```

[Senate Hearing 112-894]
[From the U.S. Government Publishing Office]

                                                        S. Hrg. 112-894
 
                 PAIN IN AMERICA: EXPLORING CHALLENGES 
                               TO RELIEF 

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                      ONE HUNDRED TWELFTH CONGRESS

                             SECOND SESSION

                                   ON

 EXAMINING PAIN IN AMERICA, FOCUSING ON EXPLORING CHALLENGES TO RELIEF

                               __________

                           FEBRUARY 14, 2012

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
      Available via the World Wide Web: http://www.gpo.gov/fdsys/

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                          Washington, DC 20402-0001 

          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                       TOM HARKIN, Iowa, Chairman

BARBARA A. MIKULSKI, Maryland              MICHAEL B. ENZI, Wyoming
JEFF BINGAMAN, New Mexico                  LAMAR ALEXANDER, Tennessee
PATTY MURRAY, Washington                   RICHARD BURR, North Carolina
BERNARD SANDERS (I), Vermont               JOHNNY ISAKSON, Georgia
ROBERT P. CASEY, JR., Pennsylvania         RAND PAUL, Kentucky
KAY R. HAGAN, North Carolina               ORRIN G. HATCH, Utah
JEFF MERKLEY, Oregon                       JOHN McCAIN, Arizona
AL FRANKEN, Minnesota                      PAT ROBERTS, Kansas
MICHAEL F. BENNET, Colorado                LISA MURKOWSKI, Alaska
SHELDON WHITEHOUSE, Rhode Island           MARK KIRK, IIllinois
RICHARD BLUMENTHAL, Connecticut
                                       

             Daniel E. Smith, Staff Director, Chief Counsel

                 Pamela J. Smith, Deputy Staff Director

              Frank Macchiarola, Republican Staff Director

                                  (ii)

                            C O N T E N T S

                               __________

                               STATEMENTS

                       TUESDAY, FEBRUARY 14, 2012

                                                                   Page

                           Committee Members

Harkin, Hon. Tom, Chairman, Committee on Health, Education, 
  Labor, and Pensions, opening statement.........................     1
Whitehouse, Hon. Sheldon, a U.S. Senator from the State of Rhode 
  Island.........................................................    22
Hagan, Hon. Kay R., a U.S. Senator from the State of North 
  Carolina.......................................................    40
Sanders, Hon. Bernard, a U.S. Senator from the State of Vermont..    44

                            Witness--Panel I

Tabak, Lawrence A., D.D.S., Ph.D., Principal Deputy Director, 
  National Institutes of Health, Washington, DC..................     2
    Prepared statement...........................................     4

                          Witnesses--Panel II

Pizzo, Philip A., M.D., Dean of the School of Medicine, Stanford 
  University School of Medicine, Stanford, CA....................    10
    Prepared statement...........................................    13
Maixner, William, D.D.S., Ph.D., Director, Center for 
  Neurosensory Disorders, University of North Carolina at Chapel 
  Hill, Chapel Hill, NC..........................................    17
    Prepared statement...........................................    19
Veasley, Christin, Executive Director, National Vulvodynia 
  Association, North Kingstown, RI...............................    23
    Prepared statement...........................................    26
Sarno, John E., M.D., Professor of Clinical Rehabilitation 
  Medicine, New York University School of Medicine, New York, NY.    33
    Prepared statement...........................................    34

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.:
    Senator Enzi.................................................    54
    Senator Hatch................................................    55
    Robert E. Shapiro, M.D., Ph.D., President, Alliance for 
      Headache Disorders Advocacy; Professor of Neurology, 
      University of Vermont College of Medicine..................    55
    Jennifer Spotila, on behalf of the Chronic Fatigue and Immune 
      Dysfunction Syndrome (CFIDS) Association of America........    62
    American Cancer Society Cancer Action Network (ACS CAN)......    63
    Response by Lawrence A. Tabak, D.D.S., Ph.D. to questions of:
        Senator Harkin...........................................    64
        Senator Hatch............................................    66

                                 (iii)

  

            PAIN IN AMERICA: EXPLORING CHALLENGES TO RELIEF

                              ----------                              

                       TUESDAY, FEBRUARY 14, 2012

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2:31 p.m. in Room 
SD-430, Dirksen Senate Office Building, Hon. Tom Harkin, 
chairman of the committee, presiding.
    Present: Senators Harkin, Sanders, Hagan, and Whitehouse.

                  Opening Statement of Senator Harkin

    The Chairman. The Senate Committee on Health, Education, 
Labor, and Pensions will come to order.
    Chronic pain is a significant public health challenge that 
has yet to receive adequate attention given the tremendous 
impact it has on people all across our Nation. It is estimated 
that approximately 116 million adults in America--more than the 
number of adults affected by heart disease, cancer, and 
diabetes combined--suffer from some form of chronic pain.
    These often debilitating conditions have a tremendous 
impact on many daily activities making it difficult for many 
individuals with chronic pain to even meet their own basic 
needs. Chronic pain profoundly affects quality of life. It 
remains one of the most challenging conditions to assess and 
effectively treat. Let me repeat that: it remains one of the 
most challenging conditions to assess and effectively treat 
even though it is one of the top reasons for doctor visits.
    Because of the pervasive impact of chronic pain, we have 
convened this important hearing today to explore the current 
state of research, care, and education with respect to chronic 
pain. To examine barriers associated with treatment and to 
discuss opportunities for further research in prevention 
strategies.
    As the Chair, not only of this committee, but of the 
Appropriations Subcommittee on Labor, Health and Human 
Services, Education and Related Agencies, I have long 
encouraged a more ambitious emphasis on pain research at the 
National Institutes of Health.
    In 2003, NIH took a huge step forward in this area by 
creating the NIH Pain Consortium. Leaders at NIH recognized 
that despite the fact that every institute and center addresses 
some aspect of chronic pain, none had the sole responsibility 
for this critically important issue, nor were the various 
institutes coordinating their pain research. This lack of 
coordination limited the attention given to pain research and 
despite advances made by the NIH Pain Consortium, more still 
needs to be done at NIH and across the Federal Government to 
address the unanswered questions surrounding diagnosis, 
treatment, and prevention of chronic pain.
    Today's hearing will largely focus, not exclusively, but 
largely focus, on the recently released report by the Institute 
of Medicine titled, ``Relieving Pain in America: A Blueprint 
for Transforming Prevention, Care, Education, and Research.'' 
This crucial report examines the issue of chronic pain in 
America, identifies some barriers to more effective pain 
research and treatment, and suggests a plan for addressing 
these barriers.
    The report advocates for enlightening health care 
providers, patients, and the public on the substantial burdens 
of living with chronic pain, and it highlights areas for 
improvement in pain research, care, and education. We need to 
do a better job of educating in medical schools and in our 
residencies about the different forms of pain and how they 
should be treated; the so-called physiological pain that 
everyone recognizes right away from a sprained ankle, a burn, a 
broken arm, or cancer where we know the physiological source of 
that pain.
    But then, how about the physiological pain for which we do 
not know the source--irritable bowel syndromes, spastic colons, 
fibromyalgia, back pain, and so many others--where there does 
not seem to be any underlying physical trauma, but we do not 
know the source. How do we educate our doctors to understand 
this and to make, as I say, the right type of assessment and 
diagnosis?
    I look forward to the testimony of our expert witnesses who 
approach the issue of chronic pain from a variety of 
perspectives, all with the goal of addressing this critical, 
but often neglected, public health issue, and this is a public 
health issue not only in what it costs this country in terms of 
dollars, but also in terms of lost productivity and loss of 
quality of life.
    I thank you all for being here today and I look forward, 
certainly, to your testimonies.
    We will have two panels. On our first panel, we will hear 
from Dr. Lawrence Tabak, the Principal Deputy Directory of the 
National Institutes of Health, our No. 2 person at NIH. Dr. 
Tabak also served as the Director of the National Institute of 
Dental and Craniofacial Research, and co-leads the NIH Pain 
Consortium.
    Dr. Tabak, welcome. Thank you for your service at the NIH. 
Your statement will be made a part of the record in its 
entirety, and if you could sum it up in several minutes or so, 
I would appreciate it. Thank you very much.
    I also ask to leave the record open for any opening 
statements by Senator Enzi or other Senators who may be coming 
here later.
    Dr. Tabak, welcome and please proceed.

STATEMENT OF LAWRENCE A. TABAK, D.D.S., Ph.D., PRINCIPAL DEPUTY 
    DIRECTOR, NATIONAL INSTITUTES OF HEALTH, WASHINGTON, DC

    Mr. Tabak. Mr. Chairman, thank you and thank you for the 
opportunity to testify about pain, one of the most important 
public health problems facing our Nation.
    I will highlight what the NIH is doing in partnership with 
other Federal agencies to advance pain research and treatment, 
and I also hope to convey some of the promising opportunities 
that science offers to overcome the challenges of preventing 
and treating chronic pain.
    Pain can provide useful information, warning our bodies of 
potential damage. However, chronic pain can be debilitating in 
terms of many long term diseases like arthritis, diabetes, or 
cancer. This pain is not only a current public health 
challenge, but an increasing problem for the future.
    Perhaps the most important modern insight about pain is 
that chronic pain, however it begins, can also become a disease 
in and of itself. This recognition of chronic pain as a disease 
has important implications for how we study pain, treat pain, 
and structure our health care system to provide care to 
patients suffering from pain.
    Congress took steps toward advancing research, education, 
and care for people with pain through specific provisions in 
the Affordable Care Act. The Act directed the Secretary of the 
Department of Health and Human Services to establish the 
Interagency Pain Research Coordinating Committee, the IPRCC. 
IPRCC responsibilities include summarizing advances in pain 
care, identifying gaps and duplications of effort across the 
Federal research portfolio, and recommending how to disseminate 
information about pain care. The IPRCC will hold its first 
meeting on February 27.
    The Secretary also engaged the Institute of Medicine, the 
IOM, to convene a conference on pain to increase recognition of 
pain as a public health problem, survey the adequacy of pain 
care, identify barriers to care, and recommend how to reduce 
these barriers. The IOM report noted that progress will require 
a better understanding of the biology of pain, improvements in 
the therapy development process, and removal of barriers to 
optimal care in the health care system at large.
    NIH activities drive improved scientific understanding, 
complement private sector therapy development, and inform the 
societal and care delivery issues that ultimately fall within 
other agencies' missions.
    The NIH Pain Consortium coordinates pain activities across 
the NIH institutes and centers with individual components of 
NIH, taking the lead on specific programs as appropriate to 
their mission.
    For example, the NIH Blueprint for Neuroscience Research is 
soliciting interdisciplinary research to learn how changes in 
neurosignaling and circuitry underlie chronic pain. Recent NIH 
initiatives also address the education of pain care 
professionals and researchers, which was another key issue 
highlighted by the IOM report.
    To complement and encourage investigator-initiated research 
on pain, NIH has undertaken many specific initiatives. These 
include one entitled, ``Mechanisms, Models, Measurement, and 
Management in Pain Research,'' which the IOM commended for its 
comprehensiveness. Other funding opportunities target specific 
conditions including, recently, ocular pain migraine, 
temporomandibular joint disorders, vulvodynia, and nerve damage 
from cancer therapy to name but a few.
    The National Center for Complementary and Alternative 
Medicine recently funded two centers on chronic low-back pain 
and is spearheading a trans-NIH agency effort under the aegis 
of the Pain Consortium to develop diagnostic criteria for back 
pain.
    The National Institute of Diabetes and Digestive and Kidney 
Diseases' Multidisciplinary Approach to the Study of Chronic 
Pelvic Pain Research Network is another example that embraces 
the systemic or whole body approach.
    In conclusion, as a scientist, I am encouraged by the 
opportunities for progress that research presents. As a 
clinician who has experience treating patients in pain, I 
embrace the important shift toward treating chronic pain as a 
complex multifaceted syndrome of its own, and I know we must 
all work together to enable the development and delivery of new 
and more effective treatments. To take full advantage of what 
medical science can provide now and in the future, the IOM 
report called for transformation of how we, as a Nation, 
understand and approach pain management and prevention.
    Next month, at the first IPRCC meeting, the committee will 
begin its work toward developing a framework to execute the 
transformation within the research community.
    Thank you, and I would be happy to answer any questions.
    [The prepared statement of Mr. Tabak follows:]
         Prepared Statement of Lawrence A. Tabak, D.D.S., Ph.D.
                              introduction
    Thank you for the opportunity to testify about one of the most 
important public health problems facing our country. Today I will 
highlight what the National Institutes of Health (NIH) is doing in 
partnership with other Federal agencies to implement the Affordable 
Care Act provisions for advancing pain research and treatment. I also 
hope to convey our excitement about progress in the science of pain and 
the promising opportunities that science offers to overcome the 
challenges of preventing and treating chronic pain.
    Pain can provide useful information that warns of potential damage 
to our bodies. Just how essential normal pain sensation is to a healthy 
life is evident from the problems faced by people who have rare 
conditions that leave them without any pain sensation, including 
repeated, severe injuries that go unnoticed. Acute pain is pain that 
has a sudden onset, lasts a short time, and can usually be linked to a 
specific injury or illness. Chronic pain lasts for several months or 
more. It can arise, for example, as a persistent pain after an original 
injury heals, as a debilitating symptom of long-term diseases, like 
arthritis, diabetes, or cancer, or in many cases from unknown causes, 
as in irritable bowel syndrome, fibromyalgia, vulvodynia, chronic 
headaches, and temporomandibular disorders. Chronic pain can also be a 
debilitating symptom of long-term diseases, like arthritis, diabetes, 
or cancer. Paradoxically, the very success of medicine in improving 
survival from cancer, heart disease, HIV/AIDS, stroke, traumatic brain 
injury, and many other diseases has increased the number of people 
confronted by chronic pain because more people are living with 
conditions that can lead to chronic pain. So too has the overall aging 
of the population, which results in more individuals suffering from 
painful conditions such as arthritis. Thus, pain is not only a current 
public health challenge, but an increasing problem for the future.
    Although chronic pain can accompany many diseases, perhaps the most 
important modern insight about chronic pain is that chronic pain, 
however it begins, can also become a disease in and of itself. Changes 
in the brain and elsewhere in the nervous system can cause pain to 
persist long after it has any adaptive value. This recognition of 
chronic pain as a disease, together with an increased understanding of 
the maladaptive physiological and psychological changes that underlie 
the persistence of pain, has important implications for how we study 
pain, treat pain, and structure our health care systems to provide care 
to patients suffering from pain.
  implementation of the affordable care act's pain research provisions
    Congress took a step toward advancing pain research, education, and 
care for people with chronic pain via specific provisions in the 
Affordable Care Act. The law directed the Secretary of HHS to establish 
the Interagency Pain Research Coordinating Committee (IPRCC) to 
coordinate efforts within HHS and across Federal agencies that support 
and conduct pain research. When the Act was signed into law, the 
Secretary, through NIH, established the IPRCC and solicited nominations 
for membership on the committee through an open, transparent process. 
NIH received nominations for almost 100 individuals. After reviewing 
the impressive group of candidates, the Secretary selected the final 
roster of committee members, heeding the guidance from the Act on the 
expertise and personal experience that should be represented, and the 
input from the public received through the nomination process. The 
IPRCC roster was announced on February 13, 2012, and the IPRCC will 
meet for the first time at the NIH on March 27, 2012. Dr. Story Landis, 
director of the National Institute of Neurological Disorders and Stroke 
(NINDS), is the interim chair. The duties of the IPRCC include 
summarizing advances in pain care research supported by Federal 
agencies, identifying critical gaps in basic and clinical research, 
ensuring there is no unnecessary duplication of efforts, recommending 
how to expand public-private research partnerships, and advising how to 
improve dissemination of information about pain care. NIH is working 
with other IPRCC member agencies to gather and analyze the agencies' 
scientific advances, research portfolios, public private partnerships, 
and education and dissemination activities for review and discussion at 
the committee's first meeting in March.
    The Affordable Care Act also called for the Secretary to engage the 
Institute of Medicine (IOM) to convene a ``Conference on Pain.'' The 
stated goals are to increase the recognition of pain as a public health 
problem; survey the adequacy of pain assessment, diagnosis, treatment, 
and management; identify barriers to care; and recommend how to reduce 
these barriers and improve pain care research, education, and clinical 
care, including public private partnerships. The Secretary, acting 
through the NIH, contracted with the IOM, which assembled an 
outstanding committee, chaired by Dr. Philip Pizzo, dean of the School 
of Medicine at Stanford University, and vice-chaired by Dr. Noreen 
Clark, director of the Center for Managing Chronic Disease at the 
University of Michigan, to conduct this independent assessment. Rather 
than a single conference to cover all topics, the committee held four 
focused meetings, from November 2010 through March 2011, providing 
extensive opportunities for public testimony. The patients, patient 
advocates, health care providers, and others who shared their 
experiences of living with pain, the state of treatment, and barriers 
to care provided vital information that significantly influenced the 
final report. Following consideration of public and expert testimony, 
analysis of the information provided by the NIH and other Federal 
agencies, closed deliberations, and the expert review that is the IOM's 
forte, the IOM issued the report ``Relieving Pain in America: A 
Blueprint for Transforming Prevention, Care, Education, and Research'' 
\1\ in June 2011, meeting the deadline set by the Affordable Care Act.
---------------------------------------------------------------------------
    \1\ http://iom.edu/Reports/2011/Relieving-Pain-in-America-A-
Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx.
---------------------------------------------------------------------------
    The IOM report contains a wealth of information and recommendations 
for the long-term scientific, medical, and societal response to the 
public health problem of chronic pain. The report's independent 
assessment of the public health and economic burden of pain was itself 
an important result. The study showed that the burden of chronic pain 
is enormous and care is far from adequate. As cited in the report, 
chronic pain affects at least 116 million Americans, costing up to $635 
billion in medical treatment and lost productivity, and producing 
incalculable suffering for people of every age. The report also 
identified specific recommendations for the NIH, and the NIH is 
responding quickly to these recommendations. As one example, the IOM 
report recommended that the NIH designate a specific NIH institute to 
lead pain research efforts, and the NIH director has officially given 
the NINDS this role. The IOM report also recommended that NIH enhance 
the activities of the trans-NIH Pain Consortium \2\ and increase 
administrative support toward that end. In response, NINDS will 
establish an office to support all activities of the Pain Consortium 
and IPRCC. Dr. Landis is also chairing an executive committee of the 
trans-NIH Pain Consortium, made up of five institute and center 
directors, that is working to enhance Consortium activities to move 
pain research forward.
---------------------------------------------------------------------------
    \2\ http://painconsortium.nih.gov/.
---------------------------------------------------------------------------
    The IOM report called for a coordinated, national effort of public 
and private organizations to create a cultural transformation in how 
the Nation understands and approaches pain management and prevention. 
To achieve this goal, the IOM recommended that the HHS Secretary work 
across and beyond government, bringing together a wide range of Federal 
agencies, private-sector, and state-level entities to create a 
``comprehensive population health-level strategy for pain prevention, 
treatment, management, and research.'' We at NIH strongly support the 
report's emphasis on greater interdisciplinary coordination at both the 
policy and research level. In order to address the research component 
of this recommendation, the first IPRCC meeting will include an 
analysis of the data on Federal agencies' pain portfolios, and the 
committee will work with HHS leadership toward developing a framework 
to execute this strategy. Coordination and efficient use of resources 
are always more important, both within HHS and across other Federal 
agencies, such as the Department of Veterans Affairs and the Department 
of Defense, which are represented on the IPRCC.
               scientific opportunities and nih research
    As the IOM report noted, progress toward alleviating chronic pain 
requires a better understanding of the biology of pain; improvements in 
the therapy development process; a greater focus on interdisciplinary 
approaches for research and the treatment, management, and prevention 
of pain; and removal of barriers to optimal care in the health care 
system at large. Congress assigned the IPRCC the task of assessing the 
landscape of activities across the Federal Government, identifying gaps 
or duplication, and recommending a future path. As the IPRCC's work 
moves forward, I would like to highlight some of NIH's activities in 
this area.
    In fiscal year 2011, NIH supported $386 million in research focused 
on chronic pain. This total does not include all of the extensive 
related research on diseases, such as cancer, arthritis, diabetes, and 
stroke that often cause chronic pain. The details of individual pain-
focused grants are publicly available on the NIH RePORTER Web site.\3\ 
NIH activities drive improved scientific understanding, complement 
private sector therapy development, and inform the work of other 
agencies on care delivery and other issues. Investigator-initiated 
research that engages the insight and ingenuity of researchers 
throughout the United States and across disciplines is the core of NIH 
success generally, and is responsible for much of the recent progress 
in the science of pain cited in the IOM report. Pain research plays to 
that strength because so many different aspects of science hold promise 
for pain. Genetics, brain imaging, engineering, molecular biology, ion 
channels, neural plasticity, behavioral sciences, and many other areas 
of expertise are being brought to bear on the problems of chronic pain. 
NIH investigator-initiated research programs support the full spectrum 
of research from basic understanding of mechanisms of pain, through 
translation of discoveries to therapeutics, and on to clinical testing 
of candidate treatments and prevention strategies.
---------------------------------------------------------------------------
    \3\ http://projectreporter.nih.gov/reporter.cfm.
---------------------------------------------------------------------------
    To complement and encourage investigator-initiated research on 
pain, NIH undertakes many specific initiatives. The NIH Pain Consortium 
coordinates pain activities across the NIH, with individual components 
of the NIH taking the lead on efforts appropriate to their missions. 
The IOM report noted the comprehensiveness of research topics in the 
broad NIH funding opportunity announcement (FOA) for research on 
``Mechanisms, Models, Measurement, and Management'' in pain research. 
The Consortium designed this FOA to stimulate a wide range of basic, 
translational, and clinical research on pain, from the micro 
perspective of molecular sciences to the macro perspective of 
behavioral and social sciences. Other recent FOAs have focused on 
specific conditions, such as ocular pain, migraine, vulvodynia, 
interstitial cystitis/painful bladder, nerve damage from cancer 
therapy, orofacial pain, and HIV/AIDS. The NIH's National Center for 
Complementary and Alternative Medicine (NCCAM) is strongly engaged in 
pain activities because people who suffer from chronic pain are 
frequent users of complementary therapies. NCCAM recently funded two 
centers to study neural processing of chronic low-back pain using 
neuroimaging and to understand how mind-body interventions affect these 
processes. NCCAM is spearheading a trans-NIH effort under the aegis of 
the Pain Consortium to engage with the research community on the 
development of diagnostic criteria for studies of chronic low-back 
pain, a critical step to performing rigorous clinical trials and 
ultimately improving care. The National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK) is leading another major effort, 
the Multidisciplinary Approach to the Study of Chronic Pelvic Pain 
(MAPP) Research Network,\4\ which includes researchers with clinical, 
epidemiological, and basic research expertise, all working 
collaboratively. The Network embraces a systemic--or wholebody--
approach in the study of interstitial cystitis/painful bladder syndrome 
(IC/PBS) and chronic prostatitis/chronic pelvic pain syndrome (CP/
CPPS).
---------------------------------------------------------------------------
    \4\ http://www.mappnetwork.org/.
---------------------------------------------------------------------------
    On a trans-NIH scale, the NIH Blueprint for Neuroscience Research 
\5\ is currently conducting a Grand Challenge on pain. The goal of the 
Grand Challenge is to establish collaborative research between pain 
scientists and non-pain neuroscientists from other fields, such as 
learning and memory, to learn how changes in neural signaling and 
circuitry underlie chronic pain.
---------------------------------------------------------------------------
    \5\ http://neuroscienceblueprint.nih.gov/.
---------------------------------------------------------------------------
    The need for education of pain care professionals and researchers 
is also a key issue highlighted by the IOM report. To address this 
issue, the NIH Pain Consortium is encouraging medical, dental, nursing 
and pharmacy schools to respond to a new funding opportunity to develop 
Centers of Excellence in Pain Education (CoEPEs).\6\ The National 
Institute on Drug Abuse (NIDA) is leading the CoEPEs program, which 
will develop pain management curriculum resources for health care 
professionals that will advance the assessment, diagnosis, and safe 
treatment of pain, while minimizing the abuse of opioid pain relievers.
---------------------------------------------------------------------------
    \6\ http://www.altarum.org/project-highlights-pain-education.
---------------------------------------------------------------------------
    NIH also conducts scientific workshops on pain, which serve several 
purposes, from catalyzing research collaboration to promoting enhanced 
interaction with patient advocacy groups. Over the last year, for 
example, workshops have focused on specific conditions including 
vulvodynia, chronic fatigue syndrome, chronic sickle cell pain, and 
temporomandibular joint disorder (TMJD or TMD), and on cross-cutting 
topics, such as sex differences in pain and overlapping chronic pain 
conditions. These workshops have led to the growing appreciation of 
common underlying mechanisms in many poorly understood chronic pain 
conditions that disproportionately affect women and served as the basis 
for NIH establishing a new trans-NIH working group on overlapping 
chronic pain conditions in the fall of 2011.
            scientific progress and a vision for the future
    Chronic pain is highly prevalent, and the treatment options for 
people suffering from pain are too often inadequate. However, it is 
important not to lose sight of scientific progress and the promise for 
the future. Consider a vision that contrasts sharply with the current 
state of pain understanding and care that the IOM described. Picture a 
new reality where physicians and patients will have a broad array of 
options for preventing and treating chronic pain, tailored to each 
person's unique pain experience and responsiveness to treatments. 
Better understanding of why acute pain becomes chronic will enable 
physicians to prevent many cases of chronic pain, or even to reverse 
the changes in the brain and nervous system that cause pain to persist. 
With advances in knowledge, when chronic pain does occur, interventions 
will reduce the pain, but limit side effects, through tools such as 
precisely targeted drugs, gene therapy, biologics, brain stimulation 
devices, and behavioral strategies. Biomarkers and non-invasive imaging 
methods will better diagnose pain and enable physicians and patients to 
optimize treatments. Together these advances will provide personalized 
and targeted therapies for each patient.
    What is particularly exciting to me is that--thanks to research 
advances in many areas of science--we are well on our way to this new 
reality. Insights from the study of neural plasticity are leading to 
new understanding of how chronic pain develops, with hints already of 
how to prevent chronic pain in some cases or even to reverse these 
persistent ``memories'' of pain when they occur. Scientists are 
beginning to define a range of biological, psycho-social, and genetic 
factors that shape individual differences in pain perception and 
response to therapies, and contribute to the considerable differences 
between the sexes in their risk for developing chronic pain conditions. 
For example, the first large-scale, prospective clinical study for a 
chronic pain condition is examining the role of these risk factors in 
onset of temporo-
mandibular joint disease (TMJD), a common and debilitating pain 
condition that predominately affects women.\7\ The exploration of genes 
involved in developing and maintaining chronic pain and those that can 
help to relieve pain has also led to many important discoveries. An 
industry funded human clinical trial using gene therapy to relieve 
cancer pain was recently completed, advancing from the NIH-funded 
preclinical studies of the research team.\8\ In another gene study, a 
gene variant discovered by NIH researchers protects some people from 
chronic pain after back surgery and may help to determine best 
therapeutic strategies for patients.\9\ Brain imaging has also provided 
insights into why some people experience pain differently and how 
chronic pain changes brain structure and function. Remarkably, there 
are tantalizing indications that people may learn to reduce their pain 
when real time brain imaging provides them immediate feedback on 
activity in pain-
related areas of their own brains.\10\ Neuroanatomical techniques, 
combined with direct examination of patients, have allowed NIH-funded 
researchers to decipher the neural basis for the troublesome extreme 
light sensitivity in migraine, one of the most common chronic pain 
conditions.\11\ As research on pain at the cellular and molecular level 
advances, several teams of scientists have identified specific 
molecules as potential targets for drugs that could block pain with 
fewer side effects. For example, the resolvins are small molecules 
biosynthesized from omega-3 fatty acids that are showing promise in 
rodent models in treating inflammatory pain without the side effects of 
other typically used analgesics.\12\ In addition, well-controlled, 
methodologically sound, NIH-funded studies have examined the 
effectiveness of alternative therapies, such as tai chi for 
fibromyalgia \13\ or massage therapy for lower back pain,\14\ providing 
much-needed evidence that these therapies might be useful for certain 
patients.
---------------------------------------------------------------------------
    \7\ Supplement to J. Pain, 2001 Nov: 12 (11); T1-T108; http://
www.jpain.org/issues?issue
_key=S1526-5900%2811%29X0013-5.
    \8\ Fink DL, et al. Ann Neurol. 2011 Aug;70(2):207-12.
    \9\ Tegeder I, et al. Nat Med. 2006 Nov;12(11):1269-77.
    \10\ deCharms RC, et al. Proc Natl Acad Sci USA. 2005 Dec 
20;102(51):18626-31.
    \11\ Noseda R, et al. Nat Neurosci. 2010 Feb;13(2):239-45.
    \12\ Xu ZZ, et al. Nat Med. 2010 May;16(5):592-7.
    \13\ Wang C, et al. N Engl J Med. 2010 Aug 19;363(8):743-54.
    \14\ Cherkin DC, et al. Ann Intern Med. 2011 Jul 5;155(1):1-9.
---------------------------------------------------------------------------
                               conclusion
    Chronic pain is a debilitating problem with enormous individual and 
societal costs. Through the newly formed IPRCC and the implementation 
of recommendations in the IOM report, NIH is enhancing collaborations 
with other agencies and the private sector to move pain research 
forward. NIH looks forward to continuing to work with the committee on 
this issue as the IPRCC activities progress. Although the scientific 
and societal challenges for improving care for chronic pain should not 
be minimized, we are excited about what the future holds. There are 
extraordinary opportunities for progress.
    Thank you and I would be happy to answer any questions.

    The Chairman. Dr. Tabak, thank you very, very much. And 
thank you again for your leadership on this issue. I just have 
a few questions. I want to delve into the Department's strategy 
with respect to coordination of pain management.
    Can you elaborate on when we can expect the Department to 
provide us with a full report on what steps the Federal 
agencies are taking to implement the IOM report 
recommendations? And is the comprehensive strategy recommended 
by the IOM being completed?
    Mr. Tabak. First step in this process, of course, was the 
establishment of the Interagency Pain Research Coordinating 
Committee. The Secretary established this in July 2010 and 
selected the final roster of 19 members; this includes 7 
Federal members, 6 academic members, and 6 public members. This 
committee will hold its first meeting on March 27 on the NIH 
campus. Dr. Story Landis, Director of NINDS, will act as the 
interim chair.
    The NIH is currently working with other IPRCC member 
agencies to gather and analyze the agency's pain-related 
scientific advances, their scientific portfolios to get an 
overview of their public-private partnerships, and their 
individual efforts toward education and dissemination. So that 
these may be reviewed and discussed at the committee's first 
meeting in March.
    The Chairman. OK. I am also interested in the promotion of 
prevention and wellness. You talked about the prevention of 
pain. As you know, a large segment of the Affordable Care Act 
is prevention and wellness.
    What about the role of prevention? I mean, it seems like we 
have an issue of chronic pain, but how do you prevent it? Are 
there prevention strategies?
    Mr. Tabak. Obviously, this is a multifaceted problem and so 
the first portion, of course, is to delineate those people who 
are most at-risk to develop chronic pain. There are a number of 
ongoing studies which seek to identify so-called risk factors 
that individuals may have, which make them particularly 
susceptible to pain. This can take the form of studies of their 
genetic backgrounds.
    For example, in the Orofacial Pain: Perspective Evaluation 
and Risk Assessment, which is termed OPPERA and you perhaps 
will hear more about that in the second panel. Individuals have 
been studied in a prospective manner and a number of genes of 
interest have been identified with those that associate with 
pain. These give you clues as to who might be particularly 
susceptible.
    Another gene variant has been discovered which seems to be 
protective for people from chronic back pain after back 
surgery. This gives you insights as to who may be more or less 
susceptible to these painful conditions.
    Another option is to begin to dissect the molecular 
pathways which underlie chronic pain and in so doing, identify 
new and novel targets that would allow you to intervene to 
either reduce or, indeed, eliminate the progression from an 
acute situation to a more chronic one.
    For example, scientists have identified several specific 
molecules from the omega-3 fatty acids which are termed 
``resolvents,'' and what these are able to do is they are able 
to reduce pain associated with inflammation which, as you know, 
is now generally treated with opioids, or cyclooxygenase or COX 
inhibitors.
    So finally, there are a series of studies that are ongoing 
using real time brain imaging, which allow us to understand how 
one is able to control one's reaction and sensation to painful 
stimuli, and in so doing this, once again, we may be able to 
come up with biomarkers that will allow us to identify the 
subset of people who are most at-risk.
    The Chairman. Very good. Dr. Tabak, thank you again, very 
much. I will leave the record open for any questions that 
Senator Enzi and others might have. Thank you very much, Dr. 
Tabak.
    Mr. Tabak. Thank you.
    The Chairman. We will call our second panel.
    Dr. Philip Pizzo, I hope I correctly pronounced that, who 
is the Chair of the IOM report that I just referenced here. Dr. 
Pizzo is joining us from Stanford University, where he is a 
professor in the Pediatrics and Microbiology and Immunology 
Department. Dr. Pizzo will focus on the IOM report and 
recommendations for future areas of research.
    Next, we have Dr. William Maixner, will you please come up 
to the witness table, please; and the same with Miss Veasley 
and also Dr. Sarno. So, Dr. Maixner, Miss Veasley, and then Dr. 
Sarno down here on the end.
    We welcome Dr. William Maixner. Dr. Maixner is the director 
of the Center for Neurosensory Disorders at the University of 
North Carolina at Chapel Hill. Dr. Maixner comes to us today 
with significant experience in the area of pain management 
research. He has experience working at NIH and has developed an 
orofacial pain management program at Chapel Hill.
    Christin Veasley, the executive director of the National 
Vulvodynia Association will share with us her personal story 
with chronic pain. Recently, she was appointed to serve on the 
Interagency Pain Research Coordinating Committee at NIH. The 
Committee was created to coordinate pain research activities 
across the Federal Government.
    Next we have Dr. John Sarno, a Professor of Rehabilitation 
Medicine at New York University Medical Center and practitioner 
at Rusk Institute of Rehabilitation Medicine. Dr. Sarno, the 
author of four books on pain, will share his work with respect 
to treating chronic pain.
    I thank all of you for coming here. Your statements will be 
made a part of the record in their entirety, and I ask you if 
you could sum up your statement in 5 or 7 minutes. There is 
probably a little light down there. I do not get too nervous if 
it goes over, unless it goes over a long time. But if you are 
summing up in 5 to 8 minutes, that is fine with me. As I said, 
your statements will all be made a part of the record in their 
entirety.
    Dr. Pizzo, again, welcome and please proceed.
    Dr. Pizzo. Thank you very much, Mr. Chairman.
    The Chairman. Punch the button.

   STATEMENT OF PHILIP A. PIZZO, M.D., DEAN OF THE SCHOOL OF 
 MEDICINE, STANFORD UNIVERSITY SCHOOL OF MEDICINE, STANFORD, CA

    Dr. Pizzo. Thank you very much, Mr. Chairman. It is an 
honor to be here with you today, and I appreciate very much 
your interest in this important topic.
    Today, I would like to share with you the results of our 
Institute of Medicine committee that I co-chaired with Noreen 
Clark from the University of Michigan.
    The important findings from our committee, alluded to 
earlier, as follows: the number of Americans suffering from 
chronic pain number 116 million, which is actually an 
underestimate because this does not take into account children, 
individuals in chronic custodial facilities, people in the 
military, and others. This is a huge problem in terms of 
magnitude of numbers, but it is equally shadowed by the 
financial impact of pain in this country as well.
    Currently, we spend between $560 to $635 billion a year on 
pain. That is more than we spend as a nation on cancer, heart 
disease, and diabetes together. It costs us $100 billion from 
our State and Federal budgets to cover the cost of pain care. 
The reality is that those expenditures are not alleviating pain 
in America as we know it today.
    Our committee was certainly mindful of the fact that there 
is much to be done in developing cost-effective methodologies 
as we go forward, but the magnitude is simply astounding.
    We recognized that we had five charges from the Affordable 
Care Act through HHS, and to the NIH in our work. The first was 
to delineate the public health patterns of care, the magnet of 
pain, the magnitude of the challenges and problems as they 
stand today.
    The second was to review the impediments and barriers to 
accessing care for individuals with pain.
    To better delineate the demographic groups and special 
populations who are impacted by pain.
    To identify the scientific tools and technologies that are 
at our disposal today and that might be used for both research, 
care, education, and treatment.
    And to discuss better ways of developing new approaches to 
researching pain through public and private partnerships.
    We were fortunate to have an outstanding committee of 19 
individuals representing virtually all professional disciplines 
from science and medicine, to law and ethics, nursing and 
clinical practitioners. We worked over a 7-month period to 
produce the report that stands before you.
    In doing so, we reviewed the literature, we held a number 
of public workshops and meetings, we reviewed testimony from 
over 2,000 individuals. We commissioned an econometric report 
to help us assess the impact of pain. We concluded that 
relieving acute and chronic pain is a significantly overlooked 
problem in the United States.
    We were guided by a series of overarching principles as we 
began our work. The first is, pain management is a moral 
imperative. The second is that chronic pain can be a disease in 
its own right. That there is a need for a more comprehensive 
approach using interdisciplinary methods to treat and diagnose 
pain, and to better utilize preventative strategies. We 
recognized the importance of collaboration between physicians, 
and patients, and other providers in the education, management, 
and prevention of pain.
    We were not specifically charged to look at the important 
issue of opioids and their use in pain. We opined on the issue 
and recognized that there are multiple sides to the important 
issue, and that this is a topic that should be further studied, 
but we mainly focused on pain from a public health perspective. 
In doing so, we also recognized the individual impact of pain, 
and I would like to read you just 4 testimonials from the over 
2,000 that we received.
    First, from an advocate,

          ``Treating a pain patient can be like fixing a car 
        with four flat tires. You cannot just inflate one tire 
        and expect a good result. You must inflate all four.''

    From a physician with chronic pain,

          ``Pain management and physical rehabilitation was 
        never addressed in my medical school curriculum, nor in 
        my family practice residency. My disability could have 
        been avoided or lessened with timely treatment, and I 
        could still be the provider instead of the patient.''

    From a clinical pharmacy specialist,

          ``We cannot successfully treat the complexity of pain 
        without treating the whole patient. Insurance companies 
        will pay for useless, expensive procedures and 
        surgeries, but won't pay for the simple cognitive 
        behavioral therapy and physical rehab therapy.''

    From a patient with chronic pain,

           ``I've a master's degree in clinical social work. I 
        have a well-documented illness that explains the cause 
        of my pain. But when my pain flares up and I go to the 
        E.R., I'll put on the hospital gown, I'll lose my 
        social status and my identity. I'll become a blank 
        slate for doctors to project their own biases and 
        prejudices on to.''

    These are just four of thousands of testimonials that led 
us to conclude that alleviating pain in America must result in 
a cultural transformation in how pain is perceived, how 
physicians and other providers care for pain, and how we 
develop our social contract with each other to advance clinical 
care, education, and research.
    We concluded 16 recommendations and in doing so, we focused 
on the public health issues; pain care and management; 
education of patients, communities, and providers; and 
research. To help our committees with this activity, we 
prioritized for the 16 recommendations as ones that we felt 
should be completed and implemented by the end of 2012. We 
brought our report forth in June 2011 with that hopeful 
expectation, and I would like to share with you the highlights 
of those four recommendations.
    The first is that the Secretary of HHS should create a 
comprehensive population-level strategy for pain prevention, 
treatment, management, and research. And that this should be 
coordinated across public and private sectors, include an 
agenda for developing research, improve pain assessment and 
management programs, improve ongoing efforts to enhance public 
awareness of pain. This should include the multiple Federal and 
private agencies.
    Second, we recommended that the Secretary of HHS with other 
Federal, State, and private sector entities should develop 
strategies for reducing the barriers of the care of pain, 
focusing in particular on populations disproportionately 
affected by and undertreated for pain.
    Third, we recommended that health care providers, 
insurance, and others should work collaboratively between pain 
specialists and primary care clinicians including referral to 
pain specialists when appropriate. There are about 4,000 pain 
specialists in the United States, not nearly enough to cover 
all those with pain. Therefore, we look to enhanced education 
and training of primary care physicians to work collaboratively 
in new care models to better direct and delineate for those 
suffering from pain.
    And finally as an immediate recommendation, we recommended 
that the Director of NIH should designate a lead institute at 
the NIH that is responsible for moving the pain research agenda 
forward along with increased support for, and scope for, the 
pain consortium. This should involve pain advocacy and 
awareness, and organizations, and should foster public and 
private partnerships.
    There were 12 other recommendations as well, and we felt 
that these recommendations serve the goal of creating a 
comprehensive population-level strategy for pain prevention, 
management, and research.
    The scope of the problems in pain management is truly 
daunting, and the limitations in knowledge and education of 
pain health care professionals are glaring. The medical 
community must actively engage in the necessary cultural 
transformation to reduce pain suffering of Americans, and work 
collaboratively to do so with the public and private sectors.
    Thank you very much for listening to me.
    [The prepared statement of Dr. Pizzo follows:]
              Prepared Statement of Philip A. Pizzo, M.D.
                                summary
    I would like to share with you some of the conclusions and 
recommendations from the Institute of Medicine Report on Relieving Pain 
in America: A Blueprint for Transforming Prevention, Care, Education 
and Research. The Patient Protection and Affordable Care Act of 2010 
required that the Department of Health and Human Services (HHS), 
through the National Institutes of Health (NIH), charge the Institutes 
of Medicine (IOM) to conduct this study. I served as the chair of a 19-
member committee that initiated its work in November 2010 and delivered 
the final report to the Congress and NIH in June 2011.
    We found that the magnitude of pain in the United States is 
astounding. More than 116 million Americans have pain that persists for 
weeks to years. That this number does not include children, individuals 
in nursing homes or chronic care facilities, prisons or the military, 
makes the impact even more significant. The total cost of pain is $560-
$635 billion per year. This is higher than the costs of cancer, 
cardiovascular diseases and diabetes together. This includes nearly 
$100 billion annually from Federal and State budgets. The committee 
fully recognizes the magnitude of these expenditures and appreciates 
that more effective and efficient approach to pain management and 
preventions must consider cost as well as effectiveness.
    The committee was charged to review and quantify the public health 
significance of pain, identify barriers to pain care, determine special 
populations impacted by pain, identify the tools and technologies to 
treat pain and enhance pain research along with public-private 
partnerships in support of pain research, care and education.
    In preparing its report the committee reviewed the literature, held 
public meetings and workshops, received testimony and comments from 
more than 2,000 Americans, and commissioned a review on the economic 
burden of care. We concluded that relieving acute and chronic pain and 
the resultant suffering will require a cultural transformation in how 
pain is perceived and judged both by people with pain and by the health 
care providers who help care for them. The overarching goal of this 
transformation should be gaining a better understanding of pain of all 
types and improving efforts to prevent, assess and treat pain. The 
committee's report offers a blueprint for achieving this transformation 
that includes 16 recommendations that address the public health 
challenges, pain care and management, the education of patients, 
communities and providers and research needs and opportunities. To help 
establish priorities, the IOM Committee recommended that 4 of its 16 
recommendations be implemented by the end of 2012 and that the 
remaining 12 recommendations be completed before the end of 2015 and 
then be maintained on an ongoing basis. The recommendations are as 
follows:

Immediate--Complete by the end of 2012
    1. The Secretary of HHS should create a comprehensive population-
level strategy for pain prevention, treatment, management and research.
    2. The Secretary of HHS along with other Federal, State and private 
sector entities should develop strategies for reducing barriers to the 
care of pain--focusing in particular on populations disproportionately 
affected by and undertreated for pain.
    3. Pain specialty professional organizations should support 
collaboration between pain specialists and primary care clinicians, 
including referral to pain specialists when appropriate.
    4. The Director of the NIH should designate a lead institute at the 
NIH that is responsible for moving pain research forward, along with an 
increase in the support for and scope of the Pain Consortium. This 
should involve pain advocacy and awareness organizations and should 
foster public-private partnerships.

    Twelve other recommendations focus on public health, clinical care, 
education and research issues that should be completed by 2015. Taken 
together, these recommendations serve the goal of creating a 
comprehensive, population-level strategy for pain prevention, 
management and research. The scope of the problems in pain management 
is daunting, and the limitations in the knowledge and education of 
health care professional are glaring. The medical community must 
actively engage in the necessary cultural transformation to reduce the 
pain and suffering of Americans. Importantly the cultural and social 
transformation needed to alleviate pain in America will require the 
collaboration of the healthcare provider community with patients and 
their families who are suffering from pain, including their 
communities, professional societies and advocacy organizations as well 
as State and Federal Governments. New public-private partnerships and a 
broad concerted effort that addresses pain as a public health 
initiative as well as an individual's source of suffering will be 
necessary if we are to make progress in alleviating pain. We must all 
be part of the dialog and the solution.
                                 ______
                                 
    1. I am Dr. Philip A Pizzo, dean of the Stanford University School 
of Medicine as well as professor of Pediatrics and of Immunology and 
Microbiology. I am a pediatric oncologist and a pediatric infectious 
disease specialist. Before joining Stanford in 2001, I was the 
physician in chief of the Children's Hospital Boston and chair of 
Pediatrics at Harvard Medical School. Prior to that I spent 23 years at 
the National Cancer Institute as a senior investigator, chief of 
pediatrics, and scientific director. I have been an elected member of 
the Institute of Medicine since 1997 and was also elected to the IOM 
Council in 2006. I chaired the Institute of Medicine's Committee on 
Relieving Pain in America: A Blueprint for Transforming Prevention, 
Care, Education and Research.
    2. Today I would like to share with you some of the conclusions and 
recommendations from our IOM Committee. First, the magnitude of pain in 
the United States is astounding.

         a.  More than 116 million Americans have pain that persists 
        for weeks to years. That this number does not include children, 
        individuals in nursing homes or chronic care facilities, 
        prisons or the military, makes the impact even more 
        significant.
         b.  The total cost of pain are $560-$635 billion per year.

            i.   This is higher than the costs of cancer, 
        cardiovascular diseases and diabetes together.
            ii.  Includes nearly $100 billion annually from Federal and 
        State budgets.

         c.  The treatments covered by these expenditures doesn't fully 
        alleviate American's pain.
         d.  The committee fully recognizes the magnitude of these 
        expenditures and appreciates that more effective and efficient 
        approach to pain management and preventions must consider cost 
        as well as effectiveness.

    3. The 2010 Patient Protection and Affordable Care Act required HHS 
to enlist the Institute of Medicine to examine pain as a public health 
problem.

         a.  Acting through the NIH, the IOM Committee on Pain that I 
        chaired along with Dr. Noreen Clark, Myron Wegman Distinguished 
        University professor and director of the Center for Managing 
        Chronic Disease at the University of Michigan, as co-chair, was 
        charged to address the current state of the science regarding 
        pain research, care and education and to specifically:

            i.   Review and quantify the public health significance of 
        pain, including the adequacy of assessment, diagnosis, 
        treatment and management of acute and chronic pain in the 
        United States.
            ii.  Identify barriers to appropriate pain care and 
        strategies to review them.
            iii.  Identify demographic groups and special populations 
        and what needs to be done to address their needs.
            iv.  Identify what scientific tools and technologies are 
        available, what strategies can enhance the training of pain 
        researchers, and what interdisciplinary research is necessary 
        in the short, and long-term to advance research and improve 
        diagnosis, care and management.
            v.  Discuss opportunities for public-private partnerships 
        in support of pain research, care and education.

         b.  Our committee included 19 members with a wide range of 
        expertise in the broad biopsychosocial aspects of pain--
        including the ethical, legal, clinical and public health 
        perspectives, along with traditional and complementary medicine 
        began its work in late November 2010. We completed our work 
        over a 7-month period, thanks to the incredible support from 
        the IOM and especially Adrienne Smith Butler, and submitted our 
        report to Congress and the NIH in June 2011.

            i.   Reviewed the literature.
            ii.  Held public meetings and workshops.
            iii.  Received testimony and comments from more than 2,000 
        Americans.
            iv.  Commissioned a review on pain's economic burden.
            v.  We concluded that relieving acute and chronic pain is a 
        significant overlooked problem in the United States.

    4. Our committee first established a number of underlying 
principles to help guide our work. Among them is that:

         a.  Pain management is a moral imperative;
         b.  Chronic pain can be a disease in itself;
         c.  There is value in comprehensive treatment that includes 
        interdisciplinary approaches, with a wider use of existing 
        knowledge and a focus on prevention;
         d.  We recognized the conundrum of opioids and that this 
        requires balance and additional review but were specifically 
        directed that this topic was not part of the charge of our 
        committee; and
         e.  We recognized the importance of collaboration of patients 
        and clinicians--in education, management and prevention and 
        that there is a value to a public health approach--to education 
        and management.

    5. While we recognize that our focus was on the public health 
implications of pain, we understood that it is the individual human 
impact of chronic pain that underscores why this is such an important 
issue for our families, patients, communities and nation. I offer just 
a couple of comments from the more than 2,000 that we received:

         a.  From an advocate: Treating a pain patient can be like 
        fixing a car with four flat tires. You cannot just inflate one 
        tire and expect a good result. You must work on all four.
         b.  From a physician with chronic pain: Pain management and 
        physical rehabilitation was never addressed in my medical 
        school curriculum nor in my family practice residency. My 
        disability could have been avoided or lessened with timely 
        treatment, and I could still be the provider instead of the 
        patient.
         c.  From a clinical pharmacy specialist: We cannot 
        successfully treat the complexity of pain without treating the 
        whole patient. Insurance companies will pay for useless, 
        expensive procedures and surgeries but won't pay for simple 
        cognitive-behavioral therapy and physical rehab therapy.
         d.  From a patient with chronic pain: I have a master's degree 
        in clinical social work. I have a well-documented illness that 
        explains the cause of my pain. But when my pain flares up and I 
        go to the ER, I'll put on the hospital gown and lose my social 
        status and my identity. I'll become a blank slate for the 
        doctors to project their own biases and prejudices.

    6. An overarching conclusion from our report on Alleviating Pain in 
America is that to reduce the impact of pain and the resultant 
suffering will require of cultural transformation in how pain is 
perceived and judged both by people with pain and by the health care 
providers who help care for them. The overarching goal of this 
transformation should be gaining a better understanding of pain of all 
types and improving efforts to prevent, assess and treat pain. The 
committees report offers a blueprint for achieving this transformation 
that included 16 recommendations that addressed:

         a.  Public health challenges;
         b.  Pain care and management;
         c.  Education of patients, communities and providers; and
         d.  Research.

    7. To help establish priorities, the IOM Committee recommended that 
4 of its 16 recommendations be implemented by the end of 2012 and that 
the remaining 12 recommendations be completed before the end of 2015 
and then be maintained on an ongoing basis. These are as follows:

         a.  Immediate--Complete by the end of 2012

            i.  The Secretary of HHS should create a comprehensive 
        population-level strategy for pain prevention, treatment, 
        management and research to:

               1.  Coordinate efforts across public and private sector;
               2.  Include agenda for developing research;
               3.  Improve pain assessment and management programs; and
               4.  Improve ongoing efforts to enhance public awareness 
        of pain.

         This should involve multiple Federal, State and private sector 
        entities--including the NIH, FDA, CDC, AHRQ, HRSA, CMS, DOD, 
        VA, professional societies and others.

            ii.  The Secretary of HHS along with other Federal, State 
        and private sector entities should develop strategies for 
        reducing barriers to the care of pain--focusing in particular 
        on populations disproportionately affected by and undertreated 
        for pain.
            iii.  Through CMS, the VA, DOD, health care providers, 
        insurers and others--support collaboration between pain 
        specialists and primary care clinicians, including referral to 
        pain specialists when appropriate.

               1.  Given the prevalence of chronic pain, it is not 
        realistic or desirable to relegate pain management to pain 
        specialists alone. There are fewer than 4,000 such specialists 
        in the United States with limited geographic coverage. Ideally 
        primary care physicians would coordinate pain management, but 
        such a change cannot be achieved without significant 
        improvements in education and training. Moreover payment 
        systems must be restructured to allow primary care physicians 
        to spend more time with patients with chronic pain and deliver 
        care more effectively. Given the increasing demands on primary 
        care physicians, it would be unfair to add expectations without 
        providing opportunities for education and payment for 
        counseling patients. Similar issues and constraints apply to 
        nurses, psychologists, physical and occupational therapists, 
        pharmacists, and practitioners of complementary and alternative 
        medicine.

           iv.  The Director of the NIH should designate a lead 
        institute at the National Institutes of Health that is 
        responsible for moving pain research forward, along with an 
        increase in the support for and scope of the Pain Consortium. 
        This should involve pain advocacy and awareness organizations 
        and should foster public private partnerships.

         b.  Near-term and enduring--complete by 2015 and maintain

            i.  Public Health

               1.  Improve the collection and reporting of data on 
        pain.

            ii.  Care

               1.  Promote and enable self-management of pain.
               2.  Provide educational opportunities in pain assessment 
        and treatment in primary care.
               3.  Revise reimbursement policies to foster coordinate 
        and evidence-based pain care.
               4.  Provide consistent and complete pain assessments.

            iii.  Education

               1.  Expand and redesign education programs to transform 
        the understanding of pain.
               2.  Improve curriculum and education for health care 
        professionals.
               3.  Increase the number of health professionals with 
        advanced expertise in pain care.

            iv.  Research

               1.  Improves the process for developing new agents for 
        pain control.
               2.  Increase support for interdisciplinary research in 
        pain.
               3.  Increase the conduct of longitudinal research in 
        pain.
               4.  Increase the training of pain researchers.

    8. These recommendations serve the goal of creating a 
comprehensive, population-level strategy for pain prevention, 
management and research. The scope of the problems in pain management 
is daunting, and the limitations in the knowledge and education of 
health care professionals are glaring. The medical community must 
actively engage in the necessary cultural transformation to reduce the 
pain and suffering of Americans. Importantly the cultural and social 
transformation needed to alleviate pain in America will require the 
collaboration of the healthcare provider community with patients and 
their families who are suffering from pain, including their 
communities, professional societies and advocacy organizations as well 
as State and Federal Government. New public-private partnerships and a 
broad concerted level that addresses pain as a public health initiative 
as well as an individuals source of suffering will be necessary if we 
are to make progress in alleviating pain. We must all be part of the 
dialog and the solution.

    The Chairman. Thank you, Dr. Pizzo. Did I pronounce that 
right?
    Dr. Pizzo. Yes, you did. Thank you.
    The Chairman. All right, Dr. Pizzo.
    Dr. Maixner, welcome. Please proceed.

 STATEMENT OF WILLIAM MAIXNER, D.D.S., Ph.D., DIRECTOR, CENTER 
  FOR NEUROSENSORY DISORDERS, UNIVERSITY OF NORTH CAROLINA AT 
                  CHAPEL HILL, CHAPEL HILL, NC

    Mr. Maixner. Thank you, Mr. Chairman.
    Let me just start by thanking the Chairman for indulging 
these testimonies. It is truly an honor for me. I was born in 
Ottumwa, IA, southeast Iowa, and so to be testifying before an 
Iowa Senator is truly an honor for me, but more so for 
representing the pain research community and the patients who 
suffer from a hidden epidemic. Let me start my formal 
statement.
    It is truly a tribute to our political system that the 
voices of many, as well as a few, can be heard and acted upon. 
Today, I would like to further detail several of the points 
made in the IOM report, ``Relieving Pain in America,'' which 
provides clear and unequivocal evidence that more than 100 
million of our fellow citizens are experiencing a silent, 
hidden, and poorly treated epidemic. An epidemic that is as 
real as the polio epidemic that visibly shackled hundreds of 
thousands of Americans, and caused individuals and families to 
suffer greatly. No less real is the suffering of millions of 
Americans who frequently suffer silently without the outward 
signs of an iron lung.
    Similar to the polio epidemic, a transformative national 
effort is needed to crush the epidemic of chronic pain 
worldwide. I submit that we now possess the tools and the 
knowledge to conquer this epidemic and to bring relief to 
millions worldwide. The real question is whether the fortitude 
and will to mount a focused campaign that results in adequate 
treatments and cures for common conditions exist within the 
United States today.
    During the remainder of my time, I would like to highlight 
some of the salient points from the IOM report, and also 
address some of the barriers that exist in the area of 
research, education, and patient care.
    We have already heard two testimonies related to the 
magnitude of this problem, impacting over 100 million Americans 
as we sit here today, with horrendous cost to society, over 
$600 billion annually paid by our society for these conditions.
    New to this committee and to the understanding of the 
public, I think, is that chronic pain is truly a disease. It is 
more than a symptom. It is a disease in its own right. We 
understand the biology to a large extent, and many of the 
genetic and biological principles that lead to this very 
devastating set of conditions.
    I firmly believe that we now have adequate knowledge with 
the biology, the psychology, and the social fabric that 
underlies chronic pain conditions, as well as the genetic 
factors that we are at the verge of being able to make 
substantial progress on this massive public health issue.
    There are, however, several fundamental barriers that 
preclude a national transformative effort that I would like to 
highlight, and recommend as outlined in the IOM report, but 
also offer some of my own perspectives on solutions as well.
    With respect to barriers to research, in my view, one of 
the major barriers represents the substantial mismatch between 
the allocation of NIH funding for pain research, though one can 
quibble about that level. It ranges from 0.4 percent to 1.3 
percent. Yet, we know that the consumption of health care 
dollars is enormous. If we look at Medicare costs alone, 14 
percent of the Medicare budget is used to treat chronic pain. 
Yet again, only about 0.8 percent of our NIH resources are used 
for the study of chronic pain.
    If we look beyond Medicare, if we look at the consumption 
of direct and indirect costs associated with treating common 
conditions, including chronic pain, we find that almost 30 
percent of direct and indirect costs are associated with the 
payment for the treatment of chronic pain conditions.
    In my view, there needs to be additional resources either 
provided to NIH targeted toward chronic pain and pain 
initiatives, or a proportionate allocation of NIH 
appropriations that are used to further address pain-related 
conditions. There are other substantial issues that are 
outlined in the IOM report related to research, but to me that 
is one of the primary fundamental research barriers that 
currently is impeding progress.
    In the area of education, it has already been alluded to 
that curriculum as a fundamental problem. I served at UNC 
School of Dentistry as Associate Dean for Academic Affairs for 
6 years, and had an opportunity to look at the curriculum 
content that we have devoted to pain management and pain 
mechanisms. I am proud to say that at UNC, we have 20-some 
hours of didactic offerings and practical offerings which, in 
my view, is still very insufficient. Compared to medical 
curriculum where the average student receives nine sessions 
related to pain management and pain mechanisms. Woefully 
inadequate, in my view, to provide competent individuals who 
are able to diagnose, assess, and treat patients with chronic 
pain conditions.
    I recommend major curriculum reform that is associated with 
discussions with accrediting agencies, and perhaps discussions 
with the Department of Education that will help mandate further 
change in curriculum. I am not one to easily recommend 
mandates, but I can tell you this is a daunting task trying to 
work in more clock hours for a specific discipline.
    Manpower issues, the lack of education has direct impact on 
the sparse manpower that we have with respect to individuals 
who are competently trained to deliver management and diagnoses 
of chronic pain conditions. I think expansion of our GME 
programs that will permit sponsored fellowships and residencies 
in health 
care related to chronic pain management would be extremely 
helpful.
    Barriers to patient care, they are substantial. As we heard 
earlier, reimbursements for primary care physicians who are on 
the frontline, reimbursement is very poor for these conditions. 
I think mechanisms need to be placed for primary care 
physicians for reimbursements, but also mechanisms to improve 
their continuing education opportunities, incentives given to 
our general physicians to promote continuing education as it 
relates to pain management.
    The need, in my view, for both patient barriers and primary 
care barriers is the need for advanced pain management centers. 
There have been words made to the effect that we need such 
centers. I think it is now time that advanced pain management 
centers become a reality. These can represent the most 
important portals of entry to the health care system, portals 
of referral from primary care physicians, portals of entry for 
patients who suffer from debilitating chronic pain conditions.
    As we all know, most chronic pain conditions in patients 
require doctor shopping, going from one doctor to another for 
diagnosis and treatment. We desperately need coordinated pain 
centers that have both education, patient care, and research 
missions behind their walls. This will be one of the most 
important aspects of action that will help break through 
barriers that both patients and clinicians face.
    I have other aspects and recommendations to my written 
testimony, but I would just like to conclude by saying that 
addressing and breaking through these barriers will not only 
improve the human condition, but will fuel new economic 
opportunities and job creation that will endure well into the 
21st century. The tools and pathways needed to conquer the 
hidden epidemic of chronic pain are now before us.
    We Americans have an established and proud history of 
curing debilitating public health epidemics and improving the 
human condition. A national initiative similar to what we 
addressed with the polio epidemic is needed. It is within our 
reach and we will relieve suffering of millions of Americans by 
so accomplishing this initiative.
    All that is required is to hear and to act upon the voices 
of those who suffer from this epidemic.
    Thank you, Chairman.
    [The prepared statement of Mr. Maixner follows:]
          Prepared Statement of William Maixner, D.D.S., Ph.D
                                summary
               chronic pain in america--a silent epidemic
     Impacts 116 million Americans, approximately $600B in 
annual costs with greater costs than cancer, heart disease, and 
diabetes combined.
     Chronic pain is a disease of the nervous system that has a 
biological basis and a pathophysiology that pain scientists are having 
great success in unraveling. This bodes well for new research 
initiatives that will result in novel treatments and cures for this 
epidemic.
     We currently have adequate knowledge of many of the 
biological events that contribute to the perception of acute and 
chronic pain, but a coordinated effort that permits the translation of 
current knowledge into clinical practice is lacking.
     Barriers to developing effective treatments and cures:

         Research:

            Major mismatch between NIH annual funding 
        (approximately 0.8 percent of NIH budget) and annual direct and 
        indirect costs of chronic pain (14 percent of annual Medicare 
        costs for treatment of pain-related conditions; approximately 
        30 percent of direct and indirect costs associated with the 
        treatment of all common diseases (cardiovascular, pulmonary, 
        cancer, endocrine, digestive diseases)).
            The review process (i.e., study sections) for pain-
        related grant applications needs to be modified to incorporate 
        reviewers with competency in pain mechanisms and pain 
        management. Grant applications associated with pain should be 
        distributed to multiple study sections and should be reviewed 
        by expert reviewers in the field of pain.
            A need to develop new methods to diagnose and treat 
        chronic pain patients based on the concept of ``personalized'' 
        medicine. This will require both large scale clinical studies 
        and basic science studies that further delineate pain 
        mechanisms and putative therapeutic targets.
            A need to expand and integrate funding 
        opportunities across public and private sectors.

         Education:

            Curriculum: Clock hours are very few and not well-
        integrated resulting in inadequate knowledge and skills-based 
        competencies regarding the evaluation and treatment of acute 
        and chronic pain conditions. There is a major need for 
        curriculum reform--mandated via accrediting agencies or by the 
        Department of Education.
            Manpower: A limited number of trained health care 
        providers, basic and clinical scientists with background and 
        interest in pain mechanisms and pain management. There is a 
        major need to expand educational opportunities for the training 
        of health care providers at all professional levels. A need to 
        focused training grants and GME-sponsored residents/fellows 
        across all areas of health care.

         Patient Care:

           Primary Care:

                 Reimbursements are poor.
                  Referral process to advance pain managements 
                units is eclectic at best with no clear ``portal'' for 
                referral and management. There is a strong need to 
                incentivize the development of pain patient portals 
                that enable rapid referral and multidisciplinary 
                management for chronic pain patients.

            Advanced Pain Management Centers of Excellence:

                  Reimbursements for non-procedure-based care 
                are poor and bundled reimbursements for 
                multidisciplinary approaches should be considered and 
                rewarded.
                  Should provide a portal of entry that is not 
                departmentally (silo) based and is integrated across 
                the health care system.
                  Partner with public-private networks to 
                conduct comparative effectiveness assessments of 
                current and new treatments.

           Patients:
                  Portals of entry into the health care system 
                are not clear resulting in ``doctor shopping'' with the 
                hope of identifying a clinical facility that 
                understands, validates, and can manage chronic pain. 
                The establishment of bona fide Pain Management Centers 
                of Excellence is required.

    Addressing and breaking through these barriers will not only 
improve the human condition but will fuel new economic opportunities 
and job creation that endure well into the 21st century.
    The tools and pathways to resolving this silent epidemic are now 
before us. We Americans have an established history of curing 
debilitating public health epidemics to improve the human condition. A 
national initiative similar to the way that we addressed the polio 
epidemic is needed and within our reach to relieve the suffering of 
millions of Americans.
                                 ______
                                 
                  pain in america--the hidden epidemic
    Senators, colleagues and guests, let me start by noting my sincere 
appreciation for the opportunity to testify before this distinguished 
body. It is a tribute to our political system that the voices of many, 
as well as the few, can be heard and acted upon. Today, I would like to 
further detail several of the points made in the IOM report Relieving 
Pain in America, which provides clear and unequivocal evidence that 
more than 100 million of our fellow citizens are experiencing a silent, 
hidden, and poorly treated epidemic. An epidemic that is as real as the 
polio epidemic that visibly shackled hundreds of thousands of Americans 
and caused individuals and their families much suffering. No less real 
is the suffering of millions of Americans who frequently suffer 
silently without the outward signs of an iron lung. Similar to the 
polio epidemic, a transformative national effort is needed to crush the 
epidemic of chronic pain worldwide. I submit that we now possess the 
tools and knowledge to conquer this epidemic and to bring relief to 
many millions worldwide. The real question is whether we have the 
fortitude and will to mount a focused campaign that results in adequate 
treatments and cures for common chronic pain conditions.
    During the next few minutes I would like to provide you with an 
overview of what I consider to be the salient points of the IOM report 
and then address issues related to barriers to research, education, and 
patient care that collectively impair a transformative initiative that 
will defeat this hidden epidemic.
    While the IOM report Relieving Pain in America draws several 
evidence-based findings, I would like to highlight a few key findings:

    1. The epidemic of chronic pain impacts over 100 million Americans.
    2. The direct medical costs and indirect annual costs associated 
with chronic pain is approximately $600B, which is greater than the 
societal annual cost for cancer, heart disease, and diabetes combined.
    3. Chronic pain is more than a symptom that causes patients to seek 
treatment. It is a disease of the nervous system that has a biological 
basis and a pathophysiology. Today, well-trained and dedicated pain 
scientists are making great progress in unraveling the biological, 
psychological, and genetic mysteries of chronic pain. This bodes well 
for new research initiatives that can lead to novel treatments and 
cures for this epidemic.
    4. While we have adequate knowledge of many of the bio-psychosocial 
and genetic factors that contribute to the perception of acute and 
chronic pain, a coordinated national public and private effort is 
required to successfully translate current knowledge into clinical 
practice.

    While we are making progress in unraveling the epidemic of chronic 
pain, future progress in delivering relief to millions faces many 
hardened and daunting barriers that require a transformation in the way 
we think about chronic pain and the delivery of health care to the 
millions who suffer from this epidemic. I would like to highlight some 
of the barriers that are impeding this transformative effort and offer 
potential solutions that will enable the transformative step to occur.

     Research:

      1.  There is a major mismatch between NIH annual funding 
(approximately 0.8 percent of NIH budget) and annual direct and 
indirect costs of chronic pain (14 percent of annual Medicare costs for 
treatment of pain-related conditions; approximately 30 percent of 
direct and indirect costs associated with the treatment of all common 
diseases (cardiovascular, pulmonary, cancer, endocrine, digestive 
diseases)).

           Recommendation: A greater share of Federal funding for pain 
        research is needed and can be provided by additional targeted 
        funding to the NIH or a portion of allocated NIH appropriations 
        should be devoted to pain research.

      2.  The review process (i.e., study sections) for pain-related 
grant applications needs to be modified to incorporate reviewers with 
competency in pain mechanisms and pain management.

           Recommendation: Grant applications associated with pain 
        should be distributed to multiple study sections and should be 
        reviewed by expert reviewers in the field of pain.

      3.  There is a substantial need to develop new methods for 
diagnosing and treating chronic pain patients based on the concept of 
``personalized'' medicine.

           Recommendation: The funding of clinical studies and basic 
        science studies that further delineate pain mechanisms and 
        putative therapeutic targets with a focus on identifying key 
        clinical characteristics (phenotypes, biomarkers, molecular 
        profiles) that permit diagnoses based on patient heterogeneity 
        and result in personalized or tailored pain therapies.

      4.  In order to accomplish a transformative national research 
initiative coordinated public-private initiatives are required.

           Recommendation: That the newly formed Interagency Pain 
        Committee be charged with developing, integrating and 
        monitoring public-private funding opportunities.

     Education:

      1.  Curriculum: Clock hours are very few and not well-integrated 
resulting in inadequate knowledge and skills-based competencies with 
respect to the ability of health care providers to evaluate and treat 
acute and chronic pain conditions.

           Recommendation: Mandated curriculum reform--mandated via 
        accrediting agencies and/or by the Department of Education.

      2.  Manpower: A limited number of trained health care providers, 
basic and clinical scientists with background and interest in pain 
mechanisms and pain management. There is a major need to expand 
educational opportunities for the training of health care providers at 
all professional levels.

           Recommendation: Provide resources for training grants and 
        GME-sponsored residents/fellows training across all areas of 
        health care.

     Patient Care:

      1.  Primary Care:

            Reimbursements are poor and when coupled with 
        inadequate education in the area of pain diagnosis and 
        treatment results in inadequate patient care.

            Recommendation: Increase reimbursement for services 
        provided in the primary care setting and provide incentives to 
        complete CME offerings in pain management.

            Referral process to advance pain managements units 
        is eclectic at best with no clear ``portal'' for referral and 
        management.

            Recommendation: There is a strong need to create 
        incentives/funding that leads to the development of referral 
        portals to Advance Pain Management Centers, which will enable 
        rapid referral and results in the multidisciplinary management 
        of chronic pain patients.

      2.  Advanced Pain Management Centers of Excellence:

            Reimbursements for non-procedure-based care is 
        poor.

            Recommendation: Create bundled reimbursements for 
        multidisciplinary approaches.

            Should provide a portal of entry that is not 
        departmentally (silo) based and is integrated across the health 
        care system.

            Recommendation: Provide funding to support the initial 
        infrastructure development of several Advance Pain Centers of 
        Excellence which integrate across the health care delivery 
        system. These centers should have mission statements related to 
        patient care, research, and education.

            These centers should be on the forefront of 
        conducting comparative effectiveness studies.

            Recommendation: Federally funded Advanced Pain Centers 
        should partner with public-private networks and other regional 
        Advanced Pain Centers to conduct comparative effectiveness 
        assessments of current and new treatments.

      3.  Patients:

            Portals of entry into the health care system are 
        not clear resulting in ``doctor shopping'' with the hope and 
        luck of identifying a clinical facility that understands, 
        validates, and can manage chronic pain.

            Recommendation: The establishment of bona fide Advanced 
        Pain Centers of Excellence which are ``branded'' and have 
        public visibility.

    Addressing and breaking through these barriers will not only 
improve the human condition but will fuel new economic opportunities 
and job creation that will endure well into the 21st century. The tools 
and pathways needed to conquer the hidden epidemic of chronic pain are 
now before us. We Americans have an established and proud history of 
curing debilitating public health epidemics to improve the Human 
Condition. A national initiative similar to the way that we addressed 
the polio epidemic is needed and within our reach and will relieve the 
suffering of millions of Americans. All that is required is to hear and 
to act upon the voices of those who suffer from this epidemic.

    The Chairman. Thank you, very much, Dr. Maixner. I had 
briefly introduced Miss Veasley when she came to the panel, but 
I would yield to Senator Whitehouse for further elaboration on 
our next witness.
    Senator Whitehouse.
    Senator Whitehouse. Thank you, Chairman. If you do not 
mind, I would also like to make a brief comment.
    The Chairman. Yes, sir.

                    Statement of Senator Whitehouse

    Senator Whitehouse. First of all, thank you for holding a 
hearing on this important topic. The costs that come with 
chronic pain are enormous, and they are not just health care 
costs measured in dollars. They are also human costs measured 
in quality of life.
    As Rhode Island's attorney general, I brought together a 
group of health care stakeholders to look into problems we were 
facing in making pain management a routine part of patient 
care. Our work centered on simple things like making pain a 
fifth vital sign, recorded by the medical establishment. If my 
memory serves, Memorial Hospital was the first to take that 
step, and other Rhode Island hospitals have since followed.
    Promoting awareness and education about pain management, 
particularly for patients nearing the end of life both across 
providers and patients, has to be a fundamental part of any 
strategy to improving pain care. We worked with Dr. Joan Teno 
of Brown University who had done a study showing that the 
majority of families who are with a dying loved one reported 
that their loved one had died in pain. Of the families who 
reported that their loved one had died in pain, a majority of 
the families described that family member's pain as severe or 
excruciating.
    It is a really important issue and it gives me great 
pleasure to introduce Christin Veasley, who is a dedicated 
advocate and the executive director of the National Vulvodynia 
Association. She plays a critical role in raising awareness and 
understanding about vulvodynia and pain disorders that 
disproportionately affect women, and she also happens to be a 
resident of North Kingstown, RI.
    Christin received her bachelor of science from the 
University of Wisconsin. Before coming to the National 
Vulvodynia Association, she worked in the Department of 
Neurology at the Johns Hopkins University School of Medicine 
investigating the neurophysiological mechanisms of pelvic pain 
and inflammation.
    I am pleased to announce that Chris was recently appointed 
to the NIH's new Interagency Pain Research Coordinating 
Committee. Her personal and professional experience will be a 
great asset to the committee whose mission is to identify gaps 
in basic and clinical research on the symptoms, causes, and 
treatment of pain.
    Chris, congratulations on that achievement and that 
important assignment. We look forward to hearing your testimony 
today and I will close, again, with my gratitude to the 
Chairman for allowing me to recognize a native Rhode Islander 
who we are very proud of.
    The Chairman. Thank you, Senator Whitehouse, and thank you 
for your opening comments too.
    Miss Veasley, as I said, your statement will be made a part 
of the record in its entirety. Please proceed as you so desire.

  STATEMENT OF CHRISTIN VEASLEY, EXECUTIVE DIRECTOR, NATIONAL 
          VULVODYNIA ASSOCIATION, NORTH KINGSTOWN, RI

    Ms. Veasley. Thank you, Senator Whitehouse, Chairman 
Harkin.
    As director of the NVA, an organization that serves a long-
neglected and stigmatized group of women with chronic vulvar or 
genital pain, and as a pain sufferer myself, it is truly a 
privilege that I do not take lightly to be before you today to 
share just some of what millions of Americans are experiencing 
in their daily battle against chronic pain.
    We are very grateful for the committee's work calling on 
the IOM to study what the IOM committee concluded is a national 
crisis that we have a moral imperative to address. The IOM 
report and today's hearing have given us renewed hope. Hope 
that our country is listening to us, cares about our plight, 
and is ready to enact long overdue change to help us regain 
some quality of life and our ability to contribute to society.
    I survived a near-fatal accident when I was 15-years-old 
and also found a resolution to the debilitating vulvar pain I 
experienced in my twenties. I have had residual back and neck 
pain for 20 years and since 2008, I have developed jaw and 
facial pain, as well as migraine headache. My story echoes the 
experiences of millions. I am just one of many.
    The reality is that my choice in being here today, while it 
is a privilege, means that for the rest of this week and maybe 
next, that I will be somewhat incapacitated, and many in our 
country really do not have this choice anymore.
    From the moment I open my eyes every morning, the first 
thing I feel is pain and it stays with me throughout the day. 
As the number of hours I devote to managing appointments, pain 
symptoms, and medication side effects, which right now average 
about 25 hours a week for me, my normal daily activities have 
become more and more difficult, and the most meaningful pieces 
of me and my life feel like they slowly fade away.
    Due to inadequate research efforts, doctors do not have the 
training or scientific information they need to effectively 
manage pain. As patients, we are left completely disillusioned, 
forced to navigate the health care system on our own, and 
implement a trial and error process that can easily take months 
to years to find a treatment to lessen the pain that we 
experience.
    In the last 4 years alone, I have been to specialists in 
four different States. I have tried 15 different treatments, 
and I still live with moderate to severe daily pain that 
impacts every part of my life. I have easily spent $10,000 on 
out-of-pocket expenses alone in the last 2 years. I am 
privileged to have an understanding employer and good health 
insurance, which many in our country do not have.
    Pain exhausts, depletes, dehumanizes, and drains you in 
every single capacity: physically, emotionally, spiritually, 
and financially. It is only by God's grace and with the support 
of my family that I function as well as I do.
    And because pain's very purpose is to warn you that 
something is wrong with your body, it is completely impossible 
to ignore. Your mind is cloudy. Your attention is scattered, 
and it feels like you live with a veil over your face, blurred 
and unfocused. Work goes undone. Productivity and efficiency 
feel like things of the past. I only selectively engage in 
activities that I once enjoyed with my family because of the 
increased pain and disability that follow. Life does not stop; 
it just simply goes on in our absence.
    Chronic pain is an invisible disability. You would not be 
able to tell by looking at me today that I have any kind of 
problem. You look fine on the outside, but many feel like dying 
on the inside. When you suffer from pain in an area of your 
body that is still not candidly discussed by our country like 
women with vulvodynia do, the suffering they feel is further 
compounded with embarrassment, stigma, and isolation.
    As the IOM report highlights, all of what I have just 
described disparately impacts women. Further, mounting research 
shows that once you develop one pain syndrome, you are more 
likely to develop pain in other areas of your body. This is the 
reason why the NVA joined forces with the Endometriosis 
Association, the CFIDS Association of America, and the TMJ 
Association to form the Chronic Pain Research Alliance, the 
first collaborative advocacy effort to advance a smarter and 
more cost-effective approach to research on neglected pain 
conditions that frequently co-occur and disproportionately 
impact women. In addition to vulvodynia, there are TMJ, chronic 
fatigue, endometriosis, fibromyalgia, interstitial cystitis, 
irritable bowel, and headache.
    Our 2010 report drew many of the same conclusions as the 
IOM's. Women have more frequent, more severe, and longer 
lasting pain than men, but are treated less aggressively. Their 
reports are routinely dismissed as psychogenic or hysterical, 
and therefore not real frequently leading to mental health 
diagnoses. Our failure to deal with just these conditions adds 
a wasteful $80 billion a year to our growing health care bill, 
and despite this impressive toll, the NIH's research investment 
average just $1.36 per affected woman in 2010.
    The end result, as we have already heard, is that the 
afflicted are routinely misdiagnosed, shuffled from office to 
office, inappropriately treated, and left without hope. It 
takes months to years and multiple consults to obtain an 
accurate diagnosis, and when one is given, evidence-based 
treatments are limited, forcing the afflicted to experiment 
with multiple treatments with unknown benefit and risk.
    Because of this disparity and the historical neglect of 
these conditions, it is essential for future pain initiatives 
to include a long overdue and appropriate inclusion of these 
conditions. We applaud the HELP Committee, the IOM, and the NIH 
for your initial steps to address this national crisis. We 
strongly support the IOM's main recommendation that by the end 
of 2012, HHS should create a comprehensive population-level 
strategy for pain.
    Additionally, all of the recommendations stem back to one 
thing, and that is research. We need an increased, smarter, and 
more cost-effective Federal research approach by placing 
greater priority on collaborative research across the 
conditions, as well as across NIH institutes and Federal 
agencies. It is only through research that we will better 
understand the mechanisms of pain, delineate effective 
treatments, and that the medical community will have the 
scientifically proven information they need to make appropriate 
diagnostic and treatment recommendations. Then, and only then, 
will the haphazard treatment of pain, as well as the costly and 
wasteful health care spending come to an end giving the 
millions of American pain sufferers and their families the one 
thing that we desperately want returned to us and that is our 
lives.
    Thank you.
    [The prepared statement of Ms. Veasley follows:]
                 Prepared Statement of Christin Veasley
                                summary
    The Institute of Medicine (IOM) report and today's hearing give us 
renewed hope that our country is listening to us, cares about our 
plight, and is ready to enact overdue change to help us regain our 
quality of life and ability to contribute to society.
    I survived a near-fatal car accident in my teens and found a 
resolution to the debilitating vulvar pain I experienced in my 
twenties; however, back and neck pain have been an unwanted companion 
for 21 years and since 2008, I've developed jaw and facial pain, as 
well as migraine headaches. Normal daily living has progressively 
become more difficult. I spend 25 hours a week managing pain, 
appointments and medication side effects. Due to a woefully inadequate 
research effort, doctors don't have the scientific information they 
need to adequately diagnose and treat pain. As patients, we are left 
completely disillusioned, forced to navigate the health care system on 
our own and implement a trial-and-error process to find treatment(s) to 
lessen the pain. In the last 4 years, I've been to specialists in four 
states, have tried 15 treatments and still suffer with moderate to 
severe daily pain. In the last 2 years, I've easily spent over $10,000 
in out-of-pocket expenses alone. Pain exhausts, depletes and drains you 
in every capacity--physically, emotionally, spiritually and 
financially. It is only by God's grace, and with the support of my 
family, that I function as well as I do. Because pain's very purpose is 
to warn you that something is wrong, it is impossible to ignore. My 
mind is cloudy and my attention is scattered, like living with a veil 
over my face--blurred and unfocused. Work goes undone, I feel 
unproductive and I only selectively engage in activities that I once 
enjoyed with my family because of the increased pain/disability that 
follows. Life doesn't stop--it simply goes on in my absence. In social 
settings, I pretend to the best of my ability to be OK because people 
don't understand. Chronic pain is an invisible disability, and the 
associated suffering is further compounded with embarrassment, 
isolation and stigma.
    Further, a growing body of scientific evidence shows that once you 
develop one pain syndrome, you are more likely to develop pain in other 
areas of your body. Also, as the IOM report highlights, all of what 
I've just described disparately affects women. This is the reason why 
the NVA joined forces with the Endometriosis Association, CFIDS 
Association of America and The TMJ Association to form the Chronic Pain 
Research Alliance (CPRA)--the first collaborative advocacy effort 
dedicated to alleviating the suffering caused by neglected pain 
conditions that frequently co-occur and disproportionately affect women 
including: vulvodynia, temporomandibular disorders, chronic fatigue 
syndrome, endometriosis, fibromyalgia, interstitial cystitis, irritable 
bowel syndrome and chronic headache. Our groundbreaking 2010 report 
drew many of the same conclusions as those reached by the IOM. (Please 
see the attached report* and patient comments.) The report's key 
findings include:
---------------------------------------------------------------------------
    * The report referred to may be found at www.EndWomensPain.org/
WIP2011ReportFINAL
(1).pdf.

    (1) Women report pain that is more frequent and more severe, and of 
longer duration than men, but are treated less aggressively. Health 
care providers are more likely to dismiss women's pain reports as 
``emotional, psychogenic, hysterical or oversensitive'' and therefore 
``not real,'' leading to more frequent mental health diagnoses.
    (2) Our failure to effectively deal with these disorders adds $80 
billion annually to our country's growing health care bill, and much of 
this could be saved through an expanded research effort and 
improvements in diagnosis and treatment.
    (3) Despite their impressive personal and economic toll, NIH's 
research investment in these conditions is severely shortchanged, 
averaging just $1.36 per affected woman in 2010. What little research 
that has been conducted has lacked sufficient coordination, 
interdisciplinary collaboration and direction.
    (4) The end result is that sufferers are routinely misdiagnosed, 
shuffled from office to office, inappropriately treated and left 
without hope, needlessly suffering. It takes months to years, and 
multiple consults, to obtain an accurate diagnosis. When a diagnosis is 
given, evidenced-based treatments are limited, forcing the afflicted to 
experiment with a myriad of therapies with unknown risks/benefits until 
they find a treatment(s) to relieve some of the pain.

    We applaud Congress, NIH and the IOM for their initial steps to 
address this national crisis. Going forward, it is essential that:

    (1) HHS-funded research on these conditions is significantly 
increased, and taxpayer investments be made more efficient and 
effective by placing greater priority on collaborative 
interdisciplinary research across the conditions, as well as across HHS 
agencies and NIH Institutes and Offices;
    (2) HHS agencies aggressively expand, in a multidisciplinary 
fashion, the cadre of scientists who study chronic pain; and
    (3) HHS launch an aggressive awareness campaign that includes the 
most current scientific information on the diagnosis, treatment and 
prevention of these disorders, to educate health care professionals, 
patients and the American public.

    It is only through an expanded, smarter and more cost-effective 
Federal research effort that: (i) we will better understand the causes 
and mechanisms of chronic pain, as well as delineate effective 
treatments; (ii) the medical community will learn how to recognize and 
adequately manage pain; and (iii) medical professionals will have the 
scientifically proven information they need to make appropriate 
diagnostic and treatment recommendations. Then, and only then, will the 
haphazard treatment of chronic pain, as well as costly and wasteful 
health care spending come to an end, giving the millions of American 
pain sufferers the one thing they desperately want returned to them--
their lives.
                                 ______
                                 
    Chairman Harkin, Ranking Member Enzi, members of the committee, 
thank you for the opportunity to speak with you about how chronic pain 
affects the lives of millions in our country.
    We extend our sincere gratitude to the committee for passing a 
bipartisan amendment that called upon the prestigious Institute of 
Medicine (IOM) to study this public health crisis and develop 
recommendations on how to improve pain research, medical care and 
education. I cannot overstate its importance. The IOM report and 
today's hearing give us renewed hope--hope that our country is 
listening to us, cares about our plight, and is ready to enact long-
overdue change to help us regain our quality of life and ability to 
contribute to society.
    My name is Christin Veasley. I am the executive director of the 
National Vulvodynia Association (NVA), a non-profit organization 
dedicated to improving the lives of the 1 in 4 American women, and 
countless adolescents who, throughout their lifetime, suffer with 
chronic vulvar (genital) pain. In addition to serving as an 
organizational representative, I am also a chronic pain sufferer 
myself. I survived a near-fatal car accident in my teens and found a 
resolution to the debilitating vulvar pain I experienced in my 
twenties; however, back and neck pain have been an unwanted companion 
for 21 years, and since 2008, I've developed jaw and facial pain, as 
well as migraine headaches.
    My story echoes the experiences of millions in our country who 
bravely fight pain every day of their lives. From the moment I open my 
eyes each morning, the first thing I feel is pain. Just to get out of 
bed can be an insurmountable challenge. Normal daily living has become 
more and more difficult and it is a struggle to just get through the 
day. As the number of hours devoted to medical appointments, managing 
pain symptoms and coping with unpleasant side effects of medications 
increase, which for me currently averages 25 hours per week, the most 
meaningful parts of life can slowly fade away if you're not diligent. 
Pain exhausts, depletes and drains you in every capacity--physically, 
emotionally, spiritually and financially. It feels like my life and 
spirit are being sucked dry, and I have to fight to remain an active 
participant in my own life. It is only by God's grace and the support 
of my family that I function as well as I do.
    Because the very purpose of pain is to warn you that something is 
wrong with your body, it is impossible to ignore it. I am constantly 
distracted. No matter how hard I try to focus, my mind is cloudy and my 
attention is scattered, like living with a veil over my face--blurred 
and unfocused. Work goes undone. Productivity and efficiency are things 
of the past. I only selectively engage in activities that I once 
enjoyed with my husband and daughters because of the increased pain and 
disability that follow. Life doesn't stop--it simply goes on in my 
absence. In social settings, I do my best to pretend that I'm OK, 
because no matter how well-intentioned others may be, they simply can't 
understand. Having previously experienced pain in the vulva for 7 
years--a part of the body that is not openly discussed in our society--
I can testify that the suffering is further compounded by 
embarrassment, stigma and isolation. While it may be socially 
acceptable to tell another that you have a headache, women are not 
comfortable disclosing their inability to sit due to vulvar pain. 
Chronic pain is an invisible disability. Sadness, isolation, 
frustration, anger, anxiety, and a host of other unwanted emotions and 
feelings can dominate you and easily change who you are.
    It's logical to ask, ``why not see a different doctor or get better 
treatment? '' The answer was recently summarized by a leading pain 
physician in the journal Lancet:

          ``Overall, currently available treatments provide modest 
        improvements in pain and minimum improvements in physical and 
        emotional functioning. The quality of evidence is mediocre and 
        has not improved substantially during the last decade.''--(Turk 
        DC, et al., Lancet 2011;377:2226-35.)

Because of this, doctors don't have the scientific information they 
need to make appropriate diagnostic and treatment recommendations. They 
look at me, shrug their shoulders and really don't have any idea 
whether a certain medication or treatment is going to work. As 
patients, we are left completely disillusioned, forced to navigate the 
health care system on our own and implement a trial-and-error process 
to find a treatment(s) to lessen the pain. In the last 4 years alone, 
I've been to specialists in four different States, have tried 15 
different treatments and still suffer with moderate to severe daily 
pain. In the last 2 years, I've easily spent over $10,000 in out-of-
pocket expenses alone. While I am fortunate to have an understanding 
employer and good health insurance, many in our country are not.

          ``After years of misdiagnoses (in my twenties), four 
        miscarriages, four surgeries and, finally, a total abdominal 
        hysterectomy at the age of 25, I am living proof of how poorly 
        women's health needs are addressed. I suffered excruciating 
        pain. This horrible disease ate through my body and eventually 
        devoured my dreams. It is my hope and prayer that no other 
        young woman on the brink of her life endure the pain, 
        humiliation and disappointments that I experienced.''--Shelli, 
        an endometriosis patient

    A growing body of scientific evidence backs my experience and that 
of millions of pain sufferers, i.e., once you suffer from one chronic 
pain disorder, you are more likely to develop additional pain 
conditions in other parts of your body. Additionally, as highlighted in 
the IOM report, all of what I've just described disparately affects 
women with chronic pain.
    This is the reason why the NVA joined forces with the Endometriosis 
Association, Chronic Fatigue and Immune Deficiency Syndrome Association 
of America and The TMJ Association, to form the Chronic Pain Research 
Alliance (CPRA)--the first collaborative scientific advocacy effort in 
our country dedicated to alleviating the significant human suffering 
caused by prevalent, neglected and poorly understood pain conditions 
that frequently co-occur and disproportionately affect women. These 
disorders include vulvodynia, temporomandibular disorders, chronic 
fatigue syndrome, endometriosis, fibromyalgia, interstitial cystitis, 
irritable bowel syndrome and chronic headache.
    In 2010, the CPRA launched the Campaign to End Chronic Pain in 
Women and released the ground-breaking report, Chronic Pain in Women: 
Neglect, Dismissal and Discrimination: Analysis and Policy 
Recommendations, which for the first time in history documents the 
human and financial toll that these conditions impose on women, their 
families and the U.S. economy. (Please see the attached report and 
additional patient comments.)
    The report's key findings include:

    (1) Women report pain that is more frequent, more severe and of 
longer duration than men, but are nonetheless treated for pain less 
aggressively. Women's pain reports are often taken less seriously by 
health care professionals than men's. Medical professionals are more 
likely to dismiss women's pain reports as ``emotional, psychogenic, 
hysterical or oversensitive'' and therefore ``not real,'' leading to 
more frequent mental health diagnoses.
    (2) Our failure to effectively deal with these pain disorders adds 
as much as $80 billion a year in direct and indirect costs to America's 
annual health care bill, much of which could be saved through an 
expanded Federal research effort and improvements in diagnosis and 
treatment.
    (3) Despite their impressive personal and economic costs, research 
funding through the National Institutes of Health (NIH) is severely 
shortchanged, averaging just $1.36 per affected woman in 2010. This is 
less than a tenth of 1 percent of the annual estimated cost of these 
conditions. Also, what little research that has been conducted has 
lacked sufficient coordination, interdisciplinary collaboration and 
direction. As a result, the disorders' underlying causes are unknown, 
diagnostic protocols are lacking and there are very few, if any, 
scientifically proven treatments. Health care professionals are 
therefore left without adequate knowledge to appropriately diagnose and 
treat chronic pain sufferers.

          ``Consider that lost productivity due to diabetes cost $58 
        billion in 2007 [and in 2008], NIH spent just over $1 billion 
        on diabetes research and invested 1.7 cents for every 
        productivity dollar lost. In comparison, last year the NIH 
        spent only $4 million in CFS research--an investment of less 
        than one one-hundredth of a penny for every productivity dollar 
        lost.''--Jennie Spotila, chronic fatigue syndrome patient

    (4) The end result is that Americans suffering with these pain 
conditions are routinely misdiagnosed, shuffled from office to office, 
inappropriately treated and left without answers or hope, needlessly 
suffering. It typically takes several months to years, and multiple 
consultations, to obtain an accurate diagnosis. When a diagnosis is 
given, evidence-based treatment options are severely limited. Sufferers 
are forced to experiment with a myriad of therapies, most with unknown 
risks and benefits, until they find a treatment(s) to relieve some of 
their painful symptoms.

          ``The reason they gave me when they refused to treat me at 
        the emergency room was, `We can't treat you for pain because we 
        would be treating a symptom rather than the cause of a 
        problem.' My response to them was, `After 12 years of surgeries 
        and treatment and over $200,000 in medical expenses, no one has 
        fixed the problem, and in fact, it has gotten worse.' ''--TMJ 
        patient

    We applaud Congress, the National Institutes of Health and the 
Institute of Medicine for their initial steps to address the alarming 
public health crisis. Going forward, it is essential that:

    (1) HHS-funded research on these conditions is significantly 
increased, and taxpayer investments be made more efficient and 
effective by placing greater priority on collaborative 
interdisciplinary research across the conditions, as well as across HHS 
agencies and NIH Institutes and Offices.
    (2) HHS agencies aggressively expand, in a multidisciplinary 
fashion, the cadre of scientists dedicated to studying chronic pain.
    (3) HHS launch an aggressive multiyear awareness campaign, which 
includes the most current scientific information on the diagnosis, 
treatment and prevention of these disorders, to educate health care 
professionals, patients and the American public.

    It is only through an expanded, smarter and more cost-effective 
Federal research effort that: (i) we will better understand the causes 
and mechanisms of chronic pain, as well as delineate which treatments 
are effective and do not harm; (ii) the medical community at large will 
learn how to recognize and adequately manage pain; and (iii) medical 
professionals will have scientifically proven information they need to 
make appropriate diagnostic and treatment recommendations. Then, and 
only then, will the haphazard treatment of chronic pain, as well as 
costly and wasteful health care spending come to an end, giving the 
millions of American pain sufferers like Madalyn the one thing they 
desperately want returned to them--their lives.

          ``My doctors just threw up their hands, not knowing what to 
        do with me. I went to four doctors and each one said something 
        different. I can't believe I have to go through this, and the 
        expense is unbelievable. I am in so much pain and I just want 
        my life back.''--Madalyn, age 19 (suffers from chronic fatigue 
        syndrome, fibromyalgia and TMJ)

    Attachment--Chronic Pain Research Alliance--Quotes/Stories from 
                      Patients and Family Members
    ``After examining me and doing an ultrasound, my doctors said the 
only problem I had was in my head. . . .''--Rosemarie, endometriosis 
patient
    ``Is it too much to ask that we, the patients, no longer be bound 
to a system where no one professional takes responsibility for the 
patient--a system of unbelievable referrals with unscientific, unproven 
treatments (and hope) sold to the patient by each referring physician? 
In many cases, patients end up worse and more and more destitute, yet 
they grasp for hope with each referral. Is it too much to ask that we 
get the protection we deserve under the Hippocratic Oath to do no harm 
and the laws of the United States?''--Terrie Cowley, TMJ patient and 
President of The TMJ Association
    ``I am a 26-year-old female with fibromyalgia and a mixed 
connective tissue disorder (MCTD) closely related to systemic lupus 
erythematous, and I experience widespread muscle and neuropathic pain 
that oftentimes becomes so debilitating that it impairs basic 
functioning such as standing and walking. After several attempts at 
managing my pain through different narcotic pain relievers that had 
failed, my rheumatologist referred me to the medical center's pain 
clinic to have a pain medicine specialist take over the pain management 
aspect of my case. Among his reasons for referring me to a pain 
medicine specialist, the rheumatologist claimed, was that he was 
already overwhelmed with managing my disease to keep the MCTD from 
chronically flaring up and keeping track of the prescription 
medications relating to those goals. He explained that adding and 
monitoring narcotics further complicated his workload and required 
additional time to monitor interactions as well as his vulnerable Drug 
Enforcement Administration number.''--Fibromy-
algia patient
    ``It's a relief to finally have names for my conditions after 
suffering most of my life with a myriad of symptoms.''--Susan, 
vulvodynia, interstitial cystitis, and fibro-
myalgia patient
    ``My doctors just threw up their hands, not knowing what to do with 
me. I went to four doctors and each one said something different. I 
can't believe I have to go through this, and the expense is 
unbelievable. I am in so much pain and want my life back.''--Madalyn, 
TMJ, chronic fatigue syndrome and fibromyalgia patient
    A compilation of e-mails received by the TMJ Association:

    ``I have a 46 year old son that is suffering from severe TMJ. He 
has been under treatment for 15 years for it and everything they have 
tried, including several TMJ surgeries, have failed. He has now lost 
his job, (Fire Investigator), has no benefits, is filing bankruptcy and 
was so desperate with the pain. He lives in Austin, TX. I am willing to 
sell my home and apply the money to help him. My husband and I are 73 & 
74 so our lives are not as important as his is. He has 2 children still 
living at home. Since my husband spent 28 years in the army, I think we 
can get help with housing with them, for us. Please, please, is there 
any help for him? ''--David's mother (April 2008)
    ``Our son died as a result of all the suffering he had. David 
became addicted to his prescription drugs and had gone to a short term 
rehab but needed more help. He stayed with us for 2 years and finally 
went to the hospital to detox, stayed 3 days and then agreed to go into 
Teen Challenge. His heart had become weakened over the years of 
prescription medications and he put a Fentanyl patch on and then to get 
more relief, he put the other patch in his mouth. It was too much for 
his heart. He was a brilliant man, adored his 3 children and wanted so 
much to get well. He died September 29, 2010 at the age of 48 sitting 
in a chair in our backyard and my husband found him very shortly after 
he died. David left behind a wife, 26 and 19 year old daughter, and a 
21 year old son. It is so hard to see what the family can suffer 
through all this . . . but these young ones of ours have paid the price 
for the pain and addiction. Our hearts go out to anyone suffering this 
dreadful disease. You are doing such a great work and we will keep you 
in our prayers for February 14th Senate Hearing.''--David's mother 
(January 2012)
    ``The hardest thing was to approach my condition rationally, 
because I needed doctors to take me seriously. What I really wanted to 
do was to scream or cry out of frustration and utter desperation.''--
Vulvodynia patient
    ``My periods were getting worse, but I was used to having 
debilitating pain so I did not think that it was necessarily unusual. 
Eventually, out of sheer desperation, I went to a local clinic . . . 
and [the doctor there] found a pelvic mass of approximately 6-7 cm . . 
. that needed surgical removal. I was in a state of shock. How did it 
get that way? I had seen doctors on a regular basis for the last year. 
While I awaited surgery, I had another period where I started 
hemorrhaging and drifted in and out of consciousness on the floor of a 
washroom at work. Finally the surgery took place and the doctor told me 
I had endometriosis.''--Endometriosis patient
    ``I did get my insurance to pay for most of this by not calling it 
TMJ (they don't like those letters). My doctor called it jaw joint 
surgery and a bone spur. The surgery cost over $30,000 and I paid $100 
co-pay.''--TMJ patient
    ``The reason they gave me when they refused to treat me at the 
emergency room was, ``We can't treat you for pain because we would be 
treating a symptom rather than the cause of a problem.'' My response to 
them was, ``After 12 years of surgeries and treatment and over $200,000 
in medical expenses, no one has fixed the problem, and in fact, it has 
gotten worse.'' The hospital then refused any treatment, even though my 
blood pressure/temperature was high, and then labeled me a ``drug-
seeker'' on my hospital records. Now, I am petrified every time I have 
to ask for pain medications.''--TMJ patient
    ``Consider that lost productivity due to diabetes cost $58 billion 
in 2007. Last year [2008], NIH spent just over $1 billion on diabetes 
research. In other words, NIH invested 1.7 cents for every productivity 
dollar lost. If NIH allocated research funds to CFS as it has to 
diabetes, then a 1.7 cent investment per dollar lost would translate 
into $1.3 billion dollars in annual research. Apparently, NIH believes 
that CFS does not merit such investment. Last year the NIH spent only 
$4 million in CFS research--an investment of less than one one-
hundredth of a penny for every productivity dollar lost.''--Jennie M. 
Spotila, chronic fatigue syndrome patient
    ``My daughter has had endo for over 4 years. Our insurance dropped 
us because the RN at the company said my daughter (a teen) could have a 
hysterectomy and not run up all these bills!''--Jeannie
    ``I have constant headaches, neck pain, ear and jaw pain. I can't 
get rid of it. Comes and goes like a roller coaster. Not a happy way to 
live.''--Michael, TMJ patient
    ``Endometriosis runs in my family. I suffered years of infertility 
and had three surgeries. Now my daughter who is 22 has all the 
symptoms. She's talking to a doctor that wants to burn the lesions 
off--that's what was done to mine. Have we made no progress at all in 
reducing scar tissue? ''--Susan
    ``I am a post-hysterectomy survivor of endometriosis. We found out 
about my daughter's endo when she was 11. She had painful symptoms 
before her first period and we went to numerous doctors who told us 
everything from ``Amanda or a family member is making up these symptoms 
to get attention and/or drugs'' to ``Amanda just needs to understand 
that cramps are a way of life for women.'' Her first surgery was at age 
12 and even the doctor who performed the surgery was shocked at the 
extensiveness of her endo. Now two-and-a-half years later, Lupron, 
drugs, and more surgery, we are making a last effort to save her 
reproductive ability.''--Kari
    ``I suffer from TMJ have horrible pain in my jaw from constantly 
clenching it. I've had all new caps put on my bottom teeth and have had 
4 teeth pulled due to them breaking as a result of the strain. At times 
my jaw will lock and it hurts to open my mouth. I wear a night guard 
that provides some relief at night. This whole process has become 
extremely expensive and my insurance isn't picking up most of it . . . 
''--Jacqueline, TMJ patient.
    ``I suspect there is a lot of suicide in women and girls with endo. 
I attempted suicide several times as a teen because the pain was that 
intense. I was planning on trying again in my mid-20's when I 
discovered the Association. I suspect I may have been successful that 
time. The Endometriosis Association literally saved my life.''--Terri
    ``My 18 year old is suffering terribly with endo, so much so that 
she has been unable to attend school for the past 1\1/2\ years and it 
has cost her participating in graduation this week. She thankfully is a 
strong willed young woman and my husband and I are her supporters 100 
percent of the way. We are at a loss on treatment however. She has had 
two laser treatments with minimal lasting results. My husband is a 
family physician and he particularly feels helpless.''--J.
    ``I have suffered with intermittent headaches, jaw pain, loss of 
sleep, poor quality sleep for almost 10 years due to jaw clenching/
TMJD. I have had two different bite guards, my teeth adjusted for 
proper bite, seen two different general dentists and two subspecialist 
dentists. It is obvious to me that there is little consensus between 
different practitioners and that more research into the treatment of 
this disorder is needed.''--Tara, TMJ patient
    ``After years of misdiagnoses (in my twenties), four miscarriages, 
four surgeries and, finally, a total abdominal hysterectomy at the age 
of 25, I am living proof of how poorly women's health needs are 
addressed. I suffered excruciating pain and continual bleeding for 
months. Handed a Rx for Valium or some other medication to ``calm'' me 
because doctors felt my symptoms were emotionally induced. This 
horrible disease ate through my body and eventually devoured my dreams. 
Years later I find myself with rheumatoid pains, diagnosis of 
fibromyalgia, Hodgkin's lymphoma and breast cancer. It is my hope and 
prayer that no other young woman on the brink of her life endure the 
pain, humiliation and disappointments that I experienced.''--Shelli
    ``I feel as if I am at the end of my rope. I have lost my job and 
may end up losing my home. I have been able to work since December 2010 
& ended up getting fired in January 2011 because my FMLA didn't get 
approved. I also suffer from allergies and my ENT & I originally 
thought that was the cause of my ear pain. However, once the redness in 
my ear tubes went away we discovered I also had TMJ Disorders.''--
Laura, TMJ patient
    ``Endometriosis bites to the very soul of our lives--everyday! I 
have grieved the loss of friends, the loss of employment and 
purposefulness. It's unbelievable to realize how the basic concept of 
many is that endo is only a pain thing! Oh, goodness, how can I ever 
explain that endo is so very much more? It's fatigue, it's allergies to 
all kinds of chemicals/cleansers/perfumes (any kind of public place is 
a menagerie of smells to be allergic to!), it's erosion of the can-do 
attitude, it's a hounding, cureless ``poison'' in my body that affects 
every facet of one's life!.''--Janeen
    ``I am 19 years old. I had to graduate from a homeschool program 
because I was just not physically able to go to school every day. I 
have not been able to work and every day I hear about that from my 
parents. I am not able to live up to who they want me to be. It's hard 
for me because I had always made them proud (i.e., sports, school, 
community service) but now I can't. They think that I am lazy, when 
really I want to work. I would do anything to feel well enough to be 
able to go to a job every day. I don't know what I can do to make them 
understand what I am going through. I have become severely depressed, 
developed an eating disorder and feel that every day to get up is a 
challenge.''--Zoe
    ``I am 24 and I was diagnosed with vulvodynia when I was 18. I 
experienced symptoms when I first had intercourse at the age of 17 and 
was in excruciating pain. All I could do was curl up on the couch the 
next day. At first, I thought that the pain was normal, that it was 
supposed to hurt the first time. But the pain wasn't getting better so 
I went to the doctor, actually four [doctors], and they all told me 
different versions of the same thing: I was just ``tight'' or ``small'' 
inside; that I just need to relax, that I should just have more sex, 
etc. One even suggested that I have a glass of wine (remember I was 17 
at the time).
    I finally found a knowledgeable provider who told me that I had 
vulvodynia. For the past 5 years I have been on different treatments 
including physical therapy, biofeedback and several drug regimens. I've 
also had a vestibulectomy surgery and then a follow up surgery and I am 
[still] in chronic pain.
    It has been very difficult growing up with this. It has affected so 
much in my life. Now, after years of living with this, and going 
through incredibly painful, ultimately unsuccessful, surgeries I 
sometimes feel as if I have come to terms with this condition. For the 
most part, I just accept that this part of my life is not going to 
change and that accepting it and moving on is what I am working on. But 
I have to say; sometimes it seems that it will be an impossible feat to 
find a partner who will happily be with me for the rest of his life, 
especially if I'm not able to have sexual intercourse because of my 
vulvodynia.''--Tamara
    ``I am the concerned and exhausted mother of a beautiful teenage 
daughter who has been suffering for about 5 years with excruciating and 
sometimes unexplainable pain. I am tired, frustrated and feel like a 
failure because I cannot help my daughter. I am watching her change, 
struggling through pain, trying desperately to stay in school and 
beginning to feel as if there is no end to her misery. Plus, the fact 
that we have already put in enough money into this we could've bought 
her a new car and it still isn't over.''--Dawn, Mother of a TMJ patient
    ``At age 19, I married the man who was and still is my best friend. 
I was a virgin until our wedding night and when my husband and I first 
tried to have sex, I cried from the pain. We thought that was just the 
way things were when sex was new, but in my gut, I had known for years 
that something was wrong. Confusion and depression followed. I never 
wanted to attempt sexual or even mildly intimate contact, and our 
relationship suffered because of it. At age 20, I was told my symptoms 
were psychological and that I simply needed to stretch my vagina.
    After so many painful and misunderstood exams, and so many shed 
tears, at age 21, I was diagnosed with vulvodynia. My gynecologist 
could only offer me anti-
depressants in an attempt to numb the physical pain, but the side 
effects were too much for me and I soon stopped. It took 3 more years 
before I was finally able to see a doctor who could help and provide me 
with treatment options. I am now 24 and am on a treatment plan. Though 
there is still discomfort, the condition, for me, is largely in my 
control. Two weeks of treatment was all it took for me to improve, and 
I had waited in the dark for more than 10 years.''--Angela
    ``I am a 16 year old with endo. I was diagnosed this May along with 
my mother. For years doctors have never taken the pain that my mother 
and I feel seriously. Sometimes family members even thought that it was 
hard to believe we were in as much pain as we said we were. One day my 
boyfriend was reading the newspaper and found an article about endo. He 
suggested that I might have it, so I brought it to the attention of my 
mother. My mother and I read it and it hit too close to home. A month 
later we saw a gynecologist who understood what we were going through. 
Just the fact that someone understood and didn't think we were crazy 
made us feels so much better. I was put on the pill, and most of the 
symptoms have been suppressed. As for my mother, she's still waiting 
for more options.''--Emily
    ``Why do our girls have to suffer so?''--Mother of an endometriosis 
patient
    ``The other women, and men, that I have spoken to have gone through 
a series of doctor appointments and tests, and felt like they were 
walking through a maze without any light in sight.''--Kathleen 
Matarazzo Speca
    ``You're almost relieved when your blood work or tests show 
something because you're like finally this doctor with their fancy 
degrees is going to believe me, that there is something wrong with 
me.''--Therese McAllister
    ``There is a belief there that when a woman has temporomandibular 
joint disorder, that it is all because of their stress and their 
age.''--Therese McAllister
    ``I had a surgeon that looked at me and said, `Well all women have 
endometriosis, and you just need to shake yourself off and get back to 
work.' ''--Therese McAllister
    ``We know from a lot of research that providers are less likely to 
make an accurate and speedy diagnosis of female patients, based on what 
we call feminine style. The way that females, in this culture and this 
country especially, are trained to communicate at a very early age, are 
trained to be nicer, to use more qualifiers, to be more indirect, to be 
more relational--which means we spend more time getting to know 
someone.''--Melinda Villagran, Ph.D., Associate Professor of Health 
Communication George Mason University
    ``I'm in too much pain to spend an hour and a half on hold with an 
insurance company, and the insurance companies know that, and they take 
advantage of it.''--Jennifer Feldman
    ``Twelve surgeries later, I now have bilateral joints. Instead of a 
house, I have a jaw.''--Beth Bigge
    ``I think if this was something that men were suffering from, there 
would be a lot more money going into the research, and would be a lot 
more solutions out there for them to choose from.''--Karen, Vulvodynia 
patient

    The Chairman. Thank you, Miss Veasley.
    Now, Dr. John Sarno. As I said, Dr. Sarno was the author of 
four books, the first being ``Mind Over Back Pain'' in 1984; 
the second, ``Healing Back Pain,'' in 1991; the third is ``The 
Mindbody Prescription,'' 1998; and the fourth book is, ``The 
Divided Mind,'' which I have right here, in 2006.
    Dr. Sarno, welcome to our committee. Please proceed.

    STATEMENT OF JOHN E. SARNO, M.D., PROFESSOR OF CLINICAL 
    REHABILITATION MEDICINE, NEW YORK UNIVERSITY SCHOOL OF 
                     MEDICINE, NEW YORK, NY

    Dr. Sarno. Thank you, Senator Harkin. Thank you for 
inviting me.
    Pain syndromes can be grouped into two categories: those 
resulting from injury--this is the way I see it--from injury, 
surgery, or associated with severe infection as seen in 
patients in an acute hospital setting, and those with pain in 
the back, neck, shoulders, and limbs of a psychophysical 
origin. The high incidence of the latter group has evolved into 
a public health problem of great magnitude over the past 40 
years.
    It has been estimated that 80 percent of the population 
have a history of one of these painful conditions, which has 
led to the performance of a great deal of unnecessary surgery, 
and the widespread use of pain medication.
    It is troubling to realize that the pattern of pain and 
physical examination findings often do not correlate with the 
presumed reason for the pain.
    For example, pain might be attributed to degenerative 
arthritic changes at the lower end of the spine, but the 
patient might have pain in places that have nothing to do with 
the bones in that area, or someone might have a lumbar disc 
that was herniated to the left and have pain in the right leg. 
More importantly was the observation that 88 percent of the 
people with these pains had histories of such things as tension 
or migraine headache, heartburn, hiatus hernia, stomach ulcer, 
colitis, spastic colon, irritable bowel syndrome, hay fever, 
and asthma--that is quite a listing--eczema, and a variety of 
other disorders, all of which have been strongly suspected by 
physicians of being emotionally based. The pain syndrome here 
referred to as a tension myoneural syndrome, we believe to be 
fundamentally and mostly emotionally based.
    Simple awareness of the diagnosis itself, we have found, 
can be therapeutic and eliminate the pain. For some patients, 
who accept the concept of what is going on, it is necessary to 
work with a psychologist to get at the root of the problem. 
Although back pain may disappear spontaneously, in many 
patients it becomes a lifelong problem.
    There is no logic to the traditional physical treatment. 
Instead, experience has shown, in my experience, that the only 
successful and permanent way to treat the problem is by 
teaching patients to understand what they have. A physician, 
because he recognizes both the physical and psychological 
dimensions of the condition must make the diagnosis. This 
cannot be made by a psychologist or a psychiatrist.
    It goes without saying that pain syndrome must always be 
properly studied to rule out serious conditions such as cancer, 
tumors, bone disease, and many others.
    The presence of persistent pain anywhere requires a 
comprehensive examination and tests. Although this disorder, 
the tension myoneural syndrome is the result of emotional 
phenomena, it is a physical disorder and must be studied as 
such. It is not, ``in the patient's head.''
    There is a need to raise consciousness both inside and 
outside the field of medicine to help people or change people's 
perception of the cause of common pain syndrome, which 
represent a major public health problem.
    Science requires, of course, that all new ideas be 
validated by experience and replication. It is essential that 
these ideas also be subjected to research study in the future.
    Thank you.
    [The prepared statement of Dr. Sarno follows:]
               Prepared Statement of John E. Sarno, M.D.
                                summary
    Pain syndromes can be grouped into two categories: Those resulting 
from injury, surgery, or associated with severe infection, as seen in 
patients in an acute hospital setting, and those with pain in the back, 
neck, shoulders and limbs of a psychophysical origin. The high 
incidence of the latter group has evolved into a public health problem 
of great magnitude over the past 40 years. It has been estimated that 
80 percent of the population have a history of one of these painful 
conditions which has led to the performance of a great deal of 
unnecessary surgery and the widespread use of pain medication.
    It is troubling to realize that the pattern of pain and physical 
examination findings often does not correlate with the presumed reason 
for the pain. For example, pain might be attributed to degenerative 
arthritic changes at the lower end of the spine but the patient might 
have pain in places that had nothing to do with the bones in that area. 
Or someone might have a lumbar disc that was herniated to the left and 
have pain in the right leg.
    More importantly was my observation that 88 percent of the people 
seen had histories of such things as tension or migraine headache, 
heartburn, hiatus hernia, stomach ulcer, colitis, spastic colon, 
irritable bowel syndrome, hay fever, asthma, eczema and a variety of 
other disorders, all of which were strongly suspected by physicians of 
being emotionally based. This pain syndrome is referred to as the 
Tension Myoneural Syndrome (TMS).
    When that theory was put to the test and patients were treated 
accordingly, there was an improvement in treatment results. In fact, it 
was then possible to predict with some accuracy which patients would do 
well and which would probably fail. Simple awareness of the diagnosis 
itself can be therapeutic and eliminate pain. On occasion it is 
necessary for the patient to work with a psychologist to get at the 
psychological root of the problem. Although back pain may disappear 
spontaneously, in many patients it becomes a lifelong problem.
    There is no logic to the traditional physical treatment. Instead, 
experience has shown that the only successful and permanent way to 
treat the problem is by teaching patients to understand what they have. 
The notion of treating the ``whole person'' was not new to my thinking 
since I specialized in physical medicine and rehabilitation where this 
concept is fundamental.
    A physician, because he recognizes both the physical and 
psychological dimensions of the condition, must make the diagnosis. It 
goes without saying that pain syndromes must always be properly studied 
to rule out serious disorders such as cancer, tumors, bone disease and 
many other conditions. The presence of persistent pain anywhere 
requires comprehensive examination and tests. Though TMS is the result 
of emotional phenomenon, it is a physical disorder and must be studied 
as such. It is not ``in the patient's head.''
    There is a need to raise consciousness both inside and outside the 
field of medicine to help change people's perception of the cause of 
the common pain syndromes which represent a major public health 
problem. Science requires that all new ideas be validated by experience 
and replication. It is essential that these ideas be subjected to 
research study in the future.
                                 ______
                                 
    Pain syndromes can be broadly grouped into two categories: Those 
resulting from injury, surgery, or associated with severe infection, as 
seen in patients in an acute hospital setting, and those with pain in 
the back, neck, shoulders and limbs of a psychophysical origin. The 
high incidence of the latter group has evolved into a public health 
problem of great magnitude over the past 40 years. It has been 
estimated that 80 percent of the population have a history of one of 
these painful conditions which has led to the performance of a great 
deal of unnecessary surgery and the widespread use of pain medication.
    Contemporary medicine does not recognize the psychological basis 
for a segment of these common pain syndromes. The biases that common 
pain must be the result of structural abnormalities of the spine, or 
chemical or mechanically induced deficiencies of muscle, coupled with 
the belief that emotions do not induce physiological change, have 
contributed to the exponential increase in the incidence of these now 
common pain disorders.
    I first became aware of the high incidence of pain involving the 
back, neck, shoulders, buttocks, and limbs when I joined the staff of 
the Rusk Institute of Rehabilitation Medicine, as Director of 
Outpatient Services in 1965. Conventional medical training had taught 
me that these pains were primarily due to a variety of structural 
abnormalities of the spine most commonly arthritic and disc disorders, 
or to a vague group of muscle conditions attributed to poor posture, 
underexercise, overexertion and the like. Pain in the legs or arms was 
presumed due to compression (pinching of nerves). However, it was not 
at all clear how these abnormalities actually produced the pain.
    The experience of treating these patients was frustrating and 
depressing; one could never predict the outcome. Further, it was 
troubling to realize that the pattern of pain and physical examination 
findings often did not correlate with the presumed reason for the pain. 
For example, pain might be attributed to degenerative arthritic changes 
at the lower end of the spine but the patient might have pain in places 
that had nothing to do with the bones in that area. Or someone might 
have a lumbar disc that was herniated to the left and have pain in the 
right leg.
    Along with doubt about the accuracy of conventional diagnoses there 
came the realization that the primary tissues involved were nerve and 
muscle, specifically of the neck, shoulders, back and buttocks. Even 
more important was the observation that 88 percent of the people seen 
had histories of such things as tension or migraine headache, 
heartburn, hiatus hernia, stomach ulcer, colitis, spastic colon, 
irritable bowel syndrome, hay fever, asthma, eczema and a variety of 
other disorders, all of which were strongly suspected by physicians of 
being emotionally based. This pain syndrome is referred to as the 
Tension Myoneural Syndrome (TMS).
    When that theory was put to the test and patients were treated 
accordingly, there was an improvement in treatment results. In fact, it 
was then possible to predict with some accuracy which patients would do 
well and which would probably fail. Simple awareness of the diagnosis 
can be therapeutic and eliminate pain. On occasion it is necessary for 
the patient to work with a psychologist to get at the psychological 
root of the problem. Although back pain may disappear spontaneously, in 
many patients it becomes a lifelong problem.
    What are the emotions that stimulate the psychological reaction? 
They are legion. Everyday life pressures are obvious. Not so obvious, 
but of greater importance, are the self-imposed pressures of the need 
to be perfect and good, stimulated by the predominant culture of our 
time.
    There is no logic to the traditional physical treatment. Instead, 
experience has shown that the only successful and permanent way to 
treat the problem is by teaching patients to understand what they have. 
The notion of treating the ``whole person'' was not new to my thinking 
since I was specialized in physical medicine and rehabilitation where 
this concept is fundamental.
    Though the cause of this common pain disorder is emotional, the 
diagnosis must be made on physical rather than psychological grounds, 
in the tradition of clinical medicine. Psychologists may suspect that 
patients' symptoms are psychologically induced but, not trained in 
physical diagnosis, cannot say with certainty that they have TMS. A 
physician, because he recognizes both physical and psychological 
dimensions of the condition, must make the diagnosis. It goes without 
saying that pain syndromes must always be properly studied to rule out 
serious disorders such as cancer, tumors, bone disease and many other 
conditions. The presence of persistent pain anywhere requires 
comprehensive examination and tests. Though TMS is the result of 
emotional phenomenon, it is a physical disorder. It is not ``in the 
patient's head.''
    Judging by the reactions of doctors in my immediate environment, 
most either ignore or reject the diagnosis. A few physicians in my own 
specialty say that they see the validity of the diagnosis but find it 
difficult to treat such patients. One hopes that the younger generation 
of physicians will be more open to this diagnosis.
    There is a need to raise consciousness both inside and outside the 
field of medicine to help change people's perception of the cause of 
the common pain syndromes which represent a major public health 
problem. Science requires that all new ideas be validated by experience 
and replication. It is essential that these ideas be subjected to 
research study in the future.

    The Chairman. Thank you, Dr. Sarno.
    Now we will start a series of 5-minute rounds of questions, 
or I should say, a dialog with all of you.
    Dr. Sarno, something you just said, I am going to skip 
around here a little bit. Where is it? Miss Veasley said 
something that I wanted to address.
    Miss Veasley, in talking about a report, said that,

          ``Medical professionals are more likely to dismiss 
        women's pain reports as emotional, psychogenic, 
        hysterical, or oversensitive, and therefore not real, 
        leading to more frequent mental health diagnosis.''

    So I ask you, is their pain real or is it just in her head?
    Dr. Sarno. The pain is always real, but I think the problem 
is, it is not recognized sufficiently that emotional phenomena 
can actually bring on pain. If you would like a physiologic 
explanation, that is simple too. The simple reduction of blood 
flow, which can easily be accomplished by the brain to vital 
spinal nerves or any spinal nerve for that matter, but usually 
it is more in certain areas--the low back, for example, or the 
neck or shoulders--is easily done. I think that it is important 
to recognize that emotions can stimulate physiologic change.
    Mr. Maixner. Mr. Chairman, may I also address that?
    The Chairman. Dr. Maixner. Sure.
    Mr. Maixner. Yes. I agree totally with what was just said. 
I think it is very important that we do not dissociate mind-
body when we talk about chronic pain conditions, and put 
chronic pain conditions into strictly an in-their-head 
psychological component.
    It is very clear from current research that there is an 
underlying neurobiology that is associated with affect, and 
mood, and emotionality. There is a neurochemistry. There is a 
very well-assessed neurobiology, and we know that many of the 
pain pathways that our patients have activated, activate these 
same pathways in the brain that are involved in affect and 
mood, and emotional response.
    Chronic pain is really a mosaic. It is a mosaic of 
interactions between the affective domains of the brain and 
those areas of the brain involved in processing pain 
information. They are overlaid. It is really impossible for us 
to dissociate mind-body. In fact, when we talk about the 
emotional-psychological aspects of pain, we are really talking 
about an underlying neurobiology that leads to the overall 
gestalt of the sensation that our patients complain about.
    The Chairman. Dr. Pizzo, I see you want to comment also. 
Yes.
    Dr. Pizzo. Thank you. I certainly agree and appreciate that 
there is a broad array of contributing factors, as has been 
stated. I think it is also important for us to be very 
sensitive to the words we use and the way that they are 
received.
    There is today a significant amount of perception felt by 
those suffering from chronic pain and, in fact, those called to 
serve on behalf of patients that there is a significant amount 
of, ``emotional'' contribution.
    I think while there is no doubt that our emotions 
contribute to our physiology, I think that we have much work to 
do to look at our approach to pain, just as we do other 
neurological and psychiatric illnesses from a physiological 
perspective as well.
    This is a very complex interrelated array of events, and I 
think one of the things that our committee certainly heard, and 
that data ascribes, that one of the challenges that happens in 
medicine is that when we do not know an answer, we often 
ascribe it onto something else. Those assignments are often 
emotional and almost contributed back to the individual, as if 
that individual becomes the victim of their own suffering.
    Therefore, the view of our committee was this really speaks 
to why there needs to be a cultural and social transformation 
in how we look at pain in its vast manifestations that affect 
individuals in very discrete and individual ways. To ground it 
in a better understanding of biology and illness, which is 
truly biopsychosocial, but which has much to be learned about 
its very manifestations and actions.
    The Chairman. Yes, Ms. Veasley.
    Ms. Veasley. Thank you. I certainly do not deny that my 
emotional health or anyone else that suffers with pain affects 
my ability to effectively cope with both the physical suffering 
and the effects of pain on my life. While I was hit by a car 
and nearly died, my pain has never been questioned by any 
medical provider, but this is not the experience of the average 
pain patient in our country.
    And I would just put out there that there are many examples 
in medical history, for example, ulcers that were once 
attributable to stress and inability to emotionally cope, that 
we now know answers to. Their cause is bacteria, and just 
because we do not understand yet due to the inadequate research 
effort that we have had, the mechanisms and risks that result 
in chronic pain does not mean that it is made up in your mind 
and is not real. Thank you.
    The Chairman. If I might respond, I think what Dr. Sarno 
was saying, and I have looked at this a lot, is not in 
someone's head. It is that certain psychological things that 
are happening in a person's unconscious can actually create 
things that cause real physical pain. As he said, the 
unconscious can sometimes, in order to hide some other thing in 
your mind, could stem the flow of oxygen to a muscle or to a 
nerve. That tightens it up and you feel real pain. I do not 
think Dr. Sarno is in any way suggesting that this is anything 
in your head. It is just that certain emotional or certain 
unconscious underlying of people's minds sometimes create the 
pathways to real physical pain. If I might, am I correct in 
that?
    Dr. Sarno. Yes. As I said, emotional phenomena can be 
responsible for physiologic pain and that is the important 
thing to bear in mind.
    The Chairman. Dr. Pizzo, in looking over this ``Relieving 
Pain in America,'' and looking at some of the different 
approaches that were taken, I do not see that being researched 
that much. Now, maybe I just do not understand it all that 
well, but I do not see that kind of an approach being 
researched. Is that so or not so?
    Dr. Pizzo. The approach, meaning the emotional basis for 
pain?
    The Chairman. Yes, not emotions being affected by pain.
    Dr. Pizzo. Right, right.
    The Chairman. But the emotions--and ``emotions'' is a word 
that I do not like--but the unconscious mind, something going 
on deep inside is causing certain physiological reactions in 
your body that are painful.
    Dr. Pizzo. Yes. I think our view of the research needs 
around pain are actually quite broad and not defined by any 
boundary, and my comments earlier are not to pit one approach 
against the other, not to say that emotions are good or bad, or 
a physiologic pain, but more important than that is that it not 
manifest.
    But rather, in our society today, there is a degree of 
stereotyping that does take place, advertently and 
inadvertently, and that has consequences, and it is not 
infrequent. Just as a matter of observation, that when 
something is not physiologically defined, it is often 
attributed to an emotional reaction. That is really what I was 
addressing and speaking to.
    I think it is important and we heard very eloquently from 
Christin that when one manifests a degree of pain based upon an 
organ manifestation like cancer, there is often a rallying of 
our community to that individual because it defines suffering. 
See, I know this from my own life experience as a pediatric 
oncologist, someone who has cared for children with cancer and 
pain for many decades.
    When someone comes in with a pain that is not fully defined 
or delineated as you described extremely eloquently, we make 
other assignments in terms of cause and etiology, and that is 
what creates the bias of both our providers, doctors, nurses, 
communities, our insurers, what they will pay for and not pay 
for, and these are profoundly important.
    We are all too much a society today, a medical world today 
that is focused on doing something. Our insurance companies, in 
regards to pain, really are more focused on doing a procedure 
or giving medication, and less about, for example, cognitive or 
behavioral therapies or physical therapies which will work 
probably as well or better. I think we need a broad approach 
based on science.
    I just want to also underscore your earlier question about 
research. We need a lot more research, and the research is not 
simply about what we think we know, but what we do not know. 
There is an extraordinary need for much more fundamental, basic 
research in what causes pain, how it is manifested, and how we 
can go about treating it.
    The therapies that we have today, although they work in 
many people, are quite limited and we need brand new insights 
to develop better approaches and innovations that will only 
come from very fundamental research as well.
    The Chairman. Very well stated, thank you very much, Dr. 
Pizzo.
    Senator Whitehouse.
    Senator Whitehouse. Thank you, Chairman. And thank you, 
again, for holding this hearing. I think it is very important 
and helpful.
    I am going back now a couple of years to when we started 
working on this in Rhode Island. The thing that struck me was 
the extent to which, in various health care settings, the pain 
that a patient was experiencing was either deprecated or 
overlooked entirely, and that there was a systematic bias 
against recording it and reporting it. So even if you were able 
to convince the doctor on duty at a particular time that you 
were in great agony, when they went off-shift and somebody else 
came on, and they looked at your paper record, there was 
nothing to clue them because, at that point, pain was not 
treated as a vital sign and was not part of the equation. There 
was even some doubt about whether it was possible to do that 
given that there is some subjectivity involved, but clearly, 
that was something that we were able to get around.
    My concern is how do we make sure that the hard records 
that exist in nursing homes, in hospitals, in various settings 
of patient care, particularly as we move into an electronic 
health record environment, have appropriate fields so that the 
patient's pain experience is being recorded, and can be treated 
seriously? Do you feel that we are there nationally at this 
point? I see a lot of heads nodding no.
    Do you feel that a Federal standard requiring that certain 
steps be taken with respect to the day-to-day records, would 
that be a good idea? Is this something that we should be--I 
have been very active along with the Chairman and others on 
electronic health records, and meaningful use, and all that. 
Should we be focusing on this as a topic in that discussion as 
well? Let me start with Ms. Veasley. She gets the Rhode Island 
jump.
    Ms. Veasley. Well, it is difficult because we do not have 
the answers for patients, but yet, we have millions of patients 
flooding doctors' offices every day needing help. And until we 
have that basic research, until we teach compassionate care, 
until providers understand that while we may not know all the 
mechanisms, just like many other diseases of the central 
nervous system, there are things that you can do to help 
patients.
    To continue to ignore the pain that someone reports, I 
mean, as you previously mentioned, end of life care. I recently 
lost my mother-in-law to pancreatic cancer, which is 
excruciating. Never once was her pain questioned, but the 
ability to treat it was hampered by the fact that we do not 
have the answers yet or providers. They are left to kind of 
come to their own conclusions based upon their clinical 
experience kind of treat pain as they see it. We really have to 
advance research and quickly.
    Senator Whitehouse. Dr. Pizzo.
    Dr. Pizzo. Thank you very much for asking that question, 
which is enormously important.
    We are moving as a nation much more toward a refined 
electronic medical system, and the U.S. Congress and the 
Affordable Care Act is helping with that, and we appreciate 
that.
    Our committee did delineate, just as you suspected, that 
even though we have a lot of data, a lot of demographic data 
that is already in hand, there is much more that we need. It is 
one of the recommendations that we made to the Secretary of HHS 
and the related agencies to really facilitate a better 
collection of information that could help guide, much more 
deeply, the impact of pain on individuals. The metrics that we 
have are important, but relatively limited, and I agree with 
you that this would be enormously important going forward.
    Senator Whitehouse. Dr. Maixner.
    Mr. Maixner. Yes. I agree and I think we have very, very 
good methodology available to us to rapidly assess both 
inpatient, outpatient levels of pain, and I think it could be 
easily implemented into electronic patient record.
    I think the larger problem is how is that information acted 
upon by the health care system? When there is really a 
substantial pain, do we have well-trained individuals who can 
respond to that cry? Do we have individuals who can impact what 
we assess? The assessment tools are clearly there, but again, 
as I articulated in my testimony, we have very poor education 
with respect to pain and pain management, which greatly impacts 
the manpower that can respond to the epidemic that I discussed.
    Senator Whitehouse. I see that my time has expired. 
Chairman, thank you very much.
    The Chairman. Just as a followup to Senator Whitehouse. Dr. 
Sarno, a new patient comes in to you, and they have pain. What 
do you do? How do you assess that person's pain? What process?
    Dr. Sarno. As I said, he has to be thoroughly worked up, 
and studied, and all of the known pathological processes that 
could be involved. That is absolutely essential. When all of 
the important things have been ruled out, then I think it is 
possible to go into some detail with that individual about his 
life, what is going on, and so on.
    Because I think that one, I want to say the same thing I 
said before, emotional phenomena can bring about physiologic 
change, and we have to keep that in mind. Obviously, we have to 
make sure that there is nothing else going on, so exhaustive 
studies are indicated before we would then begin to think about 
emotions and with pain.
    The Chairman. Thank you very much.
    Senator Hagan.

                       Statement of Senator Hagan

    Senator Hagan. Thank you, Mr. Chairman, and thank you for 
holding this hearing.
    I think it is extremely important because I do know that 
there are millions of people in our country today that are 
obviously suffering and in chronic pain. Dr. Maixner, and all 
of you, welcome, and I appreciate the expertise that we have 
here as well as personal experts.
    Dr. Maixner, you seemed very optimistic in your testimony 
about the future for pain research and treatment. In your 
testimony, you state that, ``Pain scientists are having great 
success in unraveling the pathophysiology and biological basis 
of pain.''
    Can you describe to me some of the ways that we, as 
policymakers, can be helpful to ensure a successful path 
forward in this area of research and treatment?
    Mr. Maixner. Yes, thank you, Senator, for the question. 
Thank you, Senator, for the question.
    We are making great headway in the fundamental 
understanding of the biology, psychology, and genetics and 
molecular pathways that underlie common pain conditions. We 
have identified many of the risk factors that lead to 
conditions like PMD, fibromyalgia, and many of the so-called 
common, idiopathic pain conditions.
    This is a parallel to what has happened in the 
cardiovascular community where risk factors such as lipids, 
cholesterol, stress, those factors have led to interventions, 
led to treatments, and prevention.
    We are at that step now in the pain field where we have 
identified biological factors, genetic factors, psychological 
factors, not all, but many are now at our hand that we could 
begin to put them together into models to develop potentially 
new treatment strategies that relate to cognitive behavioral 
therapies, other types of behavioral therapies that can 
influence emotional response and distress. We have identified 
new targets for drug development. Novel targets for drug 
development that, I think, could be very helpful in the future.
    We have the pieces, but we do not have initiatives that are 
large enough and well enough funded by both public and private 
entities that allow us to put these pieces together to study 
them prospectively, to evaluate the validity of our 
hypothetical constructs that we have with these risk factors.
    What I think is truly needed are large scale, population-
based studies that are housed out of these advanced pain 
centers of excellence that I have noted. These centers would 
have not only a patient care mission related to the portal by 
which physicians and patients come into treatment, but 
represent also research initiatives to actually document the 
validity of these risk factors, to document the effective 
therapies that we can now conceptualize from these theories 
that we have now put forward. To demonstrate the comparative 
effectiveness across many existing treatments and new 
treatments that we can advance.
    We are at that point, where we can put forward large scale, 
proof of concept trials that could lead to new interventions, 
both behavioral interventions and therapeutic interventions.
    Senator Hagan. Thank you. Dr. Pizzo and Dr. Maixner, you 
discussed doctor shopping; I know Dr. Maixner has. Sometimes 
this is a barrier to properly treating patients with chronic 
pain.
    On average, how many doctors does a patient suffering from 
chronic pain see before getting a proper diagnosis? If you have 
any estimates on the cost of the numbers of different doctors 
that a patient might go to? What does that cost the health care 
system? And is it because the patient does not get the response 
or they are still in pain that they feel they have to go to 
another doctor or are they also looking for more medication?
    Dr. Pizzo. Yes. Senator, I think that is an important 
question. I wonder if I could just slightly broaden it, if you 
would be willing?
    Senator Hagan. Please.
    Dr. Pizzo. Clearly, what we know today, and as you have 
heard, is that we are spending as a nation between $565 to $630 
billion a year on pain, and that over 116 million individuals 
are affected by it.
    Many of those individuals do not have access to health care 
as we would like them to be able to. Even though we have some 
wonderful centers and need more, as Dr. Maixner has described, 
where really expert care can be given, as a Nation, we really 
need to think about a much more distributed model so that care 
is available to underserved communities who disproportionately 
are affected by pain.
    African-American and Hispanic communities have a higher 
proportional degree of pain than other communities. Those 
suffering from some of the diseases that Christin Veasley and 
others have spoken about are disproportionately affected by 
their pain, and that means that we need a different care model. 
We need a different distribution of providers, both primary 
care physicians working together with specialists, nurses, 
pharmacists, and other on the frontlines, who might work in 
tandem with those centers, creating new partnerships between 
them. We need to pay for those services in a different way.
    Right now, there is a disincentive that happens because of 
our current fee for service health care model, which does not 
allow enough time for physicians, or nurses, or others to spend 
with patients to listen to their stories, gather the 
information, and develop a portfolio or plan that is going to 
really be meaningful for them. That is another area that we 
need to do.
    We need to think about how the payment system is 
restructured so that we are not just paying for expensive 
services, but paying for those that fit the patient.
    The reality is that there are lots of therapies that are 
available today. Not one particular one is best for all 
patients, and not all are good for any one patient. We really 
need to look at the right match between them.
    I would say that we certainly have innovations and 
interventions that are available today, but we have a great 
need for defining more. There is a great need for defining new, 
innovative therapies that we hardly know about today. We are 
just at the cusp of learning more about the nervous system and 
how it works, and I think there are great opportunities that 
lie ahead. I hope that these, coupled with better educational 
portfolio for physicians, nurses, and other providers on a 
distributed level working in tandem with specialists can create 
a new, public health approach to dealing with this very severe 
problem.
    Senator Hagan. How about the actual doctor shopping?
    Dr. Pizzo. There is a fair amount of doctor shopping that 
goes on largely because no one individual is often satisfied 
with the results that they are having. On our committee, and 
Christin could speak to this, we have heard this many times. In 
fact, we have heard from some of our committee members who 
suffered from pain that if you do not get the results from one 
person, you should seek another because there may be another 
approach that will be beneficial to you. Do not give up. 
Empowerment of individuals is a really significant part of the 
equation.
    On the other hand, many go from one doctor to another 
because Doctor A, B, C or Provider A, B, C never listened, 
never engaged, and never helped. That is something we need to 
see about as well.
    Senator Hagan. Miss Veasley.
    Ms. Veasley. Yes, I could respond to actually both of your 
questions. Thank you.
    In regards, we hear a lot about translational science and 
in any area, all the pain research in the world, or research on 
any given condition that takes place, if it does not trickle 
down to the patient for which it is supposed to serve, it is 
not helping.
    I see a great opportunity for Federal initiatives to 
support ongoing educational and awareness initiatives aimed at 
both the medical community, the public, and patients to 
continually keep us all informed of the latest research that is 
coming out of UNC and other great institutions around the 
country. Right now, we do not have that. Even though some of 
these really great advances are taking place, it is not getting 
down to your average physician and your average patient.
    In regards to doctor shopping, again, this goes right back 
to research. If we do not have basic research to inform 
clinicians of what the causes and effective treatments are for 
any pain condition, they are left to their own clinical 
conjecture to make decisions on what a patient's cause or 
treatment may be, and this even happens in the pain community.
    We find physicians who just specialize in pharmacology, 
they just specialize in nerve blocks, or implanting devices in 
patients, even though a mound of research has shown that 
multidisciplinary care is how to treat pain. So you have many 
reasons why patients go from doctor to doctor.
    One is that they are told that their problem is not real. 
``Your pain doesn't exist. You must be imagining this. I don't 
see any sign, or inflammation, or any problem that you may 
have.'' We do not understand the mechanisms.
    I can tell you from personal experience and also from 
talking with thousands of patients that for as many doctors as 
you see, because we do not have this basic research, you are 
going to get that many diagnoses and that many different 
treatment recommendations. As I mentioned in my testimony, that 
leaves it up to a patient to fend for themselves and try to 
decide, ``Out of all of these treatments which is going to help 
me? '' That is completely impossible for anybody to do 
regardless of your level of education or socioeconomic status.
    Senator Hagan. Thank you. My time is up.
    The Chairman. Senator Sanders.

                      Statement of Senator Sanders

    Senator Sanders.Thank you very much, Mr. Chairman, for 
holding this important hearing. And thank you all very much, 
panelists, for being here.
    What I would like to begin with, Mr. Chairman, is ask 
unanimous consent to have testimony from Dr. Robert Shapiro, 
who is an expert on headache, be put into the record, if that 
is OK.
    The Chairman. Yes.
    Senator Sanders. Is that OK?
    The Chairman. Certainly.
    [The information referred to may be found in Additional 
Material.]
    Senator Sanders. I was interested by--a couple of issues 
spring out to me. No. 1, the Institute of Medicine report found 
that a person with lower educational level, and presumably also 
lower income people, are more prone to suffer pain. As Chair of 
the subcommittee on primary health care we did, some months 
ago, a hearing on poverty as a death sentence. What we found is 
that if you are in the bottom 20 percentile, you are going to 
die 6\1/2\ years earlier than if you are in the top 20 percent.
    I would imagine--so I would like to ask you, I guess what 
you are saying is that if you are poor, if you are uneducated, 
you are more likely to become ill. You are more likely to 
become ill. You are more likely to experience pain.
    Could somebody speak to that?
    Mr. Maixner. Yes, Senator. I could speak to that. I think 
that one's socioeconomic status actually may be a surrogate 
marker of environmental exposures; the type of exposures that 
puts one at risk for the development of a variety of chronic 
pain conditions.
    We know that physical injury is one such physical 
environmental exposure that can activate genetic pathways that 
lead to pain conditions. Individuals in lower socioeconomic 
classes are prone and experience much greater physical labor, 
and are more prone to physical injury.
    We also know that distress, psychological distress is also 
a big driver of genetic pathways that can lead to the up-
regulation of pain processing and affect a mood that our pain 
patients experience. Again, lower socioeconomic status, I 
believe, is a surrogate marker for the amount of distress, the 
environmental exposure. One of the important environmental 
exposures, in addition to injury that can drive these pain 
systems----
    Senator Sanders. So you are saying environmental exposure 
as stress. In other words----
    Mr. Maixner. As stress.
    Senator Sanders. Struggle in terms of how to feed your 
family, or take care of your child, or go to work.
    Mr. Maixner. Exactly.
    Senator Sanders. Fix a car that broke down.
    Mr. Maixner. Right.
    Senator Sanders. That contributes to illness, which 
contributes to pain.
    Mr. Maixner. And produces the emotionality that we have 
just heard about that, in fact, can influence the immune 
system; the genetics of the expression of genetic pathways. 
These are what I call ``environmental exposures,'' that are of 
higher density and higher magnitude in individuals who fall 
within social economic classes of the lower tiers.
    Senator Sanders. Dr. Sarno.
    Dr. Sarno. I would like to suggest a more Freudian, if you 
will, or psychodynamic explanation, and that is that poor 
people are poor and they are angry. They are furious, as a 
matter of fact about what society has allowed to happen. That 
fury will evoke physical symptomatology, believe it or not, as 
a defense against a rage. They cannot rage and rage, so what 
happens is that they get sick, and I believe that this is an 
extremely common phenomenon.
    Senator Sanders. I mean, rather than burning down the 
Capitol, they are turning that anger against themselves, right?
    Dr. Sarno. Exactly.
    Senator Sanders. Let me ask--yes, Dr. Pizzo.
    Dr. Pizzo. One comment, because I think this is a very 
important discussion, and I am glad you raised the issue very 
much.
    I think one other facet that extends from what Dr. Maixner 
said is that there is an interrelationship between acute pain 
and chronic pain. If you are not able to access care because of 
socioeconomic limitations, there is a probability that what 
might have been a self-limited problem becomes a more chronic 
and persistent one.
    So from a preventative strategy and an economic strategy, 
early intervention is certainly better than delayed 
intervention.
    Senator Sanders. Which is why some of us, among other 
things, are trying to build community health centers all over 
the country.
    Dr. Pizzo. Yes.
    Senator Sanders. I wanted to ask one other question. I do 
not know if it was--I apologize for being late. Are we going to 
hold a hearing, Mr. Chairman, in a couple of weeks on dental 
care access? My understanding is that one of the major reasons 
for absenteeism among children is dental problems and 
toothaches, and we have a huge problem there as well.
    Does anybody want to say anything about dental care and 
lack of dental access, and tooth pain, and so forth?
    Mr. Maixner. I would just like to note that this continues 
to be an evolving problem especially amongst the lower 
socioeconomic population that many of us in the academic 
community serve.
    Access to care for children still remains a problem, 
especially as it relates to good pain services and pain 
management. It is really a neglected area of pain management 
and we find it in the general community. Patients have great 
difficulty finding access for this type of treatment.
    Senator Sanders. I think you have a whole lot of children 
and other people are walking around with teeth that are rotting 
in their mouths, and causing infections, and it is very 
painful.
    Dr. Pizzo. Right. That is right. In fact, our Institute of 
Medicine report that the numbered 116 million Americans 
suffering from pain did not include children in that number. 
Missing from that number is children, and children do suffer 
pain, as you well recognize.
    Senator Sanders. Good. Chairman, thank you.
    The Chairman. That is in the area of the kind of acute pain 
that then leads later on to chronic pain.
    Dr. Pizzo. That is right.
    The Chairman. That kind of acute pain is, perhaps, more 
easily diagnosed early on and the question is: do they have 
access to that kind of diagnosis and that kind of treatment?
    Dr. Pizzo. That is right. Exactly.
    The Chairman. Dr. Pizzo, have you ever read any of Dr. 
Sarno's books: ``Mind Over Back Pain,'' 1984; ``Healing Back 
Pain,'' 1991; ``The Mindbody Prescription,'' 1998; or ``The 
Divided Mind,'' 2006?
    Dr. Pizzo. No, I have not read them.
    The Chairman. OK. That is OK. Dr. Maixner, have you ever 
read any of his books?
    Mr. Maixner. I have not, but I am very familiar with James-
Lange and Cannon's theories which, I think, are elaborated, I 
think, quite well in the books is what I would guess.
    The Chairman. Miss Veasley, have you ever read? OK. Have 
you read your books, Dr. Sarno? No.
    [Laughter.]
    Here is why I ask that question. You cannot read 
everything. Now, Ms. Veasley told her story. I am going to tell 
you my story and why Dr. Sarno is sitting there, and why as 
chairman I had him here.
    I have always been healthy. Jet pilot in the Navy, 
physically active all my life, took pride in my physical 
health. In 1988, I just checked with the doctor's office over 
here. I did not know it was that long ago. In 1988, I had an 
episode with my back, extremely painful.
    I was walking down the hallway right out here in the 
Dirksen Building and pain hit my back so hard, I fell right on 
my butt, right out here. Kind of embarrassing, you know. I did 
not know what was happening to me.
    It got a little bit better, but at one point, I was working 
on the American's With Disabilities Act, of all things, as the 
chairman of the subcommittee of this committee, and I could not 
even walk back and forth. I had to put a cot over in the 
Capitol for me to lie on.
    Shortly after that, I had an MRI. They looked at the MRI 
and said, ``Well, you've got a bulging disc--cause you some 
problems. You should take an anti-inflammatory.'' So I did. The 
pain went away. About 3 years after that, this is in the mid-
1990s, again, I got back pains so bad, I was in Los Angeles. I 
was in a hotel room. I had to go to the bathroom. I could not 
even get--I had to crawl to get to the bathroom.
    I came back here, had another MRI. ``Well, you still have a 
bulging disc, but there's this little hole down there where all 
your nerves go through.'' That is my layman's term of putting 
it. ``And that thing is not so--maybe you need to have that 
thing opened up or something like that.'' I thought about that 
for a while and I dismissed it because my back pain went away.
    After a while, it went away, but every time it would come, 
I could barely sit. I could barely stand. I could barely move. 
Painful. I even had a chiropractor come into my office once. I 
had to take a plane trip someplace, he had to work over my back 
so I could even get on the airplane, and actually it worked. 
Chiropractic worked, made me feel better, anyway, long enough 
to get on the airplane.
    Then in 2004, I had another episode and it was really bad, 
and I remember I was at the National Convention up in Boston. I 
could barely move. In fact, I could not. I curtailed my 
activities there.
    I came back and that was my third MRI. I sent them up to 
the Hospital for Special Surgery in New York to have them 
looked at. I wanted to get another opinion. Well, ``Yes, I 
probably needed steroid shots and I needed to have that hole 
opened up,'' whatever that was.
    I had breakfast one morning with Mr. Ira Brind, he is a 
former chair of the Thomas Jefferson University Hospital in 
Philadelphia, just a friend of mine. I told him I was not 
looking forward to this but,

          ``I had checked with the doctors here and they said I 
        probably needed to have back surgery. In fact, one of 
        the doctors had told me they had had back surgery and 
        they were fine.''

    I really was not looking forward to that. That is what I 
told Ira. I said, ``I guess I am going to have to have this 
back surgery. Plus, it has been going on for all these years.''
    He said,

          ``Don't do it. Don't do this. I am going to send you 
        something. I am going to send you a CD, and I am going 
        to send you a book, and read those first before you 
        take any action.''

    I got them the next day; he sent them down the next day 
from Philadelphia, and it was a CD and a book by Dr. Sarno, 
``Healing Back Pain.'' I read this through and I thought, ``You 
know, that sounds like me. That really sounds like me.'' So I 
began to follow his regimen and that was in 2004.
    I have not had a back pain since. I have never had any 
surgery. I have never had steroid shots or anything like that. 
I have not had any back pain since. Now, that is not quite 
true. Every once in a while, I do get a little tinge of back 
pain, but I know what is causing it. I have the knowledge that 
I know what is causing it.
    Now, I am going to expose myself here to this audience and 
whoever else is watching. Now, sometimes when I tell people 
this, they think I am nuts. They say, ``Well, what do you do? 
'' And I said, ``It's very easy. I talk to my back,'' and what 
I say is basically,

          ``I don't have cancer. I don't have anything wrong 
        with my spine. I don't have any injuries. So therefore, 
        it's coming from stress. Somehow, I'm being stressed 
        out, and my spinal nerves and stuff are being deprived 
        of oxygen, and that's what's causing it. What I need to 
        do is ignore that and I need to go about my daily 
        activities just as though I was completely well.''

    When I do that, it goes away.
    I do not know that the IOM is looking at this. Now, you 
might say, ``Well, that's just you.''
    This is a survey that was put in the book, ``In 1999,'' and 
again, this is a small cohort.

          ``They had 104 patients on whom data was collected. 
        The following year, they reached 85 of the group to 
        determine outcome. There were 39 males and 52 females 
        in the group, and they were interested in the outcome.
          ``The categories for level of pain risk follows: 37 
        patients reportedly now had little or no pain; 22 
        patients reported they were not 80 to 100 percent 
        improved; 13 patients reported they were 40 to 80 
        percent improved; 13 patients reported no change to 40 
        percent improvement; 46 patients reported they were now 
        unrestricted physically. These figures are 
        extraordinary when one considers that the treatment of 
        this physical disorder is educational augmented in some 
        cases by analytically oriented psychotherapy.
          ``Seventy percent of this group had good relief from 
        pain and seventy-five percent were restored to normal 
        or near-normal physical function.''

    I wonder why we are not looking at things like this.
    Now, I have one more story. I have a near relative of mine, 
a close relative of mine. She was diagnosed with fibromyalgia; 
terrible pain. She is a young woman. And, because of my 
connections and things with NIH and stuff, I found some of the 
best doctors to talk to her about her fibromyalgia, and they 
did. She lives up in Pennsylvania, and so I would talk to her 
every so often, ask her how she is getting along, and nothing 
was getting better. She had withdrawn from her family, 
withdrawn from things. I do not want to go into this in too 
much depth.
    Last year, I checked up on her. I wanted to check up on 
her, see how she was doing. She said, ``You know, I think I've 
cured my fibromyalgia.'' I said, ``Really? Was it that last 
doctor I set you up with? '' She said, ``No, a friend of mine 
gave me this DVD and a book by this Dr. Sarno in New York.'' 
Now, I had never mentioned his name to her. I had not thought 
about him in that context, and she now is, I would not say 
totally pain-free, but she is over her fibromyalgia.
    When I see two things like this, one personal to me, my own 
self, and another with a close relative, I wonder why is this 
not being looked at? Dr. Pizzo, why is this not being looked 
at?
    Now, Dr. Maixner, I am going to go with you, Dr. Pizzo too, 
but what Ms. Veasley said here is very important. She says,

          ``It is logical to ask, `Why not see a different 
        doctor or get better treatment?' The answer was 
        recently summarized by a leading pain physician in the 
        journal Lancet. `Overall, currently available 
        treatments provide modest improvements in pain and 
        minimum improvements in physical and emotional 
        functioning. The quality of evidence is mediocre and 
        has not improved substantially during the last decade.' 
        ''

    Dr. Maixner, not to pick on you or anything.
    Mr. Maixner. Right.
    The Chairman. You said, here on this page, ``I submit that 
we now possess the tools and knowledge to conquer this epidemic 
and to bring relief to many millions worldwide.'' I read what 
was in The Lancet saying that, ``The quality of evidence is 
mediocre and has not improved substantially during the last 
decade,'' and there are other things that are not being looked 
at. I do not know that we do have the tools and knowledge right 
now, unless we start looking at all these other methodologies.
    Now, again, I am talking about chronic pain that is not the 
result of cancer or putting my hand in a fire.
    Mr. Maixner. Right.
    The Chairman. Or tooth problems or things like that.
    Mr. Maixner. Right.
    The Chairman. I am talking about chronic pain that seems, 
during diagnosis, to have no physiological basis that they can 
find, and that is where you go from doctor, to doctor, to 
doctor, to doctor.
    Mr. Maixner. Exactly.
    The Chairman. That is why I wondered, do we really possess 
the knowledge and tools or not? I know Dr. Pizzo wanted to 
respond, but I am going to ask Dr. Maixner.
    Dr. Pizzo. That is great.
    Mr. Maixner. Let me comment on a few of your comments, 
Senator.
    As you articulated the back problem, brought me back to my 
own at the age of 18, baling hay, southern Iowa, I ruptured a 
disc, and as you recounted your story, my lower back began to 
ache, again, the emotional response, the tension that was just 
spoken to.
    I do want to note, though, that there may be a 
misunderstanding about the nature of the IOM report and its 
perspective on the importance of behavioral interventions. 
Again, the primary tenet of the report is that chronic pain 
conditions where there is a major mismatch between what we see 
pathologically and what the patient experiences is best 
explained by the biopsychosocial model.
    Within that is the psycho component of it, where there are 
very good demonstrations of what we call cognitive behavioral 
therapies, educational therapy, awareness therapy, self 
therapies, which are part of the overall rubric that 
multidisciplinary pain programs use. There is actually 
reasonably good so-called meta-analyses using both operant, 
what is called operant behavioral therapies and cognitive 
behavioral therapies, some of which you have just described in 
your own case that are effective in some patients.
    One of the challenges that we have is really trying to 
identify those subpopulations that will respond, like you and 
like I, when we engage our own intrinsic cognitive behavioral 
methods to alleviate this pain. I do think that the IOM report, 
from my reading of it, has tried to capture that.
    The issue is if it is not common practice across the United 
States in part because of reimbursement issues. The 
psychologists are not reimbursed well for their therapies. That 
is why I advocated bundled services, bundled reimbursements in 
multidisciplinary pain programs, which allow this type of 
educational perspectives to occur.
    I do think that the IOM report has noted this very 
important therapeutic intervention.
    The Chairman. I just noted it, but is it minuscule?
    Mr. Maixner. It is minuscule.
    The Chairman. Minuscule?
    Mr. Maixner. I would agree with that.
    The Chairman. And yet----
    Mr. Maixner. One other comment too. From our own research, 
we are finding that one of the primary domains of risk is what 
is called somatic awareness. That is the ability of the 
individual patient to sense both the internal milieu as well as 
the external environment, and it is our belief this represents 
augmentation or excitement of the central nervous system, that 
sensory stimuli are actually augmented in their processing. 
This allows us to think about our lower back pain, and those 
pathways in the brain involved in back pain, actually can 
rekindle and show expression again.
    We believe that that is one of the targets, one of the 
targets for intervention trying to decrease somatic awareness 
which may be influenced by the emotionality of the memory that 
we generate.
    The Chairman. I do not know if that was inherent with me or 
you, but can people be taught this?
    Mr. Maixner. Yes. Not all individuals can respond, though. 
So I think that is the trick.
    The Chairman. OK. Dr. Pizzo, I am sorry.
    Dr. Pizzo. First of all, thank you so much for sharing your 
personal story, which is deeply meaningful and moving, and I am 
glad that you are doing well. I would say just a couple of 
other things, if I may.
    First, the IOM report that I chaired, along with others, 
was not a call to a specific intervention or therapy, but a 
call to action. It really identified the problems broadly. It 
did not identify what roots specifically should be taken for 
any one individual and did recognize, just as you have heard, 
that there will be different approaches for different 
individuals.
    Now, I would say that like you, all of our lives are shaped 
by our personal experiences. Mine comes from being a pediatric 
oncologist, someone who lived through the era of HIV in 
children and the impact of that illness on pain. It comes from 
being the spouse of someone who suffers from fibromyalgia, who 
has had decades' worth of chronic pain. I have witnessed on a 
personal level that approach to intervention of very different 
sorts from psychological and psychiatric, to pharmacological 
and behavioral, and physiological and physical can have varying 
degrees of impact.
    The point being there is not, unfortunately, a single 
solution, and I think that really underscores part of the 
message. If there was a single solution to the problem 
affecting 116 or more million people in this country, we would 
celebrate it and embrace it.
    What we have recognized is that while there are therapies 
that can impact some, many need and would benefit from other 
innovations and interventions, and we need to work on that as 
well. And not lose sight of those who have tried and have not 
yet benefited from the medical therapies that are available 
today.
    The Chairman. You are absolutely right, and that is why 
during all my tenure here in the Senate as Chair of this 
committee, of being on this committee, chair of the 
Appropriations Committee on NIH, I always wanted to open the 
doors and windows to everything. I want a lot of issues looked 
at. I do not want anything just dismissed out of hand. After 
all, it was my legislation that started the Complementary and 
Alternative and Integrative Medicine.
    Dr. Pizzo. I was at the NIH when you did that, and very 
proud that you did.
    The Chairman. Not that I say that this is the answer, but 
we ought to be looking at these things.
    Dr. Pizzo. Right.
    The Chairman. And examining them, just like what happened 
with me. I am not saying it is going to work for everybody, but 
at least it ought to be looked at----
    Dr. Pizzo. That is right.
    The Chairman. And researched and tried.
    Dr. Pizzo. That is right.
    The Chairman. I mean, it ought to be a part of it, not just 
some little footnote someplace, but really, really delved into. 
Miss Veasley, yes.
    Ms. Veasley. I think you sharing your story, mine, and the 
millions of others really points out that we just do not 
understand pain. There are multiple pathways by which people 
can develop pain and effectively treat pain. And, similar to 
what you discussed, I have done all kinds of mind-body 
techniques, relaxation, stress reduction, exercise, yoga, 
biofeedback, all of these things and I, too, in a little 
different way.
    I am a person of faith. I also speak to my pain a little 
different way. But I can tell you that I am still left with 
severe pain and it is only on the left side of my body. I was 
hit by a car on my right side; I only have pain on the left 
side of my body.
    While your experience is very real, mine is very real, as 
are all of these others. We really cannot expect to understand 
pain when we are not researching it. When the United States 
spends 96 percent less than it does on diabetes, heart disease, 
and cancer, how can we expect to understand all of these 
mechanisms?
    There is genetic evidence that people are predisposed to 
develop either heightened or less pain. There are studies and 
documentation of people who are born without the ability to 
sense pain at all, which is not to their advantage because they 
end up injuring themselves, but this is evidence that there is 
a genetic component there.
    There is also evidence that pain can actually be a 
dysfunction of the pain sensing network in our body itself. It 
can be a dysfunction or a disease of the central and peripheral 
nervous system.
    What you said brings us right back to the same point. We 
are never going to be able to tease all this apart until we 
have an adequate research effort that looks at all of this.
    The Chairman. I could not agree more. I am sorry. Senator 
Whitehouse, I sort have been dominating the question and 
answer.
    Senator Whitehouse. That is fine.
    The Chairman. I hope you forgive me.
    Senator Whitehouse. I am set. Thank you very much. I 
appreciate very much the witnesses' work in this challenging 
area.
    I would invite anybody who wishes to respond in the form of 
a response to a question for the record, with thoughts about 
the ways in which the paper and electronic recordkeeping of the 
health care system can be improved, to improve awareness about 
peoples' pain conditions, forcing the issue of vital signs, 
making sure electronic health records address this. I would be 
delighted to get your more thorough answers in writing, so that 
we can evaluate them. I appreciate it.
    Again, Chairman, thank you.
    The Chairman. Thank you. Dr. Sarno, I have been kind of 
picking on you lately here. Do you have anything else to add at 
all to what we have been saying? You have been doing this for 
40----
    Dr. Sarno. Five.
    The Chairman [continuing]. Forty-five years. You have seen 
a lot of patients. Do you have anything else to add to that?
    Dr. Sarno. Not really. It is just the idea that in medicine 
in general, there is a tendency to look at things from the 
anatomical and physiologic point of view. And perhaps not 
recognize the impact of emotions on the physiology, and that is 
the only thing that I would say. Keep an open mind about that 
because I believe that there are----
    The Chairman. I hope that we will do more research in that 
area. That is what I hope that this group will now start to 
take a closer look at.
    To try to sum up, Dr. Pizzo, thank you. You talked about 
how much we are spending a year and how much is coming from our 
Federal and State budgets, this is a huge impact on our 
financial wherewithal. You said that it is a moral imperative. 
I believe that. It is a disease in its own right, and I think 
you also said we need collaboration. We need a lot of 
collaboration among a lot of different disciplines to really 
look at this.
    Dr. Maixner, you talked about the barriers, the mismatch of 
money at NIH. I could not agree more. We are going to take a 
look at that. This committee will, well, my other committee 
that I wear another hat on, the appropriations committee, we 
are going to look at that. You talked about education. Only 
nine sessions in medical school on this, on something so 
prevalent, and I sort of said that at the beginning. How do we 
get our residencies more in tune with diagnosing people and 
focusing on pain?
    You also mentioned the doctor shopping and what is 
happening there. Again, we need to educate our doctors, our 
practitioners, and our primary care people a little bit better 
than what we have been doing in the past.
    Miss Veasley, you bring a very poignant, personal story to 
this. There are a lot of people like you around this country, 
maybe not with vulvodynia, but with fibromyalgia, irritable 
bowel syndromes, back pain, all kinds of things that we need to 
know more about, and how we do more research, get more research 
into these areas. No doubt about it. You bring a very strong 
personal story.
    Dr. Pizzo said, ``We need new, innovative therapies that we 
may not know about.'' I think that is pretty profound. ``We 
need new innovative therapies we may not know about.'' How many 
people out there on this committee and others do not know about 
45 years of practice, and treating people, and honing this to a 
fine degree on how you treat people with chronic pain that has 
no--now this is where I should not practice medicine without a 
license--but without a physiological basis.
    I think that Dr. Sarno mentioned that the first thing to do 
is also always look at that. You do that first, and then if 
there is nothing there, then you have to move to a different 
modality.
    This is my own statement. I think there are too many people 
in our society, this is what you have talked about, Dr. 
Maixner, some of us are equipped somehow, different people 
think different ways. Different people can cope with things 
differently and assess things differently. There are just too 
many people in our country that think there is a pill, a drug, 
or a surgery that is going to cure whatever you have. I think 
maybe we have been brought up to think that, and that there is 
something out there, ``If I just get the right pill, the right 
drug, the right surgery, it's going to cure me.'' I do not know 
that we have put enough into the up front prevention.
    I guess I will close on this, that when I think about 
prevention in the area of pain, it is educating not just the 
doctors and the residencies, but people when they go through 
school. That they are knowledgeable about pain, and chronic 
pain, and what causes pain, and how you deal with these things. 
So that they become more knowledgeable about their own systems 
and how different things affect them. Then maybe we will not 
always be thinking that we can just do whatever we want. There 
is a pill, or a drug, or a surgery out there that is going to 
cure what ails us.
    There is a lot here. I mean, we have to do more research in 
this area, but it has to be broad. I will continue to say that 
this whole area of mind-body cannot be just a footnote. It has 
to be integral to this whole search that we are doing on how to 
relieve so many people that have real pain, real pain. Not in 
your head; it is in your body. Where it comes from, we do not 
know yet, but that is the one thing I have learned from Dr. 
Sarno that this is real, physical pain. It is not in your head. 
It is real, physical pain.
    I thank you all very much. I thought this was a very 
enlightening session and I appreciate all the wonderful work 
you do. I look forward to working with you on the committee 
itself in the future, and to do what we can to approach this 
issue of pain in a thorough, holistic, comprehensive method 
than we have been doing in the past.
    I ask unanimous consent that testimony from the Chronic 
Fatigue and Immune Dysfunction Syndrome Association of America 
be submitted for the record in memory of Christie Gaffe of 
Williamsburg, IA.
    I also ask unanimous consent that testimony from the 
American Cancer Society Cancer Action Network be submitted for 
the record.
    [The information referred to may be found in Additional 
Material.]
    If there is nothing else to add, then the record will also 
remain open for 10 days for any statements or questions from 
other members of the committee.

    With that, the committee will stand adjourned. Thank you.
    [Additional material follows.]

                          ADDITIONAL MATERIAL

                   Prepared Statement of Senator Enzi

    Anyone who has ever had a serious injury or condition knows 
how difficult managing pain can be. For over 100 million 
Americans affected by chronic pain, the challenge of dealing 
with pain is ever-present in their lives. While pain is 
experienced differently by each individual, there are some 
common challenges faced by folks that range from access to care 
in rural areas to the need for new treatments and therapies. I 
look forward to today's hearing, and thank the witnesses for 
being here and presenting their perspectives on how we can 
better prevent, treat, and manage pain and overcome the 
challenges presented by pain.
    Research has played a crucial role in our understanding of 
pain--both in how it can be useful to warn of damage to our 
bodies, but also how it can be harmful and how we can attempt 
to mitigate it. Thanks to the work of scientists and 
researchers across the country, including at many academic 
institutions and at the National Institutes of Health, we now 
have a better grasp of the biology of pain which has, in turn, 
informed the development of more effective therapies and 
improved pain management. Still, we must continue to focus on 
how we can better leverage our precious research dollars to 
improve the prevention, treatment, and management of pain. The 
Institute of Medicine (IOM) report, ``Relieving Pain in 
America: A Blueprint for Transforming Prevention, Care, 
Education, and Research'' highlighted some of these research 
challenges, and NIH has already acted on some of the report's 
recommendations.
    I look forward to the testimony of Dr. Tabak and hearing 
about the latest research being conducted at NIH, and also of 
Dr. Maixner about his work in pain research. Several 
initiatives in the past sought to ensure the coordination of 
Federal research efforts to ensure we are avoiding duplicative 
efforts, including through the creation of the NIH Pain 
Consortium to promote collaboration across the Institutes and 
Centers.
    Another critical component of managing pain is educating 
pain care professionals and patients alike. The report 
highlighted the need for improving the understanding of health 
professionals and the general public on the complexities of 
pain and the challenges of managing chronic pain. The patient 
and the provider both benefit from improved pain assessments 
and more targeted treatments and management strategies. Many 
health professional and pain associations and academic 
institutions have been seeking to improve provider 
understanding of pain, available treatments, and how to best 
manage pain.
    Pain is based on the individual, so I understand a one-
size-fits-all approach will not work. The witnesses on the 
second panel will speak to the challenges of research, 
providing care, and living daily with pain. I want to thank the 
witnesses who have dedicated their time to educating and 
teaching us about their story and the discoveries they have 
made in this area. I hope that we continue to make progress 
addressing pain in America.

                  Prepared Statement of Senator Hatch

    I would like to thank Senators Harkin and Enzi for 
convening today's hearing on such an important issue affecting 
millions of American patients and caregivers. I also thank our 
witness panels for joining us today.
    Every American experiences pain; and millions suffer from 
chronic, debilitating pain that interferes with their everyday 
lives. Chronic pain impacts not only individual sufferers 
themselves, but also their families, friends, employers, co-
workers, and communities.
    This report was authorized by bipartisan legislation 
entitled the National Pain Care Policy Act which I co-authored.
    Pain is the most common reason Americans seek health care 
services and is also a leading cause of disability, yet most 
pain sufferers fail to get proper assessment, diagnosis, 
treatment and management of their pain. Additionally, health 
care providers often face challenges to learning about or 
providing appropriate pain care management.
    I look forward to hearing about potential solutions to 
resolving these challenges in the most fiscally responsible and 
efficient ways possible. Again, thank you all for being here 
today and I look forward to hearing your testimony.
   Prepared Statement of Robert E. Shapiro, M.D., Ph.D., President, 
   Alliance for Headache Disorders Advocacy; Professor of Neurology, 
               University of Vermont College of Medicine
    Chairman Harkin, Ranking Member Enzi, and members of the HELP 
Committee, thank you very much for providing me with this valuable 
opportunity to discuss the impact of headache disorders in our country.
    My name is Bob Shapiro. I am president of the Alliance for Headache 
Disorders Advocacy, a coalition of 10 national and regional not-for-
profit organizations advocating on behalf of Americans with disabling 
headache disorders. I am also a practicing physician, research 
scientist, and a professor of neurology at the University of Vermont 
College of Medicine.
                   headache: the scope of the problem
    Headache in America is a wholly misunderstood phenomenon. Half of 
Americans will experience some type of headache this year,\1\ and more 
than 90 percent of Americans will experience headache in their 
lifetimes.\2\ While mild headaches are a nearly universal human 
experience, their near ubiquity combined with a century of direct-to-
consumer promotion of inexpensive over-the-counter analgesics, has 
reinforced an impression that headaches are only a minor problem except 
for those with a low tolerance for pain. This is profoundly mistaken.
    In fact, headache is a symptom that is common to a broad category 
of neurological disorders. Chronic migraine, post-traumatic headache, 
chronic daily headache, cluster headache and related disorders exact 
tremendous social, economic, and personal burdens that collectively 
comprise a smoldering and neglected major public health crisis. 
However, due to broad public familiarity with mild headaches and their 
near-absence of fatal complications, these incapacitating disorders are 
caught in a blind spot of public inattention. While they are highly 
prevalent, costly, and disabling, they are nonetheless stigmatized and 
dismissed.
    First, some facts may be useful:

     Headache disorders result in more than $31 billion in 
annual U.S. direct and indirect economic costs,\3\ \4\ exceeding the 
estimated annual U.S. costs of epilepsy, asthma and ovarian cancer 
combined.\5\ Furthermore, recent data suggest that total U.S. costs due 
to headache disorders may actually be three times higher than previous 
estimates.\6\
     Headache is the most common symptom of concussive or mild 
traumatic brain injuries. Among veterans of the Iraq/Afghanistan 
conflicts, 37 percent of servicemen and 57 percent of servicewomen 
reported ongoing migraine if there was a deployment history of 
concussive injury and any pre-deployment history of migraine.\7\ \8\ 
More than 500,000 concussions in the United States are sustained 
annually by children playing tackle football.
     World Health Organization (WHO) data indicate that 
migraine is the 19th leading cause of life lived with disability,\9\ 
\10\ and by itself results in more lost years of healthy life 
(``disability-adjusted life years'') in the United States annually than 
multiple sclerosis, epilepsy, ovarian cancer, and tuberculosis 
combined.\11\
     Almost one in five Americans (approximately 60 million 
people) will experience an attack of some form of migraine this year. 
Fewer than half of these people have formally received this 
diagnosis.\12\ \13\ \14\ \15\
     75 percent of adult Americans with episodic migraine are 
women,\13\ predominantly of childbearing age, however the very high 
prevalence of migraine overall means that it is not just a women's 
disorder.
     4 percent of Americans have headaches of more than 4 hours 
duration, at least 15 days per month,\12\ defined as ``chronic daily 
headache.''
     Severe headaches disproportionately affect individuals 
with low-income or limited education, as well as some minority groups 
such as Native Americans.\16\ \17\
     Cluster headache, a recurrent episodic disorder virtually 
unknown to the general public and typically unrecognized by physicians, 
is reputed to be the most severe pain that humans can experience. More 
than half of cluster headache sufferers have recurrent thoughts of 
suicide.\18\ It has a prevalence of approximately 1 in a 1,000, 
comparable to multiple sclerosis.
     Migraine with aura increases the risk of cardiovascular 
disease and is linked to more than 1,500 deaths in the United States 
annually, even after all other known risk factors have been accounted 
for.\19\ \20\ Americans with migraine with aura or frequent migraine 
are also more than three times more likely to attempt suicide than 
those without migraine, irrespective of the presence of depression.\21\ 
\22\ Migraine is highly co-morbid with depression, anxiety, asthma, 
epilepsy, substance abuse, obesity, and multiple other disorders which 
compound disability and suffering.\23\
                   health care for headache disorders
    Given the broad scope and huge burden of headache disorders in 
America, what healthcare resources are arrayed to manage the problem? 
Unfortunately, headache disorders have historically been neglected by 
practicing physicians. Early formulations of migraine described it as a 
psychiatric disorder \24\ or stigmatizing \25\ misbehavior particularly 
afflicting women of weak constitution but otherwise having no physical 
abnormalities. Such impressions have led generations of physicians to a 
well-entrenched dismissal of migraine as a non-serious malady of 
complainers.
    Unsurprisingly, few doctors have chosen to care for patients with 
headaches. While headache is the primary clinical focus area for more 
than half of America's approximately 7,000 neurologists,\26\ a total of 
only 290 U.S. physicians are certified by the United Council of 
Neurological Subspecialties (UCNS) as having specialty training in 
Headache Medicine.\27\ On average there is only one UCNS certified U.S. 
headache physician for approximately 43,000 Americans with chronic 
daily headache or approximately 200,000 Americans with migraine. A 
survey in 2004 \28\ found that most academic neurology departments in 
the United States did not actually have a dedicated headache specialist 
on faculty and there are currently only 17 UCNS accredited fellowship 
programs in the United States to train new headache specialists.\29\ 
With few academic mentors and clinical training program opportunities, 
the outlook for recruitment of new headache medicine providers and 
clinician-scientists is bleak. It would be inaccurate to say that 
organized medicine has abandoned headache patients; it never took them 
seriously to begin with.
    An unintended consequence of recent health care reform presents a 
further potential threat to patient access to headache care. To promote 
primary and preventative care, the Patient Protection and Affordable 
Care Act of 2010 (PPACA) provides for incentive bonuses to cognitive 
care providers, but only for those providers of particular primary care 
specialties.\30\ That is, under PPACA, incentives are only accorded to 
certain types of doctors rather than just to the type of medicine 
practiced. While headache care is very heavily weighted to cognitive 
over procedural care and headache medicine providers often provide 
primary or principal medical care, almost all headache medicine 
providers are ineligible for the PPACA incentives: 85 percent of UCNS 
certified headache providers are neurologists \27\ and neurology is not 
a medical specialty cited under the provision. Furthermore, recent 
proposals to resolve the failed Medicare Sustainable Growth Rate 
reimbursement formula have included consideration of steep cuts to 
procedural medical specialties. In this case, neurologists would also 
be inappropriately grouped with surgeons rather than with internists 
for these purposes. Ineligibility for PPACA incentives, combined with 
imposition of significant Medicare reimbursement cuts, could render 
already financially tenuous headache care practices as unviable. Such 
an outcome would be especially problematic for patients with headache 
disorders since they often rely on headache providers for delivery of 
their primary or principal medical care.
    Therapeutic options for headache disorders are few. Over the past 
50 years, only one novel drug, sumatriptan,\31\ has been developed 
specifically for the acute treatment of migraine and subsequently 
approved following an FDA priority review. While the approval of 
sumatriptan in 1992 was a breakthrough, the drug does not work 
immediately, it is ineffective in 40 percent of attacks and a quarter 
of migraine patients \32\ and it is contraindicated in many other 
patients with cardiovascular disease. Six ``me-too drugs'',\31\ that 
are structurally and therapeutically similar to sumatriptan, were 
subsequently FDA approved, but these have not substantially changed the 
landscape of available therapies. Moreover, sumatriptan remains 
expensive even though it is now available in generic form.
    Opioid medications, which are a mainstay of therapy for acute pain 
conditions, have a very limited role in the care of recurrent headache 
disorders such as migraine. Opioids characteristically render other 
headache medications less effective and their use in migraine 
significantly increases the risk for worsened attack severity and 
frequency.\33\ \34\ However, because of the relatively higher cost of 
triptans and generally inadequate knowledge of headache practice among 
both primary care providers and insurance carriers, 20 percent of U.S. 
migraine patients must still rely on opioid and barbiturate medications 
for the acute treatment of attacks.\35\
    Four drugs are FDA-approved and marketed for the prevention of 
episodic migraine and one drug for the prevention of chronic migraine. 
All of these drugs were initially FDA-approved for other medical 
indications, all have significant potential side effects limiting 
tolerability, none are curative, and many patients are not responsive 
to any of them.
                     research on headache disorders
    Headache disorders research has never been adequately funded. 
Perhaps taking a cue from physicians, the National Institutes of Health 
has also neglected headache disorders, and very limited funding for 
headache disorders research has been available through the Department 
of Defense, private philanthropies, or any other sources. In 2011, the 
NIH expended $21 million on all headache disorders research, comprising 
less than 0.07 percent of the overall budget.\36\ Moreover, NIH 
estimates an actual decline in such funding to $20 million through 
fiscal year 2013.\36\ While the NIH has sponsored at least six 
investigator conferences and ``workshops'' over the past 4 years to 
discuss the planning for headache disorders research,\37\ it has not 
issued any Request for Applications (RFAs) or other Funding 
Opportunities with funds set-aside to prioritize the actual conduct of 
such research. In fact, only once has the NIH ever issued an RFA on 
migraine research \38\; it funded a total of four grants in 2007 but 
did not appreciably increase overall funding for the disorder. The NIH 
has not funded a research grant on cluster headache in more than 25 
years. Two NIH standing peer-review study sections each have one 
headache research scientist currently serving a 3-year term, though 
neither study section is otherwise focused on the review of headache 
disorders grant proposals.\39\
    In this climate of poor research funding and uncertain grant 
proposal review, few seasoned scientists have entered the headache 
field. Furthermore, promising early-stage scientists are often led by 
their academic mentors to consider this to be a dead-end career track, 
thereby exacerbating the shortage of investigators. Of 14,229 research 
presentations at the 2006 annual meeting of the Society for 
Neuroscience, only 22 were related to headache disorders.\40\ Over the 
past 35 years, the preeminent science journals Nature and Science have 
each published only one research report related to migraine. High-
impact general medical journals publish almost nine times as many 
articles on asthma as on migraine.\41\ Of the progress that has 
occurred in migraine research in the past two decades, a 
disproportionate number of seminal findings have emerged from non-U.S. 
laboratories. For example, of the eight genes for migraine 
susceptibility that have been identified to date, seven of them were 
discovered by non-U.S. investigative teams.\42\ \43\ \44\ \45\ \46\ 
\47\ \48\ \49\
   migraine and epilepsy: similar disorders, divergent research paths
    Regarding the direct benefits to patients that can result from NIH 
research funding, an instructive comparison can be made between two 
highly similar disorders, migraine and epilepsy. Both are paroxysmal 
brain disorders that share in common some identified genes, brain 
events, and medications.\50\ They also often occur together in the same 
individuals. While both may be disabling, according to WHO data,\11\ 
migraine results in 3 times more lost years of healthy life as epilepsy 
annually in the United States. Migraine is also far more prevalent and 
costly overall.\51\ \52\
    By contrast to migraine however, the NIH has invested well in 
epilepsy research over the past 20 years.\36\ \51\ In 2011, NIH 
expenditures on epilepsy totaled $152 million versus $16 million for 
migraine. NIH epilepsy programs have included a ``benchmarks'' 
initiative to guide new investigators and a remarkably successful, 
cost-effective, and largely unsung, early-stage screening program to 
identify promising new drugs.\51\ \53\ The NIH also has a standing 
peer-review study section that is largely and specifically devoted to 
ensuring fair and informed review of epilepsy grant proposals.\54\ The 
returns on this investment for epilepsy have been impressive. Over the 
past 20 years, while FDA approvals for novel migraine drugs have 
languished, patients with epilepsy have benefited measurably by the FDA 
approval of 14 novel anti-seizure medications, and even more drugs are 
in late stage clinical trials.\51\
    The comparison between migraine and epilepsy drug approvals starkly 
underscores the pivotal role that NIH-funded fundamental and 
translational research plays in drug discovery. In the case of 
migraine, the pharmaceutical industry has simply not delivered on its 
own. The recent successes in epilepsy drug development offer the clear 
promise that with comparable NIH investigator-initiated research 
funding, fair and informed peer-review of grant proposals, and 
implementation of a robust NIH migraine drug screening program, 
multiple novel and effective therapies would emerge for patients with 
headache disorders.
          a way forward for americans with headache disorders
    The NINDS mission is ``to reduce the burden of neurological 
disease.'' \55\ This mission cannot be realized without addressing a 
major source of that burden: the untended crisis of Americans with 
disabling headache disorders. Moreover, the persistent neglect of such 
a large source of U.S. disease burden indicates a lapse in NIH 
surveillance of sources of disease burden and a lack of a formal policy 
to take disease burden measures into consideration in prioritizing 
research funding. NIH must have a policy that ensures that any 
significant source of disease burden is never so grossly misaligned 
with the application of NIH resources in the future. We urge NIH to 
focus on the funding of innovative burden of illness research with the 
goal of developing measures that may guide public policy acceptable to 
a consensus of NIH stakeholders. Adoption of more objective criteria 
for the distribution of NIH funding, based in part on improved disease 
burden measures, should increase transparency, reduce the 
politicization of the NIH funding process overall, and ensure that all 
Americans are equitably benefiting from tax-payer funded research.
    In the meantime, Americans with headache disorders warrant an NIH 
commitment of a magnitude at least equal to that currently directed 
toward alleviating epilepsy. We urge immediate and remedial attention 
to building NIH intramural and extramural programs for headache 
disorders research, and to implementation of the recommendations of the 
NIH Headache Research Planning Meeting Report of October 2011, 
``Opportunities and Priorities for Headache Research.'' \56\
    In particular, we believe that new NIH programs should include:

     The establishment of regional academic headache disorders 
research and care ``centers of excellence'' to train clinicians in 
headache medicine and clinician-
scientists to pursue research in this area.
    Without adequate NIH-funded research and academic programs devoted 
to headache disorders, there will continue to be limited, or non-
existent, institutional support in medical schools for the training of 
headache medicine clinicians and clinician-scientists.
     Major new and sustained set-aside funding of investigator-
initiated fundamental and translational research on headache disorders, 
especially pertaining to identification of biomarkers and development 
of relevant models of disease.
    To attract and retain quality investigators to this field, it is 
necessary to ensure that adequate funding sources will be sustained and 
that peer-review of grant proposals will be informed and fair.
     Establishment of a migraine drug screening program to 
foster early stage development of novel and effective therapies.
    Such a drug screening program could be implemented by extension of 
the established anticonvulsant screening program and might be mostly 
self-funded through modest fees assessed of pharmaceutical industry 
users and targeted to the Foundation for the NIH.

    To assure access to effective headache care for patients, we urge 
inclusion of headache specialty providers in the incentive 
reimbursements that will be accorded to primary health care providers 
in health care reform, and also in the protections from cuts in 
reimbursements which may result from resolution of the Medicare 
Sustainable Growth Rate formula.
                      headache patient testimonies
    I conclude with the unedited voices of a few, among thousands, of 
Americans who have recently provided comments on a petition urging 
congressional attention to headache disorders \57\:
    SSGT Leslie W. from Brooklyn, NY writes:

    As a combat vet served a tour of duty in Afghanistan, I have 
constant headaches and our VA doctors have no explanation for them

    Michelle L. from Newport News, VA writes:

          I have not shut myself off from life, my head pain has shut 
        life off from me. I would hate to see another person go through 
        life as lonely and afraid as I am at this very moment.

    Joyce W. from Glen Rock, NJ writes:

          My father suffered from cluster migraines. In 1980, he chose 
        to end his life at age 52 rather than live with these headaches 
        any longer. 32 years later and there are still no good answers.

    Gail B. from Mexico, MO writes:

          18-22 days a month I am in bed with a migraine, and NO ONE 
        can help me. NO clinic, no headache specialist & no 
        neurologist. lost my career, my marriage & my life. My son 
        received a TBI from an IED in Iraq, he now suffers also but 
        with memory loss, yet he's deployable. Go figure.

    Rose H., Colorado Springs, CO writes:

          Little by little I'm losing more and more of my life to 
        migraines . . . my job, school, friends and all of the events I 
        cannot attend due to the debilitating pain, visual disturbances 
        and all of the other symptoms of migraines. Please help me get 
        my life back by recognizing migraines as the taker of lives 
        they are and bring about the changes necessary for better 
        understanding and treatment.

    Kathy B. from Alta Vista, KS writes:

          chronic migrainer here . . . getting worse not better and the 
        meds aren't working. . . . lost my normal life everything 
        revolves around my migraines I have no life anymore only 
        horrible days and semi functional days

    Alicia H. from Arlington, OR writes:

          You have no idea how bad this can be until you see your best 
        friend laying under a table in the fetal position screaming. 
        With their eyes bleeding from the pressure.

    Lorri P. from La Marque, TX writes:

          I have suffered from Migraine headaches for more than 26 
        years. Due to Migraines, I left active duty military, I have 
        missed out on much of my daughters' lives growing up, I have 
        placed undue stress on my marriage and have been on full 
        disability for the last 4 years. This is not living.

    Catherine H. from Wasilla, AK writes:

          I was forced to seek social security disability at age 45 for 
        migraine. I have now been on disability for over 18 years. I 
        never realized my full potential in earnings nor did I really 
        utilize my college education. Indeed, I was forced to declare 
        bankruptcy and will probably spend the remainder of my adult 
        life on public assistance, food stamps and HUD housing 
        assistance to augment my Social Security Disability income. The 
        financial loss includes lost taxes on a professional income, 
        loss because of bankruptcy and a loss to the Nation in public 
        assistance to support me that includes almost 20 years of 
        medical costs for migraine drugs at between $1200 $200 per 
        month!

    Misty S. from Washington, DC writes:

          PLEASE, PLEASE, PLEASE increase funding for research and 
        clinical trials to find the cause of CLUSTER HEADACHE attacks. 
        Over the past 20 years, I have been to countless doctors and 
        tried over 35 ineffective medications with horrible side 
        effects. I just want to be able to live and enjoy life rather 
        than dreading with fear my next CLUSTER HEADACHE attack.

    Carrie S. from Charlotte, NC writes:

          So many of us have to stop working and live on government aid 
        because of headache disorder disabilities. With lack of 
        education, funding for research, and new treatment options, we 
        have no other option than to continue living this way. Give the 
        Nation education, research funding, and new treatment options, 
        and I guarantee that you will be shocked at how many Americans 
        will benefit and be able to go back to work, thus paying back 
        into the system. Help us so that we can help you.

    Kenneth B. from Santa Monica, CA writes:

          Many more people are suffering than anyone knows as you can't 
        see it like if someone had a broken arm for example. Millions 
        of us are suffering in silence and only more research will 
        bring an end to our problems . . .

    Susan V. from Lake Forest, IL writes:

          Adolescents suffer greatly as well and the school system has 
        no provisions to accommodate this malady and continue their 
        education. Many end up dropping out and having to figure out an 
        education on their own later in life. What a waste of talent & 
        potential.

    Patricia D. from Highland, CA writes:

          I have suffered with migraines since the age of 13. It has 
        now been 34 years with no answers as to why I am getting them 
        or a medicine that helps. Sad to say I have gotten a migraine 
        every day of my life for numerous years. I am tired, depressed 
        and have lost my joy. I have exhausted the help of 4 
        neurologists and 2 pain specialists in the past 10 years. I've 
        left doctor appointments crying because I was told, ``I have 
        done all I can to help you. There is nothing left to try.'' My 
        family has spent thousands of dollars to try and help me 
        because my insurance would not cover different treatments and 
        medicines. I have tried to get into migraine trials but after 
        they see all that I have tried and medicines I have taken they 
        deny me. Unless you walk in the shoes of a chronic daily 
        migraine sufferer, you cannot relate! No matter how much you 
        try you will never understand what we go through. My prayers 
        are out to all who suffer from debilitating headaches!

    Sandy S. from Des Plaines, IL writes:

          Signing this with a migraine, hoping someone we elected will 
        listen to us for a change.

    Thank you very much for your attention.
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Prepared Statement of Jennifer Spotila on behalf of the Chronic Fatigue 
     and Immune Dysfunction Syndrome (CFIDS) Association of America
                                summary
    This testimony is submitted on behalf of the CFIDS Association of 
America, in loving memory of Christy Gaffey of Williamsburg, IA. 
Christy lost her battle with chronic fatigue syndrome (CFS) and 
interstitial cystitis on February 9, 2012 at the age of 52. She was an 
advocate for these medical conditions and, in days of better health, 
participated in lobby days organized by the CFIDS Association. With 
this testimony at today's hearing chaired by Senator Tom Harkin--her 
Senator--we recognize Christy's life and the voice she once gave to all 
who have been jailed by chronic pain conditions. We implore, in 
Christy's memory and for all those who have been lost too early to 
these conditions, that today's hearing mark the beginning of serious 
action to address and curb the personal, family, community, State and 
national toll exacted by conditions marked by chronic pain.
                               about cfs
    Also known as chronic fatigue and immune dysfunction syndrome 
(CFIDS) and myalgic encephalomyelitis (ME) or ME/CFS, CFS is a complex 
illness that results in a constellation of debilitating symptoms, 
including incapacitating fatigue (experienced as profound exhaustion 
and extremely poor stamina), sleep difficulties and problems with 
concentration and short-term memory. The hallmark of CFS is post-
exertional relapse, a worsening of symptoms following even minor 
physical or mental exertion that persists for days or weeks. It's also 
accompanied by pain in the joints and muscles, tender lymph nodes, sore 
throat and headaches. It often has an acute, flu-like onset within 
hours or days.
                 about the cfids association of america
    The Association's mission is to make CFS widely understood, 
diagnosable, curable and preventable. Our strategy is to stimulate 
research aimed at the early detection, objective diagnosis and 
effective treatment of CFS through expanded public, private and 
commercial investment. Second only to the Federal Government in funding 
initiatives for CFS, since 1987 the Association has invested more than 
$30 million in initiatives to end the life-altering disability, stigma 
and isolation of CFS. The CFIDS Association of America is a member of 
the Chronic Pain Research Alliance. For information and resources, 
visit www.research1st.com or www.cfids.org.
                                 ______
                                 
    Chronic fatigue syndrome is the name of my illness. I cannot count 
the number of people who have said to me, ``I had no idea that CFS had 
pain as a symptom.'' But it does. Think about the last time you had the 
flu. Did you lie in bed, shaking and aching all over, too weak to sit 
up? Yes. That is what my pain is like, but it is like that every day. 
Pain is always with me. It follows me around like my shadow. Just as a 
shadow changes shape with the light, my pain expands, contracts, and 
tries to swallow me whole. There is nowhere I go, nothing I do that is 
unaffected by pain.
    Aching, throbbing, heavy, sharp, tingling, stabbing, crushing--all 
these words cannot fully describe my pain. Sometimes I lie in bed, 
weighed down by it. Or I might be sitting up and feel pain like a lance 
through trigger points in my back. My wrists ache, my toe joints hurt. 
One day, it's my calves that tighten and cramp. Another day, my neck 
pinches and headaches loom. There are times when my whole spine is on 
fire and nothing I do alleviates the pain. There are times when the 
gentlest touch is more than I can bear, even my husband's hand on my 
arm or my hair brushing against my neck.
    I've worked with physical therapists. One said there was no hope 
when my body did not respond to the prescribed program. My current 
physical therapist has made great progress in loosening the trigger 
points in my back, but there has been no change in my overall pain 
level or experience. The catch-22 is that the exertion of going to 
physical therapy twice a week and the daily stretching regimen does, in 
itself, increase my pain. I tried acupuncture, too. The needles are 
supposed to be painless, but I felt ropes of fire shooting out from 
every needle site.
    I've consulted with pain management experts. Over the years I've 
tried aspirin, bextra, celebrex, cymbalta, flexeril, gabapentin, 
ibuprofen, imitrex, lidocaine injections, lidoderm patches, lyrica, 
pamelor, percocet, soma, topomax, tylenol, tylenol 3, tramadol, 
venlafaxine, vicodin, and wellbutrin. Most of these medications either 
did not help, or helped but came with intolerable side effects. Pamelor 
caused dreadful acid reflux. Topomax caused flashing lights in my 
peripheral vision. When my doctor decided to discontinue venlafaxine, 
it took me more than 2 months to wean off the dose and even then I 
endured withdrawal symptoms. I developed a frightening hypersensitivity 
reaction to tramadol, forcing me to discontinue the one drug that 
worked very well for me. Opiates like percocet and vicodin were a dream 
come true. The few weeks I was on percocet after the tramadol 
hypersensitivity were the only pain-free weeks I have had in more than 
15 years. No doctor is willing to prescribe them for me long term. 
Instead, my pain management doctor believes the goal is to keep my pain 
manageable, not to make me pain-free.
    Pain is intertwined with fatigue like a snarl of barbed wire. Being 
in pain makes me more tired. Activity makes me more tired and increases 
the pain. I always have to be careful about my physical position--legs 
and back fully supported, neck not too bent. Some days, I cannot get 
out of bed at all. Even when I am able to function, pain limits what I 
can do. I am fortunate not to have intense, localized pain that might 
prevent me from reaching for an object or moving in a specific 
direction. Instead, the pain hovers in the background, creeping ever 
higher. The generalized ache grows stronger and louder until it 
overwhelms every thought or intention. I might take a few steps out of 
my cell but pain, my jailer, will always shove me back in and slam that 
cell door shut.
    On good days, I get through the day with a few hours of activity 
such as cooking or paying bills. By the time dinner is over and the 
dishes are done, I am on the verge of collapse. A hot pack and bed by 7 
p.m.--I feel like a 90-year-old invalid. On bad days, I max out on all 
my pain medications. If I am very lucky, the medications will keep the 
pain to a tolerable level. There have been many nights when all I could 
do was whimper. More than once, I have contemplated going to the 
emergency room for pain relief on nights like that. But what would they 
do for me? How would they view me, a 40-something with normal blood 
work who insists she needs medication for intractable pain? I have 
never bothered to find out.
    Living with this pain is like juggling while riding a unicycle. One 
lapse of focus, one dropped ball and everything comes crashing down. 
The delicate balance of rest, medication, and physical therapy will 
keep the pain at bay, but inevitably, something destroys that balance 
and the pain comes roaring back. No one can pedal a unicycle 
indefinitely. I try my best, but sometimes, living with this pain 
doesn't feel much like living at all.
Prepared Statement of the American Cancer Society Cancer Action Network 
                               (ACS CAN)
    On behalf of millions of cancer patients, survivors and their 
families, the American Cancer Society Cancer Action Network (ACS CAN), 
the advocacy affiliate of the American Cancer Society commends the 
Senate Health, Education, Labor, and Pensions Committee (HELP) for 
holding this important hearing to address the public health impact of 
pain in America.
    More than 1.5 million new cases of cancer will be diagnosed this 
year. Pain remains one of the most feared and burdensome symptoms for 
these cancer patients, as well as for survivors and their families. 
Approximately 30 percent of patients newly diagnosed with cancer, 30-50 
percent of patients undergoing treatment, and 70-90 percent of patients 
with advanced disease experience pain. Pain can also continue into 
long-term survivorship, often persisting for years after cancer 
treatment concludes.
    It is disheartening that while nearly all cancer-related pain can 
be relieved, its prevalence and its under-treatment have remained 
consistently high and largely unchanged for more than four decades.\1\ 
The situation is even worse for the 116 million American adults 
experiencing chronic non-cancer pain, particularly among our Nation's 
medically underserved and most vulnerable populations.
---------------------------------------------------------------------------
    \1\ Van den Beuken-van Everdingen MHN, deRijke JM, Kessels AG, et 
al. Prevalence of pain in patients with cancer: a systematic review of 
the past 40 years. Ann Oncol. 2007;18:1437-49.
---------------------------------------------------------------------------
    The Institute of Medicine's comprehensive 2011 report, Relieving 
Pain in America, provides an essential, evidence-based blueprint for 
addressing this preventable suffering, highlighting consensus expert 
recommendations to advance pain control research, education, awareness 
and access. Public awareness about pain is essential to adequately 
equip patients and families with knowledge they need to demand more 
from the health care system to both save lives and help stop their 
suffering. Pain, worry and other symptoms and side effects of cancer 
and its treatment, for example, are not just inevitable consequences of 
chronic illness. They typically can be controlled. The public needs to 
expect that health care professionals and the health care system do 
more to treat the burden of illness and preserve their quality of life.
    People in pain are also the most disempowered. They are often too 
sick to advocate for themselves, and their caregivers are too 
overwhelmed. Frequently patients' families will ask, ``What am I doing 
wrong? '' Oftentimes patients think that they are alone, and that their 
struggle with chronic pain is unique to their situation, or by fault of 
their own--but it is not. Our Nation's health care system simply is not 
set up to deliver pain care efficiently and in a manner that is most 
beneficial to patients. Patients and families need our help to address 
this needless suffering so they can understand that pain care is 
available and know what they need to ask for. Health professionals and 
health systems in turn need to be ready and able to provide quality 
pain care for every patient, at every bedside, in every care setting.
    The 2011 IOM report also suggests the need for directed pain 
research, which is essential for building the evidence base that will 
guide clinical practice and delivery of quality pain care. It also 
calls for enhanced professional training in pain assessment, 
management, and prescribing core competencies. Despite only very 
limited exposure during their professional training, medical, nursing 
and pharmacy professionals do recognize the importance of pain 
management to quality health care. However, they also acknowledge that 
there is room for improvement in delivering quality pain and symptom 
management, doctor-patient communication, and coordination and 
continuity of care. Specialized training emphasis for pain assessment 
and care is also essential among professionals who routinely care for 
children and young adults living with pain, such as pediatric and young 
adult cancer populations, as well as health professionals caring for 
other medically underserved populations, including racial and ethnic 
groups, where health disparities are prevalent.
    ACS CAN has been actively involved in advocating for the 
development and delivery of the Relieving Pain in America report, and 
is equally committed now to helping ensure implementation of the 
report's recommendations. We stand ready to work with Congress, the 
Department of Health and Human Services, the health care community, and 
the many Federal and State agencies and enforcement officials that will 
need to be involved in addressing the IOM recommendations so we can 
together promote better care and improved quality of life for all 
people living with pain.
      Responses to Questions of Senator Harkin and Senator Hatch 
                  by Lawrence A. Tabak, D.D.S., Ph.D.
                             senator harkin
    Question 1. Thank you for your testimony at our hearing, ``Pain in 
America: Exploring Challenges to Relief ''. At the hearing you touched 
on what the agency was doing with respect to implementing the IOM 
report recommendations. Can you elaborate on this response and provide 
a clear sense of the specific steps the Department of Health and Human 
Services is taking to implement the IOM report's recommendations?
    Answer 1. The IOM report, Relieving Pain in America: A Blueprint 
for Transforming Prevention, Care, Education, and Research included a 
number of recommendations to the Department of Health and Human 
Services for improving pain prevention, care, education, and research. 
It specifically directs five recommendations to the NIH for improving 
the state of pain research in the United States. These recommendations 
are described below:
    In its first recommendation, to be implemented by the end of 2012, 
the IOM report asks NIH to designate a lead institute at the NIH 
responsible for moving pain research forward and increase the support 
for and the scope of the Pain Consortium. In response to this 
recommendation, the NIH Director has designated the NINDS as the 
specific IC to lead NIH's pain research efforts. Dr. Story Landis, the 
NINDS Director who chairs the Pain Consortium Executive Committee will 
lead enhanced coordination of trans-NIH pain research efforts. In 2011, 
the NIH Pain Consortium increased its level of trans-NIH collaboration 
and coordination and supported a number of pain disorder workshops and 
conferences on chronic fatigue syndrome, vulvodynia, sickle cell pain, 
temporomandibular joint disorders, and overlapping chronic pain 
condition. The Consortium also established new trans-NIH working groups 
on chronic lower back pain and overlapping chronic pain conditions.
    NINDS will also establish a dedicated office to support the 
activities of the NIH Pain Consortium and the newly created Interagency 
Pain Research Coordinating Committee (IPRCC). The IPRCC has been tasked 
with developing a summary of federally funded pain research advances 
and identifying critical gaps in basic and clinical pain research. The 
IPRCC will also make recommendations on how to avoid duplication of 
research effort, best disseminate information on pain care, and build 
public-private partnerships to expand pain research. During the 
Committee's inaugural meeting on March 27, 2012, Dr. Sean Mackey, who 
served on the IOM report panel and is now a member of the IPRCC, will 
brief the IPRCC on the IOM report.
    The IOM report also recommends that the NIH work with other 
agencies and research groups to improve the process for developing new 
agents for pain control, increase support for interdisciplinary 
research in pain, increase the conduct of longitudinal research in 
pain, and increase the training of pain researchers by end of 2015. NIH 
is currently moving forward with a number of activities in response to 
these near-term recommendations as detailed below.
(i) Improve the Process for Developing New Agents for Pain Control
    The NIH and FDA are involved in a high level NIH-FDA leadership 
council that is exploring better coordination of NIH and FDA efforts to 
improve regulatory science and overcome hurdles in the drug development 
pipeline. Members of the NIH Pain Consortium currently participate in 
an advisory committee for the Analgesic Clinical Trial Translations, 
Innovations, Opportunities, and Networks (ACTTION) initiative, a 
public-private partnership program sponsored by FDA to streamline the 
discovery and development of analgesics. In May 2012, NIH and the FDA 
plan to hold a state of the science workshop on assessing opioid 
efficacy and analgesic treatment in conjunction with the 7th Annual NIH 
Pain Consortium Symposium focusing on advancing pain therapies. NIH is 
also conducting research to develop medications for chronic pain that 
could circumvent the problematic side effects (e.g. tolerance and 
dependence) of many current medications.
(ii) Increase Support for Interdisciplinary Research in Pain
    As a member of the IPRCC, NIH is currently conducting a portfolio 
analysis of federally funded pain research to determine current 
investments in basic, translational, and clinical pain research and the 
IPRCC will continue this effort with the input of designated 
individuals from the relevant Federal agencies. These efforts will 
inform strategies for increasing support for interdisciplinary research 
in pain.
(iii) Increase the Conduct of Longitudinal Research in Pain
    NIH currently funds several large-scale longitudinal studies on 
pain. For example, the Orofacial Pain: Prospective Evaluation and Risk 
Assessment (OPPERA) is a $19 million study tracking 3,200 initially 
healthy male and female volunteers, ages 18-44, to identify risk 
factors associated with the development of temporomandibular joint and 
muscle disorders (TMJDs). Preliminary results have found important 
mutations linked to these disorders. The Spine Patient Outcomes 
Research Trial (SPORT) is studying the effectiveness of different 
treatments for low-back pain. The Patient-Reported Outcomes Measurement 
Information System (PROMIS) is creating psychometrically robust 
patient-reported banks of questions to measure pain in clinical trials 
for various chronic diseases, while the Multidisciplinary Approach to 
Chronic Pelvic Pain (MAPP) Research Network is focusing on how and why 
people develop urologic chronic pelvic pain disorders, and how their 
disease changes over time. It also examines genetic, behavioral/
lifestyle, environmental, and other factors as contributors to disease. 
As part of the IPRCC, NIH is also assessing current research to help 
inform the gaps and opportunities for increasing support for 
longitudinal studies in pain.
(iv) Increase the Training of Pain Researchers
    In addition to current training programs, NIH recently launched new 
initiatives to increase the number of training opportunities for pain 
researchers. For example, the National Institute of Nursing Research 
currently holds an intramural Methodologies Boot Camp on the NIH campus 
to develop improved research capacity in the science of pain. The 
National Institute of Dental and Craniofacial Research will support new 
Institutional Career Development Awards for Enhancing Research Capacity 
in TMJD and Orofacial Pain (K12) to develop independent clinical 
scientists. In a new trans-NIH effort, led by the National Institute on 
Drug Abuse, NIH plans to support new Centers of Excellence in Pain 
Education (CoEPEs) at dental, medical, nursing, and other professional 
schools to develop and disseminate pain management curriculum resources 
for health care professionals and to provide leadership for change in 
pain management education. Finally, as a member of the IPRCC, NIH is 
compiling information on Federal training programs which will inform 
the consideration and development of additional training programs.
                             senator hatch
    Question 1. Should research funding for chronic pain illness be 
based on an illness's patient population?
    Answer 1. When setting priorities for specific conditions or 
disease areas, NIH takes into account a number of factors, including 
disease burden. The specific amount of NIH funding for a particular 
disease, however, is largely determined by the state of the science and 
the extent of highly meritorious research proposed by the scientific 
community. For example, if basic research or related disease-specific 
research suggests promising hypotheses to test, proposals to test these 
hypotheses may be submitted to NIH and may be funded if found to be 
scientifically meritorious. If there are too many gaps in knowledge, 
however, the most productive next step may be to encourage more basic 
research until new hypotheses are developed. NIH continually evaluates 
what is known, what is not known, and what we need to know to solve the 
problem before us--identifying knowledge gaps and developing the 
roadmap to solutions.
    NIH supports research in many chronic pain illnesses including 
neuropathic pain, cancer pain, musculoskeletal pain, chronic fatigue 
syndrome, migraine, endometriosis, fibromyalgia, interstitial cystitis, 
temporomandibular disorders (TMJD) and vulvodynia among others. Chronic 
pain can also become a disease in and of itself and can manifest as a 
persistent pain state that outlasts an acute injury or illness, or 
arises in the absence of an identified causative mechanism. NIH 
research on understanding and treating pain in general, such as 
investigating factors involved in the transition from acute to chronic 
pain, complements research on specific conditions, and together these 
contribute to a significant research portfolio aimed at alleviating the 
suffering of a large population of patients.

    Question 2. The term ``central pain'' was originally used to 
describe a condition that occurred in individuals who, following a 
stroke or spinal cord lesion, subsequently developed pain. In this case 
``central'' referred to the fact that the lesion leading to pain 
occurred within the CNS--either spinal cord or brain. More recently, 
however, the term has expanded to describe any CNS dysfunction or 
pathology that may be contributing to the development or maintenance of 
chronic pain. Another term that has often been used to describe this 
same phenomenon is ``central sensitization.'' What might be the best 
way to research central sensitization?
    Answer 2. Central pain or central pain syndrome is caused by injury 
or a disease process that causes dysfunction of a part of the central 
nervous system (CNS). It can be caused by stroke, tumors, trauma, 
seizures, or pathology associated with diseases of the CNS, such as 
multiple sclerosis or Parkinson's disease. The extent and 
characteristics of central pain are variable, but are related to the 
affected neural structures. Central sensitization differs somewhat from 
central pain; it is an amplified response of the CNS to painful or non-
painful sensory input. This hypersensitivity of the CNS contributes to 
inducing and maintaining a persistent pain state in many chronic pain 
conditions. NIH funds research on understanding the underlying 
mechanisms of central sensitization and identifying the multiple and 
varied contributions of dysfunctional changes in the CNS that lead to 
and maintain persistent pain. For example, work supported by NIH is 
exploring the role of increased activity of neurotransmitters 
(chemicals involved in transmitting signals from one nerve cell to 
another) in enhancing neuronal activity in response to pain. NIH-funded 
research has also demonstrated the role of increased activity in 
certain brain structures in contributing to amplified pain signals or 
in causing or maintaining persistent pain. For instance, repeated 
activation of certain brainstem neurons causes an increase in their 
activity associated with a transition from episodic to chronic daily 
headaches.&
    Approaches to studying central sensitization must include research 
on the altered neuronal activity or ``plasticity'' at multiple levels 
of the CNS. While there has been extensive research on altered 
signaling pathways and neuronal responses throughout the central 
nervous system, a strategy is needed to integrate information on how 
these changes interact in persistent pain states. Brain regions 
previously not considered to be involved in pain are emerging as 
candidate regions with improved imaging techniques. These brain areas 
need to be further explored for their neurobio-
logical contributions to pain, as well as their functional outcomes in 
maintenance and recovery from pain. Emerging imaging techniques, 
including resting state fMRI offer a powerful tool for understanding 
how pain alters normal patterns of neuronal connectivity in the brain 
and can be exploited to determine whether changes are unique to 
different pain conditions, can be used to predict analgesic response, 
or can serve as a marker for transition to chronic pain and recovery. 
Such a multifaceted approach will add to the many potential therapeutic 
targets already being explored and facilitate development of drugs 
designed to block or reverse central sensitization.

    Question 3. Since many chronic pain illnesses co-exist, should a 
certain percentage of research funding focus on the central nervous 
system as a common tying element before studying individual illnesses?
    Answer 3. The NIH recognizes the important role of structural and 
functional changes in the central nervous system (CNS) as an underlying 
factor in persistent pain states, and a significant portion of the NIH 
pain research portfolio is focused on these areas. Since the 
description of central sensitization (an amplified response of the CNS 
to painful or non-painful sensory input) in 1983, understanding its 
role in persistent pain and its potential for novel drug development 
has been an important focus of basic and translational research (also 
see response to question 2). Various approaches and novel research 
techniques have contributed to a number of studies ranging from 
deciphering cellular and molecular changes in the nervous system to 
understanding altered functional neural circuits associated with 
chronic pain, as well as clinical studies on human pain conditions. NIH 
also recognizes that the basis for co-existence of multiple pain 
conditions in an individual is very likely linked to maladaptive 
changes in the central nervous system and is investing considerable 
effort and resources to this issue.
    NIH funding levels are driven largely by scientific opportunity and 
by the amount of meritorious research proposed by investigators in the 
particular field. Disease-specific funding totals often do not reflect 
the likely benefits of basic research or research on other conditions 
that may inform that disease. New scientific opportunities often flow 
from NIH-sponsored research on broad scientific themes (such as genome 
projects, development of instrumentation, training in clinical 
research, or developments in basic science). Historically, support of 
these themes has often yielded insights and capacity to stimulate 
research to address specific diseases.
    NIH supports a multi-faceted approach to studying pain, including 
understanding the underlying mechanisms such as the role of the CNS, 
deciphering the molecular and cellular basis of a number of chronic 
pain conditions, and developing therapies to treat chronic pain, to 
yield the most valuable insights and discoveries.

    Question 4. Motor vehicle accidents have been identified as a major 
adverse event precipitating chronic pain illnesses. Which Institute at 
NIH is best designed to oversee longitudinal research to know the long-
term adverse health effects of motor vehicle accidents?
    Answer 4. Motor vehicle accidents are traumatic events that can 
cause multisystem injuries leading to a range of acute and chronic 
health problems, including musculoskeletal pain, neuropathic pain, 
psychological trauma, and emotional effects.
    NIH supports extensive research and training on effects and 
treatments for different types of injuries caused by motor vehicle 
accidents and other traumatic events. NIH Institutes support academic 
research centers and training programs in trauma, burn, and wound 
healing; research on biological mechanisms and treatments for chronic 
neuropathic pain resulting from traumatic brain and spinal injury; and 
research on biomarkers, diagnostics, and clinical trials of 
interventions for traumatic brain injuries in general. Multiple NIH-
funded studies are investigating the underlying processes and non-
pharmacological treatments for chronic neck and back pain as well as 
research on post-traumatic stress disorder (PTSD) and emotional pain 
which may result from particularly serious vehicular accidents. NIH 
also supports a $30 million, 5-year Medical Rehabilitation Research 
Infrastructure Network (www.ncmrr.org) to enhance the capability of 
researchers investigating functional recovery and developing therapies 
to improve the lives of people with disabilities.
    Given the breadth of injuries and chronic pain illnesses resulting 
from motor vehicular accidents, trans-NIH efforts--rather than those of 
one particular NIH Institute or Center--are best suited to address 
these research issues. For example, one of the Grand Challenges of the 
NIH Blueprint for Neuroscience Research (a cooperative trans-NIH effort 
among the 15 NIH institutes, centers, and offices that support 
neuroscience research) is focused on the Transition from Acute to 
Chronic Neuropathic Pain, and addresses the maladaptive neural changes 
that occur during the development of chronic pain. In addition, the NIH 
Pain Consortium with membership from 25 NIH Institutes, Centers, and 
Offices actively promotes collaboration on cross-cutting areas of pain 
research.
    While NIH does not currently support longitudinal studies 
specifically targeting chronic pain resulting from motor vehicle 
accidents, it does support significant longitudinal research on various 
chronic pain disorders and traumatic head and spine injury. For 
example, the Spine Patient Outcomes Research Trial (SPORT) is studying 
the effectiveness of different treatments for lower back pain. Another 
longitudinal project is utilizing brain imaging to study functional 
recovery after traumatic brain injury.

    Question 5. It has been suggested that studies are needed to 
closely follow the longitudinal development of fibromyalgia (FM) by 
following individuals from when they first develop acute symptoms, to 
when they develop co-morbid FM. Are there any current longitudinal 
studies for chronic pain?
    Answer 5. NIH currently supports longitudinal studies on a number 
of chronic pain conditions including fibromyalgia (FM). The Self-
Monitoring and Review Tool (SMART) Log Program offers a web-based self-
management tool that enables FM sufferers to identify significant 
linkages between their personal symptom levels and their personal self-
management efforts over time in order to plan their own optimal 
approach to disease management. Another longitudinal study will 
document for the first time the physical, psychosocial, and emotional 
outcomes of fibromyalgia in young adults over a prolonged (5 year) 
timeframe. A comprehensive set of measures, including pain, will be 
used to determine the outcome trajectories of the cohort compared to 
healthy controls. In the Multidisciplinary Approach to the Study of 
Chronic Pelvic Pain (MAPP) study, an ``inception cohort'' of people 
with new onset of interstitial cystitis/chronic prostatitis is being 
followed longitudinally to see who centralizes their pain and 
subsequently develops FM. NIH-supported research is also examining risk 
factors for developing several overlapping chronic pain conditions, 
including fibromyalgia.
    In addition to fibromyalgia, NIH supports longitudinal studies on 
chronic pain disorders including lower back pain, pelvic pain, and 
temporomandibular joint disorders (TMJD). For instance, the Spine 
Patient Outcomes Research Trial (SPORT) is the first comprehensive 
study to look at the effectiveness of different treatments for lower 
back pain. SPORT also has shown that surgery is superior to non-
operative treatments for the most common causes of severe lower back 
pain. Another longitudinal study has identified predictive markers of 
patients at risk of transitioning to chronic lower back pain by 
tracking brain changes. The Patient-Reported Outcomes Measurement 
Information System (PROMIS) www.nihpromis.org is creating 
psychometrically robust patient-reported banks of questions to measure 
pain in clinical trials for various chronic diseases.
    Studies on chronic pelvic pain syndromes include a comprehensive 
project with case-control and longitudinal studies to evaluate the role 
of infectious agents as causative factors and investigate biological 
and behavioral risk factors for developing chronic pelvic pain. A 
longitudinal population-based study will assess genetic and hormonal 
factors to determine prevalence, incidence, persistence, and remission 
of vulvodynia among a population of healthy women and those with new or 
repeat onset of the disorder.
    The Orofacial Pain: Prospective Evaluation and Risk Assessment 
(OPPERA) is a longitudinal study of 3,200 initially disease-free 
subjects who are being followed for at least 5 years to see how many 
develop first-onset TMJD. The study is examining biological, 
psychological, and behavioral risk factors that may predispose 
individuals to develop TMJD and preliminary results suggest that TMJD 
may be associated with genetic variability and changes in how the 
nervous system perceives pain.

    Question 6. The IOM report points out that developing more 
effective pain relievers and adapting the regulatory process to enable 
more efficient evaluation of potentially effective therapies remains a 
challenge. My understanding is that there are promising therapies 
currently under review at the FDA. What is the status of new treatments 
for pain under review at the FDA?
    Answer 6. The Food and Drug Administration (FDA or the Agency) 
continues to review the science and data related to pain products with 
public workshops and advisory committees. In late May, FDA will hold a 
public workshop to discuss the available data on the efficacy of 
analgesics in the treatment of chronic non-cancer pain (CNCP). In 
addition, we are planning to hold a public FDA Advisory Committee to 
provide a forum to discuss the data on the use of hydrocodone 
combination medications in the treatment of chronic pain, as well as 
the data on misuse and abuse of these products and the potential impact 
of their rescheduling. As for the status of particular drug products, 
confidentiality laws prohibit FDA from disclosing information about the 
pre-approval process, unless the manufacturer has already made that 
information public.

    Question 7. The IOM Report discusses early childhood trauma as a 
strong indicator of development of chronic pain in adults in later 
life. How might this be researched to find psychological interventions 
as a preventative measure to developing chronic pain and curative 
measure to treat pain?
    Answer 7. While the association between early childhood trauma and 
chronic pain conditions has not been studied extensively, there are a 
number of studies being supported by NIH institutes and Centers focused 
on understanding the links between trauma and the development of 
chronic pain that may aid in the development of ways to treat and 
prevent pain, including psychological interventions.
    NIH-funded research compared prospective data from the Longitudinal 
Studies of Child Abuse and Neglect (5 prospective studies of child 
maltreatment) with retrospective information from adults with 
gastrointestinal symptoms and found that psychological, physical, or 
sexual abuse was significantly associated with abdominal pain and other 
symptoms. This approach of combining information from existing data 
bases with retrospective data will be useful in defining the 
association of early trauma with other chronic pain disorders and 
determining effective psychological and other intervention strategies. 
Ongoing studies funded by the National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK) will collect retrospective data, 
genotype data, and early trauma information on adults with interstitial 
cystitis (bladder) pain and irritable bowel syndrome to determine their 
influence as risk factors in developing adult pain and other disease 
symptoms. The findings will help to determine how risk factors relate 
to treatment response and ultimately help to tailor therapies.
    The National Institute of Mental Health (NIMH) supports research to 
understand the links between trauma exposure and the development of 
mental disorders such as depression, anxiety, and post-traumatic stress 
disorder (PTSD), as well as the development of co-occurring conditions, 
such as chronic pain. For example, NIMH is currently supporting 
research on post-trauma changes in the hypothalamic-pituitary-adrenal 
(HPA) axis--a brain-body circuit that plays a critical role in the 
body's response to stress. Emerging evidence suggests that prolonged 
malfunction of the HPA axis in response to stress can cause potentially 
harmful inflammation, which is associated with symptoms of chronic pain 
and other complications. Furthermore, each of these conditions has been 
reported as occurring more often in individuals with PTSD. 
Understanding the links between anxiety, inflammation, and chronic pain 
holds the potential for identifying new and more effective treatments 
and preventive interventions for children and adults following trauma 
exposure.
    NIMH also supports research on understanding and treating the co-
occurrence of depression and pain. For example, NIMH-funded researchers 
are studying the brain circuits of individuals with major depressive 
disorder to determine how the emotional processing of pain may bias the 
perception and modulation of the pain response. NIMH is supporting 
another project to develop a psychotherapeutic intervention tailored 
specifically for primary care patients with major depressive disorder 
and co-occurring chronic lower back pain. The study will establish the 
feasibility and acceptability of a research design for an eventual 
randomized clinical trial.
    The Eunice Kennedy Shriver National Institute of Child Health and 
Human Development (NICHD) supports research on the effects of pain and 
stress very early in life. A research group funded in part by the NICHD 
recently released results from several studies that examined longer-
term effects of pain and stress in infants born very premature (defined 
as babies born 32 weeks of gestation or less). One study showed that 
positive child-mother interactions helped lower stress in the extremely 
preterm children, whose initial stress hormone levels were much higher 
than other children's levels. Another study showed that children born 
very preterm developed cognitive problems including deficits in memory 
and problem-solving skills. Understanding how early stressors affect 
these infants' brain development may help to find ways to make preterm 
infants' first weeks of life easier and to promote healthy development. 
Information from these studies is available online at http://
nichd.nih.gov/news/resources/spotlight/012612-effects-preterm-
birth.cfm.

    [Whereupon, at 4:22 p.m., the hearing was adjourned.]

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