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 

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

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(II)

COMMITTEE ON ENERGY AND COMMERCE 

JOE BARTON, Texas, Chairman 

RALPH M. HALL, Texas 

MICHAEL BILIRAKIS, Florida 

 Vice Chairman 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

PAUL E. GILLMOR, Ohio 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

CHARLIE NORWOOD, Georgia 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. “CHIP” PICKERING, Mississippi 

 Vice Chairman

VITO FOSSELLA, New York 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

CHARLES F. BASS, New Hampshire 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

C.L. “BUTCH” OTTER, Idaho 

SUE MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

GRESHAM BARRETT, South Carolina 

JOHN D. DINGELL, Michigan 

 Ranking Member 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

SHERROD BROWN, Ohio 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

ALBERT R. WYNN, Maryland 

GENE GREEN, Texas 

TED STRICKLAND, Ohio 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

TOM ALLEN, Maine 

JIM DAVIS, Florida 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

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 

MICHAEL BILIRAKIS, Florida 

FRED UPTON, Michigan 

PAUL E. GILLMOR, Ohio 

CHARLIE NORWOOD, Georgia 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

JOHN B. SHADEGG, Arizona 

CHARLES W. “CHIP” PICKERING, Mississippi 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO, California 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE MYRICK, North Carolina 

MICHAEL C. BURGESS, Texas 

JOE BARTON, Texas 

 (EX OFFICIO)

SHERROD BROWN, Ohio 

 Ranking Member 

HENRY A. WAXMAN, California 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

GENE GREEN, Texas 

TED STRICKLAND, Ohio 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

TOM ALLEN, Maine 

JIM DAVIS, Florida 

TAMMY BALDWIN, Wisconsin 

JOHN D. DINGELL, Michigan 

 (EX OFFICIO)
(III)

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 

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 

(1) 
2

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. 
3

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 wellbeing. 

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. 
4

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. 
5

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. 
6

 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. 
7

 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:] 
8

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. 
9

 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 nonpartisan 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. 
10

 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. 
11

 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 
12

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. 
13

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 
14

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. 
15

 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; 
16

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. 
17

 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 longterm 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 shortterm 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 
18

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 
19

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 
20

• 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, 
21

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. 
22

 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 
23

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. 
24

 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 
25

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 clinicallyproven 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. 
26

 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 bloodbrain barrier, which is especially important. Studies suggest that the 

dose required to manage this chronic pain can be as small as onehundredth 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 costeffective 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 
27

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. 
28

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. 
29

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, electricitydelivering 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 
30

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 
31

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 
32

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 
33

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. 
34

 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 stateof-the-art, new, cutting-edge science, basic science, but they have to have 
35

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. 
36

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. 
37

• 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. 
38

 

 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®), which can be inhaled through a nebulizer, and bosentan (Tracleer®) and 

sildenafil (Viagra®), 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 hypertension1

. 

2) Testing of whether sildenafil therapy can halt blood vessel damage that 

causes patients who have sickle cell anemia or thalassemia to develop 

1

 Hunter CJ, Dejam A, Blood AB, Shields H, Kim-Shapiro DB, Machado RF, Tarekegn 

S, Mulla N, Hopper AO, Schechter AN, Power GG, Gladwin MT. Inhaled nebulized 

nitrite is a hypoxia-sensitive NO-dependent selective pulmonary vasodilator. Nature 

Medicine. October 2004; volume10, issue 10: pages 1122-1127. 
39

 

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 endorgan 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 

2

 Gladwin MT, Sachdev V, Jison ML, Shizukuda Y, Plehn JF, Minter K, Brown B, Coles 

WA, Nichols JS, Ernst I, Hunter LA, Blackwelder WC, Schechter AN, Rodgers GP, 

Castro O, Ognibene FP. Pulmonary hypertension as a risk factor for death in patients 

with sickle cell disease. New England Journal of Medicine. February 26, 2004; volume 

350, issue 9: pages 886-895. 

3

 Morris CR, Kato GJ, Poljakovic M, Wang X, Blackwelder WC, Sachdev V, Hazen SL, 

Vichinsky EP, Morris SM Jr, Gladwin MT. Dysregulated arginine metabolism, 

hemolysis-associated pulmonary hypertension, and mortality in sickle cell disease. 

JAMA – Journal of the American Medical Association. July 6, 2005; volume 294, issue 

1: pages 81-90. 
40

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 
41

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 
42

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 
43

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, 
44

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. 
45

 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 TillemannDick. 

 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. 
46

 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 
47

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. 
48

 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 lifesaving 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 
49

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 
50

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. 
51

 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? 
52

 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 
53

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 cuttingedge, 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 
54

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 
55

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 
56

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 
57

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 
58

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 socalled 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 
59

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 
60

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 
61

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 
62

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 
63

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. 
64

 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 
65

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 HIVassociated 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-ofthe-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 
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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 
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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. 
68

 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 
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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. 
70

 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. 
71

 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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