFESSOR, DEPARTMENT OF PHYSIOLOGY AND 
BIOPHYSICS, UNIVERSITY OF COLORADO HEALTH SCIENCES CENTER; DR. 
DARRELL G. KIRCH, PRESIDENT, ASSOCIATION OF AMERICAN MEDICAL COLLEGES; AND 
DR. LEO FURCHT, BOARD OF DIRECTORS, FEDERATION OF AMERICAN SOCIETIES FOR 
EXPERIMENTAL BIOLOGY.  
  
        CHAIRMAN BARTON.  We welcome all of you gentlemen, and 
we will start with you, Dr. Miller.
        DR. MILLER.  Thank you, Mr. Chairman and members of the 
House committee. 
        I am Ed Miller.  I am the Dean and CEO of Johns Hopkins 
Medicine, and I thank you for this invitation to speak to you.  I 
especially want to thank Chairman Barton for his persistence in 
developing draft legislation that recognizes the importance of 
biomedical research. 
        We also want long-term solutions and cures for devastating 
diseases and not mere Band-Aids. 
        Chairman Barton went the extra mile this summer meeting 
with me and my colleagues to get our input as this bill started to 
evolve.  It has been a long, hard road, but the draft bill represents a 
major step forward in providing dollars to keep biomedical 
research on a fast track.  It also will put NIH in a fast track to 
internal reform so it keeps pace with the way research is conducted 
today.  
        Let me start by commending the leaders in Washington for 
their foresight in doubling the NIH research budget between 1998 
and 2003.  Many of the dramatic advances in identifying early 
indicators and causes of disease were the result of well-spent 
Federal dollars.  In recent years, however, there has been a hold 
down in additional support that is beginning to slow research.  At 
Johns Hopkins, we have annually led the Nation in NIH research 
dollars, and we have made significant investments in young 
investigators to support the Nation's effort to advance science.  
However, there has been a marked decline in new grants awarded 
to our School of Medicine.  Fewer projects are being funded, and 
NIH support of our ongoing investigation is being cut.  
        In fiscal year 2002, the average funding of a new grant was 
$142,210 for the School of Medicine.  However, in fiscal year 
2006, the funding dropped nearly $50,000 per grant to $92,683, a 
34.8 percent decline. 
        Hardest hit are the young investigators.  I fear we may lose a 
generation of enthusiastic scientists if they conclude that NIH is 
out of their reach, and we must not let that happen.  The bill's 
provision for a 5 percent increase in the annual funding is of 
greatest importance.  When I met with the Chairman this summer, 
we agreed that the traditional walls separating branches of medical 
sciences need to be demolished.  Today, we know it takes a 
community of scientists from many disciplines to unravel the 
mysteries of the human body.  Let me give you a few examples 
from Hopkins. 
        We have created the Institute for Computational Medicine.  We 
are harnessing advances in computational methods to analyze and 
model disease mechanisms so that we can understand how diseases 
progress, predict who is at risk, and deliver effective and 
innovative treatments.  This requires collaboration among 
biomedical engineers, geneticists, biochemists, mathematicians, 
computer scientists, clinicians and researchers.  
        Hopkins has also established the Institute for NanoBio 
Technology, bringing together diverse experts to conduct research 
at the atomic or molecular level.  
        Just this month, the Institute announced it found a way to use a 
very brief burst of electricity to release biomolecules and nano 
particles from tiny gold launch pads.  This technique may someday 
be used to disperse small amounts of medicine, on command, with 
increased precision, from a chip implanted in the body.  
Meanwhile, Hopkins Applied Physics Lab is leading a vast 
inter-disciplinary team in a project funded by DARPA to develop 
in just a few years a bionic arm that looks, feels and performs like 
a natural limb.  That is the way future scientific inquiries will be 
conducted, and Chairman Barton's bill recognizes this reality.  
Biomedical research is an inter-disciplinary challenge.  
        Creating a Common Fund to promote trans-NIH research 
activities represents an important commitment to collaborative 
science.  It is the quickest and most sensible way to find cures and 
treatments.  The Common Fund will encourage new high-risk ideas 
that bring together investigators from fields that have not 
previously collaborated.  
        I hope a few areas in the bill can be clarified.  First, awards 
from the Common Fund should include a mechanism to support 
young investigators.  Most ideas that turn into Nobel Prizes come 
from investigators before they reach the age of 40.  Second, it is 
important that the Common Fund empower small groups as well as 
large inter-disciplinary groups.  Some big ideas still come from 
small groups.  
        I am convinced we are on the cusp of a dramatic 
transformation of health sciences discovery.  Just think what would 
happen if we could come up with ways to prevent diabetes or 
chronic lung disease or Alzheimer's.  Think of the dramatic impact 
this would have on shrinking the Medicare and Medicaid budgets, 
not to mention the dramatic impact of millions of suffering 
Americans.  
        The NIH is the engine that drives American biomedical 
research.  The more we can do to increase the horsepower of that 
engine, the faster we can discover cures and treatments on a 
broader scale.  
        That concludes my remarks, Mr. Chairman. 
        CHAIRMAN BARTON.  Thank you. 
        [The prepared statement of Dr. Edward Miller follows:] 

PREPARED STATEMENT OF EDWARD D. MILLER, M.D., CHIEF 
EXECUTIVE OFFICER, JOHNS HOPKINS MEDICINE

Introduction
        Mr. Chairman and members of the Committee, thank you so 
much for inviting me to testify today at this very important 
hearing.  I am Ed Miller, Dean of the Medical Faculty and CEO of 
Johns Hopkins Medicine.  Johns Hopkins Medicine is the 
organization that represents The Johns Hopkins University School 
of Medicine and Johns Hopkins Health System.    
        Let me start by commending leaders in Washington for their 
foresight in doubling the National Institutes of Health (NIH) 
research budget between 1998 and 2003.  Many of the startling 
advances in identifying early indicators and causes of diseases are 
the result of those well-spent federal research dollars.  I am 
convinced we are on the cusp of a dramatic transformation in 
health science discovery and cures.
        I would like to recognize the persistence of Chairman Barton in 
developing draft legislation that embraces the importance of 
biomedical research.  We are grateful to you for reaching out to us 
and for caring about NIH enough to want to make it "better," and 
for leading the way to provide much needed increases in funding.  
The bill's provision for a 5 percent increase in annual funding is 
hugely important and it will accelerate crucial research.  In 
addition, the creation of a "Common Fund" to promote trans-NIH 
research activities represents an important commitment to 
collaborative science. We at Johns Hopkins believe this is the 
quickest and most sensible way to find cures and treatments.  

Justification of NIH Funding
        Congressional and administration support for biomedical 
research has helped to transform our ability to detect disease, treat 
patients, and deliver healthcare with greater effectiveness and 
affordability.  At the same time, the return on investment for the 
American taxpayer has been high, as research has fostered 
discoveries that have led to new patents and products, and to the 
creation of new companies and job opportunities.  
        However, today the NIH budget is facing severe constriction.  
Indeed, one could say the federal funding of life sciences is in a 
crisis.  For FY 2006, the NIH budget was cut in both nominal and 
real terms.  For FY 2007, the budget is essentially frozen.  This 
marks the third year in a row NIH funding has been cut, when 
adjusted for inflation.  The biomedical research enterprise created 
by the NIH doubling has been cut by nearly 11 percent in real 
terms since 2003.  Going forward, at a minimum for NIH, anything 
less than a funding level at least equal to the medical inflation 
index is a cut, and will weaken the nation's role as a worldwide 
leader in the biomedical field.  
        At Johns Hopkins, we have annually led the nation in NIH 
research dollars and we have made significant investments in 
young investigators to support the nation's efforts to advance 
science.  However, there has been a marked decline in grants 
awarded to our School of Medicine.  Fewer projects are being 
funded and NIH support of on-going investigations is being cut.  
Recent figures suggest that the number of grants and overall 
funding levels have declined.  In FY 2002, the average funding 
level per grant was $142,210 for the School of Medicine.  By FY 
2006, the funding level dropped nearly $50,000 per grant to 
$92,683, a decline of 34.8 percent.  Hardest hit are America's 
young researchers.  I fear we may lose a generation of enthusiastic, 
inquisitive scientists if they conclude NIH grants are out of reach.  
We must not let that happen.  
        The increased and sustained funding for biomedical research is 
important to the majority of Americans.  According to public 
opinion polling conducted in 2005 by Research!America, 58 
percent of Americans say that increasing U.S. funding for medical 
and health research now is essential to our future health and 
economic prosperity.  Similarly, 79 percent of Americans agree 
that even if it brings no immediate benefits, basic science research 
which advances the frontiers of knowledge is necessary and should 
be supported by the federal government. 
        While the President and Congress have embraced the notion 
that funding for basic research is essential to strengthening 
America's competitive standing in the world, funding for 
biomedical research has not kept pace with this commitment.  
Aggressive, stable, and sustained federal spending on the NIH and 
biomedical research must be understood and embraced as a critical 
component of America's competitiveness.  The fact is federal 
investments in biomedicine and basic science across the disciplines 
have taken the U.S. to the leading edge of innovation.  The 
question we now face is whether as a country we are willing to pay 
the price to remain in the lead.  
        We believe the 5 percent increase in annual authorizations 
proposed is a sound investment.  Sustainable and predicable 
funding levels for the NIH are critical to allowing researchers to 
deliver improved treatments that not only enhance quality of life 
for patients but can reduce health care costs.

How Research Can Impact Health Care Cost
        When advocates for increasing biomedical research funding 
meet with members of Congress and their staff, they are often 
asked: what have we to show for the money that NIH has received 
in the past?  As we think about this question it is important to 
recognize the pace of biomedical research and science in general is 
often slow and unpredictable.  It may be years before we can point 
to specific therapies or new medical devices that can trace their 
origins to recently funded efforts.  But the simple answer is: we 
have a great deal to show!  Here are four powerful examples of 
what Johns Hopkins scientists have accomplished in terms of 
improving healthcare and reducing costs thanks to NIH support. 

Detection of Vision Problems of Diabetics
        Diabetes is the leading cause of blindness in adults, with 
12,000 to 24,000 new cases each year. Early identification of retina 
disease is critical to stave off vision loss, especially for the 10 
million diabetics who are 60 years or older, most of them on 
Medicare or Medicaid.  Yet more than half of all diabetics fail to 
get an annual eye exam as recommended by the American 
Diabetes Association.  To address this dilemma, Dr. Ran Zeimer, 
director of the Ophthalmic Physics Laboratory at Johns Hopkins 
Wilmer Eye Institute, came up with a novel solution after more 
than a decade of research: why not develop an easy-to-use digital 
camera that tests for retinopathy when diabetics visit their primary 
care physicians for check-ups?
        Thanks to NIH support, Dr. Zeimer perfected an instrument 
called the DigiScope.  The DigiScope takes images of the retina in 
just minutes as patients sit in front of an automated camera and 
look at a series of blinking lights.  These images are then 
transmitted via the Internet to a reading center for expert 
interpretation.  Over 20,000 individuals not under the care of an 
ophthalmologist have been screened to date in primary care 
physicians' offices.  Those with vision-threatening disease have 
been identified and referred to eye specialists.  In most cases, 
diabetics without complications are spared visits to an 
ophthalmologist, while Medicare and Medicaid are spared an 
expense.

Advances in Treatment for Sickle Cell Patients.  
        Thanks to continuous NIH grants extending back to 1982, Drs. 
George Dover and Samuel Charache of Johns Hopkins spent their 
careers fighting sickle cell disease - a miserable, inherited illness 
in which sickle-shaped red blood cells get stuck in narrow channels 
and block blood flow to tissue and vital organs.  Patients with 
sickle cell disease - 72,000 in the United States - suffer frequent 
bouts of fatigue and shortness of breath, joint and body organ pains 
that turn excruciating and lead to frequent hospitalizations.  The 
pneumonia-like conditions, chest pains, and fever can be life-
threatening.  Until fairly recently, early death was the norm, with 
life expectancy for a sickle cell patient projected to be only 20 to 
30 years.
        In the 1990s, Drs. Dover, Charache, and their Hopkins research 
team found that a cancer drug (hydroxyurea) did remarkable things 
for sickle cell sufferers.  A 1995 NIH-supported multi-center study 
proved hydroxyurea therapy dramatically reduces the frequency 
and severity of painful episodes, hospitalizations and transfusions.  
In a 2003 study, daily hydroxyurea doses led to 30 percent fewer 
hospital days, 58 percent fewer transfusions and a 40 percent 
reduction in deaths.  Today, hydroxyurea therapy is recommended 
for adults and adolescents with moderate-to-severe recurrent pain.  
As a result, the life expectancy for sickle cell patients has doubled.  
        There have been financial benefits, too.  According to another 
NIH-sponsored study, hydroxyurea therapy saves the U.S. health 
care system $5,210 per sickle cell patient per year.  With 72,000 
Americans suffering from sickle cell disease, the potential annual 
savings is more than $375 million.  

Faster Diagnoses in Emergency Rooms
        With the existing threat of bioterrorism, it is crucial to find 
ways for swiftly identifying patients in hospital emergency rooms 
who have biochemical pathogens or life-threatening infectious 
diseases, such as meningitis, sepsis and bacterial endocarditis (an 
infection of the inner lining of the heart or heart valves).  Current 
testing methods are time-consuming and usually lead to delays in 
diagnosing and treating these diseases.  The current blood and 
culture tests for some diseases can take 24 hours or more. 
        Dr. Richard E. Rothman of Johns Hopkins Department of 
Emergency Medicine is working on novel ways to identify 
multiple blood-borne and pulmonary infectious diseases and 
bioterrorism pathogens in a hurry.  His patented molecular 
diagnostic tests involve both exhaled breath and body fluids.  Early 
experiments have shown these new diagnostic tools can detect 25 
common bacterial infections and five categories of bioterrorism 
agents in fewer than 4 hours, and faster response times are 
expected as the diagnostic tools are fine-tuned.  

Cell-Based Therapies for Heart Attacks
        Heart attacks represent a critical health problem facing this 
country.  Each year, 565,000 Americans suffer heart attacks, 
300,000 have recurring heart attacks, and 3 million deal with 
congestive heart failure.  The costs for these patients are 
staggering: an estimated $403 billion in 2005, with outpatient costs 
alone consuming $120 billion.  
        Researchers are on the cusp of developing remarkable therapies 
that could revolutionize coronary treatment.  One laboratory 
research group led by Hopkins' chief of cardiology, Dr. Eduardo 
Marban, is studying a treatment using a patient's own cardiac stem 
cells to repair damaged heart tissue soon after a heart attack and to 
regenerate weakened heart muscle.  This could avert the need for 
expensive heart transplants.  By using a patient's own cardiac stem 
cells, there also would be no risk of an immune-response rejection.
        Meanwhile, Hopkins cardiologist Dr. Joshua Hare is engaged 
in a project that involves clinical trials with recent heart attack 
patients who are being given injections of adult bone-marrow stem 
cells.  Dr. Hare's research revealed that stem cells harvested from a 
pig's bone marrow and injected into another pig's damaged heart 
restored heart function and repaired up to 75 percent of the 
damaged muscle in just two months.  A $12 million dollar, five-
year NIH grant to the Johns Hopkins Heart Institute is making this 
exciting work possible. 

Why Johns Hopkins Supports the Common Fund
        While the research efforts outlined above have produced 
improvements in clinical care and are driving a radical change in 
treatments, shifting to a new paradigm in how we fund and conduct 
biomedical research requires new thinking that crosses traditional 
boundaries.  Medical centers have traditionally housed clinical 
researchers and basic scientist separately based on their 
departmental affiliations.  These affiliations can create artificial 
barriers to collaborative research efforts.  For some types of 
research, it often  makes more sense for researchers from different 
departments to be co-located to facilitate interactions. 
        At Johns Hopkins, we have been able to tear down some of the 
traditional silos separating the branches of medical science to 
create a village of investigators to find cures and advance research.  
That work has been supported through various sources, but the 
most important source for biomedical research, the NIH, also 
needs a vehicle to sustain research that crosses these traditional 
silos.   
        The proposed Common Fund that will support trans-NIH 
research activities would represent an important commitment to 
collaborative science.  At John Hopkins, we see this as the quickest 
and most sensible way to find cures and treatments.  The 
movement to supporting a village of investigators is critical in 
combining all that we have learned to advance cures.  However, it 
is important to note that this type of research is also not a silver 
bullet.  We need to strike a balance between funding traditional 
research efforts and trans-NIH research.  
        The reason we need to create the Common Fund and support 
trans-NIH science can be easily seen in the area of cancer 
treatment.  In 1971, when President Nixon signed the National 
Cancer Act, the word cancer was equated to a death sentence.  
According to the National Cancer Society's "Cancer Facts and 
Figures 2006," for all races the overall cancer survival rate was 
only 50 percent in 1974.  Today, while survival rates fluctuate for 
particular cancers or populations, in almost every category we have 
improved survival rates.  For example, in 1974 the survival rate for 
breast cancer for all women was 75 percent, while the most recent 
data available (1995-2001)  report a survival rate of 88 percent.  
During these same time periods, the survival rate for colon cancer 
increased from 50 percent to 64 percent.  
        These survival rates increased because we were able to change 
how the disease was treated over the past 25-years, improving 
diagnostic techniques and expanding treatment options.  However, 
on September 16, 2006, researchers at Johns Hopkins announced 
that they had cracked the genetic code for breast and colon cancers.  
This information is the equivalent of looking at the enemy's game 
plan and revealed that the average number of mutant genes in each 
cancer is about 100, and at least 20 of them are likely to be critical 
for tumor formation.  Just as important, the investigators found that 
each cancer has a different blueprint, so we now know that no two 
patient diseases are identical.  This will not only guide cancer 
research for the next decade, it will lead to a better understanding 
why patients respond differently to the same therapies.
        While this announcement is critical to advancing the treatment 
of cancer, we need to step back and understand what went into this 
discovery.  The team used 22 cancer samples and information from 
the Human Genome Project to examine the more than 13,000 best-
known genes.  Then, the team examined the DNA code of the 
13,000 genes by dividing each gene into overlapping sections, to 
obtain 130,000 sections for analysis.  Then, the samples were 
amplified through more than 3 million biochemical reactions.  
Next, the sequences were fed through a computer to compare 
normal sequences with those from the tumor samples.  More than 
800,000 suspicious regions were visually inspected, one by one, to 
verify true mutations.  In the end, the Hopkins team combed 
through 465 million nucleotides, which are the individual 
chemicals that pair together to build the rungs of the DNA ladder 
that compose genetic instructions.  
        It is important to understand that this work required a large, 
diverse team.  The Johns Hopkins research team alone included 13 
investigators and countless others at the University of South 
Carolina, Case Western Reserve University, University Hospitals 
of Cleveland, Texas Southwestern Medical Center, University of 
Maryland, Howard Hughes Medical Institute, and Agencourt 
Bioscience Corp.  The success of this project is due to the village 
of researchers and recent advances in DNA sequencing and 
bioinformatics.
        To support and advance this type of research, various institutes 
and centers, many of which are virtual, have been organized at 
Johns Hopkins.  These centers of interdisciplinary research teams 
include not only investigators from different departments within 
the School of Medicine, but faculty from different schools and 
divisions across Johns Hopkins University as a whole.  Below are a 
few more examples of these efforts.

Institute for Computational Medicine
        Johns Hopkins University created the Institute for 
Computational Medicine (ICM) - the first of its kind in the world - 
because the nature of biomedical research has been transformed 
during the past decade. This transformation has been driven in 
large part by the development of new technologies for high 
throughput data generation which now make it possible to acquire 
gene sequences, measure the complement of genes and proteins 
expressed in cells and/or tissues, map protein-protein interactions 
and image functional properties of cells, tissue and organs under a 
wide range of conditions.  The impact of these technologies on 
identification of the cause, diagnosis and treatment of human 
illness will be profound. 
        It will soon be common for clinical research studies to collect 
genetic, transcriptional, proteomic, imaging and clinical data from 
every patient in large, carefully selected cohorts sharing a specific 
disease diagnosis.  The challenge of the coming decade will be 
how best to use these multi-scale biomedical data to gain a 
quantitative understanding of disease mechanisms. 

Institute for NanoBio Technology
        The Institute for NanoBio Technology (INBT), hopes to 
revolutionize health care by bringing together expertise from 
medicine, engineering, and public health to create new knowledge 
and groundbreaking technologies.  Research is currently underway 
in the following areas: cancer, cystic fibrosis, vaccines, asthma, 
hemophilia, spinal cord injury and peripheral nerve regeneration.  
        Approximately 100,000 children and adults worldwide are 
diagnosed with cystic fibrosis, a fatal genetic disease. While 
antibiotics treat infections caused by the disease and expectorants 
allow clearing the airways of mucus that makes it difficult to 
breathe, no cure is available.  The DNA sequence that could cure 
cystic fibrosis was discovered years ago, but a successful therapy 
has not yet been developed. The challenge lies in designing a 
therapeutic DNA carrier that can reach cells affected by the 
disease.  However, since cells in the airway are coated with a 
mucus barrier, delivery is very difficult.  The Institute's goal is to 
create nanoparticle carriers with recognition and binding properties 
that can overcome the mucus barrier and attach therapeutic genes 
to lung cells. 
        Current therapies for cancer, including radiation and 
chemotherapy, are destructive to the body, often causing negative 
side effects and additional health problems.  Techniques and 
methods for diagnosing and monitoring cancer often slow 
treatment time and reduce overall effectiveness.  However, what if 
you could simultaneously detect malignant cells, image and treat 
them, and monitor efficacy of the treatment inside the body?  Over 
the next 10 years, the Institute plans   to develop nanoscale devices 
that detect cancer cells, report relevant diagnostic information, and 
deliver chemotherapeutic agents or therapeutic genes directly into 
the malignant cells.  Targeting these devices to only interact with 
cancerous cells would spare healthy cells, greatly reducing or 
eliminating side effects that accompany many current cancer 
therapies.  Also, simultaneous imaging and molecular profiling 
would allow non-invasive monitoring of tumors and treatment 
efficacy, resulting in better and faster patient care.

Institute for Basic Biomedical Sciences
        The Institute for Basic Biomedical Sciences (IBBS) was 
created to focus on a number of biological problems including 
epigenetics, sensory biology, metabolism and obesity, cell 
dynamics, drug addiction, chemoprotection, transport biology and 
high throughput approaches to biological research.  The institute 
brings together experts from fields including biology, physics, 
chemistry, mathematics, computer science and engineering. 
        Research efforts include bringing together a broad range of 
scientific expertise in both experimental and theoretical biology to 
further study the advances already made in genomic studies.  IBBS 
researchers will examine how cells and whole organisms are 
structured, how they function and how they control interactions of 
the multitude of chemical compounds they contain.   
        Meanwhile, other researchers will study how cells use sugars 
and fats to build molecules required for survival, how cells 
regulate the conversion of food into energy, and how the body 
regulates levels of hormones and other chemicals in response to 
available nutrients.  Research will focus on metabolism at a 
cellular level looking at factors influencing cell survival, growth 
and aging.  At the level of the whole organism, the IBBS will 
address how nutrients, hormone levels and energy usage affects 
reproduction, exercise capacity, cognitive function, feeding 
behaviors and longevity, which is important in understanding 
obesity and diabetes.

The Future of Surgery: I4M
	Today, surgery is based on technology and tools that have that 
not truly changed in decades.  Even with the development of 
minimally invasive surgery, skilled teams are asked to operate with 
limited knowledge, hampered sight, and outdated tools.  However, 
computer-integrated systems and information-based technology 
can transform interventional medicine in the same way they have 
transformed manufacturing and other sectors of our society.  
The Johns Hopkins University I4M (Integrating Imaging, 
Interventions, and Informatics in Medicine) initiative addresses the 
technological, clinical and educational challenges that need to be 
met in order to realize the full potential of this new age of 
healthcare.  I4M enables physicians, engineers, and scientists from 
different departments and schools to work together, bringing the 
power of trans-disciplinary collaboration to solve problems that go 
beyond the scope of any single discipline.   

Next Generation of Artificial Limb
        A multi-disciplinary team of scientists and engineers are 
undertaking an ambitious project to develop a next-generation of 
mechanical arm that will look, feel, perform and be controlled like 
a natural limb.  The advanced prosthetic arm will allow a user to 
button a shirt, tune a radio, and feel the warmth of a loved one's 
hand.  
        Today, the current state-of-the-art myoelectric arm allows users 
to control hand and arm movements by deliberately flexing a 
muscle or through mechanical movement.  Still, these devices have 
relatively limited degrees of motion and can generally allow 
control of only one motion at a time.  In order to improve on 
current technology, the team plans to develop a device able to 
perform at strengths, speeds and angles with 22 degrees of freedom 
to match the performance of the human arm while maintaining the 
person's ability to control the arm.  To succeed in this effort will 
require breakthrough research in neural control, sensory input, 
advanced mechanics and actuators, and prosthesis design and 
integration.  
        While Johns Hopkins University Applied Physics Laboratory 
will lead the effort, the team includes faculty from Johns Hopkins' 
Schools of Medicine, Engineering, and Public Health.  
Furthermore, staff from research institutions and businesses around 
the world including: Arizona State University, the BioSTAR 
Group, California Institute of Technology, National Rehabilitation 
Hospital, Northwestern University and the Northwestern 
University Prosthetics Research Laboratory, Oak Ridge National 
Laboratories, Otto Bock Health Care (Austria), Rehabilitation 
Institute of Chicago, Umea University (Sweden), University of 
Michigan, University of Rochester, University of California, 
Irvine, University of Southern California, University of Utah and 
Vanderbilt University will participate in the project.

Operations of the Common Fund
        As was noted earlier, while the Common Fund can help tear 
down barriers to advancing research and cures, its creation must 
not threaten the successes that the current model has produced.  
Instead, both traditional funding methods and the Common Fund 
must operate to support and enhance the best scientific research.  
As the committee moves forward with the creation of the Common 
Fund, I hope you will consider these important elements.

        1. Awards from the Common Fund should include a 
mechanism to support young investigators.  Most ideas that 
turn into Nobel Prizes come from investigators before they 
reach the age of 40. Support for their work must continue.  
While some young investigators will continue to seek 
support from traditional NIH funding streams, we also want 
to support these young investigators efforts on broad 
research projects. 

        On September 17, 2006, Carol Greider of the Johns 
Hopkins School of Medicine was awarded the most 
prestigious prize in American medicine - the Lasker Award.  
Dr. Greider, age 45, will share the award with two scientists 
who participated in the co-discovery.  The award is based 
on findings of cell function and genetics, which occurred 
twenty years ago, and is considered today to be one the 
most advanced areas of biomedical research.  

        2. It is important that the Common Fund empower small 
groups as well as large inter-disciplinary teams.  Some big 
ideas and important research programs can come from 
smaller groups and these ideas need to be equally 
supported.

        3. While some collaborations are more natural, the Common 
Fund needs to be used to encourage new, high risk ideas 
that bring together investigators from fields that have not 
previously collaborated.  Encouraging these types of 
projects will promote new ideas and new groups of 
scientists and clinicians working together.  These efforts 
can change science and medicine and currently cannot be 
funded through the regular channels.

        4. Science and technology is changing much faster than ever 
before and funding mechanisms need to change as well.  
While the Common Fund is a step in the right direction, 
this effort along with traditional funding channels, need to 
be evaluated to ensure funding streams are as dynamic as 
the research.  If the funding channels are not flexible, we 
could be limiting the research community's efforts to 
advance science.

        Thank you for your efforts to strengthen America's biomedical 
research community.  Johns Hopkins stands ready to support you 
in this important endeavor. I invite you and your staff to visit our 
campuses, explore our facilities and meet our researchers face to 
face.  You will find no more persuasive argument for the 
inestimable value of investment in research than witnessing the 
innovative enterprise firsthand.  

        CHAIRMAN BARTON.  Dr. Kirch.
        DR. KIRCH.  My name is Darrell Kirch, and I have the honor of 
serving as the President of the Association of American Medical 
Colleges.  I am testifying today on behalf of the AAMC in support 
of the National Institutes of Health Reform Act of 2006. 
        The institutions we represent at the AAMC receive more than 
half of all the extramural funds awarded by NIH.  Chairman 
Barton, we are indebted to you for your personal commitment to 
this legislation and to the NIH, and to the overall research effort 
for our Nation.  As you mentioned earlier, you have indeed 
listened to us.  We very much appreciate the significant changes 
that you have made over the course of the past year.  
        Over 18 months ago, the AAMC established an ad hoc 
committee of academic medical center leaders who reviewed and 
engaged the issues that arose as the legislation was developed.  The 
members of our committee have reviewed the current draft, and 
they are pleased to see that the issues that we raised during those 
discussions have been addressed. 
        The AAMC believes that the NIH is indeed one of this 
Nation's greatest achievements.  We concur with Dr. Zerhouni that 
the research conducted and supported at NIH is transforming our 
day-to-day practice of medicine. 
        We also fully recognize the public's large investment in the 
NIH and in our member institutions where much of the research is 
carried out, and we recognize that this comes with a series of 
responsibilities and obligations.  We believe that the biomedical 
investigators and research staff, both at the NIH and at our 
institutions, work extremely hard to maintain the trust that has 
been placed in them by our fellow citizens.  But given the vital 
importance of this area of the public trust, we must do better.  We 
believe the legislation you have proposed provides tools to 
enhance that accountability and the robust systems that are already 
in place at the NIH. 
        We join with all the medical research community and my 
colleagues here in applauding and supporting your call for 
additional funding above the inflationary levels of the Biomedical 
Research and Development Price Index.  We need that support to 
foster new initiatives while sustaining current endeavors.  
        In particular, we strongly endorse the bill's recognition of the 
vital importance of those new investigators and 
investigator-initiated research to promote ongoing innovation and 
continued world leadership by our Nation's medical research 
enterprise.  
        The AAMC supports the establishment of a formal strategic 
planning process to identify areas of trans-NIH research to take full 
advantage of all the emerging scientific opportunities and the 
major public health challenges that we face.  Mr. Chairman, we 
strongly agree with you that decisions regarding research projects 
to be supported should be based on scientific merit, not on political 
decisions.  
        The AAMC also endorses the creation of the comprehensive 
electronic reporting systems proposed in the legislation.  We agree 
those will enhance the agency's accountability by providing 
transparency across the institutes and centers to all stakeholders.  
Scientists, patients, policy makers, we all will benefit from 
increased access to good information, and that will supply new 
insights into the value the public is deriving from its investment in 
this basic and clinical research. 
        The AAMC fully supports the creation of the dedicated source 
of funding, known as the Common Fund, to support trans-NIH 
initiatives.  Our community is especially pleased that the 
legislation provides a reasonable rate of growth for the Common 
Fund that is linked clearly to the growth of the overall NIH budget.  
        We have provided the committee with several 
recommendations that we believe would strengthen the bill and 
build even greater community support.  We respectfully ask the 
committee to consider those proposals, which I have attached to 
our testimony, either through technical refinements in the 
legislative text or in the report language accompanying the bill 
when it takes up the legislation.  
        But most of all, we thank you all for your efforts on behalf of 
the NIH.  We look forward to working with you and your 
colleagues in the House as well as the Senate and the NIH in 
support of the legislation as it moves forward. 
        Thank you very much for having me here today. 
        CHAIRMAN BARTON.  Thank you, Dr. Kirch. 
        [The prepared statement of Dr. Darrell G. Kirch follows:] 

PREPARED STATEMENT OF DARREL G. KIRCH, M.D., PRESIDENT, 
ASSOCIATION OF AMERICAN MEDICAL COLLEGES

        We are indebted to the Chairman for his personal commitment 
to this legislation, to the NIH, and to the nation's medical research 
effort.  Members of our ad hoc Working Committee on NIH 
Reauthorization have reviewed the current draft and are very 
pleased that many of the issues they have raised during the past 
year have been addressed.  The AAMC endorses the legislation.
        We strongly concur with NIH Director Zerhouni that research 
conducted and supported by the NIH has and will continue to 
transform the practice of medicine.  The public's large investment 
in the NIH, and in our member institutions where much of the 
nation's medical research is carried out, comes with a series of 
responsibilities and obligations.  The proposed legislation provides 
an appropriate vehicle to enhance the robust systems of 
accountability that currently exist at the NIH. 
        The AAMC supports the call for additional funding above the 
level of the Biomedical Research and Development Price Index 
(BRDPI) to foster new initiatives while sustaining ongoing 
endeavors.  We strongly endorse the bill's recognition of the vital 
importance of new investigators and investigator-initiated research.
        The AAMC supports the establishment of a formal strategic 
planning process to identify areas of trans-NIH research to take full 
advantage of emerging scientific opportunities and to address 
pressing public health challenges.  We note that the proposed 
composition of the Council of Councils strikes an appropriate 
balance between the need for scientific input and the desire for 
broader representation of the various stakeholder communities, and 
concur that decisions regarding the research projects to be 
supported through the Common Fund should be based on scientific 
merit and not political decisions.
        The AAMC endorses the creation of a comprehensive 
electronic reporting system across all of the NIH's institutes and 
centers, which will supply new insights into the value the public 
has derived from its sustained investment in basic and clinical 
research.
        The AAMC fully supports the creation of a Common Fund to 
support trans-NIH initiatives and is pleased that the legislation 
provides a reasonable rate of growth for the Common Fund that is 
linked to the growth of the overall NIH budget.  We propose that 
the Director of the NIH, in consultation with the Council of 
Councils, submit a thorough evaluation of the Common Fund and 
the research resources supported by the Fund prior to any decision 
about increasing the size of the Fund beyond 5 percent.  
        We have provided the committee with additional 
recommendations that we believe would strengthen the bill and 
build even greater community support. We respectfully ask the 
committee to consider these proposals, either through technical 
refinements in the legislative text or in the report language 
accompanying the bill.


        My name is Darrell Kirch, M.D., and as President of the 
Association of American Medical Colleges (AAMC), I am pleased 
to have this opportunity to testify on behalf of the AAMC in 
support of the National Institutes of Health Reform Act of 2006.  
The AAMC represents all 125 accredited U.S. medical schools; 
nearly 400 major teaching hospitals and health systems, including 
68 Department of Veterans Affairs medical centers; and 96 
academic and scientific societies representing 109,000 faculty 
members. These institutions annually receive more than half of all 
extramural funds awarded by the National Institutes of Health 
(NIH).
        Chairman Barton, we are indebted to you for your personal 
commitment to this legislation, to the NIH, and to the nation's 
medical research effort.  I and several members of the AAMC's ad 
hoc Working Committee on NIH Reauthorization had the 
opportunity to meet with you in July to discuss your thoughts 
about the future directions for NIH, the need for increased 
transparency and accountability, and the role this legislation would 
play in achieving these objectives.
        We recognize and appreciate the significant changes that you 
have made in this proposal during the course of the past year.  In 
January 2005, the AAMC established an ad hoc committee of 
academic medical center leaders, co-chaired by Robert Kelch, 
M.D., Executive Vice President for Medical Affairs and CEO of 
the University of Michigan Health System, and Philip Pizzo, M.D., 
Dean of the Stanford University School of Medicine, to review and 
engage the issues that arose as this legislation developed.  This 
committee reviewed earlier discussion drafts of this legislation that 
were released last year, and provided extensive comments that 
formed the basis for the statement the AAMC submitted to this 
committee last July.  Our advisory committee has been fully 
apprised of the ongoing discussions between our respective staffs 
throughout the summer and has provided advice on the 
Association's positions throughout this process.  Members of our 
committee have reviewed the current draft and are very pleased 
that many of the issues they have raised during the past year have 
been addressed.  
        The AAMC believes that the NIH is one of this nation's 
greatest achievements.  The Federal Government's unwavering 
commitment to medical research, embodied in its investment in the 
NIH for nearly 70 years, has created a medical research enterprise 
that is the envy of the world and has contributed greatly to 
improving the health and well-being of all Americans, indeed of all 
humankind.  We strongly concur with NIH Director Elias Zerhouni 
that the research conducted and supported by the NIH has and will 
continue to transform the practice of medicine.
        We fully recognize that the public's large investment in the 
NIH, and in our member institutions where much of the nation's 
medical research is carried out, comes with a series of 
responsibilities and obligations.  We recognize that we have been 
entrusted by the American people to be proper stewards of their 
funds, to conduct research in an unbiased manner, and to protect 
the safety and dignity of the thousands of individuals who 
volunteer to participate in research studies.  We believe that the 
biomedical investigators and research staff both at the NIH and at 
our institutions work very hard to maintain the trust that has been 
placed in them by our fellow citizens.  But given the vital 
importance of this area of the public trust, we must do better. We 
believe that the legislation you have proposed provides an 
appropriate vehicle to enhance the robust systems of accountability 
that currently exist at the NIH. 
        This legislation proposes changes that we believe will enhance 
the effectiveness of the NIH at a time when our nation faces 
unprecedented scientific opportunities and health challenges. We 
join with all members of the medical research community in 
applauding and supporting your call for additional funding above 
the level of the Biomedical Research and Development Price Index 
(BRDPI) to foster new initiatives while sustaining ongoing 
endeavors.  In particular, we strongly endorse the bill's recognition 
of the vital importance of new investigators and investigator-
initiated research to promote ongoing innovation and ingenuity and 
continued world leadership by the nation's medical research 
enterprise.
        The AAMC supports the establishment of a formal strategic 
planning process to identify areas of trans-NIH research to take full 
advantage of emerging scientific opportunities and to address 
pressing public health challenges.  We are pleased that the 
planning process outlined in the legislation mirrors the actions that 
the NIH has already undertaken through its Office of Portfolio 
Analysis and Strategic Initiatives.  We also note that the proposed 
composition of the Council of Councils strikes an appropriate 
balance between the need for scientific input and the desire for 
broader representation of the various stakeholder communities.  
Mr. Chairman, we strongly agree with you that the decisions 
regarding the research projects to be supported should be based on 
scientific merit and not political decisions.
        The AAMC also endorses the creation of a comprehensive 
electronic reporting system, which we agree will enhance the 
agency's accountability by providing increased transparency across 
all of the NIH's institutes and centers to all stakeholders.  
Scientists, patients, and policymakers all will benefit from 
increased access to this information, which will supply new 
insights into the value the public has derived from its sustained 
investment in basic and clinical research.
        The AAMC fully supports the creation of a dedicated source of 
funding, known as the Common Fund, to support the trans-NIH 
initiatives identified.  Our community strongly believes that 
increases in this fund should not come at the expense of ongoing 
research programs, and we are pleased that the current legislation 
provides a reasonable rate of growth for the Common Fund that is 
linked to the growth of the overall NIH budget.
        Once the Common Fund reaches 5 percent of the total NIH 
budget, the Director of the NIH, in consultation with the Council 
of Councils, is to submit recommendations to the Congress for 
further changes in the size of the Common Fund.  We would 
propose modifying this provision by requiring the Director of the 
NIH, in consultation with the Council of Councils, to submit a 
thorough evaluation of the Common Fund and the research and 
research resources supported by the Fund prior to any decision 
about the size of the Fund. We believe that impartial assessment of 
the activities supported by the Fund, and its successes and 
shortcomings, is essential for the NIH, the Congress, and the 
stakeholders to make an informed judgment about the future size 
of and directions for the Common Fund.
        Regarding the proposed uses of the Common Fund, we offer 
the following suggestions. Maintaining adequate funding 
opportunities for first-time NIH R01 applicants, and establishing 
"academic homes for clinical and translational science" by fully 
funding the number of Clinical Transformation Science Awards 
(CTSA) projected in FY2007 and 2008 are very high trans-NIH 
priorities. To meet these priorities will be especially challenging 
for the Institutes and Centers if the NIH budget remains 
constrained in the next two or more fiscal years. Accordingly, we 
propose that the report language make explicitly clear that monies 
from the Common Fund should be used to support first-time NIH 
R01 applicants, perhaps on a matching basis with the individual 
Institutes and Centers, and to fully fund the number of CTSA 
awards required to meet the NIH's previously projected target.
        In the description of the activities to be identified by the 
Division of Program Coordination, Planning and Strategic 
Initiatives to be supported by the Common Fund, we propose the 
legislative language be amended to permit the support of research 
resources as well as research.  We believe this recommendation is 
consistent with the support currently provided by the NIH 
Roadmap for analytical tools such as innovative technologies, 
databases, and research networks, and for training translational and 
clinical researchers.
        We have provided the committee with these and some 
additional recommendations that we believe would strengthen the 
bill and build even greater community support. We respectfully ask 
the committee to consider these proposals, which I have attached 
to my testimony, either through technical refinements in the 
legislative text or in the report language accompanying the bill, 
when it takes up the legislation.


National Institutes of Health Reform Act of 2006 
Technical Refinements
Submitted by the Association of American Medical Colleges
September 19, 2006 
 
1. Maintaining adequate funding opportunities for first-time NIH 
R01 applicants, and establishing "academic homes for clinical and 
translational science" by fully funding the number of Clinical 
Transformation Science Awards (CTSA) projected in FY2007 and 
2008 are very high trans-NIH priorities. To meet these priorities 
will be especially challenging for the Institutes and Centers if the 
NIH budget remains constrained in the next two or more fiscal 
years.  Accordingly, we propose that the report language make 
explicitly clear that monies from the Common Fund should be used 
to support first-time NIH R01 applicants, perhaps on a matching 
basis with the individual Institutes and Centers, and to fully fund 
the number of CTSA awards required to meet the NIH's previously 
projected target. 
 
2. In the description of the activities to be identified by the 
Division of Program Coordination, Planning and Strategic 
Initiatives to be supported by the Common Fund, we propose the 
following additions to the legislative language: 
	a. On page 21, line 3, amend "identify research that represents" 
to "identify 	research and research resources that address". 
	b. On page 21, line 8, after "additional research" insert "or to 
meet research needs". 
We believe these changes would facilitate our first 
recommendation and are consistent with the support currently 
provided by the NIH Roadmap for analytical tools such as 
innovative technologies, databases, and research networks, and for 
training translational and clinical researchers. 
 
3. We wish to be certain that our understanding is correct that all 
research to be supported by the Common Fund will undergo the 
same rigorous peer review of scientific merit required under 42 
USC 289a. 
 
4. Under the evaluation of the Common Fund, we propose that, in 
addition to the recommendations to Congress on the size of the 
Fund (page 32, lines 2-5), the Director of the NIH should submit 
an evaluation of the Common Fund and the research and research 
resources supported by the Fund. We believe that a thorough 
assessment of the activities supported by the Fund, and its 
successes and shortcomings, is essential for the NIH, the Congress, 
and the stakeholders to make an informed judgment about the 
future size of and directions for the Fund. 
 
5. For the demonstration projects authorized under section 
(beginning on page 48), we propose that the Director of NIH 
submit an evaluation of these programs to the Congress at the end 
of the third year of the programs, including an assessment of 
whether the awards made under the programs met the goals and 
priorities established by the Director. We believe this information 
is essential for the NIH, the Congress, and the stakeholders to 
make an informed judgment about the continuation of the 
programs. We further propose that as part of this evaluation, 
consideration be made to supporting any continuation of the 
programs through the Common Fund. 
 
6. We note that the Secretary "may select" the Director of NIH to 
chair the Scientific Management Review Board (page 13, lines 23-
24). We believe this would undermine the appearance of 
independence of this Board and would place the Director in a very 
uncomfortable situation if he or she exercises the authority granted 
to object to the Board's recommendations for major changes to 
existing Institutes and Centers (page 17, beginning at line 7). We 
propose eliminating the option for the Director of NIH the chair 
the Board. We support having the Director as a permanent member 
of the Board on an ex officio basis (page 12, lines 5-6). We also 
suggest that the presence of Institute and Center Directors on the 
Board could also raise questions about the Board's independence. 
The "interests" of the Institutes and centers might be better 
represented by appointing senior, accomplished, long-term 
awardees, who could provide a more independent perspective on 
the relevant scientific opportunities and needs, as well as on the 
functioning of the Institute or Center with which they have had a 
long history of interactions. 
 
7. The bill states the Director of the NIH "shall approve the 
establishment of all national centers of excellence recommended 
by the national research institutes, other than centers recognized 
under section 414;" (page 23, lines 8-11). The purpose and 
justification for this new authority are unclear, nor is it clear why 
the national cancer research and demonstration centers authorized 
under 42 USC 285a-3 are uniquely exempted. Centers of 
excellence created by the individual Institutes have gone through 
rigorous review processes of scientific merit and programmatic 
relevance, and should not, in our view, require further approval by 
the NIH Director. We propose removing this provision.


        Darrell G. Kirch, M.D. is president and chief executive 
officer of the Association of American Medical Colleges (AAMC), 
a position he assumed on July 1, 2006.  Founded in 1876, the 
AAMC is a Washington, D.C.-based, non-profit association 
representing all 125 accredited U.S. and 17 accredited Canadian 
medical schools, nearly 400 teaching hospitals and health systems, 
including 68 Department of Veterans Affairs medical centers; and 
96 academic and scientific societies.  Through these institutions 
and organizations, the AAMC also represents 109,000 faculty 
members, 67,000 medical students, and 104,000 resident 
physicians.
        A distinguished medical scientist, educator, physician, and 
noted authority on organization and management issues at 
academic medical centers, Dr. Kirch's career spans all aspects of 
academic medicine and includes leadership positions at two 
medical schools and teaching hospitals, as well as at the National 
Institutes of Health (NIH).  
        Before becoming the AAMC's fourth president, Dr. Kirch was 
selected to be chair-elect of the association, and served as the co-
chair of the Liaison Committee on Medical Education (LCME) and 
as a member-at-large of the National Board of Medical Examiners 
(NMBE).  He also has served as chair of the AAMC's Council of 
Deans Administrative Board and as chair of the American Medical 
Association's Section on Medical Schools.
        Dr. Kirch comes to the AAMC after six years as senior vice 
president for health affairs, dean of the college of medicine, and 
CEO of the Milton S. Hershey Medical Center at The Pennsylvania 
State University, where he and his leadership team are credited 
with revitalizing the institution and guiding it through a period of 
major expansion.  During his tenure, the college of medicine 
received its full accreditation from the LCME, and the medical 
center showed exceptionally solid fiscal results and dramatic 
growth in clinical activity.  Under his stewardship, total research 
funding for the Penn State Hershey campus also grew from less 
than $55 million to more than $100 million in only five years.  
Before joining Penn State, Dr. Kirch held a number of leadership 
positions at the Medical College of Georgia from 1994 to 2000, 
including dean of the medical school, senior vice president for 
clinical activities, and dean of the school of graduate studies.  
        As a psychiatrist and clinical neuroscientist, Dr. Kirch is a 
leading expert on the biological basis of and treatments for severe 
neuropsychiatric disorders.  Following the completion of his 
residency training at the University of Colorado Health Sciences 
Center, he joined the National Institute of Mental Health (NIMH), 
in Bethesda, Maryland, where he was named acting scientific 
director in 1993.  
        Dr. Kirch is a native of Denver and received both his B.A and 
M.D. degrees from the University of Colorado.  He has had an 
active career as a clinician and researcher, and has held medical 
faculty positions at Penn State, the Medical College of Georgia, 
and George Washington University.  
        Dr. Kirch is an active member of several professional societies, 
including the American College of Psychiatrists, the American 
Medical Association, and the American Psychiatric Association.  A 
prolific writer and public speaker, he has published more than 100 
articles and made over 130 presentations to national medical and 
scientific organizations.

        CHAIRMAN BARTON.  Dr. Eckel.
        DR. ECKEL.  Chairman Barton, Congressman Dingell, and 
members of the committee, as immediate past president of the 
American Heart Association and on behalf of the American Heart 
Association and our more than 22 million volunteers and 
supporters, I want to thank you for the opportunity to testify on the 
National Institutes of Health Reform Act of 2006.  I salute you for 
your leadership in taking on an issue of such importance to the 
health of our Nation. 
        I also want to note that our Chief Executive Officer, Cass 
Wheeler, is here today to demonstrate the Association's support for 
your work. 
        Over the past 50 years, the improved diagnosis and treatment 
of heart disease and stroke has led to a--we have seen a remarkable 
increase in survival.  According to the NIH, 1.6 million lives since 
the 1960s that otherwise would have been lost to heart disease 
alone.  
        Yet in spite of the progress, the sad and alarming truth is that 
we now may be losing ground.  An estimated 71 million American 
adults still suffer from cardiovascular disease.  Although we have 
increased our educational efforts, studies suggest that escalating 
rates of diabetes, obesity and other risk factors may actually 
reverse four decades of declining mortality. 
        To make matters worse, demographic trends will soon worsen 
the situation.  As the Baby Boom generation ages, cardiovascular 
disease will spike dramatically and deaths from heart disease alone 
are projected to increase 2.5-fold faster than the population. We 
will soon face a cardiovascular crisis of staggering proportions 
with major implications for healthcare cost and the quality of care 
for our fellow citizens.  
        Mr. Chairman, there are no easy solutions.  But we at the 
American Heart Association strongly believe that the proposals 
contained in this legislation can provide the necessary framework 
and balance for real and positive change.  It is an important and 
meaningful step in the right direction. 
        The Association supports this bill because the organizational 
adjustments, which improve the NIH's flexibility, collaboration 
and accountability, will help take an already world renowned 
research institution and its work to the next level.  
        These changes will direct resources more effectively and 
efficiently to current and emerging health problems, including 
those related to cardiovascular disease.  One key example is the 
allocation of additional resources into trans-NIH research through 
the Common Fund.  
        I am currently a member of the Advisory Council of the 
National Institutes of Diabetes, Digestive and Kidney Diseases, 
where we have been engaged in a trans-NIH obesity initiative that 
involves 21 institutes and centers.  These well-invested tax dollars 
will not only focus on the genetic and environmental basis of 
obesity and diabetes and establish an evidence-based approach for 
prevention, but also go towards reducing disability and death from 
cardiovascular disease.  Moreover, from joint efforts with our 
private-sector colleagues, more effective therapies of prevention 
and management will certainly ensue.  This, Mr. Chairman, is an 
example of the kind of collaboration that your legislation will 
facilitate through the Common Fund.  
        Mr. Chairman, I would be remiss if I didn't point out that 
although NIH's structural and operational reforms are certainly 
important, the agency also needs the necessary funds to carry out 
its mission.  If we can match these reforms with a stable funding 
commitment recommended in the bill, the American Heart 
Association believes that we can be far more successful in the 
research needed to confront and overcome the terrible 
cardiovascular crisis that threatens to overwhelm the health and 
economic well-being of our Nation and the world. 
        Mr. Chairman, Congressman Dingell and members of the 
committee, I thank you for the opportunity to testify before you 
today. 
        CHAIRMAN BARTON.  Thank you, DR. ECKEL.  I want to thank 
the American Heart Association and NIH for making it possible for 
me to be here today.  I am one of the 160 million Americans who 
has benefited from their research, so I personally appreciate what 
you have done. 
        [The prepared statement of Dr. Robert H. Eckel follows:] 

PREPARED STATEMENT OF ROBERT H. ECKEL, M.D., PROFESSOR, 
DEPARTMENT OF PHYSIOLOGY AND BIOPHYSICS, UNIVERSITY OF 
COLORADO HEALTH SERVICES CENTER

        Chairman Barton, Congressman Dingell and Members of the 
Committee, on behalf of the American Heart Association (AHA) 
and our more than 22 million volunteers and supporters, I want to 
thank you for this opportunity to present our views on the 
"National Institutes of Health Reform Act of 2006" and for your 
leadership in taking on this issue of such great importance to our 
nation and fellow citizens. 
        I am saddened to report today that cardiovascular disease 
(CVD) remains the number one and most costly killer of 
Americans, and is fast becoming a worldwide epidemic - one of 
the so-called diseases of development.  However, there is hope.  
Medical research can help reverse these lethal trends, and holds the 
key to an eventual cure for heart disease, stroke and all other forms 
of cardiovascular disease. 
        The American Heart Association has set the ambitious but 
feasible target of reducing cardiovascular disease and risk by 25 
percent by the year 2010.  And as major stakeholders in this 
debate, we have carefully reviewed the legislation before the 
Committee, and concluded that its proposed changes can help put 
us on the right path to meeting this goal. 

Research Makes a Difference
        Mr. Chairman, over the past 50 years, we have made enormous 
progress in the battle against cardiovascular disease.  As many of 
us know from personal experience and loss, it was once all too 
common for a person who suffered a heart attack or stroke to die, 
or be severely debilitated or disabled following one. 
        In those early years of the CVD fight, the tools available to 
medical practitioners and researchers for diagnosis and treatment 
were limited, funding was scarce, and the problem was 
compounded by the fact that the vast majority of Americans knew 
little about what they could do in their day-to-day lives to help 
prevent this horrible and potentially lethal affliction. 
        However, through a strong partnership between the federal 
government and the medical research community and deliberate 
and focused action, we have made great strides since those first 
days. From the groundbreaking Framingham Heart Study and other 
studies that advanced our understanding of CVD risk factors, to 
new drugs, such as clot-busters and statins, we have witnessed 
first-hand what can be accomplished through medical research.   
        The improved diagnosis and treatment of heart disease and 
stroke has also been nothing less than remarkable - as has the 
improved survival rate.  Indeed, according to the NIH, we have 
saved 1.6 million lives since the 1960s that otherwise would have 
been lost to heart disease.  Much of this progress can be attributed 
to our investment in NIH-sponsored heart and stroke research. 

New Challenges Threaten Our Ability to Achieve Goals 
        In spite of this progress in the war against cardiovascular 
disease, we are far from declaring victory.  An estimated 71 
million American adults now suffer from heart disease, stroke, and 
other forms of CVD.  The morbidity and mortality rates are still 
staggering.  Nearly 2,500 Americans die of CVD each day - an 
average of one death every 35 seconds.  That is the equivalent of 
losing one entire small town in America every 24 hours. The 
alarming truth is that we may be losing ground.  Although we have 
increased our educational efforts, studies suggest that increased 
rates of diabetes, obesity and other risk factors may reverse four 
decades of declining mortality
        In addition, demographics will soon worsen the situation.  As 
the baby boom generation ages, the prevalence of cardiovascular 
disease will increase dramatically, because although this disease 
can strike at any stage of life - the likelihood increases with age.  
Deaths from heart disease alone are projected to increase 2.5 times 
faster than the population.  Mortality from the most common type 
of stroke is projected to increase by nearly 100 percent between 
2000 and 2032.  Beyond the toll in human suffering and death, 
cardiovascular disease also comes with a steep price tag.  It will 
cost Americans an estimated $403 billion in medical expenses and 
lost productivity in 2006 - more than any other disease and more 
than the projected budget deficit for this year.  We will soon face a 
cardiovascular crisis of staggering proportions, with major 
implications for health care costs and quality of care for our fellow 
citizens.

Reforms in this Bill Address These Challenges
        We strongly believe that the reforms proposed in this 
legislation are both prudent and necessary to help address these 
challenges.  In 2002, the AHA testified before the Institute of 
Medicine (IOM) on NIH's "optimal organization structure."  We 
recommended four key principles -   transparency, flexibility, 
collaboration, and translation - to guide this ideal architecture.  
Many   were reflected in IOM's recommendations issued in 2003 
and are in turn, embodied in the legislation before the Committee 
today.  
        For example, the creation of a new Division for Program 
Coordination, Planning, and Strategic Initiatives will give the 
Director the flexibility needed to respond to emerging disease 
threats in an agile, comprehensive and coordinated manner that 
does not exist today.  The creation of a common research fund to 
support more trans-NIH research recognizes the need for 
collaboration on problems like obesity, which is a significant risk 
fact for heart disease, stroke, diabetes, cancer, and other diseases, 
and also supports clinical research, which helps enable the 
translation of basic research into patient care.  In addition, the new 
agency-wide performance system and consolidated reporting 
would help promote greater transparency, produce more accurate 
and credible data on disease funding and outcomes, and enable 
patient advocacy groups to use this data to make a strong and 
credible case for federal funding for medical research.
        The bill authorizes 5 percent increases for NIH for each of the 
next three fiscal years (FY 2007-2009.)  We would ideally have 
hoped for a higher level.  Since the end of the so-called "doubling 
period," funding for NIH has declined in real terms (adjusted for 
medical research inflation) in every year; it would take an increase 
of more than 10 percent in FY 2007 just to restore NIH to its post-
doubling level.  However, we recognize the current budget 
realities:  the level set for 
        FY 2007 reflects budget recommendations made by the 
American Heart Association and the broader medical research 
community.  If we can match these reforms with the stable funding 
commitment recommended in the bill, the American Heart 
Association believes that we can be much more successful in the 
research needed to confront and overcome the terrible 
cardiovascular crisis that threatens to overwhelm the health and 
economic well-being of our nation - and the world.  
        I would now like to turn to the Association's specific 
observations and recommendations about key proposals in the 
legislation. 

The Common Fund 
        In addition to promoting "shared funds" controlled by the 
Institutes' and Centers' directors, the legislation would establish a 
"common fund" to focus entirely on trans-NIH research projects - 
those that may cut across more than one disease, or where one 
disease or risk factor may influence another.  This provision 
implements IOM's recommendation to "enhance and increase 
trans-NIH strategic planning and funding," and we agree that 
interdisciplinary interaction is critical to promoting new initiatives 
and aligning medical research.
        Two recent examples of trans-NIH research funding illustrate 
the tangible benefits of collaborating on cardiovascular disease: (1) 
the NIH strategic plan for obesity research; and (2) the NIH 
blueprint for neuroscience research.  
        Obesity is a major risk factor for heart disease and stroke, as 
well as for many other diseases, including diabetes, certain 
cancers, liver disease, osteoarthritis, sleep apnea, and depression. 
And obesity does more than affect life lines; it also affects 
government's bottom line - costs.    According to a recent study by 
economists Kenneth Thorpe and David Howard, obesity and other 
chronic conditions were major factors driving virtually all 
Medicare spending growth for the past 15 years.  The rate of 
obesity among Medicare patients doubled from 1987 to 2002, and 
spending on those individuals rose more than twofold.  
        The increase in obesity over the past 30 years has been fueled 
by a complex interplay of many factors and calls for a broad 
spectrum of research, including molecular, genetic, behavioral, 
environmental, epidemiological, and clinical studies.  The NIH 
strategic plan for obesity research provides a guide for 
coordinating obesity-related research activities across the 
organization based on the identification of areas of greatest 
scientific opportunity and challenge.  It is a wise choice as these 
well-invested taxpayer dollars will not only focus on the genetic 
and environmental basis of obesity and diabetes and establish an 
evidence-based approach for prevention, but also go towards 
reducing disability and death from cardiovascular disease.  
Moreover, through joint efforts with our private sector colleagues, 
more effective therapies of prevention and management will 
certainly ensue.  
        The NIH blueprint for neuroscience research is supported by 
15 Institutes and Centers.  Blueprint initiatives have focused on 
neuroscience tools, training in the neurobiology of disease for 
basic science, genome analysis, neuroimaging, genetic mouse 
models, core research facilities, and clinical assessment tools.  By 
pooling resources and expertise, this collaborative effort helps 
advance neurosciences and the emergence of new technologies that 
will lead to breakthroughs in stroke and other brain disorders.  
        These are just two examples of the many collaborative efforts 
within the NIH that increase the effectiveness of the nation's 
investment in health-related research 

Authorizations for the Common Fund 
        We are pleased that that the draft legislation sets a ceiling on 
trans-NIH research at five percent - the same level as 
recommended in the IOM report.  If the NIH receives increases 
assumed in the draft legislation of five percent-a-year through FY 
2009, the Common Fund could reach the targeted five percent 
level as early as FY 2008.  

Agency-wide Reporting System
        The AHA supports the creation of an agency-wide electronic 
reporting system to catalogue NIH's research activities in a 
standardized format.  The current decentralized data collection 
mechanisms make it difficult to determine how much has been 
spent on cardiovascular research and for what purposes.  This year, 
for example, cardiovascular-related research was conducted by 18 
Institutes and Centers, with their own distinct methods of 
reporting.
 	Other provisions in the bill would require the Director to 
submit biennially a report to Congress that lays out the strategic 
plans and research activities of the entire agency in a 
comprehensive fashion.  As previously noted, these new reporting 
requirements should help increase the transparency of NIH 
research activities and give us the information we need to make a 
compelling case for adequate research funding. 
        Nevertheless, we are concerned that Section 403(a)(5) of the 
bill neglects to require a separate category for heart disease and 
stroke - the number one and number three killers of Americans, 
respectively, in the biennial report of the Director.  We urge the 
Director to include a separate subsection for cardiovascular 
disease, or to include information for heart disease and stroke 
under the appropriate category in the same standardized format as 
all other diseases, disorders, and other adverse health conditions. 

Strategic Planning Process
        The Association supports the proposed strategic planning 
process that transcends - but does not supplant - the planning, 
priority setting, and research activities of individual Institutes and 
Centers.  Many of these changes are being implemented now 
through the Office of Portfolio Analysis and Strategic Initiatives 
(OPASI).  The proposed new Division of Program Coordination, 
Planning, and Strategic Initiatives would carry on these activities.
        One objective of this new coordinating function is to identify 
and plan for emerging scientific opportunities and rising health 
challenges that involve collaboration between two or more 
Institutes or Centers.  Given its "Number One" killer status, we 
strongly recommend that cardiovascular disease be included as one 
of the challenges to be addressed in the strategic planning process.  
As part of this planning process, we urge the Division to develop 
long-term projections of the incidence and prevalence of chronic 
diseases in coordination with other appropriate Federal agencies.  
These long-term projections would help guide research efforts 
aimed at reducing the economic and health burden of an aging 
population.

Scientific Management Review Board
        The bill would create an advisory council or "Scientific 
Management Review Board" to periodically review the NIH's 
structural organization.  The Association supports the requirement 
that the Board include the Directors of at least nine Institutes and 
Centers.  We also support the requirement that the Board consult 
with organizations representing patients and that at least one Board 
meeting should address the needs and opportunities of patients and 
their families.  We believe that the American Heart Association 
should to be among the groups with which the Board consults on 
the NIH's organization, as we are able to represent both patient and 
family views.  

Conclusion
        The AHA is heartened that Chairman Barton and the 
Committee recognize and appreciate the important role of patient 
stakeholders in NIH's mission.  We have made considerable 
progress over the years, but face daunting challenges in the years 
ahead.  We support this legislation because we believe that the 
organizational and other changes recommended in this bill will 
help direct resources more effectively to current health concerns, 
and help bring about the achievements in research necessary to 
confront the cardiovascular crisis that threatens the health and 
economic well-being of our nation and the world.  

        CHAIRMAN BARTON.  Dr. Furcht.
        DR. FURCHT.  Thank you, Mr. Chairman, Ranking Member and 
members, it is my privilege to be here today representing the 
Federation of American Societies For Experimental Biology, or 
FASEB.  This is a coalition of 21 different scientific societies 
representing more than 80,000 biomedical researchers.  On behalf 
of FASEB and the research community, I would like to thank you 
for your leadership and your continuing commitment to NIH. 
        In reauthorizing this critical agency, you have outlined a vision 
for increased transparency, common sense accountability and 
innovative progress in our battle against the scourge of diseases, 
and for meeting our most pressing public health needs. 
        The scientific community is especially grateful for your 
determination to authorize increases for NIH for each of the 3 
years covered by your draft legislation.  Your championing of NIH 
funding at a sustainable level above the cost of inflation is 
enormously important for both science and human health. 
On behalf of FASEB, and as a physician scientist myself, I 
want to applaud your outstanding leadership on calling on NIH to 
emphasize and preserve investigator-initiated competitive 
peer-reviewed grants. 
        Investigator-initiated competitive research has proven 
extraordinarily successful in generating the research discoveries 
that have led to some of our most effective and important medical 
treatments.  To illustrate this point, I would like to provide just a 
few examples of what investigator-initiated research really means.  
This is scientists across the country using evidence at hand and 
their own creative abilities to generate new ideas to solve serious 
problems.  Investigator-initiated research has identified the BRCA 
1 and 2 genes, which put women at very high risk for breast 
cancer, and has given us Tamoxifen, Letrozole and Herceptin, and 
other drugs to treat breast cancer.  It has led us to clot busting 
drugs to halt heart attacks and statins, and high blood pressure 
medications to protect us from heart disease.  In addition, 
premature infants are able to draw breath thanks to surfactant, 
discovered by researchers trying to understand how the lungs 
work. 
        FASEB believes wholeheartedly that by placing most of its 
resources in investigator-initiated peer-reviewed research, NIH 
ensures that Federal taxpayers' dollars are supporting the very best 
science.  However, we also recognize that challenges arise that 
require larger scale resources or multi-disciplinary approaches.  
This is why FASEB supports the establishment of a Common Fund 
for research focused on critical public health challenges and 
evolving areas of scientific opportunities, as well as its growth to a 
final level of 5 percent.  Clearly, discoveries in one field may have 
broad application to a host of diseases which is consistent with the 
idea of supporting cross-cutting multi-institute research.  
        In discussing the Common Fund concept, my colleagues within 
FASEB were able to name a number of ongoing projects that we 
believe fit this vision and spirit of the Common Fund as articulated 
by the NIH Reform Act.  The Neuroscience Blueprint Obesity 
Initiative, Clinical and Translation Science Awards, Pathways to 
Independence Grants for first time investigators, the creation of 
trans-NIH genomics resources, and studies related to the 
interaction of genes on the environment are currently being funded 
or under consideration by the institutes and centers.  We hope that 
the institutes and centers will be able to seek resources from the 
Common Fund to dedicate to these and other collaborative efforts. 
        We also strongly recommend that the vastly increased 
Common Fund resources be used to fund trans-NIH priorities such 
as funding first-time investigators, loan repayment programs that 
encourage physician scientists to stay in research. 
Continuing to attract new investigators is key to maintaining 
the vitality of the biomedical workforce.  With growing constraints 
on the NIH budget, we believe that there is no better use for the 
Common Fund resources than the creation of a sufficient pool of 
resources for new investigators. 
        Mr. Chairman, Ranking Member and members, FASEB and 
the scientists we represent are grateful for your sustained 
leadership to assure that NIH continues to excel in supporting the 
highest quality of medical science.  In endorsing NIH 
reauthorization, FASEB is proud to join with you in paving the 
way for reinvigorated investment in medical research.  We stand 
ready to work with you and your staff to move this important piece 
of legislation forward.  Thank you. 
        [The prepared statement of Dr. Leo T. Furcht follows:] 

PREPARED STATEMENT OF LEO T. FURCHT, M.D., BOARD OF 
DIRECTORS, FEDERATION OF AMERICAN SOCIETIES FOR 
EXPERIMENTAL BIOLOGY

        I am here today representing the Federation of American 
Societies for Experimental Biology or FASEB, a coalition of 21 
scientific societies representing more than 80,000 biomedical 
researchers. It is an honor to appear before this Committee to 
support the reauthorization of the National Institutes of Health - 
the world's leading biomedical research organization. 
        A half-century of sustained public investment in NIH has 
dramatically advanced the health and improved the lives of the 
American people and of people around the globe. Mr. Chairman, it 
is my privilege today, on behalf of FASEB and the biomedical 
research community, to thank you and the members of Committee 
for your leadership and your continuing commitment to NIH. In 
reauthorizing this critical agency, you have outlined a vision for 
increased transparency, commonsense accountability and 
innovative progress in our battle against the scourge of diseases 
and for meeting our most pressing public health needs. 
        Through actively seeking input from the research community, 
you have developed a model for NIH that both improves upon the 
current system and preserves those aspects that have allowed NIH 
to achieve its global preeminence in medical research. The 
research community spoke, you listened, and we want to express 
our appreciation for your efforts and consideration.  
        The scientific community is especially grateful for your 
determination to authorize increases in NIH funding for each of the 
three years covered by your draft legislation. The enormous 
promise of medical and scientific research - in both lifesaving and 
economic terms - will not be realized without such support. Your 
championing of NIH funding at a sustainable level, above the cost 
of inflation, is enormously important.
        On behalf of FASEB, and as a physician scientist myself, I 
want to applaud your outstanding leadership in calling on the NIH 
to emphasize and preserve investigator-initiated, competitive, peer 
reviewed grants.  This mechanism allows highly skilled scientists 
to propose the direction and priorities for further research, based 
on their own expertise and insight. Investigator-initiated, 
competitive research has proven extraordinarily successful in 
generating the research discoveries that have led to some of our 
most effective medical treatments. 
        To illustrate this point I would like to provide a few examples 
of what investigator -initiated research really means: scientists all 
across the country using the evidence at hand and their own 
creative abilities to generate new ideas to solve serious health 
problems. Investigator-initiated research has identified the BRCA 
1 and 2 genes, which put women at very high risk for breast 
cancer, and has given us tamoxifen, letrozole and Herceptin to treat 
breast cancer. It has led us to clot busting drugs to halt heart 
attacks and statins and high blood pressure medications to protect 
us from heart disease. Premature infants are able to draw breath 
thanks to surfactant, discovered by a researcher trying to 
understand how lungs work. Insulin for diabetes, acyclovir for 
viruses, the HIV "triple cocktail," Gleevec for leukemia - all of 
these breakthroughs, and many more, resulted from individual 
scientists pursuing questions of interest and importance and putting 
the pieces together to save and extend the lives of millions of 
people each year. Our nation trains and attracts the best scientific 
talent in the world; allowing these researchers' intrepid 
imaginations to set the course of discovery is the best way to 
improve health and well-being. 
        FASEB believes wholeheartedly that by placing most of its 
resources in investigator-initiated peer reviewed research, NIH 
ensures that federal taxpayers' dollars support the best science. 
However, we also recognize that challenges arise that require 
larger scale resources or a multi-disciplinary approach. This is why 
FASEB supports the establishment of a "common fund" for 
research focused on critical public health challenges and evolving 
areas of scientific opportunities as well as its growth to a final level 
of five percent. Clearly, discoveries in one field may have broad 
application to a host of diseases, which is consistent with the idea 
of supporting cross-cutting, multiple-institute research. 
        In discussing the "common fund" concept, my colleagues 
within FASEB were able to name a number of ongoing projects 
that we believe fit the vision and spirit of the "common fund," as 
articulated by the NIH Reform Act. The Neuroscience Blueprint, 
Obesity Initiative, Clinical and Translational Science Awards, 
Pathways to Independence grants for first-time investigators, the 
creation of trans-NIH genomics resources, and studies related to 
the interaction of genes and environment are all currently being 
funded or under consideration by the institutes and centers. We 
hope that institutes and centers will be able to seek resources from 
the "common fund" to dedicate to these and other collaborative 
efforts. 
        We also strongly recommend that the vastly increased common 
fund resources be used to fund trans-NIH priorities such as funding 
for first-time investigators and loan repayment programs that 
encourage physician-scientists to stay in research. Continuing to 
attract new investigators is key to maintaining the vitality of the 
biomedical workforce, and with growing constraints on the NIH 
budget we believe that there is no better use for the common fund 
resources than the creation of a sufficient pool of resources for new 
investigators. This is particularly crucial now, as we try to keep our 
most talented young investigators in the pipeline by ensuring 
independent research support is available to them. 
        FASEB also strongly endorses your proposal to create an 
infrastructure to evaluate the NIH research portfolio to ensure that 
urgent public health needs and scientific opportunities are 
addressed in a timely manner. The reporting system which you 
have outlined will provide increased transparency and 
accountability. 
        This more transparent administrative structure would make 
NIH more accessible to the external community. Patient groups 
and researchers would have better access to information and have 
more direct input on program design.  Because NIH funding is 
supported by federal tax dollars, it is essential that the agency 
inform both the public and elected representatives of the value of 
the research it supports.  It is also critically important that NIH 
inform the public and members of Congress that the path to 
preventing and curing human disease requires a sustained and 
long-term investment in basic and clinical research.
        It is clear that we all share a mutual desire to improve our 
nation's health and well-being through the lifesaving research 
funded by NIH. NIH-supported research represents a dual 
investment in the future of our nation: first, by helping to assure 
the health, security and quality of life of our citizens; and second, 
by training the current - and future - scientific and technical 
workforce needed to maintain our progress and keep the United 
States the world leader in biomedical research. In endorsing NIH 
reauthorization, FASEB is proud to join with you in paving the 
way for reinvigorated investment in medical research.
        Mr. Chairman, FASEB and the scientists we represent are 
grateful for your sustained leadership to assure that NIH continues 
to excel in supporting the highest quality medical science. 
Although we have only had a short time to review the bill itself, 
and would welcome the opportunity to comment further in writing 
on some of the finer details of the language, we stand ready to 
work with you and your staff to move this important piece of 
legislation forward.
        
        CHAIRMAN BARTON.  Thank you, Doctor. 
The Chair recognizes himself for the first series of questions.  I 
have waited a long time for the answer to this question, so I want 
to make sure we get it on the record. 
Do each of you and your organizations endorse the bill that is 
before us?  We will start with you, Dr. Miller.  
        DR. MILLER.  Yes, we fully support the bill before us.  
        CHAIRMAN BARTON.  Dr. Kirch.  
        DR. KIRCH.  As does the Association of American Medical 
Colleges.  
        CHAIRMAN BARTON.  That is a yes?  
        DR. ECKEL.  Yes.  As does the American Heart Association.
        CHAIRMAN BARTON.  I am tempted to ask the same question 
again, but I won't.  I can't tell you how hard we worked to get 
those yeses. 
        Do you seek passage in this Congress?  Dr. Miller.  
        DR. MILLER.  Yes, sir.  I think this is important to America's 
health.  Yes, it is that important. 
        CHAIRMAN BARTON.  Dr. Kirch.  
        DR. KIRCH.  The things this bill proposes are overdue, we 
support that. 
        CHAIRMAN BARTON.  Dr. Eckel.  
        DR. ECKEL.  I agree. 
        CHAIRMAN BARTON.  Okay, and Dr. Furcht.  
        DR. FURCHT.  We would hope that very much would occur. 
        CHAIRMAN BARTON.  I think all of you in your opening 
statements commented on the Common Fund and how important 
that is to have a robust Common Fund.  Would any of you like to 
elaborate on that?  Anybody?
        DR. MILLER.  Let me start.  I am used to the Common Fund as 
a dean of a medical school, it is called the Dean's Tax.  Essentially, 
those are funds that come to the dean, and the dean is able to use 
those funds to drive new initiatives.  I will give you one example.  
18 months ago, Burt Vogelstein, one of our pre-eminent scientists, 
came to my office and said "Ed, I think I can sequence the whole 
genome for both breast cancer and colon cancer, but it is going to 
cost about $4.5 million; I have $2.5 million, can you come up with 
another $2 million?"  Last week, in Science Express, Burt 
Vogelstein and his team published genome for those two cancers.  
That was an example where, without that funding available, that 
discovery could not have been made.  That is a real breakthrough, 
and everybody will say that is a breakthrough because that is just 
the beginning of how we are going to find out how many missteps 
there are in the cancer and what happens and why a cancer occurs. 
        CHAIRMAN BARTON.  Would anybody else want to comment on 
the Common Fund?  
        DR. KIRCH.  I would just add that the notion of the Common 
Fund really parallels the way the world of science has changed.  
The four of us sitting at this table started our careers in a world 
where almost all science was individual investigator oriented.  
While as Dr. Furcht pointed out, that remains important.  In the 
complex world we live in today, more and more projects are so 
complicated that they require broad teams of people drawn from 
different disciplines.  The Common Fund simply recognizes that 
problems less and less are owned by a single institute, they cross 
institutes. 
        CHAIRMAN BARTON.  Dr. Eckel.  
        DR. ECKEL.  Mr. Chairman, the Obesity Strategic Plan at the 
NIH is a perfect example of this kind of collaboration.  Directors 
Betsy Nabel and Allen Speigel recently combined efforts to try to 
get NHLBI and NIDDK to take a leadership role here.  As part of 
the advisory council I was involved, to some extent, in that 
process, and now 21 institutes and centers have signed on to this 
important area that is epidemic in our society. 
        Another brief case in point is the fact that I am an 
endocrinologist, but have recently stepped down as President of the 
American Heart Association.  I am not a cardiologist, yet 
metabolic diseases, including obesity and diabetes, are so 
paramount in causing cardiovascular disease that I think the area of 
science I represent is important to cardiologists.  Case in point. 
        CHAIRMAN BARTON.  Dr. Furcht.  
        DR. FURCHT.  Thank you.  The Common Fund is extremely 
important to our scientists because many of the fundamental 
discoveries that are made in research aren't necessarily 
disease-specific.  It is the creativity and the insight of an 
investigator finding an unintended observation, an unexpected 
observation that can sometimes lead to a tremendous breakthrough 
in finding cures for diseases that are not necessarily 
institute-specific or necessarily disease-specific at the outset.  So 
we strongly encourage the benefit and the utility of the Common 
Fund. 
        CHAIRMAN BARTON.  Well, my time is about to expire.  I want 
to thank each of you and your associations for working with us.  
There has been a lot of give and take.  I know that you all have 
been pressured by some in your organizations, and I appreciate the 
"give" that you have given, but you can tell them that you have 
been very good negotiators in getting people like myself, 
Mr. Dingell, and his staff to give back.  We have truly worked 
back and forth and through numerous iterations so that we have a 
work product that I think we can all be proud of.  
        I appreciate your endorsement of the bill.  I want to pledge to 
you that if we have a good markup tomorrow, and I am confident 
that this will be something that gets through the House very 
quickly.  I am working very hard and I encourage you to help so 
that we can get it through the other body quickly also and get it 
done in this Congress. 
        With that, I am going to recognize the distinguished member 
from California, Mr. Waxman, for his questions.  
        MR. WAXMAN.  Thank you, Mr. Chairman.  
        Dr. Kirch, let me start with you.  I am sure you are familiar 
with the IOM report, Enhancing the Vitality of the National 
Institutes of Health, but I want to direct you to the specific section 
detailing IOM's recommendation on how structural changes to the 
number of institutes and centers should be made.  
        It appears Chairman Barton's mark is missing two critical 
elements contained in the IOM report; one, the director can 
reorganize the institute and centers without using the completely 
open public process.  There is a requirement that he go through a 
public rule-making process, but that does not mean that a public 
hearing or forum of the type IOM recommends is required. 
        Secondly, under the bill, the director can reorganize institutes 
and centers on his or her own with the approval of the Secretary 
and after providing Congress with 90-days notice of the 
reorganization.  This is quite different, as I read it, from the IOM 
report which says that the NIH director, along with an investigative 
committee, should make recommendations to Congress for 
reorganization after an open public process.  Congress would then 
use the findings in the report to inform our actions in passing 
legislation to make structural changes at the NIH.  
        Do you agree with the IOM, that public hearings, both the 
scientific forums and the public forums, should be a requirement 
before any structural changes are made at the NIH?  And do you 
agree that the bill should explicitly state that public forums are 
required?  
        DR. KIRCH.  First, I would stress that the organization I 
represent, the AAMC, and the IOM are different organizations and 
independent organizations.  I am familiar with the IOM report.  I 
am also fairly familiar with the structural workings of the NIH, 
having worked personally at the NIH for almost 13 years. 
I am not an expert in how Congress and Federal agencies deal 
with issues like this.  I can tell you that I believe that the 
complexities of the NIH structure, together with the complexities 
of science, are such now that our focus should be less on the ways 
NIH is divided and more on the tools that NIH is given to bridge 
institutes and centers.  So our focus in this legislation has been on 
its provision of tools to bridge across institutes and centers. 
        MR. WAXMAN.  So it isn't that you disagree with the IOM 
recommendation, it is that you are not an expert in it, and you want 
NIH to have as much authority as possible to reorganize the 
institutes and other agencies within NIH?  
        DR. KIRCH.  What I am saying is that I believe the focus in this 
legislation has been on giving the NIH tools to bridge and 
transcend institutes.  It does not appear to me that the focus of our 
discussions has been on the internal structuring of individual 
institutes. 
        MR. WAXMAN.  Do you think that the director should be able 
to abolish institutes?  
        DR. KIRCH.  My reading of the legislation is not that it gives 
the director unilateral authority to abolish institutes. 
        MR. WAXMAN.  Well, let me put it this way:  Do you agree 
with the Institute of Medicine that it should be Congress, not the 
director, actually making the structural changes at NIH?  
        DR. KIRCH.  As somebody who works with all the Nation's 
medical schools and teaching hospitals, I would hope that 
Congress and the Federal agencies would find ways to work 
together to serve the public interest. 
        MR. WAXMAN.  The Scientific Management and Review 
Board, as I understand it, has 21 members, including nine possibly 
from the largest institutes.  Further, it can actually be chaired by 
the director of NIH.  Since the director receives the 
recommendations and actually is provided a procedure to follow if 
he disagrees with them, it does seem unusual to also allow him to 
serve as the executive director.  
        Dr. Kirch, you indicated some concern here.  Would you 
elaborate?  And I would be interested in anybody else on the panel 
who might have concerns or suggestions about the membership.
        DR. KIRCH.  As I mention in my testimony, we have provided 
some additional comments that we hope the committee in its 
wisdom could deal with in the process.  One of those comments is 
directed at the notion of the potential difficult position this could 
place an NIH director in, and we would hope there could be some 
discussion of that. 
        MR. WAXMAN.  Anybody else want to comment on that issue 
on the panel?  
        DR. ECKEL.  The American Heart Association, Representative 
Waxman, feels strongly that patient groups should have 
representation on that council.  The American Heart Association is 
an example of an organization that stands for a significant disease 
burden in our society.  So we would further recommend that an 
organization like the AHA be included on this council. 
        CHAIRMAN BARTON.  The gentleman's time has expired. 
        Before we yield to Dr. Norwood, I would like to point out that 
the thesis of the gentleman's question is current law.  The 
Secretary of HHS has the authority, under current law, to do some 
of the things that you have enumerated.  The draft before us 
actually puts more public input, obviously not as much as you 
wish, but more into the process.  So it is moving in the direction of 
the intent of your questions, as I understand them. 
        MR. WAXMAN.  Mr. Chairman, if you would yield to me.  The 
current law that allows the director to make some of these 
decisions has never been used.  Here we would be adopting a very 
clear and specific authorization for them to do these things where 
they have never done it before.  I think that invites it to be used, 
and I have questions about it.  Perhaps we can discuss them.  
        CHAIRMAN BARTON.  I understand, but we are not changing the 
authority you reference.  My only point is that this is current law.  
That is not an addition that is in this draft.  
We certainly have tried to empower the agencies.  We have 
tried to empower public input to make it more open and more 
transparent.  So we are moving in the direction that I think the 
intent of your question has implied. 
        MR. WAXMAN.  Well, I disagree with you.  Because the current 
law that has been there for some time, that has never been 
implemented, is something that NIH may not feel is the right path 
for them to take.  But now we are saying, take this path.  Some of 
these other procedures are added in, but I would rather not have 
that at all.  I think Congress ought to be the one to make these final 
decisions.  
        CHAIRMAN BARTON.  Mr. Norwood.
        MR. NORWOOD.  Thank you very much, Mr. Chairman.  
        Gentlemen, I have 5 minutes.  I want to ask one question, and I 
would ask each of you to perhaps answer that in 1 minute so we 
can get through everybody.  
        Happily, everybody at the table seems to be in agreement that 
this is good legislation, it is long past due, and everybody seems to 
be okay with it, generally.  I want to ask if any of you have 
anything about this you think is wrong or should be changed at this 
point in time that is in our draft legislation.  
        Dr. Miller, could we start with you? 
        DR. MILLER.  Well, I have looked at it very closely, and I 
believe the legislation addresses the issues we have concern with:  
that it supports young investigators through the Common Fund, it 
allows the Director to have additional funds to do transinstitute 
work, which I think is incredibly important; but the most important 
thing is that it increases the overall NIH budget, which I think is 
the most crucial element.
        MR. NORWOOD.  Thank you.  
        Dr. Kirch.  
        DR. KIRCH.  As I said, we offered a number of suggestions.  I 
would not put them under the heading of changing the legislation; 
rather, I view them as suggestions as to how it might be improved.  
They are too detailed to go into here, but in general they are adding 
some specificity in some areas to simply ensure that the intentions 
of the bill are carried out in the complex practice of science.
        MR. NORWOOD.  Have you offered these suggestions before?  
        DR. KIRCH.  These have been provided to the committee.  
        MR. NORWOOD.  And have they been provided in writing?  
        DR. KIRCH.  Yes.  
        MR. NORWOOD.  Okay.  Pardon the interruption.  
Just highlight a little bit more and then we can look at the 
details.
        DR. KIRCH.  Well, I share with my colleagues at the table a 
concern about our investigators of the future.  They are an 
endangered group right now, and I think ensuring that the 
Common Fund could be applied to their development is a high 
priority that we would like to see specified.  
        DR. ECKEL.  The American Heart Association has another 
concern beyond the council that ultimately reviews the decisions 
made for the Common Fund.  In section 403(a)(5) of the bill, there 
is no language to require a separate category for heart disease and 
stroke, the number one and number three killers of Americans.  
The American Heart Association would urge the Director to 
include a separate subsection for cardiovascular disease.  
        So the agency-wide reporting system, at present, neglects heart 
disease and stroke.  We would simply like that included.  
        MR. NORWOOD.  Certainly appreciate that comment.  Coming 
from you, I would say the same thing.  
Yes, sir.  
        DR. FURCHT.  FASEB is very supportive of this draft bill.  I 
think, as was stated earlier, the most critical thing for us is the 
increase in the authorization for the NIH budget.  
        Whether we recognize it or not, there is a crisis in academia 
today where young people are turning away from our field of 
biomedical research because of the tremendous competition and 
the fear of failure, if you will, of having to compete in the 
academic marketplace.  We think that by virtue of increasing this, 
creating the Common Fund that is split between the new increases 
in appropriated dollars coupled with the enhanced transparency 
and accountability, all have benefits that we would all like to see to 
improve the use of taxpayer dollars for biomedical research.  
        So we are very comfortable with that.
        MR. NORWOOD.  Part of this, for us, is this business called 
collaboration.  And other useful things, I think, that are in the bill, 
organizational things--I think probably, Dr. Miller, you have done 
a lot of that over at your institute.  Would any of you support this 
bill if it had level funding?  
        DR. FURCHT.  That would be challenging.
        MR. NORWOOD.  So you are not interested in the other parts.  
You just want more money.
        DR. FURCHT.  No.  I think there are better ways to use the 
money, which I think the bill covers; but we also need more 
money.  
        MR. NORWOOD.  But if it didn't have more money, you 
wouldn't support it?  
        DR. FURCHT.  No, there are some good things in the bill.  
        MR. NORWOOD.  Good.  All of you feel that way.  
        DR. KIRCH.  If I may, one of the things that I think have been 
discussed at length is the fact that level funding, combined with 
creating a stronger Common Fund, would cause collateral damage 
to the current scientific base that none of us would want to see. 
        MR. NORWOOD.  Dr. Kirch, I think we probably don't disagree 
with you there.  I'm trying to find out if we had just simply given 
you more money, would that have satisfied everybody.  
        That doesn't satisfy this committee, I am sure, and I hope it 
wouldn't have satisfied all of you; because some of us think that 
part of this isn't just more money, but it is how the money is being 
used and is it being used, from the taxpayers' point of view, as 
wisely as possible.  
        Thank you, Mr. Chairman.  
        MR. UPTON.  [Presiding.]  Dr. Miller, did you want to answer 
that question?  
        DR. MILLER.  I could not agree with you more.  I believe you 
are correct, more money, but how you allocate that money and 
how you protect those young investigators.  So I think those are 
crucial things.  
        Not that the other Institutes aren't doing great work, and we 
want those to continue, but we have to have ways to bring people 
together, and this is a mechanism to do that.  
        MR. UPTON.  The gentleman from Illinois, Mr. Rush.  
        MR. RUSH.  Thank you, Mr. Chairman.  I want to ask all four 
of you basically three questions, but I want to preface my remarks 
with these four comments.  
        Eighty percent of NIH funds goes out to the private sector.  In 
the area of diversity, there is no way to validate or determine the 
level of diversity among the private sector and clinical trials.  It is 
also unknown to us what is the NIH oversight role over the private 
sector as it relates to diversity.  Even though current Federal law 
requires inclusion of women and minorities in clinical trials, it still 
is a real issue that this committee and the American people face.  
        The three questions that I have for each of you:  
        Are there health disparities in clinical trials and otherwise, 
including researchers and also subjects?  
        The second question:  Why is this so, if you agree.  
        And the third question is:  What are your organizations--your 
schools, your medical schools, your universities--what are you 
doing about this blatant level of injustice as it relates to diversity 
issues in our Nation?  
        DR. MILLER.  Start with me, I guess.  
        At Johns Hopkins, that has been a big issue.  Johns Hopkins 
sits in an area of the city that is a very poor part of the city.  We 
see a very diverse group of patients.  It is part of all of our clinical 
studies that we have a very richly mixed group that are entered into 
our clinical trials.  It is one of the elements.  
        It is a core value of Hopkins to be a diverse institution.  We 
just recently adopted that.  
        And, lastly, we have the Urban Health Institute which looks at 
the community that surrounds Hopkins and tries to address the 
issues that you have raised in a very meaningful way across the 
School of Nursing, the Bloomberg School of Public Health, the 
School of Medicine and in the hospital and health system.  
        So I think we certainly understand your concerns.  We are 
trying to address those concerns.  We try to recruit faculty that will 
be able to help us move this whole process forward, and I think we 
have made real progress over the last 5 years.  
        DR. KIRCH.  I would choose to focus on the question you asked 
regarding essentially the scientific workforce and its diversity.  I 
think my colleagues are very prepared to speak to the way trials are 
conducted and studies are conducted.  
        The Association of American Medical Colleges has had this as 
one of its strategic issues for well over a decade.  We have been 
working very hard to bring more underrepresented minorities into 
medicine and into science.  It has, quite honestly, been a tough 
struggle, but we are slowly but surely making some progress.  
        I think this dovetails with one of the issues that has been 
discussed today, which is how important it is to support young 
scientists.  If we can recruit them into careers in medicine and 
science, but then fail to provide them the early research support 
that they need and they leave medicine and science, that's a great 
tragedy and a great loss.  
        So we are continuing to work on that entire pipeline 
progression from before medical school and graduate school on out 
into the practice of medicine and the practice of science with a 
number of initiatives.  
        DR. ECKEL.  Congressman, it is the law of the land that lack of 
diversification is unacceptable from a scientific perspective in 
terms of recruiting subjects into clinical trials.  Every consent form 
that I develop that relates to the use of a medication or an 
experimental procedure in human subjects must include women, 
minorities, and children.  The only reason that those types of 
individuals would be excluded would be on a scientific or medical 
basis.  In other words, we are encouraged and work hard at trying 
to recruit minorities and other diverse populations in research.  
        Secondly, why does it exist?  I share with you the theme of this 
being a political and social issue.  The American Heart Association 
is very concerned about this problem.  Since I was nominated and 
selected to be President-elect over 2 years ago, every board of 
directors meeting I have been to at the American Heart Association 
has included this topic for discussion, and there is proactive 
positioning of the AHA in this area of diversity.  
        We work hard through multiple mechanisms to enhance the 
diversification and retention of diverse staff and volunteers for the 
organization.  In fact, our last volunteer leadership conference, 
held here in Washington last spring, dealt with diversity as a topic.  
So the AHA recognizes the issue and is attempting to solve this 
important problem.  
        DR. FURCHT.  Congressman, I'm personally keenly aware of 
this.  
        A friend and colleague at Minnesota, a cardiologist, did a 
seminal trial that approved the first drug treatment for African 
American patients with hypertension and protecting them from 
heart failure.  It was a landmark study.  I think that we all must 
attend and be more acutely aware of these issues to remedy the 
past, and I think all of our organizations and individuals personally 
are doing that.  
        One thing that our organization, FASEB, is doing is that we 
have a special program called the MARC Program that is 
specifically designed to attract and train minorities in biomedical 
research.  This is a flourishing program.  We are very proud of it, 
and we continue to hope that it grows, because it is by virtue of 
creating a workforce that is specifically interested in some of these 
problems that we will provide the long-term solution to the things 
you care about so much.  
        MR. RUSH.  Thank you 
        MR. UPTON.  Dr. Murphy.  
        MR. MURPHY.  Thank you, Mr. Chairman, and it is really quite 
a delight to be in front of this distinguished panel here.  I myself 
remain as an adjunct faculty member, which means the University 
of Pennsylvania doesn't have to pay me, but they can call me to 
lecture at any time at the School of Medicine and also the School 
of Public Health.  
        An area of key concern to me is how we get the Institutes to 
work together; and that is why this Common Fund, I am 
particularly excited about in some areas in particular.  I know a lot 
of things that grab the news about what comes out of the Institutes 
are things in the molecular or genetic or the microbiological level 
of great discoveries.  And yet, as we move from the lab bench to 
the hospital bed to the world at large, I consider it extremely 
important that we are taking these things and making sure they are 
applied to what we can learn, particularly about the aspects I 
mentioned before, about integrated care and about patient safety.  
        I would like comments from you as to how you see this bill as 
it is written, and what could be added to it and what could assist 
that flexibility.  I am thinking in terms of this:  that when we hear 
numbers--for example, that 70,000, 80,000, or 100,000 people a 
year may die due to problems with patient safety in hospitals; that 
we have $50 billion a year wasted on infections that are picked up 
at hospital settings; when we recognize that people with heart 
disease have double the risk for depression and those who have 
untreated depression with heart disease, their medical costs are 
double.  
        Those are areas where tremendous knowledge can come out of 
integrating the research together at NIH to help work towards, how 
do we come up with practical solutions, as Congress has addressed 
this issue, with the cost of health care.  I see this as an important 
part of NIH's mission, though not specifically spelled out, but I 
think it is an important part.  
        We, in Congress, are all deeply concerned on both sides of the 
aisle about people having healthcare be accessible and affordable, 
and we recognize that many people who are covered by Medicare 
and Medicaid, and community health centers--all things which this 
committee is passionate about working with--are important, but we 
also have to recognize that 45 percent of the Federal mandatory 
budget is healthcare.  We have spent a lot of money on that.  
And our Nation, through bureaucracy, through paperwork and 
inefficiency, wastes a lot of money too.  My estimate is between 
$300 billion and $500 billion that doesn't get to the patient, but is 
wasted somewhere else.  
        This is my only question, and I want to see some help on this, 
as to how you see this bill helping the Institutes work together 
towards integrating some of those aspects of care and improving 
patient safety.
        Dr. Miller, can we start off with you?
        DR. MILLER.  Well, certainly the issue of patient safety has 
been high on everybody's radar screen for the past several years.  
One of the things we found at Hopkins over the past 4 or 5 years 
has been that you can drive it with research.  That is, if you start to 
take some measurements and you take a look at what your 
infection rates, either catheter-related or surgical-site infections, or 
medication errors and so forth, and then really look at what the 
best practices are and how can you drive those numbers down to 
zero, there is a tremendous amount of research in that because it is 
not easily done.  
        I think we all kind of come to a certain point, and we can't 
drive it any lower; and then we find someone who has found some 
way to do it.  So I think we can take some of these dollars and 
drive some of those initiatives to really improve the safety in the 
care delivery model.  
        One of the things you see in the care delivery model is the 
processes that are at fault.  It is not the people.  Therefore, you 
need to have a research protocol to look at those processes and 
make them better so that patients are not injured.  
        So I think there is a tremendous advantage to having, for 
instance, the Common Fund be able to direct some of those dollars 
and have Institutes work together.  You can see where NCI, where 
one of the biggest issues probably is medication error in patients 
receiving chemotherapeutic agents, how can you minimize the 
chances that a patient will be injured by either getting the wrong 
dose or the wrong drug?  
        So I see a lot of advantages for that.
        MR. MURPHY.  Thank you.  
        Dr. Kirch. 
        DR. KIRCH.  Well, I think your observation was right on target.  
If we simply focus on the molecular basis of disease, we can still 
have systems that fail on the other end.  I think one of the real 
breakthroughs made by Dr. Zerhouni, when he first proposed the 
roadmap for NIH research, which this legislation really nicely 
dovetails with, was his vision of this spectrum.  This 
transformation from the laboratory bench all the way out to the 
health of the population, the quality of care, and the delivery 
system in which the care occurs.  I think what this bill does is 
simply give the NIH a very well-defined tool to accomplish that.  
        I was very struck by one of the examples that you yourself 
gave in your earlier comments.  So many of the diseases that 
burden our country in terms of pain and cost have strong 
behavioral components.  So it isn't just understanding the 
molecular basis of those diseases.  A disease such as obesity, it is 
understanding the social, environmental, and behavioral context in 
which they work.  That requires multiple Institutes coming 
together.
        MR. MURPHY.  Thank you.  
        Dr. Eckel.  
        DR. ECKEL.  I'd like to address the example you gave about 
depression and cardiovascular disease.  
        NIMH and NHLBI would both claim those areas, as they both 
have activities going on in the science and medicine of depression 
and heart disease.  Yet, when this issue came up in a recent 
conversation on the Manuscript Oversight Committee of the 
American Heart Association, it was clear that the state of the art of 
depressive illness and heart disease really is not well understood.  
        So I will use that as an example of where the Common Fund, 
with appropriate oversight and coordination of activities, the NIH 
could be used to develop a question that has a research base that 
could ultimately lead to an answer.  We don't know whether 
depressed patients who get antidepression treatment show reduced 
risks for cardiovascular disease.  Nor do we know if patients with 
heart disease who are deemed depressed, whether, once treated, 
experience a reduction in second events.  
        This is research, and I think the Common Fund could help 
solve that collaborative need.
        MR. MURPHY.  Dr. Furcht. 
        DR. FURCHT.  Thank you.  We, too, support the notion that the 
Common Fund can allow funding for nontraditional types of 
questions that have not been asked before.  The Common Fund 
allows flexibility to address, in a more incisive way, questions such 
as patient safety and those relationships where different diseases or 
cures seem unrelated.  
        I am reminded of the anecdotal evidence with some of the 
nonsteroidal anti-inflammatories where patients are now seeing 
decreased cancer in those taking it chronically.  Why does that 
happen?  How was that not thought of?  
        So it is these types of investigations and answering questions 
such as you raise which are fundamental for all physician groups 
and clinical practices and hospitals in the country relative to patient 
safety that I think the Common Fund would be allowed to address.
        MR. MURPHY.  Mr. Chairman, I think if they are able to show 
how they can save hundreds of billions of dollars through some of 
these things with the Common Fund, they will have earned a lot 
more money for NIH. 
        CHAIRMAN BARTON.  [Presiding.] There you go.  
        MR. MURPHY.  Thank you, Mr. Chairman.
        CHAIRMAN BARTON.  Mr. Green.  
        MR. GREEN.  Thank you, Mr. Chairman.
        Dr. Kirch, I am glad my colleague from Pennsylvania asked 
that question because I have some questions on the Common Fund 
also and suggestions in ensuring Common Fund research is subject 
to the same peer review standards as other NIH research.  I have 
heard similar feelings from extramural grantees, who also want to 
ensure the peer review process under the Common Fund is equally 
rigorous for intramural as well as extramural applicants.  
        Can you speak to this issue with the perspective from these 
extramural grantees?  And do you think report language will 
satisfy that concern, if that is possible? 
        DR. MILLER.  I believe that the way it's written, and I don't 
know exactly, but it would seem to me there is enough safeguard 
and oversight of the use of those funds in the reporting 
relationship, especially at the 3-year period.  I would imagine that 
any director who would use those funds would want to use an 
outside, or a group of experts inside and outside the institution to 
help that person decide, are those funds well spent or not?  
        MR. GREEN.  But would they be subject to the same peer 
review as that in the legislation, that you know of?  
        DR. MILLER.  I don't know the answer, but one of the strengths 
of NIH has been the peer review system.  I think that's the one that 
we have lived by for years, and I think it has really done us well.  
        MR. GREEN.  I would hope, Mr. Chairman, that is of a little 
concern, to make sure the peer review process covers the Common 
Fund.  
        And this question is for the whole panel.  Since this legislation 
includes a new concept, such as the Council of Councils' Scientific 
Management Review Board, I want to make sure the makeup and 
the operations of these entities are balanced and appropriately 
reflect our scientific research needs. 
        While legislative text establishing the Scientific Management 
Review Board contains language ensuring the smaller institutes 
and centers, the text establishing the Council of Councils offers no 
such guarantee of inclusion by these smaller institutes.  It's my 
understanding the Council of Councils provision in the bill mirrors 
the way the advisory council is established under the Office of 
Portfolio Analysis and Strategic Initiatives.  
        Can any of the witnesses speak to their experience with that 
advisory council in this office currently?  And moving forward, do 
you have concern about the inclusion of these smaller institutes 
and centers in the Council of Councils directing trans-NIH 
research?  Is there any opinion on that, on the smaller institutes and 
the centers as compared to this large Council of Councils group, or 
compared to what similarly we have now?  
        DR. ECKEL.  I would have to ask whether the language of the 
bill contains that information.  According to your question, 
apparently it does not. 
        MR. GREEN.  No, it doesn't.  I guess the concern is, how is this 
under the current Office of Portfolio Analysis and Strategic 
Initiatives?  And I would think, from the bill, that the Council of 
Councils is just a broader group for that.  And, again, we don't 
want to lose some of our smaller initiatives in this umbrella group.  
Is there any concern of that?  Have you had any concern on this?  
        DR. FURCHT.  Well, it is an issue we at FASEB have discussed, 
but our hope is that with the balance of this Council of Councils, 
inside and outside, that you would achieve essentially the wisest 
decision when all is said and done.  
        It would be very difficult to represent every single interest 
group or institute or center director in such a process. 
        MR. GREEN.  I know.  I always said the best committee is a 
three-person committee, with me as Chair and somebody devoted 
to me as my second vote.  But we need to make sure we have a 
broad representation, particularly from the smaller institutes, I 
guess.  
        DR. MILLER.  We have no concerns.  
        MR. GREEN.  Okay.  
Mr. Chairman, that's all the questions I have.  I appreciate the 
time.  
        CHAIRMAN BARTON.  We thank the gentleman from Houston.  
        Mr. Shimkus, do you wish to ask questions?  
        MR. SHIMKUS.  Thank you, Mr. Chairman.  I am going to be 
real brief.  I want to thank you for your testimony, the written 
testimony and also the answering of the questions.  It is pretty 
exciting to see, to come this far, to a point where we are ready to 
move on the legislation.  I think your responses have been very, 
very helpful to us.  
        And as I said in my opening statement, the issue on the 
common funding, which seems to be a current refrain, and 
addressing issues where the individual institutes and centers might 
have had challenges before, through this process.  Because I think 
the older we get, the more we know people with various diseases 
and maladies and illnesses; and we know that this research does 
cross over a lot of boundaries.  
        So I am very excited and very pleased with the testimony, and I 
think it just emboldens us to move sooner rather than later and get 
this show on the road.  
        So, Mr. Chairman, I just want to thank the panelists and yield 
back my time.  
        CHAIRMAN BARTON.  The gentleman yields back.  
In order of appearance, it would be Congressman Upton.  
        MR. UPTON.  Thank you, Mr. Chairman, and I appreciate the 
opportunity to have this hearing and obviously will support the bill 
tomorrow as well.  
        Dr. Miller, I have just a couple of questions.  One, I think each 
of us here has certainly health causes that all of us support and take 
a real interest in.  One of them for me is cystic fibrosis, which you 
mentioned in your testimony when you indicated that a successful 
therapy has yet to be developed, yet we think we can find a cure.  
        And, again, I have met with a good number of folks involved in 
this particular disease, and I have seen the promise come about in 
the length of time that now someone, once they are diagnosed with 
cystic fibrosis, has the opportunity to live, I want to say it is double 
or even more than that in terms of years.  
        I just wondered how you think this bill will impact that cure 
really getting into all of the impacted lives that are out there?  
        DR. MILLER.  Well, I share your concern especially with cystic 
fibrosis.  When I went to medical school, life expectancy was 12 or 
13, and now we are well into the 40s and 50s for some people.  
Having had a relative with the disease, who died at age 14, I know 
about this.  
        One of the things that I see, however, is that we have always 
been trying to look for the magic gene that is going to cure that 
patient.  It looks to me like there are going to have to be other 
technologies brought in.  So what is going to happen in 
bioengineering and how we can make new proteins to help fix the 
defect, these are areas that I think funds could be brought to 
address that issue, which have not, because we have been kind of 
working again in these silos.  How do you bring in other people 
and say, listen, I have a problem and I can't figure it out; can I 
bring a bioengineer, can I bring a biochemist in, can I bring more 
people to solve the problem?  
        I think this is one of the ways it is going to happen.  
        MR. UPTON.  Well, I was one of those, and I think it was a little 
more than 10 years ago that the debate began to double the funds 
for the NIH; and, of course, it was a very strong bipartisan effort 
that was successful in both the House and the Senate.  And I would 
like to think that it is because of that effort, things like the progress 
we have made in cystic fibrosis and others, that we have really 
come a long way and provided hope for those families and 
certainly the individuals that are impacted.  
        What other examples beyond cystic fibrosis might you be able 
to cite, for sure, that investment has done great things?  
        DR. MILLER.  Well, I think if you just look in areas of 
oncology, I believe this is the first year in the United States that the 
death rate from cancer has fallen.  I think that is a dramatic 
example.  
        I think issues that have been raised in terms of heart and lung 
disease are very impressive, and that would not have occurred.  I 
think we can all remember what happened when someone had a 
heart attack a few years ago, compared to the therapies they have 
today.  
        What we are doing in the areas, admittedly oncology, but in 
terms of leukemia.  My mother-in-law had lymphoma.  That was a 
deadly disease.  She lived for another 12 years after the diagnosis.  
That would not have happened. 
        MR. UPTON.  And that's a good thing, right?  That your 
mother-in-law lived another 12 years?  
        DR. MILLER.  She was great.  I knew her since I was 14, so, 
yeah, she was kind of like second mom.  Yeah. 
        MR. UPTON.  Just wanted to make sure. 
        DR. MILLER.  I think there are multiple, multiple examples out 
there where the doubling of the NIH has made a true impact on the 
health of this country. 
        MR. UPTON.  Yes, Dr. Kirch?  
        DR. KIRCH.  If I may, one of the things that always concerns 
me is, if we as a society expect things to change overnight in terms 
of dealing with these tough, tough diseases, we make a mistake.  
Change is step-wise and progressive, but that change can be huge.  
        When I started medical school, 80 percent of children with 
leukemia died.  Today, 80 percent of children with leukemia go on 
to have a full life.  That is transformational, but it didn't happen all 
at once.  It was a series, over the years, of steps forward.  And we 
have seen that in many other areas of science.  
        Everyone at this table thought in the early 1980s that our 
hospitals today would be bursting at the seams with terminal AIDS 
patients.  We haven't cured AIDS, but we have found some very, 
very effective treatments.  
        MR. UPTON.  Dr. Furcht.  
        DR. FURCHT.  Yes, if I might comment on the utility of the 
Common Fund and these trans-NIH initiatives by another example, 
in the late 1970s and 1980s there was a specific program at NIH 
called the Special Virus Cancer program, trying to find the virus 
that caused cancer.  Well, that was or wasn't found, but what has 
come out of that is that in studying animal cells that were infected 
with different cancer viruses, it was found that they produced 
factors that made blood vessels grow, that made the cells grow, 
whatever; and today we now have drugs in the marketplace that 
patients are getting that are based on discoveries made while 
studying tumor viruses in mice or chickens.  So how could that 
have been planned at the time?  
        And it is the ability to have this flexibility that this bill will 
promote that I think will allow who knows what in the next 10 to 
20 years as far as new therapies for patients. 
        MR. UPTON.  I think that underscores the need to get this bill 
done.  And from every discussion that I have had, I think it is 
clearly going to be bipartisan; and I look forward to its passage in 
full committee tomorrow and on the floor as early as next week.  
And I commend Chairman Barton for working with both sides of 
the aisle and with our colleagues in the Senate to try to get this 
thing done, because I really do think it will make a great 
difference.  
        CHAIRMAN BARTON.  The gentleman's time has expired.
        Congresswoman Blackburn.  
        MRS. BLACKBURN.  Thank you, Mr. Chairman, and thank you 
to all of you for your time and for being here.  
        I am not a physician like Mr. Murphy or Mr. Norwood, or Mr. 
Burgess, who sits beside me, but I am one of those who has been a 
volunteer and a board member for a children's hospital and a lung 
association and a cancer society and arthritis, and--as my husband 
always says--disease efforts, and putting time and energy into 
raising money.  
        One of the things we always learned through that was the 
importance of accountability and the importance of the public 
being able to know that, as we went to them and raised funds, we 
were accountable and we were going to do good things and put our 
aim on giving a good product and serving the community.  
        As we have worked through this situation with NIH in the 
hearings and looked at legislation, the accountability factor 
continues to come up time and time again.  And we have held 
some hearings recently, the Oversight and Investigations 
Subcommittee has held some hearings, on some of the ethics 
problems with NIH researchers.  And even though we have 
doubled the NIH budget for years, the tentacles of those ethics 
problems, as deeply seated as they seem to be with NIH--it does a 
lot to undermine the faith that the public in general has of the NIH.  
        I have found it to be very unfortunate, because I am one of 
those that likes to see you all make strides--not just steps but 
strides--when it comes to medical research and answering 
problems.  And having lost a mother-in-law to Alzheimer's, I have 
found it very unfortunate that part of the ethics breaches that we 
experienced dealt with that research.  It is really an unfortunate 
thing to happen.  
        But just a quick yes or no, do any of you think that we should 
have some provisions in the bill that would prohibit similar ethics 
breaches?  And you may not have followed the hearings we have 
done; you may have.  
        Dr. Furcht, looks like you have.
        DR. FURCHT.  Yes, I am keenly aware of that; and if I could 
give you a little bit more of an extended answer, but not long--
        MRS. BLACKBURN.  Very quickly.
        DR. FURCHT. --we think this is extremely important.  I don't 
believe it needs to be part of the bill. 
        MRS. BLACKBURN.  Would you support it as a separate bill?  
        DR. FURCHT.  Potentially.  We are coming at this in a different 
way.  Our organization is leading a coalition, AAMCAAU and 
others are beginning to work with us where we want to establish 
common national standards relative to research, ethics, conflict of 
interest in research, et cetera; and we are hoping to move that 
forward.  We actually have a grant to work on that.  
        MRS. BLACKBURN.  Okay, so you would favor it through the 
rulemaking process as opposed to through legislation?  
        DR. FURCHT.  Correct. 
        MRS. BLACKBURN.  All right.  
        Anyone else with a quick comment on that?  
        DR. MILLER.  I agree with that approach.  As a matter of fact, 
Dr. Kirch and I are going to Cleveland tonight to spend all day 
talking about conflict-of-interest issues in biomedical research.  
We think it is very important.  
        I think one of the problems is that not one size fits all 
problems.  And I think you have to look at when is the public good 
going to be benefited by moving products forward from the basic 
research into the business world.  And how is that going to occur, 
and what kinds of conflicts might surround it versus ones where 
the market might be manipulated and some bad things can occur?  
        So it is a difficult issue, and it is one, I think, we are all 
wrestling with.  
        MRS. BLACKBURN.  Okay, thank you.  
        I have one other quick question I want to pose to you all.  The 
bill does establish a reporting system, but we know this is fake, 
within the bill.  And one of the things that has come up as we have 
gone through the hearings is access to information, being certain 
that when research has been done, that the information is 
catalogued, or that papers are written, and that there is a way for 
that to be picked up and carried on so that it does not drop.  
        One of the things that had come up, had been mentioned by 
some folks that are out of Tennessee where I am from--I represent 
some of Memphis, some of Nashville, and a lot of area in between-
-would be for papers to be submitted--when they are done with 
federally funded research, papers to be submitted and then those 
papers made available on a free public database.  
        Would any of you have a problem with that?  Anyone care to 
answer?  
        Dr. Miller, go ahead.  
        DR. MILLER.  This would be before the paper has been 
reviewed, peer reviewed?  
        MRS. BLACKBURN.  Yes, and I understand what you are saying, 
the verification process of that. 
        DR. MILLER.  You know, if someone sets up an experiment and 
they give an answer that says "yes" or "no" and the experimental 
design is wrong, you can't believe the answer.  
        So peer review would kind of say, that design is appropriate, 
they did the data, they collected the patients at the appropriate rate, 
the numbers were appropriate, and the conclusions they raised 
were valid.  
        If it goes in without that, it is just meaningless data.  
        MRS. BLACKBURN.  Okay.  Sometimes I know, as we have 
found from some of our global warming research, that the 
community of scientists that handles that peer review can be very 
difficult, too, and can also color how people--anyone else with 
something to say?  
        CHAIRMAN BARTON.  The gentlelady's time has expired.
        MRS. BLACKBURN.  I am out of time, and I thank you, 
Mr. Chairman.  
        CHAIRMAN BARTON.  Mr. Terry.  
MR. TERRY.  No questions. 
        CHAIRMAN BARTON.  Mr. Deal.  
        MR. DEAL.  Thank you, Mr. Chairman.  I want to apologize for 
not being here to hear your testimony, but I was on the floor 
handling some health-related resolutions, and we passed about four 
of them just a minute ago.  One of them dealt with the goal of 
achieving a conquer over cancer by the year 2015, which, of 
course, is a goal that all of us would like to see achieved.  I am 
hopeful that what we are doing here in this reauthorization, as well 
as reorganization, of the NIH will assist in that endeavor.  
        I really don't have any questions to ask of you.  I just want to 
thank all of you for being here.  
        And I want to thank the Chairman for his dogged persistence in 
moving this issue forward.  It would not be where it is had it not 
been for his insistence that we do something in what I think all of 
us consider a very important area.  
        And, also, I want to thank the staff.  They have worked 
extremely hard to bring this issue forward.  
And thank you, gentlemen, for being here today.  
        And I yield back, Mr. Chairman. 
        CHAIRMAN BARTON.  Almost like a Georgia Bulldog, you 
might say.  
        Well, I want to thank you gentlemen and I want to thank your 
organizations.  This is a historic moment.  We are going to have an 
open markup tomorrow.  Obviously, there are going to be members 
that offer amendments, but I think the base bill is a very good work 
product, and it is because of your willingness to cooperate on 
behalf of your organizations with our committee staff and Mr. 
Dingell.  So I do congratulate you and I look forward to working 
with you in the next several weeks.  
        With that, we will release you.  I know some of you have a 
plane to catch.  I know, Dr. Miller, you do.  So we want to bring 
the Director of the NIH forward, Dr. Elias Zerhouni.  
        Welcome again before the committee, Dr. Zerhouni.  It goes 
without saying that you are a valuable member of the executive 
branch and have done an excellent job in managing the NIH.  We 
appreciate you and your staff's comments on the various drafts of 
the bill.  
        We want to recognize you for such time as you may consume 
to comment on the draft, and then we will have some questions.  
But welcome once again to the committee.

STATEMENT OF         DR. ELIAS A. ZERHOUNI, DIRECTOR, 
NATIONAL INSTITUTES OF HEALTH

        DR. ZERHOUNI.  Thank you, Mr. Chairman, and members of 
the committee.  I am Elias Zerhouni; I am the Director of the 
National Institutes of Health, and I am here today at your request 
to testify about the legislative reauthorization of NIH.  
        Interestingly enough, the current reauthorization proposal will 
be only the third omnibus reauthorization of NIH since enactment 
of the Public Health Service Act in 1944.  Omnibus 
reauthorizations occurred in 1985 and 1993, and those previous 
acts primarily extended the number of institutes and centers at 
NIH, concentrating on specific diseases, organ systems, and 
special populations.  
        Throughout the periods of budgetary and structural growth, 
NIH truly drove the biomedical research engine of our Nation 
toward unprecedented scientific discoveries that have 
fundamentally changed public health.  For example, our success in 
addressing acute illnesses has shifted the landscape of disease.  
Today, our population suffers more from chronic and more 
manageable diseases that account for over 75 percent of our 
healthcare expenditures.  
        The key transformation underlying all of these changes, as you 
have heard from the prior witnesses, has been the convergence of 
science.  Scientific concepts have become more intertwined across 
all diseases and conditions.  As we have learned more about the 
molecular causes of diseases, we have found great similarities 
between the mechanisms that lead to diseases once thought 
unrelated.  You just heard an example for research on viruses and 
cancer which found application in AIDS treatments.  
        Often research in one field finds unexpected application in 
another.  The greatest research advances of recent years involve 
the fields of molecular and cell biology, as well as genomics and 
proteomics, among others.  But their applications will not be 
limited to specific diseases or populations.  They will be applied to 
all diseases and all populations, and that will require greater 
interdisciplinary efforts.  
        NIH strives to encourage these new ways of conceptualizing 
and addressing scientific questions and to encourage their 
translation from the laboratory to the clinic.  Already, as you have 
heard probably from the other witnesses, such approaches are 
yielding a trove of discoveries, from mental disorders to cancer to 
prevention of AIDS-related blindness, as examples.  
        We all have great expectations for the advancement of 
biomedical research in coming years, but the question members of 
this committee have consistently asked me, repeatedly over the 
past 4 years, is:  Does the current structure of NIH allow the more 
multidisciplinary and collaborative approach to science required to 
meet these expectations?  Is the structure that has emerged from 
the past 50 years tending in any way to impede good function?  I 
think this is the central issue that this bill addresses extremely well.  
        I think there is no doubt that science will require more 
collaboration and more interaction.  And, in fact, as we understand 
more about life processes, we also understand that overlap between 
concepts, between mechanisms, is more likely to happen in the 
future.  And the boundaries between the specific science and 
mission areas of the institutes and centers are increasingly blurred 
and now require more interaction.  
        Today, in addition to that, public health has changed.  Patients 
often suffer from more than one disease at a time, creating the need 
for greater coordination of care, as well, in our population.  And I 
have to say that our institutes and centers, their directors, have 
increasingly worked collaboratively whenever appropriate.  And, 
clearly, I think NIH through the past several years has taken 
advantage of the breakthroughs that were made, thanks to the 
support that you have provided NIH; and we are clearly showing 
the results in terms of exploiting the human genome that was 
completed in 2003, as well as the new research that identifies the 
common causes of very complex diseases.  
        Nonetheless, better mechanisms of functional integration that 
enhance synergy across all of NIH need to be found.  I believe that 
the proposed bill serves this purpose by preserving to the largest 
extent the autonomy of the institutes and centers, while creating a 
Common Fund and a shared, transparent mechanism for addressing 
issues that no single institute or center can address.  
        Over the past 4 years, NIH has experimented with ways to 
accomplish these goals by implementing a series of initiatives, 
such as the Roadmap for Medical Research, the NIH Plan for 
Obesity Research that integrates the efforts of about 21 Institutes, 
and the Neuroscience Blueprint that integrates the efforts of all of 
the institutes that have an interest in the brain, mind and behavior. 
        All of these initiatives are really designed to take rapid 
advantage of the enormous progress, but what we need is really a 
flexible process that allows you to take advantage of emerging 
opportunities or public health problems without going through a 
protracted mechanism of give-and-take, if you will, especially as 
we are facing constrained budgets.  
        Actually, one scientist put it to me in a very tangible way.  He 
said, Imagine that the human genome project came up today when 
the NIH budget is flat.  Would we find a mechanism to fund the 
human genome project when you have constrained budgetary 
times?  And the issue is, without such a mechanism, functional 
integration, collaborative research, the promotion of new ways of 
doing research, and taking advantage of unique opportunities will 
be hampered.  
        So this is why I think that the proposal that you have put 
forward avoids, in my view, a bureaucratic top-down process and 
preserves objectivity by relying on the time-honored NIH system 
of peer review and evaluation, which I think should be preserved 
and defended, because I think it allows a transparent process of 
priority-setting, but also makes sure the best science is funded.  
        I strongly urge the committee to also ensure that the growth of 
the Common Fund be tied to increases in the NIH in your 
appropriation.  I cannot tell you how difficult the situation is 
currently, and I know that you have been extremely generous in 
doubling the NIH budget.  Yet, at the same time, I can also tell you 
that the institutions around the country have made enormous 
investments in increasing the research capacity of our country.  
        For example, today we receive twice as many applications as 
we did before the doubling, and each application, because of 
inflation, is 40 percent more expensive.  The competition for funds 
is greater than ever.  
        Success rates prior to the doubling and during the doubling 
were above 30 percent; today they are below 20 percent, and my 
concern is that new investigators, new scientists will come forward 
and embrace the challenges that we all face and need to be 
supported.  I think it is very important, therefore, not to deviate 
from supporting these activities through a Common Fund and 
essentially take it from current programs.  
        The proposal also tracks, I believe, the IOM recommendations, 
including establishing a formal process for reorganizing offices 
and programs, standardization of data and information systems at 
NIH.  I think that the pursuit of scientific opportunity is best served 
through investigator-initiated grants, which have been and should 
remain the mainstay of our research-supported mechanisms.  
        Balance in the portfolio of the entire NIH is what we need, and 
addressing emerging issues, whether in public health or in terms of 
scientific opportunity or maintaining a vibrant workforce, such as 
new investigators, are all purposes that the Common Fund should 
be open to.  I believe strongly that free exploration of ideas 
generated by the scientists themselves has been and will continue 
to be the key to our long-term success.  
        I think the fundamental vision of NIH in the 21st Century, 
going forward, is that we hope to transform medicine and health 
from a curative paradigm, where we waited for a disease to strike 
the patient before we intervened; I think the progress we have 
made over the past 10 years lets us envision a completely new 
world where medicine will be predictive and personalized and 
preemptive.  This is what we call the three Ps of the future of 
medicine.  And I think NIH is strategically positioned to do that 
and is investing in research where we could identify and 
predictably tell patients what diseases they are at risk for, 
personalize the treatment that we need to implement, and hopefully 
preempt rather than treat disease, which will be orders of 
magnitude more effective than what we are doing today.  
        I believe that our vision, which is to transform medicine and 
health through NIH-supported discoveries, is probably the only 
hope that we have of greatly reducing healthcare costs in the 
future.  
        This concludes my testimony, and I will be pleased to respond 
to any questions, sir.
        [The prepared statement of Dr. Elias A. Zerhouni follows:] 

PREPARED STATEMENT OF ELIAS A. ZERHOUNI, M.D., DIRECTOR, 
NATIONAL INSTITUTES OF HEALTH

        Chairman Barton and Members of the Committee. I am Dr. 
Elias A. Zerhouni, Director of the National Institutes of Health 
(NIH), and I am here today at your request to testify about the 
legislative reauthorization of NIH. The current reauthorization 
proposal would be only the third omnibus reauthorization of NIH 
since enactment of the Public Health Service Act in 1944. 
Omnibus reauthorizations occurred in 1985 and 1993. Those 
previous acts expanded the number of Institutes and Centers at 
NIH, concentrating on specific diseases, organ systems, and 
special populations.
        As a result of such structural growth and appropriation 
increases, highlighted by the doubling of NIH's budget between 
1998 and 2003, the NIH is a far different organization than it was 
13 years ago, when Congress last reauthorized Title IV of the 
Public Health Service Act. Our budget is nearly $29 billion. We 
have over 17,000 employees.
        Throughout its history, NIH drove the biomedical research 
engine of our Nation toward unprecedented scientific discoveries 
that improved public health and fundamentally changed the nature 
of medicine as well as the burden of disease. Our success in 
addressing acute illnesses has shifted the landscape of disease from 
once acute, severe, and lethal conditions to more chronic and 
manageable conditions.
        However, as the Institute of Medicine observed in 2002, 
"While NIH's success is to be celebrated, success alone does not 
answer fully the question of whether there is a better way to 
proceed, particularly as one faces a future where the world of 
biomedical sciences is being rapidly transformed in all its 
dimensions."
        The key transformation has been the convergence of scientific 
concepts, approaches, opportunities, and needs across all diseases 
and conditions. As we have learned more about the molecular 
causes of diseases, we have found great similarities between the 
mechanisms that lead to diseases once thought unrelated. Often, 
research in one field finds unexpected application in another.  The 
greatest research advances of recent years involve the fields of 
molecular and cell biology as well as genomics and proteomics, 
among others. Their applications will not be limited to specific 
diseases or populations. They will be applied to all diseases and all 
populations. This will require greater interdisciplinary efforts. NIH 
strives to encourage these new ways of conceptualizing and 
addressing scientific questions and to encourage their translation 
from the laboratory to the clinic. At the same time, we work 
towards increasing our understanding of the behavioral and social 
sciences necessary to insure the success of biological approaches 
to health and disease.
        For example, the convergence of science underlies the new 
Genes and Environment Initiative in NIH's FY 2007 budget 
request to Congress. This is a project designed to address a broad 
array of health and disease concerns and will build on advances in 
multiple areas of science, including genomic sequencing 
technology and environmental science. It will give us the 
unprecedented ability to discover the potential causes of the 10 
most common diseases afflicting the U.S. population. Already such 
approaches are yielding a trove of discoveries in areas from mental 
disorders, to cancer, to the prevention of age-related blindness.
        We have great expectations for the advancement of biomedical 
research in the coming years. The question now being asked by 
Congress, the scientific community, medical providers, patients, 
and NIH itself is: does the current structure of NIH allow the 
multi-disciplinary and collaborative approach to science required 
to meet these expectations?  In this era of enormous potential and 
scientific convergence, how does NIH best adapt?
        Fundamental science has rapidly evolved due to recent 
advances in new fields such as genomics, proteomics, and many 
other breakthrough discoveries. The boundaries between the 
specific science areas of each of NIH's 27 Institutes and Centers 
(ICs) are increasingly blurred and now require greater 
interdisciplinary interactions.  Our population faces chronic and 
complex diseases, which now account for over 75% of healthcare 
expenditures.  Patients often suffer from more than one disease at a 
time affecting multiple organ systems, mechanisms, and life 
stages, creating the need for greater coordination. In many ways, 
ICs have already responded and are working together whenever 
appropriate. 
        Better mechanisms of functional integration that enhance 
synergy across all of NIH need to be found. Some provisions in the 
proposed bill serve this purpose by creating a common and shared 
mechanism for addressing issues that no single IC can address, and 
providing opportunities for ongoing formal review of the structure 
of NIH through input from IC Directors, scientific advisors, and 
other stakeholders. Over the past 4 years, NIH has experimented 
with ways to accomplish these goals by implementing a series of 
trans-NIH initiatives such as the Roadmap for Medical Research, 
the NIH Plan for Obesity Research, the Neuroscience Blueprint, 
and many other initiatives, all designed to take rapid advantage of 
the enormous progress made during the doubling of the NIH 
budget.  Establishing these formal mechanisms of integration gives 
NIH a great opportunity to build on its remarkable success to date.
 	The bill under consideration fosters interdisciplinary research 
and strategic planning by establishing an organization to integrate 
the work of the ICs through the identification of trans-NIH 
research programs that will broadly impact all areas of research. 
Further, the bill would create a funding mechanism - a common 
fund for shared purposes - for greater coordination of NIH 
research, whenever appropriate, as determined through an open 
and collaborative consultation and advisory process involving all 
relevant stakeholders. This fund is in conformity with the Common 
Fund for shared needs that NIH has already established to support 
trans-NIH initiatives, as discussed below. The bill preserves the 
time-honored NIH system of peer review and evaluation.  
        I believe the current proposal will preserve such vital 
authorities as peer review and the pursuit of scientific opportunity 
through investigator-initiated grants - which have been and should 
remain the mainstay of our research support mechanisms. I believe 
strongly that free exploration of ideas generated by the scientists 
themselves is the key to our long term success. Human subjects 
protections, and the requirement to disseminate research findings 
to the public will remain, as in our current authorization. I think the 
Committee is focused on organizational efficiency and 
effectiveness, which is the principal challenge for an increasingly 
large and complex organization.
        This bill creates a central planning and analysis division for 
trans-NIH research within the Office of the NIH Director. NIH has 
recently established such an office through administrative 
mechanisms. It will be instructive to the Committee to share NIH's 
vision for the function of this new organization.
        The mission of the new Office for Portfolio and Analysis and 
Strategic Initiatives (Office) is to provide NIH and its constituent 
ICs with the methods and information necessary to manage their 
large and complex scientific portfolios, to identify - in concert 
with multiple other inputs - important areas of emerging scientific 
opportunities or rising public health challenges and to assist in the 
acceleration of investments in these areas. Bringing together these 
diverse components of the agency will facilitate "functional 
integration" of NIH in a time of unprecedented scientific 
opportunities. It will help the agency to increase its effectiveness 
and efficiency in advancing science, ultimately resulting in the 
acceleration of basic research discoveries and speeding the 
translation of those discoveries into applications that improve the 
health of the American people. 
        The Office will accomplish its mission through the activities of 
three divisions and an office of the director. The mission of the 
Division of Resource Development and Analysis (DRDA) is to 
employ resources (databases, analytic tools, and methodologies), 
and to develop specifications for new resources, when needed, in 
order to conduct assessments based on NIH and other databases in 
support of portfolio analyses and priority setting in scientific areas 
of interest across NIH. DRDA will also be a resource for portfolio 
management at the programmatic level, should individual ICs 
request the Division's expertise or tools. 
        The Division of Strategic Coordination (DSC) is responsible 
for integrating information and managing the process by which 
recommendations are developed to inform the priority-setting and 
decision-making processes of the NIH in formulating trans-NIH 
strategic initiatives. These initiatives will address exceptional 
scientific opportunities and emerging public health needs. The 
DSC will provide the Director with the information needed to 
allocate resources effectively for trans-NIH efforts. Although the 
new office will not have grant-making authority, the DSC will 
provide an "incubator space" for trans-NIH initiatives, and support 
priority projects on a time-limited basis (generally 5 years and not 
to exceed 10 years). This will support continuous development of 
new, trans-NIH efforts adaptive to public health and scientific 
opportunities and issues through all available mechanisms, 
including individual investigator-initiated research grants as 
determined by scientific consultations. Support will come from 
pooled resources (the Common Fund). 
        The Division of Evaluation and Systematic Assessments 
(DESA) will plan, conduct, coordinate, and support program 
evaluations, including, but not limited to, Institute and Center-
specific program and project evaluations; evaluations of trans-NIH 
activities, including Roadmap initiatives; and systematic 
assessments, such as those required by the Government 
Performance and Results Act (GPRA) and the OMB Program 
Assessment Rating Tool (PART). The functions of DESA will 
allow for strategic planning and the coordination and evaluation of 
the NIH research agenda and portfolio and provide essential 
information for determining NIH-wide resource allocations.
        The Office will make use of a "Common Fund" for shared NIH 
needs. The Common Fund is an annual set-aside fund created from 
an agreed-upon percentage of the annual budgets of each of the 
NIH ICs to support activities/efforts identified by the Office. 
Office operations will not be funded out of the Common Fund. 
        Stakeholders, including the scientific and advocacy 
communities, will be invited to submit ideas for new initiatives on 
a regular basis. These nominations will be considered by the NIH 
leadership, external consultants, IC Directors, representatives of IC 
advisory councils, and other advisory councils. Once a new 
initiative is approved, it will be assigned to a lead IC for further 
development and administrative oversight. Funds from the 
Common Fund will be used to support the initiative. The progress 
of each initiative will be subject to rigorous review. There will be 
an annual review of progress and a major review at year 3-4 that 
will determine, not later than year 5, whether to renew the 
initiative for a final 5-year period, continue the research but 
transfer support to a more appropriate Institute or Center, or 
complete the initiative. No initiative will remain for more than 10 
years, thus insuring the long-term flexibility and vitality of this 
approach. 
        I remind the Committee that Title III of the Public Health 
Service Act authorizes the Secretary of Health and Human 
Services to use the Public Health Service to "encourage, cooperate 
with, and render assistance to other appropriate public authorities, 
scientific institutions, and scientists in the conduct of, and promote 
the coordination of, research, investigations, experiments, 
demonstrations, and studies relating to the causes, diagnosis, 
treatment, control, and prevention of physical and mental diseases 
and impairments of man . . . ." 
        Over the past 50 years, the achievements of NIH and our 
academic and industry partners in medical research are nothing 
short of remarkable. According to the latest report on the Nation's 
health from the Centers for Disease Control and Prevention (CDC), 
life expectancy continues to rise, now at an unprecedented 78 years 
for the total U.S. population. Since 1950, the age-adjusted death 
rate for the total population declined by a remarkable 43 percent. 
Life expectancy has increased by one year in every five for the past 
30 years. Americans are not only living longer, they are healthier. 
For instance, the disability rate of American seniors dropped by 
almost 30 percent in the past 20 years, owing to a range of 
scientific advances.
        In the past 30 years, death rates of two leading killers, 
cardiovascular disease and stroke, have declined by 63 percent and 
70 percent, respectively. Such medical breakthroughs as drug-
coated stents, therapies to achieve safe levels of blood pressure, 
and cholesterol lowering drugs have cut the expected number of 
deaths from heart attacks this year by more than half. In the past 
year alone, more than a million lives were saved. 
        For patients affected with AIDS, the development of highly 
active antiretroviral therapy (HAART), the result of work 
performed by a cadre of NIH-supported scientists and their 
counterparts in industry, has transformed AIDS into a manageable 
disease, preventing hundreds of thousands of hospitalizations and 
early deaths. The advances have had a particular impact on 
children. Today, fewer than 50 HIV-infected babies are born each 
year in the United States, sparing 16,000 to 20,000 infants from 
mother-to-child AIDS transmission. 
        This year, for the first time in history, the absolute number of 
cancer deaths in the U.S. has decreased. We now have ten million 
cancer survivors. We can detect and treat cancer at earlier stages. 
Targeted therapies have emerged, using specific molecular 
targeting to treat tumors with new agents. NIH's National Cancer 
Institute and others have identified biomarkers of cancer, 
foreshadowing an era when the disease can be predicted before 
symptoms appear, and treatment can be effectively targeted and 
personalized to the individual cancer patient. 
        For the first time in history, scientific progress allows us to 
hope for a revolutionary era when medicine will move from being 
curative and inherently costly in nature to become predictive, 
personalized, and preemptive.  Toward this goal, NIH is 
strategically investing in research to further our understanding of 
the fundamental causes of diseases at their earliest molecular 
stages so that we can reliably predict how and when a disease will 
develop and in whom.  Because we now know that individuals 
respond differently to environmental changes according to their 
genetic endowment and their own behavioral responses, we can 
envision the ability to precisely target treatment on a personalized 
basis.  Ultimately, this individualized approach, completely 
different than how we treat patients today, will allow us to preempt 
disease before it occurs with the hope of reducing future healthcare 
costs.  Our vision is simply to transform medicine and health 
through accelerated discoveries.
        This concludes my testimony. I will be pleased to respond to 
any questions Members of the Committee have.

        CHAIRMAN BARTON.  Thank you, Dr. Zerhouni.  I am going to 
recognize myself for the first 5-minute questioning period.
        As a Presidential appointee and the Director of the NIH, are 
you allowed to endorse specific bills?  
        DR. ZERHOUNI.  Unfortunately not. 
        CHAIRMAN BARTON.  Okay.  If you were allowed to endorse 
specific bills, what would your tendency be on this particular bill if 
you were allowed to do something like that?  
        DR. ZERHOUNI.  As I said, I think the bill addresses some 
issues that not only I, but many in our community have felt over 
the years, that NIH is an outstanding institution, that there is 
nothing broken.  The structures of NIH have served us well.  But 
science has evolved, and I think that rigid structures that stand in 
the way of better function are things you would want to reexamine, 
and I think your bill is doing that. 
        CHAIRMAN BARTON.  Okay.  Could you comment on the 
current system, or lack thereof, at NIH about coordinating across 
the institutes the different inventories and the different reporting 
systems and information systems with what is in the pending draft 
bill?  
        DR. ZERHOUNI.  Right.  This is an issue that the institute 
directors and myself have grappled with.  
And, actually, 2 years ago the institute directors and I realized 
that because of the complexity of NIH today, as compared to its 
complexity 10 or 15 years ago, it is really important to have 
modern information systems to be able to accountably understand 
what is being done among the different entities of NIH.  So having 
this common standard, a common way of reporting, of analyzing 
our research, we feel is something that the agency needs.  
In addition to that, I think it will simplify our interaction with 
the oversight functions of Congress and all of the other issues that 
you face in interacting with our agency and providing a very 
effective and common interface, if you will, between the agency 
and the stakeholders that will increase the transparency.  
So we are in favor of that, and the IOM also recommended that 
we do something about that.  
        CHAIRMAN BARTON.  One of the things that the NIH prides 
itself on, justifiably, is its peer review system.  Is there anything in 
the draft bill that compromises or weakens the peer review process 
currently in place at NIH?  
        DR. ZERHOUNI.  I am not aware of that.  And I would say no 
matter what we do, we need to preserve that system.  It has served 
us well.  
        CHAIRMAN BARTON.  With regard to the implementation of this 
Common Fund, do you believe that the peer review process will 
function compatibly with the Common Fund?  
        DR. ZERHOUNI.  Oh, absolutely.  I think there should be no 
exception to programs or initiatives at NIH that do not go through 
the filter of peer review both at the concept stage--before you even 
ask for people to apply or encourage people to apply, you need to 
have what I will call "transparent checks and balances," having 
enough advisory structures that are open to both members of the 
scientific community and the public--like a Council of Councils, 
multiple consultations.  So that is before you even start a program.  
        And then, when the program is launched, I think we need to 
absolutely have independent peer review for each one of them. 
        CHAIRMAN BARTON.  Mr. Waxman, in his questions to the first 
panel, was concerned that, under current law, the HHS Secretary 
and the Director had the ability to unilaterally make changes in the 
structure of NIH without congressional oversight.  Would you care 
to comment on your authority under current law, and the HHS 
Secretary's, and also whether the draft before us provides more 
public input and transparency to any institutional changes that 
might be considered?  
        DR. ZERHOUNI.  I am not familiar with the details of the current 
law, but it seems to me that the fundamental law is not changed.  In 
other words, the authorities exist already for creation of a center, 
removal of a center with the secretarial input.  This is part of the 
last reauthorization of the NIH, I believe, started in 1985 or at that 
time, I believe. 
        I think that what the new bill does, which is something that the 
Institute of Medicine has been recommending, is to create an 
explicit process.  Because even though it is in current law, NIH 
directors have been reluctant to use that.  Remember that almost 
every institute and center has been created through congressional 
action, not NIH action, except perhaps with the Human Genome 
Institute and a couple of the centers.  
        What my understanding is is that you are really creating a more 
transparent public process that will allow consideration on a 
regular basis of the structure of NIH, which hasn't really happened 
in the past because, as you well know, between last year and this 
year you have felt the pressures of constituent groups in terms of 
not losing structures, and we really need an independent, 
arm's-length process-- 
        CHAIRMAN BARTON.  The draft does freeze a number of 
institutes at what is currently authorized, which I think is currently 
27.  Is that a good idea or a bad idea?  
        DR. ZERHOUNI.  In my view, it is a good idea.  I don't think 
institutes that go from a $5 billion institute like National Cancer 
Institute to the Fogarty International of $67 million of budget with 
very important missions--I think there is a limit to the number of 
units you can create without losing efficiency. 
        CHAIRMAN BARTON.  And then my final question before I 
recognize Mr. Waxman.  Given your answer to that question--
which I agree with, by the way--we have right now before the 
committee five or six pending bills that are specialty bills for 
various disease-specific groups or organ groups, and they all have 
legitimate concerns.  I think they are sincere, and I think they 
address needs that need to be addressed.  How do we integrate 
these new concerns, new diseases or prioritize existing disease 
groups or organ groups that currently don't have their own institute 
within this framework?  
        DR. ZERHOUNI.  First, I would not go along with creating new 
formal authorized structures with their own administration and 
duplication essentially.  I think we need to find ways through the 
functional integration mechanism that we are talking about to 
make sure that the two issues that I often see are, one, a disease 
that is overlapping with multiple institutes where there is a sense 
that coordination and integration is not happening.  There are 
dozens of bills that contain language that instructs the NIH to have 
coordinating committees for this and coordinating committees for 
that.  That is very important.  It is a good mechanism.  I think it is 
better to do it functionally than to do it in a new structure. 
        CHAIRMAN BARTON.  Okay, thank you, Doctor. 
        Mr. Waxman.  
        MR. WAXMAN.  Thank you, Mr. Chairman.  
        Dr. Zerhouni, good to see you again. 
        Under this bill, NIH will have a sizeable Common Fund in the 
Office of the Director that supports trans-institute research.  Is it 
your understanding or intent that grants from the Common Fund 
would be made from the Office of the Director?  Would you 
operate like another institute?  Or would you expect the individual 
institutes to actually make the grants?  
        Also, I wonder if you would elaborate on how peer review 
would be carried out.  Does the Council on Councils actually do 
the peer review?  
        DR. ZERHOUNI.  Mr. Waxman, what I think is very important to 
go back to is that the Common Fund--no initiative in the Common 
Fund is supposed to be permanent, but every initiative will last 5 
years, at most 10 years.  The Common Fund is really an incubator 
for new ideas to support public health needs that are not addressed; 
and, therefore, the idea that the Office of the Director would grant 
grants is not a good idea, in my opinion.  
        I think what should be done is identify the areas where there 
are gaps in the portfolio.  The Council of Councils role is really to 
prioritize those.  Because even though you think it is a large fund, 
it is only 5 percent of the NIH budget, if it gets there, given our 
budgetary constraints; and, therefore, I think it is important to have 
the Council of Councils identify the priorities and suggest what 
programs should be funded.  But once that is decided, institutes 
that are most relevant to the area should really grant the programs 
and use the same peer review as they currently do. 
        MR. WAXMAN.  The Chairman's bill requires that every 2 years 
you submit reports describing the research activities at NIH to 
Congress.  Much of the report would be a simple listing or a 
category of the grants that are ongoing research conducted and 
supported by NIH.  
        However, the bill would also require that you compile 
extensive descriptive information regarding the studies.  For 
example, for research on specific diseases, you would be required 
to submit a statement of objectives regarding the research, the 
means for achieving the objectives, and a date by which the 
objectives are expected to be achieved and justifications for 
revisions for the plans.  
        I certainly see the value of having widespread access to this 
kind of information.  But I want to make sure that, in the way we 
are asking for it, we haven't given NIH an impossible or overly 
burdensome task.  Could you comment on that?  
        DR. ZERHOUNI.  The potential is there to create an overly 
onerous task if the current reporting structure is not also lightened 
enough for us.  
        I think what we are trying to do here is really to create an 
interface where the reporting will be more transparent and easier to 
get from the various parties that are interested in it.  But the issue 
that you have in reporting is often overlapped between, for 
example, pediatric cancer.  How do you account for this?  Is it a 
pediatric disease or a cancer investment?  And often this is a 
difficult situation to resolve. 
        However, I think that putting measures--metrics on research is 
unwise in my opinion in the sense of saying, you know, when is it 
that you are going to find a cure for cancer. 
        MR. WAXMAN.  So you would prefer a less burdensome 
process.
        DR. ZERHOUNI.  Yes. 
        MR. WAXMAN.  Under the bill, the Director is charged with 
approving all clinical Centers of Excellence recommended by the 
National Research Institutes, other than NCI.  Do you consider this 
to be a new authority, and how does this provision change how the 
Centers of Excellence operate today?  
        DR. ZERHOUNI.  That issue came up because of the 
proliferation of centers and the fact that it is very hard, once you 
have a center, to really move away from that even though the 
science may have moved.  
        I am concerned about centers because, as I have told you, 
investigator-initiated research is really important.  Centers really 
consume a significant amount of resources without necessarily 
serving all of the purposes that we would like them to serve at all 
times.  So institute directors and myself have been talking about 
how do we make sure that there is a second level of review when 
you are going to create Centers of Excellence, which by their 
nature almost never sunset. 
        MR. WAXMAN.  Is this a new authority, then, as you see it?  
        DR. ZERHOUNI.  I think it is not in the previous authorization, 
yes. 
        MR. WAXMAN.  As I understand it, 50 percent of any increases 
and appropriations over and above the preceding fiscal year would 
be required to go into the Common Fund, but it looks like the 
Director has the discretion to take these funds from any of the 
accounts at NIH.  Is that your understanding and would you favor 
some guidance on where the funds for the Common Fund should 
be taken from?  For example, if we said that the funds should be 
taken proportionally from a specified set of accounts?  Or would it 
be better and easier if the appropriator simply directly appropriated 
into the Common Fund account?  
        DR. ZERHOUNI.  I think the current design is a set-aside 
percentage from the budget of every institute so that there is, in 
fact, a shared Common Fund.  This isn't an extraneous fund that is 
directed without participation by all the institutes.  You really need 
that sense of coming around the table. 
        In terms of technical execution, what we find is because the 
Common Fund does not grant its own grants and that we--because 
we allocate that to service specific institutes for execution, we need 
the flexibility to moving the Common Fund to that institute 
whenever needed.  So I don't now have a preference one way or 
the other, as long as it doesn't lose that functionality. 
        MR. WAXMAN.  The existing law seems to give the Secretary 
and the Director the ability to abolish institutes, to change the 
structure right now, but that has never been used.  You indicated 
when Congress adopts a provision that there be an office, let's say, 
on women's health or other purposes that you have respected it or 
your predecessors have respected it and never invoked that 
authority.  This bill gives a very specific authority to make these 
changes without Congress approving them.  It sets out a process, 
but it isn't a recommendation to Congress.  It is advising Congress 
that this is going to be done unless Congress reverses it.  Is that 
what you intend because you want the authority you don't think 
you have?  
        DR. ZERHOUNI.  Well, first of all--
        MR. WAXMAN.  Or do you think you ought to have your 
recommendation first?  
        DR. ZERHOUNI.  Well, first of all, I think the authority that you 
are referring to is in current law; and the fact that it has not been 
used is because there hasn't been a defined process that is 
transparent where there are checks and balances or you have 
outside consultation to really evaluate what it is that is right at the 
time for science.  The IOM recommended that some process be 
implemented to do that. 
        MR. WAXMAN.  They also recommended that it be a 
recommendation to Congress from the NIH, not that NIH act 
unilaterally.
        DR. ZERHOUNI.  There are two levels of organization you need 
to consider.  One is, within an institute, it is important to leave the 
institute directors with the ability to change things within institutes, 
according to what their sense of mission is and what the strategic 
plan is.  I don't think that is an issue. 
        What you are referring to is creation or removal of institutes 
that are specially authorized.  I think it would be quite unusual for 
an NIH director to do that single-handedly.  I don't think that has 
been used in the past simply because these institutes have been 
created by Congress, in most cases. 
        So I think the key here is not to have more authority.  The key 
here is to have the discipline of looking at structure so that it 
doesn't become fossilized.  
        So whatever process is found--I mean, I don't have a hunger 
for that authority.  I just want the right thing to be done for NIH.  
        You will hear from previous directors and current members of 
the scientific community that there are institutes that are 
converging so much that perhaps different ways of integrating 
them might be a good idea.  Do I want this unilateral authority?  
No.  I don't think that is survivable, given the fact that over the 
past year any suggestion for change will be resisted, unless it is 
done through a process where there is consensus to be achieved.  
So my goal is not to create any new authority except those that are 
in law. 
        CHAIRMAN BARTON.  The gentleman's time has expired. 
        The gentleman from Georgia, Dr. Norwood.  
        MR. NORWOOD.  Thank you very much, Mr. Chairman. 
Dr. Zerhouni, I want to thank you for the job that you do.
        DR. ZERHOUNI.  Thank you. 
        MR. NORWOOD.  You are a very fortunate man.  You have a 
great job at a great institute, and the American people appreciate 
everything, I believe, that is happening over there. 
        This new bill seems to emphasize collaboration, which I think 
means when, in doing research, you might talk to your neighbor in 
another institute, if you are particularly working on the same thing, 
and it probably would be a good idea to share some of this 
together.  Is that what you see collaboration as being?  
        DR. ZERHOUNI.  Right.  I think that is the idea, especially 
because--and it is necessary to have a balance between autonomy, 
because then you don't have a one-size-fits-all and you have 
different ideas.  But it is also important to recognize the changes 
that are occurring in science and public health, and that is why I 
think pushing towards collaboration is a good direction. 
        MR. NORWOOD.  Well, the bill seems to imply that if institutes 
collaborate there is potentially additional funds from the general 
fund if you do that well. 
        Collaboration, it would seem to me, might mean more than just 
sharing money, but it also might seem to me to be sharing ideas 
and research efforts together.  Am I on the right track?  
        DR. ZERHOUNI.  You are absolutely on the right track.  That is 
the intent I think of the committee's language today where the 
division of portfolio analysis and strategic coordination is 
proposed.  I think that is the instrument that you need.  You need 
an intelligent function that looks across on a regular basis across 
all mission areas of the NIH.  That is point number one. 
        Point number two, as you know, institutes have their budgets; 
and, in the past, it was very hard--if you had an initiative, unless 
the institutes came together, it was very hard to commingle funds 
and go after that initiative together.  This will allow you to do that, 
for a small percentage of the NIH budget, not a large percentage.  
So that gives us more flexibility and gives us the ability to be 
responsive. 
        MR. NORWOOD.  Well, just to be clear for the record and for 
my own personal satisfaction, let's say, for example, that the 
Dental Institute is doing stem cell research on baby teeth, but down 
the hall another institute also is doing stem cell research, and these 
two institutes are talking to each other, working together, trying to 
help each other but are not necessarily sharing any funds to do that.  
Under this bill, would that be collaboration?  
        DR. ZERHOUNI.  No, this is actually something that happens 
now, where institutes may in fact work in areas of science and 
spend their own funds for their own scientists, and they coordinate 
without commingling funds.  
        What the Common Fund will do is will allow NIH to be 
responsive to new areas of science, things that are unproven, things 
that institutes on their own cannot do by themselves.  So it is really 
a Common Fund for shared needs, not just between two institutes.  
It is really for all of NIH. 
        MR. NORWOOD.  But it doesn't necessarily depend on getting 
into--that general fund doesn't necessarily depend on just sharing 
funds.
        DR. ZERHOUNI.  That is right. 
        MR. NORWOOD.  Quickly, because I need to get in another 
question, a lot has been said here today about health disparities.  I 
was an original sponsor of the legislation that created the National 
Center for Minority Health and Health Disparities at NIH, and I 
had the honor of managing that bill when we passed it on the floor.  
Would you agree that health disparities remain a major problem for 
our healthcare delivery system today?  
        DR. ZERHOUNI.  I agree. 
        MR. NORWOOD.  And would you agree that the National Center 
for Minority Health and Health Disparities plays an important role 
in addressing these problems?  
        DR. ZERHOUNI.  It does play an important role.  I just want to 
make sure, also, that we shouldn't let the other institutes think that 
because there is SCM they do not have the responsibility.  So it is 
the responsibility of the entire NIH. 
        MR. NORWOOD.  Understood.  
Finally, this bill gives you a lot of new authority and that, I 
trust, you will use wisely and responsibly, I am sort of--that is a 
given in my mind.  But would you state for the record that you will 
continue to work to eliminate health disparities by working with 
the Center and in fact with all of NIH?  
        DR. ZERHOUNI.  As you know, the Center has a special 
legislation that obligates us to do that, so we absolutely will.  First 
of all, without legislation we would do it; and in the current 
legislation we do it. 
        MR. NORWOOD.  Thank you very much, Doctor, Mr. Chairman. 
        CHAIRMAN BARTON.  Mr. Rush.  And Mr. Norwood, could you 
come Chair for a while?  
        MR. NORWOOD.  I can't.  I would love to, but I have got to see 
an all-powerful senator. 
        CHAIRMAN BARTON.  Mr. Shimkus, can you come Chair then?  
        Mr. Rush, you are recognized for 5 minutes. 
        MR. RUSH.  Thank you, Mr. Chairman. 
        Dr. Zerhouni, how do you think the committee print before us 
today addresses what you refer to in your budget to eliminate--to 
reduce and eliminate health disparities 2002 to 2006?  How does 
this current committee print--how does it help us to address this 
foremost issue in your own words?  
        DR. ZERHOUNI.  I am sorry, I missed the beginning of your 
question.  Are you referring to the bill?  
        MR. RUSH.  Yes.  How does the bill--the committee print that is 
before us, that will be before us tomorrow, how does it address the, 
quote, "foremost health challenge," which is disparities among 
minorities?  
        DR. ZERHOUNI.  I think it does not address it specifically, nor 
does it address specific health issues across NIH.  The purpose of 
this fund is to assemble scientists and public stakeholders on a 
regular basis to, in fact, make the case, if there is a strong case, to 
say we need more effort here or we are overlapping there, we are 
inefficient over there.  That is the purpose of this bill, is better 
coordination, better understanding of, in this case, health 
disparities.  What is the portfolio across NIH?  How can we 
enhance that?  Do we need to put in Common Fund resources there 
now?  Is it a priority, remembering that that is a small percentage 
of the total budget? 
        MR. RUSH.  The Center for Minority Health and Health 
Disparities, that Center operates as a one-stop--does this center 
have any kind of authority that will spread throughout NIH in 
terms of other disparate minority health initiatives?  Is this Center 
a clearinghouse, used as a clearinghouse?  
        DR. ZERHOUNI.  As you know, the Center has the responsibility 
of coming up with the NIH strategic plan for Minority and Health 
Disparities, so on a regular basis it convenes all the other institutes.  
So the authority to do that also accounts for--
        MR. RUSH.  What about enforcement?  Does it have any 
enforcement mechanisms?  
        DR. ZERHOUNI.  Through the reforming mechanism, it 
accounts, obviously, tracking for the strategic plan, stimulating the 
collaboration with the other institutes.  Each institute has in itself a 
responsibility for minority health and health disparities because I 
think you want every institute to be committed to it. 
        MR. RUSH.  Okay.  Does the Center on Minority Health and 
Health Disparities have any oversight authority over the private 
research universities and organizations?  Does it have any 
authority over them?  
        DR. ZERHOUNI.  I believe so.  Through any granting 
mechanism they have no authority, but they have, obviously, the 
relationship of a Federal agency through a private institution, yes. 
        MR. RUSH.  And do you have--have you had any instances 
where you have had to utilize that authority at all as it relates to 
private institutions, universities and colleges as it relates to their 
minority--health disparities as it relates to--
        DR. ZERHOUNI.  Right.  Well, as you know, the Center has 
special authorities to support Title 736 institutions and has done so 
in supporting what you would call seed infrastructure funding and 
supporting the endowment of these institutions, so there is a large 
program within, which is about a third of the budget, that supports 
specifically such institutions. 
        MR. RUSH.  So are you saying then that the Center can verify to 
this committee that all of the clinical trials conducted by these 
private entities, that they have no disparity issues related?  
        DR. ZERHOUNI.  Oh, that authority--okay.  I think you are 
asking me whether or not the health disparities--the Center has 
enforcement authority over compliance with health disparities 
recruitment.  For example, minority health--recruitment of 
minorities in trial, that I don't think exists as an authority of the 
Center.  
But across NIH we have policies related to fair representation 
across all trials, across all institutes for that, and we ask every 
institution and every clinical trial to report on a specific basis 
participation from minority and underserved populations.  But it is 
not a specific authority of the Center.  It is a general authority of 
the--it is the general requirement of the NIH. 
        MR. SHIMKUS. [Presiding.]  The gentleman's time is expired, 
and I will recognize myself for 5 minutes.  I just have two quick 
questions, Dr. Zerhouni. 
        As you know, back in 2002, I was a sponsor of legislation that 
codified the Office of Rare Diseases at NIH.  What plans does the 
NIH have to advance the study of rare diseases?  Which is a 
problem.  Because it is rare, the ability of the folks who would then 
get a return on the investment based upon medical research is a 
hard case to make.  So that is where we got involved and 
appreciate what has been done; and the concern is, in this 
reorganization restructuring, what is going to happen to the rare 
disease?  
        DR. ZERHOUNI.  The authorities of the office will not be 
changed at all.  I think these offices play an important role in 
understanding the specific issues that relate to their mission--in this 
case, rare diseases.  
        As you know, there are hundreds of rare diseases; and, 
therefore, their scope is quite large.  So we need to preserve, in 
fact, the ability of this office to continue to issue strategic plans, 
issue priorities, coordinate with other agencies as it has in the past.  
So our vision is that those should remain intact, authorities and 
visions should remain intact. 
        MR. SHIMKUS.  Thank you.  
        My final question is, we have had numerous hearings on NIH 
over the years, and sometimes as members of the full committee--
and, really, the subcommittee has a better handle on what you do 
and how you do it and where you do it.  Sometimes the public as a 
whole stirs things up, sometimes beneficially and things that we 
think are good.  So the question is, part of this reform as to how do 
we get better information out in the public domain so they really 
understand how you work, how you choose priorities, where the 
money goes to, where are the results--so how do you perceive us 
getting information out in the public domain which the public at 
large would have a better chance of understanding?  
        DR. ZERHOUNI.  I think transparency is very important.  I think 
we have tried to the greatest extent possible.  What we find is that 
sometimes it is difficult to classify what you are doing specifically 
for one disease, one purpose because, as I give the example 
pediatric cancer, is it pediatrics or is it cancer?  So we want to 
increase the transparency by creating a common language, a 
common standard and using technologies that we call knowledge 
management that will allow to look at the portfolio in many 
different ways. 
        What is really obvious is that to create transparency you need 
to facilitate access to the information and have a common standard 
across all institutes, and I think that is what this bill will do, in 
addition to the coordination function in the coming--the functional 
integration that we talked about. 
        MR. SHIMKUS.  Great.  That is all the questions I have, so I will 
yield back my time.  
        Now I would like to recognize my friend from Michigan, Mr. 
Stupak.  
        MR. STUPAK.  Thank you.  
        Dr. Zerhouni, as I mentioned in my opening statement, the 
Oversight and Investigation Subcommittee, we have been holding 
hearings on Dr. Trey Sunderland and Dr. Thomas Walsh and their 
misdealings as NIH scientists.  These scientists are still currently 
conducting research at NIH, despite their ethical and possibly 
illegal wrongdoings. 
        At last week's hearing, Dr. Kington claimed NIH did not have 
the authority to take disciplinary action against these two 
individuals because they were members of the Commissioned 
Corps.  I have since learned that, according to the Public Health 
Service Manual, PHS commissioned officers are subject to 
involuntary transfer or involuntary reassignment at any time to 
meet the needs of the organizational component; and in this case it 
would be NIH.  So, as I read this, it seems to me NIH can demand 
that these two employees be re-assigned, transferred.  So I am 
completely at a loss as to why NIH has not done that.
        DR. ZERHOUNI.  I am not aware of that specific authority to the 
NIH.  It might be an authority of the Public Health Service--
        MR. STUPAK.  Public Health Service, which says--I am 
quoting--Public Health Service commissioned officers are subject 
to involuntary transfer or involuntary reassignment at any time to 
meet the needs of the organizational component, end of quote.  
And organizational component in this case would be NIH, would it 
not?  
        DR. ZERHOUNI.  To serve the needs of the organizational 
component.  Because, as you know, the Public Health Service 
Corps is under the Surgeon General and the Assistant Secretary for 
Health.  I think in this particular case what is really important is we 
are not talking about a functional reassignment, this is a 
disciplinary process where we--
        MR. STUPAK.  What is the difference?  I mean, if you can re-
assign a person if they have serious ethical violations and possible 
criminal violations, why would you keep them at NIH doing 
research?  Why wouldn't you re-assign them and get them out of 
there?  Doesn't that send a bad signal to everybody else at NIH?  
        DR. ZERHOUNI.  First of all, I think that, in this particular case, 
I would like for the record--because I have heard some comments--
for the members of the committee to also take notice that every 
event that you are referring to occurred many years ago, several 
years ago; and the new rules that NIH has implemented in the 
ethics domain are the most stringent rules that have been created 
by any agency, including the total ban on interactions and conflict 
between our scientists and industry.  That is--I hope that is 
recognized as the degree of seriousness--
        MR. STUPAK.  That may be so, but it is hard for us to believe 
that when you still have these people working for you.
        DR. ZERHOUNI.  No, sir.  We have two people at NIH, and I 
think the due process for these two depends not on the NIH as you 
have heard but on the Public Health Service Corps.  And if the 
interpretation is different, I am absolutely more than happy to look 
at it. 
        MR. STUPAK.  Did they receive a $50,000 retention bonus from 
your agency?  
        DR. ZERHOUNI.  That I think is not a good decision.  I was not 
aware--
        MR. STUPAK.  Well, did they receive a $50,000 retention 
bonus?  I am sorry, $15,000?  
        DR. ZERHOUNI.  I am not sure of that, and I will--
        MR. STUPAK.  I will tell you what.  I will follow those up in 
writing. 
        Let me ask you this question:  At the last hearing we had on the 
NIH draft bill, I spoke about the importance of pediatric drug 
studies that NIH is tasked with doing, because the drug companies 
are not doing it.  It is important that these studies are done.  
Because, as you know, drugs are typically approved by the FDA 
for adults, and drugs are widely used in pediatric patients without 
any efficacy or safety information specific to the pediatric 
population.  In fact, only about 25 percent of the drugs in the U.S. 
today have been studied and labeled for pediatric patients.  
        Since 2003, NIH has been required to assemble a list of drugs 
for which pediatric studies are needed.  There are currently 51 
drugs on this list.  Only nine have efforts under way to begin 
designing or conducting these studies.  No drug has been removed 
from this list because of a completed study.  It shows that this 
program isn't working as well as Congress intended, so I would 
like to hear your views on it. 
        I would also like to point out that this program was created in 
response to efforts by myself and others to strengthen the authority 
of the FDA to require drug companies to do pediatric studies.  
Given the poor performance of this program, I think we need to 
revisit the authority of the FDA to require drug companies to do 
pediatric studies.  So what recommendations do you have on how 
we can best move forward with pediatric studies, and what 
enforcement do we have to make companies--we have 51 of them, 
only nine have been done, how do we get them to do these studies?  
What recommendation would have you for us?  
        DR. ZERHOUNI.  Well, first of all, I have to agree with your 
interest and concern about the fact that pediatric drugs need to be 
tested in pediatric patients.  We have spent approximately $25 
million in 2005, and the same in 2006, to test the drugs that were 
on the list that you mentioned, nine out of the 51.  These research 
protocols in children are much more difficult than they are to 
conduct in adults.  They need to be thoughtfully evaluated, and it 
takes more than 2 years to basically do a trial.  So I think that to 
say that the program is not responding is a little premature.  I think 
we need to really give it a little more time to see if these trials are 
providing that answer. 
        Now there is an issue that you may want to consider, and that is 
that off-patented and unpatented drugs are a different issue in 
terms of pediatric trials, and that could be a clarification that would 
be right helpful to the field.  The role of the foundation for NIH 
obviously, in terms of supporting these trials, that needs to also be, 
perhaps, enhanced and clarified in terms of how do you fund these 
trials.  These trials are very expensive.  Research in children is, by 
definition, much more difficult to do; and we need to just continue 
the effort.  But you have my agreement on this one in terms of 
finding better ways to test all these drugs as fast as we can. 
        MR. SHIMKUS.  The gentleman's time is expired. 
        MR. STUPAK.  Mr. Chairman, I think we are going to have 
further time to follow up with written questions?  
        MR. SHIMKUS.  Yes, if you hang around.  
        Just for point of clarification that staff counsel has advised me 
on is these retention bonuses were denied by the Public Health 
Service Corps Commission, so there was a process by which they 
didn't receive the bonus commissions.  
        So, with that, I would like to recognize Dr. Burgess for his 
round of questions.  
        MR. BURGESS.  Thank you, Mr. Chairman.  
        Dr. Zerhouni, good to see you again.  I apologize for not being 
here during the earlier part of the questioning, so if I ask things that 
have already been asked, I apologize, but it won't hurt to hear them 
again.  
        I will ask the question that Chairman Barton asked of the other 
panel, and since I wasn't here to hear your response, is this good 
legislation that we have before us?  
        DR. ZERHOUNI.  Well, as you know, as a member of the 
executive branch, I can't comment on legislation.  
        What I said was, during my opening statement, is the fact that 
finding better ways of performing collaborative science in a time 
when sciences converge and public health issues are really seen 
across categories of patients where patients themselves suffer from 
several diseases at once, better ways of integrating the function of 
a complex organization like NIH are welcome, and I think this bill 
is going in that direction, and we believe that this is the right 
direction to go to. 
        MR. BURGESS.  We heard some comments during the opening 
statements about the funding levels.  Can you elaborate a little bit 
on the funding levels as proposed in this authorization bill?  Do 
you see them as adequate for the NIH to be able to perform its 
mission?  
        DR. ZERHOUNI.  I don't know what the comments were.  Were 
they not enough or too much?  
        MR. BURGESS.  Well, on this side, it was too much; and, that 
side, it was not enough.
        DR. ZERHOUNI.  Well, you are putting me in a difficult 
position.  Because as the Director of an agency that sees the 
challenges ahead of us, with 6,600 diseases and conditions and 
new fields of research, I pointed out that this year NIH is going to 
receive twice as many applications for research from twice as 
many scientists almost, and each grant is more expensive by 30 or 
40 percent, so any help we can get is welcome. 
        MR. BURGESS.  Well, Dr. Miller, I think, in his statement 
alluded to the young and aggressive scientist--and I didn't realize 
that you don't come up with a Nobel-Prize-worthy thought after 
40.  That was a little intimidating when I heard that.  But, at any 
rate, he said it was important to capture these young scientists 
while their enthusiasm burned brightest.  Are you going to have the 
tools that you need with this authorization bill to do that?  
        DR. ZERHOUNI.  Yes, I think so.  It would be very helpful to 
have the ability to move funds towards areas of priority such as, 
for example, the development of the pipeline of talent that we need 
to maintain our competitiveness in the future.  And I think if Dr. 
Miller said that, I fully endorse that.  My main concern is new 
investigators, new ideas and making sure that we have the Nobel 
Prizes of the future in this country. 
        MR. BURGESS.  Yes, sir.  
        On the issue of the disparity issue that has been talked about at 
some length, I know when I visited Dr. Eschenbach at the National 
Cancer Institute, for example, he gave me a publication that the 
NCI has put out about making healthcare disparities disappear, 
which is part of the National Cancer Institute's mission.  I am 
assuming that the other institutes have similar work that they do on 
health care disparities as well, that that is an ongoing process and 
not purely consigned to the one institute that is involved with 
studying disparities.
        DR. ZERHOUNI.  Right.  Actually, every institute has a program 
and has a focus on health disparities across the entire portfolio, but 
the National Center for Minority Health and Health Disparities 
really keeps track of that and initiates the strategic plan which is 
reviewed and submitted to Congress.  
        So I think every institute is and should be concerned and 
committed to alleviate this issue, which is in the top five priorities 
of the NIH, from my standpoint. 
        MR. BURGESS.  How often are those reports issued?  
        DR. ZERHOUNI.  I believe the strategic plan and the report is a 
yearly progress report, and the strategic plan, if I am not--I don't 
know the details, but it should be renewed every 2 to 3 years. 
        MR. BURGESS.  Mr. Chairman, I don't know if it is possible 
that the committee staff could make that available to Members of 
Congress, but I think that would be very helpful. 
        Mr. Stupak's question about the--to which you replied that 
there was a total ban on outside influence with NIH researchers, 
which I appreciate as something that you thought was necessary at 
the time, but it also concerns me that, as we talk about these bright 
young researchers and wanting to have access to the best and the 
brightest, that having this total ban on outside activities is perhaps 
pernicious to recruiting the best and the brightest.  A system that 
would allow that but would have complete transparency so 
everything is reportable and above board and everyone knows 
about it would seem to be more satisfactory.  Is there any chance 
we can move to a system like that?  
        DR. ZERHOUNI.  Right.  I think you are referring to one of 
probably the most difficult decisions we have had ever had to 
make.  The issue was very simply, in my view, that it was very 
important to establish a system where you could oversee these 
activities, but, in the meantime, you really couldn't afford to have 
what we call outside activities.  These are the private activities of 
scientists with industry.  
        We do not want to stop the interaction when it is a positive 
interaction that helps the public good; and, really, how you draw 
the line is that we are encouraging official activities through the--
and without payment on the side.  Currently, we want our scientists 
to interact with industry.  
        However, I have the same concern you have; and that is that, 
over a long period of time, do you really impoverish the 
environment for the scientists at NIH?  I have to say this is one of 
the most difficult issues that we have to deal with.  So we put a 
study period of 1 year, and we are going to evaluate the impact this 
has on the quality of our science, our retention, recruitment and all 
of that.  As we do, as obviously we have shown before, we will 
evaluate the impact and perhaps look at different ways of 
implementing what I think you want, and that is an agency that you 
can trust, that the advice of which is unimpeachable. 
        MR. SHIMKUS.  The gentleman's time is expired. 
The Chair recognizes the gentleman from Pennsylvania, 
        Mr. Doyle.  
        MR. DOYLE.  Thank you. 
        Dr. Zerhouni, welcome, and thank you for being here today.  
        I want to start by commending your leadership in developing 
and implementing the NIH's public access policy, the first of its 
kind in any Federal agency.  Public access to taxpayer-funded 
research in my view is an extremely important tool that NIH can 
use to better manage its research portfolio while delivering all its 
benefits to the research community and the public. 
        When you unveiled NIH's policy in Access Policy in February 
of 2005, you said, and I quote, we are saying that scientists should 
release their findings as soon as possible for the benefit of the 
public.  After all, the public paid for them.  With less than 4 
percent of the original manuscripts being deposited in PubMed 
Central under the policy, it seems clear to me that this aspect of the 
policy isn't working as well as we all hoped it would.  
        I agree with the comments you made earlier this year, that the 
current policy's voluntary nature is not providing an adequate 
incentive for investigators to comply.  What specific actions can 
NIH take to increase the participation rate?  
        DR. ZERHOUNI.  Well, as you know, what I tried to do was to, 
initially, move the ball forward.  Because when I looked at that 
issue, nothing really happened.  So we need to really start 
somewhere.  
        And the two things we did was say, okay, let's start voluntary, 
since a lot of people said this is a good thing, and let's put an 
oversight mechanism to see that the policy addresses some of the 
concerns that were there before the policy was implemented, that it 
would be very costly, that we couldn't deliver the product, if you 
will, and so on.  So we needed to have a phase of evaluation in a 
dynamic process by which we could then readjust the policy. 
        As you said, the voluntary component, for whatever reason, is 
at 4 or 5 percent right now; and that is not enough.  From my 
standpoint, we need to have a full database of what is being 
produced through funding by NIH.  I need to be able to exploit that 
for portfolio management, for reporting to Congress was 
mentioned just a few seconds ago, and, third, I think, at a 
reasonable time, the public should have access to what it pays for.  
        Even though I recognize completely the important 
contributions of publishers and scientific societies to the peer 
review process, I believe it is very important not to damage that 
component.  So we need to find a sweet spot here; and I have 
asked our staff to, in fact, look at all aspects and all options of this 
policy as we speak--I am going to have meetings with them very 
soon--and to evaluate, in fact, what components of the policy need 
to be modified.
        MR. DOYLE.  I see that both the Public Access Working Group 
and the National Library Medicine Board of Regents have 
recommended that NIH revise the existing public access policy so 
that it is made mandatory and require articles to be submitted 
within 6 months of publication to a journal.  
        What is your take on that recommendation, and do you intend 
to implement any of these recommendations?  Or, if not, what 
revisions to these recommendations--
        DR. ZERHOUNI.  That is an excellent point.  Obviously, if you 
get a recommendation like that, you don't understand if it was 
unanimous or not.  It wasn't, and it was basically a divided 
recommendation, although the majority was obviously behind the 
recommendation that you just described, a mandatory 6 months. 
        I believe that we need to evaluate what the next steps are going 
to be in this policy by looking at both sides of the issue and try to 
find a sweet spot where we can, in fact, make sure that both 
mandatory incentives are there, if needed, or positive incentives 
are there, if needed, to achieve the goals that I initiated.  But I can 
say that I don't think we should do it at the expense of damaging 
scientific societies.  
        For example, one of the societies that strongly opposes the 
policy we have taken is the Federation of Experimental Biology 
Society, and I need to be sensitive to that.  So, obviously, it is like 
a jury.  If everybody was on the same page, I would have moved 
already.
        MR. DOYLE.  Sure.  And nobody wants to put the publishers--
this isn't about trying to impact them negatively.  
        You know, one of the charges we are getting from some of the 
associations and some of the publishers is there has been no 
hearings on NIH's public access policy.  As a final question, 
before you implemented the current policy, what steps did your 
agency take to listen to the scientific community, the publishers 
and the public?  
        DR. ZERHOUNI.  Sir, we had, if I recall, three meetings where 
we had stakeholders come, scientific community, publishers, 
societies, librarians, and heard about all of them.  Obviously, we 
also had a rulemaking process where we received public 
comments.  We had administration meetings within the 
Administration.  We had, obviously, input from Congress, both 
sides of--I mean, the Senate and the House, both sides of the aisle.  
All of that was occurring at the time.
        MR. DOYLE.  Thank you very much.  I look forward to working 
with you to make this policy even better.
        DR. ZERHOUNI.  Thank you. 
        MR. SHIMKUS.  The gentleman's time is expired. 
        The Chair wants to ask unanimous consent that those members 
wishing to submit questions to return in writing will have the 
appropriate amount of days in which to do that.  Is there objection?  
Hearing none, so ordered. 
        The Chair recognizes the gentleman from Michigan, Mr. 
Rogers. 
        MR. ROGERS.  Doctor, thank you for your patience today and 
for being here in front of the committee and committing so much 
time.  
        You and I have had discussions not only here but outside of the 
committee on pain care and pain care management.  I want to 
applaud you.  I think you have taken--we have come a long way 
since I got here in 2001 in our discussions on pain care and how 
we treat it both in research and development and education and 
access. In this bill, there is a requirement that a summary of the 
research activities throughout the agencies include pain care and 
palliative care.  Give me your opinion.  Where do you think that 
takes NIH and where that allows us to go when we talk about pain 
care management in the United States?  
        DR. ZERHOUNI.  As you know, my feeling is that this is a very 
critical issue not just in the delivery of healthcare, but it is also a 
critical research issue that needs to be worked out across all 
institutes and across all diseases, as you well know; and I think the 
consortium on pain is doing a great job under the leadership of Dr. 
Tabac, and the funding shows it.  Even though the budget has been 
pretty much flat over the past 3 years, since the end of the doubling 
in 2006, funding for pain research went up almost by 20 percent.  
So there is a realization that this needs to be done. 
Integrating pain and pain issues in every disease is an 
important goal, so I am in favor of having that being a permanent 
component of reporting, if I understand your question. 
        MR. ROGERS.  Yes, when we got here, it was less than 1 
percent of NIH budget was dedicated to pain.  And when you look 
at how that cross-sections every disease--cancer, AIDS, arthritis, 
you name it--it is a component of what brings that patient to that 
physician or that care provider.  
        We still to this day, even though funding has gone up, have 
very little understanding--and I agree with you, on the research--in 
education even when it comes on behalf of physicians.  And one of 
the things that concerns me today is now it has become a little 
more chic, pain care management.  There are shingles going up all 
across America, and there is not a very good understanding, I don't 
believe, because there is no coordinated way to find out what is the 
best practice in pain care management for ailment A or B or C.  
What we are finding is these doctors have set up their own 
networks trying to understand it, doing their own networking 
across the country, probably not the best practice for something we 
know impacts so many Americans and so many Americans to the 
point that it has really taken away their quality of life almost 
completely.  So I am very eager to see this pass and very eager to 
continue to work with you.  
        You know, I always say it is lend me your ear and we can solve 
the pain problem, education, access and research.  I think we are 
still behind.  I am not as convinced as you are on the consortium's 
ability to impact it.  I do believe we need to heighten that 
awareness and continue that cross-section for research, and I look 
forward to working with you.  Especially when this comes out and 
you have highlighted, I think this is going to be important for us 
all, I think.  And I hope you are watching all those shingles going 
up around the country.
        DR. ZERHOUNI.  Right.  Exactly.  And it is quite a process that 
is ongoing right now.  So that is why I think we have an interest in 
making sure that that is represented in our analysis.  This is one of 
the reasons why I think the legislation proposing a division of 
portfolio analysis and strategic initiatives is important.  Because 
then you have an explicit, non-special-interest-driven process that 
allows you to address questions like what you are referring to. 
        MR. ROGERS.  Doctor, thank you very much.
        DR. ZERHOUNI.  Thank you very much. 
        MR. ROGERS.  I yield back. 
        MR. SHIMKUS.  The gentleman yields back his time.  
        I want to thank you, Dr. Zerhouni. 
        I want to make an announcement.  The markup of this bill will 
be tomorrow at 10 a.m.  It will be followed by an assortment of 
other bills.  Members should be prepared to be here late tomorrow 
night.  
        I want to thank you for your time.  I think everybody is really 
excited about moving forward.  
        With that, I am going to adjourn this hearing.  
        [Whereupon, at 4:58 p.m., the committee was adjourned.]
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