[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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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
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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.
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\1\ http://iom.edu/Reports/2011/Relieving-Pain-in-America-A-
Blueprint-for-Transforming-Prevention-Care-Education-Research.aspx.
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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.
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\2\ http://painconsortium.nih.gov/.
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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.
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\3\ http://projectreporter.nih.gov/reporter.cfm.
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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).
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\4\ http://www.mappnetwork.org/.
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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.
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\5\ http://neuroscienceblueprint.nih.gov/.
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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.
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\6\ http://www.altarum.org/project-highlights-pain-education.
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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.
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\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.
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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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57. http://act.allianceforheadacheadvocacy.org/5624/urge-
congressional-hearings-on-impact-migraine-headache-disorders/. Accessed
2/13/12.
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.
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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.]