[Senate Hearing 106-742]
[From the U.S. Government Publishing Office]
S. Hrg. 106-742
ALTERNATIVE MEDICINES
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SIXTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/congress/
senate
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COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington FRANK R. LAUTENBERG, New Jersey
MITCH McCONNELL, Kentucky TOM HARKIN, Iowa
CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HARRY REID, Nevada
JUDD GREGG, New Hampshire HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
JON KYL, Arizona
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, Minority Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
SLADE GORTON, Washington ERNEST F. HOLLINGS, South Carolina
JUDD GREGG, New Hampshire DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas HERB KOHL, Wisconsin
TED STEVENS, Alaska PATTY MURRAY, Washington
JON KYL, Arizona DIANNE FEINSTEIN, California
ROBERT C. BYRD, West Virginia
(Ex officio)
Professional Staff
Bettilou Taylor
Mary Dietrich
Jim Sourwine
Ellen Murray (Minority)
Administrative Support
Kevin Johnson
Carole Geagley (Minority)
C O N T E N T S
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Page
Opening statement of Senator Arlen Specter....................... 1
Opening statement of Senator Tom Harkin.......................... 2
Opening statement of Senator Jon Kyl............................. 4
Statement of Stephen Straus, M.D., Director, National Center for
Complementary and Alternative Medicine......................... 5
Prepared statement........................................... 6
Prepared statement of Peter G. Kaufmann.......................... 9
Statement of Andrew Weil, M.D., Director, Program in Integrative
Medicine....................................................... 16
Prepared statement........................................... 18
Statement of Mary Jo Kreitzer, Ph.D., Director, Spirituality and
Healing, Katherine J. Kensford Center for Nursing Leadership... 24
Prepared statement........................................... 25
Statement of Herbert Benson, M.D., President, Mind/Body Medical
Institute, Associate Professor of Medicine, Harvard Medical
School......................................................... 33
Prepared statement........................................... 40
Summary statement of James Cassidy............................... 34
Prepared statement........................................... 35
Summary statement of Kristen Magnacca............................ 36
Prepared statement........................................... 37
Statement of Dean Ornish, M.D., Founder and President, Preventive
Medicine Research Institute.................................... 50
Prepared statement........................................... 53
Statement of Walter Czapliewicz.................................. 57
Prepared statement........................................... 59
ALTERNATIVE MEDICINES
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TUESDAY, MARCH 28, 2000
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:29 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Kyl, Harkin, and Murray.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Good morning, ladies and gentlemen. The
hour of 9:30 having arrived, we will begin this hearing of the
Appropriations Subcommittee for Labor, Health, Human Services
and Education. And today we have a very interesting hearing on
what is called alternative or complementary or supplementary
medicine.
There have been over the decades and centuries a great many
treatments outside of the established medical profession, which
seem to have worked. And they are now being incorporated in an
expanding body of medical care in the United States.
Acupuncture is an ancient Chinese treatment once considered
alternative but proven to be a method for treating pain the
past couple of decades. Reserpine was the first drug treatment
for high blood pressure, derived from a traditional Indian
herbal medicine.
Digitalis, an English drug, an important plant-based
product used for the treatment of heart disease from the flower
foxglove. It was discovered in England, it is said, by the
witch of Shropshire. Quinine, used by Native Americans to treat
fevers of malaria from the bark of the cinchona tree.
In the past several years, there has been a marked trend
toward the trend of alternative or supplementary medicine. I
was frankly surprised to see the statistic that 42 percent of
United States health care consumers spent $27 billion on
alternative supplementary medical treatments. I am not so
surprised about the $27 billion. Those figures are hard to
comprehend. But for 42 percent of Americans to be into this
form of treatment is very, very extraordinary, I think.
My colleague, Senator Tom Harkin, who should be joining us
shortly, has been a leader in the field of stimulating
alternative, supplementary or complementary medicine. And with
my backing in 1992, we persuaded the Office of the National
Institutes of Health to establish the Office of Alternative
Medicine.
In 1998, the Office of Alternative Medicine was elevated to
the National Center for Complementary and Alternative Medicine.
We have been working to provide increased funding in these
areas. And, in 1999, NIH awarded five mind/body center grants
at $2 million each for a total of $10 million.
One of our distinguished witnesses today is Dr. Herbert
Benson, who has pioneered in the field of mind/body. After
reading one of his books many years ago, I called him and
sought his advice.
Many people are yet to recognize the connection of mind/
body, but I can attest personally to severe back problems I got
after I lost an election in 1973. I have not had back problems
since, and I have not lost an election since. I do not know if
David Hume would say there is a causal connection, or if it
would stand a demur or get to a jury on causality. But that is
a field of tremendous importance, and we are trying to
stimulate research and study in the field.
Dr. Andrew Weil was in Philadelphia recently. Senator Jon
Kyl is about to introduce Dr. Weil. Senator Kyl came into the
anteroom and proudly told me about Dr. Weil being an Arizonan.
I asked Senator Kyl if he knew Dr. Weil was born in
Philadelphia. I forget Senator Kyl's answer, but we had 1,200
people come out to listen to Dr. Weil the other night, and it
was quite an outpouring.
We have Dr. Dean Ornish, the founder and director of
Preventive Medicine Research Institute. Friends of mine, the
Rubens, proclaimed Dr. Ornish's genius many years ago. So we
have really an extraordinary group to supplement Dr. Stephen
Straus, the director of the National Center for Complementary
and Alternative Medicine.
There is a great deal more which could be said about what
we are trying to do to stimulate the National Institutes of
Health in running tests. We have anecdotal results, but it is
important that these medicines, that these alternative
procedures be thoroughly tested in the scientific context. And
candidly, it has been a little hard to bring NIH along on that
field, but a very powerful advocate on the subject is Senator
Tom Harkin, my distinguished ranking member.
When the Democrats control the Senate, Tom chairs the
subcommittee. I like it better when the Republicans control the
Senate, so I can get to chair the subcommittee.
But we work as partners. There is no Democratic or
Republican way to deal with health care or education or worker
safety. And I learned a long time ago that if you want to get
something done in Washington, you have to cross party lines.
So before yielding to Senator Kyl, I will call on our
distinguished ranking member, Senator Tom Harkin.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. Thank you very much, Mr. Chairman. Quite
frankly, there are times when I am glad you are chairing. I
mean, there are times when I wish I was chairing. So it kind of
balances out once in a while. When you get into contentious
issues sometimes, it is nice when you have to take the lead on
some of those things.
Senator Specter. You mean the blame.
Senator Harkin. Right. Exactly.
But I really want to thank you for holding this hearing.
And we have a very distinguished panel of witnesses today. Mr.
Chairman, both you and I share a very deep interest in the
field of complementary and alternative medicine. We have
discussed it personally many times.
My basic belief is that we need to take advantage of every
possible method of keeping people healthy. And we cannot
approach health care with biases that limit potential
breakthroughs, either conventional or alternative.
I believe our health care system will be strengthened, if
we bring together the best of both. And as American consumers
demand freedom to choose the health care they use, they need
and expect reliable information on these treatments.
That is why I pushed so hard. And you and I, Mr. Chairman,
have made some important progress in the last decade. In 1991--
that is when I was chairing--we worked to establish the Office
of Alternative Medicine at NIH to make sure that quality
research----
Senator Specter. Before you arrived, Senator Harkin, I gave
you credit for the leadership of getting it started.
Senator Harkin. Well, then we changed, and you have
continued it. So I appreciate that very much.
But we got it established. And in 1998, again with you as
chairing, we worked together to make that office into a center
for complimentary and alternative medicine. The center can now
make its own decisions regarding which studies to fund,
allowing those with the greatest expertise and alternative
therapy research to decide the direction of research in their
own field.
I have met with the center's director, Dr. Stephen Straus,
who is here today. I am very optimistic about some of the
things the center is doing.
We took another step forward last year, when we included
funding, Mr. Chairman, to create the White House Commission on
Complementary and Alternative Medicine Policy. That commission,
which was just announced a couple of weeks ago, is to give us
recommendations on how to catch public policy up to the
consumer interest in and use of these therapies. This
commission will look at whether training of health
professionals in complementary and alternative method therapies
is adequate, should Federal higher education loans be available
to those studying in CAM fields, is credentialing and licensing
of CAM providers adequate, should health plans cover more CAM
therapies.
These are just a few of the critical questions the
commission will explore. Unfortunately, the commissioners have
yet to be appointed, but I am hoping that that will happen very
shortly.
So, Mr. Chairman, we have a number of leaders and
innovators in health care with us today. Each of them has done
great work, I think, both in complementary and alternative
medicine, but also in bringing the two fields of traditional
medicine and complementary and alternative medicine together.
Sometimes I wonder which is traditional. Sometimes the
complementary and alternative medicine fields have been more
traditional, if you go back a couple thousand years, than the
so-called traditional methodologies that we have been using for
the last, say, century.
So I look forward to their statements. I look forward to
their advice, as we continue our joint efforts in this area.
Thank you.
Senator Specter. Thank you very much, Senator Harkin.
I would like now to turn to Senator Kyl.
The floor is yours, Senator Kyl.
OPENING STATEMENT OF SENATOR JON KYL
Senator Kyl. Thank you very much, Mr. Chairman. I
appreciate the opportunity to introduce Dr. Weil, even though
he will not be the first person to testify here. You and I
serve on another committee, and I have to chair that committee
at a meeting beginning at 10:00 o'clock.
Incidently, I note that there are many people born in
Philadelphia who now live in Arizona. And we are happy for
that.
Senator Specter. Iowa, too.
Senator Kyl. But I know on the whole you would rather be in
Philadelphia.
In any event, I appreciate the chance to say a few words
about Dr. Weil here. He is the director of the Program in
Integrative Medicine at the University of Arizona College of
Medicine. He received his A.B. degree in biology from Harvard
and an M.D. from Harvard Medical School. And the University of
Arizona, which is my alma mater, Dr. Weil teaches alternative
medicine, mind/body interactions and medical botany.
As you know, integrative medicine refers to an approach
that incorporates conventional and alternative therapies into
the practice of medicine. The University of Arizona's program
of integrative medicine is a national leader in the development
of the practice of integrative medicine.
In 1997, under Dr. Weil's leadership, the University began
the Nation's first post-graduate training program in
integrative medicine and pioneered a continuing integrative
medical education project. In a few months, the program will
initiate the Nation's first integrative medicine distance
learning courses.
These courses will use technology to bring integrative
medicine education to physicians and nurse practitioners all
across the world.
Dr. Weil is also the founder of the Foundation for
Integrative Medicine, a national organization dedicated to
gaining widespread acceptance of the value of the integrative
approach to health care. He is author of eight books, including
two international bestsellers. His eighth book, Eating Well for
Optimum Health, is currently number one on the New York Times'
Bestseller List.
He was named by Time Magazine as one of the Nation's most
influential people in 1997, incidently the year that the
Program for Integrative Medicine was founded. Dr. Weil has
noted evolutions in the practice of medicine and patients'
increasing dissatisfaction with what is seen as a cold and
impersonal medical system sometimes.
So I am very pleased to welcome Dr. Weil to testify before
this subcommittee on this timely subject, and compliment you,
Mr. Chairman, for conducting this hearing.
Senator Specter. Thank you very much, Senator Kyl.
STATEMENT OF STEPHEN STRAUS, M.D., DIRECTOR, NATIONAL
CENTER FOR COMPLEMENTARY AND ALTERNATIVE
MEDICINE
ACCOMPANIED BY PETER KAUFMANN, PH.D., LEADER OF THE BEHAVIORAL MEDICINE
RESEARCH GROUP, NATIONAL HEART, LUNG AND BLOOD INSTITUTE,
NATIONAL INSTITUTES OF HEALTH
Senator Specter. Our first witness is Dr. Stephen Straus,
first director for the National Center for Complementary and
Alternative Medicine. An intramural scientist at NIH for 23
years, he is most widely known for his pioneering research on
chronic fatigue syndrome.
He has had extensive clinical research experience with Lyme
disease, chronic hepatitis B, HIV/AIDS. Medical degree from
Columbia, bachelor's degree from MIT.
He is accompanied by Dr. Peter Kaufmann, acting director of
the Office of Behavioral and Social Sciences Research, a leader
in the field of behavioral medicine research group of the
National Heart, Lung and Blood Institute. Ph.D. from the
University of Chicago, a master's and bachelors from Loyola.
Thank you for joining us, Dr. Straus and Dr. Kaufmann. As
is our custom, there is a 5-minute green light which will go
on. And if that is observed, it will leave us the maximum
amount of time for dialogues, questions and answers.
So, Dr. Straus, the floor is yours.
Dr. Straus. Thank you, Mr. Chairman. Good morning, Senator
Harkin, members of the committee. It is a pleasure to appear
before you in my capacity as NCCAM's first director, to
summarize very briefly our current work with particular
emphasis on the areas of mind/body medicine training and
integrative medicine.
As you so eloquently stated in your introductory remarks,
the American people have a growing interest in complementary
and alternative medicine. And they are relying on these many
modalities with the hope and the expectation that they will
sustain and improve their health. Our task at NCCAM is to
provide the scientific support to help guide the American
public; information that the public so greatly deserves.
I will illustrate for you very briefly with two panels to
your right both the challenges and the opportunities afforded
by complementary and alternative medicine. This first panel
summarizes an important study published a few months ago using
St. John's Wort for treatment of depression. The improvement in
depression shown in green afforded by St. John's Wort was
comparable to that afforded by a classic tricyclic
antidepressant, Imipramine, and both superior to placebo.
But while active, the next panel shows that botanicals like
St. John's Wort have hidden and unforeseen consequences. Here
my colleagues at the NIH have studied the effects of St. John's
Wort on the body's handling of one of our most important HIV
drugs, in this instance, Indinavir. In the green are the normal
blood levels of Indinavir that are achieved. But when St.
John's Wort is added to the regimen, it speeds the clearance of
that drug from the blood, to levels that are sub-optimal for
AIDS therapy.
So while there is increased use of complementary and
alternative medical tools, if they are to be active, they must
have actions on the body. And we must study both the efficacy
and the safety of these various modalities. Complementary and
alternative medicine encompasses a very broad portfolio of
opportunities that we are attempting to address with important
guidance of our many stakeholders and our advisors.
Among the many disciplines is the area of mind/body
medicine, part of which overlaps with the field of
complementary and alternative medicine in the instance in which
the modalities are not yet proven or yet well integrated into
medical care.
Among our portfolio of studies in mind/body medicine are
eight current projects that we are funding, including projects
at the Maharishi University in Iowa and at Dr. Weil's home
institution at the University of Arizona in Tucson, which I had
the pleasure of visiting in February.
Our approach to studies of mind/body medicine will be like
the broader field of complementary and alternative medicine,
applying the most rigorous scientific tools to provide the
American public definitive answers. I believe that the results
of our research efforts will over time lead to the successful
integration of safe and effective practices into mainstream
medicine. Medicine, after all, is a constantly evolving field.
And our research portfolio will provide definitive information.
Our important, newly announced initiative to fund studies
of both factors that promote and prevent effective integration
of practices will help as well. And recall, as you mentioned,
that CAM is a new scientific discipline. And we have the
important charge to build a cadre of competent investigators to
lead this science forward.
We have announced within the past 4 months our ability to
fund the full panoply of pre-doctoral and post-doctoral
training and curriculum development initiatives for CAM
investigators.
PREPARED STATEMENTS
We are funding intramural and extramural centers in CAM,
including Dr. Weil's Center. And ultimately, their efforts
coupled with those of our own other centers will be translated
for the public through effective communication. An informed
public will adopt the best therapies and reject those that are
unproven or unsafe.
Thank you, Mr. Chairman. I would be happy to answer any
questions you have.
[The statements follows:]
Prepared Statement of Stephen E. Straus
Mr. Chairman and Members of the Committee: I appreciate the
opportunity to appear before you today to address the subcommittee's
interests in complementary and alternative medicine (CAM), training of
CAM researchers, NCCAM's plans for facilitating integration of CAM
modalities with conventional health care, and our support of mind-body
research.
Accompanying me is Dr. Peter Kaufmann, Acting Director of the NIH
Office of Behavioral and Social Science Research (OBSSR). He will be
pleased to respond to any questions you may have regarding the overall
NIH portfolio of research on behavioral and mind-body research
supported across the NIH Institutes and Centers.
My presence here today, and moreover, NCCAM's very existence,
reflects the growing public interest in complementary and alternative
medicine (or CAM, as we call it), and the belief that various CAM
therapies may play a role in improved public health. Approximately 42
percent of U.S. healthcare consumers spent $27 billion on CAM therapies
in 1997. In recognition of this growing consumer trend, Congress in
1998 elevated the NIH Office of Alternative Medicine (OAM), expanded
its mandate, creating the NCCAM, and affording it administrative
authority to design and manage its own research portfolio. The Congress
has continued to reflect the growing interest in CAM by further
increasing funding for the Center in fiscal year 2000 to $68.4 million.
We are indeed appreciative of this support.
As the NCCAM's first permanent director, I am excited by the
challenge put before me. As CAM use by the American people has steadily
increased, many have asked whether reports of success with these
treatments are valid. A number of practices, once considered
unorthodox, have proven safe and effective and assimilated seamlessly
into current medical practice. Acupuncture is routinely applied to
manage chronic pain and nausea associated with chemotherapy. Some of
our most important drugs--digitalis, vincristine, and taxol--are of
botanical origin. Practices such as meditation and support groups are
now accepted as important allies in our fight against disease and
disability.
In the absence of definitive evidence of effectiveness, however,
alternative practices may impart untoward consequences. It is critical
that untested but widely used CAM treatments be rigorously evaluated
for safety and efficacy. Likewise, promising new approaches worthy of
more intensive study must be identified. I am energized by this
challenge to help provide the American public the guidance it seeks.
NCCAM's strategy for taking on this challenge is different from
that used by other NIH Institutes and Centers (ICs). While the research
of other ICs is usually driven by basic scientific discoveries, NCCAM
has chosen to focus most heavily on definitive clinical trials of
widely utilized modalities that, from evidence-based reviews, appear to
be the most promising. Compelling and rigorous data and not just
anecdotes must be provided to the public, and we must educate
conventional medical practitioners about the panoply of effective CAM
practices, so they can be integrated into patient care.
Accordingly, the NCCAM is developing a strategic plan to ensure
that these responsibilities are consistent with our continued growth,
development and research directions. Five strategic areas have been
identified as: Investing in research; training CAM investigators;
expanding outreach; facilitating integration; and practicing
responsible stewardship.
ST. JOHN'S WORT--OPPORTUNITIES AND CHALLENGES
Already, NCCAM has developed a diverse research portfolio in
partnership with the other NIH Institutes and Centers. Among these are
some of the largest, and certainly the most definitive Phase III
clinical trials ever undertaken for a range of CAM therapies. Allow me
to highlight one of these studies to illustrate both the promises and
the challenges presented by CAM therapies.
Extracts of St. John's wort, a widely distributed flowering plant,
have become quite popular as a treatment for depression. In fact, by
some accounts, it is the number one selling nutritional supplement.
Because of this intense interest, NCCAM, the National Institute of
Mental Health, and the NIH Office of Dietary Supplements are
collaborating on a study of the safety and effectiveness of St. John's
wort for the treatment of depression. While that study is now nearing
completion, those of other groups have underscored our interest in
learning more about this botanical.
A recent report in The British Medical Journal, for example, showed
that St. John's wort is more effective than placebo in treatment of
depression, and perhaps as effective as an older generation anti-
depressant drug Imipramine. NCCAM's study, which is considerably larger
than the European trial, compares St. John's wort with placebo and with
Zoloft, currently one of the most commonly used anti-depressants.
However, the therapeutic promise of St. John's wort and of botanical
products like it, is accompanied by risks that the public has largely
ignored. An NIH study published February 12th in the Lancet found that
St. John's wort, when taken together with the important HIV protease-
inhibiting drug, Indinavir, increased the rate at which Indinavir was
eliminated from the bloodstream, to the extent that blood levels fell
below the desired level for effective AIDS treatment. Interestingly,
other studies have suggested that St. John's wort has a similar effect
on cyclosporin A, a drug used to prevent the rejection of transplanted
organs. The use of St. John's wort may also increase an individual's
sensitivity to exposure to the sun.
As these studies demonstrate, the dearth of credible scientific
evidence on CAM practices provides unprecedented opportunity for
determining the safety and efficacy of CAM modalities. Included in our
already very broad research agenda are studies of mind-body medicine.
NCCAM'S MIND-BODY RESEARCH
Mind-body medicine encompasses a spectrum of behavioral,
biomedical, social, and spiritual components of our makeup that
interact on a continuing basis in health and disease. This broad
discipline overlaps partially with the NCCAM mission. The CAM community
does not consider it a priority for NCCAM to study mind-body approaches
that have a well-documented theoretical and evidence base such as
patient education, biofeedback, and cognitive-behavioral approaches
that are all addressed extensively by the other ICs working in concert
with OBSSR. On the other hand, the types of projects NCCAM supported
are rigorous studies of mind-body modalities involving: (1) still
undocumented CAM techniques; (2) modalities for which there is little
evidence in the conventional medical research community; and (3)
unorthodox uses for otherwise conventionally-accepted mind-body
techniques, such as hypnosis.
In keeping with this approach, the NCCAM portfolio already contains
studies on:
--efficacy of relaxation/guided imagery and chamomile tea for
treating bowel disorders in children;
--self-hypnosis, acupuncture, and osteopathic manipulation for
children with cerebral palsy;
--palliative benefits of hatha yoga on cognitive and behavioral
changes associated with aging and neurological disorders in
multiple sclerosis patients and in the healthy elderly;
--reducing hypertension and other cardiovascular disease (CVD) risk
factors through meditation;
--a combination of relaxation training, hypnosis, and guided imagery
employed during radiologic procedures to reduce the need for
intravenous drugs and improve patient safety;
--improvement in well-being and immune function as a result of self-
transcendence in members of a breast cancer support group;
--biofeedback and yoga to treat asthma; and
--Tai Chi, compared to western exercise, in preventing frailty in the
elderly.
One key aspect of mind-body research involves studies of the
``placebo effect.'' Later this year, NCCAM, in collaboration with NIDDK
and other ICs, will convene a trans-NIH conference on this subject.
Goals of the conference include providing a scholarly assessment of the
state of the field; identifying areas for which there is scant
research, but considerable opportunity; and recommending a research
agenda to move the field forward, in particular projects to be pursued
by interested ICs through individual or joint initiatives with NCCAM.
Elucidating the nature of the placebo effect will help us better
harness the healing power of the mind.
INTEGRATIVE MEDICINE, RESEARCH TRAINING, AND COMMUNICATIONS
Medicine is an ever evolving discipline. It integrates or rejects
approaches based on scientific evidence. The results of rigorous
research in CAM, including studies of mind-body medicine, will enhance
the successful integration of safe and effective modalities into
mainstream medical practice. NCCAM initiated a series of specific
activities to facilitate this. On December 13, 1999, NCCAM solicited
applications to foster incorporation of CAM information into the
curricula of medical and allied health schools and continuing medical
education programs. Also, the NCCAM must educate eager medical students
about CAM so that they may knowledgeably guide their patients toward
safe and effective CAM applications. In addition, we must work to
overcome the reluctance of conventional physicians to consider
validated CAM therapies and to assimilate proven ones into their
practice. To this end, on December 13, 1999, the Center established a
Clinical Research Curriculum Award (CRCA) to attract talented
individuals to CAM research and to provide them with the critical
skills that are needed. NCCAM also plans to solicit applications for
applied research focusing on identifying barriers to the use of CAM
modalities by conventional physicians; developing strategies to
incorporate validated CAM interventions into standard medical practice;
and evaluating the effects of this incorporation.
Integrative medicine is also a key goal of NCCAM's planned
Intramural Research Program and a component of NCCAM's Specialized
Research Centers. Each of the Specialized Research Centers focuses on
one of several areas, including pediatrics, addiction, cardiovascular
disease (CVD), minority aging and CVD, aging, neurological disorders,
craniofacial health, arthritis, and chiropractic medicine. In addition
to these nine Centers, NCCAM and the NIH Office of Dietary Supplements
jointly established two Dietary Supplements Research Centers to advance
the science of botanicals, including issues of their composition,
safety, and biological action. Another request for Center grant
applications focusing on asthma and cancer was released for fiscal year
2000. This, coupled with our anticipated solicitation of one more
botanical center in fiscal year 2000, will likely bring our total
number of NCCAM-supported centers to as many as 15. Research training
is conducted by these Centers, in part to advance our goals in
integrative medicine, but also to assist us in building a cadre of
skilled CAM investigators. Some of NCCAM's Centers spend as much as ten
percent of their budget on training. In this regard, in two weeks I
will be addressing the Deans of all U.S. medical schools on the subject
of NCCAM's research and research training agenda.
Specific statutory authority enables the NCCAM to reach out
directly to the public and practitioners to provide them with critical
and valid information regarding the safety and effectiveness of CAM
therapies. This provides another vehicle for facilitating integration.
A focal point for information about NCCAM programs and research
findings is the NCCAM Information Clearinghouse, which develops and
disseminates fact sheets, information packages, and publications to
enhance public understanding about CAM research supported by the NIH.
Its quarterly newsletter, Complementary & Alternative Medicine at the
NIH is distributed to 6,000 subscribers. The NCCAM's award winning
World Wide Web site, first established two years ago, reflects the
NCCAM's growth in size and stature. Averaging more than 460,000 hits
per month, the site includes links to NCCAM program areas, news and
events, research grants, funding opportunities, and resources.
Assembled by NCCAM from the National Library of Medicine's (NLM)
MEDLINE database, the CAM Citation Index (CCI) affords the public
access to approximately 175,000 bibliographic citations searchable by
CAM system, disease, or method. Also, in February 1999, NCCAM joined
the federally supported Combined Health Information Database (CHID),
which includes a variety of health information materials not available
in other government databases, including nearly 1,000 CAM citations not
available elsewhere.
NCCAM sponsors national meetings, consensus conferences, and
workshops. As outreach to research and medical professionals, CAM
practitioners, and the health care consuming public, NCCAM has
initiated a series of town meetings. The first of this series was held
on March 15 in Boston, in conjunction with the Center for Alternative
Medicine Research and Education of Beth Israel Deaconess Medical
Center. Over 500 attendees heard presentations on the importance of CAM
research. Many substantive issues were raised in the public forum
portion of the program. The opportunity for dialog at the local level
is important for us, not only for disseminating key research findings,
but also for the public to provide perspective and help us shape our
overall research strategy.
CONCLUSION
In closing, I would like to share with the Subcommittee my vision
of where I expect complementary and alternative medicine to be in the
years to come. I am confident that NCCAM's leadership will stimulate
both the conventional and CAM communities to conduct compelling
scientific research. Several therapeutic and preventative modalities
currently deemed elements of CAM will prove effective. Based on
rigorous evidence, these interventions will be integrated into
conventional medical education and practice, and the term
``complementary and alternative medicine'' will be superseded by the
concept of ``integrative medicine.'' The field of integrative medicine
will be seen as providing novel insights and tools for human health,
and not as a source of tension that insinuates itself between and among
practitioners of the healing arts and their patients. Modalities found
to be unsafe or ineffective will be rejected readily by a well-informed
public.
I would be pleased to answer your questions on NCCAM's activities
and plans.
______
Prepared Statement of Peter G. Kaufmann
Mr. Chairman, I am pleased to submit the following statement on the
role of the Office of Behavioral and Social Sciences Research (OBSSR)
in fostering behavioral and social sciences research at the National
Institutes of Health (NIH) as background information for the
Subcommittee.
OBSSR GUIDING PHILOSOPHY
In 1993 the U.S. Congress created the Office of Behavioral and
Social Sciences Research (OBSSR) in the Office of the Director, NIH, in
recognition of the key role that behavioral and social factors often
play in illness and health. The guiding philosophy of OBSSR is that
scientific advances in the understanding, treatment, and prevention of
disease will be accelerated by greater attention to behavioral and
social factors and their interaction with biomedical variables.
Currently, NIH supports approximately $1.6 billion in behavioral and
social sciences research. (See attached funding table.)
MISSION AND RESPONSIBILITIES
The mission of the OBSSR is to stimulate behavioral and social
sciences research throughout NIH and to incorporate these areas of
research more fully into others of the NIH health research enterprise.
The major responsibilities of the office and its director are:
--to provide leadership and direction in the development, refinement,
and implementation of a trans-NIH plan to increase the scope of
and support for behavioral and social sciences research;
--to inform and advise the director of NIH and other key officials of
trends and developments having significant bearing on the
missions of the NIH, Department of Health and Human Services,
and other Federal agencies;
--to serve as the principal NIH spokesperson regarding research on
the importance of behavioral, social, and lifestyle factors in
the initiation, treatment, and prevention of disease; and to
advise and consult on these topics with NIH scientists and
others within and outside the Federal Government;
--to develop a standard definition of ``behavioral and social
sciences research,'' assess the current levels of NIH support
for this research, and develop an overall strategy for the
expansion and incorporation of these disciplines across NIH
institutes and centers;
--to promote cross-cutting, interdisciplinary research, and to
incorporate a biobehavioral perspective into research on the
promotion of good health, and the prevention, treatment, and
cure of diseases;
--to develop initiatives designed to stimulate research in the
behavioral and social sciences;
--to ensure that findings from behavioral and social sciences
research are disseminated to the public;
--to sponsor seminars, symposia, workshops, and conferences at the
NIH and at national and international scientific meetings on
state-of-the-art behavioral and social sciences research.
MIND/BODY RESEARCH
One example of the kind of behavioral and social sciences research
that OBSSR promotes across all of the institutes and centers is mind/
body research. Funding for mind/body research is significant and broad
at NIH. Fourteen institutes and centers estimate that they will fund a
total of approximately $125.3 million in mind/body research in fiscal
year 2001. Approximately 50 percent of OBSSR's budget is specifically
designated for mind/body research. A breakdown of that funding by
institute and center follows.
FUNDING FOR MIND/BODY RESEARCH AT NIH
[In millions of dollars]
----------------------------------------------------------------------------------------------------------------
Fiscal year--
Participating -----------------------------------------------
1999 actual 2000 estimate 2001 estimate
----------------------------------------------------------------------------------------------------------------
NCI............................................................. 10.9 12.0 13.1
NHLBI........................................................... 19.5 21.7 22.9
NIDCR........................................................... 2.3 2.6 2.8
NINDS........................................................... 1.6 1.8 1.8
NICHD........................................................... 13.2 15.1 15.9
NIEHS........................................................... 1.1 1.1 1.2
NIA............................................................. 4.4 5.1 5.3
NIAMS........................................................... 3.2 3.6 3.8
NIMH............................................................ 5.7 6.5 6.9
NIAAA........................................................... 32.5 33.9 33.2
NINR............................................................ 1.0 1.1 1.6
NCRR............................................................ 4.2 5.3 5.6
NCCAM........................................................... 0.5 0.6 0.7
OD.............................................................. 10.0 10.1 10.6
-----------------------------------------------
NIH \1\................................................... 110.0 120.6 125.3
----------------------------------------------------------------------------------------------------------------
\1\ May not add due to rounding.
EXAMPLES OF MIND/BODY RESEARCH
Mind/body research encompasses behavioral, social and biomedical
research on the interrelationships among cognition, emotion, biological
functioning, and physical health. In recent years, we have made
significant advances in the field of mind/body research. Provided below
are examples of studies that exemplify the influence of psychological,
behavioral, and social processes on all levels of biological
functioning and health.
--For more than 10 years, the National Institute of Mental Health has
funded research that examines the psychological and
physiological effects of a group psychotherapy intervention for
women with metastatic breast cancer. There is evidence that
this treatment enhances coping and social support, reduces mood
disturbance and pain, and may extend survival time. This work
is now expanding to assess the physiological basis of
psychosocial effects on cancer survival. It will evaluate
whether lower cortisol levels and higher immune activity,
especially natural killer cell cytotoxicity, will result from
group psychotherapy and will predict longer survival.
--Research funded by the National Institute of Dental and
Craniofacial Research is examining how stress affects the
ability to heal. Care givers for those stricken with Alzheimer
disease and students taking academic examinations are groups
who clearly experience stress. Studies show that skin wounds in
Alzheimer's care givers heal at a rate 25 percent slower than
those who are not under chronic stress. Students taking final
exams took 40 percent longer to heal than when they were not
under the pressure of exams.
--An ongoing investigation at the National Institute of Mental Health
is studying the link between social environment, psychological
states (positive and negative affect, personal control, self-
esteem) and vulnerability to upper respiratory infections. This
research previously demonstrated that stress increases
susceptibility to upper respiratory infection while the support
of larger social networks decrease susceptibility. The current
study will attempt to identify causal pathways (psychological,
health practice and biological) linking stress, social network
size, and disease susceptibility.
--An ongoing study at the National Cancer Institute is seeking to
assess the effect of a stress reduction intervention program on
the quality of life and immunologic function of women diagnosed
with breast cancer. The study will use a well established and
cost effective stress reduction technique known as Mindfulness-
based Stress Reduction (MBSR) as the intervention method. MBSR
has been previously shown to be effective in improving the
ability to cope with stress and to promote psychological and
physical well being. The effect of MBSR on women with breast
cancer has never been studied. The investigators will test
whether MBSR will produce greater improvement in psychological,
social, and somatic functioning in the group receiving this
intervention, compared to the group that does not. The
investigators will also test whether MBSR will produce enhanced
immune functioning.
--A study that examines the relationship between stress, immune
function, and HIV disease progression in African American women
in rural South Florida is supported by the National Institute
of Mental Health. Previous work has demonstrated that stress is
predictive of early HIV progression and that this mind-body
interaction may be mediated by the impact of stress on key
parameters of cellular immunity. Current research employs
repeated measures to (1) establish a definite relationship
between stress and HIV progression; (2) begin to determine
whether important changes in host defense (killer cell levels
and their functional activity) correlate with stress associated
changes in clinical status; (3) determine if alterations in
glucocorticoid function correlate with changes in immune/
disease status. The results of these investigations will
enhance the possibility of understanding causal mechanisms in
stress and immune based illness at physiological cellular and
molecular levels.
--The National Heart, Lung and Blood Institute is examining the
pathways through which mental stress influences heart function
in health and illness. The primary objectives are to evaluate
the relative importance of psychological, neurological, and
cardiovascular factors in precipitating heart attacks. Coronary
heart disease patients as well as normal individuals are being
studied through mental stress testing, mood and affect,
personality variables, biochemical variables, and autonomic
nervous system function. This study is one of the most
comprehensive studies of mind-body interactions in
cardiovascular health, and spawned a collaborative study of
mental stress as a foreboding factor for cardiac events.
--The largest randomized clinical trial ever undertaken in the field
of mind-body medicine examines whether treating depression and
enhancing social support facilitates recovery from heart
attack. This seven-year study is funded by the National Heart,
Lung, and Blood Institute and has enrolled nearly 2,500 heart
patients from nine centers nationwide.
--A project examining the mechanisms by which hypertension impairs
intellectual function is supported by the National Heart, Lung,
and Blood Institute. Positron Emission Tomography (PET)
functional brain imaging permits scientists to test the
hypothesis that hypertension impairs cerebral blood flow
response. With the advent of ultrasound measurements,
investigators can also test a second hypothesis that
atherosclerosis of the carotid arteries influences intellectual
function.
CONGRESSIONAL INTEREST IN MIND/BODY RESEARCH
In fiscal year 1999 OBSSR received $10 million from Congress to
establish five mind/body research centers. An RFA to fund five centers
was issued in January 1999. OBSSR received 18 applications in response
to the RFA. Following initial peer and secondary council reviews, NIH
awarded five Specialized Centers Grants (P50) at approximately $2
million (total costs) each in September 1999 to the University of
Michigan, University of Pittsburgh Medical Center/Carnegie Mellon,
University of Miami, University of Wisconsin and Ohio State University.
NCI, NHLBI, NICHD, NIMH, and, NIDCR are administering the awards. The
Centers support both basic research and clinical applications focusing
on the influence of beliefs, attitudes and values on physical health;
the determinants or antecedents of health-related beliefs, attitudes,
and values; and stress management approaches to disease prevention and
treatment. It will take about two years before the first results from
the research supported through these Centers will be available.
The Center Directors and leaders of their research projects will be
meeting with NIH staff on May 1-2, 2000 in the first of their annual
meetings. The goal of this meeting is to familiarize each other with
their research goals and projects and to explore avenues of
coordination and cooperation.
Actual and projected funding for the Mind/Body Centers is as
follows:
----------------------------------------------------------------------------------------------------------------
Fiscal year--
Institute -------------------------------------------------------------------------------
1999 actual 2000 estimate 2001 estimate 2002 estimate 2003 estimate
----------------------------------------------------------------------------------------------------------------
NCI............................. $2,015,187 $2,046,384 $2,101,822 $2,158,930 $2,217,094
NHLBI........................... 2,000,002 2,143,982 2,202,180 2,089,273 2,050,320
NICHD........................... 1,999,100 2,038,179 2,059,895 1,968,479 1,825,140
NIDCR........................... 1,995,569 1,956,068 1,972,841 2,037,693 2,089,959
NIMH............................ 2,005,331 1,937,560 1,995,695 2,026,417 2,035,356
----------------------------------------------------------------------------------------------------------------
CONCLUSION
Mind/body research has a long and significant history of support at
14 institutes and centers at the NIH. OBSSR, an office whose mandate is
to encourage additional funding and coordinate trans-NIH initiatives in
mind/body medicine, is ideally located for this purpose in the Office
of the Director. With broad funding support across the institutes and
centers, and an office that serves as a central coordinating locus,
mind/body research at NIH is in an excellent position to continue to
flourish.
Thank you for your interest in the role of OBSSR in fostering mind/
body approaches to health and healing at NIH.
Senator Specter. Thank you very much, Dr. Straus. I noted
your comments about grants to Iowa and Arizona. Was it
inadvertent that Pennsylvania was not mentioned?
Dr. Straus. Actually, Pennsylvania receives the largest
funding of any State to this time, largely through the very
important clinical trial chaired out of the University of
Pittsburgh, a 5-year study of gingko biloba for prevention of
dementia in otherwise healthy aging Americans.
Senator Specter. Well, I am very glad to have those facts
on the record.
Dr. Straus, there has been considerable resistence to
complementary alternative integrated medicine by the
established medical profession. Do you see an easing of that
resistance? And what do you think can be done to give a push to
these alternative, complementary integrated approaches, which
have established themselves with some substantial degree of
reliability.
Dr. Straus. That is a very important question, Senator. The
very fact that I accepted the offer to chair this center is an
indication that the mainstream scientific community now
appreciates that there are terrific challenges and
opportunities. And with your help and that of the American
people, we now have the independence and the resources to apply
well-proven scientific principles to address complementary and
alternative medical practices, the same way we do all other new
ideas in medicine.
It is true that mainstream medicine has, to some extent,
resisted some of these new ideas, but medicine has always been
an evolving discipline. As you mentioned in your introductory
remarks, there are practices today that were once considered
quite alternative. Early in this century, radiation therapy was
considered extreme.
Senator Specter. Let me interrupt you, Doctor----
Dr. Straus. Yes, sir.
Senator Specter [continuing]. Perhaps to go on to another
question, because time is very limited. When you talk about the
funding, Senator Harkin and I have taken the lead with this
subcommittee in providing the funding.
Mind/body medicine was funded for the first time in 1998 at
$55 million. Now it is up to more than $125 million.
Complementary and alternative medicine was at a $42 million
level in 1997. Now it is almost four times that, a little over
$160 million.
And while you have to make the ultimate judgments, we are
very concerned about the need for training for medical and
other health care professionals in integrative medicine and
incorporating integrative medicine into medical school
curricula. In order to do that, there is going to have to be a
push from your agency. I know Dr. Weil has a keen interest and
has pointed out that issue.
Let me hear of your plans to move in that direction.
Dr. Straus. Certainly. First of all, we are currently
funding some of Dr. Weil's fellows.
Senator Specter. But how about the medical training and the
medical school curricula?
Dr. Straus. We announced a few months ago an intent to fund
what is known as a CAM education project grant. We expect $1.5
million of funding this first year. That will fund education of
young individuals to become CAM investigators at all the allied
health professional schools, including nursing, dental, medical
and osteopathic.
We also announced and intend to fund clinical research
curriculum awards. We expect a seven-fold increase this year
over last year in our funding for training and career
development of CAM investigators.
Senator Specter. Dr. Straus, the issue of mind/body has
been recognized to a substantial extent but is still looked
upon with some skepticism by many. And there is the aspect of
spiritual counseling, the prayer, so to speak, on the impact on
physical ailments.
We would be interested in your evaluation of the efficacy
of the mind/body approach and your suggestions as to what can
be done to better educate the public on the facts on this
issue.
Dr. Straus. Many parts of mind/body medicine have been very
well integrated already, cognitive behavioral therapies and
hypnosis and biofeedback and many exercise regimes. There is
only a small part of mind/body medicine that is not embraced
well by the other NIH institutes and centers. And we are
conducting studies of spirituality and yoga and the like.
I think the best approach is to continue to address the
opportunities of mind/body medicine across all the disciplines
and fields within the NIH.
Senator Specter. Would you amplify what you mean by
``addressing spirituality''?
Dr. Straus. We are funding studies of the use of
spirituality in healing processes. I addressed a workshop on
religion and spirituality----
Senator Specter. Religion and spirituality?
Dr. Straus. Yes--this past November. And we look forward to
receiving applications to conduct additional such studies.
Senator Specter. Do you see any conflict whatsoever or
potential conflict on spirituality and religion in a mind/body
funding by the Federal Government?
Dr. Straus. Not when we are asking scientific questions; it
is beneficial ultimately to the American public.
Senator Specter. So the issue as to approach is an
individual one, if the individual chooses something spiritual
or religious. And NIH is studying the physical impact in a
scientific context.
Dr. Straus. Yes.
Senator Specter. So you do not see a conflict.
Dr. Straus. I do not.
Senator Specter. Senator Harkin.
Senator Harkin. Thank you very much, Mr. Chairman.
Dr. Straus, again, I want to compliment you on your early
leadership of the National Center. I believe it is doing some
very important work and seemingly headed in the right
direction. I want to clear up a couple of things here.
First of all, we just heard the chairman state that out of
all of NIH, there is about $160 million this year for some kind
of complementary and alternative medicine. I want to point out
that the National Center gets about $67 million this year.
That is less than \1/2\ of 1 percent of the total funding
for the entire NIH. I want to make that clear. Less than \1/2\
of 1 percent of the total funding for NIH goes to the National
Center for Complementary and Alternative Medicine.
If you throw in what the National Cancer Institute and all
the others are doing here to get up to the $160 million, that
is still less than 1 percent of the total funding for NIH that
goes to complementary and alternative medicine. And yet over
half of the American people every year spend more money out of
pocket for complementary and alternative medicine care and
visits than they do in going to the so-called traditional
method group.
And so I have been hearing reports in the press and stuff
about how much money we are spending here. But in keeping with
where the American people are going and what they want and what
they are doing, it is woefully inadequate in terms of taking a
look at the promising therapies and to really take a look at
what is happening with a lot of the nutraceuticals that people
are taking today.
So I wanted to clear that up. It may sound like a lot of
money, but in the scheme of things, less than 1 percent of the
total funding for NIH goes for this. Now having said that, I
see all these different branches of NIH, all the different
institutes spending this money.
For example, the National Cancer Institute lists $38.4
million they are spending this year on complementary and
alternative medicine.
My question to you, Dr. Straus, is: Do you have a good
handle on what they are doing? And how closely are you
coordinating with the National Cancer Institute to find out
just what they are spending their money on?
Dr. Straus. Your comments are very cogent, Senator. Shortly
after assuming the position of director, I met with the
director of the National Cancer Institute to discuss this very
issue.
And he assured me of very broad support for his office for
complementary and alternative medicine, whose director, Dr.
Jeff White, and I meet at least on a monthly basis. We are
developing public information and website information together.
We are cosponsoring a major study of shark cartilage for
the treatment of lung cancer and many other initiatives. They
are conducting additional studies using green tea as well for
cancer prevention.
Senator Harkin. But when they do these studies, when NCI
does it, how do they peer review them? Do they do them through
your office, or do they peer review them in their own?
Dr. Straus. Applications to the NIH, as you know, go to the
Center for Scientific Review. And they are reviewed in the
normal study sections. In the instance of a shark cartilage
study, or shall I say the green tea study, it would go to a
cancer therapy study section. Our peer review group reviews
applications that we in NCCAM call for specifically.
Senator Harkin. Say that last again.
Dr. Straus. NCCAM's own peer review group reviews
applications that we have called for specifically.
Senator Harkin. I understand that. That is why we set that
up.
Dr. Straus. Yes, sir.
Senator Harkin. How confident are you that the peer review
process for all these other institutes spending what they say
they are spending--and I am not certain. I tell you, I want
everyone to know that I have some real questions about this,
about just what they are spending their money on and listing it
as complementary and alternative medicine. And I intend to
pursue this further with the directors of each of the
institutes.
I am just wondering about the peer review process. I have
been through this a long time.
Dr. Straus. Yes, sir.
Senator Harkin. And I know what that is like. And that is
why we insisted that for NCAM the peer review process involve
practitioners of complementary and alternative medicine.
I have said before, would you ever have a peer group to
peer review a request, a research request, for some kind of a
cancer chemotherapy, and that peer review did not contain one
oncologist? What if they were just all podiatrists? I mean,
that is what we are getting into.
And if in fact we are looking at complementary and
alternative medicine, some of those people ought to be on that
peer review committee.
Dr. Straus. If I may respond, my staff sees listings of
every application that comes to the NIH. I am confident that we
have an opportunity to fund them, even if other institutes do
not. And in addition, the review panels often request our
recommendations for practitioners who have expertise in those
particular areas to join the standing review panel. So that
does happen, Senator.
Senator Harkin. One last thing. The statute that we passed
that set up the center requires a full-time liaison from every
institute to your center. Has that been established?
Dr. Straus. Yes, sir. I chair a trans-agency committee on
complementary and alternative medicine. We are meeting again in
another several days. I have addressed them this past fall.
Senator Harkin. Good. That is very encouraging.
Dr. Straus. Thank you, sir.
Senator Specter. Thank you very much, Senator Harkin.
Thank you very much, Dr. Straus and Dr. Kaufman.
Dr. Kaufman is here to answer questions. And if there were
more time, we would have had some questions. But we do thank
you very much for coming. And as is customary, the agenda is so
full, but we will be talking to both of you later. Thank you.
Dr. Straus. Thank you. I look forward to it.
STATEMENT OF ANDREW WEIL, M.D., DIRECTOR, PROGRAM IN
INTEGRATIVE MEDICINE
Senator Specter. Let us turn now to our second panel, Dr.
Andrew Weil and Dr. Mary Jo Kreitzer.
As previously announced, Dr. Weil is the director of the
Program in Integrative Medicine at the University of Arizona
College of Medicine where he teaches alternative medicine,
mind/body interactions, and medical botany.
He is the founder of the Foundation for Integrative
Medicine and has written and lectured extensively on
alternative medicine, medicinal plants, and the redesign of
medical education. Medical degree from Harvard Medical School
and a bachelor's degree from Harvard University.
And in the interest of full disclosure, which is always a
good idea, Dr. Weil and Senator Kyl and I came through the back
room for the benefit of television. There is a documentary in
process on Dr. Weil. Maybe it is on Senator Kyl. I am not sure.
But that was why we entered in that manner. And there is no
demonstration of favoritism to any witness. There may be a
little favoritism to television, but not witnesses.
Dr. Weil, you are claimed by at least two States, Arizona
and Pennsylvania. And Pennsylvania has priority. Thank you for
joining us. And we look forward to your testimony.
Dr. Weil. Thank you, Senator Specter, Senator Harkin. Thank
you for inviting me here to testify.
I would also like to acknowledge your strong leadership in
this area of working to provide the American public with a
better form of medicine. And I would also like to say I am very
happy to appear with distinguished colleagues in this field
this morning.
The vast numbers of patients who are seeking care outside
of conventional medicine represent a crisis of confidence with
American medicine today. I travel around this country very
frequently and speak in many different venues and interact with
many different kinds of patients. I think I have a clear sense
of what people are looking for in their visits to doctors
today.
They want doctors who have time to explain to them in
language they can understand the nature of their problems, who
will not just promote drugs and surgery as the only way of
doing treatment, doctors who are at least minimally aware of
nutritional influences on health and can answer intelligently
questions about uses of dietary supplements, a source of great
confusion to the public today.
They want doctors who are sensitive to mind/body
interactions and are willing to look at patients as more than
just physical bodies. They want doctors who will not laugh at
them if they bring up questions about Chinese medicine or
homeopathy or other forms of treatment that are not taught in
American medical schools.
I think those are very reasonable requests. But the fact is
that that is not how we are training physicians today. So there
is a widening gulf between what patients expect from their
doctors and what they are getting. And in their frustration,
they are going elsewhere.
I think most of these people, if given their first choice,
would go to a medically trained person, to a medical doctor, a
doctor of osteopathic medicine, who was open minded and able to
guide them through the maze of conflicting treatment options
out there. That clearly would be people's first choice.
So it seems to me that the fundamental problem is medical
education. The way we are training doctors today does not meet
the needs of the public. Now there is an argument that you will
hear from some academicians that changes in medical education
must be guided by science and research, not by consumerism. But
I think in this case consumers are indicating severe failings
in medical education.
The fact that medial education in this country does not
include basic information about nutrition and how many kinds of
disease can be influenced by making dietary change is
inexcusable.
The fact that our country does not train physicians in the
use of botanicals or that teach them differences between whole
plant products and isolated chemicals from plants is
inexcusable and puts us, by the way, at a great disadvantage in
the world, where other countries like Japan and Germany are way
ahead of us in this area.
What we are trying to do at the Program in Integrative
Medicine is to develop new models of medical education. The
fellowship training that we do provides an excuse for
developing curriculum in these areas that are now missing from
conventional medical education that will be there when medical
schools open to this possibility.
And by the way, I think there is increasingly openness
within the schools. Some key schools, such as the University of
California, San Francisco, Stanford, Duke University, among
others, the University of Minnesota, have indicated willingness
to move in this direction. Jefferson Medical College, as you
know, has started a strong initiative in this area as well.
But these programs are fledgling programs. They are
struggling. They need support. And without Federal direction
and guidance, there is a real danger that they are going to
fail. With due respect to Dr. Straus, the National Center for
Complementary and Alternative Medicine provides no mechanisms
for funding of these efforts. We are not in the business of
training researchers. That is one aspect of what we do.
But the only money that NCAM says is available is for
training of researchers in complementary and alternative
medicine. That is not the issue here. The issue is where is the
money to support curriculum development, to develop new models
of training physicians that can meet the needs of consumers
today?
PREPARED STATEMENT
At the moment, we see no mechanisms for getting that kind
of support from the Federal Government. And if it is not going
to come from the National Center for Complementary and
Alternative Medicine, I would make a plea to this subcommittee
to think about ways of designing other structures through which
Federal funds can come to support an effort that is clearly
needed.
Thank you.
[The statement follows:]
Prepared Statement of Andrew Weil
Mr. Chairman, Senator Harkin, and members of the Subcommittee,
thank you for inviting me to testify this morning. For many, many
years, I have been personally and professionally engaged in the very
issue under consideration by the Subcommittee this morning. I am
encouraged by the level of interest Congress has shown in behavioral,
alternative, and mind-body medicine.
I would be remiss if I did not recognize the hard work Chairman
Specter and Senator Harkin put into the fiscal year 2000 Labor, Health
and Human Services, and Education bill. In strong and certain language,
the Subcommittee recognized the importance of training physicians in
integrative medicine. This language underscores our responsibility to
meet the needs of the rapidly growing number of consumers who are
demanding a more healing-oriented system of healthcare.
Recent data indicate that nearly 50 percent of all U.S. healthcare
consumers have sought alternative medicine in some capacity, creating
the expectation that physicians should be knowledgeably guiding their
patients through a course of treatment that is right for them. We can
do this by ensuring that physicians and other healthcare providers have
access to appropriate levels of education and training in the valuable
relationship between alternative and conventional medicine. This is the
spirit of integrative medicine--maximizing the body's innate potential
for self-healing by weaving alternative approaches into mainstream
medicine.
With consumers' growing interest in a more integrative approach to
healthcare and Congress' intent to fund integrative medicine education
and training programs, allow me to share the unique and specific work
we are doing at the University of Arizona to develop a model which best
responds to these expectations.
The University of Arizona Program in Integrative Medicine was
established in 1996 with seven objectives:
(1) Establish integrative medicine as a new direction within
academic medicine, not as a new specialty;
(2) Develop a new model of medical education and curricula for use
by other medical institutions;
(3) Train physicians, pharmacists, nurses and other healthcare
providers in the theory and practice of integrative medicine;
(4) Challenge physicians and other healthcare providers to commit
to their own health and healing;
(5) Develop integrative medicine clinics as models for clinical
education, patient care, and outcomes research;
(6) Research theories and methods of integrative medicine including
effectiveness of new models of medical education; and
(7) Produce leaders who will establish similar programs at other
academic institutions and set policy and direction for healthcare in
the 21st century.
The mission of the Program in Integrative Medicine is to foster the
redesign of medical education to incorporate the philosophy of
integrative medicine. The Program developed a core curriculum which is
adapted for its various educational components: the Fellowship in
Integrative Medicine, the Associate Fellowship in Integrative Medicine
(the ``distance learning'' model for clinicians), Continuing
Professional Education (CPE), pre-medical and medical education, and
education of healthcare professionals.
It is important to note that this curriculum does not represent a
linear process. Rather, curriculum components are interwoven to form an
educational program that provides students, physicians and other
healthcare professionals with a comprehensive education depicting the
philosophies, principles and practices that are central to integrative
medicine.
Philosophical Foundations.--The most fundamental distinction of
integrative medicine is to shift the orientation of medicine from
disease to healing. This requires students to closely examine their
attitudes, not only with respect to medicine but also the manner in
which they view the world. Courses include healing oriented medicine,
the philosophy of science, medicine and culture, the art of medicine
and research education.
Lifestyle Practices.--A basic principle of integrative medicine is
that the manner in which we live clearly affects our health and
disease. Lifestyle practices and prevention are central to this
approach. This component of the curriculum focuses on the basic aspects
of life and health that are addressed in the care of patients as well
as practitioners of integrative medicine. Courses include spirituality
and medicine, mind/body medicine, nutrition, and physical activity.
Therapeutic Systems and Modalities.--This component explores a
variety of modalities and therapeutic systems. The history, theories,
appropriate applications and scientific evidence are presented for each
system and modality. Physicians, healthcare professionals and students
learn the techniques for some of these therapeutic modalities. More
frequently, by presenting the theories and appropriate applications for
these systems and modalities, those persons participating in the
Program learn when and to whom they should refer their patients for the
best treatment strategy individualized for their care. Courses include
botanical medicine, manual medicine, Chinese medicine, homeopathy,
energy medicine, guided imagery and hypnotherapy.
The coursework described above, while often taught experientially,
is content-oriented. The following are more process-oriented, and are
not, therefore, broken down into specific courses.
Personal Development and Reflection.--Approaches involved in the
practice of integrative medicine require practitioners to commit to
their own process of self-exploration and personal development. The
current methods used to educate medical students often result in the
underdevelopment or degradation of these processes, and often translate
into sub-optimal interactions with patients. This component of the
curriculum is focused on methods for relaxation and self-examination of
the healthcare professional. Included are such practices as meditation,
personal reflection and group process.
Clinical Integration.--The process of integrating philosophically
different systems of medicine into one comprehensive treatment plan for
each patient is one of the most central features of the practice of
integrative medicine. The goal is to teach the art of integration, not
simply the strengths and weaknesses of alternative practices.
In the absence of physicians or other healthcare providers who are
educated and practiced in the art of integration, patients are torn
between the instructions they receive from their conventional
physicians, alternative care providers, health food clerks, the
Internet, and their families in making their own medical decisions.
Healthcare providers must be skilled in understanding when and how to
incorporate alternative approaches and to counsel patients against
useless or fraudulent practices. This component also focuses on the
integration of such philosophies and approaches into the practitioners'
own personal and professional life.
Furthering the Field/Implementation.--This curriculum component is
designed to help physicians and other practitioners put into practice
what they have learned. There is strong focus on physicians as leaders
functioning as agents of social change. Content areas include practical
skills such as public speaking, business planning and management
skills; social-political aspects of integrative medicine; medicine and
law; and related ethical issues. For clinicians in practice, the
emphasis is placed in putting this education into action within their
clinical settings.
This core curriculum serves as the blueprint from which specific
curricula are designed to meet the needs of the various educational
components of the Program in Integrative Medicine.
THE FELLOWSHIP IN INTEGRATIVE MEDICINE
The Fellowship is a two-year, intensive program, incorporating
didactic instruction, direct research and clinical experience, which is
available to MDs and DOs who have completed residencies in primary care
specialties. The objective of the Fellowship is to produce leaders in
integrative medicine: individuals who will go on to other universities
and healthcare institutions to establish similar programs and set
policy and direction for healthcare in the 21st century; in other
words, to ``train the trainers.''
A comprehensive, intensive course of study of the principles,
theories and practices of integrative medicine is available to a
relatively limited number of competitively selected, board-certified
physicians. Such physicians, at the end of the Fellowship Program, are
qualified to institute parallel programs in integrative medicine in
medical and health professions institutions throughout the United
States.
Of the first graduating class of Fellows in Integrative Medicine in
the United States, which graduated in June 1999, three have received
appointments to develop programs in integrative medicine at
Northwestern University-Evanston, Beth Israel Medical Center and East
Tennessee State University College of Medicine. The fourth graduate
remained with the University of Arizona Program in Integrative Medicine
to lead the CPE portion of the Program and, more recently, to serve as
a resource to other medical and health professions institutions that
are seeking to develop programs in integrative medicine.
In addition to the basic research education, Fellows regularly
attend journal groups, during which time they review and learn to
critically evaluate published studies in complementary and alternative
medicine. The didactic instruction Fellows receive early in the program
prepares them to develop and conduct direct research during the later
part of the initial year and the second year of the Fellowship. This
research is conducted under the guidance of their chosen research
mentor, who is conducting research in the Program.
ASSOCIATE FELLOWSHIP IN INTEGRATIVE MEDICINE
The Associate Fellowship is an Internet-based distance-learning
program to provide physicians throughout the country the opportunity to
learn integrative medicine. The Associate Fellowship is the newest
component of the Program, and will begin the education of Associate
Fellows in the fall of 2000. The Associate Fellowship will consist of
approximately 1,000 hours of study over a two-year period and will
include Internet-based study, real-world assignments and three one-week
sessions at the Program in Integrative Medicine at the University of
Arizona Health Sciences Center in Tucson.
Internet technology was selected as the primary instructional
medium in that it provides a ``real-time,'' interactive learning forum
that is highly appropriate for problem-based learning. Because
integrative medicine is a rapidly developing field, this format allows
faculty and participants to keep up to date easily by responding to new
information and discoveries.
During their three on-site training sessions in Tucson, Associate
Fellows will meet the faculty of the Program in Integrative Medicine,
learn mind-body skills such as meditation and guided imagery,
participate in case conferences and learn strategies for sustained
personal/professional development and leadership activities in their
respective home communities.
The first enrollment in August 2000 will be limited to 40
participants. As of March 2000, more than 80 applications had been
received for the first enrollment. Of the 40 who were selected, five
are international applicants, 11 are from rural areas, 32 serve a
combination of urban and rural environments, and 18 are from academic
institutions. The applicants are evenly divided between males and
females. Due to the demand and the large applicant pool, consideration
is being given to adding a second class of Associate Fellows soon after
the first begins. Subsequently, 50 participants will be enrolled at
each intake. The Associate Fellowship will have at least two intakes of
physicians by 2003.
Once the Associate Fellowship is established, efforts of the
faculty and staff of the Associate Fellowship Program will be focused
on adapting the core curriculum to the specific educational
requirements of other healthcare professionals, such as nurses,
physician assistants and pharmacists. With the knowledge gained
utilizing the distance learning format, physicians and other healthcare
professionals will be prepared to establish programs in integrative
medicine in their home institutions.
CONTINUING PROFESSIONAL EDUCATION IN INTEGRATIVE MEDICINE
The Department of Continuing Professional Education (CPE)
encompasses Continuing Medical Education (CME) for physicians,
Continuing Education (CE) for nurses and pharmacists and educational
programs for healthcare professionals. The purpose of the CPE Program
is to introduce healthcare professionals and academicians to the
philosophy, basic principles and clinical application of integrative
medicine.
Participants evaluate the CME and CE curricula at the time these
courses are conducted and courses are continuously modified to be
consistent with the needs of physicians and healthcare professionals,
while ensuring that the principles and practices of integrative
medicine are accurately represented.
The CPE program differs from the Associate Fellowship in that it
provides education to a wide range of healthcare professionals. To
date, more than 4,500 individuals including physicians, nurses,
pharmacists, social workers, massage therapists, psychotherapists,
students and others have enrolled in one or more of the courses offered
by the Program in Integrative Medicine's CPE program. A total of 2,489
individuals have received Continuing Education credits: 1,335
physicians; 798 nurses, nurse practitioners and physician assistants;
and 125 pharmacists.
The Program plans to expand the opportunities for the education and
training of nurses in integrative medicine. During the initial year of
this expansion, the Fellowship curriculum will be modified to meet the
specific needs of nurse practitioners and physician assistants.
Research requirements will be identical to that of the Fellowship
program for physicians. As is the case for physicians' Fellowship
program, nurse practitioners who complete the two year program will be
prepared to develop and implement curricula in integrative medicine
within nursing education throughout the country.
MEDICAL SCHOOL EDUCATION
The Program in Integrative Medicine currently participates in and/
or presents one required course and two elective courses at the
University of Arizona College of Medicine.
I teach an interdepartmental, required course that is part of the
basic science curriculum. The course gives students an understanding of
the psycho-social and emotional aspects of clinical medicine by
exploring the biological, environmental, social and psychological
factors that influence a person as a patient. Some of the topics
covered are the doctor-patient relationship, major health problems for
children and adults, substance abuse, issues in human sexuality, coping
with chronic illness, healthcare and the elderly, death and dying,
ethical issues in medicine and legal aspects of medical care. Four two-
hour lectures are dedicated to fundamentals in integrative medicine.
The Program also conducts two elective courses. The goals are to
enable the students and residents to become familiar with the range of
available alternatives to allopathic medicine, to be able to evaluate
these systems of treatment critically, and to learn whether any
elements of them may complement orthodox approaches.
One of the electives is a patient care course in which participants
spend half the time in the Integrative Medicine Clinic with a Fellow
and attending physician, observing patients and recommending
treatments. During the other half of the rotation, students and
residents are placed with alternative practitioners in southern Arizona
(naturopaths, homeopaths, body workers, etc.) to observe their
techniques. This approach provides the students with a broad exposure
to the integration of allopathic and alternative modalities in very
different settings.
The Program also is designing an elective for the fall semester of
2000. The course will allow students to explore the role of their own
lives in their patients' lives and in the healing relationship. Based
on the principles of integrative medicine, the course is the first of
its kind to be offered in the College of Medicine at the University of
Arizona.
UNDERGRADUATE EDUCATION
Currently, faculty and Fellows of the Program in Integrative
Medicine lead discussions at the undergraduate level to teach basic
principles of integrative medicine and discuss the implications for
their professions and their lives.
For example, the University of Arizona Department of Molecular and
Cellular Biology and the Program in Integrative Medicine are
collaborating on the design of a web-based, interactive learning
environment that will enable undergraduate students to use integrative
medicine as a vehicle for exploring the philosophy of science and
medicine. This module will play a pivotal role in the professional
development of students entering the health professions by introducing
them to the philosophy and practices of integrative medicine and
illustrating how these practices can be related to their careers. This
learning module will reach approximately 1,000 students per year in
University of Arizona's Introductory Biology course, and will be
disseminated to peer institutions nationwide.
CLINICAL PRACTICE OF INTEGRATIVE MEDICINE
The Clinical Practice of Integrative Medicine was designed to meet
the challenge of shifting the orientation from one of disease to one of
healing. The goal of this approach is to teach the art of integration,
not simply the strengths and weaknesses of alternative practices or new
protocols. The Integrative Medicine Clinic is a place to begin this
discourse.
The clinical practice component, like the research component, is
directly linked to the core curriculum. Emphasis is on establishing
rapport with patients; obtaining patient histories that include the
emotional, psychological, and spiritual aspects of patients' lives;
listening carefully; assessing patients' belief systems; and presenting
treatments in ways that increase the likelihood of successful outcomes.
During the initial one-hour visit, the Fellows interview and
examine their patients and address any problems that require immediate
intervention. They then present each patient in an interdisciplinary
patient conference. At this conference, I am joined by clinicians
representing various systems of medicine including Oriental medicine,
homeopathy, mind-body medicine, osteopathy, pharmacy, nursing,
nutrition, naturopathy, and spirituality. In this forum, Fellows
develop an understanding of the different systems of medicine and
recognize the appropriate applications for these systems to create an
optimal integrative treatment plan. These plans are individualized and
often include a combination of alternative and conventional treatments.
Interestingly, it has been the experience of the clinicians and
Fellows of the Program in Integrative Medicine that the number of
botanicals and supplements patients have self-prescribed prior to their
visit to the Clinic are often reduced in the treatment plan established
by the Fellow and contributing clinicians.
After the initial visit, the patient then returns to the
Integrative Medicine Clinic for a discussion of the treatment options
with the Fellow, and may also be scheduled for an evaluation in the
clinic by an alternative practitioner together with the Fellow. The
Fellow then has the opportunity to observe their patient undergoing
evaluation and then treatment through an entirely different system from
the one in which they are trained. This results in a much deeper
understanding of alternative systems and their application.
RESEARCH IN INTEGRATIVE MEDICINE
Research in Integrative Medicine is designed to enable students and
healthcare professionals to master critical thinking about research,
including how to assess existing research and evaluate its validity and
significance, how to formulate critical research questions, and how to
design experiments and methodologies that effectively address these
questions.
In addition to didactic coursework defined in the core curriculum,
direct research experience is a requirement of the Fellowship Program.
The direct research experience is currently focused on physicians in
the second year of the Fellowship Program. Fellows may choose either to
work on an existing project under the direction of the faculty member,
or to work with a faculty member to develop a research project that is
consistent with the goals and objectives of the Program's educational,
research and clinical components.
There are currently 10 Fellows in the Program in Integrative
Medicine, four of whom are in their second year. Of these four, one
Fellow has secured funding for an independent research project, two are
in the process of applying for funding to conduct independent research
and one is participating in active research projects in the Program in
Integrative Medicine. Four of the first-year Fellows are developing
research projects. Two others are supported by a $5,000,000 five-year
NIH grant to establish and support a Pediatric Center for Complementary
and Alternative Medicine (CAM) at the University of Arizona.
FORWARDING THE FIELD OF INTEGRATIVE MEDICINE
One of the Program in Integrative Medicine's highest priorities is
to forward this field and facilitate implementation of integrative
medicine into educational curricula nationally. The intent is to change
premedical and pre-health education, pre-doctoral and postdoctoral
medical education and nursing education, and to reach out to other
healthcare professions such as pharmacy. The Program has and will
continue to take a leadership role in identifying and working with
academic institutions interested in integrating the Program's
educational and clinical models into their systems.
As you recall, in the fiscal year 2000 Labor, Health and Human
Services, and Education Appropriations bill, this subcommittee urged
the National Center for Complementary and Alternative Medicine (NCCAM)
to give priority consideration toward funding integrative medicine
education and training. The language stated:
``The Committee urges NCCAM to give priority to the funding
of postgraduate training of physicians in integrative medicine.
In particular, the Committee encourages study of strategies for
integrating complementary and alternative medicine into the
traditional premedical, predoctoral, and postdoctoral medical
education curricula. The Committee encourages NCCAM to give
consideration to funding programs at academic institutions
which offer postgraduate fellowships for physicians in
integrative medicine, continuing education in integrative
medicine for other health professionals, and distance learning
models in complementary and alternative medicine for doctors
and other health professionals throughout the country.''
As I hope has been made clear, the Program in Integrative Medicine
has developed a model standard for integrative medicine education and
training. We believe that this model best meets the intent articulated
by the subcommittee last year. Yet, approximately six months after we
submitted a proposal in this regard, NCCAM has been reluctant to
consider it.
Mr. Chairman, we appreciate that the NIH institutes and centers are
largely research entities, and we recognize the critical need to fund
research into complementary and alternative medicine applications. But
if we are not able to provide relevant education and training for our
healthcare workforce, the result will be nothing more than giving
consumers the authority to practice medicine.
Consumers must rely on their physicians, nurses, pharmacists, and
other healthcare professionals to make informed decisions on the course
of treatment that is right for them. Considering the widespread
interest in this field, the frustrations of physicians who have not
been exposed to these modalities and the overwhelming demand of
physicians for training in integrative medicine, we have a
responsibility to provide more than just research into the efficacy of
CAM applications. That is only half of the equation.
Federal funding will enable the Program to refine this
comprehensive curricula in integrative medicine for premedical,
medical, and postdoctoral medical education. Further, it will provide
increased capacity for the Program to train national leaders in the
field, physicians and other healthcare professionals, research the
effectiveness of new models of medical and clinical education, and
facilitate the integration of standardized curricula at other academic
institutions.
The University of Arizona Program in Integrative Medicine therefore
requests that the fiscal year 2001 appropriation for NCCAM include $2
million specifically for an Education Program Grant to achieve this
clinical education and training objective. Such an appropriation would
clearly reaffirm the position taken by this Subcommittee a year ago,
when you asked NCCAM to make clinical education in integrative medicine
a priority.
Mr. Chairman, we are disappointed that our proposal to NCCAM has
not been considered more formally. Further, we are concerned that NCCAM
has refused to respond to Congress' request to prioritize integrative
medicine education and training. But we have a responsibility to our
nation's physicians and their patients, and are committed to pursuing
other avenues for funding which I would be happy to discuss with you
and your staff.
Thank you for giving me the opportunity to testify this morning. I
would be glad to answer your questions.
STATEMENT OF MARY JO KREITZER, PH.D., DIRECTOR,
SPIRITUALITY AND HEALING, KATHERINE J.
KENSFORD CENTER FOR NURSING LEADERSHIP
Senator Specter. Thank you very much, Dr. Weil.
We will come back for dialogue questions and answers after
we hear from Dr. Mary Jo Kreitzer, director of Spirituality and
Healing at the University of Minnesota. She received her Ph.D.
from Minnesota, master's from the University of Iowa, and
bachelor's from Augustana.
Thank you for joining us, Dr. Kreitzer. We look forward to
your testimony.
Dr. Kreitzer. Thank you, Chairman Specter and members of
the subcommittee. I am the director of the Center for
Spirituality and Healing at the University of Minnesota where I
lead a team of physicians, nurses, chaplains and faculty
representing many disciplines, including psychology, music,
kinesiology, food science and nutrition and social work.
And our charge at the university is to integrate
complementary care, spirituality and culturally based healing
practices into the work and life of the university.
Our mission grew out of a planning process that included
consumers, third-party payers, State legislators, biomedical
and complementary practitioners, as well as representatives of
health systems. A copy of our planning document will be
appended to my written testimony.
Our mission at the center is three-fold: the generation and
dissemination of research, the education of health
professionals, and the development and evaluation of care
models that offer integrative medicine. In many universities
across the country, as Dr. Weil has described, there are
attempts being made to develop programs to integrate
integrative care. But I have to tell you that teaching is often
limited to lectures offered within an optional or shadow
curriculum.
At the University of Minnesota, we have brought integrative
medicine out of the shadows. Our medical students, for example,
get exposed to integrative medicine literally during their
first week of medical school. Our goal is that they learn from
the very beginning that there are multiple perspectives and
world views, and bio-medicine represents but one of those
perspectives.
The transformation that many of us are talking about in
health care today goes well beyond substituting an herb for a
prescription or over-the-counter drug. It is clearly a mandate
for broader access to an array of healing traditions, care that
is attentive to the whole person, the body, mind and spirit, as
well as support for self care, personal responsibility. People
want to make choices about their health and healing.
And I think it is very critical that this be understood.
Because in the old model of health care, education of
physicians was sufficient. It was both necessary and
sufficient.
Physicians were the gatekeepers to care, and consumers the
passive recipients who did what they were told to do, at least
some of the time. We now know from Eisenberg studies and others
that more visits are made to complementary and alternative
practitioners than to primary care physicians.
My argument today is that education of physicians is still
necessary, but it is not sufficient, that the agenda for
education needs to address education of both the next
generation of health care providers, as well as the hundreds of
thousands of practicing health professionals. Thus, it needs to
incorporate undergraduate, graduate and post-graduate training.
Dr. Weil has articulated the need for physician education.
But I am here to tell you that there is also a compelling need
for education of nurses, along with professionals such as
pharmacists, dentists and public health practitioners.
Nurses represent the largest group of health professionals
in the world and are in direct contact with consumers. Thus,
they are in a very key position to both educate consumers, as
well as to coordinate and integrate care.
Much of what is often called integrative medicine has been
within the domain of nursing for centuries. And this is a time
when nursing is reclaiming, reaffirming and expanding its focus
on complementary therapies to better serve the public.
Education of health professionals can also no longer occur
in isolation from one another. The reality is that if we expect
people to function as a team, we need to do a better job of
educating them as a team, interdisciplinary education.
We have initiated at the University of Minnesota a graduate
minor in complementary therapies and healing practices that
grew out of a significant demand from students currently
enrolled in graduate programs, as well as professionals
throughout the State.
This spring, we will be requesting from the National
Institutes of Health funding to expand this program to include
certificate programs, as well as distance learning options.
The transformation of health care being called for today
clearly requires funding for both education, as well as
research. The need for research is very clear, and I think it
is well understood.
PREPARED STATEMENT
But if we want to see the findings from research integrated
into practice and changes made in how care is delivered, then
we also need to invest, and invest significantly, in education
of health professionals.
Thank you very much.
[The statement follows:]
Prepared Statement of Mary Jo Kreitzer
Mr. Chairman, and Members of the Subcommittee: I am the director of
the Center for Spirituality and Healing at the University of Minnesota
where I lead an interdisciplinary team that includes physicians,
nurses, chaplains and faculty from many disciplines, including
pharmacy, psychology, music, kinesiology, food science and nutrition,
and social work. Our charge is to integrate complementary care,
spirituality and culturally based healing practices into the work and
life of the University. Our mission grew out of a University-community
planning process that included consumers, third-party payers, State
legislators, biomedical and complementary practitioners, and
representatives of health systems. After a comprehensive review of
trends and issues, a clear mandate emerged--that the University should
become a national leader and model in integrative medicine. The
University-appointed task force produced a report entitled
``Transforming Health Care: Integrating Complementary, Cross-Cultural
and Spiritual Care'' that has been distributed across the country. It
is appended to my written testimony.
Our mission as a Center is threefold: the generation and
dissemination of research, the education of healthcare professionals,
and the development and evaluation of care models that truly integrate
complementary, biomedical and culturally based approaches to healing.
In many universities across the country, where attempts are being
made to develop programs in integrative care, teaching is limited to
elective courses or to lectures offered within an optional shadow
curriculum. It is our belief at the University of Minnesota that for
integrative medicine to be legitimized, it needs to come out of the
shadows. It needs to be integrated into education, research, and
patient care. For example, our medical school students are exposed to
integrative medicine during their very first week of medical school.
The goal is to ensure that, from the very start of their training, they
learn that there are multiple perspectives and worldviews of healing,
and that biomedicine represents but one. Before they begin medical
school, they are required to read Anne Fadiman's When the Spirit
Catches You, You Fall Down a highly regarded work that describes the
experiences of a Hmong child with epilepsy caught in a medical system
that does not understand her culture and that disregards culturally
based values. Competencies in integrative medicine are also being woven
into the 4-year, undergraduate primary-care curriculum within the
medical school.
I come to Washington today with the full support of the University
president, senior vice president for the Academic Health Center and the
deans of medicine, nursing and pharmacy to seek support for increased
funding of education as well as research in integrative medicine.
The transformation of healthcare called for today goes well beyond
substituting an herb for a prescription or over-the-counter drug. It is
a mandate
--for increased access to a broader array of healing traditions.
--for care that is attentive to the whole personbody, mind, and
spirit.
--for support for self-care, in other words, consumers assuming
increased personal responsibility for their health and
wellness.
It is critical that this be understood. In the old model of
healthcare, educating physicians was both necessary and sufficient.
Physicians were the gatekeepers to care and consumers the passive
recipients. We now know from the Eisenberg studies and others, that
more visits are made to complementary and alternative practitioners
than to primary care physicians. The education of physicians is still
necessary--but it is not sufficient.
The agenda for education in integrative medicine needs to address
the education of both the next generation of healthcare providers as
well as the hundreds of thousands of presently practicing healthcare
providers.
Looking first at the next generation of health care providers: The
need for physician education has been well articulated. I am here to
tell you that there is also a compelling need for funding the education
of nurses, as well as other health professionals, such as pharmacists,
dentists, nutritionists and public health practitioners. Nurses
represent the largest group of healthcare professionals in the
country--indeed the world. Survey after survey documents that nurses
are among the most trusted of healthcare professionals, are in direct
contact with consumers of healthcare, and are in a key position to both
educate consumers and to facilitate and coordinate care that integrates
biomedical and complementary approaches to healing. While much of what
is now being called integrative medicine includes approaches to care
and healing that have been within the domain of nursing for centuries,
there is a need for nursing curriculum to reclaim and to reaffirm this
heritage and to assure that nurses are well prepared to serve the
public.
Similarly, there is a significant need to integrate complementary
and alternative medicine (CAM) content into pharmacy education. In many
drug stores and supermarkets across the country, herbs and nutritional
supplements are being sold in the absence of pharmaceutical care
practitioners who are prepared to inquire about herbal use and to
engage patients in frank, empathetic, and knowledgeable discussions
about their use of all medications and supplements. Ignoring herbal
products does not discourage their use; it simply means that consumers
will self-medicate without seeing these products as part of an overall
medication regime. This makes medication management extremely
difficult.
The education of health professionals can no longer occur in
isolation from one another. The reality is that if we expect people to
function as a team, a community of healers, we need to do a better job
of interdisciplinary education at undergraduate, graduate and post-
graduate levels. At the University of Minnesota, we have initiated an
interdisciplinary graduate minor in complementary therapies and healing
practices. This program grew out of a significant demand for education
from both students enrolled in University graduate programs and
practicing health professionals. This Spring, we will be requesting
funding from the National Institutes of Health to expand this program
to include certificate programs and distance learning options. NIH
funding has also been requested for a clinical research fellowship
program to train CAM researchers. The program is being developed by
Richard Grimm, MD, Director of the Berman Center for Clinical Outcomes,
in collaboration with the University of Minnesota and Northwestern
Health Sciences University.
Second, while training the next generation of healthcare providers
is essential, I cannot emphasize enough the importance of also
educating presently practicing healthcare professionals. Post-graduate
continuing education courses offer an opportunity to teach highly
relevant, specialty-based content to large groups of practicing
healthcare professionals. Over the next two months at the University of
Minnesota, our faculty will be teaching at an annual family practice
review, a cardiac arrhythmia conference, a diabetes conference, an
annual primary care conference, and a continuing education program on
liver and pancreatic disease. We face a tidal wave of demand and can
accommodate but a fraction of the requests we receive for education.
The transformation of healthcare called for today requires funding
for both education and research. The need for research is well
understood. However, to move beyond the generation of research to the
dissemination of research and to changes in practice will require
investment in education. We need funding to develop undergraduate,
graduate, and post-graduate educational programs, as well as funding to
train faculty who teach in academic training programs across the
country.
Senator Specter. Thank you very much, Dr. Kreitzer.
Senator Harkin.
Senator Harkin. Thank you very much. I just want to pick up
one thing Dr. Kreitzer just said. I am informed that there is a
national drugstore chain--I might as well say it, CVS--that has
now put out a document that publishes drug interactions with
nutraceuticals like St. John's Wort now so that people can look
that up now.
So they have now started including other things other than
just prescription drugs. So I think that is a step. You
mentioned about educating pharmacists. I was reading your
statement here. So as I understand it, that is one drug chain
that has taken the lead.
Dr. Weil, I want to thank you personally. I have read a
number of your books, obviously. But you published a CD
sometime ago on healing. And to anyone who has not heard it, I
am not shilling for Dr. Weil or anything like that, I want you
to know, but I have listened to it. And I must tell you, it is
just an amazing thing how it can put you in the deepest kind of
relaxation mode, especially after a stressful day or a
stressful week.
My wife also has a fairly stressful job. She is in the
private sector. She was watching me put my headphones on and
listen to this one time and got curious about it. And so she
was kind of questioning it. So I had her try it. It was just
amazing, absolutely amazing. If you have a stressful week and
you want to get the weekend off right, that is what I do.
So I want to thank you for it, because it has just done a
lot for me personally.
I also want to say one other thing, Dr. Kreitzer. The
University of Iowa Medical School has opened a clinic. I do not
know if you are familiar with it. But when a patient comes in,
that patient is thoroughly looked at and given options as to
just what type of procedure and process the patient wants to go
to.
And instead of gearing that patient first to the
traditional prescription drug, invasive type of medicine, they
are asked if they would like to try and go through
complementary and alternative-type practices first. It is an
interesting approach. And this is at the University of Iowa
Medical School.
So these things I see happening around the country. And I
think a lot of it has happened since the Office of Alternative
Medicine started in 1991. More and more medical schools are
moving in that direction. So I am very intrigued by what you
are doing north of us in Minnesota.
I just would ask both of you, and I want to ask Dr. Ornish
the same question, what direction do we go in now? We are going
to be--I think we are going to get more money for the center.
You have heard me talk about the different things that are
happening at NIH. What is the next step? What should we be
thinking about here?
Dr. Weil. Senator, again, I cannot say too strongly that I
would like you to be thinking about how we can change medical
education. I see this as fundamental to everything.
For example, there is tremendous economic incentive at the
moment for clinics facing bankruptcy or HMOs in very
competitive markets to offer complementary holistic services in
response to this consumer demand. But where are the
practitioners going to come from to direct these programs, if
our medical schools are not training people in this way?
If we want to see more and better research in mind/body
medicine or in botanical medicine, it is not going to happen
until we graduate people from an educational system that makes
them see the importance of mind/body interactions or the
importance of botanicals and differences from isolated
chemicals.
So I see that as really the root problem. That is the
fundamental thing that has to change.
Senator Harkin. Dr. Kreitzer.
Dr. Kreitzer. Senator Harkin, there are two areas that I
think funding is critical. One is to fund some programs,
educational programs, that can become national models, that can
be demonstration projects that can be replicated in other
institutions. As Dr. Weil mentioned, there are many places
around the country that are trying to do this, but attempts are
fledgling, the very early stages.
The other area where I think we need funding is to really
evaluate what is going to work in terms of integrative care,
models of care delivery. I am familiar with the University of
Iowa, having graduated there with my master's degree in
nursing.
And I have kept in contact with my colleagues there. We are
establishing a similar clinic at the University of Minnesota.
But I think we do not know yet what are going to be the most
successful factors in those clinics to target success.
Senator Harkin. The one thing we want to hear from you--I
am going to obviously ask Dean Ornish this, also--and that is,
what do we do in terms of nutrition? It seems to me that
starting with kids in high school, grade school, with the
school lunch program, school breakfast program, I do not know
that we have really done enough in this country to integrate
nutrition with medicine and to start early on to get kids to
understand what health care is about in terms of what they eat.
If you have a thought----
Dr. Weil. Senator, I think that is an understatement. The
total instruction that I got in nutrition in 4 years at Harvard
Medical School and a year of internship was 20 minutes, which
were grudgingly allowed to a dietician in one hospital I worked
at in Boston to tell us about special diets we could order for
patients. That has not changed significantly since I have been
out of medical school.
There are now 20 percent of schools that say they teach
nutrition. But when I look at what they teach, it is mostly
biochemistry. It is not the kind of information that enables
doctors to answers questions like, ``Should I eat butter or
should I eat margarine,'' or ``Is olive oil safe or is it
not,'' or ``Is it okay to take Beta-Carotene in isolated
form?'' Doctors do not know the answers to those questions
unless they make an effort to go out and learn them.
And by the way, one of the immediately obviously
consequences of the lack of sophistication about the medical
profession in this area is the utterly abysmal food that is
served in hospitals in this country, which should be a national
disgrace. And that includes the cafeterias in leading academic
medical centers, where doctors, nurses, medical students and
house officers eat. I think we have a long way to go here.
And we do not need more research. This is not an area in
which we need to train researchers. We need to change the
medical curriculum. We need to develop a practical, workable
curriculum in nutritional medicine that can be made
foundational. To regard this as alternative or complementary
would be foolish.
Dr. Kreitzer. Senator Harkin, we are beginning to offer
courses like Andrew Weil has described at the University of
Minnesota. Being a land grant institution, we also have the
advantage of having a college of agriculture on our campus, as
well as an academic health center.
And we are working very hard to establish close bridges to
connect the whole issue of landscape sustainability with human
health sustainability, another important area for
investigation.
Senator Specter. Thank you, Senator Harkin.
Before turning to Senator Murray, let me recognize Mr. Leo
Verneti, vice president of the Inner Harmony Wellness Center,
Clock Summit, PA, who is here traveling with Dr. Weil.
Now, Senator Murray.
Senator Murray. Well, thank you very much, Mr. Chairman.
Thank you for having this hearing. I think that this is an
issue that we really do need to focus on.
And certainly consumers are looking more and more at
alternative care, because they want to take control of their
own lives and make choices for themselves that work well for
them. And they are looking to a medical profession that, as you
have correctly stated, has not been trained to give them the
information they need.
As a result, they look for information in wrong places. So
I think it does behoove us to do the right thing, to provide
people with good information.
Dr. Weil, you were talking about medical education and what
doctors receive. It seems to me that the mentality has been in
our medical schools to treat diseases rather than preventive
medicine. And alternative medicine often focuses on prevention.
Is that whole philosophical issue what we really need to
address?
Dr. Weil. Sure. I think that--this is, I think, why it is a
bit wrong to emphasize complementary and alternative medicine,
because those terms suggest a focus on modalities. It is giving
doctors other tools to put in their black bags. That is not
what we should be focusing on.
What we need is a shift in perspective in the way that
doctors are trained toward an emphasis on healing and on
prevention, toward looking at new scientific models in which
some of these unexplainable therapies might be explainable,
towards a reemphasis of the doctor-patient relationship, toward
a new way of interpreting placebo responses, that rather than
seeing these as nuisances, they are really central to the
practice of the medicine.
They are healing responses. And if you can get the maximal
placebo response with a minimal intervention, that is the best
kind of medicine that you can do.
So I think we have a chance now, because of economic
factors, to really make a shift in perspective, which would be
enormously beneficial to the enterprise of medicine and
certainly to the public. And it would be a shame if we just get
focused narrowly on studying particular modalities out there.
Senator Murray. And it also goes directly to health care
insurance and how medical needs are funded. If you have a
disease, you are taken care of. If you go in and try to find
out what to do because your mother had rheumatoid arthritis,
what can I do now to make sure that I do not suffer those kinds
of things.
Dr. Weil. Exactly.
Senator Murray. It is not covered.
Dr. Weil. Exactly. I also think it would be a tragedy if
integrative medicine becomes medicine of the affluent because
insurers do not reimburse for it. So I think there is an urgent
need to look at that. This should be medicine that is available
to everybody.
Senator Murray. All right. I had one other question, and it
is a concern I have in general medicine that women are often
excluded from trials. And certain conditions and diseases that
affect women in particular are left out. How do we make sure
that as we go down this road, women's conditions and diseases
are not excluded?
Dr. Weil. I could not agree with you more. One interesting
historical observation: In 1810 Samuel Hahnemann, the inventor
of homeopathy wrote a textbook of medical principles of how to
study drugs. One of his principles was that drugs should be
tested equally on men and women in case there are differences
in gender.
I mean, that is a basic common sense principle that we have
ignored.
Senator Murray. Right. Dr. Kreitzer, do you have any
additional comments?
Dr. Kreitzer. Senator Murray, I only had one additional
comment, and that is that there is the opportunity in teaching
preventative medicine to also begin teaching health
professional students and medical students about self-care
practices.
And that, too, has been a long neglected area in the
education of health professionals. And I think until we begin
teaching people how to integrate this into their own life, it
will be hard for that to be translated to care of patients and
families.
Dr. Weil. May I? I think that is an excellent point. I feel
that doctors and other health professionals should be role
models. They should be models of health, because the best way
to teach is by example.
I think one of the black marks against the way that we
train health professionals currently is that it almost
guarantees that people will come out of that system with
unhealthy lifestyles.
Senator Murray. And Senator Harkin, I would agree with you
that we need to do a better job of teaching our kids about
nutrition. But we have to teach their parents, too, which many
parents are severely lacking in any kind of knowledge on that.
Thank you, Mr. Chairman.
Senator Specter. Thank you very much, Senator Murray.
Dr. Weil, your work has certainly popularized integrative
medicine, which I know is the term you prefer. We would be
interested to hear from you your own personal experience as to
how the response has grown. As I commented earlier, you were in
Philadelphia a couple of weeks ago, and you drew a crowd of
some 1,200 people to hear you speak with a substantial
admission price. And you have been at this for some time. Could
you tell us what the crowds were like when you started, what
they were like when you finished your second book and your
fifth book and your eighth book?
Dr. Weil. Well, they were not very big back in the 1970s,
when I started writing about this. And I think in the eighties
what I saw was that there was a growing response from
consumers, but essentially no response from academic medicine.
And what I have seen, especially in the past 2 years, and I
think especially in the past year, is increasing numbers of
people in academic medicine who come and are interested, and I
am invited to talk in venues about changes in medical
education.
Dr. Kreitzer and I are involved in an initiative that I
think is most interesting, a consortium of deans of medical
schools, who have indicated interest in this direction, to at
least open the dialogue about how we could begin to bring this
into medical curricula.
Senator Specter. When you talk about consumers, let me
interject this additional question. As I said at the outset, I
was really surprised to find that 42 percent of Americans who
get health care are looking to integrated alternative and
complementary medicine at $27 billion a year.
Now, when the consumers start to pay attention, then the
Congress pays even more attention, because consumers vote. And
there is a certain lag between what the consumers are doing,
what the Congress recognizes, and even a greater lag, perhaps,
as to what the established medical profession is willing to
undertake.
I am impressed with what you have to say about the need for
more education in the field. What concretely would you like to
see done to stimulate medical education in integrative
medicine?
Dr. Weil. I would like to see funding made available to
programs like we have at our two universities, which are
beginning the process of developing curriculum and developing
new models for training for physicians.
Senator Specter. Well, you already have the programs. How
about funding for schools that do not have the programs?
Dr. Weil. I am all for that. And what we would like to do
is develop models that can be replicated around the country.
Senator Specter. Dr. Kreitzer, you comment that you have
had this educational approach for some time. Have you had it
long enough for your doctors to have graduated, who have a feel
for complementary alternative integrative medicine to see if
they have taken the gospel from the classroom to the
practitioner's office?
Dr. Kreitzer. No, Senator Specter. We are quite early in
our process. Our medical students this fall will be the first
medical students for whom we have developed a 4-year curriculum
to integrate integrative medicine into medical school.
And I think while both Dr. Weil's program and my program
are established programs, the funding needs are very, very
critical. I think both programs receive very minimal support
from our respective institutions internally. And so we really
rely very much on grants, philanthropy, other sources of
support.
Senator Specter. Dr. Weil, I am not sure that it is your
most profound statement today among many, but your comment
about hospital food is certainly 100 percent consensus getter.
And your comment about food in the cafeterias at places where
the operators ought to know better. Now the big question for
you is: What is the cafeteria like at your place?
Dr. Weil. We have--of all the radical things that we have
been able to accomplish out there, bringing energy healers in
to work with our physicians, beginning to teach elements of
quantum and chaos theory to physicians, we have not made an
inch of progress in getting the food improved in the university
cafeteria. And----
Senator Specter. How do you expect to change America, if
you cannot change your own cafeteria?
Dr. Weil. I think that comes from my other area of work,
that is, raising the awareness of consumers to the point that
they get angry enough to bring pressure on institutions and the
big food service companies to make some changes here.
Senator Specter. Give TV a sound bite, Dr. Weil, 17 seconds
or less. What is your prescription for Americans on diet?
Dr. Weil. To eat less refined and processed food of all
kinds, more whole and natural foods. I think that is the best
thing that we could do. The growth of fast food in this country
and throughout the world is a disaster for our health.
Senator Specter. Is it practical to eat five fruits every
day?
Dr. Weil. It is absolutely practical to eat five fruits
every day.
Senator Specter. How many do you eat? Let us get personal.
Dr. Weil. Well, it varies. When I am on a book tour, that
is not fair.
But I had a big plate of melon this morning.
Senator Specter. My red light is on.
Senator Harkin.
Senator Harkin. I do not have any follow-ups. I appreciate
all that you are doing out there. And I think we are making
some great progress.
American people--you see, I think people by and large, if
they just sort of listen to their own bodies and think about
what is happening to them, and if they have information, can
make pretty darn good judgments about what is best for
themselves. They just need the information. They need the
support to enable them to make those kinds of decisions.
Right now they are geared to only one decision-making
route. And one of the purposes, hopefully, of this hearing,
what you are doing and what we are trying to do through NCAM,
is to again give people that power, the power that people need
themselves to decide for themselves what is best.
And while people may make mistakes, doctors make mistakes,
too. And I think, I still think--I will just say it one more
time for emphasis--if people have the knowledge and they have
the education and they have the pathways, if they were given
the time to listen to themselves and their own bodies, they
will make the best decisions for themselves.
Senator Specter. Thank you very much, Senator Harkin.
Thank you, Dr. Weil and Dr. Kreitzer. We know you have
other commitments. We really appreciate your being here.
Dr. Weil. Thank you.
STATEMENT OF HERBERT BENSON, M.D., PRESIDENT, MIND/BODY
MEDICAL INSTITUTE, ASSOCIATE PROFESSOR OF
MEDICINE, HARVARD MEDICAL SCHOOL
ACCOMPANIED BY:
JAMES M. CASSIDY
KRISTEN MAGNACCA
Senator Specter. We would like to turn now to panel three,
Dr. Herbert Benson and Mr. James Cassidy and Ms. Kristen
Magnacca.
Dr. Benson is a founding president of the Mind/Body Medical
Institute at Harvard Medical School, where he is associate
professor of medicine, also chief of the Division of Behavioral
Medicine at the Beth Israel Deaconess Medical Center, a
graduate of Wesleyan University at Harvard Medical School,
author or co-author of 150 scientific publications and 5 books.
And as I said earlier, someone whose writings I had read and
had consulted sometime ago.
Dr. Benson, you have two of your patients with you. And you
have a demonstration of the protocol and procedures of yours.
Dr. Benson. Thank you, Senator Specter, Senator Harkin,
members of the committee. It is a delight to be here testifying
before the committee. And I am wondering, because of the time,
whether I might change the order a bit and start off with our
two patients and then go on to an explanation of what was
occurring.
Senator Specter. Dr. Benson, your option.
Dr. Benson. Thank you.
Mr. Cassidy.
Summary Statement of James M. Cassidy
Mr. Cassidy. Thank you, Dr. Benson.
Thank you, Senator Specter and Senator Harkin. It is a
pleasure to be down here from Boston, MA, this morning, where
it is raining cats and dogs.
I wanted to tell you that I am a patient of the Cardiac
Wellness Program at the Beth Israel Deaconess Hospital. And
what you are looking at is one of the success stories, I hope.
So what you see is what you get. And I am going to give you a
brief statement of my time of 1 year with the Cardiac Wellness
Program, which started just a year ago.
In May of 1990 at the age of 64, I had major open heart
surgery, a four-way artery bypass at the Deaconess Hospital,
Boston, MA, covered by medical insurance at a cost of
approximately $100,000, and that was back in the year 1990.
After successful surgery and recuperation, I wandered through
the next 8 years without any particular motivation to stay
well.
Despite my cardiologist's warnings to keep my weight down,
a sensible diet plan and exercise, I continued to put on weight
and to generally get out of condition. For example, difficulty
in breathing, some angina pain, susceptible to colds and other
illnesses, and of course asking for major trouble.
My salvation came in the mail on January 1999 when my
medical insurance company--that is GIC. That is the Group
Insurance Commission in Boston--offered to cover my entire cost
in the Cardiac Rehabilitation Program offered by the Beth
Israel Deaconess Medical Center in Boston, MA.
Since I had retired from full-time employment, I decided to
make a New Year's resolution and to devote the year 1999 to the
program and to see what would happen.
Senator Specter. The child is--you can stay.
Ms. Magnacca. I am sorry.
Senator Specter. Come on back. You are fine.
Go ahead, Mr. Cassidy. You can handle it.
Dr. Benson. The witness is an ex-radio announcer. So I
think he could handle this.
Mr. Cassidy. I know the hearing is glad to see a baby in
here.
Senator Specter. When I was sworn in as an assistant
district attorney, my 20-month-old son rushed to the front of
the courtroom. So I am very sympathetic here.
Mr. Cassidy. Thank you, Senator.
I had previously entered several short-time programs, but
did not stay committed. I was very motivated to succeed in this
wellness program, as the long-term goals of the program kept me
focused on practical goals as I followed every directive
throughout the entire year.
The expert staff were instrumental in guiding and
motivating each class through weekly sessions of moderate
exercise, relaxation response sessions, proper nutrition that
you could live with, and interrelationship dialogue, all
designed to motivate similar cardiac patients in group therapy.
I think this group dialogue we had was most important to keep
us motivated.
As I saw and felt improvements in my own health, appearance
and general activity on life, I slowly changed my whole
attitude, became less stressful, less negative, ate sensibly
and lost weight as I entered into a new lifestyle.
The program is designed for slackers and procrastinators,
such as myself. I actually looked forward to each weekly
session with the staff and the patients, who had now become my
friends as we discussed mutual concerns. Do not forget, we are
all involved in cardiac programs, so we had something in
common.
The motivation continued at home during the week with daily
recitations of the relaxation response. We had tapes of
beautiful, soothing surf, music, wonderful music. This is
relaxing and really helps you. And breathing, important to
breathe. So we had daily exercise and nutritional and sensible
meals.
There is a lot of interesting and delicious low calorie and
no fat food out there. And this is what I am still on. But yet,
I am not suffering from it at all. It is wonderful.
My medical record speaks for itself as to my health
improvements. I have lost 50 pounds, my cholesterol is down 40
points into a very safe level, normal blood pressure, waist is
minus 7 inches and still counting. I am feeling healthier, more
alive and ready to take on new challenges, as I am now really
enjoying my golden years with a good quality of----
Senator Specter. Dr. Benson, you are up to 5 minutes of
your allotted 10. Now you are the master of ceremonies here,
but I wanted to give you----
Mr. Cassidy. I will go very quickly. I will just wind up
here.
I do a lot of work in this mind/body thing by local caring
groups in the church, senior citizen and so forth. Today at 74
years I continue my new healthier lifestyle. I want to say to
you all that it is not all severe penance, sack cloth and
ashes. We are allowed to celebrate special events, but
moderation is the watch word.
PREPARED STATEMENT
For instance, a week ago, Friday, March 17, I went out with
my wife and enjoyed my traditional corn beef and cabbage dinner
and a lot of Irish music. But I did not end up with a gallon of
Irish green beer, but rather black coffee and a clear head.
Thank you very much.
[The statement follows:]
Prepared Statement of James Cassidy
In May of 1990, at the age of 64, I had major open-heart surgery, a
four-way artery bypass at the Deaconess Hospital, Boston, MA. covered
by medical insurance company at a cost of approximately $100,000.
After successful surgery and recuperation, I wandered through the
next eight years without any particular motivation to stay well.
Despite my cardiologist's warnings to keep my weight down, a sensible
diet plan and exercise, I continued to put on weight and to generally
get out of condition--difficulty in breathing, some angina pain,
susceptible to colds and other illnesses and of course asking for
trouble.
My salvation came in the mail on January, 1999 when my medical
insurance company (GIC) Group Insurance Commission offered to cover my
costs in the Cardiac Rehabilitation Program offered by the Beth Israel
Deaconess Medical Center, Boston, MA.
Since I had retired from full time employment, I decided to make a
New Year's resolution and to devote the year 1999 to the program and to
see what would happen.
I had previously entered several short-term programs but did not
stay committed. I was very motivated to succeed in this wellness
program as the long-term goals of the program itself kept me focused on
practical goals as I followed every directive throughout the year. The
expert staff were instrumental in guiding and motivating each class
through weekly sessions of moderate exercise, relaxation-response
sessions, proper nutrition that you could live with and
interrelationship dialogue all designed to motivate similar cardiac
patients in group therapy.
As I saw and felt improvements in my own health, appearance and
general attitude on life, I slowly changed my whole attitude, became
less stressful, less negative, ate sensibly and lost weight as I
entered into a new life style.
The program is designed for slackers and procrastinators such as
myself. I actually looked forward to each weekly session with the staff
and the patients who had now become my friends as we discussed mutual
concerns.
The motivation continued at home during the week with daily
elicitation of the relaxation response (tapes of soothing surf, etc.),
daily exercise and nutritional and sensible meals (there's a lot of
interesting and delicious low calorie, no fat food out there).
My medical record speaks for itself as to my health improvement:
weight--lost 50 lbs., cholesterol--down 40 points into a very safe
level, normal blood pressure, waist--minus 7 inches and counting.
I'm feeling healthier, more alive and ready to take on new
challenges as I am now really enjoying my golden years with a good
quality of life, ready to turn over the vegetable garden and enjoy the
ever increasing grandchildren, birthday parties, and computers, too.
Mind, body, spirit--the stress reduction and spirituality aspect
was important to improved health and manifested in my increased
volunteering for many local caring activities in my church, Senior
Citizen Center (Medical Transportation, Friendly visitors, Senior
Sports), local American Legion Post and as an artist in local Artists'
Associations.
Today at 74 years I continue my new healthier lifestyle. I want to
say to you all that it's not all severe penance, sackcloth and ashes--
we are allowed to celebrate special events--but moderation is the
watchword. For instance, a week ago Friday, March 17th, I went out with
my wife and enjoyed my traditional corned beef & cabbage dinner and
Irish music--but I didn't end up with a gallon of Irish green beer, but
rather black coffee and a clear head. And as usual, the next day I went
to my YMCA working off those few extra calories and feeling great.
Senator Specter. I thank you, Mr. Cassidy.
Do you want to turn now to Ms. Magnacca?
Dr. Benson. Please.
Summary statement of Kristen Magnacca
Senator Specter. Ms. Magnacca is from Upton, MA, author of
Girlfriend to Girlfriend, a fertility companion. She is here
today to discuss her treatment experience at Harvard
University's Mind/Body Clinic. And we thank the child on her
lap, who ought to be a party to this. So welcome to both of you
and your husband, who appears to be your husband.
Ms. Magnacca. Yes.
Senator Specter. He nods, but I do not want be too
presumptive. And we will turn the time clock on again. Thank
you.
Ms. Magnacca. Thank you. Good morning. In 1997 I arrived at
the Mind/Body Clinic for Women's Health a shattered woman. For
3 years my husband Mark and I had been trying to have a baby.
We began the journey through infertility, and our lives
revolved around our childlessness. While praying to God for a
baby and strength, we began high-tech fertility treatments. A
year later, we thought our prayers had been answered when I
became pregnant.
As I wondered if our baby would have his father's soulful
eyes or possibly my strawberry blond hair, our lives were
crushed. I was faced with an atopic pregnancy, a life-
threatening medical emergency, and lost the baby. Due to
surgical complications, I was left incontinent. I experienced a
physical, emotional and spiritual crisis and fell into a
depression.
For months my husband watched as my anger at my body, my
anger at myself, my anger at him and my intense anger at God
for taking our child was slowly killing me. With our marriage
deteriorating, my husband began calling the Mind/Body
Infertility Clinic daily in hopes of getting into the program.
We both needed help.
I arrived at the first orientation class dragging my anger
and pain with me. I was not convinced I wanted to be there. But
as I listened to what the program offered, my anger began to
melt, and I felt relief. I had found a group of compassionate
experts, who knew what we were going through and could provide
guidance. Mark and I dove into the program. With each class, I
began to heal.
As my spirit and old self reappeared, everything improved.
My husband turned to me one day and said, ``Kristen, I have
so missed the sound of your laughter. It is so wonderful to
hear it again.'' I had not realized how long it had been since
I felt joy.
The tools I learned from the mind/body program, including
how to elicit the relaxation response, allowed me to reconnect
with my spirit and God. I felt as though my mind, body and soul
were through the crisis period, and I found myself once again.
It would be impossible for me to describe in words how I
felt when I discovered I was pregnant during the course,
especially when we had been told that I would never be able to
have a baby naturally. For 9 months, my husband Mark and I
joyfully awaited the birth of our child.
On September 21, 1998, at 7:46 a.m., the miracle happened.
I gave birth to a healthy baby boy, our son, Nicholas Armand
Magnacca. He arrived with his father's soulful brown eyes and
my strawberry blond hair, a 7 pounds, 7 ounce bundle of true
miracle.
PREPARED STATEMENT
I believe with all my heart that without the intervention
and life skills that we learned through the Mind/Body Clinic,
our son would not be with us today. I urge you to give your
full support to this endeavor so that other women may have
access to this incredible care and experience that I received
from the Mind/Body Institution.
Thank you.
[The statement follows:]
Prepared Statement of Kristen Magnacca
Good morning, my name is Kristen Magnacca. In 1997 I arrived at the
Beth Israel Deaconess Medical Center's Mind/Body Center for Women's
Health a shattered woman.
For three years my husband Mark and I had tried unsuccessfully to
conceive a child. We were unexpectedly thrust into the world of
infertility treatment; our life revolved around our childlessness.
We obtained the best medical intervention and progressed along the
road of assisted reproductive technologies, namely IUI's, or
Intrauterine Insemination. Being raised in a devout Catholic family, I
prayed to God, asking him to send me a baby and provide me with
strength.
It was determined that both my husband and I needed to have surgery
to help correct our conditions. Following our surgeries, I completed
three cycles of daily blood monitoring and ultrasounds culminating with
medical instruction regarding nightly hormone injections.
Our third cycle resulted in a low positive pregnancy test. We
watched while holding our breath that the hormone level would rise, and
it did. I will forever remember the words that came from my doctor:
``Kristen, for the very first time in your life you may consider
yourself pregnant!"
As I wondered if our baby would have his father's soulful eyes or
possibly his great grandfather's strawberry blond hair, I began to
bleed. It was determined that this was an ectopic pregnancy, a life-
threatening situation. The embryo had implanted itself outside of my
uterus and as a result of this my body began trying to expel the
pregnancy. I was rushed by ambulance to the hospital in serious
condition with extensive internal bleeding. My pregnancy could not
continue.
Due to surgical complications, I was left incontinent. We were also
informed that due to problems from the ectopic pregnancy, the
likelihood of a conceiving normally was non-existent. We would have to
progress to in vitro fertilization, bypassing my tubes all together. I
felt as though my body had failed me, I had no emotional strength left
and that God had abandoned me. I rapidly fell into a depression and
lost my will to go on. All at once I was experiencing a spiritual,
physical and emotional crisis.
For months, my husband watched as my anger at my body, my anger at
him and my intense anger at God for taking our child was slowly killing
me.
With our marriage deteriorating, my husband began calling the Mind/
Body Infertility Clinic daily in hopes of becoming participants. A
close friend of ours had attended the clinic and thought that it would
be beneficial given our circumstances. The class that was beginning in
a few weeks' time was full. But through my husband's persistence and
the clinic's compassion, we were allowed to join that group.
We both needed intervention, and agreed to experience this course
together in hopes of learning strategies to deal with our situation and
life. If a baby would come of this experience, that would be glorious,
but that was a secondary goal.
I arrived at the first orientation class dragging my anger and pain
with me. Then Dr. Ali Domar spoke. `` We are not going to talk about
how bad infertility is, we all know that it is, we are going to give
you strategies to deal with your situation and life.'' As I broke down
in tears, feeling her unconditional understanding, my anger began to
melt.
Mark and I dove into the exercises, listening to the relaxation
response tape before going to sleep, checking in with each other and
questioning if we had elicited the relaxation response through
``mini's.''
Waves of stress released themselves from my body, and my focus
began to return. Little by little I could see glimpses of my old self
reappearing.
The awareness that eliciting the relaxation response brought was
life altering. I remember driving my Jeep to a doctor's appointment
where we were about to discuss my next set of infertility options. As I
looked down at my hands on my steering wheel, I realized that my
knuckles were white from my unconscious grip on the wheel.
A few weeks prior I would not even noticed my state, and would not
have known to elicit the relaxation response through a ``mini.'' I
visualized the warmth of a flowing stream of water entering through my
head, washing away my unacknowledged stress. I was able to change my
state in an instant by relying on the skills I had developed through
the clinic.
With each class I instilled the recommended changes. I began to eat
a better diet and take nightly walks with my husband. On one of our
walks my husband and I shared a moment of laughter. In the middle of
the street he stopped and hugged me, saying, ``Kristen, I have missed
the sound of your laughter, it's so wonderful to hear that again.'' I
hadn't realized how long it had been since I had felt joy.
Our marriage was on the mend; our communication had greatly
improved. But most importantly, I allowed myself to be, in the
quietness of my being.
My new awareness didn't end with my physical self. I began to
reconnect with my spirit and God through the quietude of the relaxation
response. In the quiet I could start to rebuild my relationship with my
Creator.
As the weeks passed, I felt as though my mind, body and soul were
through the crisis period and I could begin to move back into a more
balanced state.
The focus of my life had been our childlessness for what seemed a
lifetime. Through the strategy of ``mindfulness'' I could now focus on
being in a restaurant with my husband instead focusing on the couple
next to us with their infant. I still longed for our child, but I re-
framed my life experience to ``mind'' how fortunate I was to be out
with my husband and to have someone else cook me dinner!
We decided to postpone our first cycle of in vitro fertilization
(IVF) and instead focus on our marriage and our new skills.
I began to come to terms with our fertility challenges. I finally
accepted the fact that our child would have to be conceived in a room
filled with medical experts, not within an intimate moment alone with
my husband.
However, despite what the doctors said, we discovered that I was
pregnant, the natural way, two months after becoming participants at
the Mind/Body Clinic. My mind, body and soul fell into alignment
through the specific strategies the clinic taught, allowing for this
unbelievable occurrence to take place.
On September 21, 1998 at 7:46 am, what the conventional medical
establishment said was impossible, happened. I gave birth to our son,
Nicolas Armand Magnacca. He arrived with his father's soulful eyes and
my grandfather's strawberry blonde hair; a 7lb, 7oz bundle of true
miracle.
Without the intervention and life altering skills that we learned
through the mind/body clinic, I believe that our son would not be with
us today.
Senator Specter. Well, that is very impressive, Ms.
Magnacca. Thank you very much.
Dr. Benson, you said you were going to bring two witnesses.
It looks like you brought three. So we will have to give you a
little extra time.
Dr. Benson. All right. I will cut down on my testimony.
It is projected that spending on health care is likely to
double----
Senator Specter. Dr. Benson, we turned the clock back on.
So you have the full 5 minutes.
Dr. Benson. Thank you.
Senator Specter, Senator Harkin, it is projected that
spending on health care is likely to double to $2.1 trillion by
the year 2007. That is a trillion dollars more than we are now
spending. I propose that mind/body medicine holds great promise
for the health care of the Nation and for reducing its cost.
Consider for a moment that I was testifying about a new
drug, and the scientific evidence indicated that this new drug
could successfully treat a wide variety of prevalent medical
conditions, conditions that lead to 60 to 90 percent of visits
to health care professionals.
Furthermore, consider that this drug could also prevent
these conditions from occurring and recurring and that it was
safe and without dangerous side effects. And consider that the
new drug was demonstrated to decrease visits to physicians by
as much as 50 percent and that this decrease could lead to
annual cost savings of more than $54 billion.
The discovery of such a drug would be front page news and
immediately embraced. Scientific evidence now exists that mind/
body belief-related, spirituality-related therapies can now
produce such clinical and economic benefits.
Health and well-being are best conceptualized by the
analogy of a three-legged stool. One leg is pharmaceuticals, a
second leg is surgery and procedures, a third leg is self-care.
Health and well-being are balanced and optimal when all three
legs of the stool are in place.
Self-care consists of health behaviors for which the
patients themselves are responsible and includes mind/body
approaches--that is, the relaxation response--the belief, the
spirituality of the patient, and stress management, as well as
including a profound influence on both nutrition and exercise.
A most essential feature of this self-care leg is the
relaxation response. Two steps are necessary to elicit it. The
first is a repetition. A repetition can be a word, a sound, a
phrase, a prayer, or even repetitive muscular activity. The
second is to disregard other thoughts when they come to mind
with the return to the repetition.
When a relaxation response is elicited, there are profound
physiologic changes, decreased metabolism, decreased heart
rate, decreased breathing, decreased muscle blood flow, brain
waves slow. And recently published data show that there are
distinct brain wave mapping changes, FMRI changes, that occur.
These changes are directly opposite to those of stress. And
please remember that stress leads to over 60 percent of visits
to health care professionals.
To elicit the relaxation response, a person may choose any
repetitive focus. But to combine its healing powers with the
profound healing powers of belief and to ensure that the
patient will adhere to the practice, the focus should be one in
which the patient believes. It may be secular, or it may be
religious.
The Mind/Body Medical Institute has created clinical
programs that offer a fully balanced three-legged stool and has
established 12 affiliates throughout the United States to
disseminate them. The programs can effectively treat the
disorders that are caused or exacerbated by stress. These
include hypertension, cardiac rhythm irregularities, many forms
of chronic pain, insomnia, infertility and the symptoms of
cancer of the symptoms of AIDS.
These programs can reduce visits to HMOs by up to 50
percent. And as noted above, such decreased visits could lead
to cost savings of over $54 billion per year. The full
integration of mind/body belief, spirituality related medicine
is completely compatible with existing health care. Mind/body
medicine responsibly fulfills the needs of our patients who
want therapies, as you were pointing out, Senator Harkin, that
enhance traditional medicine and do so in a scientifically
established, safe and cost-savings fashion.
PREPARED STATEMENT
In conclusion, I propose that in addition to increased NIH
funding for mind/body medicine, that the Health Care Financing
Administration establish large demonstration projects to
definitely test the clinical efficacy of mind/body belief,
spirituality related interventions and to assess their cost
savings.
These projects should start with medical conditions that
are prevalent and expensive, such as the prevention and
treatment of coronary artery disease, the treatment of chronic
pain, and the treatment of women's disorders that include
infertility.
Thank you for having me.
[The statement follows:]
Prepared Statement of Herbert Benson
I'm delighted to be called to testify on mind-body medical
interactions, their clinical applications and the need for their
reimbursement.
Before I start my testimony, let me say a few words about the Mind/
Body Medical Institute and the work I have been doing at the Harvard
Medical School and its affiliated hospitals for the last thirty years.
The Mind/Body Medical Institute is dedicated to performing research and
to conducting teaching and training of health care professionals in
mind-body and belief-related approaches and transmitting this
information to the general public. The Institute is now in its twelfth
year of existence. I occupy the Mind/Body Medical Institute Chair at
the Harvard Medical School as an associate professor of medicine.
It is projected that spending on healthcare is likely to double to
$2.1 trillion by the year 2007 (Smith, et al., 1998). That's a trillion
dollars more than we are spending now. Managed care savings have about
run their course. What's driving this surge in costs? It is expensive
prescription drugs, enthusiasm for new medical technology and greater
freedom to visit medical specialists whenever patients desire to do so.
Imaginative and responsible approaches to healthcare are needed. I
propose that mind-body medicine, with its self-care and belief-related
approaches, holds great promise for the nation's health and cost of
healthcare (Friedman, et al., 1995).
Consider for a moment that I were here today discussing a new drug
and the scientific evidence indicated that this new drug could
successfully treat a very wide variety of prevalent medical
conditions--conditions that lead to 60 to 90 percent of visits to
physicians. Furthermore, consider that it could also prevent these
conditions from occurring and recurring, and was safe, without
dangerous side effects. And, consider that the new drug was
demonstrated to decrease visits to doctors by as much as 50 percent and
that this decrease could lead to annual cost savings of more than $54
billion (Benson, 1996). The discovery of such a drug would be front-
page news and immediately embraced. Such scientifically validated mind-
body belief-related therapies have been shown to produce such clinical
and economic benefits, but as yet have not been so received.
My testimony will be evidence-based; the data I will present will
be scientific findings that have been published in peer-reviewed
journals. Some of these data were evaluated and supported at a 1995 NIH
Technology Assessment Conference
I will cover the following categories: stress and the fight-or-
flight response; the relaxation response; the placebo effect--the
importance of belief in healing; the three-legged stool--the importance
of balanced self-care; and the need for large demonstration projects to
definitively assess the efficacy of mind-body medicine.
STRESS AND THE FIGHT-OR-FLIGHT RESPONSE
Stress contributes to many of the medical conditions confronted by
healthcare practitioners. In fact, when the reasons for patients'
visits to physicians are examined, between 60 to 90 percent of visits
to physicians are related to stress and other psychosocial factors
(Cummings, VandenBos, 1981; Kroenke, Mangelsdorff, 1989). Current
pharmaceutical and surgical approaches cannot adequately treat stress-
related illness. Mind-body approaches including the relaxation
response, nutrition and exercise, cognitive restructuring and the
beliefs of patients have been demonstrated to successfully treat such
disorders. To better understand mind-body treatments it is best to
first understand the physiology of the stress and the fight-or-flight
response.
Stress is defined as the perception of threat or danger that
requires behavioral change. It results in increased metabolism,
increased heart rate, increased blood pressure, increased rate of
breathing and increased blood flow to the muscles. These internal
physiologic changes prepare us to fight or run away and thus the stress
reaction has been named the ``fight-or-flight'' response. The fight-or-
flight response was first described by the Harvard physiologist, Dr.
Walter B. Cannon (1941) earlier in this century. It is mediated by
increased release of catecholamines--epinephrine and norepinephrine
(adrenalin and noradrenalin)--into the blood stream. The fight-or-
flight response occurs automatically when one experiences stress,
without requiring the use of a technique.
THE RELAXATION RESPONSE
Building on the work of Swiss Nobel laureate Dr. Walter R. Hess, my
colleagues and I more than 25 years ago described a physiological
response that is the opposite of the fight-or-flight response (Benson,
1975). It results in decreased metabolism, decreased heart rate,
decreased blood pressure, and decreased rate of breathing, as well as
slower brain waves (Wallace, Benson, Wilson, 1971). We labeled this
reaction the ``relaxation response'' (Benson, Beary, Carol, 1974). Most
recently, Lazar et al used functional magnetic response imaging to
establish that when the relaxation response is elicited there is
activation in the brain of areas that control the autonomic nervous
system--the areas that control, for example, metabolism, heart and
breathing rates and blood pressure (Lazar et al, 2000, in press).
Two steps are necessary to elicit the relaxation response. They
are: (1) the repetition of a word, a sound, a prayer, a phrase, or
muscular activity (2) the passive disregard of everyday thoughts that
come to mind and a return to the repetition.
One can choose any focus, but to enhance the benefits of the
relaxation response with the healing effects of belief and to help
ensure that a person will adhere to the routine, the focus should be
one in which a person believes: if religious, a prayer could be chosen;
if not, a secular focus. Regardless of the techniques or focus that one
selects, the relaxation response will be evoked if one uses the two
basic steps.
There is no ``Benson technique'' for eliciting the relaxation
response. In fact, my colleagues and I offer people a smorgasbord of
techniques and focus words.
The following are focus words, phrases, and prayers that are
frequently used:
Secular Focus Words:
``One''
``Ocean''
``Love''
``Peace''
``Calm''
``Relax''
Religious Focus Words or Prayers:
Christian (Protestant and Catholic):
``Our Father who art in heaven,''
``The Lord is my shepherd''
Catholic:
``Hail, Mary, full of grace,''
``Lord Jesus Christ, have mercy on me''
Jewish:
``Sh'ma Yisroel,''
``Shalom,''
``Echod,'' ``The Lord is my shepherd''
Islamic: ``Insha'allah''
Hindu: ``Om''
Adherence to the two steps evokes the relaxation response. The
following is a generic technique:
Step 1. Pick a focus word or short phrase that's firmly rooted in
your belief system.
Step 2. Sit quietly in a comfortable position.
Step 3. Close your eyes.
Step 4. Relax your muscles.
Step 5. Breathe slowly and naturally, and as you do, repeat your
focus word, phrase, or prayer silently to yourself as you exhale.
Step 6. Assume a passive attitude. Don't worry about how well
you're doing. When other thoughts come to mind, simply say to yourself,
``Oh, well,'' and gently return to the repetition.
Step 7. Continue for ten to twenty minutes.
Step 8. Do not stand immediately. Continue sitting quietly for a
minute or so, allowing other thoughts to return. Then open your eyes
and sit for another minute before rising.
Step 9. Practice this technique once or twice daily.
With this generic technique, you could sit quietly in a comfortable
position, close your eyes, and relax your muscles. However, you can
also elicit the relaxation response with your eyes open; kneeling;
standing and swaying; or adopting the lotus position.
You can also jog and elicit the relaxation response, paying
attention to the cadence of your feet on the pavement ``left, right,
left, right'' and when other thoughts come into mind simply say. ``Oh,
well,'' and return to ``left, right, left, right.'' Of course you must
keep your eyes open!
Our research conducted at the Harvard Medical School as well as
that of others has documented that relaxation-response approaches,
generally used in combination with nutrition, exercise, and stress
management interventions, result in alleviation of stress-related
medical disorders. In fact, to the extent that stress causes or
exacerbates any condition, mind-body approaches that invariably include
the relaxation response have proven to be effective. Because of this
scientifically documented efficacy, a physiological basis for many
millennia-old mind-body belief-related approaches has been established
and a great deal of initial professional skepticism has been overcome.
It is essential to understand that regular elicitation of the
relaxation response results in long-term physiologic changes that
counteract the harmful effects of stress throughout the day, not only
when the relaxation response is being brought forth (Hoffman, et al,
1982). These mind-body approaches have been reported to be effective in
the treatment of disorders that include hypertension (Stuart, et al,
1987), cardiac arrhythmias (Benson, Alexander, Feldman, 1975), chronic
pain (Caudill, et al., 1991), insomnia (Jacobs, et al, 1993; Jacobs et
al, 1996), anxiety and mild and moderate depression (Benson et al.,
1978), premenstrual syndrome (Goodale, Domar, Benson, 1990), and
infertility (Domar, Seibel, Benson, 1990).
As a result of the evidence-based data, the relaxation response is
becoming a part of mainstream medicine. Approximately 60 percent of US
medical schools now teach the therapeutic use of relaxation-response
techniques (Friedman, Zuttermeister, Benson, 1993). They are
recommended therapy in standard medical textbooks and a majority of
family practitioners now use them in their practices.
The Mind/Body Medical Institute created mind-body group clinical
programs that are built upon such evidence-based medicine. The groups
are conducted by multidisciplinary teams comprised of physicians,
psychologists, nurses, nutritionists, exercise physiologists, social
workers and/or clergy. The components of the treatment are:
--elicitation of the relaxation response, the physical state of deep
rest that changes the physical and emotional responses to
stress (e.g., decrease in heart rate, blood pressure, and
muscle tension). The relaxation response may be elicited by
secular or religious techniques. The patient makes a choice
that will adhere to his or her belief system.
--cognitive-behavioral strategies to enhance coping skills
--exercise/activity programs
--nutrition management
Medications are monitored and may be adjusted. This is done in
consultation with the patients' physicians.
The program goals are to:
--bring about a reduction in symptoms
--develop an understanding of the disease or symptom process
--regain a sense of control and well-being
--modify factors or situations-such as lifestyle, diet, stress, or
physical tension-that contribute to symptoms
The mind-body medical clinic programs available include:
--Medical Symptom Reduction for general stress-related physical
symptoms such as headache, GI disorder, palpitations, fatigue
--Infertility
--HIV+/AIDS
--Cancer
--Chronic Pain/Chronic Fatigue Syndrome
--Insomnia
--Chemotherapy and Radiation Therapy (one session)
--Pre-medical, Surgical or Radiological Procedures (one session)
--Cardiac Wellness Programs for patients with hypertension, lipid
disorders, diabetes, arrhythmias and/or heart disease
--Perimenopause/Menopause
The mind-body medical clinical program visits include:
--one initial assessment
--nine to thirteen 2 hour weekly visits depending on the program
--one discharge assessment
the placebo effect and the importance of belief in healing
The importance of mind-body interactions in healing is also
profoundly evidenced by the beliefs of the patient. The effects of
belief have been called the ``placebo effect.'' Throughout history,
medicine and healing have relied heavily on non-specific factors such
as the placebo effect (Benson and Friedman, 1996). In other words, what
patients believe, think and feel can have profound effects on the body
and physicians and other healers have historically appreciated the
effects of both positive and negative emotions.
However, modern medicine has largely disregarded and ridiculed the
importance of the placebo effect by using such statements as, ``It's
all in your head,'' ``It's just the placebo effect,'' or ``It's a dummy
pill.'' These pejorative terms arose gradually over a period of decades
as specific remedies for specific illnesses were developed and the
reliance on what is now called non-specific healing factors--the
placebo effect--diminished. Because the specific therapies were and
are, so dramatically effective, they became the sole treatments
utilized.
Specific treatments such as insulin, antibiotics and cataract
surgery are truly awe-inspiring. The result was that mind-body
approaches were largely forgotten and pushed aside as the wondrous
modern pharmaceuticals and surgeries and procedures advanced. Rather
than using a combination of specific and non-specific, belief-related
therapies to promote healing, modern medicine has come to value and to
rely exclusively on the specific effects of pharmacological and
procedural interventions. It ignores the healing powers of belief.
The pioneering work of Beecher (1955) established that in patients
with conditions of pain, cough, drug-induced mood changes, headaches,
seasickness, and the common cold, the placebo effect was effective in
35 percent of the cases. Since these early findings, the placebo effect
has been documented to be effective in 50 to 90 percent of diseases
that include bronchial asthma, duodenal ulcer, angina pectoris, and
herpes simplex (Benson and Friedman, 1996; Benson, 1996).
The placebo effect is dependent on three sets of beliefs: (1) the
beliefs of the patient; (2) the beliefs of the healthcare provider (the
healer); and (3) the beliefs that ensue from the relationship between
the healthcare provider and the patient.
A study of Japanese students who were allergic to the wax of a
lacquer tree, which produces a rash similar to that of poison ivy,
provides one demonstration of the power of the belief of patient (Ikemi
and Nakagawa, 1962). The students were first blindfolded and then told
that one of their arms would be stroked with lacquer tree leaves, and
that their other arm would be stroked with chestnut tree leaves, to
which they were not allergic. However, the researchers switched the
leaves. The skin that the subjects believed to have been brushed with
the lacquer leaves, but that was actually stroked with chestnut tree
leaves, developed a rash. The skin that had actual contact with the
leaves of the lacquer tree, but that was believed to have been stroked
with the chestnut tree leaves, did not react.
A study of treatments for angina pectoris provides an example of
how beliefs of the healthcare practitioner can affect disease (Benson
and McCallie, 1979). A number of therapies for angina pectoris have
been used throughout the decades that are now known to have no
therapeutic value. These include vitamin E and bizarre internal mammary
artery surgeries. When they were used and believed in by physicians,
they had a dramatic effect. They were found to be 70 to 90 percent
effective in relieving the pain of angina pectoris. Not only would the
pain disappear, but the patients' electrocardiograms and exercise
tolerance would improve. However, when these therapies were later
invalidated and no longer believed in by physicians, their
effectiveness dropped to 30 percent or lower.
The beliefs that ensue from the relationship between physicians and
patients are the third component of the placebo effect. A study by
researchers at the Massachusetts General Hospital (Egbert, et al.,
1964) compared two matched groups of patients who were to undergo
similar operations. The doctors responsible for their anesthesia
visited both groups of patients, but interacted with them quite
differently. They made only cursory remarks to patients in one group,
but treated the other group with warm and sympathetic attention,
detailing the steps of the operation and describing the pain they would
experience. The patients who received the friendlier more supportive
visits were discharged from the hospital an average of 2.7 days sooner
and asked for half the amount of pain-alleviating medication than
patients in the other group.
Some insight into the possible brain mechanisms for the placebo
effect is provided in a study conducted by Dr. Steven Kosslyn (Kosslyn,
et al., 1993). He and his colleagues examined how the brain processes
information, both real and imagined. Subjects were asked to look at a
grid with a letter printed on it. As they did so, a PET Scan was used
to determine what areas of the brain were active in seeing the grid and
the letter. The subjects were then asked to look at the same grid
without the letter on it, but asked to visualize the letter in their
mind's eye. The PET scan was then repeated. The same area of the brain
was stimulated in both situations. In other words, from the brain's
perspective the visualization of a scene is similar to actually seeing
the scene.
This process helps to explain the placebo effect. All of our
thoughts, actions, and memories, represent the activation of specific
brain connections. Pain in an arm or leg is represented as activation
of specific brain areas. There are memories in our brains of pain.
There are also memories of being without pains. There are also brain
connections for having a skin rash and of being without a skin rash.
Thus, belief in a sugar pill or an inactive therapy can result in
activating the brain connections to ``remember'' what it is to be
without the pain or the rash. The pain or rash can be thus alleviated.
In other words, thoughts can activate brain connections that can result
in physical healing.
The biased words ``placebo effect'' should be discarded and changed
to ``remembered wellness.'' Remembered wellness is what explains this
powerful mind-body belief reaction and the words, remembered wellness,
have a positive connotation.
Placebos are not the only way to evoke remembered wellness.
Consider the most profound belief Americans share. Ninety-five percent
of the U.S. population believe in God (Gallup, 1990). Research by
different investigators working in different locations throughout the
United States have repeatedly demonstrated a connection amongst
religious beliefs and greater well-being, better quality of life, and
lower rates of depression, anxiety and substance abuse (Koenig, 1998).
Religious beliefs and practices have been associated with decreased
mortality and enhanced physical health (Koenig, et al, 1997; 1998).
They are also associated with a lower use of expensive health services
(Koenig, Larson, 1998). Recently, such research has appeared in
respected medical journals and has begun to influence both the
education of physicians and the practice of medicine (Marwick, 1995;
Levin et al., 1997).
The effects of the relaxation response should not be confused with
remembered wellness (the placebo effect). The relaxation response is a
specific, proven mind-body intervention. The measurable, predictable,
and reproducible changes of the relaxation response will occur when you
follow the two specific steps--belief is not essential. It is like
penicillin--it will work whether believed in or not.
the three-legged stool and the importance of balanced self-care
Health and well being and the incorporation of mind-body therapies
in medical care are best conceptualized in terms of an analogy of a
three-legged stool (Benson and Friedman, 1996; Benson, 1996). One leg
is pharmaceuticals, the second is surgery and procedures, and the third
leg is self-care. Self-care consists of health habits and behaviors for
which patients themselves can be responsible. Specifically, self-care
includes the relaxation response, beliefs, stress management, nutrition
and exercise. Health and well-being are balanced and optimal when all
three legs of the stool are in place. Of course, attention to nutrition
and exercise has been recognized for centuries. In contrast, the
scientific documentation of mind-body interactions has only recently
been presented.
For more than a hundred years medicine has relied almost
exclusively on the first two legs of the stool: pharmaceuticals and
surgery. Without the support of the third leg through mind-body and
belief-related approaches, the treatment of many medical conditions is
unbalanced and inadequate. Patients receive less than optimal clinical
care and the care they receive is more costly.
Mind-body medicine is different from what is called alternative and
complementary medicine. Mind-body medicine is evidence-based whereas
alternative medicine is not. If alternative medicine were evidence-
based, it would no longer be alternative. Secondarily, alternative
medicine is akin to the first two legs of the three-legged stool--there
is little difference between an herb and a pharmaceutical or between
acupuncture and surgery. They are both given to or conducted on the
patient. In contrast, self-care is performed by the patient. Finally,
alternative medicine is cost additive whereas self-care saves money.
One example of how mind-body group programs can reduce costs was
shown through a study conducted at the Harvard Community Health Plan
(Hellman, et al., 1990). Two group mind-body interventions that evoke
the relaxation response were compared among high-utilizing primary care
patients who experienced physical symptoms which had psychosocial
components. The symptoms included palpitations, shortness of breath,
gastrointestinal complaints, headaches, and sleeplessness. Both
interventions offered patients educational materials, relaxation-
response training, and awareness training, and both included cognitive
restructuring. These groups were compared with a randomized control
group that received only information about stress management, not the
actual interventions. Six months after treatment only the patients in
the mind-body groups reported less physical and psychological
discomfort and averaged about 50 percent fewer visits to the health
plan than the patients in the control group. The estimated net savings
to the HMO above the cost of the intervention for the mind-body
patients was $85 per participant in the first 6 months.
Chronic pain and insomnia are two other examples of the successful
integration into mainstream medicine of mind-body interventions (NIH
Technology Assessment Panel on Integration of Behavioral and Relaxation
Approaches Into the Treatment of Chronic Pain and Insomnia, 1996).
Millions of Americans are in chronic pain, which by definition, is pain
that cannot be eliminated, but must be managed. Chronic pain sufferers,
motivated both by medical and emotional factors, often become frequent
users of the medical system. The treatment of chronic pain becomes
extremely costly and frustrating for patients and healthcare providers.
In one study, clinic usage was assessed among chronic pain patients at
an HMO who participated in an outpatient mind-body group program, of
which the relaxation response was an integral part (Caudill, et al.,
1991). In addition to decreases in the severity of pain as well as in
anxiety, depression and anger, there was a 36 percent reduction in
clinic visits among program participants for over two years following
the intervention as compared to their clinic usage prior to the
intervention. In the 109 patients studied, the decreased visits
projected to estimated net savings of $12,000 for the first year
following treatment and $24,000 for the second year.
Another example of how these same mind-body group interventions can
result in better medical care and reduce medical costs is in the
treatment of another extremely common disorder, insomnia (NIH
Technology Assessment Panel on Integration of Behavioral and Relaxation
Approaches Into the Treatment of chronic Pain and Insomnia, 1996).
Approximately 35 percent of the adult population experiences insomnia.
Half of these insomniacs consider it a serious problem. Billions of
dollars are spent each year on sleeping medications, making insomnia an
extremely expensive condition. In fact, the direct costs to the nation
are approximately $15.4 billion yearly and the actual costs in terms of
reduced quality of life, lowered productivity and increased morbidity
are astronomical. Although frequently employed, sleeping pills are not
effective in the long term. The shortcomings of such drug therapy,
along with recognition of the role of behavioral features of insomnia,
prompted the development of mind-body behavioral interventions for this
condition. Researchers at our laboratories at the Mind/Body Medical
Institute studied the efficacy of a multifactorial behavioral
intervention for insomnia that included relaxation-response training.
Compared to controls, those subjects who received behavioral and
relaxation-response treatment showed significantly more improvement in
sleep patterns. On average, before treatment it took patients 78
minutes to fall asleep. After treatment, it took 19 minutes. Patients
who received behavioral and relaxation response treatment became
indistinguishable from normal sleepers. In fact, the 75 percent
reduction in sleep-onset latency observed in the treated group is the
highest ever reported in the literature (Jacobs, G.D. et al, 1993;
Jacobs, Benson, Friedman, 1996).
It is also important to remember that the research on mind-body,
behavioral therapies in the treatment of both chronic pain and insomnia
were reviewed in 1995 at a NIH Technology and Assessment Conference.
The planning committee chairman was my late friend and colleague Dr.
Richard Friedman. Dr. Julius Richmond, former Surgeon General of the
United States Public Health Service and Assistant Secretary for Health
of the Department of Health and Human Services under President Carter,
was the chair of the independent panel (before he became a trustee of
the Mind/Body Medical Institute) that reviewed the evidence. Dr.
Richmond stated in a press conference that it was ``imperative'' that
these interventions be integrated into routine medical care.
As I noted earlier, if medical care continues to be based only on
two legs, it is estimated that the costs for this care will double in
the next decade (Smith, et al., 1998). Mind-body programs are
scientifically proven strategies that can be thoroughly integrated with
pharmaceuticals and surgery and procedures and, they offer cost
savings. I've also noted that 60 to 90 percent of physician office
visits are related to stress-related conditions. To estimate the monies
that could be saved per year by the application of mind-body therapies,
I used 75 percent as an average. I estimated that half of these doctor
office visits--or 37.5 percent--could be eliminated with a greater use
of mind-body approaches. Using 1994 statistics, there were
approximately 670,000 practicing physicians in the United States who
reported an average of 74.2 patient visits per doctor per week, for a
total of 3,858.4 office visits per doctor that year. Each visit for an
established patient cost an average of $56.2. Thus, the average cost
per year was 670,0003,858.4$56.2 = $145.3 billion. By
reducing these visits by 37.5 percent, the cost savings would be $54.5
billion, for one year alone (Benson, 1996).
The full integration of mind/body, self-care medicine is completely
compatible with existing healthcare approaches. The integration is
important not only for better health and well-being, but also for a
more economically-feasible healthcare system. Mind-body medicine
responsibly fulfills the needs of our people who want therapies that
enhance and complement traditional medicine and that do so in a
scientifically-established, safe, and cost-savings fashion. Mind-body
and belief-related interventions hold such promise that they should be
further researched, advocated and utilized for the health and well-
being of the people of our nation.
PROPOSED DEMONSTRATION PROJECTS
I propose that the Health Care Financing Administration establish
large demonstration projects to definitively test the clinical efficacy
of mind-body and belief-related interventions and to assess the cost-
savings afforded by such approaches. These projects should start with
medical conditions that are prevalent and expensive, such as, the
prevention and treatment of coronary artery disease; the treatment of
chronic pain; and the treatment of women's disorders including
infertility.
Senator Specter. Dr. Benson, thank you very much for that
testimony and for bringing Ms. Magnacca and Mr. Cassidy here
today. Very informational and really very helpful.
As noted earlier, but worth repeating, the mind/body
medicine funding started in 1998 at $54.9 million and is now in
excess of $125 million. And we would be interested in knowing
your personal response, since you began to press mind/body as
one of the national/international experts. I have commented
about a back problem, which I developed after losing an
election in 1973.
And I was skeptical at the time that there was any
connection. And since, I have come to believe that there was a
causal connection.
But there is, I think fairly stated, a great deal of
skepticism among most people about the mind/body connection.
When you talk about a cure for cancer and you talk about
beliefs, would you amplify how in a medical context--and you
are a distinguished cardiologist--that works? How does the work
range from mind to belief to body on something as difficult as
cancer?
Dr. Benson. To the best of my knowledge, there is no
evidence that stress or mind/body reactions either cause or can
reverse cancer. But what we are effective in doing is changing
the symptomotology that a patient recognizes or experiences
when they have cancer. If a woman learns she has breast cancer,
she is no longer Jane Smith. She is Jane Smith, breast cancer
patient. And frequently, the symptoms come not from the cancer
itself, but from the knowledge of being a different person and
the stress of having to adjust to it. It is those symptoms we
can effectively treat.
However, Senator, there are many conditions that are
directly affected by stress.
Senator Specter. Such as?
Dr. Benson. For example, tension headaches. Many forms of
hypertension are directly related to stress.
Senator Specter. How about back pain?
Dr. Benson. Back pain. Pain indeed is often a memory of a
pain itself that stress can exacerbate. If you can turn off
that memory by a belief system, by remembering what it was to
be without the pain, remembering wellness, if you will,
remembered wellness is our term to describe the placebo effect,
it is a way of dissociating the pain and forgetting the pain
and, in many cases, the pain can be alleviated.
Insomnia, for example, affects 60 million Americans. Our
clinics are now having published results which are showing a
75-percent cure rate of insomnia, which has a cost to the
Nation of literally hundreds of billions of dollars a year
because of the problems of insomnia.
Senator Specter. Dr. Benson, what has been the public's
reaction to the mind/body approach? What differences have you
noted since you began your career? I would be interested in
when that was when you started to develop your approach to
mind/body and how it has expanded and become better accepted.
Dr. Benson. My career dates back to my fellowship at
Harvard Medical School in the department of physiology. And
that--actually, it goes further back. It goes back to my very
training at Harvard Medical School. Mind/body was unaccepted as
a discipline at the time. In fact, when I started studying
stress, I was told I was throwing away, in effect, a promising
career to do so.
The change has been spectacular. The acceptance by mind/
body is now widespread. There is a marked gender difference in
understanding mind/body. For women, there is no issue in
understanding that mind has a profound influence on body. Men
often need a disease condition to be convinced that that
reaction is there.
I think because of the fact that the scientific data have
now established this, the establishment itself is now widely
accepting mind/body as a direction to go.
Senator Specter. Are the HMOs funding the medical
treatments related to mind/body? Have you persuaded HMOs about
that $54 billion figure?
Dr. Benson. Yes, Senator, it is a major issue, but I am
proud to say in Massachusetts our programs are largely covered
by HMOs. It is our goal to extend this nationally now. And
therein lies the issue. Namely, we are training health care
professionals and people from HMOs themselves. But the fact is
that they often do not change their billing practices.
Ninety-nine percent of physicians believe that belief can
heal, and religious belief can heal. Ninety-four percent of HMO
executives believe the same. Yet only 10 percent of HMO
executives have instituted such plans into their own practices.
The data are there.
As I pointed out, this is an intervention that can
effectively treat 60 to 90 percent of visits to physicians. A
change must occur. And the way people recognize that disease
comes not only, or disease need only be treated by the first
two legs of the three-legged stool, namely pharmaceuticals,
herbs or acupuncture and surgery.
These are procedures done to people. What we are talking
about is what people can do for themselves. There is a profound
desire for people to do this. We recognize that and get these
services paid for.
Senator Specter. Thank you very much, Dr. Benson.
Senator Harkin.
Senator Harkin. Thank you very much, Dr. Benson, for being
here and bringing these two witnesses, who----
Senator Specter. Three witnesses.
Senator Harkin. Three witnesses. Thank you, Mr. Chairman.
That is why you are chairman. You recognize those things.
Because I believe what you just told, both you, Mr. Cassidy
and Ms. Magnacca, really, I think, illustrate the efficacy of
different approaches to healing and well-being.
I agree with you, Dr. Benson, that in the realm of well-
being, that we have given short shrift to what you say should
be discarded as the placebo effect. I agree with you. That word
ought to be discarded. I do not think it has a place. It is a
pejorative type of a term. And we ought to get rid of it,
because the mind does have a lot to do with how we are and what
we do and how we feel and our well-being.
So everything you have done in all your research, I think,
points to that. You and I are both on the advisory committee of
a group called the inter-faith coalition for spiritual
counseling and healing. And again, I believe these types of
groups can add a lot to our health care system in America.
I might disagree with you a little bit, a couple of
percentage points here, when you say mind/body medicine is
different from what we call alternative and complementary
medicine. Mind/body medicine is evidenced based, whereas
alternative medicine is not. If alternative medicine were
evidenced based, it would no longer be alternative. You say
that alternative medicine is akin to the first two legs of this
three-legged stool. Finally, alternative medicine is cost
additive, where self-care saves money.
Well, that is kind of where I depart a little bit there
from you. I think that a lot of alternative medicine has been
evidenced based. But we have a different paradigm in how we
look at the evidence for medical care in this country.
Acupuncture, for example, has been well known for years to
alleviate pain.
I am not going to bore you with the whole story of my
brother and acupuncture and watching medical doctors watch an
acupuncturist relieve his pain, when he was dying of cancer.
But it has been evidenced based. The evidence is there, but we
have not looked at it.
So I think a lot of alternative and complementary medicine
has been quite adequately evidenced based, just not in our
frame of reference. That is all.
Second, I do not think that complementary alternative
medicine is cost additive. I think it can replace a lot of the
traditional forms of medicine that we are now doing. Take St.
John's Wort, for example. If St. John's Wort--I think it is
proving to be quite an acceptable regime for depression. And it
is a lot more inexpensive, for example, than taking the
pharmaceutical drugs for depression.
So I just want to tell you, because those words leaped out
at me. And I hope that perhaps, since you are a friend of mine,
we might discuss this later on.
Dr. Benson. Fair enough. May I respond briefly now?
Senator Harkin. Sure. Sure.
Dr. Benson. With respect to evidenced based, the question I
have is that there is no--let me state that I do believe that
alternative medicines help a great many people. Clearly there
are testimonies and there are studies to this effect.
The question I have, is it really the alternative medicine
working or might not it be the belief in the alternative
medicine that is working?
And I will not deny that many of our routine medicine may
work, not because of their inherent pharmaceutical, but because
of the belief in that pharmaceutical. What I am trying to
emphasize is the extraordinary power of belief that we in
medicine have ridiculed for more than 100 years. Yet the
placebo effect that I now would like to call remembered
wellness is effective in 50 to 90 percent of diseases that
include angina pectoris, asthmas, skin rashes, rheumatoid
arthritis, congestive failure.
I think alternative medicine should be explored. I wholly
agree with that. But let us control and that we not ascribe to
the alternative medicine what is truly the--may be the belief
in the alternative medicine.
Senator Harkin. I guess my response is, what difference
does it make? I mean, if someone is taking an herbal remedy and
it helps them and they feel better and they are healthier--I
mean, I have talked to people who have taken Chinese herbs that
get rid of asthma, for example. Now you might say it does not,
but they believe it does. So what?
Dr. Benson. I thoroughly agree with that, Senator, but what
it does do is diminish the knowledge and the use of what our
true power is; that is our power of belief. As humans, we have
come to believe that something done to us, be it an herb or a
pharmaceutical, is more powerful than what we can do for
ourselves.
And I will not deny the power of our pharmaceuticals, our
surgery, our herbs and what have you. What I am trying to
emphasize is what may be the underlying power in many of these
therapies, and that is our belief system. And for many the most
powerful belief system may well be belief in spirituality.
Senator Harkin. Well, obviously from my comments earlier, I
agree with you on that. It is just that I also feel that in
many ways, whether it is herbal supplements, vitamins, for
example, we know what effect vitamin E has on people and
vitamin C, for example. I mean, this is not just clearly in
one's mind. It has to do with the physiological reactions in
your body that the vitamins help and minerals help.
We know what nutrition, for example, does. We could get
back into that again. This is not entirely in your mind. It has
something to do with what the physiological reactions in your
body are. So it is not just mind.
Dr. Benson. I agree with that, Senator. But what we often
deny is the mind component. I am not saying it is all mind. Of
course the vitamin could well help. But let us also pay due
attention to how belief may enhance the inherent properties of
the vitamin. That is why I am arguing so for a three-legged
stool.
If we simply argue that herbs and vitamins and
pharmaceuticals are one leg, surgery and procedures,
acupuncture and massage are another, those are done to you.
What I would like to emphasize is the due respect and research
to support what we can do for ourselves. And in that component,
belief is a vital part.
Senator Specter. The Chair finds you two men in agreement.
Senator Harkin. I think we are pretty much in agreement.
Dr. Benson. I think we are, too.
Senator Specter. Thank you very much, Dr. Benson, Ms.
Magnacca and Mr. Cassidy. We really appreciate your coming
here. And I think that your views, Dr. Benson, are very
important for America's health. And I think they are catching
on. And perhaps this hearing will give a little extra boost.
Thank you.
STATEMENT OF DEAN ORNISH, M.D., FOUNDER AND PRESIDENT,
PREVENTIVE MEDICINE RESEARCH INSTITUTE
Senator Specter. We now turn to our fourth panel, Dr. Dean
Ornish and Mr. Walter Czapliewicz.
Dr. Ornish is the founder, president and director of the
Preventive Medicine Research Institute in Sausalito,
California, clinical professor of medicine at the University of
California, San Francisco, and founder of Osher Center for
Integrative Medicine, written extensively about how
comprehensive lifestyle changes can reverse coronary heart
disease, medical degree from Baylor College and bachelor's
degree from the University of Texas.
Welcome, Dr. Ornish, and the floor is yours.
Dr. Ornish. Thank you. Mr. Chairman, Senator Harkin,
distinguished colleagues, thank you very much for the privilege
of being here today. I just want to begin by acknowledging your
leadership in bringing funding and in bringing science to this
area, which I am deeply grateful for.
I believe that the medicine of the 21st century should
integrate the best of allopathic, mind/body medicine and
complementary medicine. Our work is a model of the
scientifically based approach that may be helpful in building
bridges between these. In our research, my colleagues and I use
the latest in high-tech, state-of-the-art medical technology to
prove the power of these ancient and low-tech and low cost
interventions.
We have conducted a series of scientific studies
demonstrating that the progression of even severe heart disease
can often be reversed without drugs or surgery. Our program
includes a very low fat, plant-based, whole foods diet, stress
management techniques, modern exercise, smoking cessation and
psycho-social support.
The idea that heart disease might be reversible was a
radical concept when I first began doing studies in this area
23 years ago. But that idea has now become mainstream. And we
have published our findings in leading peer reviewed medical
and scientific medical journals.
The improvement in quality of life for these patients is
dramatic. We found a 91-percent reduction in the amount of
chest pain. Most of them became pain-free within weeks. But
they not only felt better, in most cases they were better in
ways we could actually measure. They showed even more reversal
of heart disease after 5 years than after 1 year. And we found
that they had two-and-a-half times fewer heart attacks,
bypasses, angioplasties and other things.
I think these findings are giving many people new hope and
new choices that they did not have before, as Mr. Czapliewicz
will later discuss. In contrast, the patients in the control
group, who were making the more conventional changes, like a
30-percent fat diet, got worse and worse over time, rather than
better and better.
I think these findings have particular significance for
women, because heart disease is by far the leading cause of
death in women. Women have less access to angioplasty and
bypass surgery than men do. When they do get operated on, they
have higher morbidity and mortality than men. But the good news
is that women seem to be able to reverse heart disease even
easier than men simply through making diet and lifestyle
changes.
We found that our program is not only medically effective,
but also cost effective in the diverse selection of hospitals
and other sites around the country, including ones in Iowa and
Pennsylvania. Seventy-seven percent of people who were eligible
for bypass surgery or angioplasty were able to safely avoid it
simply by changing diet and lifestyle with an immediate savings
of almost $30,000 per patient.
We also found that the older patients improved as much as
the younger ones, which is not what I thought we would find.
And we found that since the risk of surgery increases with age,
but the benefits of lifestyle changes occur at any age, you can
argue that this a particular benefit in those in the Medicare
population.
Over 40 insurance companies are covering our program in the
sites that we have trained. And also, a high mark, Blue Cross/
Blue Shield of Pennsylvania was the first insurer to both
provide and cover the program to its members.
We also found that several people who had such severe heart
disease that they were waiting for a heart transplant were able
to get off the heart transplant list because they improved so
much, which saves an average of almost $300,000 a patient, not
to mention the suffering that comes from having to go through
that.
Also, Congress, including Senator Stevens and other members
of this committee, appropriated funds via the Department of
Defense for us to train at the Walter Reed Army Medical Center
and the Bethesda National Naval Medical Center in our program.
So finally we can now order people to meditate and eat healthy.
We appreciate that HCFA finally agreed to move forward with
the demonstration project of our work, to determine the
effectiveness of our program in the medical population, thereby
making it available to Americans who most need it, regardless
of their ability to pay. And I want to again acknowledge
Senators Specter and Harkin for their support of that.
We believe that this can provide a new model for lowering
Medicare costs without compromising the quality of care or
access to care by addressing the underlying causes of why
people get sick, rather than just literally or figuratively
bypassing them.
A few years ago, we began conducting the first randomized
trial to see if prostate cancer could be reversed by a similar
program. And our preliminary data are very encouraging. We are
finding that PSA levels are going down in the experimental
group, and they are going up in the control group in direct
relation to their adherence.
I believe in the power of science to help sort out
conflicting claims, to distinguish what works from what does
not and for whom and under what circumstances. And as you both
indicated, the question is not should Americans be using
alternative medicine, they already are, but with adequate
information scientifically to make informed and intelligent
choices.
I applaud Congress, and particularly the two of you, for
its role in establishing the NIH Center for Complementary and
Alternative Medicine and the NIH Office of Behavioral and
Social Sciences Research. But, Senator Harkin, as you pointed
out, the budgets are still only a half percent of the overall
NIH budget.
And therefore, I respectfully request Congress to consider
substantial increases in funding for rigorous scientific
research into the efficacy of various approaches in
complementary and alternative medicine and mind/body medicine,
such as those described by Dr. Weil, Dr. Benson and others.
PREPARED STATEMENT
Whatever is learned will be of great interest. So please
encourage HCFA to cover alternative medicine and mind/body
programs, if they have demonstrated safety and medical efficacy
in randomized control trials published in peer review journals.
Anecdotal evidence is important, but it is not sufficient.
Thank you.
[The statement follows:]
Prepared Statement of Dean Ornish
INTRODUCTION AND BACKGROUND
Mr. Chairman, members of the Committee, distinguished colleagues,
thank you very much for the privilege of being here today. My name is
Dean Ornish, M.D. I am the founder and president of the non-profit
Preventive Medicine Research Institute and Clinical Professor of
Medicine at the School of Medicine, University of California, San
Francisco (UCSF), where I am also one of the founders of the new Osher
Center for Integrative Medicine at UCSF. Also, I was recently appointed
to the Presidential White House Commission on Complementary and
Alternative Medicine Policy.
For the past 23 years, my colleagues and I at the non-profit
Preventive Medicine Research Institute have conducted a series of
scientific studies and randomized clinical trials demonstrating, for
the first time, that the progression of even severe coronary heart
disease often can be reversed by making comprehensive changes in diet
and lifestyle, without coronary bypass surgery, angioplasty, or a
lifetime of cholesterol-lowering drugs. These lifestyle changes include
a very low-fat, plant-based, whole foods diet, stress management
techniques, moderate exercise, smoking cessation, and psychosocial
support. We published our findings in the leading peer-reviewed medical
and scientific journals.
Our work is a model of a scientifically-based approach that may be
helpful to others in building bridges between the alternative and
conventional medical communities. The idea that heart disease might be
reversible was a radical concept when we began our first study; now, it
has become mainstream and is generally accepted as true by most
cardiologists and scientists.
I am a scientist as well as a clinician because I believe in the
power of science to help sort out conflicting claims and to distinguish
fact from fancy, what sounds plausible from what is real, what works
and what doesn't, for whom, and under what circumstances. Indeed, that
is the whole point of science: as Tom Cruise playing Jerry Maguire
might say if he were a scientist, ``Show me the data!'' The peer-
reviewed scientific process is about people challenging each other to
demonstrate scientific evidence, not just their opinions or beliefs, to
support their position. Not everything that counts can be counted, and
not everything meaningful is measurable, but much is.
Nowhere are there more conflicting claims than in the area of
complementary or alternative medicine. The question is not, ``Should
Americans seek out alternative medicine practitioners,'' because they
already are. Although there is relatively little hard scientific
evidence proving the value of most alternative medicine approaches,
several studies have revealed that as much money is spent out of pocket
for complementary or alternative medicine than for traditional
physician services. In most cases, these decisions are being made with
inadequate scientific information to make informed and intelligent
choices.
Therefore, I respectfully request the Committee on Appropriations
of the U.S. Senate to consider substantial increases in funding for
rigorous scientific research into the efficacy of various approaches in
complementary and mind/body medicine such as those offered by Dr.
Benson, Dr. Weil, and others. Whatever is learned will be of great
interest. Those approaches that are found to be safe and effective
should be covered by Medicare and other third-party payers so that
these methods can be more widely available to other Americans who may
benefit from them. Scientific studies that find other approaches to be
ineffective or unsafe will be of great value in helping to protect the
American people as well as Medicare from fraud and abuse. Anecdotal
evidence is not sufficient.
I applaud Congress for establishing the Office of Alternative
Medicine and elevating its status and funding to the NIH National
Center for Complementary and Alternative Medicine. However, their
budget is still only a small fraction of the overall NIH budget.
Although at least 50 percent of the determinants of our health are our
behaviors such as diet and lifestyle, only 1.4 percent of the national
health expenditures and only 7 percent of the NIH budget is devoted to
these areas.
The editors of The New England Journal of Medicine (1998;339(12),
p. 839-841) stated, ``There cannot be two kinds of medicine--
conventional and alternative. There is only medicine that has been
adequately tested and medicine that has not, medicine that works and
medicine that may or may not work. Once a treatment has been tested
rigorously, it no longer matters whether it was considered alternative
at the outset. If it is found to be reasonably safe and effective, it
will be accepted.'' But this presumes that funding is available to for
rigorous testing.
Although research in alternative and mind/body medicine is so
important, it is very difficult to obtain funding to do these studies.
In my experience, it is often a catch-22: there is a presumption at the
NIH and among many funding agencies that these approaches have little
value, so they are reluctant to fund studies to determine their
effectiveness, yet one cannot assess their effectiveness without
funding to do the research. Thus, it is important to increase funding
and support for the National Center for Complementary and Alternative
Medicine and to encourage the rest of the NIH to conduct rigorous
research in these areas. The presumption that unstudied approaches have
no value is itself unscientific until these approaches are
scientifically studied and tested.
The medicine of the 21st century should integrate the best of
traditional allopathic medicine and complementary or alternative
medicine. Our research has demonstrated that this integrated approach
is both medically effective and cost effective.
We tend to think of advances in medicine as a new drug, a new
surgical technique, a laser, something high-tech and expensive. We
often have a hard time believing that the simple choices that we make
each day in our lives--what we eat, how we respond to stress, whether
or not we smoke, how much we exercise, and the quality of our social
relationships--can make such a powerful difference in our health and
well-being, even in our survival, but they often do.
When we treat these underlying causes of diet and lifestyle, we
find that the body often has a remarkable capacity to begin healing
itself, and much more quickly than had once been thought possible. On
the other hand, if we just literally bypass the problem with surgery or
figuratively with drugs without also addressing these underlying
causes, then the same problem may recur, new problems may emerge, or we
may be faced with painful choices--like mopping up the floor around an
overflowing sink without also turning off the faucet.
For example, one-third to one-half of angioplastied arteries
restenose (clog up) again after only four to six months, and up to one-
half of bypass grafts reocclude within only a few years. When this
occurs, then coronary bypass surgery or coronary angioplasty is often
repeated, thereby incurring additional costs. Yet over $20 billion were
spent in the United States last year just on these two operations, many
of which could be avoided by making comprehensive changes in diet and
lifestyle.
In our research, we use the latest high-tech, expensive, state-of-
the-art medical technologies such as computer-analyzed quantitative
coronary arteriography and cardiac PET scans to prove the power of
ancient, low-tech, and inexpensive alternative and mind/body
interventions. Below is a summary of some of our scientific studies:
CAN LIFESTYLE CHANGES REVERSE HEART DISEASE?
We began conducting research in 1977 to determine if coronary heart
disease is reversible by making intensive changes in diet and
lifestyle. Within a few weeks after making comprehensive lifestyle
changes, the patients in our research reported a 91 percent average
reduction in the frequency of angina. Most of the patients became
essentially pain-free, including those who had been unable to work or
engage in daily activities due to severe chest pain. Within a month, we
measured increased blood flow to the heart and improvements in the
heart's ability to pump. And within a year, even severely blocked
coronary arteries began to improve in 82 percent of the patients. The
improvement in quality of life was dramatic for most of these patients.
These research findings were published in the most well-respected
peer-reviewed medical journals, including the Journal of the American
Medical Association, The Lancet, Circulation, The American Journal of
Cardiology, and others. This research was funded in part by the
National Heart, Lung, and Blood Institute of the National Institutes of
Health.
We found that most of the study participants were able to maintain
comprehensive lifestyle changes for at least five years. On average,
they demonstrated even more reversal of heart disease after five years
than after one year. In contrast, the patients in the comparison group
who made only the moderate lifestyle changes recommended by many
physicians and agencies (i.e., a 30 percent fat diet) worsened after
one year and their coronary arteries became even more clogged after
five years.
Thus, instead of getting worse and worse, these patients who made
comprehensive lifestyle changes on average got better and better. Also,
we found that the incidence of cardiac events (e.g., heart attacks,
strokes, bypass surgery, and angioplasty ) was 2.5 times lower in the
group that made comprehensive lifestyle changes after five years. A
one-hour documentary of this work was broadcast on NOVA, the PBS
science series, and was featured on Bill Moyers' PBS series, Healing &
The Mind.
These research findings have particular significance for Americans
in the Medicare population. One of the most meaningful findings in our
research was that the older patients improved as much as the younger
ones. When we began the research, we believed that the younger patients
with milder disease would be more likely to show regression, but we
were wrong. Instead, the primary determinant of change in their
coronary artery disease was neither age nor disease severity but
adherence to the recommended changes in diet and lifestyle. No matter
how old they were, on average, the more people changed their diet and
lifestyle, the more they improved. Indeed, the oldest patient in our
study (now 86) showed more reversal than anyone. This is a very hopeful
message for Medicare patients, since the risks of bypass surgery and
angioplasty increase with age, but the benefits of comprehensive
lifestyle changes may occur at any age.
These findings also have particular significance for women. Heart
disease is, by far, the leading cause of death in women in the Medicare
population. Women have less access to bypass surgery and angioplasty.
When women undergo these operations, they have higher morbidity and
mortality rates than men. However, women seem to be able to reverse
heart disease more easily than men when they make comprehensive
lifestyle changes.
MULTICENTER LIFESTYLE DEMONSTRATION PROJECT
The next research question was: how practical and cost-effective is
this lifestyle program?
There is bipartisan interest in finding ways to control health care
costs without compromising the quality of care. Many people are
concerned that the managed care approaches of shortening hospital
stays, shifting from inpatient to outpatient surgery, forcing doctors
to see more and more patients in less and less time, etc., may
compromise the quality of care because they do not address the
lifestyle factors that often lead to illnesses like coronary heart
disease.
Beginning five years ago, my colleagues and I established the
Multicenter Lifestyle Demonstration Project. It was designed to
determine (a) if we could train other teams of health professionals in
diverse regions of the country to motivate their patients to follow
this lifestyle program; (b) if this program may be an equivalently safe
and effective alternative to bypass surgery and angioplasty in selected
patients with severe but stable coronary artery disease; and (c) the
resulting cost savings. In other words, can some patients avoid bypass
surgery and angioplasty by making comprehensive lifestyle changes at
lower cost without increasing cardiac morbidity and mortality?
In the past, lifestyle changes have been viewed only as prevention,
increasing costs in the short run for a possible savings years later.
Now, this program is offered as a scientifically-proven alternative
treatment to many patients who otherwise were eligible for coronary
artery bypass surgery or angioplasty, thereby resulting in an immediate
and substantial cost savings.
For every patient who chooses this lifestyle program rather than
undergoing bypass surgery or angioplasty , thousands of dollars are
immediately saved that otherwise would have been spent; much more when
complications occur. (Of course, this does not include sparing the
patient the trauma of undergoing cardiac surgery.) Also, providing
lifestyle changes as a direct alternative for patients who otherwise
would receive coronary bypass surgery or coronary angioplasty may
result in significant long-term cost savings.
Through our non-profit research institute (PMRI), we trained a
diverse selection of hospitals around the country. Also, Highmark Blue
Cross Blue Shield of Western Pennsylvania was the first insurer to both
cover and to provide this program to its members, now at three
different sites, including Windber Hospital in Johnstown, PA. Mutual of
Omaha was the first insurance company to cover this program in 1993.
Over 40 other insurance companies are covering this approach as a
defined program either for all qualified members or on a case by case
basis at the sites we have trained.
In brief, we found that 77 percent of people who were eligible for
bypass surgery or angioplasty were able to avoid it safely by making
comprehensive diet and lifestyle changes in the hospitals we trained.
Mutual of Omaha calculated an immediate savings of almost $30,000 per
patient. Patients reported reductions in angina comparable to what can
be achieved with bypass surgery or angioplasty without the costs or
risks of surgery. These findings were published in the American Journal
of Cardiology in November 1998. We also found that patients who needed
bypass surgery or angioplasty were able to reduce the likelihood of
needing another operation by making comprehensive lifestyle changes
after surgery. Since then, of the 300 heart patients at Highmark Blue
Cross Blue Shield who are in the program, none has suffered a heart
attack, stroke, or required bypass surgery, only one patient underwent
angioplasty, and none has died.
Several patients with such severe heart disease that they were
waiting on the heart transplant list for a donor heart (due to ischemic
cardiomyopathies) improved sufficiently that they were able to get off
the heart transplant list. This improvement was not only clinically but
also objectively verified by cardiac PET scans and/or echocardiograms.
Avoiding a heart transplant saves more than $300,000 per patient as
well as significant physical and emotional trauma.
In summary, we found that we were able to train other health
professionals to motivate their patients to make and maintain
comprehensive lifestyle changes to a larger degree than have ever been
reported in a real-world environment. These lifestyle changes resulted
in cost savings that were immediate and dramatic in most of these
patients. These findings are giving many people new hope and new
choices.
MEDICARE
Over 500,000 Americans die annually from coronary artery disease,
making it the leading cause of death in this country. Approximately
500,000 coronary artery bypass operations and approximately 600,000
coronary angioplasties were performed in the United States in 1998 at a
combined cost of over $20 billion, more than for any other surgical
procedure. Much of this expense is paid for by Medicare. Not everyone
is interested in changing lifestyle, and some people with extremely
severe and unstable disease may benefit from surgery, but billions of
dollars per year could be saved immediately if only some of the people
who were eligible for bypass surgery or angioplasty were able to avoid
it by making comprehensive lifestyle changes instead.
Unfortunately, for many Americans on Medicare, the denial of
coverage is the denial of access. Because of the success of our
research and demonstration projects, we asked the Health Care Financing
Administration (HCFA) to provide coverage for this program. We believe
that this can help provide a new model for lowering Medicare costs
without compromising the quality of care or access to care. In short, a
model that is caring and compassionate as well as cost-effective and
competent.
This approach empowers the individual, may immediately and
substantially reduce health care costs while improving the quality of
care, and offers the information and tools that allow individuals to be
responsible for their own health care choices and decisions. It
provides access to quality, compassionate, and affordable health care
to those who most need it.
Because of the success of our Multicenter Lifestyle Demonstration
Project, HCFA conducted their own internal peer review of our program.
Recently, HCFA agreed to move forward with a demonstration project to
determine the medical effectiveness of our program in the Medicare
population. If they validate the cost savings that we have already
shown in the Multicenter Lifestyle Demonstration Project, then they may
decide to cover this program as a defined benefit for all Medicare
beneficiaries. If this happens, then most other insurance companies may
do the same, thereby making the program available to the people who
most need it.
Medicare coverage also affects medical training and education. If
we demonstrate the cost-effectiveness of our program in the Medicare
population, we will provide a new model for lowering Medicare costs
without compromising the quality of care or access to care. This
demonstration project is about to begin in the sites we have trained.
Also, Congress appropriated funds via the Department of Defense for
us to train the Walter Reed Army Medical Center and the Bethesda
National Naval Medical Center in our program for reversing heart
disease. The program at Walter Reed is scheduled to begin operation
next month.
CAN PROSTATE CANCER BE SLOWED, STOPPED, OR REVERSED BY CHANGING
LIFESTYLE?
Three years ago, we began conducting the first randomized
controlled trial to determine if prostate cancer may be affected by
making comprehensive changes in diet and lifestyle, without surgery,
radiation, or drug (hormonal) treatments.
The scientific evidence from animal studies, epidemiological
studies, and anecdotal case reports in humans is very similar to the
way it was with respect to coronary heart disease when my colleagues
and I began conducting research in this area over twenty years ago. For
example, the incidence of clinically significant prostate cancer (as
well as heart disease, breast cancer, and colon cancer) is much lower
in parts of the world that eat a predominantly low-fat, whole foods,
plant-based diet. Subgroups of people in the U.S. who eat this diet
also have much lower rates of prostate cancer and breast cancer than
those eating a typical American diet.
This study is being conducted in collaboration with Peter Carroll,
M.D. (Chairman, Department of Urology, UCSF School of Medicine) and
William Fair, M.D. (Professor and recent Chairman of Urology, Memorial
Sloan-Kettering Cancer Center in New York). Patients with biopsy-proven
prostate cancer who have elected to undergo ``watchful waiting'' (i.e.,
no treatment) are randomly assigned to an experimental group that is
asked to make comprehensive diet and lifestyle changes or to a control
group that is not. Both groups are studied and compared.
Because of these epidemiological, animal, and anecdotal human data,
I am encouraged by the possibility of being able to determine if the
progression of prostate cancer may be modified in humans. If we are
successful in demonstrating that we may affect the progression of
prostate cancer, the implications for helping to prevent prostate
cancer may be of equal importance. Also, these findings may extend to
some other forms of cancer, including breast cancer and colon cancer,
both of which have been linked to diets high in fat and animal protein.
We have the opportunity to determine the effects of diet and
comprehensive lifestyle changes on prostate cancer without confounding
variables, a study that would not be ethically possible in breast
cancer, colon cancer, or related illnesses. Whatever we show, the data
will be of wide interest.
In our study, patients are tested with PSA levels and free PSA
levels twice at baseline and again every three months thereafter for
one year. Additional tests include MRI and MR spectroscopy scans of the
prostate to determine tumor size and activity. These are performed at
baseline and after one year.
While it would be premature and unwise to draw any definitive
conclusions from a study that is still in progress, our preliminary
data are encouraging. Dr. Carroll and I presented our interim findings
at scientific meeting organized by the National Cancer Institute in
Baltimore in August and at the CapCURE annual scientific session in
October 1999. We found that PSA levels are decreasing in the
experimental group and increasing in the control group. Also, the
degree of adherence to the lifestyle program was directly correlated
with changes in PSA.
In summary, our experience provides a model for taking alternative
medicine mind/body interventions into the mainstream. First, conduct
rigorous scientific studies published in peer-reviewed medical and
scientific journals to evaluate medical effectiveness and to understand
mechanisms of healing. Then, conduct studies to demonstrate cost
effectiveness. Finally, obtain coverage from third party payers and
Medicare to make this program available to those who may benefit from
it.
I would be grateful if Congress would increase the support of
research in alternative medicine and mind/body interventions and
encourage the Health Care Financing Administration to cover alternative
medicine and mind/body programs that have demonstrated medically
effectiveness in randomized controlled trials published in peer-
reviewed medical journals. In particular, please consider increasing
the budgets of the NIH National Center for Complementary and
Alternative Medicine, the NIH Office of Behavioral and Social Sciences
Research, and related governmental agencies.
Thank you very much for the opportunity to share these thoughts
with you today.
Senator Specter. Thank you very much, Dr. Ornish.
STATEMENT OF WALTER CZAPLIEWICZ
Senator Specter. We will now turn to Mr. Walter
Czapliewicz, assistant general manager for Bidwell Food
Services in Pittsburgh, here today to discuss his participation
in ``The Dean Ornish Program for Reversing Heart Disease.''
Regrettably, I am going to have to excuse myself at this
point. I am due on the Senate floor. We are debating an
amendment which I am an original co-sponsor. I want to thank
you for coming, gentlemen. And I think we are moving forward on
this very important subject. And this today's hearing, I think,
is a big help.
My distinguished colleague, Senator Harkin, has agreed to
chair for the remaining time, which is relatively brief.
Thank you.
Mr. Czapliewicz. Thank you, Senator.
Good morning. My name is Walt Czapliewicz, and I am 44
years old and a resident of Pittsburgh, PA. About 11 weeks ago,
I became a participant in the Dr. Dean Ornish Program for
Reversing Heart Disease offered by Highmark Blue Cross/Blue
Shield.
I came to the program with a medical history of
hypertension and coronary heart disease. In fact, before I
joined the Ornish Program, I had three heart attacks. The first
one was on Christmas Day in 1996. I had two more heart attacks
in the following year. And I had bypass surgery in October of
1997.
I seemed to be doing well for about 2 years. Then in the
fall of 1999 I started experiencing chest pain again. The
bypass was clogging up again. The pain became more and more
frequent. So I was taking nitroglycerine pills several times a
week. I would get pain after walking, after meals or during
times of stress. I could tell by how I felt that I knew I was
going to have a fourth heart attack and need more bypass
surgery soon.
As the new year approached, I saw a story in the newspaper
about Dr. Ornish's program. I asked my cardiologist for his
thoughts, and he recommended it. I started the program 10 weeks
ago. Right from the start, I followed it 100 percent. Within
the first 10 days, my chest pain diminished greatly. And it was
completely gone after 6 weeks. In fact, I have not had any
chest pain since then.
I have lost 34 pounds in the past 10 weeks, even though I
am eating more food and more frequently than before, so I do
not feel deprived or hungry. Because the food is low in fat, it
is also low in calories. When I started the program, my stress
test was abnormal.
After only 6 weeks, it came back negative. And after just 9
weeks in the program, my resting blood pressure went from 160
over 80 to 128 over 72. My cholesterol is also much lower,
overall from 193 to 114. And my triglycerides have decreased
from 316 to 103.
All four of the program's components, diet, exercise,
stress management and group support, have been a true blessing
to me. The results I have experienced in the first weeks alone
made me even more committed to the program. I am fortunate to
live in an area where my health insurance company, Highmark
Blue Cross/Blue Shield, had the vision to make this program a
reality.
In 1997 Highmark became the first health insurer in the
country to both provide and pay for the Ornish Program for
their customers. My experience with the program and the
Highmark staff has been nothing but positive. Many of the
participants are over age 65. In fact, I was the youngest in my
group.
But as we all know, heart disease can strike any of us,
young and old alike. The older participants in the program are
doing as well as the younger ones.
We share group meals, exercise sessions and, perhaps most
importantly, our life experiences, all of which created a
close-knit group working toward a common goal, good health. I
manage stress so much better than before.
The nutrition portion of the program also has contributed
to my improved health status and more positive attitude. The
diet consists primarily of fruits, vegetables, grains, beans,
non-fat dairy egg whites, and no added oils, which make the
diet about 10 percent fat. I also was advised to take some
vitamins and fish oil supplements.
I manage a catering company, so this was a big change in my
diet at first. But now I like it. The recipes in the program
from appetizers to desserts are delicious, nutritious and easy
to prepare. And I feel so much better. It is worth it.
The program's supervision is also very comforting. We are
guided through the program sessions by some very skilled
professionals, including a medical director, registered
dieticians, exercise physiologists, stress management
instructors, behavior health clinicians, and nurse case
managers. All participants remain under the care and control of
their own physicians, who receive regular progress reports and
copies of all tests.
In closing, I would like to reiterate my dramatic
improvements in the Dr. Dean Ornish Program. This program
reflects a commitment to offering innovative solutions that
truly improve one's health. The program treats the underlying
causes of heart disease, not just the symptoms, and may spare
patients from surgery and, most importantly, improve their
quality of life.
PREPARED STATEMENT
I think that just about everyone would benefit from a
program like this, whether or not they had heart disease. And I
hope the Government can find ways to make programs like this
more widely available. Thanks to this program, I feel like I am
35 again. I feel better, look better, and I am healthier than I
have been in years.
Coming into the program, I knew I was going to have another
heart attack and need bypass surgery soon. But now I do not.
And now I do not have to endure the pain and fear. And I truly
believe this program saved my life.
Thank you.
[The statement follows:]
Prepared Stastement of Walter Czapliewicz
Good morning. My name is Walter Czapliewicz. I'm 44 years old and a
resident of Pittsburgh, Pennsylvania. About 11 weeks ago, I became a
participant in the Dr. Dean Ornish Program For Reversing Heart Disease
offered by Highmark Blue Cross Blue Shield.
I came to the program with a medical history of hypertension and
coronary heart disease. In fact, before I joined the Ornish program, I
had three heart attacks. The first one was on Christmas day in 1996. I
had two more heart attacks in the following year. I had bypass surgery
in October of 1997.
I seemed to be doing well for about two years. Then, in the Fall of
1999, I started experiencing chest pain again. The bypasses were
clogging up again. The pain became more and more frequent, so I was
taking nitroglycerine pills several times a week. I would get pain
after walking, after meals, or during times of stress.
I could tell by how I felt that I knew I was going to have a fourth
heart attack and need more bypass surgery soon.
As the New Year approached, I saw a story in the newspaper about
Dr. Ornish's Program. I asked my cardiologist, Dr. Bryan Donahoe, for
his thoughts, and he recommended it. I started the program 10 weeks
ago; right from the start, I followed it 100 percent.
Within the first ten days, my chest pain diminished greatly, and it
was completely gone after six weeks! In fact, I haven't had any chest
pain since then. I've lost 34 pounds in the past 10 weeks even though
I'm eating more food and more frequently than before, so I don't feel
deprived or hungry. Because the food is low in fat, it's also low in
calories.
When I started the program, my stress test was abnormal; after only
six weeks, it came back negative. And, after just nine weeks of the
program, my resting blood pressure went from 160/80 to 128/72. My
cholesterol is also much lower.
All four of the program's components diet, exercise, stress
management, and group support have been a true blessing to me. The
results I've experienced in the first weeks alone made me even more
committed to the program.
I am fortunate to live in an area where my health insurance
company, Highmark Blue Cross Blue Shield, had the vision to make this
program a reality. In 1997, Highmark became the first health insurer in
the country to both provide and pay for the Ornish program for their
customers.
My experience with the program and the Highmark staff has been
nothing but positive. Many of the participants are over age 65. In
fact, I was the youngest in my group. But, as we all know, heart
disease can strike any of us, young and old alike. The older
participants in the program are doing as well as the younger ones.
We share group meals, exercise sessions, and, perhaps most
importantly, our life experiences all of which created a close-knit
group working toward a common goal: good health. I manage stress so
much better than before.
The nutrition portion of the program also has contributed to my
improved health status and more positive attitude. The diet consists
primarily of fruits, vegetables, grains, beans, non-fat dairy egg
whites and no added oils, which makes the diet about 10 percent fat. I
also was advised to take some vitamins and fish oil supplements.
I manage a catering company, so this was a big change in my diet at
first, but now I like it. The recipes in the program from appetizers to
desserts are delicious, nutritious, and easy to prepare. And I feel so
much better, it's worth it.
The program supervision is also very comforting. We are guided
through the program sessions by some very skilled professionals
including a medical director, registered dietitians, exercise
physiologists, stress management instructors, behavioral health
clinicians, and nurse case managers.
All participants remain under the care and control of their own
physicians, who receive regular progress reports and copies of all
tests.
In closing, I'd like to reiterate my dramatic improvements in the
Dr. Dean Ornish Program. This program reflects a commitment to offering
innovative solutions that truly improve one's health. The program
treats the underlying causes of heart disease not just the symptoms and
may spare patients from surgery and, most importantly, improve their
quality of life.
I think that just about everyone would benefit from a program like
this, whether or not they had heart disease. I hope the government can
find ways to make programs like this more widely available.
Thanks to this program, I feel like I'm 35 again. I feel better,
look better, and am healthier than I have been in years. Coming into
the program, I knew I was going to have a heart attack and need more
bypass surgery soon, but now I don't. Now, I don't have to endure the
pain and fear. I truly believe this program saved my life.
Senator Harkin [presiding]. Thank you very much. Pronounce
your last name, so I do not mispronounce it.
Mr. Czapliewicz. Czapliewicz.
Senator Harkin. Thank you very much for that testimony, Mr.
Czapliewicz.
And thank you, Dr. Ornish, for being here and for all the
great work that you do. I have a couple three questions. First
of all, I remember I visited--I was in New York, I think, at
the Einstein Medical Center back in 1993, just----
Dr. Ornish. Beth Israel, I think.
Senator Harkin. Maybe it was Beth Israel. I forget exactly
where I was, but Beth Israel. It was about 1993, just about the
time when a couple insurance companies were starting to provide
coverage. So I visited some of your patients in New York at
that time and was just astounded at the progress that they had
made. And every single one of them was like Mr. Czapliewicz.
They were just overjoyed at what had happened to them.
Well, that was in 1993. This is 7 years later. Now you say
some other insurance companies are now starting to cover this,
right? You have how many--there is more than just a couple.
Dr. Ornish. There are about 40 altogether. And recently,
Medicare agreed to move forward on its demonstration project.
But it is a slow process.
Senator Harkin. Now Medicare is not doing anything in this,
though, right?
Dr. Ornish. Well, you know, we tend to think of advanced in
medicine as a new drug or a new surgical technique or new laser
or something really high tech and expensive. And insurance
companies often have a hard time believing that the simple
choices that we make in our lives every day, you know, like
what we eat and how we respond to stress and so on, can make
such a powerful difference.
But as you say, Mr. Czapliewicz, the stories that you have
heard, I mean, I see this over and over and over again. It is
frustrating to me that there is not more coverage for something
that is not only the right thing to do, but can save them so
much money.
Senator Harkin. Absolutely. And make them feel better. I
guess I just want to make a point here for the record again,
that--and for the people of the press who are here. If someone
who is on Medicare goes in for bypass surgery, Medicare pays
for it.
Dr. Ornish. That is right.
Senator Harkin. If someone with the same situation wants to
go into your program, will Medicare pay for it?
Dr. Ornish. No, sir. Well, actually they will now, because
they just agreed to do a demonstration.
Senator Harkin. Well, that is only in a demonstration mode.
Dr. Ornish. But not as a defined benefit. No, sir. And it
is unfortunate, because we have already shown that it can save
an average of $30,000. These are--you know, traditionally
insurance companies have been reluctant to pay for alternative
medicine or mind/body interventions, in part because they say
these are prevention.
It may take 5 years to see the benefit. By then, they have
changed companies. So why should we spend our money for some
future benefit that, chances are, someone else is going to get.
And we said this is not just prevention, it is an
alternative treatment. And for every man or woman who would
have undergone bypass surgery who can avoid it, you save
$30,000 immediately. You know, real dollars today, not just
theoretical dollars years later. Their skepticism was, well,
you know, people cannot change, it is too hard, so we will end
up paying for the bypass anyway.
Well, we have shown in a demonstration project, and we have
now trained over 20 sites, that almost 80 percent of the people
were able to avoid the surgery. It has taken us 6 years going
back and forth with the Health Care Financing Administration
just to get to the point where we are finally ready to begin a
demonstration project. Even so though this is something that is
in the best interest of everyone, the American people, HCFA can
do something innovative.
And, you know, as you know, traditional approaches to
saving money are really frustrating Americans, shortening
hospital stays, shifting to outpatient surgery, forcing doctors
to see more and more patients in less and less time. None of
those really address the more fundamental causes of why people
get sick. And that is one of the reasons why people are going
to alternative practitioners, because they spend time with
people, and they listen to them, and they do not rush them out.
So what we are trying to do is to create a new model that
is more caring and more compassionate, whereby treating the
underlying causes instead of just bypassing them, you know,
literally or figuratively, it saves money, as well as being the
right thing to do.
And as Dr. Benson says, it empowers people with
information, rather than just doing things to them, which, you
know, half or the angioplasties clog up within just 4 to 6
months, and up to half of the bypasses within just a few years.
And we spent $20 billion last year just on those two
operations.
These kind of approaches go way beyond heart diseases. We
focused on that as a model for how powerful these changes can
be. And nothing would please me more than if Congress could,
you know pass legislation so that the Health Care Financing
Administration can make this available. Because if they cover
it, everyone will cover it.
And in the final analysis, we doctors do what we get paid
to do. And we get trained to do what we get paid to do. So no
single effect that Congress could do would make a bigger
difference in medical practice and medical education than
passing legislation encouraging the Health Care Financing
Administration to cover these kinds of interventions.
Senator Harkin. We have been on them for some time, because
it is evidence based now. Honestly, I wish I knew why they were
dragging their feet so much. I guess it is just part of a
larger question. We have the evidence of the efficacy of your
approach.
Dr. Ornish. Yes.
Senator Harkin. Why is it taking so long for it to be
accepted in normal practice? Why are we not integrating these
into current practices?
Dr. Ornish. Well, Senator, I have asked myself that
question a long time, because I have been doing this work for
23 years. And I used to think that if we just did good science
and the science was well accepted, that would change medical
practice.
But I was naive. It is not enough to have good science. I
am the scientist. I believe in the power of science. I am
continuing to do science. I think science can really help
people sort out what is truth from what is not.
But it is more than science that is required. It is
reimbursement. And as I say, if we change reimbursement, we
change medical practice, and we change medical education. It is
very difficult for entrench bureaucracies to do things that are
innovative, because there is always a risk associated with it.
But I think that, here again, if Congress legislated HCFA
with the authority and the requirement to begin doing not only
demonstrations like what we are doing, but covering those
programs that have the science, nothing will make a faster and
more powerful difference in the American people. And it would
save billions of dollars a year.
Senator Harkin. I think one of the problems we have is
that, like Mr. Czapliewicz, when you entered the program, you
had supervision, you had a support group, you had all of that
around you. I think for a lot of people out there they just do
not have that.
People say, yes, I would like to change my lifestyle, I
would like to change it. But they have to have support. They
have had a whole lifetime of eating fat foods and terrible
diets and not exercising. And somehow they need the kind of
integration into a group that you had. But people do not have
that. So the only thing they have left is to go in and have
bypass surgery.
Dr. Ornish. Well, that is why we are trying to create new
models in medicine that are more caring and compassionate that
are also more cost effective and competent. And, you know, if I
went into an insurance company or Medicare and said, we want to
create places for people to learn to create community and open
their hearts to each other, they would show me the door.
But if we can show them PET scans and the angiograms and
the specthalium and the rate--the--showing these people are
getting better, and for every dollar they spend they are saving
several more--it also allows us to address not only things like
diet and exercise, which are so important, but the kind of
things that Dr. Benson writes so eloquently about, the psycho-
social, the emotional and the spiritual dimensions as well.
Senator Harkin. Just a couple other things. We have to
close up here. Your study on prostate cancer, is the--I was
trying to read through your statement there. But is this based
on more use of soy-based products?
Dr. Ornish. It is a soy-based project, too.
Senator Harkin. And isoflavins and things like that?
Dr. Ornish. Yes, sir. It includes that. But it is also a
program very similar to what we found can reverse heart
disease. And it is being funded in part by the Department of
Defense through its appropriation and also through foundations
like Captor and others.
It is a multi-factorial interventions, because I think we
are at a place with respect to prostate cancer very similar to
where we were with heart disease 23 years ago. If you look at
the animal data, the epidemiological data.
You know, like in China they have a fraction, 120 times
less prostate cancer than we have here. But when they begin to
eat here and live like us, they begin to die like us, not only
heart disease, but prostate, breast, colon cancer, all kinds of
other diseases.
And so I think that we are taking men who have biopsy-
proven cancer, who have decided not to be treated
conventionally, randomly divided them into two groups. Half of
them go through our program, half of them do not. And we
compare them.
We are doing this in collaboration with Memorial Sloan-
Kettering Cancer Center in New York and at UCSF. And we are
finding that it seems to be making a difference. And I think
that if it is true for prostate cancer, it will likely be true
for breast and colon cancer as well.
Senator Harkin. How about the step previous, before you
have biopsy-proven prostate cancer, as a preventative measure?
Dr. Ornish. Well, clearly, we focused on areas where people
are sick, to try to show that if you can reverse disease,
clearly you can prevent it. It may take years to wait for the
heart attack that does not come or the prostate cancer that
does not come.
But if you can take somebody who is already sick and turn
that around, then clearly it works to prevent it even better.
In particular with heart disease, that is important
because, you know, a third of people first find out they have a
heart problem when they die from it, which of course is not a
good way to find out. And so prevention is what we really need
to be talking about.
You mentioned earlier about teaching our children how to
eat more healthfully. I think that is really where it has to
begin. But here again, it really comes down to Congress.
Your leadership, Senator, and Senator Specter's leadership
in setting up the Center for Alternative Medicine, the National
CCAM, is making a huge difference. But if we can now take the
next step and get legislation passed, it could be a quantum
breakthrough.
Senator Harkin. Well, I would like to have some more of
your thoughts on the legislation. You are mostly talking about
reimbursement is what you are talking about, I guess, right?
Dr. Ornish. Well, again, reimbursement is the single most
important factor in medical practice and medical education.
Even Dr. Weil talked about the difficulties they are having.
And, you know, he is very prominent. So we need to provide--it
is like, you know, what Willy Sutton said, if we can show where
the money is, I think that the other things will follow. Not at
the expense of the science.
And here again, I would like to see two things, in summary.
More money for research in this area to get the science, to
help people sort things out. You know, one of the catch-22's is
that it is very hard to get funding to do these studies,
because they do not think it is worth doing. And without the
funding, you cannot show it is worth doing. And if they do not
think it is worth doing, they do not want to fund it.
So funding to support this, to do good science, and
legislation to encourage Medicare to cover programs like this
and like Dr. Benson's and others, because if these are covered,
doctors will do it. And until then, it will remain on the
fringes of medical practice, no matter how good the science is.
Senator Harkin. Lastly, on a personal note, talking about
diets and nutrition, I have prided myself on having a good diet
and good nutrition program for myself and for my wife. But our
two daughters grew up, and they always cooked our meals. That
was part of the deal.
When they were in high school, they had to cook dinner for
us. Right? We got our own breakfast. And so we had a good
regimen.
Well, they are both gone now. So my wife works and I work.
I get home late. She gets home late. Put something in the
microwave and just read the ingredients on this stuff.
Dr. Ornish. I know.
Senator Harkin. They are awful. So I have gone to health
food stores and places to look for more--fast food is wrong.
What do you call it?
Dr. Ornish. Convenience.
Senator Harkin. Convenience foods that are quick, that you
can eat. Now it seems to me that somebody has to start making
better foods in convenience packages that are more healthy than
what we are finding. I mean, they are either loaded with fat or
the sodium level is out of this world.
I am just wondering. You are on top of all this. Is there
anything going on that would provide more convenience foods
that are in accordance with the diets that you and others have
outlined?
Dr. Ornish. Well, as a matter of fact, I have worked with
ConAgro to develop a line of foods--I have consulted with
them--that fit these guidelines, to try to make it easier for
people to eat this way. As a scientist, I am trying to do the
best research I can. But as an educator, I am trying to get
this out to people who can benefit from it.
But the great thing about America is supply and demand. And
as people become more educated about the power of these changes
in diet and lifestyle, as we get more coverage to make these
kinds of things available, then consumers will begin demanding
that. And then manufacturers will begin making them available.
Senator Harkin. Well, I hope so. There is a dearth of good
products out there right now for people that need to eat in a
hurry.
Dr. Ornish. I agree. I am also working with Web MD, an
Internet provider, to get this information out worldwide to
people who can benefit from it. There is a globalization of
illness that is occurring around the world, as people begin to
copy our fast foods and so on.
But we can use that same technology to get information to
people that can heal them, as opposed to causing them to become
sick.
Senator Harkin. OK. Well, thank you very much, Dr. Ornish
and Mr. Czapliewicz, Dr. Benson, Dr. Straus, whoever else is
left here.
Thank you all very much. It has been a very interesting and
very good hearing.
Dr. Ornish. Thank you, Senator. I am very grateful.
Senator Harkin. Again, I want to compliment Dr. Straus and
his leadership at NCAM and look forward to doing some more
things in the future in terms of what you have talked about
here, reimbursement and--I also want to look at some of the
provisions in mind/body health that we might be able to move
ahead on, too.
So thank you all very much for all of your leadership in
this area. You are truly making a big difference out there.
Thank you, all.
Dr. Ornish. Thank you, Senator. So are you.
CONCLUSION OF HEARING
Senator Harkin. Thank you all very much for being here,
that concludes the hearing. The subcommittee will stand in
recess subject to the call of the Chair.
[Whereupon, at 11:26 a.m., Tuesday, March 28, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
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