<DOC>
[109th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:25704.wais]


 
                     IMPROVING AMERICA'S HEALTH:  
                     EXAMINING FEDERAL RESEARCH 
                        EFFORTS FOR PULMONARY 
                    HYPERTENSION AND CHRONIC PAIN
______________________________________________________________________


                                HEARING

                              BEFORE THE

                        SUBCOMMITTEE ON HEALTH

                                OF THE 

                       COMMITTEE ON ENERGY AND 

                               COMMERCE

                       HOUSE OF REPRESENTATIVES


                     ONE HUNDRED NINTH CONGRESS

                               FIRST SESSION
                                 _________

                              DECEMBER 8, 2005
                                 _________

                             Serial No. 109-43
                                 _________

Printed for the use of the Committee on Energy and Commerce









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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
STEVE BUYER, Indiana                       DIANA DEGETTE, Colorado
GEORGE RADANOVICH, California              LOIS CAPPS, California
CHARLES F. BASS, New Hampshire             MIKE DOYLE, Pennsylvania
JOSEPH R. PITTS, Pennsylvania              TOM ALLEN, Maine
MARY BONO, California                      JIM DAVIS, Florida
GREG WALDEN, Oregon                        JAN SCHAKOWSKY, Illinois
LEE TERRY, Nebraska                        HILDA L. SOLIS, California
MIKE FERGUSON, New Jersey                  CHARLES A. GONZALEZ, Texas
MIKE ROGERS, Michigan                      JAY INSLEE, Washington
C.L. "BUTCH" OTTER, Idaho                  TAMMY BALDWIN, Wisconsin
SUE MYRICK, North Carolina                 MIKE ROSS, Arkansas
JOHN SULLIVAN, Oklahoma
TIM MURPHY, Pennsylvania
MICHAEL C. BURGESS, Texas
MARSHA BLACKBURN, Tennessee
GRESHAM BARRETT, South Carolina


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

                              ________

                     SUBCOMMITTEE ON HEALTH
                 NATHAN DEAL, Georgia, Chairman
RALPH M. HALL, Texas                       SHERROD BROWN, Ohio
MICHAEL BILIRAKIS, Florida                    Ranking Member
FRED UPTON, Michigan                       HENRY A. WAXMAN, California
PAUL E. GILLMOR, Ohio                      EDOLPHUS TOWNS, New York
CHARLIE NORWOOD, Georgia                   FRANK PALLONE, JR., New Jersey
BARBARA CUBIN, Wyoming                     BART GORDON, Tennessee
JOHN SHIMKUS, Illinois                     BOBBY L. RUSH, Illinois
JOHN B. SHADEGG, Arizona                   ANNA G. ESHOO, California
CHARLES W. "CHIP" PICKERING,  Mississippi  GENE GREEN, Texas
STEVE BUYER, Indiana                       TED STRICKLAND, Ohio
JOSEPH R. PITTS, Pennsylvania              DIANA DEGETTE, Colorado
MARY BONO, California                      LOIS CAPPS, California
MIKE FERGUSON, New Jersey                  TOM ALLEN, Maine
MIKE ROGERS, Michigan                      JIM DAVIS, Florida
SUE MYRICK, North Carolina                 TAMMY BALDWIN, Wisconsin
MICHAEL C. BURGESS, Texas                  JOHN D. DINGELL, Michigan
JOE BARTON, Texas                             (EX OFFICIO)
  (EX OFFICIO)   










                                CONTENTS
                                 ________

                                                                Page

Testimony of:

Saper, Joel, Founder and Director, Michigan Head Pain 
                     and Neurological Institute.............     18
Pruden, John, Captain, United States Army...................     22
Vander Zanden, Jake, Vice President and General Manager, 
Medtronic Global Pain Management............................     27
Gladwin, Mark, Chief, Vascular Medicine Branch, National Heart, 
Lung, and Blood Institute, National Institutes of Health....     36
Hicks, Carl, Vice President, Advocacy, Pulmonary Hypertension 
  Association 	                                                 42
Tilleman-Dick, Charity Sunshine.............................     49
Additional material submitted for the record:
   Gladwin, Mark, Chief, Vascular Medicine Branch, National 
    Heart, Lung, and Blood Institute, National Institutes of 
    Health, response for the record.........................     72
Saper, Joel, Founder and Director, Michigan Head Pain and 
 Neurological Institute, response for the record............     75
Stanley, Karen, President, Oncology Nursing Society, letter 
  dated December 8, 2005 to Hon. Nathan Deal................     79








                                     (II)









                     IMPROVING AMERICA'S HEALTH:  
                      EXAMINING FEDERAL RESEARCH 
                        EFFORTS FOR PULMONARY 
                    HYPERTENSION AND CHRONIC PAIN


                       THURSDAY, DECEMBER 8, 2005

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

  The subcommittee met, pursuant to notice, at 10:08 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. Nathan Deal 
[chairman] presiding.
  Members present:  Representatives Bilirakis, Shimkus, Pitts, 
Ferguson, Rogers, Myrick, Burgess, Pallone, Green, Capps, Deal, Lantos, 
and Brady.
  Staff present:  Jeanne Haggerty, Professional Staff Member; 
Brandon Clark, Policy Coordinator; Chad Grant, Legislative Clerk; John 
Ford, Minority Counsel; Jessica McNiece, Minority Research Assistant; 
and Alec Gerlach, Minority Staff Assistant.
  MR. DEAL.  The chair recognizes himself for an opening 
statement.
  I want to, first of all, welcome all of our witnesses here 
today.  And for those who are in attendance to this hearing, thank you 
for your presence as well.
  I think this is a significant hearing.  We have a panel of 
expert witnesses appearing before us, some of whom are the victims of 
the diseases that we are going to be talking about, and others who are 
 certainly experts in their own right with regard to seeking relief and 
cures for those diseases.  We are also going to examine what the 
National Institutes of Health has to say in their studies and in their 
actions to try to improve conditions and improve patient outcomes in 
these two areas.
  We look forward to hearing their testimony, and we are grateful 
to all of you for your participation in today's hearing.
  As our witnesses will attest, I am sure, if given the choice 
no one would choose to live with either chronic pain or pulmonary 
 hypertension, which are the two subjects that we are looking at today.
  I believe that these two conditions highlight the need for further 
 advancement in scientific research at agencies like the National 
Institutes of Health.  That is why I have joined with Chairman Barton, 
the Chairman of our full committee, in developing legislation that will 
help eliminate inefficiencies in the organizational structure of the NIH 
in order to help increase research investments and outcomes.
  I believe that is why we must realign budget items, create a new 
and more transparent reporting system, and expand the authority of the 
NIH Director to manage the research portfolio of this very important 
agency.  I believe that by improving the outcomes in scientific 
recovery, we can vastly improve the lives of people like two of our 
witnesses today, Charity and Captain Pruden.
And I will introduce our witness panel in just a few minutes after the 
 conclusion of other opening statements, but at this time, I would like 
to ask of the committee unanimous consent that two of our members who 
are not members of this subcommittee or our full committee be allowed 
to join us here on the dais and to make brief opening statements at the 
 conclusion of the opening statements of other members of this 
subcommittee, and that would be our good friends, the Honorable Tom 
Lantos, and our other good friend, the Honorable Kevin Brady.  Without 
 objection, it is so ordered.  You gentlemen may come to the front.
  [The prepared statement of Hon. Nathan Deal follows:]

PREPARED STATEMENT OF THE HON. NATHAN DEAL, CHAIRMAN, SUBCOMMITTEE ON 
HEALTH

The Committee will come to order, and the Chair recognizes himself for 
an opening statement.
We have an expert panel of witnesses appearing before us today that will 
help us better understand chronic pain and pulmonary hypertension and 
examine what the National Institutes of Health and others are doing to 
study these conditions and improve patient outcomes.  We look forward 
to hearing your testimony, and we are grateful for your participation 
in today's hearing.
Today's panel includes the following six experts:  Dr. Joel Saper, 
Founder and Director of the Michigan Head Pain and Neurological 
Institute; Captain John Pruden, United States Army; Mr. Jake Vander 
Zanden, Vice President and General Manager of Medtronic Global Pain 
 Management; Dr. Mark Gladwin, Chief of the Vascular Medicine Branch of 
the National Heart Lung and Blood Institute of the National Institutes 
of Health; Carl Hicks, Vice President of Advocacy for the Pulmonary 
 Hypertension Association; and, Ms. Charity Sunshine Tillemann-Dick, 
 accomplished vocal performer, advocate for those who share her 
experience of living with pulmonary hypertension, and granddaughter of 
the  Honorable Tom Lantos of California.  
As our witnesses will attest, if given the choice, no one would choose 
to live with chronic pain or pulmonary hypertension, and I believe that 
these two conditions highlight the need for further advancement in 
scientific research at agencies like the National Institutes of Health. 
That is why I have joined with Chairman Barton in developing legislation 
that will help eliminate inefficiencies in the organizational structure 
of the NIH in order to help increase research investments and outcomes.
 I believe that is why we must realign budget items, create a new, more 
 transparent reporting system, and expand the authority of the NIH 
Director to manage the research portfolio of this very important agency. 
I believe that by improving the outcomes of scientific discovery we can 
vastly improve the lives of people like Charity and Captain Pruden.
Again, I welcome our witnesses and thank them for their participation.  
I now recognize my friend from Ohio, Mr. Brown, for five minutes for his
 opening statement.

MR. DEAL.  I will now recognize my colleague for the purpose of his 
opening statement, Mr. Pallone.
  MR. PALLONE.  Thank you, Mr. Chairman.
  I would ask unanimous consent to include in the record a statement of 
our Ranking Member, Congressman Sherrod Brown.
MR. DEAL.  Without objection.
[The prepared statement of Hon. Sherrod Brown follows:]

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

Thank you Mr. Chairman and thank you to the witnesses for joining us 
today. 
  We are here today to discuss ways to improve research and care for 
very two serious health issues: pain care and pulmonary hypertension. 
No one wants to see a family member in pain, or to experience it 
themselves. Yet we tend not to conceptualize pain as a health 
phenomenon on its own. It's always a symptom of something else. 
Unfortunately, for the 75 million Americans suffering from acute or 
chronic pain each year, this is not just a secondary condition. Pain 
is something that they live with day in and day out; something that 
can truly shape their physical, mental and social well-being. 
Not only is this a burden on the individual and their family, but it 
leads to lost productivity in the workforce, with billions of work 
days, and therefore dollars, lost. 
There's no one-size-fits-treatment here since everyone experiences 
pain differently. And unfortunately, our knowledge of appropriate 
pain management is seriously underdeveloped. 
We need to raise awareness about the importance of treating pain and 
providing palliative care, and we need to invest in better understanding 
its dimensions and finding appropriate diagnostic tools and treatments. 
The National Pain Care Policy Act of 2005 would recognize improving 
pain and palliative care as a national priority. The Act would assemble 
a White House conference on the issue, create a specialized center 
within the National Institutes of Health, support a national awareness
 campaign to educate providers and consumers about the availability of 
pain treatment options and patients' rights, as well as ensure that 
our military personnel and veterans receive prompt and adequate pain 
care. 
We are also here to talk about pulmonary hypertension, a serious health 
care disorder afflicting an estimated one hundred thousand Americans, 
 predominantly women. Pulmonary hypertension results from a dangerous 
increase in blood pressure in the lungs. Depending on the severity, 
this can ultimately lead to heart failure and death. 
Unfortunately, because the most common signs and symptoms-including 
fatigue and shortness of breath-are associated with a number of 
conditions, pulmonary hypertension is often misdiagnosed. By the time 
patients receive an accurate diagnosis, it may be too late for them to 
receive the transplants that could save their lives. 
The Pulmonary Hypertension Research Act would establish a series of 
pulmonary hypertension centers focused on research, diagnosis and 
treatment of this serious ailment. As part of this initiative, training 
 programs would be established for health care professionals to 
promote earlier diagnosis and thereby make a real step to improve 
patient outcomes. 
The bill will also create an information clearinghouse for providers 
and the public to facilitate greater knowledge and understanding of 
the disease. 
These are important health care issues and they are very deserving of 
our focus this morning. I commend the chairman for bringing these 
pieces of legislation to the Committee's attention and I look forward 
to hearing from our witnesses. 
Thank you, Mr. Chairman.

	MR. PALLONE.  Mr. Chairman, today, thanks to the benefits of 
 government-funded research, we incredibly increased our knowledge 
about a number of diseases, including HIV-AIDS, Alzheimer's, 
osteoporosis, heart disease, and other chronic and debilitating 
diseases, and these advancements have enabled us to better prevent, 
treat, and cure many ailments that were once thought to be incurable.
	Over the past 100 years, government-funded research has led to 
a number of scientific and medical advances.  The development of 
vaccines and the use and the common practice of medicine has helped 
reduce the incidents and in some cases stamp out diseases such as small 
pox, hepatitis B virus, measles, and polio.  New treatments have been
 developed to treat cancer, heart disease, and mental illness.  
Additionally, we have been able to improve the quality of life in 
millions of Americans inflicted with these chronic and often painful 
 conditions.
	Yet there is so much more work to be done.  Today's hearing 
focuses on Federal research activities, or more importantly, the lack 
thereof, on two specific conditions: chronic pain management, and 
pulmonary hypertension.  Mr. Chairman, pulmonary hypertension is a 
serious disease where blood pressure in the lungs rises to dangerously 
high levels.  Over time, the increased pressure damages both the large 
and small pulmonary arteries in the lungs and can result in heart 
failure.  Many people who suffer from PH are diagnosed only after the 
disease has entered advanced stages, far too late to provide for any 
effective treatment or care.
	While researchers have made strides at understanding how this 
rare disease functions and impacts people, we still don't know enough.
  Additional medical research is clearly needed.  Here, not enough 
information exists about chronic pain.  Just like pulmonary hypertension,
 until recently, it has received relatively scant attention from 
medical researchers.  But here is what we do know.  Chronic pain 
disables more people in America than cancer or heart disease.  It costs 
the U.S. economy more than $90 billion per year in medical costs, 
disability payments, and productivity, as well as the emotional toll 
this condition takes on patients and their loved ones.  Yet there is
 relatively little research done on this condition.
	I would like to commend my colleagues who have helped to raise 
the awareness about these conditions by introducing legislation. 
 Representative Mike Rogers, a Republican from Michigan, has offered
 legislation regarding chronic pain that would declare adequate pain 
research education and treatment as national public health priorities. 
Also, Representative Kevin Brady of Texas and Tom Lantos of California
 have introduced H.R. 3005, the Pulmonary Hypertension Research Act of 
2005, of which I am a co-sponsor.  This bill would provide for much-
needed research and help raise awareness about pulmonary hypertension.
	I would also like to commend our panel of witnesses for the 
work that they are doing to help raise awareness about these conditions. 
I understand that Congressman Lantos' granddaughter is with us today as 
a witness.  I would like to welcome her to the committee, as well as 
all of our other witnesses, and we look forward to hearing your 
testimony.
	I thank you again for calling today's hearing, Mr. Chairman.  I 
think that we can all agree that much of the medical and scientific 
advances we have made over the past century would not have been possible 
if it were not for the government support.  But again, significant 
challenges remain that will require continued Federal commitment.  
Research into pulmonary hypertension and chronic pain are just the tip 
of the iceberg.  Our Nation is faced with a number of health-related 
problems that will require substantial investment in medical research, 
 including an aging population who undoubtedly continue to suffer from 
age-related diseases, traditional killers like HIV-AIDS and cancer, as 
well as new and emerging threats like avian influenza and other 
infectious diseases.
	While I know that most of us here today agree that the 
commitment to Federal research must continue, advances in medical 
research may suffer because our Nation is currently overextended.  
Increasing amounts of money for the war in Iraq combined with tax cuts 
to the wealthy have significantly drained the Treasury, as indicated 
by the large Federal deficits we have been running.  As a result, 
domestic priorities have suffered.  If we are going to be serious 
about continuing the progress we have made in the past 100 years, then 
we need to put our money where our mouth is.  It is not fair to continue 
to make empty promises to those who depend on government-funded research 
for the cures and treatments they so desperately need.
	I yield back, Mr. Chairman.
	MR. DEAL.  I thank the gentleman.
	I recognize our distinguished colleague, Mr. Bilirakis, for an 
opening statement.
	MR. BILIRAKIS.  Thank you, Mr. Chairman.  And I, too, thank you 
for calling this hearing.
	As former chairman of this subcommittee, I understand the 
competing demands, Mr. Chairman, with which you are faced and appreciate 
your willingness to devote time to these important issues.
	The two topics which are the focus of this hearing are lesser
 known but nonetheless debilitating conditions, which effect millions of
 Americans each year and carry with them enormous personal and economic 
costs.
	I first became aware of pulmonary hypertension when our 
colleague from California, Congressman Lantos, approached me several 
months ago and told me that his granddaughter, who we will hear from 
shortly, is suffering from this disease, which primarily affects young 
women.  Tens of thousands of Americans share compelling stories like
 hers.  They are all looking to us to help them beat this cruel disease.
	This disease, which, as I understand it, is a blood vessel 
disorder in the lungs, which causes the pressure in the heart's 
pulmonary artery to rise, is very often life-threatening and can 
significantly shorten the life expectancy of those who have it.  It is 
often misdiagnosed because its early symptoms are consistent with many 
other common conditions.  The delayed diagnosis of pulmonary 
hypertension means fewer and more severe options for those it afflicts, 
which makes research into its prevention and treatment particularly, 
Mr. Chairman, important.
	I share with nearly 250 of our colleagues in co-sponsoring H.R. 
3005, the Pulmonary Hypertension Research Act.  It is bipartisan 
legislation to expand, intensify, and coordinate Federal research 
efforts in pulmonary hypertension.  I believe it is critically important 
to ensure that Federal research efforts in this area are as protected 
as possible to best help those suffering from this disease and support 
those seeking its cure.
	I also am pleased that we are exploring the issue of chronic 
pain and pain management research.  While there are no definitive 
statistics of how many Americans suffer from chronic pain and to what 
extent it impacts our society, there is little doubt that chronic pain 
is a serious public health problem that deserves our attention.  I met 
last year with comedian and entertainer Jerry Lewis, who told me he 
had suffered from chronic pain for more than 30 years before receiving
 neurostimulation, which we will hear about later.  He recounted how
 he had tried pain medications, physical therapy, and other traditional 
and non-traditional treatments to alleviate his hip and back pain.  He 
described the sense of despair and hopelessness that chronic pain 
sufferers live with each day of their lives.  We let it up to those 
who live with this type of pain to encourage Federal efforts in this 
area, and I also commend our colleague from Michigan, Mr. Rogers, for
 introducing legislation that seeks to raise public awareness about 
chronic pain and establish a national pain care policy.
	Mr. Chairman, along with you and others, I look forward to 
hearing the testimony of today's witnesses and working with each other, 
the members of this committee, in a bipartisan basis, underlining 
bipartisan, to maximize Federal research efforts for pulmonary 
hypertension and chronic pain.
	And again, I thank you, Mr. Chairman.
	MR. DEAL.  I thank the gentleman.
	I am pleased to recognize our colleague, Ms. Capps, for an 
opening statement.
	MS. CAPPS.  Thank you, Mr. Chairman, for calling together 
this important hearing.  I am going to waive my opening statement, but 
I do want to welcome each of our witnesses coming to testify today, 
and would hope that this committee take appropriate action commensurate 
with the expertise that we are about to hear.
	I yield back.
	MR. DEAL.  I thank the lady.
	Dr. Burgess is recognized for an opening statement.
	MR. BURGESS.  Thank you, Mr. Chairman.
	And in the interest of time, I wanted to hear from our panel.  
I will waive my opening statement as well.
	MR. DEAL.  I thank the gentleman.
	Mr. Green is recognized for an opening statement.
	MR. GREEN.  Thank you, Mr. Chairman.
	And I would like to welcome my good friend and colleague, Kevin 
Brady, to our Energy and Commerce hearing, and also Tom Lantos, who is a
 good friend, and of course, his granddaughter and Tom's wife are here.
	Mr. Chairman, I waive my opening statement, but I appreciate you
 calling this hearing on the issue of chronic pain management and also 
on the issue of pulmonary hypertension.
	Thank you.
	MR. DEAL.  Thank you.
	I recognize Mr. Ferguson for an opening statement.
	MR. FERGUSON.  Thank you, Mr. Chairman.
	I will also submit my statement for the record, but I do want 
to welcome our panelists.  I certainly welcome Mr. Lantos' granddaughter, 
and I welcome Mr. Lantos and Mr. Brady to join us for this important 
hearing today.
	Thank you.
	[The prepared statement of Hon. Mike Ferguson follows:]


PREPARED STATEMENT OF THE HON. MIKE FERGUSON, A REPRESENTATIVE IN 
CONGRESS FROM THE STATE OF NEW JERSEY

	Mr. Chairman, thank you for holding this important hearing that 
will delve into two afflictions that are a cause of concern for many 
people in our country.
	It is important that we have hearings like this to shine light 
on the problems of people who suffer from these ailments.  
	More importantly, we will discuss solutions and what we can do 
to initiate action and find cures.  
	Today, we are concentrating on those who suffer from chronic 
pain and people who have pulmonary hypertension.
	Chronic pain is pain that persists and is different than the 
normal pain reaction that is experienced with an injury.  Chronic pain
 sometimes continues for days, weeks and months.
	Cancer pain is form of chronic pain - so is arthritis.  Back 
or neck injury can cause chronic pain - or some even suffer chronic 
pain without an injury or evidence of body damage.  
	There are ways to treat chronic pain - including medication, 
	acupuncture, local electrical stimulation and brain stimulation - 
	and even surgery.  
	But it is important that more is done to make sure that people 
receive the treatment they need to help cope with chronic pain.  
	Pulmonary hypertension is an illness that leads to high blood 
pressure in the arteries that supply the lungs.  The blood vessels 
that supply the lungs constrict and thicken, making it harder to 
supply the lungs with needed blood.  
	It is a serious illness, and treatment is available.  I look 
forward to hearing from the witnesses, including Congressman Lantos' 
 granddaughter to tell us about the problem and how we can help.
	Thank you again, Mr. Chairman, for having this hearing on these
 diseases that affect so many people.  I look forward to hearing from 
our panelists.  I yield back my time.

	MR. DEAL.  I thank the gentleman.
	I recognize Mr. Rogers, who is one of the leaders in the issue 
of chronic pain, and I recognize him for his opening statement.
	MR. ROGERS.  Thank you, Mr. Chairman.
	I will make an opening statement.
	I do want to thank you from the bottom of my heart for bringing 
this forward.  We worked with Mr. Bilirakis last year, and he has done 
a great amount to help bring attention to this issue.  Your effort to 
not only talk about it in the NIH hearings but this hearing alone, I 
think, sends a pretty clear message that we finally have gotten pain 
care and chronic pain relief on the radar screen.  Millions of Americans 
thank you for that, Mr. Chairman.
	And I also want to welcome Dr. Joel Saper, a friend who I have 
known in this endeavor for almost 10 years, I think, who has brought a 
lot of relief to a lot of suffering people and has given them hope. So,
 Doctor, thank you for your efforts.  Thanks for being here today.  I 
 certainly appreciate it.
	And with that, Mr. Chairman, I will yield back.
	MR. DEAL.  I thank the gentleman.
	Ms. Myrick, you are recognized for an opening statement.
	MS. MYRICK.  Well, I just welcome everybody.
	Thank you.
	MR. DEAL.  Thank you.
	Mr. Lantos, we are pleased to have you with us today, and we 
will recognize you for an opening statement.
	MR. LANTOS.  Thank you very much, Mr. Chairman.
	I want to express my deepest appreciation to you and to members 
of the committee for holding this hearing.  In the quarter-century I 
have served in this body, this is the most important hearing from my 
personal point of view, and I am profoundly appreciative of your 
cooperation.
	I am immensely proud that my granddaughter, Charity, has 
courageously decided to share her story with us today.
	As you will hear, Mr. Chairman, pulmonary hypertension is an 
illness that has had a devastating impact on tens of thousands of 
American families, including our own.  I want to thank the Pulmonary 
 Hypertension Association and their Vice President for Advocacy, my 
good friend Colonel Carl Hicks, for his presentation.  Their advocacy 
on behalf of the pulmonary hypertension community is making a 
tremendous difference in the lives of thousands of people.
	Mr. Chairman, pulmonary hypertension has historically been a 
fatal diagnosis for patients.  This is no longer true.  I am so 
delighted to report to you that we are turning the corner in the fight 
against this condition.  With the discovery of the first gene 
associated with PH in 2000, the development of a range of new treatment
 options, and the growing awareness of this disease, there is 
tremendous hope for the future.  According to the scientific experts I 
have spoken with, we are at a turning point in our understanding of 
this condition.  The opportunities for major progress are truly 
remarkable.
	In an effort to capitalize on these opportunities, my dear 
friend, Congressman Kevin Brady, and I have introduced H.R. 3005, the
 Pulmonary Hypertension Research Act.  This important legislation will 
expand pulmonary hypertension research activities at the National Heart, 
Lung, and Blood Institute of the National Institutes of Health.  I am
 immensely grateful that over 240 of our colleagues on a totally 
non-partisan basis have seen fit to co-sponsor our legislation, and I am
 deeply grateful to both the Republican and the Democratic leadership of 
the House for supporting us.
	As you know, Mr. Chairman, a companion bill has been introduced 
in the Senate by Senators John Cornyn and Barbara Mikulski and the 
growing number of senators that are supporting this legislation.
	I would like to take this opportunity to express my gratitude 
to the leadership of the NIH and for their efforts in the fight against
 pulmonary hypertension.  Dr. Leah Zarhouni and Dr. Betzenager have 
been tremendous partners, and we look forward to working with them to 
bring an answer to this condition.
	There is some scientific justification for an expansion of 
research in this area, and I am personally committed to ensuring that 
we take the next step in the fight against the condition so that 
Charity and hundreds of thousands of other patients will enjoy a long 
and healthy life.
	Thank you, Mr. Chairman.
MR. DEAL.  I thank the gentleman.
	Mr. Brady, you are recognized for an opening statement.
	MR. BRADY.  Thank you, Mr. Chairman.
	I want to thank Chairman Deal and the members of the Health 
	Subcommittee for your thoughtful concern about the growing health 
challenges of pulmonary hypertension and chronic pain.  Last month 
was pulmonary hypertension awareness month, so, Mr. Chairman, your 
timing could not be better.
	I want to also thank the panelists, like Tom, for appearing.  
The National Heart, Lung, and Blood Institute has been especially 
involved in PH under the leadership of its Director, Dr. Nabel, and I
 appreciate Dr. Gladwin being here today.
	The Pulmonary Hypertension Association, whose membership has 
just exploded in numbers in recent years, is a valuable and tireless 
advocate for this disease, and I appreciate you, Mr. Hicks, for being 
here today.  And Charity Sunshine Tillemann-Dick is the beautiful and 
very talented granddaughter of our highly-respected colleague, 
Mr. Lantos, who is the lead Democrat on the H.R. 3005, the Pulmonary
 Hypertension Research Act.  More importantly, Tom and his granddaughter 
have really put a rocket booster of awareness and push behind this 
effort to find a cure for this disease.  And Tom, I appreciate you so 
much for your leadership on this issue and Charity for all of your role 
in this.
	Pulmonary hypertension is a complex disease, as Mr. Pallone said. 
It is considered a rare disease, but as Congressman Green's fellow 
Houstonian, the President of the University of Texas Health Science 
Center recently said at a meeting with the Texas Medical Center, "This 
is becoming not so rare at all among adults."  Historically, it affects 
women of childbearing age, but now this disease is impacting Americans 
of all ages and all races, more than 100,000 today and growing larger 
each year.  And patients with other illnesses, such as lupus, HIV, 
sickle cell anemia, and scleroderma are particularly vulnerable to PH.  
For now, it is an incurable disease, but we have the power to change 
that.
	I decided to do just that when one of my closest friends noticed 
that his 5-year-old daughter, Emily Stibbs, could not keep up with 
others on her bike during a parade.  She would have to rest each morning 
as she came down the stairs at breakfast time.  After several tries, she 
was eventually diagnosed with primary pulmonary hypertension.  Shortly 
after, I attended the funeral of a young 17-year-old girl in our 
community in The Woodlands.  Her teenage friends told us at the service 
how she had spent the last year of her life working with the Make A 
Wish Foundation to ensure that she left a legacy.  I don't think 17-year-
olds ought to have to worry about leaving a legacy.
	So the good news is, as Tom said, we are making progress thanks 
to the supportive leadership of Chairman Bilirakis and Chairman Deal of 
this committee, Federal research in pulmonary hypertension to the NIH 
has nearly tripled since 1997 to $30 million.  Now $30 million doesn't 
seem like a lot, admittedly, but combined with the private research and 
the fundraising efforts by the PH Association community, it is already 
having an impact.  The number of new treatments for PH are growing.  The 
first was only brought on line in 1997.  Today we have five available 
and five more in trials.  That is important, because for patients, the 
trick is to stretch out each phase of the disease's progression.  
	Best of all, the survivor rate after diagnosis has now doubled 
from about 2 to 3 years to 5 years.  Now that may not seem like great 
strides to you, but it is precious hope for many.  Some patients may 
even be able to manage their disorder for 15 to 20 years or longer. 
 And unlike some diseases, we don't have a celebrity spokesman, because 
ours don't live long enough to be a celebrity spokesman, so we have to 
reach out through patients and to you for this support.
	And how can Congress keep this progress going?
	Well, for the past 5 to 6 years, the Congress, our office, 
the National Heart, Lung, and Blood Institute, and the Pulmonary 
Hypertension Association has formed a working partnership that 
established medical infrastructure to attack this disease.  We have 
targeted research carefully and wisely, recruited new investigators 
and scientists.  We are educating the medical community and reaching 
out to medical researchers in related fields.
	And I will conclude by telling you I can report to this 
committee that very careful infrastructure is now in place to make 
that large push a tour de cure for this disease.  And on behalf of 
Congressman Lantos and myself, I urge you to continue this effective
 partnership and to support the Pulmonary Hypertension Research Act.  
This measure establishes Centers of Excellence within the NIH to 
increase basic and clinical research to $50 million each in the next 
5 years.  Each day, we are offering more and more hope to PH patients.  
Our goal is to one day offer a cure.
	Thank you, Mr. Chairman.
	[The prepared statement of Hon. Kevin Brady follows:]

PREPARED STATEMENT OF HON. KEVIN BRADY, A REPRESENTATIVE IN CONGRESS 
FROM THE STATE OF TEXAS

OPENING
	I wish to thank Chairman Deal and members of the Health 
Subcommittee for your thoughtful concern about the growing health 
challenges of pulmonary hypertension and chronic pain. This is 
Pulmonary Hypertension Awareness Month, so the timing is perfect.  
	I also want to thank the panelists for appearing:
- The National Heart, Lung, and Blood Institute has been especially 
involved in PH under the leadership of its Director, Dr. Elizabeth 
Nabel. (Dr. Mark Gladwin is appearing today)
- The Pulmonary Hypertension Association, whose membership has exploded 
in numbers in recent years, is proving a valuable and tireless advocate 
for this disease. (Carl Hicks, VP of PHA).
- And Charity Sunshine Tillemann-Dick is the beautiful and talented
 granddaughter of our highly respected colleague, Congressman Tom 
Lantos - the lead Democrat on HR 3005, the Pulmonary Hypertension
 Research Act.  
	Pulmonary Hypertension is a complex health problem - continuous 
high blood pressure in the pulmonary artery in the lungs that results in 
an enlarged heart and eventually losing the ability to pump. It's 
considered a rare disease, but as Dr. James Willerson, president of the
 University of Texas Health Science Center recently stated at a meeting 
at the Texas Medical Center, this is becoming not so rare at all among 
adults. 
	Historically affecting women of child bearing age, this disease 
now attacks Americans of all ages and all races in growing numbers - 
more than 100,000 today and growing larger.   Patients with other 
illnesses, such as Lupus, HIV, sickle cell anemia and scleroderma have
 particular vulnerability to PH. 
	For now it is an incurable disease. But we have the power to 
change that. 
	I decided to do just that when one of my closest friends noticed 
at a parade his five year-old daughter - Emily Stibbs - could not keep up 
on her bicycle with the other kids, and  had to rest each time she simply
 walked down the stairs at their home. She was, after several tries,
 eventually diagnosed with Primary Pulmonary Hypertension. 
	Shortly after I  attended the funeral of a young 17 year old girl 
in our community - Kristen Cote - whose  teenage friends recounted during 
the service how she spent the last year of her life helping the local 
Make-A-Wish Foundation because she wanted to leave a legacy for her life.
 Seventeen year olds just shouldn't be spending their days concerned 
about leaving a legacy. 

PROGRESS
	The good news is that we're making progress. 
	Federal research in Pulmonary Hypertension through the National
 Institutes of Health has nearly tripled since 1997 to $30 million. 
That's not much, admittedly, but combined with private research and
 fundraising efforts by the PH patient community, it's already having 
an impact. 
	The number of new treatments for PH are growing. The first, 
FLOLAN, was introduced in 1996. Now there are five FDA-approved 
treatments and five more in trials. That's important because for 
patients the trick is to stretch out each phase of the disease's  
progression. 
	Best of all, the survival rate after diagnosis has now doubled 
from 2-3 years for most PH patients to 5 years. That may not seem like 
great strides to you, but it's precious hope for many. Some patients 
may even be able to manage the disorder for 15-20 years or longer.

HOW CAN CONGRESS KEEP THIS PROGRESS GOING?
	For the past five-six years our office, the National Heart, 
Lung and Blood Institute and the Pulmonary Hypertension Association have
 created a working partnership to establish a medical infrastructure to 
attack this disease: targeting research carefully and wisely, recruiting 
new investigators and scientists, educating the medical community and
  reaching out to medical researchers in related fields. 
	I can report to you the infrastructure is now in place to push 
toward a cure for this disease.     
	On behalf of Congressman Lantos and myself, I urge you to 
continue this effective partnership and to support The Pulmonary 
Hypertension Research Act, HR 3005, which has 240 bi-partisan sponsors. 
The measure establishes Centers of Excellence within NIH to increase 
basic and clinical research by $50 million each of the next five years, 
train new investigators, collect better data and generate more accurate 
and timely physician diagnosis. 
	Each day we are offering more and more hope to PH patients.  Our 
goal is to one day offer a cure. 
	Thank you. 

	MR. DEAL.  Thank you.
	Mr. Shimkus, would you care to make an opening statement?
	MR. SHIMKUS.  Not after my roommate just talked.  I'm done.
	[Additional statements submitted for the record follow:]

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

	Thank you, Chairman Deal, for holding this hearing today.  
This hearing addresses two serious conditions. Both pulmonary 
hypertension and chronic pain are debilitating and in some cases fatal
 conditions.  I am pleased that the Committee is examining these 
important issues and learning about what current research is being done 
and how our efforts to address these problems could be improved.
	Chronic pain and pulmonary hypertension are terrible disorders 
that affect millions of people. I commend my friends on the Committee, 
Mr. Rogers and Mr. Norwood, for all of their work on chronic care 
management.  1'd also like to welcome my colleagues Mr. Lantos and 
Mr. Brady here today.  While they are not Members of the Energy and 
Commerce Committee, both have been extremely active with regard to 
pulmonary hypertension.
	I believe that today's hearing will further stress the 
importance of something that I am deeply committed to, and that is the
 reauthorization of the National Institutes of Health. Members of this
 Committee know that one of my top priorities is making improvements at 
our public health agencies, and particularly at the NIH.  Although 
NIH's research portfolio is largely dedicated to basic research that
 transcends disease specific research, applying this research so that 
it directly benefits patients suffering from specific disease like 
pulmonary hypertension or chronic pain, is critical.  I believe that 
improving the organization and structure of NIH could maximize our 
investments in public health.  
	Once again, I appreciate all of the time the witnesses have 
taken to make this an informative hearing.  Thank you for helping us
 to raise awareness about chronic pain and pulmonary hypertension so 
that more Americans recognize the symptoms of these conditions and can
 begin treatments early.

PREPARED STATEMENT OF HON. BARBARA CUBIN, A REPRESENTATIVE IN CONGRESS 
FROM THE STATE OF WYOMING

	Thank you Chairman, for calling today's hearing.  I'd also like 
to thank the witnesses who have agreed to join us here today, as well 
as Representative Lantos, who is accompanying his Granddaughter.  Today, 
we will have the opportunity to gain a better understanding of two very
 devastating and unfortunate medical conditions.  We will also discuss 
how Federal research dollars can be most effectively used to research 
both chronic pain and pulmonary hypertension.  
	Over 100 million Americans today are living with some form of 
chronic pain, and approximately 100,000 suffer from primary pulmonary
 hypertension.  These conditions are frequently very difficult to 
diagnose, and the prognosis is often bleak.  Like any chronic disease, 
the long term treatment to mitigate the effects of these conditions 
can be prohibitively expensive.  For example, it is estimated that 
pulmonary hypertension patients pay as much as $100,000 a year for
 medications.  However, the costs associated with chronic illness extend 
far beyond anything that can be measured in monetary value.  I have 
personally seen the heartbreaking struggle to cope with the daily 
impacts of chronic pain, and I would not wish this hardship on any 
family.  The challenge to adapt one's lifestyle in a manner that 
compensates for pain management can be overwhelming, frustrating, and
 depressing.  I hope today's hearing will reveal insight on current 
research endeavors that may help patients better manage chronic pain. 
	I am aware several institutes and centers at the National 
Institutes of Health are engaged in ongoing research regarding 
management of different types of chronic pain.  I expect today's hearing 
to shed light on these continuing efforts, as well as emphasize the 
importance of sharing information to prevent duplicative research. In
 addition, I will also be interested to hear what technological 
advances private industry has made to help patients better manage 
chronic pain.  Living with chronic pain can be more devastating than 
a catastrophic health crisis, but I do believe medical technology can 
be utilized to help patients continue to enjoy life.  
	Once again, I thank the Chairman for calling this hearing, and 
I reserve the balance of my time.

PREPARED STATEMENT OF HON. CHARLIE NORWOOD, A REPRESENTATIVE IN CONGRESS 
FROM THE STATE OF GEORGIA

	Thank you Mr. Chairman,
	We don't do a good enough job to alleviate pain. We do not 
understand chronic pain, and we have barely scratched the surface of 
how chronic pain impacts Americans. There is a significant problem of 
under-treatment of pain and our medical professionals lack proper 
training in pain management. The federal government's approach has been 
often misguided.
	Millions of Americans, often needlessly, suffer from acute and 
chronic pain.  45% of Americans will seek care for persistent pain at 
some point in their lives and 70% of cancer patients in the U.S. suffer 
from chronic pain.
	Pain has a tremendous cost in terms of health care services, 
lost productivity and personal suffering.
	For many of these patients, drug therapy is an important part 
of treatment.  Thankfully, effective prescription medications are 
available. While not all pain medications are controlled substances, 
many are. 
	I am proud to be a cosponsor of Mr. Roger's legislation (H.R. 
1020) to expand the study and treatment of pain. However, if we don't 
address prescription drug abuse, no bill expanding access is going to 
make a lick of  difference. No doctor will want anything to do with 
providing these services.
	We need a comprehensive strategy that removes bad actors while
 increasing our understanding of pain. Mr. Roger's bill plays a part, 
and NASPER - legislation I authored encouraging state prescription abuse
 monitoring programs - was a good first step.
	A compelling need also exists for abuse-resistance drugs. In 
addition, I plan on reintroducing legislation that's going to address 
some other issues.
	For example we need to reign in Internet pharmacies.  Right now, 
I could go on the Internet and buy a controlled substance just by 
pointing and clicking two things: "I need this drug, and I'm not 
lying."  
	The addiction community tells me these sites represent one of 
the easiest ways of getting access to controlled substances, and that 
fact should worry us all.
	Also, I want to know when a drug leaves a manufacturer, where 
does it go?  If a secondary wholesaler buys counterfeit drugs and sells 
them to a retailer, how do we know? What is the best means to dispose 
of an unused controlled substance?
	My legislation is going to try to answer some of those 
questions.
	Above all, we need to address these issues so that the true 
victims of prescription drug abuse-patients suffering from chronic 
pain-will be able to reap the benefits of the medical research aimed 
at alleviating their suffering. I look forward to the testimony of 
our witnesses.

	MR. DEAL.  Wise man.
	We do, indeed, have a distinguished panel, and I am pleased to 
	introduce them at this time.
	First of all, Dr. Joel Saper, who is the Founder and Director 
of the Michigan Head Pain and Neurological Institute, Captain John 
Pruden of the United States Army, Mr. Jake Vander Zanden, Vice 
President and General Manger of Medtronic Global Pain Management, Dr. 
Mark Gladwin, Chief of the Vascular Medicine Branch of the National 
Heart, Lung, and Blood Institute of the National Institutes of Health, 
Mr. Carl Hicks, Vice President of Advocacy for the Pulmonary 
Hypertension Association, and Ms. Charity Sunshine Tillemann-Dick, 
accomplished vocal performer, advocate for those who share her 
experience of living with pulmonary hypertension, and of course, as 
already has been stated, the granddaughter of our friend, the honorable 
Tom Lantos of California.
	Welcome.  And Dr. Saper, we will start with you.
	I would remind everyone that we already have made your written
 statements a part of the record, and if you would just summarize those
 statements for us, we would appreciate it.
	Dr. Saper.  Let us make sure the microphone is on.  There you go.

STATEMENTS OF JOEL SAPER, FOUNDER AND DIRECTOR, MICHIGAN HEAD PAIN 
AND NEUROLOGICAL INSTITUTE; JOHN PRUDEN, UNITED STATES ARMY; JAKE 
VANDER ZANDEN, VICE PRESIDENT AND GENERAL MANAGER, MEDTRONIC GLOBAL 
PAIN MANAGEMENT; MARK GLADWIN, CHIEF, VASCULAR MEDICINE BRANCH, 
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE, NATIONAL INSTITUTES OF 
HEALTH; CARL HICKS, VICE PRESIDENT, ADVOCACY, PULMONARY HYPERTENSION
 ASSOCIATION; AND CHARITY SUNSHINE TILLEMANN-DICK

	MR. SAPER.  Thank you, Mr. Chairman.
	I am the Director of the Michigan Head Pain and Neurological 
Institute and Chairman of the Pain Care Coalition, and I am also 
current past President officer of the American Headache Society, the
 American Pain Society, and the American Academy of Pain Medicine, 
among others.  I am a board-certified neurologist and a pain 
specialist and clinical associate professor of neurology.
	I have devoted my entire 35-year professional career to 
research, teaching, and clinical practice to improving the lives of 
people who suffer from severe pain.
	Mr. Chairman, the problem of pain in this country is an 
enormous size.  As Mr. Pallone already noted, pain is the most common 
reason people seek medical help.  Over 100 million Americans suffer 
from continuous and frequent pain, and chronic pain is the leading 
cause of disability.  Reduced productivity due to pain to employers' 
costs between $60 and $120 billion annually, and the total cost of 
pain to the healthcare system and the broader economy cannot even be
 calculated, but it is larger than any other health condition, such 
as heart disease, hypertension, or diabetes.  Chronic back pain alone 
is estimated to cost over $25 billion to national healthcare 
tabulations.
	Most illnesses lead to pain, and chronic pain leads to many 
other illnesses.  From the acute pain of trauma or surgery or sickle 
cell disease, severe burns, cancer, heart disease, AIDS, diabetes, 
MS, migraine, and so many more, pain cuts indiscriminately across 
demographic lines and across the populations of this subcommittee that 
so wants to serve the elderly, the disabled, and the medically 
indigent.
	Pain can kill.  It can kill the spirit, vitality, and the 
will to live.  Pain also alters the immune system and changes the 
brain.  It makes its victims more vulnerable to other diseases.  
Moreover, loss of income, careers, quality of personal and family life 
and the joy of living are trumped by the daily and persistent agony 
of pain and the desperation and isolation that comes with it.  The 
lives of those afflicted and their families are placed on the brink 
if not defeated altogether.
	And despite great scientific strides in the past decade, 
improved treatment facilities and techniques, the availability of 
powerful medicines, and credentialed specialists, we are far from 
accomplishing a satisfactory impact on this enormous worldwide 
problem.  Too many people suffer daily severe pain.  We have no 
panaceas.  We need more knowledge and more tools.
	I understand that the subcommittee's primary interest today 
is in assessing the adequacy of Federal research on chronic pain.  It 
is discouraging to report that halfway through the congressionally-
declared decade of pain control in research, that the research 
commitment to pain is woefully inadequate and hardly proportional to 
the burden pain places on this society.  An exhaustive study of NIH 
pain research concluded that NIH devotes a scant 1 percent of its 
research budget to projects with a primary focus on pain.  There is 
little indication that NIH considers pain research to be a higher 
priority today than it was 10 years ago.
	Nor does the data suggest a concerted effort to prioritize 
what little the NIH does invest in pain or to coordinate that 
investment across the institutes.  Immediate means for expanded
 research in pain include, among many others, basic research to both 
fully understand the complex mechanisms of pain perception and how 
pain changes the brain; better understanding of the linkages between 
brain mechanisms and emotions; gender differences between males and 
females with respect to response to treatment and how pain affects 
them, basic and clinical research into how acute pain becomes chronic 
pain; a better understanding of the long-term risks and benefits of 
our treatments; and, of course, new and breakthrough treatments and 
therapies are badly needed.
	Mr. Chairman, I could go on, but I know time does not permit, 
and we will make this data and other research priorities available to 
you and your staff.
	Pain, as a public health problem, demands a comprehensive
 Federal response promoting research, education, and access to care. For 
this reason, the Pain Care Coalition and dozens of other professional 
and patient advocates strongly support H.R. 1020, the National Pain 
Care Policy Act, introduced by Congressman Rogers.  It is the only 
 comprehensive pain bill pending in the current Congress, and indeed, 
it is the only comprehensive pain bill ever introduced in Congress.  
And I urge you to hold further hearings in this subcommittee to explore
 problems with education and access to care, which are of equal 
importance to those in research, which we are discussing today.
	Mr. Chairman, in a comprehensive pain bill, there are several 
short-term measures that could make a difference.  These include 
requiring more coordination across institutes, Federal reporting of 
what NIH already spends, and more extramural participation in the 
priority-setting process.  These steps could be taken now at very 
little cost, and I urge you to consider them.
	In closing, Mr. Chairman, I want to share a personal brief
 perspective.  Our center in Ann Arbor is a national referral center 
for patients with intractable and severe pain.  Many of those sent to 
us are children, and most of our patients are adults in their working 
years who cannot work.  The majority comes to our center on large 
dosages of narcotic medications, and despite these, the pain is 
worsened, and so have the desperation and the side effects.  They 
have exhausted their insurance, they have no insurance, or what 
insurance they have won't cover pain care.  Most can not function 
normally or even go to school or even care for their families.  We 
are able to help many of these, but too many are not able to be 
helped.  Lives become hopeless, people give up, and you know that 
story from Michigan.
	Mr. Chairman, thank you again for bringing these issues 
forward to the committee and to the House.  My colleagues and I in 
the Pain Care Coalition look forward to working with you and 
Congressman Rogers and others.  Working together, I know we can make 
a difference for the millions who suffer in pain today and every day 
of their lives.
	Thank you.
	[The prepared statement of Joel Saper follows:]

PREPARED STATEMENT OF JOEL SAPER, FOUNDER AND DIRECTOR, MICHIGAN HEAD
 PAIN AND NEUROLOGICAL INSTITUTE

 	Mr. Chairman and Members of the Subcommittee, thank you for the
 opportunity to appear before you today.  I welcome this hearing, and 
I applaud your leadership and that of Congressman Rogers, in bringing 
national attention to pain as a major public health problem in this 
country.
	I am Joel Saper, Founder and Director of the Michigan Head Pain 
and Neurological Institute in Ann Arbor, Michigan, and Chair of the 
Pain Care Coalition. I am also a current or past president/officer or 
director of the American Headache Society, the American Pain Society 
and the American Academy of Pain Medicine, among others.    I am a 
board-certified neurologist and pain specialist, and Clinical 
Associate Professor of Neurology, and I have devoted my entire 
professional life (35 years), through research, teaching, and 
clinical practice, to improving the lives of people who suffer from 
pain.  

The Problem
	Mr. Chairman, the problem of pain in this country is of enormous 
size:
* Pain is the most common reason people seek medical help.
* Over 100 million Americans suffer from continuous or frequent pain.
* Chronic pain is a leading cause of disability, both temporary and 
permanent.
* Reduced productivity due to pain costs employers somewhere between 
$60 and $100 Billion annually.
* The total cost of pain to the health care system and the broader 
economy cannot be currently calculated but is larger than any other 
health care condition, such as heart disease, hypertension, or 
diabetes. A single example--chronic back pain-is estimated to add 
over $25 Billion annually to national health care costs.
* Most illnesses lead to pain, and chronic pain leads to many other 
illnesses.    From the acute pain of trauma or surgery or sickle cell 
disease or severe burns to the chronic pain of cancer, heart disease, 
AIDS, MS, arthritis, bone disease, diabetes, colitis, back and neck 
disorders, migraine, fibromyalgia, RSD, TMJ, and on and on and on,
 pain cuts indiscriminately across demographic lines, and across 
the populations that this Subcommittee does so much to serve-the 
elderly, the disabled, and the medically indigent. 
* Pain can kill:  it can kill the spirit, vitality, and the will to 
live.  Pain also alters the immune system and makes its victims more
 vulnerable to other diseases.  Moreover, loss of income, careers, 
quality of personal and family life, and the joy of living are trumped 
by the daily and persistent agony of pain and the desperation and 
isolation that come with it.  The lives of those afflicted and their 
families are placed on the brink, if not defeated altogether. 
* And despite great scientific strides in the past decade, improved 
treatment facilities and techniques, the availability of powerful 
medications, and credentialed specialists, we are far from 
accomplishing a satisfactory impact on this enormous world-wide 
health problem.  Too many people suffer daily, severe pain.  We have 
no panaceas.  We need more knowledge and more tools

The Federal Research Commitment
	I understand that the Subcommittee's primary interest today is 
in assessing the adequacy of federal research on chronic pain. It is
 discouraging to report that, half way through the Congressionally-
declared Decade of Pain Control and Research, that research commitment 
is woefully inadequate, and hardly proportional to the burden pain 
imposes on the population.  An exhaustive study of NIH pain research, 
based on FY 2003 grant awards, concluded that NIH devotes a scant 1% 
of its research budget to projects with a primary focus on pain. 
Broadening the inquiry to include grants that have some, perhaps 
only marginal, relationship to pain, only adds another 1 and 1/2% of 
the pie. While longitudinal data is not readily available, there is 
little indication that NIH considers pain research to be a higher 
priority, in any sense of the word, today than it was ten years ago. 
	Nor does the data suggest a concerted effort to prioritize 
what little the NIH does invest in pain, or to coordinate that 
investment across Institutes, Centers and programs. If back pain costs 
the health system $26 Billion annually, is an investment in all forms 
of musculoskeletal pain research of less than $50 Million-one fifth of 
one percent-- reasonable? If cancer pain gets another $50 Million, why 
does cardiac pain get less than $2 Million, or headache less than $20 
Million? To put the latter figure in perspective, it represents less 
than one dollar a year for each and every migraine sufferer in this 
country.  And if cancer pain does get $50 Million, why is a third of 
that funded through channels other than the National Cancer Institute? 
Or, if some Institutes devote 80% or more of their pain research effort 
to basic research, why do others spend 90% or more on clinical research 
at the expense of basic research?
	Immediate needs for expanded research in pain include, among 
many others, the following broad areas:
* Basic research to more fully understand complex mechanisms of pain
 perception and development in the brain;
* Better understanding of the linkages between brain mechanisms and 
emotions that effect the perception and severity of pain;
* Basic and clinical research into how acute pain (e.g. post operative 
or trauma pain)  becomes chronic pain, and how to prevent it; and
* Better understanding of the long term risks of current therapies on
 brain function and long term pain prevention.
	Mr. Chairman, I could go on but time does not permit, and we 
will make this data and other research priorities available to you 
and your staffs so that you may draw your own conclusions from it.  
Let me instead suggest some possible solutions.

Recommendations
	The enormity of pain as a public health problem demands a 
	comprehensive federal response promoting research, education and 
	access to care. For this reason, the Pain Care Coalition and dozens 
	of other professional and patient advocates strongly support HR 1020, 
	the National Pain Care Policy Act, introduced by Cong. Rogers. It is 
	the only comprehensive pain bill pending in the current Congress. 
	Indeed, it is the only comprehensive pain bill ever introduced in 
	the Congress, and I urge you to hold further hearings in this 
	Subcommittee to explore problems of education and access which are 
	equal in importance to those of research which we are discussing 
	today.
	Short of a comprehensive and long term response to the major 
public health problem which pain represents, there are a number of short 
term measures in the area of research alone  which the Subcommittee 
should consider.   
	First, I understand that both Congressional and NIH leadership 
are seeking more effective "trans Institute" coordination of research
 activities. Chronic pain research would be a natural candidate for 
such an initiative. With funding spread across three principal 
Institutes, and a dozen more with smaller concentrations, the 
benefits of enhanced coordination and cross fertilization could be
 significant.  NIH's existing "Pain Consortium," which now exists 
mostly in theory, could, with modest funding and staff, become a 
powerful tool for assessing and setting priorities across the various 
offices with a stake in pain research.   
	Second, better information could be a powerful tool for better
 prioritization of research dollars. The data I described a few moments 
ago were gleaned from NIH records by private researchers. NIH itself 
should be required to explain to this Committee and other interested
 legislators what it does on pain each year, why it focuses where it 
does, and what is being accomplished. This would help the NIH Director 
set priorities in his annual budget requests, and help legislators 
assess whether those requests reflect an adequate allocation of 
research dollars to the needs of patients in pain. 
	Third, extra-mural participation is critical to identifying the 
most pressing research needs in the pain field. Currently, perhaps 
because pain has no single home at NIH, there is no structured 
opportunity for either basic scientists or clinicians in the pain field 
to work with NIH leadership to establish a broad pain research agenda. 
With the Decade of Pain Control and Research half over, now would seem 
an opportune time to bring people together to take stock of what has 
been accomplished, and what remains to be done.  
	Fourth, NIH needs to invest in infrastructure development in 
the pain field. Other significant disease categories have either 
intra-mural or extra-mural centers of clinical and research excellence, 
and in many cases both, that advance research over years and sometimes
 decades. This capacity is seriously lacking in pain research. 
	These are modest suggestions. They will not produce dramatic 
research breakthroughs, nor bring immediate relief to the millions of 
chronic pain patients in this country. But they also won't bust any 
budgets in a time of fierce competition for research dollars. Nor will 
they complicate the NIH organizational chart at a time when many of 
you seek to simplify it. I commend them to your consideration, and 
would be pleased to explore them in more detail with you. 
	In closing, Mr. Chairman, I want to share a personal perspective.
 Our center in Ann Arbor is a national referral center for patients with
 intractable and severe pain problems.  Many of those sent to us are 
children, and most patients are in their working years.  The majority 
come to our center on large dosages of narcotic medications, and despite
 these, the pain has worsened, and so has the desperation and side
 effects.  Most cannot work or go to school or even care for their 
families.  Despite the challenges, we are able to help many of these 
people, but many are not helpable.   Lives become hopeless.
	Mr. Chairman, thank you again for bringing these issues forward 
to this Committee and in the House. My colleagues and I in the Pain 
Care Coalition look forward to working with you, Congressman Rogers, 
and others. Working together, I know we can make a difference for 
millions who suffer in pain today and every day of their lives.

	MR. DEAL.  Thank you, Dr. Saper.
	Captain Pruden.
	CAPTAIN PRUDEN.  Mr. Chairman, members of the subcommittee, I 
thank you for your time today.
	I have kind of a perspective on pain.  I was, 2 years ago, 
wounded in Baghdad by an IB.  I took 173 pieces of shrapnel and one 
bullet.  Over the course of the next 2 years, I underwent 20 operations.
  I had numerous pain care specialists working with me.  This is 
actually my first trip out of the wheelchair today, and it is exciting 
to be up and around.  It is a little bit painful, but things are going 
pretty well.
	Before I joined the military, I was working for EMS.  I worked 
as an EMT.  I had had some experience with pain, but nothing quite 
prepared me for the experiences I had being wounded and coping with 
this severe chronic pain, and witnessing my surgeons and the men and 
women to my left and right in uniform, who were also wounded, trying 
to cope with this chronic severe pain.  Partially due to this chronic 
pain, this past summer, I decided to have my leg amputated after 
trying to deal with it for 2 years.  It was a tough decision.  I think 
it was the right one.  Pain really changes your life.  It is a 
debilitating thing.  I found myself adjusting my schedule, changing what
 I was doing day in and day out to try to facilitate my pain.  I would 
look at a given activity and think, "How much is this going to cost me 
in pain?  How long am I going to have to recover after this?  And how 
much medication am I going to have to take to cope with this?  Is it 
worth it?"
	Telling you about the uncontrolled pain and how difficult that 
is, you know, I will talk about some of the things that happened with 
Mike here.  I had some really good pain management care through 
narcotics, through Oxycontin.  I have been on that drug for 28 months.
  Actually, I have recently weaned myself off of that.  After the 
amputation, my pain level has decreased, and I have been able to get 
off that medication entirely, but I can't state strongly enough what a 
benefit that was to me, and how it allowed me to get on with my life.  
There is a great fear out there of narcotics, and it seems like the 
medical community is oftentimes hesitant to prescribe needed narcotics 
for pain because of fear of legal implications or prosecution by 
Federal or State officials.
	One thing over the past few years, also, is my soldiers are back 
in Iraq right now for the next year and we have already lost some 
soldiers and have brought several back, unfortunately, severely wounded.
  I have been working with them week in and week out.  And there are a 
lot of gaps in their pain care.  I have a little bit of a medical 
background.  I was an officer, and through my assertiveness and them 
pushing some buttons, I was able to get the care that I needed getting 
to the right people, but unfortunately, there is a big gap between the
 hospital and adequate palliative care.  Unfortunately, they fall 
through the cracks too often and don't ask for help due to several 
factors, as you know, the stigmas associated with taking narcotics for 
pain care, you try and be tough and not ask for help if we need.  It's 
amazing how many guys just live with the pain and suck it up and try to 
drive on.
	Looking at some of the gaps in treatment and care that I have
 witnessed, it seems important to me to have physicians who understand 
all of the different medications and treatments that are available for 
pain management, and more importantly to have good links with the 
experts, with the palliative care experts and the anesthesiologists so
 that there is not that gap, that disconnect.
	And then finally, you know, there really is a lot to understand, 
and I went through about 12 different physicians and anesthesiologists 
over the past couple of years.  I tried over half a dozen different 
pain medications.  Oxycontin was the one that worked best for me, but 
I saw some other guys that it didn't work for.  There are some pain 
conditions that there is nothing out there to treat right now.  It seems 
like the H.R. 1020 would take positive steps in the direction of 
facilitating research to address these issues and then try to help 
millions of people suffering from chronic pain nationwide.
	Thank you.
	[The prepared statement of Captain Jonathan D. Pruden follows:]

PREPARED STATEMENT OF CAPTAIN JOHN PRUDEN, UNITED STATES ARMY

	On 01JUL03 I was severely injured in an IED attack near the 
UN headquarters in Eastern Baghdad, Iraq.  I was there with the Third 
Infantry Division on the initial movement up from Kuwait.  I had some 
previous experience with pain from severely breaking my right leg in 
college playing flag football requiring three operations.   I also 
worked as an EMT for almost three years where I encountered a great 
deal of acute pain due to disease and physical trauma.  None of these
 experiences prepared me for what it is like to live with chronic pain.
	After taking 173 pieces of shrapnel and one bullet I quickly 
became hypovolemic, due to tremendous blood loss from both legs, and a 
large hole in my back.  Tourniquets were placed on both my legs as I 
started to go into shock.  After a couple of surgeries at a CSH in Iraq 
to stabilize me, I was MEDEVACed to Landstuhl in Germany, and after a 
couple more surgeries I made it to Walter Reed.  Over the next two 
years I had numerous surgeries to try to put me back together.  After 
a total of 18 surgeries at six different Army hospitals I elected to 
have my right leg amputated this past summer.
	The decision to amputate was not an easy one but it was, in 
hindsight, right one.  One of the primary reasons I decided to amputate 
my leg was the chronic pain it caused and the acute pain I experienced 
each day at Physical Therapy as I attempted to bear weight on it.  For 
two years I coped with, often times, debilitating pain.  
	Pain is a powerful thing.  It changes everything.  Your whole 
life is altered to accommodate it.  In military hospitals all around 
the nation I witnessed strong young Infantrymen, Medics, and Snipers 
buckle under its crushing weight.  Exhausted emotionally and physically 
they cried out in pain.  I recall many long painful, sleepless nights 
at in hospitals and at home.  When the pain was at its worst I would 
have done almost anything to rid myself of it but all I could do was 
call a nurse and hope they could ease the pain a little with another 
dose of Morphine.  After a surgery or a tough Physical Therapy session 
all I could focus on was the pain.  I really enjoy reading but my 
chronic everyday pain when uncontrolled was such that I couldn't focus 
to read.  I found myself changing my activities and my schedule to 
accommodate my pain.  I would often look at potential activities with an 
eye to how much pain it would cost me and subsequently how much 
medication and rest I would need to recover from it. Each day I would
 anxiously await the time I could take my medications, not so much 
because of a physical dependence, but  because of a real need to control 
my pain.
	In the same breath as I describe the challenges of uncontrolled 
pain I'll tell you how, for the most part, my pain was effectively 
managed with Oxycontin. During my extensive hospital stays I had dozens 
of physicians, specialists, and anesthesiologists.  Through them I tried 
at least half a dozen pain control medications, and Oxycontin was 
consistently the best for managing my pain without the roller coaster 
effect and with minimal side effects.    
	Narcotics such as Oxycontin conjure up images of drug abuse, 
crime, and addiction for many people.  While concerns over the illegal 
or improper use of narcotics are certainly legitimate.  The line between 
the two should be very clear.  Physicians should have unambiguous 
guidelines about what is legal.  The fear of federal or state 
prosecution, unfortunately, makes many physicians hesitant to prescribe 
opiods even when they may be the best pain control tool for certain
 individuals.
	Many physicians and patients fear that the physical dependence
 sometimes caused by narcotics will lead to addiction and drug abuse.  
This is seldom the case and is extremely rare among patients using 
Oxycontin for palliative care.  After 28 months using Oxycontin I was 
able to stop with no real problem through a gradual reduction.  I can't 
state strongly enough the profoundly positive effect Oxycontin had on 
my life.  
	It is understandable that some patients would have 
misconceptions about the realities of pain medication use but 
physicians should have a comprehensive understanding of available 
medications and pain care techniques. More importantly they should know 
the pain management resourses available to their patients and have a 
close working relationship with pain management specalists. 
	To often, I witnessed a disconnect between physicians and 
palliative care experts.  With my medical background, rank, and a 
little assertiveness I ensured that I saw the anesthesiologists who 
could best address my pain.  Unfortunately,  some of the wounded 
soldiers I've been working with do not get the pain care they need 
because they are afraid to ask for it,  are ashamed to ask for drugs 
to control their  pain due to social stigmas associated with the abuse 
of pain medications, or are simply trying to be tough.  The fear of 
addiction and the associated stigma of drug use ironically may lead to 
more profoundly addictive behavior.  One of my old soldiers was wounded 
and returned from Iraq this past summer.  As we were talking he bragged 
how he was not using his pain meds, but unfortunately it turns out he was 
self medicating with alcohol to cope with the pain.
	The prevalent attitudes towards the use of narcotics for 
palliative care need to be changed.  When I was contacted to testify 
here today I was reluctant.  I was feared showing my soldiers how much 
I pain effected my life, how badly I needed Oxycontin just to get by, 
and was embarrassed to be seen whining to Congressmen about my pain.  
But as I though about it I realized how important it is that you all
 understand some of the difficulties encountered by those living with 
pain in the hope that through this legislation you can address some of 
the profound shortfalls in palliative care.  
	The main reason I'm here is because I saw, firsthand, soldiers 
who slipped in to the void that often exists between the front door of 
the hospital and the adequate treatment of chronic pain.  I've witnessed 
the strong fear of certain pain medications among both doctors and 
patients that sometimes results in inadequate pain care.  I've also
 experienced the lack of understanding in the medical community about 
what causes pain and how we can best treat it.  This bill does a great 
deal to address these very real and widespread issues.  In the time 
allotted I could not share all stories of soldiers coping with pain 
nor all of my own struggles but I hope this testimony will in some 
small way help you all understand the debilitating effects of pain 
and move you toward action to address the needs of millions who are 
living in pain. 

	MR. DEAL.  I must say, Captain Pruden, you truly honor us with 
your presence here today.  We all respect and admire your courage, your
 dedication to our country, and we commend you for what you continue to 
do to help your fellow soldiers who have been wounded.  We salute you.  
Thank you for being here with us.
	CAPTAIN PRUDEN.  Thank you.  Thank you, sir.
	MR. DEAL.  Mr. Vander Zanden, it is a hard act to follow, but 
welcome.
	MR. VANDER ZANDEN.  Thank you.
	Members of the committee, Chairman Deal, on behalf of Medtronic 
and the millions of patients like Captain Pruden we serve who suffer 
chronic diseases like chronic pain and pulmonary hypertension, I thank 
you for the opportunity to be here today.
	In my role, I am Vice President and General Manager of 
Medtronic's Global Pain Management Division, and Medtronic is 
headquartered in Minnesota.  We are the leading medical technology 
company providing lifelong solutions for people with chronic diseases.
	As a company, we are investing over $1 billion in research and
 development just this year alone.  Medtronic shares the subcommittee's
 commitment to increasing the understanding of these conditions and
 continually improving the therapies available to patients.  We would 
like to share with you some of the ideas and the therapies that 
Medtronic currently has available in the areas of chronic pain and 
pulmonary hypertension, and provide you a glimpse into a few of the 
innovative treatments we have on the horizon.
	As you have heard this morning, chronic pain is an epidemic in 
this country.  Approximately 25 percent of the American population 
suffers from chronic pain.  That is actually one out of every four 
people.  Every year, 40 million physician visits are related to pain
 management.  The economic impact is staggering: 515 million workdays 
and nearly $50 billion in economic costs on an annual basis, and an 
astounding $100 billion in medical expenses are incurred due to chronic 
pain.  These figures don't begin to tell the countless stories of 
suffering, depression, isolation, even suicide that are often 
experienced by chronic pain sufferers and the tremendous impact this 
has on their families and their loved ones.
	Unfortunately, chronic pain is not easy to treat.  The reality 
is that many patients simply gave up in their search for relief, and 
instead resolve to living their lives suffering in persistent pain, as 
you have heard Captain Pruden say.  It is exactly these patients that
 Medtronic serves with our pain therapies.  Medtronic has successfully 
treated hundreds of thousands of people who suffer from chronic pain 
with our neurostimulation and drug delivery therapies.  These are 
clinically-proven and minimally-invasive options for those who have 
lost hope and they could find relief and live life to the fullest 
again.  Neurostimulation is a type of implantable pain therapy, and it
 actually stimulates the spinal cord with a mild electrical impulse 
that actually blocks the signals from reaching the brain, essentially
 replacing the pain signals with a mild tingling sensation.  The 
Medtronic neurostimulator is small.  It is about the size of a stopwatch.
  It is surgically placed under the skin where it sends impulses to the 
spinal cord through one or more specially insulated wires, basically 
called leads, and these are also surgically placed.  And I do believe 
you have got some pictures in front of you in your packet that outline 
some of our devices.
	Based on the needs of the individual patients, the physician 
can customize the pain relief to maximize the effectiveness of the 
treatment based on every individual's need.  The device is used to 
treat individuals suffering from pain as a result of failed back 
surgeries, complex regional pain syndrome, as well as degenerative 
disk diseases and painful neuropathies.  More than 150,000 people 
world-wide have received Medtronic neurostimulation devices for 
pain, including the famous comedian that you heard about earlier this 
morning, Jerry Lewis, who some of you have met, perhaps most recently 
when he visited Capitol Hill in support of H.R. 1020, the National Pain 
Care Policy Act.
	In addition to our neurostimulation system, Medtronic also
 manufactures the world's only implantable, programmable drug infusion
 systems.  These systems, commonly referred to as drug pumps, consist of 
a pump placed under the skin of the abdomen and a catheter that is then 
placed into the intraspinal space surrounding the spinal column to 
deliver tiny doses of liquid morphine directly to where the product 
is needed.
	The systems like the spinal cord simulation include a remote 
control or patient programmer, and this is preprogrammed by the 
physician so that the patient can have the appropriate dose of 
medication to avoid error or abuse.  I will also point out that because 
our drug pumps deliver medication directly into the intraspinal space, 
it doesn't pass the blood-brain barrier, which is especially important. 
 Studies suggest that the dose required to manage this chronic pain can 
be as small as one-hundredth of the amount of oral medication required 
to do the same thing.  As a result, the overall side effects to the 
patient are also generally significantly reduced.
	We believe that our new technologies are providing better, 
more cost-effective medical outcomes, and the example is our 
neurostimulator called Restorer, benefits patients living with the 
most severe types of pain who might otherwise limit the use of their
 neurostimulator to conserve the actual battery power that is available 
with a lower power model.  By being able to recharge it, they don't 
need to hold onto that power and save it for when they really need it.
	We are also expanding the conditions for where this type of 
implanted electricity-delivering therapy can be used.  We hope that 
this therapy can provide relief to the more than 28 million Americans
 who suffer chronic migraines and can't be treated with standard 
migraine treatments.
	While technologies continue to advance, without patient access 
to these therapies, the undertreatment of pain will continue to be one 
of the country's top public health problems.  In order to address these
 problems, Medtronic is actively engaged with the patient and provider
 community to support the National Pain Care Policy Act introduced by
 Congressman Rogers.  I am grateful for his leadership in raising this 
issue, and this is an important public health concern.
	One of the disturbing barriers addressed in this bill is simply 
the lack of understanding of the array of clinically-effective therapies 
that are available.  An astounding 40 percent of people with chronic
 pain do go to the doctor and then stop because they haven't been able 
to find effective options.  Further, many general practitioners are 
not fully aware of the treatment options that are available for them.  
With enhanced education, perhaps we will see more internists and 
general practitioners recognize chronic pain and have knowledge or an
 available referral pattern and treatment options available.  While 
this isn't a simple solution, this is a complex disease, raising the
 visibility of the problem and starting the national dialogue on how 
to ensure that chronic pain sufferers get the care that they need is a 
good first step in addressing the issue.
	Another area that needs additional Federal focus is pulmonary
 hypertension, a rare, debilitating, and ultimately fatal disease of 
the lungs.  You will hear more about this disease from the distinguished
 witnesses on the panel.  Medtronic MiniMed, our diabetes business 
located in North Ridge, California, offers a delivery system for the
 administration of Remodulin, a drug used to treat pulmonary hypertension 
that dilates affected blood vessels in the lung tissue and increases 
blood flow and improving the overall oxygen exchange.  Patients receive 
this drug through the use of Medtronic's medication delivery pump that
 delivers the drug under the skin, similar to our insulin pump used to 
treat type I diabetes.  Given the nature of the drug, for many years, 
this has been the best way to deliver the drug.  And virtually, the 
pump is about the size of a pager.  It is totally portable.  It 
delivers smaller doses.  It is readily absorbed, and there are fewer 
side effects, which is very, very convenient for the patients.
	We are grateful of the subcommittee's interest in both 
pulmonary hypertension and chronic pain.  We thank you for the 
opportunity to discuss some of the therapies Medtronic has available to 
these suffering patients, and we welcome the opportunity to work with 
the subcommittee to increase understanding of these diseases and ensure 
that patients have timely access to life-saving and life-enhancing
 technologies.
	Thank you.
	[The prepared statement of Jake Vander Zanden follows:]

PREPARED STATEMENT OF JAKE VANDER ZANDEN, VICE PRESIDENT AND GENERAL 
MANAGER, MEDTRONIC GLOBAL PAIN MANAGEMENT

	Chairman Deal, Ranking Member Brown, Members of the Committee:
	On behalf of Medtronic and the millions of patients we serve 
who suffer from chronic diseases such as chronic pain and Pulmonary
 Hypertension, I thank you for the opportunity to be here today.  My 
name is Jake Vander Zanden and I am the Vice President and General 
Manager of Medtronic's Global Pain Management Division.  Medtronic, 
headquartered in Minnesota, is the world's leading medical technology 
company that provides lifelong solutions for people with chronic 
disease.  With deep roots in the treatment of heart disease, Medtronic 
now provides a wide range of cardiovascular, neurological, gastro-uro, 
spinal and diabetes therapies that help physicians solve the most 
challenging, life-limiting medical problems that exist today.  In fact, 
every six seconds, someone's life is saved or improved by a Medtronic
 technology.  I think our mission says it best: "Medtronic is firmly 
dedicated to alleviating pain, restoring health and extending life 
throughout the world."  
	As a company that is investing over $1 billion into research 
and development this year alone, Medtronic shares the Subcommittee's
 commitment to increasing our understanding of these conditions and
 continually improving the therapies available to patients.  Today, 
I would like to share with you information on some of the therapies 
that Medtronic currently has available in the areas of chronic pain 
and Pulmonary Hypertension, and provide a glimpse into a few of the 
innovative treatments we have on the horizon.  


Chronic Pain
	Chronic pain is an epidemic in this country:
* Approximately 25 percent of the American population suffers from 
chronic pain - that's one in every four people
* Each year, more than 40 million physician visits are related to pain 
* The economic impact is staggering - 515 workdays are lost as a result 
of pain with an economic cost of nearly $50 billion
* Annually, an astounding $100 billion in medical expenses are incurred 
due to chronic pain
	And these figures don't begin to tell the countless stories of
 suffering, depression and isolation - even suicide - experienced by 
chronic pain sufferers and the tremendous impact this has on a pain 
sufferer's family and loved ones.   
	Unfortunately, chronic pain is not easy to treat.  Dr. Joel 
Seres may have said it best when he offered, "Chronic pain infers the 
failure of medical care.  If previous treatment had been successful 
the patient would not be experiencing pain."  The reality is that many
 patients simply give up in their search for relief and instead decide 
to live their lives suffering from chronic pain.  It is exactly these 
patients that Medtronic serves with our pain therapies. 
	Building on proven core Medtronic technologies, like the 
pacemaker, used to treat chronic disease in other areas of the body, 
Medtronic has successfully treated hundreds of thousands of people who 
suffer from chronic pain with our neurostimulation and drug delivery
 therapies.  These are clinically proven and minimally invasive options 
for those who had lost hope that they could find relief and live life 
to the fullest again.  While these therapies are not for everyone, 
they do provide a viable option for those patients who have not 
otherwise been successfully treated.  
	Neurostimulation is a type of implantable pain therapy that 
stimulates the spinal cord with mild, electrical impulses that block 
pain signals from reaching the brain, essentially replacing the pain 
signals with a mild tingling sensation. 
	The Medtronic neurostimulator is small (about the size of a
 stopwatch), and is surgically placed under the skin where it sends 
the impulses to the spinal cord through one or more special "insulated" 
wires called leads, that are also surgically placed.  Based on the 
needs of individual patients, physicians can customize the pain relief 
to maximize the effectiveness of the treatment. This device is used to 
treat individuals suffering from pain as a result of back surgeries, 
complex regional pain syndrome, as well as degenerative disk disease 
and painful neuropathies. 
	There are two types of fully implantable neurostimulators 
available, rechargeable and non-recharageable, allowing physicians to 
choose the right device to best address the pain management needs of 
their patient.  The neurostimulation systems typically consist of an
 implantable neurostimulator, the implantable lead and extension. 
 Additionally, a programmer is used by physicians and patients to 
adjust the level of stimulation within physician prescribed limits as 
well as turn the system on or off.  
	More than 150,000 people worldwide have received Medtronic
 neurostimulation systems for pain, including the famed comedian, 
Jerry Lewis, whom some of you have met - perhaps most recently in 
September when he visited Capitol Hill in support of H.R. 1020, the 
"National Pain Care Policy Act."
	In addition to our neurostimulation system, Medtronic 
manufactures the world's only implantable, programmable drug infusion
 systems. Over 100,000 people have been treated with these systems 
throughout the world.  These systems, commonly referred to as "drug 
pumps," consist of an implantable, programmable pump placed under the 
skin of the abdomen and a catheter that is placed in the intraspinal 
space surrounding the spinal column, to deliver liquid morphine directly 
to where it's needed.  The systems, like the spinal cord stimulators, 
include a "remote control" or patient programmer.  These systems are 
also pre-programmed by physicians with the appropriate dose of 
medication.  We recently received FDA approval for the first "remote 
control" that allows patients to administer their own "supplemental" 
doses of pain medication, when they need it, through our implantable 
drug pumps.
	I'll also point out that because our drug pumps deliver 
medication directly into the intraspinal space, the dose required to 
manage the patient's chronic pain is typically only a small fraction of 
the amount required by oral (ie, pills) or other administration.  As a 
result, the side effects are generally significantly reduced.  For 
example, our pumps may better enable an end-stage cancer patient to 
spend her final months in the company of family and friends, without 
the high levels of drowsiness, and other side effects that can arise 
from high-dosage oral pain medications.
	Our spinal cord stimulation devices, as well as our "drug pumps" 
for chronic pain, often are implanted in patients because other options 
to manage their pain have failed.  Instead, patients continue to have 
pain after repeated back surgeries, or they may have suffered other 
injuries or chronic conditions that leave them with persistent, 
debilitating pain.  A significant number of patients use them to manage 
the severe pain associated with the progression or treatment of 
malignant cancer, providing them better quality of life. 

Future Technologies for the Treatment of Chronic Pain
	While our neurostimulation and drug delivery systems have 
provided relief to hundreds of thousands of those with chronic pain, 
there are still too many people who are suffering in silence, and who 
need to know about these additional medical options to adequately 
manage their pain.   
	We believe that new technologies are providing better, more 
cost-effective medical outcomes.  For example, our neurostimulator 
called Restore, which was made available to patients in the U.S. this 
past spring, builds on our existing neurostimulation system by 
offering a rechargeable battery, which benefits patients living with 
the most severe types of pain who might otherwise limit the use of 
their neurostimulator to conserve or "hoard" the battery power that's
 available through a lower-power model.  With both the neurostimulator 
and the pumps, the size of the devices have become significantly 
smaller over the years, and the features have been enhanced to provide 
both the physician and patient greater control in managing pain 
	We are also expanding the conditions for which this type of
 implantable, electricity-delivering therapy can be used.  Studies 
are currently underway to test the feasibility of using 
neurostimulation to treat severe, chronic migraine patients.  We are 
hopeful that this therapy will provide relief to the more than 
28 million Americans who suffer from migraine headaches that cannot be 
treated with standard migraine treatments.
	Future products will no doubt be smaller to improve patient 
comfort and satisfaction with these devices.  New "sensing" technology 
under development could drive change in the way patient outcomes are 
measured, by allowing physicians to measure patient improvement as a 
result of our devices, more objectively than they can now.

Patients Must have Access to Available Treatments
	As I previously mentioned, chronic pain is not easy to treat and 
I am confident that industry, clinicians and most importantly patients 
would greatly benefit from research that would give us a better 
understanding of the causes of pain and lead us to improved treatment 
options.  Medtronic invests in many projects each year to support 
on-going research efforts in the field of pain.
	Unfortunately, many people who are currently living with chronic 
pain are looking for more immediate solutions for their chronic pain.  
Many chronic pain sufferers have not found the relief they need due to
 unnecessary barriers that hinder access to new therapies.  While our
 technologies continue to advance, without patient access to these 
therapies, the under-treatment of pain will continue to be one of 
this country's top public health problems.  
	Medtronic has actively engaged with the patient and provider 
community to support H.R. 1020, the "National Pain Care Policy Act",
 introduced by Congressman Mike Rogers.  This piece of legislation
 systematically addresses many of the factors that have lead to the 
under-treatment of chronic pain.  We are grateful to Congressman Rogers 
for his leadership in raising awareness of this important public health
 concern.
	A disturbing barrier to access is simply a lack of understand 
of the array of clinically effective therapies already available.  
Forty percent of people with chronic pain do not go to the doctor for 
their pain because they believe that nothing can be done to treat it.  
In a study conducted by the Mayday Fund, 92 percent of respondents 
considered pain to be a part of life and nearly 35 percent would wait 
until the pain becomes unbearable before taking medication.  
	When they do visit a physician, treatment is often inadequate 
for over half of all patients seeking care, forcing them to change 
physicians before they find relief.  Societal beliefs about pain have
 reinforced the idea that living with pain is a sign of strength.  
Addressing these misconceptions by helping to elevate understanding of 
this disease will greatly assist chronic pain sufferers in getting the 
help they need.  
	There are also institutional barriers to effective pain 
treatment.  For many years medical schools addressed the treatment of 
pain as an afterthought associated with an underlying condition.  
Increased understanding about the science of pain has helped to define 
pain as a condition that needs to be treated and taught as a distinct 
medical condition.  Medtronic supports the initiatives contained in the
 Roger's bill to help ensure that all physicians have access to current
 information on the wide array of pain therapies available to patients 
today.  With enhanced education, perhaps we will see more internists and
 general practitioners recognize chronic pain and have knowledge or 
available referral and treatment options.
	While there isn't a simple solution to this complex disease, 
raising the visibility of the problem of under treatment and starting 
the national dialogue on how to ensure that chronic pain sufferers get 
the care they need is a good first step in addressing the problem. 
 Information sharing may be one of the easiest and most cost-effective 
ways to begin to chip away at the barriers preventing optimal pain 
treatment.   Research to better define the chronic pain patient 
population, and public awareness campaigns aimed at educating the public
 on the nature of this disease, would dramatically improve the treatment 
of pain in this country.

Pulmonary Hypertension
	Pulmonary Hypertension (PH) is a rare, debilitating and 
ultimately fatal disease of the lungs that affects approximately one 
or two people per million, totaling approximately 100,000 people 
worldwide.  Pulmonary hypertension is a rare blood vessel disorder in 
which the pressure in the pulmonary artery (the blood vessel that leads 
from the heart to the lungs) rises above normal levels and may become 
life threatening. Symptoms of pulmonary hypertension include shortness 
of breath with minimal exertion, fatigue, chest pain, dizzy spells and
 fainting.
  	The cause of Primary Pulmonary Hypertension is a mystery, but 
is thought to have a latent genetic component that is "activated" after 
a viral or bacterial infection in the blood vessels that supply the 
patient's lung tissue.   Secondary forms of the disease, which is more
 frequently observed, are seen as an adverse effect of the now-banned 
diet pills Redux and fen-phen and as a complication of lupus and other
 rheumatologic disorders. How and why this combination of drugs caused 
the increase is not well understood, but this "new" population is 
primarily young women between the ages of 21 and 40.  
	Medtronic MiniMed, our diabetes business located in Northridge
 California, offers a delivery system for the administration of 
Remodulin, a drug that dilates affected blood vessels in the lung 
tissue increasing blood flow and improving oxygen exchange.  Patients 
receive this drug through the use of Medtronic's medication delivery 
pump that delivers the drug under the skin and is similar to an insulin 
pump used to treat Type I diabetes.  Many patients have found the 
medication pump to be a more convenient way to administer the therapy 
as the pump is about the size of a pager, it is totally portable, and 
delivers smaller doses, which is more readily absorbed and with fewer 
side effects.
	Given the devastating nature of this disease and the need for
 increased research, Medtronic strongly supports H.R. 3005, the 
"Pulmonary Hypertension Research Act of 2005," which creates three 
Centers of Excellence at the National Institutes of Health dedicated 
to learning more about this disease as well as instituting an important 
public awareness campaign aimed at increasing the patient and medical
 community's knowledge of this disease.   

Conclusion
	We are grateful for the Subcommittee's interest in both Pulmonary
 Hypertension and chronic pain and thank you for the opportunity to 
discuss some of the therapies Medtronic has made available to suffering
 patients.  While Medtronic shares the vision of finding a cure for 
pulmonary hypertension and chronic pain, we continue to look for ways 
to improve the quality of life for those afflicted with these and many 
other chronic conditions.  We welcome the opportunity to work with this
 Subcommittee to increase understanding of these diseases and ensure 
that patients have timely access to life-saving and life-enhancing
 technologies.


	
	MR. DEAL.  Thank you.
	Dr. Gladwin.
	MR. GLADWIN.  Mr. Chairman, members of the subcommittee, 
Mr. Brady, and Mr. Lantos, thank you very much for the opportunity to
 speak to you today about research being conducted at the National 
Heart, Lung, and Blood Institute addressing pulmonary hypertension.  
I am also humbled and honored to sit with Mr. Hicks and Charity.  Your
 testimonies are very motivating for clinical researchers, like me, 
taking care of other patients with pulmonary hypertension.
	What I would like to do today is briefly outline the basic 
chronology of pulmonary hypertension and summarize our research efforts 
to develop new treatments and detection strategies and describe our 
vision for future research activities coming from the Heart, Lung, and 
Blood Institute.
	As you have heard already, pulmonary hypertension is a 
disabling condition caused by the narrowing of the small arteries that 
serve the lung.  This results in an increase in the pressure, not 
measured at the arm, but within the lungs.  As these arteries tighten, 
the right heart, which pumps blood through the lung, encounters 
increasing resistance, as if pipes in a plumbing system are narrowed.  
The right heart is not equipped to deal with these high pressures, and 
over time, begins to fail.  As the right heart fails, the ability to 
deliver oxygen and nutrients to the body decreases the ability to pump.
	From a symptomatic standpoint, patients with pulmonary 
hypertension will present with rapid heart rates, dizziness, shortness 
of breath especially with exertion, chest pressure, tightness, fatigue, 
and ultimately fainting.  These symptoms are so general and non-specific 
that the disease is often not diagnosed until the overworked right heart 
is close to complete failure, very late in the course of the disease.
	Patients with this often progress to the point that they can't
 accomplish the simplest activities of daily living.  My patients will
 complain of inability to vacuum the floor of their living room, 
inability to cook, inability to walk upstairs, across a room, and 
often inability to speak in a full sentence without taking a deep 
breath.
	Pulmonary hypertension can be fatal, but new treatments are 
available that can slow its progression and improve the quality of 
life.  The disease really exists in two forms.  The first is primary 
or endopathic pulmonary hypertension.  This is the cause of pulmonary
 hypertension where it is not associated with the systemic illness, 
and we really don't know the precipitating cause.  The pathology is 
the same in this type of pulmonary hypertension as well as in 
secondary pulmonary hypertension, where that is pulmonary hypertension 
that is associated with a systemic disease.  These systemic diseases 
include scleroderma, sickle cell disease, HIV infection, and a host of 
other conditions.
	Basic transrelational and clinical studies have led to, really, 
the discovery of two fundamental mechanisms that lead to pulmonary
 hypertension.  The first is the disregulation of chemicals produced by 
blood vessels that they dilate or open up the blood vessels and opposing
 chemicals that are constrictors that constrict the vessel.  Our blood 
vessels normally have a very refined balance of these constrictors and
 dilators, and this becomes disregulated pulmonary hypertension.
	The second major mechanism is a proliferative, almost cancerous
 response of the smooth muscles within the blood vessels that invade and 
fill up the lumen or the inside of the blood vessel, and this creates a
 blockage of the pulmonary arteries.
	With regard to the first mechanism, these chemicals are released 
from endothelium, which are the cells that line blood vessels.  These are
 dilating chemicals, and then there are constrictor chemicals.  The 
dilating chemicals include Prostacyclin, which is actually the first 
FDA-approved drug for pulmonary hypertension and the drug that really 
broke open the therapeutic side to this field.  This discovery of this
 compound led to the Nobel Prize in Physiology Medicine that was awarded 
in 1982.
	The second compound, something that I study personally, is nitric
 oxide, a gas molecule present in cigarette smoke, car exhaust, but also 
made by our bodies.  The discovery of this molecule led to the Nobel 
Prize Award in 1998.  This is also a very important dilating agent.
	Both of these chemicals not only dilate and open up blood 
vessels, but they block clotting and they block abnormal growth of 
cells.  So they maintain homeostasis of our blood vessel system.  These
 dilators are opposed by constrictors; a principal one being a chemical 
called endothelin-1.  This is one of the most potent constrictor 
molecules ever discovered.  It is actually analogous to a chemical 
found called sarafatoxin in snake venom, so when the snake bites 
someone, there is a potent constriction in the tissues.  So you can 
imagine what happens when this chemical rises in the blood of patients 
with pulmonary hypertension.
	Over the past decade, I think we are really at the cusp of a 
perfect storm of basic science and clinical development of drugs.  
There are really, in the last 5 years, five FDA-approved drugs and 
another five coming for the treatment of pulmonary hypertension based 
on the evolving field of vascular biology and these big discoveries 
that led to these two Nobel Prizes.
	The first part is Prostacyclin.  You have heard about that.  
It requires a continuous infusion, an iced pump.  Patients often 
require two pumps so there is a backup one, because you can't have 
that continuous infusion fail.  And a recent advance, the development 
of another Prostacyclin analog allows infusion not to be cooled, which 
is an important advance for the quality of life for patients.  Also 
very exciting, there has now been development of an inhaled form of
 Prostacyclin that patients can use.
	And most important for patients and their quality of life, 
there are now two pills available.  The first is Bosentan.  Again, 
these are targeting these fundamental basic science discoveries.  
Bosentan blocks the endothelin receptor, that constrictor receptor.  
And Bosentan is taken twice a day.  There a number of drugs in this 
class that is now being developed.  The second oral drug is Viagra, 
of all things, or Sildenafil, which was just FDA-approved in the last 
month.  This drug potentates the nitric oxide dilating signal, and it 
turns out, really by a stroke of luck, that the lung vasculature has a 
high level of the enzyme that Viagra blocks, so it specifically lowers 
the pressure in the lungs, and this was just FDA approved.
	Again, all of these classes that you hear about on Super Bowl
 commercials of drugs are now being developed for pulmonary 
hypertension.  These existing medications improve the quality of life, 
they increase survival, but they do not and can not cure the disease,
 unfortunately, because they only act in that first step, the 
disregulation of constrictors and dilators.  The second step, we 
believe, is very important, and this is that this rise in pressure is 
being driven by a proliferation of growth, almost a cancerous growth, 
of the smooth muscle cells that invade into the center of the blood 
vessel.
	If you look at the pathology of someone who has unfortunately 
passed away with this condition, there is no blood vessel left.  There 
is this cancerous extension of cells into the middle of it.  There is 
nothing left to vasodilate.
	Many of the efforts targeting these diseases are being funded 
by the Heart, Lung, and Blood Institute.  One of the exciting avenues 
is the use of anti-cancer drugs, or drugs derived from the coronary 
artery disease field that targets this abnormal growth of cells.  And 
I would be quite interested to answer questions about this area.  I 
think it is very exciting.  It is a big promise for the future.
	Many of these efforts are funded by the Heart, Lung, and Blood
 Institute, which supports a robust research effort in pulmonary 
hypertension.  In fiscal year 2005, their research portfolio included 
more than 90 investigator-funded grants.  I have a list.  I would be 
happy to go over that with you.  In this year, the funding hit $30.8 
million, which is a doubling over the last 5 years in funding.
	In addition to this, we have requested grant applications for 
three or four pulmonary vascular disease clinical research centers, 
and the proposals are in now for these centers.  These centers are 
extremely exciting, because they are going to infuse basic science, 
pre-clinical animal models of the disease, and require clinical 
research projects as well.  Every one of these score grants requires 
that the center have state-of-the-art, new, cutting-edge science, 
basic science, but they have to have two clinical projects as well.  
So it will add the clinical and basic scientists together.
	We are also monitoring, in 2006, a multi-center trial to test 
whether Viagra is beneficial for patients who have pulmonary 
hypertension with sickle cell disease, and we will assess the best 
ideas, whether they come from the individual investigators with 
creativity who submit grant applications and we are committed to 
maintaining the financial flexibility to fund the most promising 
grant applications.
	I am also proud to announce, under the dynamic leadership of 
Dr. Nable that we have started a new research effort right here in 
the intramural division of the Heart, Lung, and Blood Institute in 
Bethesda that I am leading in the newly-formed Vascular Medicine 
Branch.  This is a branch entirely devoted to the study of blood 
vessel disease therapies.
	The initiative has four major goals.  The first is to develop 
new therapies for pulmonary hypertension.  We currently are recruiting
 patients for five phase one and two clinical trials, and are launching 
two large, multi-center phase three trials for pulmonary hypertension
 associated with sickle cell disease.  We believe the studies emanating 
from this will have spill-over effects, important spill-over effects 
for all forms of pulmonary hypertension, because the disease and the
 mechanism, the pathology is the same.
	We have also identified a new medication in the intramural 
division, sodium nitrite, which can be easily nebulized with a current 
asthma delivery system, and this decreases pulmonary pressures in 
animal models of neonatal pulmonary hypertension.  These are babies 
who develop pulmonary hypertension.
	The second effort is to test whether therapy can halt blood 
vessel damage that occurs in patients with sickle cell disease and
 thalassemia.  We have discovered, in a large regional study, that 
patients with sickle cell disease suffer a very high attack rate to 
pulmonary hypertension.  One-third of adults by age 35 have pulmonary
 hypertension.  It is the major cause of death.  This is 20,000 
Americans.  Patients with pulmonary hypertension that have sickle cell 
disease have a 10-fold increase risk of death compared to those without.
	Our third effort is to identify pre-disease in that risk 
populations.  As you know, as is the case with diabetes with systemic 
high blood pressure measured at the arm, we keep lowering and lowering 
the target therapy, that if we can treat early disease, we have a 
better chance of preventing its eventual progression.  We believe that 
there is a similar opportunity in pulmonary hypertension.  And there 
are diseases with such a high attack rate of pulmonary hypertension 
that we can screen those populations.  This includes scleredema, 
HIV-infected patients, sickle cell patients, and thalassemia patients.
	And finally, an exciting development is the implementation of 
phase one and two chemotherapeutic drug trials and novel small molecule 
drug trials that are again targeting this cancerous proliferation of the
 vasculature.  We think such anti-proliferative therapy is going to be 
key for reversal of disease rather than simply improving symptoms.
	Just of the script, I will say that this is a very exciting 
time that, as a clinician and a scientist, I had a patient in the 
intensive care unit more than a month ago who was a young woman with 
a 17-year-old son who came into the ICU in severe right heart failure.  
She had 60 pounds of weight gain from right heart failure, an inability 
to pump that blood around to the heart.  She was near death in the ICU, 
was saying good-bye to her family members.  When I started as a resident,
 Prostacyclin wasn't yet available beyond specialty centers.  We were 
able to start her on three FDA-approved drugs, an infusion of 
Prostacyclin, Bosentan, and Sildenafil.  We managed, over one week, to 
get 60 pounds of fluid off of her, get her out on oxygen and two pills, 
and she is alive and doing very well today.  This is an unheard of 
development for an orphan disease, and a very exciting time which will 
require us to educate our young clinicians in knowing how to use all of 
these drugs as well.
	So thanks to the efforts of researchers, patient advocates, the
 support of Congress, the American taxpayers, and advocates, pulmonary
 hypertension is moving from the ranks of diseases that were once 
considered to be untreatable to the growing list of conditions for 
which medical science offers a hope for a better quality of life and 
more years to enjoy it.  Our goal is to restore the health to those 
who suffer from pulmonary hypertension and to prevent others from 
developing this dreadful disease.
	And thank you for being committed to this noble cause and for 
allowing me to speak.  And I would love to answer questions.
	[The prepared statement of Mark Gladwin follows:]

PREPARED STATEMENT OF MARK GLADWIN, CHIEF, VASCULAR MEDICINE BRANCH, 
NATIONAL HEART, LUNG, AND BLOOD INSTITUTE, NATIONAL INSTITUTES OF HEALTH

Major points - December 8, 2005, Testimony of Dr. Mark Gladwin to the
House Energy and Commerce Subcommittee on Health

* Over the past decade, several drugs that affect vessel dilation and
 constriction have received FDA approval.  The first drugs available 
were given via injection, but three drugs recently have been approved 
that can be inhaled or swallowed.
* Researchers now believe that pulmonary hypertension also is caused by 
a cancer-like proliferation of smooth muscle cells of the pulmonary 
artery and hypothesize that anti-cancer drugs may have applications as
 therapies for pulmonary hypertension patients. 
* In FY 2005, the NHLBI research portfolio included more than 90 research 
and training projects on pulmonary hypertension.  The Institute also 
issued a Request for Applications for 3 or 4 pulmonary vascular disease
 research centers.  In FY 2006, the NHLBI plans to launch a new program 
to test whether sildenafil therapy is beneficial for patients who have
 pulmonary hypertension in conjunction with sickle cell anemia.  
* The NHLBI started a new research effort, the Vascular Medicine Branch, 
in the Division of Intramural Research.  Under the leadership of 
Dr. Gladwin, the branch has four major goals:  
o Development of new therapies for pulmonary hypertension.  
o Testing of whether sildenafil therapy can halt blood vessel damage 
that causes patients who have sickle cell anemia or thalassemia to 
develop pulmonary hypertension.  
o Identification of "pre-disease" in high-risk patients.  
o Development of clinical trials of compounds to reverse the cancer-
like proliferation of smooth muscle cells.  

Testimony of Mark T. Gladwin, M.D.
	Mr. Chairman and members of the Subcommittee, thank you for 
the opportunity to appear before you today to discuss research on 
pulmonary hypertension conducted by the National Heart, Lung, and 
Blood Institute (NHLBI), part of the National Institutes of Health, 
an agency of the U.S. Department of Health and Human Services.  Today 
I will briefly outline what we know about the basic biology of 
pulmonary hypertension, summarize our research efforts to develop 
new treatments and detection strategies, and describe our vision for 
future research activities.
	Pulmonary hypertension is a disabling condition caused by a 
narrowing of the small arteries that carry blood through the lungs, 
resulting in damage to the heart.  As the arteries tighten, the heart 
must work harder to pump blood through them.  Pulmonary hypertension 
can manifest itself as rapid heart rate, dizziness, shortness of breath, 
chest pain, fatigue, and fainting-symptoms so general that the disease 
is often not diagnosed until the overworked heart muscle has become too 
weak to pump enough blood through the lungs and the patient is unable 
to perform even the simplest daily activities.  Pulmonary hypertension 
can be fatal, but new treatments are available that can slow its 
progression and improve quality of life. 
	The disease exists in two forms:  primary pulmonary 
hypertension (PPH), which arises without any clear-cut underlying 
illness to precipitate it, and secondary pulmonary hypertension, which 
is caused by another illness such as sickle cell anemia or HIV infection.
  Basic, translational, and clinical studies have led to the discovery of 
two different mechanisms common to both forms of the disease:  
(1) blood vessel dilation/constriction; and (2) blood vessel blockage. 
	The first mechanism involves some chemicals released from the 
lining of blood vessels (called the endothelium) that open up or dilate 
blood vessels and other opposing chemicals that constrict the blood 
vessels.  Dilating chemicals include prostacyclin (the compound for 
which the Nobel Prize in Physiology or Medicine was awarded in 1982) 
and nitric oxide (the subject of the 1998 Nobel Prize in Physiology or
 Medicine).  Both are potent biological molecules that not only open 
up blood vessels but also block clotting and abnormal cellular growth.  
They are opposed by potent constrictors such as endothelin, a chemical 
that is structurally very similar to sarafotoxins found in snake venom.
	Over the past decade, several drugs that attenuate these 
	vasoconstrictor chemicals have been developed and have received FDA 
approval.  Discovery of these drugs led to a revolution in therapy and
 provided new hope for patients by reducing symptoms, increasing 
exercise capacity, and improving survival.  The first of these drugs, 
however, has to be given through a permanent catheter placed in a vein 
in the neck and connected to a battery-powered iced pump.  Treatment 
became a little easier for some patients in 2002 when the FDA approved 
a second, more stable drug that could be infused under the skin 
(thereby reducing a patient's likelihood of infection) and, because the 
drug did not need to be chilled, could be administered by a mini-pump 
that was not heavily weighed down by ice.  Over the past 12 months, 
three additional drugs that are even easier for patients to take have 
been approved for treatment of pulmonary hypertension:  iloprost
 (Ventavis(r)), which can be inhaled through a nebulizer, and 
bosentan (Tracleer(r)) and sildenafil (Viagra(r)), which are swallowed 
as pills.  Furthermore, these recent advances have opened the door to 
an avalanche of new related medications with different receptor 
targets, different half-lives, and different side-effect profiles.
	The existing medications clearly improve the quality of life 
and increase survival, but they do not and cannot cure the disease 
because they act only on the first critical mechanism of pulmonary
 hypertension.  Researchers now believe that the devastating blood 
pressure increase in pulmonary vessels also is caused by an abnormal, 
almost cancerous (though not metastatic, i.e., not spreading to other
 tissues), proliferation of the smooth muscle cells of the pulmonary 
artery that crowds the blood vessel and eventually chokes off all 
blood flow.  Scientists are building on advances in treatments for 
patients who have cancer or coronary heart disease as they search 
for compounds that can interfere with the cancer-like growths and 
thereby not only prevent disease progression but also cure the disease 
by reversing vessel obstruction.
	Many of those efforts are funded by the NHLBI, which supports a 
robust research effort in pulmonary hypertension.  In Fiscal Year (FY) 
2005, our research portfolio included more than 90 research and training
 projects on pulmonary hypertension that address the problem from 
multiple perspectives.  In FY 2005, we also requested grant applications 
for 3 or 4 pulmonary vascular disease research centers.  These centers 
will fuse basic research, studies of pre-clinical animal models, and 
human clinical trials to expedite development of the next generation 
of therapeutics.  During FY 2006, we plan to launch a new program to 
test whether sildenafil therapy is beneficial for patients who have 
pulmonary hypertension in conjunction with sickle cell anemia.  And 
because most of our best ideas come from individual investigators who 
submit grant applications, we are committed to maintaining the 
financial flexibility to fund the most promising grant applications. 
	We have also started a new research effort in the intramural 
division of the NHLBI that I am leading in the Vascular Medicine Branch.  
This important bench-to-bedside initiative has four major goals:  
1)  Development of new therapies for pulmonary hypertension.  We 
currently are recruiting patients for five phase I/II trials and are 
launching two phase III studies this year.  We have identified a new
 medication, nitrite, that can be nebulized easily with current 
asthma-delivery devices and can decrease pulmonary pressures in animal 
models of neonatal pulmonary hypertension.  
2)  Testing of whether sildenafil therapy can halt blood vessel damage 
that causes patients who have sickle cell anemia or thalassemia to 
develop pulmonary hypertension.  We have discovered that patients with 
sickle cell disease and thalassemia are developing pulmonary 
hypertension at an alarming rate2,3.  One-third of these patients, 
almost 20,000 Americans, have pulmonary hypertension, which represents 
the greatest risk for death in this population.  
3)  Identification of "pre-disease" in high-risk patients.  As is the 
case with diabetes and high blood pressure, early therapy has the 
potential to prevent end-organ complications.  We are developing 
screening biomarkers and strategies for patients at high risk of 
developing pulmonary hypertension, such as those who have scleroderma, 
HIV, or sickle cell disease, so that early disease can be identified and
 addressed.  
4)  Development of phase I/II trials using chemotherapeutic medications 
and novel small molecules to reverse the cancerous proliferation of 
smooth muscle cells in the blood vessels of the lung.  We believe such 
"anti-proliferative" therapy is the key to an ultimate cure.
	Thanks to the efforts of researchers and patient advocates and 
the support of Congress and the American taxpayers, pulmonary 
hypertension is moving from the ranks of diseases that once were 
considered to be untreatable to the growing list of conditions for which
 medical science offers hope of a better quality of life and more years
 to enjoy it.  Our goal is to restore to health those who suffer from
 pulmonary hypertension and to prevent others from developing this 
dreadful disease. 
	Thank you for being committed to this noble cause and for allowing 
me to speak with you today.  I will be happy to answer any questions you 
may have.

Mark T. Gladwin, M.D.
Chief, Vascular Medicine Branch
National Heart Lung and Blood Institute
National Institutes of Health
U.S. Department of Health and Human Services

	Mark Gladwin received his Doctor of Medicine from the 
University of Miami Honors Program in Medical Education in 1991. 
 After completing his internship and chief residency at the Oregon 
Health Sciences University in Portland, Oregon, Dr. Gladwin joined 
the National Institutes of Health (NIH) in 1995 as a critical care 
fellow at the Clinical Center.  After a one-year clinical fellowship 
in pulmonary medicine at the University of Washington in Seattle, he 
returned to the NIH Clinical Center for a research fellowship in the 
Critical Care Medicine Department under the mentorship of Drs. James
 Shelhamer, Frederick Ognibene, Alan Schechter, and Richard Cannon.  
	In 2005, Dr. Gladwin was appointed Chief of the new Vascular 
Medicine Branch in the Division of Intramural Research at NIH's 
National Heart, Lung, and Blood Institute (NHLBI).  As branch chief, 
he oversees a robust portfolio of studies to define the cellular and 
molecular mechanisms that underlie normal physiological function and 
disease processes of the lungs and their vasculature and fosters
 collaborations with researchers in the NIH Clinical Care Medicine 
Department to ensure strong and smooth interactions among laboratory 
and clinical investigations.  
	He has been involved in enrolling more than 700 patients in 
more than a dozen studies at the NIH Clinical Center and has co-
authored 82 published peer-reviewed manuscripts addressing biochemical
 mechanisms involved in blood vessel relaxation and contraction.  
Recent efforts to develop a mechanistic, clinical, and epidemiological
 description of hemolysis-associated pulmonary hypertension led to the
 observation that pulmonary hypertension occurs in 30 percent of 
patients who have sickle cell disease, is a major cause of mortality 
in this patient population, and is strongly associated with excessive
 destruction of red blood cells, high levels of iron in the blood, 
and kidney disease.  These findings, combined with his earlier 
mechanistic studies, are leading to clinical trials of compounds that 
can help patients have pulmonary hypertension in conjunction with 
sickle cell anemia or other disorders.

	MR. DEAL.  Thank you, Doctor.
	Mr. Hicks.
	MR. HICKS.  Mr. Chairman and distinguished members of the
 subcommittee, thank you for convening this important hearing, and for
 permitting me the opportunity to testify this morning.
	I, too, wish to add my sincere thanks and gratitude to Captain 
Pruden for his distinguished service.  Thank you, Captain.
	I am the Vice President for Advocacy and a volunteer of the 
Pulmonary Hypertension Association, and I am profoundly honored to 
represent the hundreds of thousands of Americans who are fighting a 
courageous battle against this deadly disease.  In particular, 
Mr. Chairman, I am pleased to bring greetings to you from a PHA Georgia 
youth group, which is headquartered in your Congressional District in
 Loganville.
	The Pulmonary Hypertension Association, which was founded by a 
handful of patients 15 years ago when there were less than 200 diagnosed
 patients with this disease, today, PHA is headquartered in Silver 
Spring, Maryland and is growing rapidly and includes over 6,000 
patients, family members, and medical professional members, an 
additional 20,000 family members, friends and supporters, and an 
international network of over 120 support groups.
	The impact of this disease upon so many Americans and their 
family members is like a nightmare you can never wake up from.  For my 
family, it began with the words spoken not far from here at Walter Reed 
Army Medical Center a few years back.  "Colonel Hicks," the doctor said, 
"Your daughter, Meaghan has less than a year to live.  We can do nothing 
for her."  Since that time, she has fought a valiant and protracted 
fight.  And due to the hellishness of this disease, we have nearly lost 
her three times, twice in the past 2 months.  Her blood is a pharmacy 
soup of many, many drugs taken in large quantities in order to survive.  
Among other things, she is taking, daily, Procardia XL, Lasix, potassium,
 Zofran, spirodactone, Coumadin, Viagra, Tracleer, Zoloft, Albuterol, 
Flovent, Flonase, Digoxin, Xanax, and, of course, Flolan.  This drug 
is delivered by pump directly to her heart, as Dr. Gladwin discussed.  
It is delivered through her chest wall 24 hours a day.  If the Flolan 
is interrupted for a period of time, that alone can kill her.  Twice in 
the last month, she has had significant interruptions.  She suffers 
chronic pain in her jaw, feet, and is frequently nauseated, and endures
 diarrhea daily as a side effect of these medications.  She is only 
24 years old.
	Meaghan will never know the joy of motherhood or even marriage.  
Were she to marry, she would lose my insurance benefits that are keeping 
her alive.  As you might imagine, the impact on our family has been
 devastating.
	There are millions more affected by this in the United States 
alone.  And although not well known and considered rare, you would be
 astounded to know that we have more Americans dying from this disease 
today in the United States than were tragically lost in combat in all
 conflicts we have encountered since the final year of World War II.  
Yes, that includes Vietnam, Korea, up through our current War on Terror.  
Even with a scope that horrific, I am sometimes asked why we should pay
 attention or focus resources on that terminal illness instead of others, 
of which there are clearly many.  The answer is, quite simply, because 
we can.
	Mr. Chairman, hope for our patients and their families lie in
 advancements made through biomedical research.  And along those lines, 
I want to take this opportunity to express PHA's deep gratitude to two
 personal heroes of mine, Congressman Kevin Brady and Congressman 
Tom Lantos, for their leadership on our behalf.  As you know, and we 
have heard this morning, they have introduced H.R. 3005, the Pulmonary
 Hypertension Research Act in the House.  This landmark bill, 
introduced only in June, already has 240 bipartisan co-sponsors, 17 of 
whom are members of this very subcommittee.  We owe a lot to these 
great champions, and we are grateful for the efforts of Congressman 
Lantos' beautiful and courageous granddaughter as well, Charity, to my 
left.
	You know, this bill H.R. 3005 calls for the establishment of 
three Centers of Excellence on pulmonary hypertension through the 
NHLBI, and these centers would focus on the following: basing clinical
 research into the cause, diagnosis, early detection, prevention, and
 treatment of pulmonary hypertension; training programs designed to 
develop the next generation of pulmonary hypertension investigators;
 continuing education on pulmonary hypertension for healthcare 
professionals; dissemination of information to the public on pulmonary
 hypertension to raise awareness; and the establishment of a pulmonary
 hypertension data system and clearinghouse.
	Mr. Chairman, you need to realize, sir, our regard the need for
 additional research.  On November the 11th, the Centers for Disease 
Control and Prevention released a long-awaited morbidity and mortality 
report on pulmonary hypertension.  In that report, the CDC states: 
"More research is needed concerning the cause, prevention, and 
treatment of pulmonary hypertension."  The science base, as 
Dr. Gladwin pointed out, must be further investigated to improve 
prevention, treatment, and case management.
	On behalf of PHA, I would like to take this opportunity to 
thank NHLBI Director, Dr. Betsy Nable, and her colleagues for their 
leadership in this fight, which has clearly been outlined this morning 
by Dr. Gladwin.  We are proud to have a partnership with this institute, 
and we are very grateful that Dr. Gladwin has taken the time to share 
his knowledge and insight with us at the hearing today.  And I must say 
that his announcement of the three centers this morning is the most 
exciting news we have heard in the known history of this disease.  
Thank you very much.  Please pass our thanks to Dr. Nable.
	Moving third, PHA is very eager to work with Congress and the 
NHLBI to establish the Centers of Excellence on pulmonary hypertension 
called for in the act.  The overwhelming support for this bipartisan
 legislation speaks to the strong interest of members in this issue, 
and we hope to make real progress in establishing these centers in 
2006.  Working together, I am confident that we can find a cure for 
Meaghan, Charity, and hundreds of thousands of Americans fighting for 
their lives against this terrible illness.
	Mr. Chairman, thank you so much for this opportunity this 
morning.
	[The prepared statement of Carl Hicks follows:]

PREPARED STATEMENT OF CARL HICKS, VICE PRESIDENT, ADVOCACY, PULMONARY
 HYPERTENSION ASSOCIATION

SUMMARY OF TESTIMONY:

1)  INTRODUCTION TO PULMONARY   HYPERTENSION AND THE PULMONARY 
HYPERTENSION ASSOCIATION.

2)  PERSONAL STORY OF MEAGHAN HICKS' BATTLE WITH THE DISEASE.

3)  DISCUSSION OF H.R. 3005, THE "PULMONARY HYPERTENSION RESEARCH ACT."

	Mr. Chairman, Congressman Brown and distinguished members of 
the subcommittee, thank you for convening this important hearing this 
morning and for the opportunity to testify.  I am Carl Hicks, Vice 
President for Advocacy with the Pulmonary Hypertension Association, 
and a proud parent of a pulmonary hypertension patient.
	I am honored today to represent the hundreds of thousands of 
Americans who are fighting a courageous battle against this 
devastating disease.  In particular Mr. Chairman, I am pleased to 
bring greetings to you from the PHA Georgia Youth Group, which is
 headquartered in your congressional district, in Loganville.  This is 
one of PHA's outstanding support groups for young PH patients, led by a
 terrific volunteer named Robin Chambless.
	Pulmonary hypertension is a serious and often fatal condition 
where the blood pressure in the lungs rises to dangerously high levels. 
In PH patients, the walls of the arteries that take blood from the right 
side of the heart to the lungs thicken and constrict.  As a result, 
the right side of the heart has to pump harder to move blood into the 
lungs, causing it to enlarge and ultimately fail.  
	PH can occur without a known cause or be secondary to other 
conditions such as; collagen vascular diseases (i.e., scleroderma and 
lupus), blood clots, HIV, sickle cell, and liver disease.  PH does not
 discriminate based on race, gender or age.  Patients develop symptoms 
that include shortness of breath, fatigue, chest pain, dizziness, and
 fainting.  
	Unfortunately, these symptoms are frequently misdiagnosed, 
leaving patients with the false impression that they have a minor 
pulmonary or cardiovascular condition.  By the time many patients 
receive an accurate diagnosis, the disease has progress to a late 
stage, making it impossible to receive a necessary heart or lung 
transplant. 
	While new treatments are available, unfortunately, PH is 
frequently misdiagnosed and often progresses to late stages by the time 
it is detected.  Although PH is chronic and incurable with a poor 
survival rate, the new treatments becoming available are providing 
a significantly improved quality of life for patients.  Recent data 
indicates that the length of survival is continuing to improve, with 
some patients able to manage the disorder for 20 years or longer.
	Fifteen years ago, when three patients who were searching to 
end their own isolation founded the Pulmonary Hypertension Association, 
there were less than 200 diagnosed cases of this disease.  It was 
virtually unknown among the general population and not well known in 
the medical community.  They soon realized that this was unacceptable, 
and formally established PHA, which is headquartered in Silver Spring,
 Maryland.  
Today, PHA includes:

- Over 6,000 patients, family members, and medical professionals. 
- An international network of over 120 support groups. 
- An active and growing patient telephone helpline. 
-	A new and fast-growing research fund. (A cooperative agreement 
has been signed with the National Heart, Lung, and Blood Institute to 
jointly create and fund five, five-year, mentored clinical research 
grants and PHA has awarded eleven Young Researcher Grants.)
- A host of numerous electronic and print publications, including the 
first medical journal devoted to pulmonary hypertension - published 
quarterly and distributed to all cardiologists, pulmonologists and
 rheumatologists in the U.S.
	Mr. Chairman, I want to take this opportunity to express PHA's 
deep gratitude to Congressman Kevin Brady and Congressman Tom Lantos 
for their leadership on our behalf.   As you know, they have introduced 
H.R. 3005, the "Pulmonary Hypertension Research Act" in the House of
 Representatives.    This landmark bill for our community has 241 
bipartisan co-sponsors, 17 of whom are members of this subcommittee.  
We owe a lot to these great champions, and we are particularly grateful 
for Congressman Lantos's beautiful and courageous granddaughter Charity, 
who is with us today.   Charity's spirit, determination and dedication 
to the fight against this disease inspires us each and every day.
	I want to tell you the story of another beautiful and 
courageous young woman, my daughter Meaghan.  The impact of this disease 
upon so many Americans and their family members is comparable to a 
nightmare you can never wake up from, right from the start. For my 
family, it began with the words spoken not far from here at Walter 
Reed Army Medical Center a few years back. "Colonel Hicks," the doctor 
said, "your daughter Meaghan has less than a year to live. We can do 
nothing for her." Since that time she has fought a valiant and 
protracted fight, and due to the hellishness of this disease, we have 
very nearly lost her 3 times, twice in the past two months. To remain 
alive now, she must take over 12 different pills daily, as well as 
flolan, an IV drug delivered by pump directly to her heart through her 
chest wall 24 hours a day. She'll never know the joy of motherhood or 
even marriage. Were she to marry she would lose my insurance benefits 
that are keeping her alive.   
	Mr. Chairman, you may be astounded to know that we have more 
Americans dying today from this illness, that is widely believed to 
ultimately be curable, than were tragically lost in combat in all 
conflicts that we have encountered since the final year of WWII. Yes, 
that includes Vietnam, Korea and all the rest, dying today, in the 
U.S. of this illness. Even with a scope that horrific, I am sometimes 
asked why we should pay attention or focus resources on that terminal 
illness instead of others, of which there are many. The answer is, 
quite simply, because we can. 
	Mr. Chairman, hope for our patients and their families lies 
in advancements made through biomedical research. According to leading
 scientists in the field, we are on the verge of tremendous 
breakthroughs in both our understanding of the disease and the 
development of new and advanced treatments.  Our scientists are more 
hopeful than they have ever been regarding the future of research in 
PH.  Ten years ago, a diagnosis of PH was essentially a death sentence, 
with only one approved treatment for the disease.  Thanks to 
advancements made through both the public and private sector, patients 
today are living longer and better lives with a choice of five FDA 
approved therapies.  
	On behalf of PHA, I would like to take this opportunity to 
thank NHLBI Director Dr. Betsy Nabel and her colleagues for their 
leadership in the battle against this disease. We are very proud of 
our partnership with the Institute and we are grateful that Dr.  
Gladwin has taken the time to share his knowledge and insight with us 
at the hearing today.
	Recognizing that we have made tremendous progress, we are also 
mindful that we are a long way from where we want to be, and that is a) 
the management of pulmonary hypertension as a treatable chronic disease 
and b) a cure for this devastating condition.  That is why the 
"Pulmonary Hypertension Research Act" is so important to our community.  
	H.R. 3005 calls for the establishment of three Centers of 
Excellence on Pulmonary Hypertension through the National Heart, Lung 
and Blood Institute at the National Institutes of Health.
  
These Centers would focus on the following activities ...
	a)  Basic and clinical research into the cause, diagnosis, 
early detection, prevention, and treatment of pulmonary hypertension..
	b)  Training programs designed to develop the next generation 
of pulmonary hypertension investigators..
	c)  Continuing education on pulmonary hypertension for health 
care professionals to help facilitate more accurate and timely diagnosis.
	d)  Dissemination of information to the public on pulmonary
 hypertension to raise awareness of the disease.
	In addition, the legislation calls on the National Heart, Lung 
and Blood Institute to establish a pulmonary hypertension data system 
and clearinghouse.	
	Mr. Chairman, all of these activities are essential to our 
efforts to take the next step in the fight against this disease.  
However, you don't have to rely solely on our word regarding the need 
for additional research.  On November 11th the Centers for Disease 
Control and Prevention released a long awaited Morbidity and Mortality 
Report on pulmonary hypertension.  In that report, the CDC states;

1) " More research is needed concerning the cause, prevention, and 
treatment of pulmonary hypertension.  Public health initiatives should 
include increasing physician awareness that early detection is needed 
to initiate prompt, effective disease management.  Additional 
epidemiologic initiatives also are needed to ascertain prevalence and
 incidence of various pulmonary hypertension disease entities."  
(Page 1, MMWR Surveillance Summary - Vol. 54 No. SS-5)

2) "Prevention efforts, including broad based public health efforts to
 increase awareness of  pulmonary hypertension and to foster appropriate
 diagnostic evaluation and timely treatment from health care providers, 
should be considered.  The science base for the etiology, pathogenesis, 
and complications of pulmonary hypertension disease entities must be 
further investigated to improve prevention, treatment, and case 
management.  Additional epidemiologic activities also are needed to 
ascertain the prevalence and incidence of various disease entities." 
(Page 7, MMWR Surveillance Summary - Vol. 54 No. SS-5)

	Moving forward, PHA would like to work with Congress and the 
NHBLI to facilitate the establishment of the Centers of Excellence on
 Pulmonary Hypertension called for in the "PH Research Act." The 
overwhelming support for this bipartisan legislation speaks to the 
strong interest of members on this issue, and we hope to make real 
progress in establishing these Centers in 2006.  Working together, 
I am confident that we can find a cure for Meaghan, Charity and the 
hundreds of thousands of other patients pinning their hopes for a 
better life on biomedical research.     
	Mr. Chairman, thank you again for the opportunity to appear 
before you today.  We appreciate your interest and your leadership on 
these issues.  I would be pleased to respond to any questions you may 
have.

	MR. DEAL.  Thank you, Colonel Hicks.  Our prayers will be with 
you and Meaghan, and thank you for your courageous leadership on this 
issue.
	MR. HICKS.  Thank you, sir.
	MR. DEAL.  We are now pleased to hear from Charity Tillemann-
Dick.
	MS. TILLEMANN-DICK.  Good morning.  Thank you, Mr. Chairman, 
Ranking Member Pallone, and honorable members of the subcommittee.
	I also would like to thank Congressman Brady, who has stepped 
out for a moment.  To the distinguished member from San Francisco, who 
happens to be my grandfather, I can only say that I feel your love so 
much every day.  Love has a way of inspiring the best in us and making 
us stand a little taller and be a little better, live to our higher 
selves and make the world a better place to be in.
	It also has the ability to inspire hope, and you and all of 
the members of the subcommittee know what I am here to talk to you 
about today.  Most of us in life are in a race against ourselves, 
really, against those things which are based on selfish, those parts 
of us which are apathetic and ignorant to find hope, to find action, 
to live the lives that we have the potential to live.
	In May of 2004, my life was changed.  It became a race against 
time, and that is what I am here to talk to you about.  My experience 
with pulmonary hypertension is typical.  When I was young, I was an 
excellent sprinter, and there are videos of me playing soccer, and 
I would run up to the ball.  I would kick it, and then I would slow 
to a shuffle, put my hands on my waist, and wait to catch my breath.  
We weren't a particularly athletic family, even though we did make an 
effort, so I always thought my problem was my lack of fitness, that 
I didn't exercise enough.  So when I turned 18, I decided that I was 
going to change that.  It was my senior year in college, and I started 
working out at least an hour a day, and sometimes 3 hours a day, 4 days 
a week.  I was almost fanatic about my exercise regimen.  And while in 
certain respects I got stronger, anytime that I would step onto a 
treadmill or try to run, I would quickly lose energy, and I would feel 
like I was going to faint.  I decided that that there were just some 
things that I couldn't do, that everyone had their natural limitations 
and I wasn't going to be an athlete, and I wasn't trying to be one.  
So I pushed it aside and put other concerns in front of me.
	The climax of my medical drama came over a 9-month period of 
time, which started on the campaign when I was doing disability on the 
street.  I was crossing one of the largest intersections in Denver, and 
I fainted in the middle of the street one morning.  Well, I had fasted 
the day before, and I hadn't eaten breakfast, and there were reasons for 
me to have fainted.  There were three subsequent syncopal episodes in 
the coming months, and with each episode, I became more concerned that 
maybe something really was wrong.  At the same time, my parents had had
 fainting episodes at similar ages at a similar time in their life, and 
they had hoped that that was what it was.  However, as I would climb the 
three stories to my apartment in Budapest every day, I would have to stop
 numerous times, I wondered what was wrong.  I knew that I wasn't 
neglecting my physical needs.  I would wake up at 5:30 every morning to 
go and exercise.  And I knew that there was something the matter.  
I went to doctors, and they suggested everything from increasing my 
salt intake, which I have found subsequently is not good for those of 
us with pulmonary hypertension.  My blood pressure in my arm was very 
low.  They would tell me to increase my caffeine intake, increase my 
intake of red meats, I am a vegetarian, and I had mild anemia, and so 
they thought that might help.
	However, regardless of the advice that I heeded from the 
medical professionals around me, I grew weaker.
	I came back to the United States, and I was having paperwork 
filled out for the next year, and the year before, I walked to the same 
gym where I had started my almost religious crusade for fitness in my 
life that was less than a mile from my home.  And Denver is a mile high, 
as you may or may not know.  I walked there with my younger brother, who 
was beginning the Air Force Academy that summer.  And as we walked, I had 
to stop what seemed like three or four times a block just to catch my 
breath.  My brother looks at me quizzically because we had a lot of 
bonding time at the gym, and he knew something was wrong.  I toned down 
my workout, but I still couldn't finish it.  On the way back, on our 
slightly downhill trek home, I was so exhausted that I stopped under 
an oak tree, and Corban said, "Charity, please, just stay here.  I will 
go get the car."  As we were driving the short drive home, we were quiet,
 which is unusual in my family.  He asked me if I was all right.  And 
with 11 siblings, the last thing you want to be is an alarmist, and so 
I said that we would find out the next day.
	As I went to the doctor the next day, at a very excellent 
physician named Susan Relsic-Kaiser.  She first talked to me about my 
physical well being and health.  I told her about my concerns.  And 
she had a long checklist that she had to go down for this paperwork 
that I needed.  At first the explanations of low blood pressure, 
anemia, and possibility of diabetes made sense.  And plus she listened 
to my heart when she immediately ordered an EKG.  I didn't have my 
contacts in.  But I thought that I was imagining things.  As I sat in 
the rather stark waiting room waiting for the doctor to return with 
the results, I heard her talking about me in the hallway, and I knew 
that I should either be very flattered or very afraid, and I was in a 
state of not knowing which to be.  I waited there for what seemed like 
a very long time.  When she came back and told me that I had a 
condition, or that I might have a condition called primary pulmonary 
 hypertension, "But don't look it up until you have a firm diagnosis," 
she cautioned me.
	Well, of course, the first thing I did was I told my mother, 
who had come to the doctor with me, about the possibility of my having 
this condition.  When we went home, we looked it up in our medical
 encyclopedia.  It wasn't there.  So I continued to our family computer 
room, and I looked it up on the computer.  I read through it.  I was 
having some of the symptoms, some of the more serious symptoms, but 
not all of them, by any means.
	However, when I read the conclusion, the prognosis was bleak, 
to say the least.  It said most patients who suffer from primary 
pulmonary hypertension, or pulmonary hypertension, die within 2 to 5 
years.  There are few treatments, and over time, they are proven to be
 ineffective.  This wasn't particularly uplifting news.  As I waited, 
and as I went in for future doctor's visits, I did receive a firm 
diagnosis that I did have idiopathic preliminary pulmonary hypertension 
or primary pulmonary hypertension.
	There have been incredible side effects from the drugs that I 
use.  I started out on a medical trial, which was effective for a short 
time.  However, by the end of last year when I went in to have a heart
 catheterization, I had pressures in my heart, which ordinarily are ten 
times the pace that any living person should have.  I then when onto an
 intravenous medication called Flovent.  I remember them telling me 
that jaw pain might be associated with this treatment.  The first night 
that I was on Flovent, I remember waking up at 2:00 in the morning, my 
face flushed and my temperature soaring and thinking that until that 
moment I had never experienced pain.  It was incredible, searing, 
burning, intense pain like I could have never imagined until having
 experienced it myself.
	It would be easy to isolate the experiences of those of us 
suffering from pulmonary hypertension to the medical drama, because 
that is what it is, and it is a very intense medical drama.  However, 
we lead very real lives.  I go to school, and well-intentioned people 
often try to remove my purse when I get up to sing or when I give a
 presentation, when I have to inform them typically in front of a 
whole classroom that I am on life-saving medication that they can't 
take away from me.  The side effects from the medications are almost
 unbearable.
	However, we live with hope, we live on hope, and we depend on 
hope of a cure, of overcoming the very real threat to our lives every 
day, the knowledge that we might not wake up in the morning, the 
knowledge that our time is running out.
	Today, I come before you to ask you for your help, for your 
support.  I just went in for a series of blood tests and a lung x-ray 
on Tuesday, and it appears that my heart is continuing to get larger.  
My body, and the bodies of hundreds of thousands of Americans who are 
living with a literal death sentence for nothing they have done are 
running on hope that cannot run this for that much longer, and we will
 continue to lose some of the best and brightest members of this 
country.  We will lose those who hold the future of our Nation in their 
hands, and you have the opportunity to make incredible contributions to 
our country, to our society.  I am asking you for your support. Please 
support legislation to help us find a cure to pulmonary hypertension.  
It is just around the corner.  The breakthroughs that are being made 
are victories for all of us suffering from pulmonary hypertension.  
And they also are victories for all of us in helping us put aside our 
selfish desires and working to be better, working to stand a little 
taller, to be our better selves.
	Ladies and gentlemen of the subcommittee, I ask you for your 
support.  I thank you so much for being here.  And thank you.
	[The prepared statement of Charity Sunshine Tillemann-Dick 
follows:]

PREPARED STATEMENT OF CHARITY SUNSHINE TILLEMANN-DICK

	Our lives are a race against ourselves - we struggle to replace 
fear with hope, selfishness with selflessness, ignorance with knowledge,
 apathy with action.  And in this contest, it is the hope that the good 
inside us will prevail.  But in May 2004, my life's race was no longer 
between my higher and baser self, but against time.
 	My story is typical of many who have suffered or who are 
suffering from PH.  From the time I was a little girl, I was an 
excellent sprinter.  We have old videos of me playing soccer, running to 
the ball and then slowing to a shuffle, hands on my waist, catching my 
breath.  We weren't a particularly athletic family, so when I'd have 
trouble running back and forth on the basketball court or finishing 
allotted laps on swim team, I would blame it on a lack of physical 
activity in my life.  So, when I was 18, I started working out - at 
least an hour a day, and sometimes three hours a day, four days a 
week.  But still, when I stepped on a treadmill to run, I would quickly 
feel faint and stopped before something happened.
 	The climax of my pre-diagnosis drama came over a nine-month 
period of time when I experienced four syncopal - or fainting -- 
episodes spanning two continents.  My first actual fainting spell came 
when I was crossing a street in Denver.  I fainted in the middle of one 
of Denver's largest intersections.  Three subsequent episodes were 
similarly dramatic; I never knew how unromantic fainting into a man's 
arms could be.  I knew something was wrong; I just didn't know what it 
was.  But I went on with my life.  Doctors told me to do everything 
from increase my salt intake to lift my blood pressure to eat red meat 
to cure mild anemia.  My parents had both experienced fainting spells 
around my age, so I hoped that perhaps, nothing was wrong.     
 	When I returned home for a visit to Denver, the Mile High City, 
in the spring of 2004, I had some medical paperwork that needed to be 
filled out for the next year.  The day before my appointment, I walked 
to my old college less than a mile away to go to the gym with my little
 brother, Corban, who was entering the Air Force Academy that summer.  
I had to stop every 25 feet or so, when I was too exhausted to go on 
without a rest.  Seeing how tired I was from a simple walk, I toned 
down my workout, which I still couldn't complete.  Finally, on our 
slightly downhill walk home, Corban, seeing something was obviously 
wrong, told me to wait under an oak tree four blocks from our home so 
he could run home and get the car.  When he returned, I got it.  
"Charity, are you all right?" he asked.  In a family of 11 children, 
the last thing anyone wants to be is an alarmist.  But it was difficult 
to explain why at 20 years old with a clean bill of health and an 
exercise regiment that I kept with religious diligence for two years, I 
became weaker.  I had to stop three to four times when climbing the 
stairs to my third story apartment in Budapest.  So, I told Corban that 
I had a doctor's appointment the next day and we'd see.   
 	I went to the doctor's.  It was a rather extensive list they 
had to check off, and Dr. Susan Wells did an excellent job.  She first
 discussed my health with me.  My arm's blood pressure was very low, 
so some of the explanations seemed logical for my problems.  But as 
soon as she listened to my heart, she ordered an EKG.  I wasn't
 wearing my contact lenses, but the tech's eyes seemed to pop open 
when the results were printed out.  I hoped I was imagining.  As I 
waited in the stark check up room, I heard the doctor talking about 
me and my accomplishments with someone for what seemed like a very 
long time.  I knew that it was time to be either very flattered or 
very concerned.  When Doctor Wells returned, she kindly informed me 
that there was a slight possibility that I was suffering from Primary
 Pulmonary Hypertension.  She advised me not too look it up until the
 diagnosis was made.  I thanked her and went on my way.  Thinking 
about it, "primary," sounded alright.  It comes first. "Pulmonary," 
whatever. Hypertension. That's me.   I told my mother who, when we 
got home, looked it up in our medical encyclopedia.  It wasn't there.
  I proceeded to our family computer room where I put it into a 
search engine.  Some things matched up, but I certainly wasn't 
suffering from all of the symptoms yet.  The prognosis didn't parse 
words.  It said, "For those suffering from Pulmonary Hypertension, 
the prognosis is bleak.  There are few effective treatments and 
patients typically die two to five years after diagnosis."  I assure 
you that is an interesting prognosis for anyone to read.  
 	In the next days and weeks, my family and my entire community 
grappled with how to deal with this disease, helping me to see a whole 
other range of societal problems.  In the next months, I realized 
while my form of the condition, Idiopathic or Primary Pulmonary 
Hypertension, was very rare, that there were 100,000 Americans like 
me, living with a very literal death sentence.  I was on a medical 
trial, but its benefits didn't last that long.  By the end of the 
year, my arterial blood pressure was nine times higher than anyone 
who is alive should have.  I took the last three weeks off of my 
studies at the conservatory and was given intravenous medication 
over the Christmas holiday.  I was told that patients experienced 
jaw pain.  At 2:00 a.m. I awoke, my face red and my temperature 
soaring.  At that moment, I realized that until then, I had never 
experienced real pain.  It was so intense, so searing, so unbearable 
that, had it not been so painful, would have been comic.  
 	It seems simple enough to isolate PH patients' experience to 
the medical drama, but we have to go on living our very real lives.  
With those I don't know well, I deal with the social awkwardness of 
the really of not being able to keep up, only going somewhere with 
elevator access, not going out to eat, and people thinking I'm clutchy 
for my never putting down my purse.  Occasionally people try to take 
it from me when I get up to sing or make a presentation. They don't 
realize that there is a line connecting my heart to the pump in that 
purse which must dispense medicine to me 24 hours a day.   Patients 
are overlooked for promotions, and I have been overlooked for castings 
because directors or employers often have valid concerns about medical
 concerns interfering with productivity or the final production.  We 
hope to live as normal a life as is possible, but in reality, our 
lives are being cut tragically short, every day.  I am in relatively 
good health, but a chest x-ray taken Tuesday indicates that even with 
the very invasive treatments I am undergoing, my heart continues to 
get larger. 
	While I feel relatively good, I don't know how much more time 
hope can keep my body alive. Without action on your part, thousands of
 American lives, including mine, will be lost, fighting this battle 
alone.  Diagnosis with a life-threatening disease is not something I 
would have ever asked for.  But I know that with funding, we can make 
this disease, first, manageable, like most forms of cancer and AIDS 
and that soon, we will find a cure.  (A situation has to be pretty 
desperate when anyone would hope their condition would be as manageable 
as AIDS or cancer!)  In our race against time, every breakthrough is a 
victory - as we approach treatments we all get closer to winning our 
race against time, and with your action, we can cure Pulmonary 
Hypertension.  
	Please do everything in your power to add Pulmonary Hypertension
 to that list of conditions that will be at least manageable if not 
cured in the next few years.  This bill is a starting point that will
 shed light on this life-threatening disease and give thousands of 
people the hope they need and deserve. 

	MR. DEAL.  Thank you, Charity.  You share the eloquence of your
 grandfather, and we thank you for your personal story.
	Even though we are dealing with very serious subjects here, 
this is, perhaps, one of the most inspirational hearings that I think I 
have attended since I have been in Congress.  And I thank all of you 
from your personal points of view from the horror stories that you 
share with us of the dangers that lurk, but also the hope that I 
think is present in some of the testimony.
	And I would like to elaborate perhaps on some of the hope. And
 Dr. Saper, I would like to start with you.
	One of the concerns that all of us have had is trying to do 
what is best for every disease, every serious condition in this 
country, using our resources most appropriately there.  Dr. Zarhouni 
at NIH, of course, has announced his road map for the reorganization 
of the NIH.  How do you view that proposal as it might pertain to the 
issue you are here for of chronic pain?  Is this something that you 
think would be helpful in dealing with the issue of chronic pain?
	MR. SAPER.  To the extent, Mr. Chairman, that I understand 
all of the aspects of the proposal, I do not think that, at this 
point, it allows for the development of a separate entity devoted to 
pain or to initiatives that primarily address the key brain and 
treatment issues related to chronic pain.  So to the extent that I 
currently understand those proposals, they don't answer the issues 
that we think are primarily relevant.
	MR. DEAL.  One of the concerns that we have heard expressed, 
however, is that in the absence of creating new institutes, which 
continues the silo effect that we have, and one of the things you 
eluded to is maybe the failure to share information across institute 
lines.  I would personally view that his initiative in that regard 
would be helpful in dealing with this issue.  I think it is going to 
be very difficult to create additional separate institutes, but I 
would hope that his road map would be an effort to be able to share 
resources, to share information so that those areas such as chronic 
pain, such as pulmonary hypertension that have not been elevated to a 
level of justifying, perhaps, in the overall scheme of things separate
 institutes that you would be able to be benefited by this new 
approach. That is the hope that I hold.
	Colonel Hicks, would you share some opinion, if any, on that 
issue?
	MR. HICKS.  Well, Mr. Chairman, I am not very well versed in 
the road map, but I would hope that the road map would not be to the 
exclusion of what we are asking for in terms of support in the House 
bill.
	MR. DEAL.  Okay.
	Dr. Gladwin, would you comment about the three organizational
 proposals?
	MR. GLADWIN.  Sure.  In terms of the road map, while there are 
some very concrete road maps initiatives that affect specific clinical
 research activities, I will say that in the intramural division, the
 philosophy of the road map is very much permeating the establishment 
at all levels.  So it is very frequent when we discuss research 
initiatives, especially clinical research initiatives.  The idea of 
the road map is brought up to support those activities.  This has had a 
direct affect on pulmonary hypertension for us with one example that I 
will give you and that is that the intramural division is typically 
not collaborated heavily with the extramural programs because of the
 separation of funding.  So when we discovered in the phase one and 
two trial that Viagra Sildenafil was very effective for patients 
with sickle cell and pulmonary hypertension, we went to Dr. Nable and 
Dr. Alving and suggested that this would be a good target strategy.  
This is before the Viagra trial came out even for FDA approval for 
patients without sickle cell disease but with pulmonary hypertension, 
and the idea of the road map was called upon to suggest that we need 
to link the intramural division with the extramural division to 
synergize this NIH money.  And so what has ended up happening now is 
there is going to be an 11-center trial.  The intramural division, I am 
the PI in the project.  I am heavily involved in the development of the
 science for this project.  We are going to be one of the non-funded 
centers.  We are going to be funded with intramural money.  We have a
 commitment from Pfizer for $1.5 million to supply drugs, even though 
this drug will become generic just 2 years after the completion of the 
trial.  So the road map initiative, that vision and that philosophy, 
had an effect, and I do see that effect.  It also just puts a 
continuous pressure on the basic science establishment that we need to 
link up basic science with clinical research.  So I think as a 
philosophy and a principle, it is guiding us.
	MR. DEAL.  Good.  Well, I am pleased to hear that, because I do 
think all of us want any breakthrough to be shared across every disease
 category and make sure that our money goes as far as it can, and 
working cooperatively, I think that is everyone's concern.
	Mr. Pallone, I will recognize you for questions.
	MR. PALLONE.  Thank you, Mr. Chairman.
	First, let me reiterate what the Chairman said and say what 
an inspiration so many of you have been this morning with your 
testimony.  I really appreciate you being here, and it really has been 
not only thought-provoking but also gives us a lot of hope about maybe 
what we can do at the government level.
	I wanted to ask.  I guess I will start with a question for 
Mr. Hicks.  In your testimony, you stated, and I quote, "I am 
sometimes asked why we should pay attention or focus resources on that
 terminal illness instead of others, of which there are many.  The 
answer is quite simple, because we can."  Do you have any more advice 
for us, you know, for the committee, on how to make improvements in 
the research priority-setting process for chronic and other illnesses, 
you know, how much money we should spend, how we should prioritize 
this versus other illnesses?
	MR. HICKS.  Well, that is a very difficult question.  I think 
that I look towards the recommendations in the legislation more than 
anything for direction with regard to pulmonary hypertension.  As I 
indicated in my testimony, I am asked that question so many times, 
and oftentimes, I get the feeling that, well, because there are so 
many, it is just too difficult to decide, and so our answer to you is 
no.  And I guess I am just coming to you as a father and as someone 
who has met many, many of these people who are, in fact, perishing 
from this illness.  Every day I get an e-mail that says that Susan 
so-and-so has just perished.  Tom Jones has just perished over here.  
For a while it seems, on the Board of the Directors, you know, you go 
to a new board meeting and someone who was on the board before is no 
longer there, and then you find out why they are not there.  So I know 
it is a difficult task for you.  I can only ask that you consider this 
one as one that is worthwhile and support the legislation.
	MR. PALLONE.  Thank you.
	I wanted to ask Dr. Gladwin a couple of questions.  The 
legislation on pulmonary hypertension that Congressmen Brady and Lantos 
have introduced calls for the establishment of three Centers of 
Excellence on pulmonary hypertension at NHLBI.  And as you know, the 
institute does have the authority to establish these centers 
administratively.  And given the strong interest in pulmonary 
hypertension within the scientific community and Congress, can you 
tell us if there are any plans at NHLBI to establish Centers of 
Excellence in this specific area?
	MR. GLADWIN.  So first of all, I am clearly a middle tier 
scientist and clinical investigator and not a policymaker, but there 
are now these requests for score centers, Centers for Clinical Research
 Excellence, that have been sent out, and all of those grant 
applications are now in.  I do have personal knowledge of the structure 
of the score grant system, and in many ways, it meets those goals of 
setting up those centers.  So what it is, is it will be three to four 
highly-funded centers that are required to have two major clinical 
research initiatives and very creative cutting-edge, vibrant basic 
science channeling into those research efforts.  In addition to that, 
Betsy Nable has now set up our branch with an intramural division, 
which really creates another center, and we will have a 3-year jump on 
all of this, and we are working on this.  So I think de facto, these 
vibrant centers are being set up.
	The other element I would mention is being inside science and 
seeing how science works, it is difficult to envision that you could 
have a system that is so productive based on funding independent novel 
ideas from independent investigators.  It is very much like the 
business model.  The NIH works like a venture capital business model.  
We put out small business grants.  The best and brightest ideas rise 
in this competitive environment, and the home runs are supported with 
future research.  And the best example that is pertinent to pulmonary
 hypertension is an emerging story, which excites me very much.  There 
was an investigator, Brian Druker at Oregon Health Science University, 
who is a basic scientist studying tylesciene chinace inhibitors and how
 tylesciene chinace, a self-signaling pathway, could modify disease.  
He was dusting old drugs off of the shelf and came upon a drug called
 chliatglybac that blocked tylesciene chinace and found out that it 
completely put into remission chronic myelogenous leukemia, CML.  Well, 
this seems unrelated to pulmonary hypertension, but in the last few 
years, it was discovered that the growth hormone is one of the 
mediators that drives the proliferative vast response in blood vessels, 
and lo and behold, this drug blocks that activation of tylesciene 
chinace.  So there was just a publication last month in the Journal 
of Clinical Investigation wherein two animal models of pulmonary 
hypertension they not only prevented pulmonary hypertension, but 
after the development, they could reverse it.  And there was a case 
report in the New England Journal of Medicine where Glybac, which is 
FDA-approved for chronic myelogenous leukemia, reversed pulmonary 
hypertension on a patient on three different drugs on a heart 
transplant list.  So these kind of remarkable, unpredictable events 
rise out of a system where you get the best and brightest around them 
and you give them the resources to innovate.  And I think this is 
complemented by these Centers of Excellence, which have been set up 
by existing leadership.
	MR. PALLONE.  Thank you.
	My time is up, and thank you.
	MR. DEAL.  I am going to recognize Mr. Rogers, because I 
believe he has to get somewhere else rather soon.
	You are recognized.
	MR. ROGERS.  Thank you, Mr. Chairman.  I certainly appreciate it.
	Charity, thank you very much.  I had the great privilege to hear 
you sing at the U.S. Embassy in Budapest.  It was one of the highlights 
of our trip.  As a matter of fact, I think you did something in
 Hungarian, but I couldn't tell you what you sang, but we knew it 
was beautiful.
	MS. TILLEMANN-DICK.  Thank you.
	MR. ROGERS.  We appreciate it.
	And just for the record, Mr. Chairman, I have to correct one 
thing.  There are many that said you got your talents from your 
grandfather, but we believe you got not only your talents and your 
good looks from your grandmother.
	MS. TILLEMANN-DICK.  I would rather look like her.
	MR. ROGERS.  For the record, I will vote for that.
	Captain, thank you very much for your service, and thanks for 
your continuing counseling of the soldiers.  It is immeasurable that 
you continue to give back to your country, and we are grateful for it.
	Dr. Saper, I have a couple of questions quickly.
	At some of the earlier hearings, we heard that it is more or 
less 13 stops for an individual pain patient seeking care before they 
are found a medical provider that was even willing to take them.  You 
want to talk about losing hope, that is where depression sets in, the 
level of suicide that we saw jump up off the charts at that level of 
patient care.  Can you talk about access?  One of the things that H.R. 
1020 talks about is access to pain care providers.  Can you talk a 
little bit about why--
	MR. SAPER.  Yes.  Yes, I can.  Thank you, Congressman Rogers.
	Pain can't be proven.  We don't have a test that shows a person 
is in pain.  And therefore, it is easily the victim of someone denying 
that that person hurts.  There is a great deal of prejudice toward 
people in pain in part for that reason and the concern that they are 
simply looking for drugs or that they simply have another agenda.  As 
a result, insurers and managed care organizations find it possible to 
deny care, to say, "Well, we don't do that."  I had a patient just 
last week, Mr. Rogers, that required hospitalization for very severe 
pain and various other complications to treatment, and I personally 
talked to the managed care person who had to approve my recommendation 
to put this person in the hospital.  And I was told, "We don't cover 
pain management."  It is common.  It happens all of the time.  Several 
years ago I talked to a managed care medical director who listened to 
me talk about this rare disorder that the patient I was treating had 
and the need to place this person in the hospital.  And after my 
lengthy discussion with this medical director, she responded that she
 was denying coverage against my recommendation for this patient.  I 
asked her if she had ever taken a course in this illness or in 
treating pain.  She said, "No," and then I asked her the question, "Do 
you even know what I am talking about?"  She said, "No, but I am going 
to deny it anyway."  That is what we feel is in the pain care community 
in trying to get coverage and provide service to people in pain.
	MR. ROGERS.  In addition, there is not a lot of training 
through the educational system on pain care.  Can you talk about that 
briefly?
	MR. SAPER.  Yes.  It is rare for a medical school to have a 
formal training program in pain.  There may be a lecture here or there, 
but pain is a major problem, and it covers many disciplines in 
professional disciplines.  A year ago, H.R. 1020 addresses medical 
education, so access and medical education and research are the truly
 important pillars of your bill, and that is why we so strongly 
support it, Congressman.
	MR. ROGERS.  Thank you.  Talk to me a little bit.  I mean, 
someone said earlier we have this NIH pain consortium.  Go away.  That 
is all we need.  Can you tell me why you think that is not appropriate?
	MR. SAPER.  Yes.  I will give you the diplomatic answer.
	MR. ROGERS.  You don't even have to be diplomatic here.
	MR. SAPER.  It was started several years ago.  I don't know 
exactly when, but it meets about two times a year.  Its last minutes 
were put forward in 2003.  It has no staff.  It has no budget.  It has 
no extramural participation.  And to the extent that I know everything 
that goes on in that consortium, it provides no benefit.  It has no 
effect.
	MR. ROGERS.  And that was the diplomatic answer?
	MR. SAPER.  That was the diplomatic answer.
	MR. ROGERS.  Doctor, thank you very much.  And thanks for the 
work that you do.
	Captain Pruden, can you tell me, what do you tell your soldiers 
that you are counseling?  I know we are running out of time, but I tell 
you, I think this is important, Mr. Chairman, to have somebody who is, 
you know, a tough Army soldier, and thank you again for your service, 
to stand up and say, "Hey, listen.  We have problems, too."  It gives 
hope, I cannot tell you, to millions of Americans.  I will tell you a 
quick story.  When I introduced this bill a few years ago, we had 
calls from all over the country of independent folks who were just 
neighbors, friends, associates that had gotten together on their own 
to have these support groups so they didn't think they were going 
crazy, because they couldn't get a doctor to treat them.  Their 
friends and family didn't understand it.  And to have someone like you 
to stand up and say, "Hey, look.  This is a problem."  I hope you know 
it gives hope to millions.
	And I just wanted to see if you could just touch on that 
briefly.  I know my time is up, Mr. Chairman.  If you will indulge me
 on this.
	Thank you, Captain.
	CAPTAIN PRUDEN.  Thank you very much.
	Obviously, as you are saying, this is a widespread problem.  
The soldiers that I am working with oftentimes feel very isolated 
because of their pain, but they don't want to be the whiners.  They 
don't want to be the one asking for help when other people are seeing 
there is not a need.  People perceive that there is not a need for this
 palliative care.  A lot of times physicians want to focus on an 
underlying disease, which is very important, but they don't have an
 understanding of how to deal with the pain when either there is not 
the ability to adequately treat the underlying disease or the ability 
to cure the disease.  I think working with these soldiers has just 
really opened up my eyes as far as how much of a stigma there is out 
there against certain forms of pain medication and how afraid people 
are to talk about it.  And I am just trying to provide what I can in 
terms of support and getting them through some of these hoops that 
they need to jump through to get the proper pain care management.  
You were talking about the 13 steps.  It is not that far in the Army 
and the Army does a pretty decent job with it, by and large.  But 
there are still a lot of guys who fall through the cracks between 
the physician and proper pain management.
	MR. ROGERS.  Okay.  Thank you very much.  Keep talking about 
it.  You are making a difference.  Thanks to the panel.  Thank you, 
Charity, too, for sharing your story.  It takes a lot of courage to be 
here.  Thank you very much.
	Mr. Chairman, thank you.
	MR. DEAL.  Thank you.
	Mr. Bilirakis.
	MR. BILIRAKIS.  Thanks, Mr. Chairman.
	Just to be clear, regarding these three Centers of Excellence 
which are required under the legislation, the Lantos Brady legislation, 
Mr. Hicks, are the three centers that Dr. Gladwin has discussed with us,
 communicated with us, and shared with us, are those satisfactory as far 
as you concerned?  In other words, is the legislation, or at least that
 portion of the legislation, necessary at this point in time?
	MR. HICKS.  Sir, I think it would be premature for me to state 
that.  This announcement being made this morning, a very important
 announcement, is really the first that we have heard of it, so we have 
got to look at it more.  But at this point, I would like to continue 
with legislation until we are certain that the needs are met otherwise.
  But I must say, once again, that we are very, very excited with this 
news this morning.  This is tremendous news for us.
	MR. BILIRAKIS.  All right.
	Dr. Gladwin, what is the timeline regarding those three centers?
	MR. GLADWIN.  Well, I know for a fact that those grant RFA was
 released and the proposals have already been received.  So now the 
study sections have met and have scored the centers, and now the 
priority scoring, based on priority scoring, the centers will be 
chosen, and a decision will be made whether it is three or four.  
Oftentimes, if it is very close on scoring, the money will be extended 
to four centers, so it could be three and it could be four.  But that 
decision about who is being funded we look for shortly.  The centers 
have now been asked to submit supplemental material, so these things 
are submitted months back.  Now the centers have opportunity to submit 
new material, and new research has been generated in the interim, and 
then the final decisions will be made.  My understanding is that these 
will start in December of 2006.
	MR. BILIRAKIS.  December 2006?  That is a good timeline.  And 
probably we are well ahead that then they would be through the 
legislation, if the legislation waiver got through the process and 
whatnot, isn't that correct?
	MR. GLADWIN.  Yes.  I also comment that our center, this 
branch, was started on October 1, but our activities preceded that.  And 
this program is being grown in the intramural division, and I welcome 
anybody here to see what we are doing there both at the basic and the 
clinical side.  I think that will really be another center. In addition 
to that, I have a list of the 90 funded investigators, and the NHLBI 
has funded this $11 million trial in patients with pulmonary 
hypertension with sickle cell.  So I think that at least the spirit is 
being enacted.
	MR. BILIRAKIS.  Okay.
	Doctor, a few years ago when I chaired this committee, we took 
a look into NIH.  We have done another one or two since then.  But I 
remember the doctors, whoever it is, that greeted us and sort of gave 
us a little bit of a background telling us that our diseases are either
 genetic or from the result of trauma.  Now that being the case, if 
that is, in fact, I guess, the case, you are talking about genetic as 
far as PH is concerned?
	MR. GLADWIN.  Actually, it depends how you would define genetic.
 But if you look at a strict mutation, a major mutation, it causes a 
large percentage of patients with that mutation to have a disease.  
There is only a very small fraction of pulmonary hypertension that is 
genetic versus so-called familial pulmonary hypertension.  This is 
caused by a mutation in this BNPR.  That is the one that was discovered 
in 2000.  That is only a very small percentage of pulmonary 
hypertension.  We don't know what the cause is in the vast majority of 
cases of pulmonary hypertension.  It could be epigenetic, meaning that 
there is multiple partial polymorphisms, or changes in genes, that lead
 to it.  It is also very possible that, as opposed to trauma, that it 
is environmental.  There is tremendous interest in the possibility that 
there could be unidentified viral infections, for example, that lead to 
this.  Research in Denver is looking at the virus that causes caposi 
sarcoma, for example, and there are other efforts to try to identify 
possible infectious etiologies.  But we really don't know, and I think 
the development of a field of vascular biology and tools, such as 
functional genomics.  You know, one thing we are working on is the 
ability to isolate, from a human, copies of few numbers of those 
circulating endothelial cells that have been shed, take those 
endothelial cells and amplify the RNA and to look genetically at what 
those cells are doing, as opposed to looking at something in a dish 
or a culture dish that is so far from the human condition.  But I 
think there has really been a basic science revolution focused on 
vascular biology to try to figure that out.
	MR. BILIRAKIS.  Well, should Charity's family all be tested 
to determine whether or not there is a possibility or probability 
that they would be susceptible to this disease and can possibly then 
catch it early on, if you will?
	MR. GLADWIN.  I don't think so.  I am answering as a clinician 
here, but the percentage of patients with that mutation is very small.  
I think that is really more of a researcher epidemiological interest 
at this point.  I think there are diseases, though, that are associated 
with a very high attack rate of pulmonary hypertension, and I am sure 
Charity knows.  Many of her friends that she has met and certain 
people with PH association know patients with scleroderma.  
Scleroderma, which is a mixed connective tissue disease, is an 
autoimmune condition.  In those patients, a recent study from Canada 
suggests that 20 percent of those patients have pulmonary hypertension 
of a mild nature, and that could be, for example, a targeted 
pre-disease.  So we believe that patients with scleroderma, they should 
all get echocardiography to screen to see if they have pulmonary 
hypertension.  And we are currently screening patients infected with 
HIV in the clinical center.  We have screened 300 patients to 
determine what percentage may have pre-disease.  In sickle cell, we 
have recommended universal screening across the United States, that 
is 70,000 adults with sickle cell, because 30 percent of pulmonary
 hypertension is caused by that.
	So I think there are some specific diseases where we need 
universal screening.  Unfortunately, primary idiopathic pulmonary 
hypertension that you have heard about occurs in two out of a 
million Americans, so it is difficult to have a screening strategy at 
this point.
	MR. BILIRAKIS.  Thank you.
	MR. GLADWIN.  I hope that answers your question.
	MR. DEAL.  Ms. Capps, you are recognized for questions.
	MS. CAPPS.  Mr. Chairman, thank you.  And I want to share your
 comments after the testimonies were finished of you saying this has 
been one of the more enlightening hearings that we have had.  And thank 
you for doing what I have always thought hearings should be about, 
which is to educate Members of Congress and help us order our 
priorities, because really, that is what we do.  And we need to do two 
things, which I think both components of the hearing did today, which 
is to remove the stigma, to remove the barriers that we might have in 
our understanding, and that is why I am thinking most especially about 
the eloquent testimony on pain by the experts in background but also 
the technology that is available.  Medtronic has a plant in my District 
in Toledo, California and many places around the country, I know, and 
you are just one example of technology that could be opening so many 
more doors that spreads across the range of what we have been talking 
about today.  But also the personal testimony.  Captain Pruden, I can't 
thank you enough for what you are doing to help to educate, particularly 
your age and your cohorts who you are surrounded with.  The stigmas to 
pain, and I would like to give you a chance to expand upon that, any of 
you, because pain is a part of what you described, Charity, so 
eloquently and painfully to hear, as well.  And I have a daughter with 
cancer, and the stigmas against giving pain medication, the fear of 
some law enforcement, that it will become addictive, that it will go 
out into the black market, all of the things that will happen that make 
us freeze in terms of doing the right thing to support both research and 
also the kind of palliative care that hospice is good at understanding 
but so often is disconnected even from mainstream medical care.  So, 
Captain, you gave your testimony, but maybe go into it a tiny bit more 
about what you ran into and what you think about now being where you 
are with this.
	CAPTAIN PRUDEN.  Sure.  I have one example to give of the sort 
of stigma that is prevalent.  I had a soldier who returned very badly 
wounded, and he is sort of on both sides of the stigma, both from his 
side and from--
	MS. CAPPS.  Being macho and being tough?
	CAPTAIN PRUDEN.  Right.  I talked to him, and I was asking him 
how he was doing and how he was walking, how he was, you know, coping, 
how his physical therapy was going.  And he said, "Well, sir, I am doing 
good.  You know.  I am in a great deal of pain, but I am not taking 
that pain medication."
	MS. CAPPS.  Yeah.
	CAPTAIN PRUDEN.  You know, "I can suck it up and I can make it
 happen."  And he was very proud of that, but then as I was around him 
more and talked to him more, I realized that he was self-medicating 
with alcohol, trying to cope with the pain, but didn't want to be 
associated with taking these opiates and narcotics.  And the other side 
of that is this gentleman was completely dedicated to returning to Iraq 
to be with his soldiers.  He lost several men over there, and his goal 
is to get better and get back, and he is undergoing some surgeries to 
remove some shrapnel before he could return.  Time and again, you keep 
hitting these walls with the social workers and different people.  He 
wasn't getting the pain medication that he needed, and a lot of times 
they would treat him like he was pretending, that he was acting like he 
needed pain medication when he didn't, and the fact was, he was very 
motivated to get off the pain medication and get back to his job.  But 
he was extremely frustrated with the physicians and some of the 
individuals who acted like he didn't need as much pain medication. He 
needed to just, you know, go on about his business.  That was one 
example.  And you know, my understanding is that proper use of narcotics 
and opiates for pain medication has a very low rate of addiction when 
they are properly used and supervised.
	MS. CAPPS.  Do you want to add to that, Dr. Saper?
	MR. SAPER.  Yes, thank you.
	I think that I would agree with the Captain's remarks.  The 
pain patient is stigmatized, and so are those of us who treat pain 
patients.
	MS. CAPPS.  Yes.
	MR. SAPER.  So there are two sides to that issue. Most patients 
who are provided narcotics or opiates do not abuse their medicine and 
do not misuse them in any way and do not divert them.  We do know that 
that can be a problem.  And we deal with that problem not by denying 
access to those treatments or access to stimulator neuromodulation but 
by training doctors to monitor what they provide their patients.  We 
do that in all care systems by teaching doctors how to use opiates are 
one tool in a broad range of services that we can provide for headache 
and general pain patients, and we have to have coverage for those 
services, the neuromodulation, the expensive medicines, and of course 
the professional services that are required.  And I think that H.R. 
1020 helps by, one, establishing the credibility of the pain problem by 
the stamp of Congress, by your involvement--
	MS. CAPPS.  Good.
	MR. SAPER.  --by your advocacy through that legislation.  And 
that allows those of us in the field treating people like Captain Pruden 
the influence with insurers and other parts of the community when we 
have to fight back.  We don't have much to fight back with right now.
	MS. CAPPS.  Well, we need to continue to help you more in this 
area, and I hope that we will.  This will be the beginning of more work 
that we can do.  We have had some legislation that I was dismayed that 
we responded to in terms of end of life pain treatment as well, but I 
want to, because this is like almost two full hearings in one Charity, 
I am so taken by the newness with which your situation has even been as
 treatable and isolated and diagnosed.  All three of you were excellent 
in opening my eyes to something I didn't know as much about, even though 
I am a nurse, but in a different era.  This was one of those unexplained 
kind of things that we just saw the side effects.
	Two things I need.  One of the things, just generally, we don't 
deal enough with so-called orphan situations, and NIH, you are our only 
hope.  Until you walk through the door as an advocate or a patient, or 
you are a doctor trying to get a trial or some research approved, you 
realize that the popular diseases or entities, and they are important, 
too, but we are not on an even playing field in this country, in terms 
of the needs that we have.  And that is what I feel like we need to be
 educated about.  And that is why I am so thankful that we have some 
built-in advocates here in Congress to remind us.  
	Charity, this is my question to you.  You were a teenager when 
you were diagnosed or when you began to have symptoms, but you don't 
want to have to carry this huge burden of trying to demonstrate to 
society that there is something that needs to be treated.
	MS. TILLEMANN-DICK.  But Congresswoman Capps, you bring up 
an interesting issue, which is diagnosis.  Pulmonary hypertension is
 invisible.  You can't see it.  It takes very invasive treatments to 
find it.  I think that we will find, as we study more, as we put more 
money into research for pulmonary hypertension, that it may very well 
be an epidemic.  I had a dear friend who died at 19 years old from 
heart failure who was perfectly healthy, by all accounts.  There was 
no indication that she was going to die.  She very well could have 
had pulmonary hypertension.  It is very difficult to find unless you 
look for it after someone dies, you know, in an autopsy.  I have been
 suffering from symptoms since I was a very little girl.  When I was 
talking about playing soccer, I was 6 years old, so that was a long 
time ago.  I remember going on hikes with my grandmother when I was 
13.  And she would be like, "Charity, really, you have to exercise 
more."  And it wasn't that I didn't exercise, because I did.  I would
 exercise for a half an hour every day when I was young, and then I 
would go out and we would play.  With 11 kids in the family, you can't 
really avoid that.  But I think that identification is one of the 
biggest battles that we have to face with pulmonary hypertension, and 
I think that as we invest more in research that we are going to find 
that there are many more people who suffer from secondary pulmonary
 hypertension and idiopathic pulmonary hypertension than we ever 
imagined.
	MS. CAPPS.  Well, thank you.  You have been very eloquent 
today.
	MS. TILLEMANN-DICK.  Thank you.
	MS. CAPPS.  Thank you.
	MR. DEAL.  Thank you.
	Dr. Burgess.
	MR. BURGESS.  Thank you, Mr. Chairman.
	And again, I want to thank the panel, each of you, for being 
here today.  Charity, I apologize.  I had to leave the room while you 
were giving your testimony.  I did read your written testimony.  And as 
I was reading that, in another life, I was a physician, and I couldn't 
help but think, gosh, how lucky you were to get to a doctor who was 
actually able to make the diagnosis.  Colonel Hicks, I don't know what 
your experience was with your daughter, but I can just imagine.  Well,
 Dr. Gladwin, perhaps you could tell us, is that unusual for someone 
to see the physician and be diagnosed at that visit that they possibly 
have primary pulmonary hypertension?  Or is it usual, is that your 
history, that someone sees various physicians for various ailments and 
then ultimately comes to the diagnosis?
	MR. GLADWIN.  Yes, absolutely.  As Charity said, there is no 
visible evidence.  We really only have three major tools to diagnose it, 
one, a relatively new one, a blood test.  A brain natriuretic peptide 
can be elevated in the blood of patients that have pulmonary 
hypertension, but that is also elevated in patients with kidney failure 
and heart failure, which are much more common.  An echocardiogram can
 have the ability to tell us non-invasively.  That is shown on the 
poster over there that the pressures are elevated in the heart.  And 
there are big advances.  The technology of echocardiography is really
 improving and the fidelity of these measurements is improving.  But 
even so, I would say, if you would just ask for an echo to be performed 
on your patient, you have probably had this experience, I would say less 
than 10 percent, even in academic medical centers, will actually measure 
the pulmonary pressure.  They focus on the left ventricle, and they tell 
you that left ventricular function.  They ignore the pulmonary pressures.
  That is changing.  For example, at the NIH, every echo requires a 
20-minute assessment of the pulmonary pressure.  We have recommended 
that in patients with sickle cell, and I think there is growing 
awareness.  More and more echoes now report the estimate of pulmonary
 pressure, and then the final test that Charity eluded to is a right 
heart catheterization where you actually put a catheter in the jugular 
vein and pass a very large thin catheter, a 70-centimeter catheter, 
through the heart chambers into the pulmonary artery to directly 
measure the pressure.  So what she had was a physician who did the 
physical exam, you know, took the time to do a good physical exam, 
took an excellent history, and as you know, the history and physical 
exam are invaluable, and was smart and attentive.  Oftentimes, even 
as a pulmonologist seeing patients, you know, I have this asthma clinic 
I do every other week just as a volunteer in the district, and I get 
patients with pulmonary diseases.  And typically, we rule out lung 
disease with CAT scans.  We rule out left ventricular disease with 
echoes.  We almost rule everything out, and then when everything is 
normal, we go, "Ah, maybe it is the pulmonary vasculature."
	So I do think that this is a vital element in future research 
and this is where the field of proteomics can really help us; the 
ability to identify small molecules and mediators in blood so that we 
could have blood tests to predict whether people have pulmonary 
hypertension, essentially like the PSA.  And there are some tasks, but 
we are not there yet, and that is somewhere I think where we are going, 
too.
	MR. BURGESS.  Very good.  What sort of educational activities 
is the NIH undertaking to make clinicians and first-line physicians and 
nurse practitioners more aware of pulmonary hypertension?
	MR. GLADWIN.  Well, I guess this is all very new, these five 
drugs, another five coming.  They are hitting at a breakneck pace.  
So physicians typically, once they have tools, as you know, once you 
have the tool, you really start trying to learn how to develop those 
tools.  But now that there are two pills, this lowers the bar for the 
ability to treat now.  And while experts don't recommend this, the 
practicing doctors are starting to treat patients.  And with the ability 
to treat, you lose what follows that, and doctors start saying, "I really 
need to know about this.  Those five drugs, I have got to learn."  
So I think there is a great focus on that.  In fact, I was at the ACCP 
meeting a few months ago, and the pulmonary hypertension sessions, you
 couldn't get in the rooms.  They were bursting with so many people 
wanting to get in there and learn about these new drugs that were 
available.  But the ACCP has put out an expert consensus statement on 
the guidelines and treatment of pulmonary hypertension.  There has 
been a new classification scheme to try to educate people on the
 classification of pulmonary hypertension in collaboration with the 
PH Association.  I think that is a very important collaboration.  
NHLBI and the PH Association are funding young, career-development 
awards.  Betsy Nable, again, is a very dynamic leader.  She is speaking 
at the American Society of Hematology meeting this Sunday.  And 
following her, an investigator from our group is going to be giving a
 preliminary presentation on the use of biomarkers to predict pulmonary
 hypertension.  And I am giving an educational session talk at the ASH 
meeting on pulmonary hypertension and sickle cell disease.
	So I think that the process of science, in terms of education, 
the development of practice guidelines, the important advocacy.  I
 received an e-mail from you guys about this meeting.  So I mean, they 
have networked with the community, which is fantastic.  So those things 
are working, but clearly, more can be done.
	MR. BURGESS.  And Dr. Gladwin, let me just ask you.  You talked 
about, of course, primary and secondary pulmonary hypertension.  You 
also talked about the two pathways by which it develops: one being
 disregulation and the other being proliferative.  Does primary or 
secondary pulmonary hypertension, does one have the propensity to be
 disregulation and the other proliferative, or is it equally 
dispersed?
	MR. GLADWIN.  It really is equally dispersed.  One of the 
remarkable things, to me, I think, is that regardless of the cause, you 
see the final similar end stage effect.  So in patients with sickle cell
 disease where we think hemolysis, the breaking up of red cells, the 
releasing of hemoglobin out of a red cell into plasma, releasing red 
cells enzymes into plasma, all of those things poison the endothelial 
cells.  And those things block nitric oxide.  They block Prostacyclin, 
and they result in this proliferation.  That ends up causing this
 proliferative filling of blood vessels and this vasoconstriction.  
Patients with idiopathic pulmonary hypertension, which could be caused 
by this mutation, could be caused by an unknown virus.  They end up 
with the same abnormality, and the drugs cross talk.  So we are seeing
 tremendous efficacy of Viagra, which has been shown in a very large 
article just published in the New England Journal of Medicine that 
works in patients like Charity with primary pulmonary hypertension. So 
these drugs work in primary pulmonary hypertension, scleredema pulmonary
 hypertension, and the HIV-associated pulmonary hypertension, and we are
 seeing effects in patients with sickle cell.  So the great news is that 
it appears to be working across types of disease.  There is one big 
exception, and that is one of the most common cause of pulmonary 
hypertension in the world is heart failure, left heart failure, with a 
backup of pressure that leads to secondary pulmonary hypertension. Some 
of the drugs are dangerous for patients that have left heart failure. 
Some of the drugs, like Viagra, may be effective in those patients.  So 
not every one of them is the same, but the vast majorities do behave
 similarly.
	MR. BURGESS.  Now you mentioned that there are five drugs that
 are FDA approved.  Has there been any difficulty with the regulatory 
burdens that the FDA imposes for people who are critically ill and 
might benefit from fast tracking of the new medication?
	MR. GLADWIN.  I will only talk from my own experience, but I 
would say no, that this is exciting.  In a lot of areas, pulmonary
 hypertension is a very exciting and informative area, because I also 
have one friend in the sickle cell field, and I study what is happening 
in pulmonary hypertension as an example of what you can do with an 
orphan disease.  With the combination of advocacy, industry involvement, 
and state-of-the-art basic science, they came together, as I said, in 
this perfect storm.  And the FDA, I think, is another example where 
this regulatory agency has really come through in a great way with 
pulmonary hypertension, and I have a personal experience, because I 
served as a scientific advisor.  I am on the steering committee for a 
clinical trial of Bosentan in sickle cell disease.  I received special
 approval from Betsy Nable to allow me to testify as a scientist, not 
as a representative of the company.  I don't receive any funding from 
them, but that was a unique industry and NIH collaboration.  I was 
there to be able to testify to the FDA about sickle cell disease, but 
they asked for fast track, and they were immediately given that.  You 
will see in the pulmonary hypertension field that almost always fast 
track status is given by the FDA.  They have accepted as a gold 
standard the 6-minute walk test, which is how far you can walk in 
6 minutes, because that is what matters for patients and their 
symptoms.  "Can I walk up the stairs?  Can I vacuum the floor?" The 
FDA has accepted that surrogate, and they accept a single, pivotal, 
phase three study.  So the bar for approval for this disease is low, 
but of course safety is ensured.  So I think this is an example for 
orphan diseases of how these collaborations and how the FDA's 
involvement from the beginning, from what I have seen, has really led 
to rapid approval of drugs.
	MR. BURGESS.  Thank you very much, Mr. Chairman.  I thank you 
for your indulgence of the time.
	MR. DEAL.  Thank you.
	Mr. Shimkus.
	MR. SHIMKUS.  Thank you, Mr. Chairman.  This has been a 
wonderful hearing.  I think we have learned a lot.
	For Captain Pruden and for our stenographer here, I will just 
give you a "hooah", and that is h-o-o-a-h.  I appreciate your service.
	In your testimony, which you stated and that I also read, I 
think we shouldn't leave this hearing without making sure we close a 
loop.  And as has been addressed by a couple of members, you raise a 
concern about these young soldiers who aren't addressing their pain 
issues or the Walter Reeds, the Bethesdas, and the doctors that are
 not trying to close that loop.  You know, a lot of us have gone 
through healthcare issues.  I had open-heart surgery.  I didn't want 
to take my pain medication, and then when my body started flipping 
out because I had this pain that was all over, you know, it is not like
 I was just having pain here, but it was an all-over pain, that your 
body just starts doing stuff that it is trying to mitigate it.  So it 
is in everybody's best interest that people address the pain issues 
and probably for a quicker recovery, which was in my case, also.  What 
do we need to do?  And I mean, you are still on the payroll.  How do 
we get you engaged?  I mean, do we need a victim?  Chairman Bilirakis, 
you know, has been really involved, many times, in veterans healthcare 
issues.  And what my issue is, I want to make sure we close the loop 
that we have an advocacy or an intermediary or somehow that we make 
sure that these soldiers are being addressed and marines and all of 
these folks that are injured so that they know that they can go, that 
someone is talking to them, and someone who doesn't need to use his 
rank or his knowledge that will address this.  And that is one of the 
main reasons, you know, that I wanted to make sure I had a chance to 
ask this question.
	CAPTAIN PRUDEN.  Sure.  You know, I think that the Army and the 
VA, from what I have seen thus far, have actually done a good job in the
 recent years, especially since the war began, of focusing on pain 
management and helping to provide, you know, pain clinics, and I think 
that that should be extended.  I think where a disconnect oftentimes 
occurs, is between the physician and the anesthesiologist or whoever 
is running the pain clinic.  I think physicians need more training in 
proper pain management so that they know what is available.  And then 
also when they don't know and the patient is complaining of pain, they 
have the wherewithal and the understanding that they should when they 
don't know how to treat it and the patients are complaining of pain, 
send them to a pain care specialist and get them through there and make 
sure that someone follows the person through.  Too often, you know, I 
think with the specialty clinics you have orthopedics and, you know,
 gastroenterology and different things, and they don't talk to the 
pain management people.  They are not following them, and then the 
pain management gets the soldier or the individual, it gives them a 
treatment course, but they are not cross talking with the people who 
are dealing with the underlying cause of the pain.  I think that is 
important.
	MR. SAPER.  Mr. Shimkus, that is a very important question you 
are asking.  And I think, honestly, that if Congress were to pass H.R. 
1020, which would give credibility and support to those of us in the 
pain care community, you know, many of us differ on how we should 
approach this or that, but the entire pain care community, patients, 
different disciplines, device makers, drug makers, the entire pain 
care community is behind H.R. 1020.  That is a powerful initiative, 
and that will give us the influence and the authority to work within 
our own systems to bring about better pain care in America.
	MR. SHIMKUS.  Well, I can definitely see how you all here at the 
table as someone's healthcare is being addressed and that people need to 
know these options and the patient needs to be aware on all of those 
issues.  And I would ask Chairman Deal and the Navy, because of Mike's
 persistence in this arena, that we may share that to the Veteran's 
Affairs Committee on this health issue, especially for our folks that 
we have closure or at least the availability of this testimony here 
that we submit over to them so that.  I am just concerned.  You know, 
the main reason I am here because I saw firsthand soldiers who slipped 
into the void.  I don't want them to slip through the void.  So I want 
to just close the loop on this as much as possible.
	MR. BILIRAKIS.  Thank you so much for bringing that up.  And I 
have already told Gene that if I had gone out of time, I wanted to go 
into basically exactly this sort of thing with the Captain.  And I 
will tell you that one of the chief causes of the Veterans' Committee 
right now is transition.  And that is critical.  And we make sure that 
this is a part of what we are looking at that.
	I wanted to ask you, though, sir.  What could have been done to 
have saved your decision or kept your decision from amputating, what is 
it, your right leg?  Obviously the pain is what brought it on.  What 
wasn't done that could have been done that existed from something like
 Medtronic is saying?  What should have Congress done that would have 
kept that decision from being made by you?
	CAPTAIN PRUDEN.  You know, the decision that I made wasn't 
solely based on pain.  That was a primary concern.  Part of it was
 functionality.  I mean, part of the reason that it didn't function 
well was because of the pain.  My leg was short and deformed, and I 
was unable to bear weight on it without a great deal of pain.  I don't 
know that I have a good answer as far as, you know, what would be 
appropriate to fix this problem.
	MR. BILIRAKIS.  Was Medtronic available to you in all of your
 counseling?  Well, I guess that is really what Mr. Shimkus counts for 
that.
	CAPTAIN PRUDEN.  About pain care options?
	MR. BILIRAKIS.  Yeah, the options that were there that--
	CAPTAIN PRUDEN.  Well, I think what could be done is facilitate,
 again, research and education so that there is more awareness of things 
like this for patients like myself and for the physicians overseeing our 
care and the research to develop new techniques.
	MR. BILIRAKIS.  But Medtronic was available?  Jerry Lewis, the
 entertainer, has been using it for quite some time, and that sort of 
thing.  I don't know whether that would have been the answer to the 
question or not, but was anything made available to you?  Did you 
know anything at all about it?
	CAPTAIN PRUDEN.  I didn't know anything about that specific 
device. I am not aware of that.
	MR. VANDER ZANDEN.  If I could just comment.  I mean, that is 
one of the things that we are really working so hard to do, and that 
is why H.R. 1020 is so important.  I mean, if you look at just our 
programs, we have got 350 million media impressions with Jerry Lewis. 
We have gotten 2 million hits to our website.  We have 65,000 active 
members of Tame the Pain.  The work that we have done partnering with 
the American Pain Foundation, especially, who is represented here today, 
the American Academy of Family Physicians.  The biggest issue right now 
is having people really understand what this is.  And I just feel the 
need to clarify for everyone--
	MR. BILIRAKIS.  Mr. Shimkus' time is long gone.  I don't know.  
It is up to you, Mr. Chairman.
	MR. VANDER ZANDEN.  If I could just summarize one point.  I mean, 
the patients we are talking about are patients who are not dealing with a
 backache.  We are not talking about people who have an injury.  We are
 talking about people who have their hand on the iron or on the stove 
and have no ability to remove it.  That is the kind of pain we are 
talking about.  We are talking about people who have changed the 
function of their lives.  They can no longer work.  They have lost 
marriages.  They have been drug addicted.  They are so far beyond hope, 
by the time they even see a pain management professional.  If they do, 
after, as we said earlier, 13 visits sometimes, by the time they enter 
that pain management practice, it may be 4 years before they actually 
get one of our therapies.  Just improving the access, improving the 
awareness through H.R. 1020 will be tremendous.
	MR. BILIRAKIS.  I thank the Chairman for giving me the time.
	MR. SHIMKUS.  Mr. Chairman, if I can just have 30 seconds.  I 
won't ask any more questions.  I just want to make brief comments.  One 
is, Dr. Gladwin, you make us proud.  I mean, I don't understand one-
fourth of what you said, but the fact that you are on our side working 
and with your knowledge, I thank you for that.  And Mr. Hicks, we feel 
your pain.  I just want to let you know that we do, also, with all of 
these other diseases, we have constituents.  I have one who recently 
died from Lou Gehrig's disease, so we also have those meetings where 
we have people lobbying in support of these diseases who don't show 
up anymore, especially as Members of Congress.  So we are with you, 
and we understand from whence you come.
	And just a final note on Medtronic.  I know that we were handed 
these.  There were, I guess, some successful technologies you brought up 
that failed or didn't pass the screening.  And it is just a comment to 
be made about our continued beating up of corporate America, because 
they do great work.  They try to perform need.  They need a return on 
their technology and their investment, and so I am glad you are on the 
team to try to address these things, and all corporate entities are not 
bad and evil.
	Thank you.
	And I yield back, Mr. Chairman.
	MR. DEAL.  Thank you.
	Ms. Myrick.
	MS. MYRICK.  Well, thank you, Mr. Chairman.
	And I would like to identify with your remarks earlier.
	And Mr. Shimkus, thank you for bringing that up with the 
Captain.
	Captain, thanks for still serving your country.  We can't 
express our gratitude enough to you for what you have been through and 
what you are doing.
	And Dr. Gladwin, again, you have given us hope.  And as John 
said, we don't understand all of it, but we can understand enough to 
know that this is good and you are making progress.
	And for Mr. Hicks and Charity, thank you for having the 
courage to come today and share with us.  We do appreciate it.
	Dr. Saper, I would like to ask you a question.  I am concerned 
about an area that we haven't really talked a lot about when you talk 
about chronic pain, and that is the mental health side.  I have a 
husband who has suffered with chronic pain for almost 20 years, and I 
know how it can drag you down.  When doctors treat people for chronic 
pain, do they do anything to deal with, I guess what you would call, 
the depressive side that comes through that, too?  Is that a normal 
course of treatment in the chronic pain field?  Is this something that 
should be looked at more in what we are talking about with all of this 
cross-pollination at NIH that we are going to be doing?
	MR. SAPER.  Yes, that is a very important area.  You know, 
there are different approaches to pain.  There are very narrow 
approaches, such as injections or pills, and then there are the 
comprehensive centers.  I direct a comprehensive center in Ann Arbor.  
And the boundary between mental pain and physical pain is an uncertain
 boundary.  All pain, mental and physical and mood, is biochemical, and 
they influence each other.  And appropriate care for chronic pain 
should include dealing with the emotional side of the pain problem, so 
we have centers.  We have doctors who give pills and then centers who 
put in stimulators and we have doctors that give injections and some 
do surgery.  And then we have comprehensive centers that try to put 
it all together for the more difficult cases, and every level of that 
pain care hierarchy is necessary to address this problem.  Our field is 
in the young years.  It is a young field.  We are just beginning to
 credentialize doctors and train them.  And the pillars of H.R. 1020 
provide us those tools: education and research and access.  And the 
mental side of pain care is very important, and I agree with you.
	MS. MYRICK.  Well, it just concerns that we are sitting here 
listening to all of you talk about the chronic pain side and then that 
this is an issue that we have not, as a group, paid a lot of attention 
to.  And a lot of people do grin and bear it.  I mean, you know, you 
can have a minor chronic pain that you put up with.  And I think, as 
John said with not taking pain medication when he had his heart 
problem, people don't realize how that really affects their overall 
body.  And so you know, what we can do to help in those areas, I hope 
that you all will stay in communication with us, because I think it is 
very important that we make people realize that this is something, that 
it is not bad to take pain medication.  They are not bad to get help, 
Captain, as you are trying to tell your guys when they really need it. 
It is not something that you are, you know, a weakling if you do.
	But I thank all of you for being here today.  It has been 
extremely informative.
	And I yield back.
	MR. DEAL.  I thank the gentlelady.
	Once again, you all have been an incredible panel.  You have 
done something that very few panels in hearings do: you have not only 
put the personal face on the issues; you provided the clinical 
expertise, you provided the mechanical radius of trying to deal with 
this.  Mr. Vander Zanden, I apologize that you were sort of left out 
of the discussion.  That was certainly not deliberate, because, as 
Mr. Shimkus says, we recognize the importance of what companies like 
yours are doing, because you are truly the link sometimes between the 
doctor who knows what needs to be done, the patient who is feeling the 
pain, and you provide a mechanism of delivering that relief, and we 
appreciate what your company and others are doing in this field.
	For those of you who are the victims of these diseases or 
these problems and the advocates on the behalf of them, I couldn't 
think that anybody could have selected better representatives than 
the ones that have appeared before this committee today.
	Thank you all so very much.  This is truly a memorable event.  
Now the responsibility is ours to try to take the education and the
 information that you have provided to us and try to, as Mr. Shimkus 
says, close the loop of making something positive and meaningful 
happen as a result of your testimony today.
	Thank you all so very much.
	The hearing is adjourned.
	[Whereupon, at 12:20 p.m., the subcommittee was adjourned.]
	[Additional material submitted for the record follows.]





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