[Senate Hearing 107-599]
[From the U.S. Government Publishing Office]
S. Hrg. 107-599
IMPACTS OF STRESS MANAGEMENT IN REVERSING HEART DISEASE
=======================================================================
HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
MAY 16, 2002--WASHINGTON, DC
__________
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______
COMMITTEE ON APPROPRIATIONS
ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii TED STEVENS, Alaska
ERNEST F. HOLLINGS, South Carolina THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont ARLEN SPECTER, Pennsylvania
TOM HARKIN, Iowa PETE V. DOMENICI, New Mexico
BARBARA A. MIKULSKI, Maryland CHRISTOPHER S. BOND, Missouri
HARRY REID, Nevada MITCH McCONNELL, Kentucky
HERB KOHL, Wisconsin CONRAD BURNS, Montana
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama
BYRON L. DORGAN, North Dakota JUDD GREGG, New Hampshire
DIANNE FEINSTEIN, California ROBERT F. BENNETT, Utah
RICHARD J. DURBIN, Illinois BEN NIGHTHORSE CAMPBELL, Colorado
TIM JOHNSON, South Dakota LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island MIKE DeWINE, Ohio
Terrence E. Sauvain, Staff Director
Charles Kieffer, Deputy Staff Director
Steven J. Cortese, Minority Staff Director
Lisa Sutherland, Minority Deputy Staff Director
------
Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
TOM HARKIN, Iowa, Chairman
ERNEST F. HOLLINGS, South Carolina ARLEN SPECTER, Pennsylvania
DANIEL K. INOUYE, Hawaii THAD COCHRAN, Mississippi
HARRY REID, Nevada JUDD GREGG, New Hampshire
HERB KOHL, Wisconsin LARRY CRAIG, Idaho
PATTY MURRAY, Washington KAY BAILEY HUTCHISON, Texas
MARY L. LANDRIEU, Louisiana TED STEVENS, Alaska
ROBERT C. BYRD, West Virginia MIKE DeWINE, Ohio
Professional Staff
Ellen Murray
Jim Sourwine
Mark Laisch
Adrienne Hallett
Erik Fatemi
Bettilou Taylor (Minority)
Mary Dietrich (Minority)
Sudip Shrikant Parikh (Minority)
Candice Rogers (Minority)
Administrative Support
Carole Geagley
C O N T E N T S
----------
Page
Opening statement of Senator Arlen Specter....................... 1
Statement of Peter G. Kaufmann, Ph.D., Behavioral Medicine
Scientific Research Group Leader, Clinical Applications and
Prevention Program, Division of Epidemiology and Clinical
Applications, National Heart, Lung, and Blood Institute,
National Institutes of Health, Department of Health and Human
Services....................................................... 2
Prepared statement........................................... 4
Statement of David B. Abrams, Ph.D., professor of psychiatry and
human behavior, Brown Medical Center........................... 6
Prepared statement........................................... 8
Statement of Herbert Benson, M.D., president, Mind/Body Medical
Institute, professor of medicine, Harvard Medical School....... 9
Prepared statement........................................... 11
Statement of Harvey Eisenberg, M.D., director, HealthView Center
for Preventive Medicine........................................ 14
Prepared statement........................................... 16
Statement of Dr. Dean Ornish, founder, president, and director,
Preventive Medicine Research Institute in Sausalito, CA,
clinical professor of medicine at the University of California,
San Francisco, a founder of UCSF'S Osher Center for Integrative
Medicine....................................................... 19
Prepared statement........................................... 23
Statement of Karen Matthews, Ph.D., director, Cardiovascular
Behavioral Medical Research Training Program, University of
Pittsburgh School of Medicine.................................. 32
Prepared statement........................................... 35
Statement of Colonel Marina Vernalis, MC, USA, D.O., Medical
Director, Cardiac Risk Prevention Center, Walter Reed Army
Medical Center................................................. 38
Prepared statement........................................... 40
IMPACTS OF STRESS MANAGEMENT IN REVERSING HEART DISEASE
----------
THURSDAY, MAY 16, 2002
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:25 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Arlen Specter presiding.
Present: Senator Specter.
opening statement of senator arlen specter
Senator Specter. Good morning, ladies and gentlemen. We
will now proceed with this hearing on the impacts of stress
management in reversing heart disease for the Subcommittee on
Labor, Health and Human Services, and Education, of the
Appropriations Committee. We have an extraordinary collection
of talent here today for this very important subject.
Our subcommittee has held numerous hearings in the 22 years
I have been here on a wide variety of subjects, but we have not
taken a look at the issue of stress management. Senator Harkin,
who is now the chairman--I chaired the committee for 6\1/2\
years until last June--and I work very closely together. We
have almost doubled the NIH budget for example, and we will
complete the doubling this year. We have worked with the CDC
holding many hearings on diet, and many hearings on
cholesterol. A wide variety of subjects, but never on stress
management.
From my own personnel experience, I have come to appreciate
the value of stress management and I am very pleased that we
have been able to assemble this extraordinary group of
scientists for this very important subject. Sometimes the
importance of the subject grows in inverse proportion to the
number of television cameras here. I am glad there is one
television camera here, but I am more interested in finding out
what the hard facts are, and I think this will attract a lot of
attention as we move through the process.
Almost every day in Washington is a complicated day. This
day is somewhat more complicated. The Reagans are receiving a
Congressional Medal of Honor today, so the President decided to
come and meet with Republican Senators before that. On my own
agenda, there is a Pennsylvania judge up for confirmation, a
very critical proceeding for the Court of Appeals. We are
having an executive session at 10 a.m., and I will have to
excuse myself for a few minutes. I may be gone only 5 minutes
or I may have to be gone longer, depending on what happens. It
may be put over until next week, which I think will be the
case, but I wanted to mention that.
I'm prepared to come back and spend as much time as we need
on this subject. The panelists are all invited to lunch, and
100 percent have accepted, for which I'm glad. However, if we
have to skip lunch for the hearing, lunch takes second place,
and all the rest of my activities with the Republican caucus
will take second place as well in order to take the time to
hear the experts. I know people have come long distances and I
am very grateful for that.
STATEMENT OF PETER G. KAUFMANN, Ph.D., BEHAVIORAL
MEDICINE SCIENTIFIC RESEARCH GROUP LEADER,
CLINICAL APPLICATIONS AND PREVENTION
PROGRAM, DIVISION OF EPIDEMIOLOGY AND
CLINICAL APPLICATIONS, NATIONAL HEART,
LUNG, AND BLOOD INSTITUTE, NATIONAL
INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH
AND HUMAN SERVICES
Senator Specter. The protocol of the committee is to hear
first from Dr. Peter G. Kaufmann. Dr. Kaufmann is the Acting
Director of the Office of Behavioral and Social Science
Research at NIH. He serves as leader of the Behavioral Medicine
Research Group at the National Heart, Lung, and Blood
Institute. He has a master's and bachelor's from Loyola, and a
Ph.D. from the University of Chicago. Our protocol dictates
that we hear from him first. So Dr. Kaufmann, we welcome you.
We have a standing committee rule of 5 minutes. It will not
be enforced. But after the presentations, there will be
extensive dialogue. I would not be so presumptuous as to say
questions, but extensive dialog. Dr. Kaufmann, the floor is
yours.
Dr. Kaufmann. Thank you, Mr. Chairman, and good morning to
everyone. Just one small correction; I'm no longer the acting
director of the Office of Behavioral and Social Science
Research, although I still am leader of the Behavioral Medicine
Scientific Research Group at the National Heart, Lung, and
Blood Institute.
Senator Specter. Then I have to find a new chief clerk for
my subcommittee. Anybody interested in the job?
Go ahead, Dr. Kaufmann.
Dr. Kaufmann. I certainly welcome the opportunity to
represent the National Heart, Lung, and Blood Institute, or the
NHLBI, at this special hearing concerning the subcommittee's
interest in the role of stress management in reversing heart
disease.
My purpose today is to give a brief overview of the state
of knowledge in this area. For many years the NHLBI has
supported a vigorous program of research on behavioral and
psychosocial impact of cardiovascular diseases, including
projects conducted by members of this distinguished panel which
is here today. As a result, in addition to the lifestyle risk
factors of smoking, physical inactivity, obesity, diet and
socioeconomic status, we know much more about the importance of
psychosocial factors such as depression, social support,
hostility, and mental stress.
For example, laboratory data obtained from heart patients
showed that mental stress and emotions such as anger could
cause myocardial ischemia, or reduced blood flow to the heart.
Patients who respond to mental stress with myocardial ischemia
are called ``mental-stress-positive.'' The large study funded
by NHLBI recently showed that heart patients who are mental-
stress-positive in the laboratory were also more likely to have
ischemia in everyday life and are more likely to die over the
subsequent 5 years.
This data adds to similar findings from studies at Duke, at
Yale, and at the Uniformed Services University of the Health
Sciences, and suggests that stress management interventions
might improve the clinical status of these patients. Definitive
evidence that stress management is effective, however, must
come from randomized clinical trials, especially trials that
involve an actual infarction as a primary outcome, which is
considered to be the gold standard. Stress management has not
been tested at this level.
Furthermore, it is generally acknowledged that the results
of completed trials are hard to analyze, in part because they
combine stress management with other rehabilitation strategies,
and therefore it is difficult to disaggregate the relative
contributions, and for other weaknesses of the clinical trial
design as well.
Clinical trials conducted by different teams usually
involve different strategies and targets, such as psychosocial
characteristics, making it difficult to compare the results.
Keeping in mind these limitations, we do note that a recent
review of a variety of treatment strategies and randomized
trials concluded that patients derive significant benefit when
psychosocial interventions are added to usual medical care.
One preliminary study funded by the Institute and conducted
at Duke University offered some of the best evidence that a
stress management program may reduce the rate of second heart
attack and the need for revascularization. Benefits may persist
for 5 years, and the study has shown that medical expenditures
may also be reduced. These promising results are now being
tested in a larger study, also funded by this Institute.
The question of whether stress management can reverse heart
disease is of considerable interest. Atherosclerosis is a
common condition involving deposition of cholesterol,
structural changes in the arterial wall, inflammation and
calcification. Aggressive lowering of blood cholesterol levels
with lipid lowering drugs can slow progressive atherosclerosis
and improve vascular function and blood flow to the heart, and
reduce heart attacks.
A small number of clinical trials involving intensive
dietary modification have shown similar success. One of these,
Dr. Ornish's heart trial, included stress management along with
diet. It is not possible to know to what extent stress
management contributed to the observed results.
It is also informative to consider that stress management
has had only limited success in reducing blood pressure, a
condition for which it has been examined much more thoroughly
than for atherosclerosis. This suggests that developing
effective stress management interventions for coronary heart
disease patients will require sustained efforts.
In conclusion, what can we do today? We believe that a well
designed clinical trial is needed to evaluate the potential of
stress management in cardiac rehabilitation. However, because
peak stress can trigger cardiac events, and initial results
conclude that a trial seems promising, it is also prudent to
include stress management in cardiac rehabilitation programs
for patients who want the intervention. To do so would improve
quality of life and promote lifestyle changes.
prepared statement
In addition, reducing high fat diets, smoking,
sedentariness and overweight reduces cardiac risks
substantially. Attention to these lifestyle factors will
benefit the public health.
So I thank you and I will be pleased to answer your
questions.
[The statement follows:]
Prepared Statement of Dr. Peter Kaufman
Mr. Chairman and Members of the Committee: I welcome the
opportunity to appear before you on behalf of the National Heart, Lung,
and Blood Institute (NHLBI) of the National Institutes of Health to
address the Subcommittee's interest in the role of stress management in
reversing heart disease.
The NHLBI has, for many years, supported a vigorous program of
research on behavioral factors that contribute to the development,
treatment, and prevention of disease. Results from that research make
it clear that several modifiable behavioral and psychosocial factors do
play a significant role. The influence of stress should be considered
in the context of these other risk factors, which include behaviors
such as smoking, physical inactivity, diets high in fat and low in
fruits and vegetables, and combinations of these risk factors that lead
to overweight and obesity. Cumulatively, clinical research on the
effects of interventions to alter these behaviors (i.e., to stop
smoking, increase physical activity, improve diet, and reduce body
weight) has shown that these lifestyle changes can be expected to
reduce cardiovascular risk significantly.
Research has also revealed associations between several
psychosocial factors and heart disease. The factors include chronic
stress, depression, inadequate social support, anxiety, hostility, and
socioeconomic status. Each has been associated with increased risk of
heart disease in epidemiological studies, and the results of laboratory
investigations have described several biological pathways through which
psychosocial factors are thought to influence cardiovascular function
and contribute to cardiovascular pathology.
As we consider the potential role of stress management in reversing
heart disease, it is informative to assess the status of evidence
linking psychological stress with cardiovascular risk. To address this
issue, the NHLBI has supported a program of research that includes
basic science, epidemiological studies, laboratory investigations, and
clinical trials.
It is well known that exercise tolerance tests are useful in
diagnosing coronary heart disease by revealing whether exercise results
in myocardial ischemia (reduced blood flow to the heart). Similarly,
studies of patients subjected to controlled mental stress in a clinical
laboratory show unambiguously that mental stress can cause myocardial
ischemia and that negative emotions such as anger can have similar
effects. Patients who respond to mental stress with myocardial ischemia
are called ``mental-stress-positive.'' Data from a large NHLBI-
initiated study, the Psychophysiological Investigations of Myocardial
Ischemia, showed that heart patients who are mental-stress-positive
during clinical stress testing also are more likely to experience
myocardial ischemia in the course of everyday life. More important,
data from this study published last month show that patients who were
mental-stress-positive were more likely to die during the 5 years after
mental stress testing than other patients. This finding confirms and
extends the evidence from three previous studies conducted at Duke
University, Yale University, and the Uniformed Services University of
the Health Sciences, which showed that mental-stress-positive patients
are at increased risk of various cardiac events, including unstable
angina, repeat heart attacks, and need for coronary revascularization.
However, definitive evidence that stress management approaches can
influence the course of heart disease must come from randomized,
controlled clinical trials that track progression of disease, reduction
of new heart attacks, or increased longevity as a result of stress
management interventions. Among these, clinical trials that involve
death as the primary outcome are the gold standard, and no stress
management trials to date have been conducted at this level.
Furthermore, although the NHLBI and others have funded a number of
clinical trials involving stress management either as a stand-alone
intervention or as a component of a broader program of lifestyle
change, it is generally acknowledged in the published scientific
literature that their results can be regarded only as preliminary.
There are several methodological reasons for this, including the fact
that combining stress management interventions with other behavioral or
rehabilitation strategies makes it difficult to disaggregate their
relative contributions to observed outcomes. Clinical trials conducted
by different teams involve interventions differing in intensity or
duration and may target different psychosocial characteristics, making
it difficult to compare their results. Nonetheless, a recent review of
a variety of treatment strategies in randomized clinical trials showed
that patients derive significant benefits when psychosocial
interventions are added to usual medical care.
One carefully conducted clinical trial, although relatively small
and preliminary, offers some of the best evidence that stress
management may be beneficial for patients with coronary heart disease.
The study, funded by the NHLBI and conducted at Duke University, showed
that patients who participated in a 4-month stress management
intervention program experienced a significantly lower rate of
recurrent heart attacks, need for revascularization, and death during
the ensuing 3 years, compared with patients who did not receive the
intervention. In addition, the data showed that patients who were at
highest risk because they experienced many episodes of myocardial
ischemia in daily life benefitted substantially from stress management:
the number of ischemic episodes was reduced greatly, suggesting that it
may be possible to identify patients who are most likely to benefit
from such interventions. Earlier this year, the study provided an
update of its results, which showed that the benefits of stress
management tended to be sustained over a 5-year period, albeit at a
reduced level. It also showed that stress management can be
economically viable, as the medical expenditures of patients in the
stress management group were significantly lower than expenses of
patients receiving usual care.
As mentioned previously, this and other studies have several
limitations, including small sample size, reliance on relatively
``soft'' clinical outcome measures, and partial randomization.
Nonetheless, the extensive data collected for these patients on mental-
stress-related cardiovascular function in the clinical laboratory as
well as in daily life have provided the necessary foundation to
undertake a trial involving a larger number of patients, which is under
way today. Two hundred and ten patients with documented coronary heart
disease will undergo comprehensive biomedical and psychosocial
evaluation, followed by random assignment to usual care, aerobic
exercise, or a stress management intervention. The study will provide
new insights into the clinical benefits of exercise and stress
management, as well as add to our knowledge of the biological pathways
through which stress affects heart function.
The question of whether ``reversal of heart disease'' is feasible
has been a subject of considerable interest and research.
Atherosclerosis in coronary arteries is a complex condition involving
deposition of cholesterol, structural changes in the lining of the
arterial wall, inflammation, and calcification, which together affect
vascular structure and function. Aggressive lowering of blood
cholesterol levels results in beneficial changes in many of these
aspects--vascular function and blood flow are improved, with an
associated decrease in the risk of coronary events. However, reversal
or regression in the sense of returning to a disease-free state does
not occur. Numerous research studies have shown the benefits of lipid-
lowering drugs on coronary artery function. Moreover, a small number of
clinical trials involving lipid-lowering via intensive dietary
modification have shown similar success. One of these, the Lifestyle
Heart Trial, included stress management as part of the intervention.
Its author, Dr. Dean Ornish, is here today. While intensive risk factor
modification through lifestyle changes has shown some success in
stabilizing coronary function and reducing cardiovascular risk, it is
not possible to know to what extent stress management contributes to
the observed results.
To assess the present status of stress management interventions
generally, it is also informative to examine the results of studies in
individuals with high blood pressure, a very well-established risk
factor for coronary heart disease. The NHLBI has supported a series of
clinical trials in this area, which has been one of the most intensive
targets of investigation for stress management. The most definitive
review article on this subject was written by David Eisenberg, who
reviewed more than 800 studies and selected 26 that met scientific
standards for evidence-based medicine. The results of the analysis,
involving 1,264 patients, showed that blood pressure was reduced by
only 2.8 mm Hg systolic and 1.3 mm Hg diastolic, results which were not
significantly different from changes observed in patients assigned to
control or ``sham'' therapies. Similar conclusions were drawn by
Podszus and Grote, who later published a review of a more narrowly
defined set of stress management studies. One of the larger stress
management studies was conducted within the NHLBI-initiated Trials of
Hypertension Prevention, involving 562 individuals with blood pressures
initially in the high-normal range, which found no statistically
significant differences between treatment and control conditions after
an 18-month intervention program.
Some of the studies published since completion of these reviews
have shown beneficial effects, but their size is too small to change
the general conclusions of the earlier review by Dr. Eisenberg. The
status of knowledge concerning the effects of stress management on
blood pressure reduction, a condition that has been studied more
extensively than atherosclerosis, suggests that developing effective
stress management interventions for coronary heart disease patients
will require continued efforts and perseverance.
In conclusion, what can we do today? We believe that definitive
evidence of beneficial effects of stress management on progression of
heart disease is not currently available. However, because the evidence
of acute effects of stress on cardiac events is well-established, and
because the results of the initial clinical trials of stress management
interventions for patients with established coronary disease appear
promising, it seems prudent to integrate stress management approaches
with cardiac rehabilitation programs for patients who want to avail
themselves of these interventions. Doing so may improve quality of life
and promote lifestyle changes as well as adherence to medical regimens.
We do know with certainty that altering several other behavioral risk
factors, namely high-fat diets, smoking, sedentariness, and overweight,
can play a very substantial role in reducing heart disease. Attention
to these areas would benefit the public health.
I would be pleased to answer your questions on this subject.
Senator Specter. Thank you very much, Dr. Kaufmann. I have
already reinstated my chief clerk because she provided a
document from the National Institutes of Health dated May 1,
2002, at 2:06 p.m., which lists you as Acting Associate
Director of Behavioral and Social Sciences. So, I guess I won't
question that. You don't have to answer that, you have a right
to remain silent. It's just I'm impressed by the precision, May
1 at 2:06 p.m.
What additional funding will be necessary for NIH above $23
billion to update these resumes?
Dr. Kaufmann. Yes, that is impressive indeed, Mr. Chairman.
Senator Specter. I would appreciate it if you will stay
where you're seated, Dr. Kaufmann, and we're going to call the
other witnesses up so that the interaction, I think, will be
preferable to my questioning you alone on behalf of a number of
views.
So, if Dr. Abrams, Dr. Benson, Dr. Eisenberg, Dr. Ornish,
Dr. Vernalis, and Dr. Matthews would step forward, we will
proceed.
STATEMENT OF DAVID B. ABRAMS, Ph.D., PROFESSOR OF
PSYCHIATRY AND HUMAN BEHAVIOR, BROWN
MEDICAL CENTER
Senator Specter. We have moved here in alphabetical order
because it is not possible to give appropriate recognition,
except on some grander basis such as alphabetical order.
Dr. David Abrams is our first witness, a professor of
psychiatry and human behavior at Brown Medical School and
founding director of the Centers for Behavioral Preventive
Medicine at the Miriam Hospital. He has had a distinguished
career in South Africa until the United States was lucky enough
to have him settle in Rhode Island. A Ph.D. in clinical
psychology from Rutgers University. Dr. Abrams made an earlier
trip to Washington to consult with the subcommittee and help us
provide the basis for this hearing, and we're very pleased to
have you here today, Dr. Abrams, and we look forward to your
testimony.
Dr. Abrams. Thank you, Mr. Chairman.
We have been hearing good news. We now know that people can
take action to slow the progression of heart disease and even
reverse it. In the past 30 years, cardiac deaths have decreased
dramatically, in part due to new medical advances, but changes
in smoking and eating behavior have played a major role as
well.
Stress is one psychosocial factor that has been linked to
the development of heart disease. Stress may be a separate risk
factor for heart disease, or it may increase the severity of
other risk factors such as smoking and diet. Acute stress can
precipitate cardiac problems. Stress can also interfere with
both providers' and patients' ability to adhere to medical
recommendations.
It is hard to separate out the effects of stress alone on
heart disease. Usually stress management is combined with other
lifestyle and medical components in a total package to reduce
heart disease. If we're going to prevent heart disease in the
first place, we must target people throughout their entire life
span. This means giving everyone in the country messages and
behavioral help with changing their behavior.
We do not fully appreciate the power of changing behavior
in the entire population. Small changes can result in huge
reductions in the absolute numbers of those with disease
burden, but this takes many years to see. Tens of thousands
fewer deaths from lung cancer in men are due to the decrease in
tobacco use over the last 30 years. Significant reductions in
cardiovascular disease, cancer, and associated Medicaid savings
have been noted in the state of California as a direct result
of their decade long aggressive antismoking campaign.
Population-wide changes in health do not capture the
headlines as much as an announcement of an artificial heart or
death due to defective tires in Ford Explorers, but over
160,000 deaths from heart disease and stroke, and 170,000 from
lung cancer, would be averted if nobody smoked.
For those who already have heart disease, we must also
focus on preventing a second cardiac event and improving
quality of life. In cardiac rehabilitation programs, the
benefit of combined behavioral and medical approach is
compelling. A summary of 37 studies found that stress
management combined with life style change programs produced a
54 percent reduction in cardiac death, and improvements in life
style as well.
Cardiac rehabilitation is highly cost effective but only 15
percent of eligible patients participate each year. Many
programs do not implement the stress, diet and life development
components very well.
So you see, there is some good news and bad news. Thousands
more lives would be saved and quality of life improved if we
could only put our research findings into practice. We must
look at our opportunities at many levels, health services,
physician and patient behavior. Public health and medical care
delivery is weakest in prevention. Our recent awareness of gaps
in public health raised by the threat of bioterrorism has
brought the need for a stronger infrastructure into sharp
focus.
We need to increase the Nation's capacity to address both
bioterrorism, as well as health promotion and disease
prevention. Both may protect and safe millions of lives. We
need research that would inform us how to rapidly translate our
science into practice. If we can reach all relevant target
audiences with best practices, our scientific discoveries will
yield an enormous return on the investment in NIH.
Continued progress depends on multidisciplinary research
that focuses on both fundamental science as well as its
translation into practice and policy. Dissemination of research
findings to other disciplines will be greatly accelerated by
the integration of biomedical methods with behavioral and
public health expertise.
We can detect those at risk for heart disease with simple
tests such as for cholesterol and lifestyle habits. As
diagnostic tests and imaging technology improves, we will need
to address these new challenges and opportunities raised by
improved screening, early detection, and the ability to track
the progression of disease in its early stages.
We can increase the availability of treatments through
interactive computer programs in the home and other
communication technologies. Tracking disease progression can
help to motivate people to change their lifestyle and then see
the progress they are making.
prepared statement
In summary, the scientific foundations of prevention and
treatment of heart disease are supported by clinical practice
guidelines. Combined medical lifestyle and stress management
can make a measurable impact on preventing or reversing the
progression of heart disease. The impact is most dramatic if we
begin as early as possible in the disease process. This is
echoed in the Hippocratic oath which states, I will prevent
disease wherever I can, for prevention is preferable to cure.
Thank you.
[The statement follows:]
Prepared Statement of Dr. David B. Abrams
what is the impact of stress management on reversing heart disease?
My name is Dr. David Abrams. I am professor and director of the
Centers for Behavioral and Preventive Medicine at Brown Medical School.
I am also President of the Society of Behavioral Medicine, the largest
organization of researchers and practitioners dedicated to integrating
behavioral and biomedical science.
We've been hearing GOOD NEWS:
We now know that people can take action to slow the progression of
heart disease and even reverse it. In the past 30 years, cardiac deaths
have decreased dramatically in part due to medical advances. But
changes in smoking and eating behavior have played a major role as
well.
Stress is one psychosocial factor that has been linked to the
development of heart disease. Stress may be a separate risk factor for
heart disease, or it may increase the severity of other risk factors
such as smoking and diet. Acute stress can precipitate cardiac
problems. Stress can also interfere with providers' and patients'
ability to adhere to medical guidelines.
It is hard to separate out the effects of stress alone on heart
disease. Usually stress management is combined with other lifestyle and
medical components to reduce heart disease.
If we are going to prevent heart disease in the first place, we
must target people throughout their entire lifespan starting at a young
age. This means giving everyone in the country messages and help with
changing their behavior.
We do not fully appreciate the power of changing behavior in the
entire population. Small changes can result in huge reductions in the
absolute numbers of those with disease burden. But this takes many
years to see. Tens of thousands fewer deaths from lung cancer in men
are due to decreasing tobacco use over the last 30 years. Significant
reductions in cardiovascular disease, cancer, and associated Medicaid
savings have been noted in the State of California as a direct result
of their decade long aggressive anti-smoking campaign.
Population wide changes in health do not capture the headlines as
much as an announcement of a new artificial heart or deaths due to
defective tires on Ford explorers. Over 160,000 deaths from heart
disease and stroke and 170,000 from lung cancer would be averted if
nobody used tobacco.
For those who already have heart disease, we must also focus on
preventing a second cardiac event and quality of life. In cardiac
rehabilitation programs, the benefits of combined behavioral and
medical approaches are compelling. A summary of 37 studies found that
stress-management and lifestyle change programs produced a 34 percent
reduction in cardiac death and improvements in lifestyle as well.
Cardiac rehabilitation is highly cost-effective, but only 15
percent of eligible patients participate each year. Many programs do
not implement the stress, diet and lifestyle components very well.
So you see there is good news and bad news. Thousands more lives
would be saved and quality of life improved if we only could put our
research findings into practice. We must look at opportunities at many
levels-health services, physician and patient behavior.
Public health and medical care delivery is weakest in prevention.
Our recent awareness of gaps in public health, raised by the threat of
bio-terrorism, has brought the need for a stronger infrastructure into
sharp focus. We need to increase the nation's capacity to address both
bio-terrorism as well as health promotion and disease prevention. Both
may protect and save millions of lives.
We need research that will inform us how to rapidly translate our
science into practice. If we can reach all relevant target audiences
with best practices, our scientific discoveries will yield an enormous
return on the investment in NIH.
Continued progress depends on multidisciplinary research that
focuses on both fundamental science and its translation into practice
and policy. Dissemination of research findings to other disciplines
will be greatly accelerated by the integration of biomedical methods
with behavioral and public health expertise.
We can detect those at high risk for heart disease with simple
tests such as for cholesterol and lifestyle habits. As diagnostic tests
and imaging technology improves, we will need to address the new
challenges and opportunities raised by improved screening, early
detection, and our ability to track the progression of disease in its
early stages.
We can increase the availability of treatments through interactive
computer programs at home and other communications technologies.
Tracking disease progression can also help to motivate people to change
their lifestyle and see the progress they are making.
In summary, the scientific foundations of prevention and treatment
of heart disease are supported by authoritative clinical practice
guidelines. Combined medical, lifestyle and stress management can make
a measurable impact on preventing or reversing progression of heart
disease. The impact is most dramatic if we begin as early as possible
in the disease process. This is echoed in the Hippocratic Oath, which
states, ``I will prevent disease whenever I can, for prevention is
preferable to cure.''
STATEMENT OF HERBERT BENSON, M.D., PRESIDENT, MIND/BODY
MEDICAL INSTITUTE, PROFESSOR OF MEDICINE,
HARVARD MEDICAL SCHOOL
Senator Specter. Thank you very much, Dr. Abrams. Our next
witness is Dr. Herbert Benson, founding president of the Mind/
Body Medical Institute at Harvard Medical School, where he is
the associate professor of medicine. He is chief of the
division of behavioral medicine at the Beth Israel Deaconess
Medical Center. He is a graduate of Wesleyan and Harvard
Medical School, and author or co-author of 6 books and over 150
scientific publications.
Dr. Benson has testified before this subcommittee on a
number of occasions, has counseled this subcommittee, and has
been the recipient of grants. It is hard to find a sufficiently
extraneous adjective for his advocacy on meditation, including
treating Arlen Specter with some limited success. Dr. Benson,
thank you for joining us today.
Dr. Benson. Thank you, Senator. It's a delight to be here
and I'm thankful for this opportunity to testify on the impact
of stress management on reversing heart disease. Stress
contributes to many medical conditions that are treated by
healthcare professionals. In fact, over 60 percent of patient
visits to healthcare professionals are related to stress and
psychosocial factors.
Stress is defined as the perception of or threat of, but
perception of a threat or danger that requires behavioral
change. Not all stress is deleterious; in fact, a certain
amount of stress is beneficial. As stress increases, so does
performance and efficiency, but only to a point. More stress
decreases performance and efficiency, and could be injurious to
health.
Stress increases metabolism, heart rate, blood pressure and
rate of breathing. These internal physiological changes have
been labeled the fight or flight response. This response is
mediated by the release of epinephrine, norepinephrine,
adrenalin, noradrenalin, if you will, into the blood stream.
The mean effect of these hormones is influenced by nitric
oxide, which can correctly counteract epinephrine, but nitric
oxide like stress can be both beneficial and harmful depending
on its concentration.
The relaxation response is a physiologic reaction opposite
to that of stress. Relaxation response is characterized by
decreased metabolism, heart rate, blood pressure and rate of
breathing, as well as slower brain ways and specifically
altered changes within the brain itself when it's being
elicited. It is also believed that the relaxation response is
directly related to increased beneficial nitric oxide activity.
Two steps are necessary to elicit the relaxation response.
They are, first, the repetition of a word, sound, prayer or
phrase, or muscular activity. Second, there should be a passive
disregard of everyday thoughts that come to mind and a return
to the repetition. There are many different behavioral
techniques that elicit the relaxation response. They include
for example, meditation, tai chi, chi gong, repetitive
exercise, yoga, and also repetitive prayer.
Relaxation response approaches are useful in the treatment
of angina pectoris and other manifestations of coronary artery
disease. For example, relaxation response techniques decrease
premature ventricular contractions in ischemic heart disease.
Further, long-term yoga has been reported to reduce coronary
atherosclerosis on coronary angiogram, and to improve
symptomatic status, including reduction of angina pectoris and
a decrease in the need for revascularization procedures, and an
increase in exercise capacity.
There are also improvements in cardiac risk factor profile
including reductions in body weight, reductions in serum
cholesterol, LDH, triglyceride levels, and an increase in HDL.
Additionally, tai chi training has been reported to facilitate
better cardiorespiratory outcome and cardiac functioning
following coronary artery bypass surgery. Relaxation response
has also been shown to enhance the physical and psychological
status of patients after rehabilitation following myocardial
infarction. Relaxation response therapy has also been shown to
improve long-term cardiovascular prognosis in coronary artery
disease as it decreases future ischemic events such as fatal
myocardial infarction.
prepared statement
In summary, stress plays a major role in cardiovascular
disease. On a molecular basis, these disorders appear to be
connected to nitric oxide pathways and a balance of the various
molecular signaling pathways that may be a crucial step in
achieving better health outcomes. Such a balance may be
stabilized or facilitated by the use of relaxation response
techniques since they counteract stress, lower epinephrine
activity, in the action, we believe, of ameliorating
restriction of nitric oxide pathways. In fact, relaxation
response techniques have been shown to be of use in the
treatment of hypertension, cardiac arrhythmias, angina pectoris
and other manifestations of coronary artery disease.
Of course, more research is necessary into not only the
fundamental molecular aspects of stress and its alleviation,
but also its clinical applications. Again, I thank you for the
opportunity to testify here today.
[The statement follows:]
Prepared Statement of Dr. Herbert Benson
I'm pleased to be called upon to testify on the impact of stress
management on reversing heart disease.
Before I start my testimony, let me say a few words about the Mind/
Body Medical Institute and the work my colleagues and 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 fourteenth year of existence. I occupy the Mind/Body Medical
Institute Chair at the Harvard Medical School as an associate professor
of medicine.
stress and the fight-or-flight response
Stress contributes to many of the medical conditions that are
confronted by healthcare practitioners. In fact, when the reasons for
patients' visits to physicians are examined, over 60 percent of visits
to physicians are related to stress and other psychosocial factors
(Cummings, VandenBos, 1981; Kroenke, Mangelsdorf, 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 fight-or-flight
response.
Stress is defined as the perception of threat or danger that
requires behavioral change. Not all stress is deleterious. In fact, a
certain amount of stress is beneficial. As stress increases, so do
performance and efficiency, but only to a point. More stress decreases
performance and efficiency and can be injurious to health.
Stress 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. Walter B. Cannon (1941), the Harvard
Medical School physiologist, described the fight-or-flight response in
the last century. It occurs automatically when one experiences stress,
without requiring the use of a technique.
The fight-or-flight response is mediated by increased release of
catecholamines--epinephrine and norepinephrine (adrenalin and
noradrenalin)--into the blood stream. The impact of these hormones is
influenced by nitric oxide, a so-called autoregulatory, signaling
molecule. It can directly counteract norepinephrine. Thus, nitric oxide
can directly affect the manifestations of stress, but like stress,
nitric oxide can be both beneficial and harmful depending upon its
concentration. A proper balance is necessary (Stefano et al, 2001, Esch
et al--in press).
stress and the heart and circulation
Stress can have major effects on the heart and circulation. It
leads to increased blood pressure, heart rate and increased clotting.
It directly influences hypertension, heart attacks, angina pectoris,
and cardiac arrhythmias. The influence of stress is dependent upon its
amount, its acute or chronic nature, the patient's predisposition to
stress and the patient's genetic make-up. Like stress, nitric oxide, as
noted above, is a double-edged sword. A small amount of so-called
constitutive nitric oxide is beneficial whereas larger amounts of so-
called inducible nitric oxide can be detrimental (Stefano et al, 2001,
Esch et al--in press).
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. 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). 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). Recently, Stefano et al (2001) have
proposed that the relaxation response actions are directly related to
increased constitutive nitric oxide activity.
Two steps are necessary to elicit the relaxation response. (Benson,
1996) They are:
(1) the repetition of a word, a sound, a prayer, a phrase, or
muscular activity and
(2) the passive disregard of everyday thoughts that come to mind
and a return to the repetition.
There are many approaches and techniques that elicit the relaxation
response. They include: repetitive prayer, meditation, tai chi, chi
gong, repetitive exercise and yoga. (Benson, 1999)
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 focuses.
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 do it 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!
the relaxation response and heart disease
Our research conducted at the Harvard Medical School as well as
that of others has documented that relaxation-response approaches,
sometimes used in combination with nutrition, exercise, and stress
management interventions, result in alleviation of stress-related heart
disorders. Because of this scientifically documented efficacy, a
physiological basis for many millennia-old mind-body belief-related
approaches has been established.
As a result of the evidence-based data, the relaxation response is
becoming a part of mainstream medicine. Approximately 60 percent of
U.S. 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.
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 such as hypertension (Stuart, et al, 1987,
Linden and Chambers, 1994) and cardiac arrhythmias (Benson, Alexander,
Feldman, 1975).
Relaxation response techniques have also been demonstrated to be
helpful in the treatment and prevention of atherosclerosis and
endothelial dysfunction. For example, Transcendental Meditation has
been shown to reduce oxidative stress and lower serum levels of lipid
peroxides, thereby reducing the risk of developing atherosclerosis
(Schneider et al, 1998). Relaxation response approaches are also useful
in the treatment of angina pectoris and other manifestations of
coronary artery disease (Benson et al, 1975, Linden et al,
1994,Manchanda, et al 2000, Cunningham et al, 2000,). For example, the
relaxation response techniques decrease premature ventricular
contractions in stable ischemic heart disease. Further, long-term yoga
has been reported to reduce coronary atherosclerosis on coronary
angiogram and to improve symptomatic status including reduction of
angina pectoris, a decrease in the need of revascularization procedures
and an increase in exercise capacity. There are also improvements in
the cardiac risk factor profile including a reduction in body weight,
serum total cholesterol, LDL, triglyceride levels and an increase in
HDL (Mahajan et al, 1999, Manchanda et al, 2000,). Additionally, tai
chi training has been reported to facilitate better cardiorespiratory
outcome and cardiac function following coronary artery bypass surgery
(Lan et al, 1999.) The relaxation response has been shown to enhance
the physical and psychological status of patients after rehabilitation
following myocardial infarction (van Dixhoorn et al, 1990). Relaxation
response therapy also has been shown to improve long-term
cardiovascular prognosis in coronary artery disease as it decreases
future ischemic events such as fatal myocardial infarction (Patel et
al, 1985).
In summary, stress plays a major role in cardiovascular diseases.
On a molecular basis, these disorders appear to be connected with
nitric oxide pathways and a balance of the various molecular signaling
pathways may be a crucial step in achieving better health outcomes.
Such a balance may be stabilized or facilitated by the use of
relaxation response techniques since they counteract stress and
norepinephrine activity through the activation of ameliorating,
constitutive, nitric oxide pathways. In fact, relaxation response
techniques have been shown to be of use in the treatment of
hypertension, cardiac arrhythmias, angina pectoris and other
manifestations of coronary artery disease.
Further research is needed to better understand these findings and
their clinical applications.
STATEMENT OF HARVEY EISENBERG, M.D., DIRECTOR,
HEALTHVIEW CENTER FOR PREVENTIVE MEDICINE
Senator Specter. Thank you very much, Dr. Benson. Our next
witness is Dr. Harvey Eisenberg, founder of the HealthView
Center for Preventive Medicine in California. A pioneer in the
field of interventional radiology and medical imaging, he is
also the inventor of the angio CAT technology. He served as
professor of radiologic sciences at UCLA, Harvard, and
Stanford. He served as a medical consultant to many businesses
over 35 years, including working as medical director at
Raytheon and Acac Labs. He has a bachelor's degree from the
University of Pennsylvania, an M.D. from Thomas Jefferson
University, and is a native of Philadelphia.
I had an opportunity to visit with Dr. Eisenberg in Newport
Beach. We see the display here of the original body scan, and
it is quite a process. We look forward to your testimony, Dr.
Eisenberg.
Dr. Eisenberg. Thank you, Senator Specter. Technology as
integration of behavioral and metabolic medicine plays an
essential role in enabling the capabilities that we consider to
be essential to achieving a paradigm shift to preventive or
proactive medicine. There is no area that this applies to more
profoundly than coronary artery disease, where we now see great
opportunities to improve our treatment approaches.
Advancing these technologies will be critical to fulfilling
this opportunity. I am using visual demonstrations here on the
screen to show, these are the factors we consider to be the
essential ones in basically preventive medicine. We need to get
earlier and more accurate diagnosis of the disease. We need to
get into actually achieving behavioral changes, and we are
doing this now visually through self visualization, which is a
very motivating process, and translates into a very educational
process that we will demonstrate here in a moment.
People in general think that a disease advances in their
body, that they go downhill in reaction to that disease
process, and that their body will in the early stage give them
a warning that there is a problem. This is true of infectious
diseases, but it isn't true of pretty much all of the diseases
that take us down in life, that change our life outcomes or the
quality of life. These diseases, like arteriosclerosis,
Alzheimer's, emphysema, and cancer, are usually present for 20,
25, 30, 40 years before the actual symptoms occur, because the
body has great compensation mechanisms that keep them in the
asymptomatic state. Even cancers are generally present for much
longer periods of time than people realize before the symptoms
will occur.
We practice medicine out here on this downward slope, but
90 percent of the disease is really back here in the
asymptomatic stage. So we spend our training dealing with
symptomatic events when in fact the real opportunity, we
believe, is to get into the disease at a much earlier stage.
Now to do that, you first need to do the early diagnosis.
We rely upon something like a physical exam to achieve that,
but the physical exam in many studies that we've known about,
showed that it really doesn't accomplish this very well, and
it's routine for us to see patients who have advanced heart
disease or masses the size of grapefruits or even larger in the
body, and who just passed their annual physical exams, and this
has not been a sufficient answer.
In areas like cancer, there is no screening test for most
of the cancers that we have and the screening tests that we
have that are good, like mammography, still have a 12 to 20
percent miss rate, and others like colonoscopy, many people
avoid because of the invasiveness.
In heart attacks the stress test that we rely upon will
only really pick up the late stage disease. And this is very
significant because we now know that about 85 percent of heart
attacks are caused by smaller plaques that suddenly rupture to
cause sudden death, much more so than the larger plaques. And
so, those will not show up with symptoms or with stress tests
and we need to get in and find these. It is very common for us
to see patients with extensive coronary artery disease that
have no symptoms or are physically fit and who have just passed
their stress test.
So the first thing is to be able to identify the disease
process at an earlier stage, and to that end we have for 23
years now been using a technique which we helped develop called
calcium screening or heart scanning, which has now evolved new
a much broader concept of a full body scan for early detection,
and it has taken us back significantly in our diagnosis
capability. We are developing a new technology with the support
of Department of Defense funding and backing of senators like
Dr. Stevens, Ted Stevens, who has seen the importance of this,
and Senator Inouye, and this is helping us get to a much
greater level of very early detection.
The body scan looks something like this. It's a very visual
process and we use this visual process to take the patient on
this virtual body tour. We are really showing them the internal
organ structures in very graphic ways and it's a very powerful
process. We get into the heart and lungs in great detail right
down to the cellular level of the air nodules. In plaque
disease we can take it to a much earlier detection capability
than our current screening tests, and very often see extensive
disease that even an angiogram has missed.
The plaques look like this. The patient gets to see the
actual plaque structure and it's very powerful for them to self
visualize this, and in fact we need to train on how to present
this information so it's not frightening but is in fact turned
into a motivational process, which is essential to the process.
So after finding the disease, you now have the bigger
challenge, and that's to take patients who are asymptomatic and
convince them that they have to make major behavioral changes
in their lives. So this indeed is a very difficult proposition,
which we are in fact having significant success in about 87
percent of patients, by showing them the visuals; the cell
visualization is very motivating. It translates into what we
call teachable modes, where we want to know how to deal with
the diseases that we almost invariably find, and certainly that
includes in many patients the heart problems, and then it
becomes a tracking process.
And the tracking is very essential. This is a patient, for
example, who had passed his stress test, had extensive disease,
actually needed bypass, but at six months after bypass, still
passing his stress test without any symptoms, we see a 130
percent increase in his plaques with the normal heart regimen.
Over the next 10 years we got him into a program much like the
Northern State program where we were able to slow this growth
rate down to about 5 to 7 percent from 150 growth rate.
In another patient, like one of my relatives with a very
bad family history of heart disease, at the age of 57 had
normal stress tests and no symptoms, we were able to take her
plaques and in a 6-month period get an almost 50 percent
volumetric reversal, as visualized by our technique which
visualizes a portion of the plaque and seems to correlate well
with how patients follow programs in terms of getting active
reversal.
Unfortunately, my cousin thought this was so wonderful that
she celebrated for a year and then grew the plaques right back.
And this emphasizes the essential working program, which
focuses on, one, the ability to reverse disease, and the need
to keep it up. Patients need to sustain process.
Smokers, we have a very effective result in getting them to
stop smoking by showing them cell visualization of the
tremendous destruction that's always present in an active
smoker.
prepared statement
So, what we need is to advance these technologies,
including the kind that we are developing that will take us up
diagnostically, and also the information technologies that Dr.
Abrams referred to. These are the essential tools that we need
to continue to develop. There is no test today or combination
of tests that actually lets us see the heart plaque, its
volume, its composition, its effect on blood flow, and its
propensity to rupture. We don't have that today, and that is
what we need and that's what's in development.
Thank you very much for this opportunity.
[The statement follows:]
Prepared Statement of Dr. Harvey Eisenberg
A consensus opinion of our national healthcare debates of the
nineties was the necessity for a paradigm shift in healthcare from our
emphasis on symptomatic (late stage) disease diagnosis and management
to the proactive diagnosis and management of earlier asymptomatic
disease. This is consistent with the Hippocratic Oath which states ``I
will prevent disease whenever I can, for prevention is preferable to
cure.'' In most diseases the body's compensation mechanisms or reserves
keep us asymptomatic while disease progresses, often for many years.
This is true of the most prevalent diseases that affect the length and
quality of life. Arteriosclerosis, the cause of heart attacks, strokes
and some hypertension starts in childhood and 25-40 years later
unpredictably causes sudden death or disability without warning in most
patients. Alzheimer's is present for 25-30 years before the devastating
symptoms that will afflict 1 of 5 patients over 80 in a steadily aging
population. Cancers are usually present for years before symptoms.
Emphysema takes massive lung destruction before symptoms. The
degenerative spine diseases that dramatically affect our quality of
life in later years start in the twenties. We currently spend the great
bulk of our healthcare dollars (trillions), in the crisis management of
the late stage effects of disease. There is increasing evidence that
the courses of all of these diseases and many others are substantially
modifiable, no matter what the genetic drive, through early detection
and advances in biomedical and behavioral sciences. Advances in these
areas continue to yield improved treatment, which under ideal
circumstances can prevent, cure, modify or even reverse disease. These
opportunities require advancement of technologies already in
development as part of a program entitled ``Reengineering Healthcare''
that we presented to congress in 1994. This proposes near term
technology driven solutions to many of our nations most pressing and
costly problems in healthcare delivery. The several elements include:
--Paradigm shift from reactive to proactive medicine
--Compacting the diagnostic process
--Improved therapy planning
--Better information
--Routine simulation
--Improved therapy performance
--Micro-invasive, precision
--Interactive computer/image guidance
--New doctor bag
--Information access
--A.I. driven decision making-updated knowledge
--Portable Dx and Rx
--Telepresent home health care
--Education
--Dx
--Rx
Our organization has been evolving technologies and early disease
management capabilities in a program entitled HealthViewTM
that integrate our advances in imaging and informatics technologies
with programs in behavioral and metabolic medicine to enable what we
perceive to be the key components in achieving the paradigm shift to
earlier disease management and preventive medicine. These include:
--Earlier and more accurate diagnosis
--Motivating patients to behavioral changing and taking
responsibility for their own healthcare initiatives through
graphic self-visualization
--Advanced and continuing graphic patient education and empowerment
--Tracking asymptomatic disease for corrective diagnosis, treatment,
and preventive maintenance
The above applications are pervasive and transcend current medical
capabilities and practices. For example the answer to cancer is
probably as simple as finding it very early, and removing or destroying
it with a variety of precisely guided minimally invasive therapies,
predominantly outpatient. Unfortunately there are currently no
screening tests for most cancers. Even the most successful tests like
mammography still have a 12-30 percent miss rate. Many women still
avoid it because it hurts, as most people avoid screening endoscopies
(colonoscopy, gastroscopy, bronchoscopy). Blood testing has produced
little beyond the prostatic serum antigen (PSA), which is still fairly
non-specific and often generates unnecessary biopsies. The annual
physical exam often misses tumors the size of grapefruits or even
larger.
In coronary artery disease, the single largest cause of premature
death, disability and economic burden, current screening tests only can
identify late stage flow obstructing disease (over 60-70 percent
blockage), when its been shown that 85 percent of heart attacks result
from the sudden rupturing and arterial blockage from plaque whose size
is below this level. Heart attack risk appears related more to the
numbers and composition of plaque than to their size, and also to
plaque biologic activity and rapidity of growth. In fact there
currently is no single test or combination of tests, including invasive
coronary angiography, that can accurately identify plaque size,
composition, numbers, or propensity to rupture. This translates to a
current inability to accurately predict risk of heart attack or to
accurately track plaque growth and metabolism to assess results of
plaque regression therapies. Over the past 23 years we have been
involved in developing a non-invasive CT heart scan that sees a portion
of the plaque (Calcium). This test approximates the numbers of plaques,
generally sees them much earlier than stress tests, and has provided
the first non-invasive plaque tracking capability. This has proven
valuable in patient management but still falls far short of the above
necessary goals. We gradually evolved this technology into a full 3-D
CT torso scan and introduced the concept of the CT screening ``body
scan'' in 1997. We integrated this scan with proprietary new
information technologies and behavioral medicine programs into a full
disease management program called HealthViewTM. In applying
HealthViewTM to over 30,000 patients, we have found it to be
lifesaving on an almost daily basis, routinely diagnosing early cancer
and life threatening heart disease in asymptomatic patients that passed
routine screenings. Over 400 physicians scanned considered it a major
advance. 98 percent of all patients, including physicians, recommend it
to family and friends. While the statistics of behavioral medicine
suggest that only 10-15 percent of patients make the lifestyle changes
recommended by their physician, our latest data is showing the full
HealthViewTM program resulted in 87 percent of patients
making immediate behavioral and lifestyle changes, including stopping
smoking. This is largely achieved through graphic self-visualization of
emerging pathology as displayed in a physician guided 3D virtual body
tour. This information when properly presented with specially trained
techniques achieves motivation and creates ``teachable moments'' of
empowering education. While such programs are moving us in the right
direction, they still fall short of the desired goals.
In order to accomplish these goals and several other elements of
the ``Reengineering Healthcare'' program we have been developing a core
technology called Volume AngioCATTM (VAC) with DOD funding.
VAC is a foundation for numerous programs of considerable pervasive
impact to healthcare delivery, and to the DOD, including military
healthcare, battlefield trauma care, baggage and ordinance scanning,
non-destructive testing, safety testing, simulation and modeling for
numerous applications.
The VAC is designed to non-invasively provide for the first time
comprehensive fused imaging of the anatomy, physiology and biochemistry
(molecular function), of the entire body. This will be accomplished
within a few seconds to minutes in 3-D and near real-time 4-D, and at
resolutions and speeds that are orders of magnitude greater than the
current state of the art. VAC has been designed to create a full body
scan, including the brain, that advances the current ``body scan'' from
a screening exam to a comprehensive and definitive diagnosis. This
should yield very low false negative results or the false positive
results that generate the need for additional unnecessary studies that
occurs with all screening techniques, and which generate questions
about cost effectiveness. VAC is expected to provide for the first time
a complete analysis of cardiovascular disease and arterial plaque
including the full size of plaques, their numbers, composition, effect
on blood flow and heart muscle performance, and information about the
likelihood of plaque rupture. This is expected to be a new powerful
tool for the very early and later stage management of cardiovascular
disease, including accurate risk assessment, improved therapy planning,
guidance, tracking, and results. VAC is also being designed to look for
cancer in several different ways simultaneously with resolutions
capable of detection down to a 1-2 millimeter level throughout the
entire body, a size almost certain to result in cure. This capability
should provide a major advance in defeating cancer. Its applications
will span a broad range of other diseases such as Alzheimer's,
emphysema, diabetes, degenerative diseases, and congenital diseases.
Altogether those represent the most prevalent and deadly diseases
affecting mankind.
The VAC is also designed to dramatically compact the diagnostic
process, potentially replacing nearly $80k worth of testing with a
single non-invasive $1,500-$2,000 test performed within seconds. Tests
replaced will include all CT, most MRI, mammography, conventional x-
rays, (chest, spine, etc.), nuclear medicine, (SPECT, PET), diagnostic
angiography and cardiac catheterizations, and diagnostic endoscopies,
(colonoscopy, gastroscopy, bronchoscopy). The use of diagnostic imaging
and associated tests has been steadily increasing. As baby boomers are
now turning 50 every 9 seconds and reaching the age of disease
manifestation these costs will escalate prohibitively. The VAC seeks to
provide a powerful solution to this impending financial crisis as well
as a substantial advance in earlier diagnosis, more definitive
diagnosis, and provide better therapy planning, guidance and results.
Additional funding is required for completion of the VAC prototype
and to advance ongoing basic research to further enhance its
performance capabilities. Funding is also needed to fulfill the many
spin off opportunities for advanced simulation and modeling, precise
image guided microsurgery, and automated diagnosis. These are enabled
by the massive integrated near real time (4D) date sets that increase
the data density from our current 200mb/exam to 5-10gb/exam, and
require the powerful VAC computational and information handling
systems. The VAC applications extend to advanced mobile rapid mass
casualty care (battlefield, homeland), and to automated baggage and
ordnance scanning.
Funding is also required to allow for advances in informatics and
computer technologies that will allow for the creation of a
sophisticated, yet cost efficient program that includes interactive
disease and lifestyle management interventions tailored to the unique
needs of each individual patient. Such interventions can be widely
disseminated at modest unit cost once initial development is completed.
This is the concept of mass customization, which leverages ``high-
tech'' while retaining the crucial elements of ``high touch'', (the
trusting, caring doctor/patient relationship.).
In addition, to advance the field as outlined above, we recommend a
demonstration test with two phases. The first phase will focus on the
development of an integrated diagnostic imaging and behavioral medicine
cardiovascular risk reduction program. Initial evaluation will
demonstrate feasibility and acceptability of the program, and will
provide evidence of effectiveness (proof of concept phase). Success in
Phase I will facilitate a second phase of more rigorous scientific
evaluation via usual NIH mechanisms (i.e., the NIH investigator-
initiated peer review grant process). Funding to develop the program
and conduct initial evaluation is being sought through other (i.e.,
non-NIH) channels to jump-start the process.
Funding vehicles: My 37 years involvement in medical technology
development as academician, consultant and medical directorships in the
medical imaging and military industrial industries lead me to the
following observations. It needs to be clearly understood by congress
that medical technology development is unique in that it generally
takes 15-20 years to develop a medical product, validate its clinical
efficacy and achieve necessary third party reimbursement to get it to
the public. This is completely unacceptable given the explosion of
current technology opportunities to improve our national healthcare. In
order to expedite this process it is recommended that funding be
targeted to come from several sources, including DOD, NIH, and
transportation. The DOD is the preferable funding source for technology
R&D and productization, which is analogus to weaponry, and requires
similar systems approach and similar information and communication
technologies. The NIH is an academic culture insufficiently experienced
in these areas and having a suboptimal track record in medical
technology/product development. The large medical manufactures are
earnings driven and risk adverse, used to letting small entities break
the envelope and buying them if successful at both product development
and proving the market. This process adds many years to rapidly
evolving technology opportunities. The venture capital community is
intensely near term and high profit driven, adverse to risk research,
and usually divorced from issues of social or national interests or
long-term quality. The military industrial companies are heavily
incentivized toward weaponry and don't understand the complex and
diverse medical market.
One of the very few places that support the essential role of risk
research in achieving real progress is DARPA, responsible for such
breakthroughs as the Internet. Most of their funding goes to small
companies in the true American spirit and foundation of
entrepreneurship. DARPA has the proper culture for fast tracking R&D
and has the knowledge base and experience to accomplish this. I have
observed them to accomplish a great deal with very little medical
budget in the brief period they were asked to do this in the late 90's.
(Accompanying booklet) accomplishing technology advancement important
to both battlefield and national healthcare. I recommend a considerable
expansion of their budget to pursue medical technology advancement.
They are also one of the few agencies capable of bringing the resources
of the military industrial complex to the table. A natural combination
with DARPA are military agencies for product development, such as the
army's MEDCOM, which includes such entities as TATRC (Telemedicine and
Advanced Technologies Research Command). This is currently where most
research is going forward for telemedicine, breast and prostate cancer.
MEDCOM's RDT&E budget should be greatly expanded in pursuit of rapid
productization.
NIH excellent track record in the biomedical sciences make it well
suited to guide development of imaging pharmaceuticals or molecular
tracers. It's also well designed to conduct clinical trials arising
from the myriad clinical applications of these new technologies,
establish demonstration projects for clinical efficacy, outcomes
analysis and cost effectiveness.
Department of transportation and homeland security offices need to
recognize that many of their needed applications such are baggage
scanning, chemical and biodetection, and mass casualty handling are
spinoffs of core technologies for medicine. They should participate in
funding the development for their specific applications, which will
provide a multiple use synergy and economy.
Thank you for the opportunity to present these programs and
viewpoints.
Senator Specter. Thank you very much, Dr. Eisenberg. As I
said earlier, I'm going to have to excuse myself for a few
moments to go to the Judiciary Committee. The matter is likely
to be held over, so I may be back very very briefly. If I have
to stay there a while, I will return as soon as I can and we
will proceed. We will take whatever time this discussion
requires. So, we stand in recess for a few moments.
STATEMENT OF DR. DEAN ORNISH, FOUNDER, PRESIDENT, AND
DIRECTOR, PREVENTIVE MEDICINE RESEARCH
INSTITUTE IN SAUSALITO, CA, CLINICAL
PROFESSOR OF MEDICINE AT THE UNIVERSITY OF
CALIFORNIA, SAN FRANCISCO, A FOUNDER OF
UCSF'S OSHER CENTER FOR INTEGRATIVE
MEDICINE
Senator Specter. The committee will reconvene. Our next
witness is Dr. Dean Ornish, founder, president and director of
the Preventive Medicine Research Institute in Sausalito, CA,
clinical professor of medicine at the University of California,
San Francisco, and a founder of UCSF's Osher Center for
Integrative Medicine. He has written extensively about how
comprehensive life style changes can reverse coronary heart
disease. He received his MD from Baylor College of Medicine,
and his bachelor's degree from the University of Texas at
Austin.
Dr. Ornish has been very helpful as a consultant to the
committee and I have had the opportunity to read two of his
books. Somebody said his talk was difficult, and I responded
that that was a vast understatement. I recently purchased some
soy products and found some of them palatable. Soy is very
good, but not even to have fish in a diet sounds very
difficult, but I'm listening. You don't have to explain that
now, Dr. Ornish. You may give us your regular testimony.
Dr. Ornish. I will be happy to. Mr. Chairman, thank you for
the privilege of being here today and I want to emphasize again
that not everybody needs to make such strict changes in life
style. What we all say about an ounce of prevention is really
true. It takes one of the worst diseases and gives us the
ability to reverse it, and I will talk about that.
I wasn't planning to show the slides but since Dr.
Eisenberg came in with this plasma screen, I thought I'd take
advantage of it. I really think all the work we have been doing
in the last 25 years can be summarized in this cartoon, that
is, our goal is not just turn off the faucet, I mean not just
to mop up the floor but also to turn off the faucet, to treat
the underlying causes of heart disease. And the idea is if you
don't treat the cause, if you just do the bypass surgery or do
an angioplasty, or medications, without also addressing the
factors that really cause heart disease, more often than not
the same problem comes back again, the bypass gets clogged up
again, and we get a new set of problems or side effects.
We all know at the health policy level they have painful
choices. As you know, we have 38 million American who don't
have health insurance, and if we simply put them in the system,
business as usual, health care costs go up exponentially, so
that if we treat the underlying causes, which to a large degree
are life style related, stress management, diet, moderate
exercise, support groups, and vitamins and supplements, we are
able to show for the first time that heart disease can actually
be reversed, and much more quickly than people had once thought
possible.
In 1977 when we began doing our work, it was thought that
heart disease could only get worse. Maybe you could slow down
the rate at which it got worse, but it was going to get worse.
And that was because the only mechanism that we understood was
the plaque in the arteries, like rust building up in a pipe
over a period of decades. We now know that it's a much more
dynamic process. The arteries can constrict or dilate. Dr.
Benson mentioned nitric oxide. There is direct connections
between your brain and the arteries all over your body. There
are things that can cause your arteries to constrict or dilate
from minute to minute. Blood clots can form or disaggregate.
And these are all directly related to stress as well as to diet
and smoking.
So when you change your diet and life style, when you
manage stress more effectively, you don't have to wait years to
see the improvement. Within hours, blood flow to the heart can
improve. We found a 91 percent reduction in the frequency of
angina within weeks, and people not only felt better but in
most cases they were better in ways that we measured and I will
show in a moment.
But in addition to these direct mechanisms, using stress
management is so important because it affects indirect
mechanisms, in other words, behaviors. It's not enough to give
people health information and expect them to change. We learned
that with smoking, everybody knows it's not healthy, but we
have to work at a deeper level. So many people are lonely,
depressed, isolated and unhappy, and telling someone who is
feeling that way they are going to live longer if they just
change their diet or manage stress, or quit smoking, it isn't
that motivating. We have to work at a deeper level.
It's like giving smokers a discount, because there isn't as
much to tell, it's just a way of talking about, instead of just
talking about risk factor reduction and living longer, most
people don't think anything bad is ever going to happen to
them. We have to work at a deeper level and to deal with the
underlying stress because people are more likely to smoke, to
overeat, to drink too much, to work too hard, to abuse drugs
when they are feeling depressed and lonely and stressed out.
In fact, studies have shown that even medications like
taking a pill like a statin drug, two-thirds of the people who
take statin drugs are no longer taking them just a year later,
and that's just taking a pill once a day. So even in terms of
getting people to take their medication, much less make changes
in diet and quit smoking and so on, we have to address the
emotional, the psychosocial, even the spiritual factors that
are underlying these behaviors.
So these people are doing a variety of stretching,
breathing, meditation, imaging relaxation techniques, and
support groups. These techniques have been around for thousands
of years. They have been around since time immemorial, they're
found in all religions, all cultures. We present them in ways,
as Dr. Benson mentioned, that are not threatening to people.
Now as I mentioned, we have a number of studies showing
that heart disease is actually reversible, and ironically we
have been using these very high tech expensive diagnostic
testing when as Dr. Eisenberg has represented on the wall right
now, to document and monitor and prove the power of these very
low tech and low cost interventions.
Here is an example of one of our patients. On the upper
left is a frame from an x-ray looking at the heart called an
angiogram, showing the narrowing, and on the right, a year
later, it's not as clogged. These monitoring of the blockages
can cause dramatic increases in blood flow. The one on the left
is a PET scan; blue and black means no blood flow, and on the
lower right, orange and white is maximum blood flow, a 300
percent in blood flow from the PET scan.
This is a man who was told he needed a bypass, decided to
do this instead, and now is still 13 years later, 16 years
later actually, has been able to avoid the bypass operation
whereas by now he would probably be on his second or third.
Somebody saved a lot of money avoiding that procedure, not to
mention the trauma.
Overall, we found that blockages got worse and worse in the
control group, and better and better in the experimental group.
One of the interesting findings after both 1 year and after 5
years, was that the more people changed the better they got.
Moderate changes don't go far enough to reverse heart disease
for most people, but more significant changes do.
I mean, I would love to be able to tell people that eating
chicken and beef and so on can reverse heart disease, but they
don't. So it's not that we try to tell people what to do, but
at least through the science, we can give people information
that Dr. Vernalis at Walter Reed, and others, are doing to give
them informed and intelligent choices and whatever they choose,
we support.
When we look at the PET scan data, and these were blindly
done in Texas, 99 percent of the patients stopped or reversed
the progression of their heart disease. We published this in
JAMA in 1995. That's pretty good. So not everybody, but most
people can stop or reverse the progression of their heart
disease with behavioral changes. We even had several patients
who were so sick that they needed a heart transplant and waited
to avoid it. Of those seven patients, all seven were able to
avoid having a heart transplant simply from changing diet,
exercise, and practicing the stress management techniques.
More recently we began a training cycle throughout the
country. There was $30 billion spent on bypass surgery and
angioplasty procedures last year, $20 billion of that in the
Medicare population, and the cartoon shows the surgeon saying,
I can operate on you or give you a strict diet, and we'd better
operate because your insurance doesn't cover a strict diet.
This is the way Medicare has been until recently as well.
And since 1993, several insurance companies have been
covering this program because we trained at a number of sites
throughout the country in the life style advantage and what we
found was that almost 80 percent of the people who were
eligible for bypass surgery or angioplasty were able to safely
avoid it for at least 3 years, and that saved an average of
almost $30,000 a patient. More recently, Hallmark Blue Cross/
Blue Shield found that in 350 patients that were first
scheduled, 348 were able to avoid a vascularization procedure,
saving more than $17,000 per patient.
And as you know, Medicare, thanks to you and your
colleagues, is now conducting a demonstration project of 1,800
patients.
The last thing I want to talk about is a more recent study
that we did with prostate cancer in collaboration with UCSF and
Memorial Sloan-Kettering Cancer Center. They found that PSA
levels, as you know, a marker for prostate cancer, rose after a
year in people who made more moderate life style changes
including stress management, but fell or got better in the
experimental group. And again, we found the same correlation,
the more people changed, the lower their PSA got, but they had
to make really big changes to turn that around.
And looking at MRI and neuroscopy, the two on the left
shown in red were diminishing or improved a year later.
prepared statement
And so, I think it's important that we address, in summary,
where we rate behaviors like diet and exercise, plus the
psychosocial, and the emotional and spiritual interventions, A,
because it's very hard to get people to even take their
medication or exercise unless you deal with these deeper
issues. And also, study after study has shown that people who
are lonely and depressed are many times more likely to get sick
and die prematurely than those who have a sense of connection
in the community. And my hope is that when people understand
how important these factors are, then they can begin to take
them more seriously, and that's part of the value of good
science. Thank you.
[The statement follows:]
Prepared Statement of Dr. 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., 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).
For the past 25 years, my colleagues and I at the 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 stress management techniques (yoga-
based stretching exercises, breathing techniques, meditation, imagery,
and progressive relaxation); a very low-fat, plant-based, whole foods
diet; moderate exercise; smoking cessation; and psychosocial support
groups. When these lifestyle causes are addressed, then improvement in
coronary heart disease may begin to occur much more quickly than had
previously been documented.
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 lifestyle causes of heart disease,
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. Over $30 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, including stress management techniques.
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 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.\1\ \2\ And within a year, even severely
blocked coronary arteries began to improve in 82 percent of the
patients.\3\ The improvement in quality of life was dramatic for most
of these patients.
---------------------------------------------------------------------------
\1\ Ornish DM, Scherwitz LW, Doody RS, et al. Effects of stress
management training and dietary changes in treating ischemic heart
disease. JAMA. 1983;249:54-59.
\2\ Ornish DM, Gotto AM, Miller RR, et al. Effects of a vegetarian
diet and selected yoga techniques in the treatment of coronary heart
disease. Clinical Research. 1979;27:720A.
\3\ Ornish DM, Brown SE, Scherwitz LW, et al. Can lifestyle changes
reverse coronary atherosclerosis? The Lifestyle Heart Trial. The
Lancet. 1990; 336:129-133.
---------------------------------------------------------------------------
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 New England Journal
of Medicine, 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.
In the Lifestyle Heart Trial, 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.\4\ \5\
---------------------------------------------------------------------------
\4\ Ornish D, Scherwitz L, Billings J, et al. Can intensive
lifestyle changes reverse coronary heart disease? Five-year follow-up
of the Lifestyle Heart Trial. JAMA. 1998;280:2001-2007.
\5\ Gould KL, Ornish D, Kirkeeide R, Brown S, et al. Improved
stenosis geometry by quantitative coronary arteriography after vigorous
risk factor modification. American Journal of Cardiology. 1992; 69:845-
853.
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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.
Cardiac PET scans revealed that 99 percent of these patients were able
to stop or reverse the progression of their coronary heart disease.\6\
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.
---------------------------------------------------------------------------
\6\ Gould KL, Ornish D, Scherwitz L, Stuart Y, Buchi M, Billings J,
Armstrong W, Ports T, Scherwitz L. Changes in myocardial perfusion
abnormalities by positron emission tomography after long-term, intense
risk factor modification. JAMA. 1995;274:894-901.
---------------------------------------------------------------------------
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. 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, decreasing reimbursement, shifting from inpatient to outpatient
surgery, and forcing doctors to see more and more patients in less and
less time may compromise the quality of care because these approaches
do not address stress and other lifestyle factors that often lead to
illnesses like heart disease.
Almost ten 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 of stress management and other lifestyle changes 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.
Is it safe to offer intensive lifestyle changes as an alternative
to revascularization?
Bypass surgery is effective in reducing angina and improving
cardiac function. However, when compared with medical therapy and
followed for 16 years, bypass surgery improved survival only in a very
small subgroup of patients (about 2 percent of those undergoing bypass
surgery): those with reduced left ventricular function and lesions of
the left main coronary artery of at least 60 percent. Median survival
was not prolonged in patients with left main disease 60 percent and
normal LV function even if a significant right coronary artery stenosis
> 70 percent was also present.\7\ \8\ \9\ \10\
---------------------------------------------------------------------------
\7\ Alderman EL., Bourassa MG, Cohen LS, et al. Ten year follow up
of survival and myocardial infarction in the randomized Coronary Artery
Surgical Study. Circulation. 1990;82, 1629-1646.
\8\ Varnauskas, E., for the European Coronary Surgery Study Group.
Twelve-year follow-up of survival in the randomized European Coronary
Surgery Study. New England Journal of Medicine. 1998;319, 332-337.
\9\ Chaitman BR., Fisher LD, Bourassa MG, et al. Effect of coronary
bypass surgery on survival patterns in subsets of patients with left
main coronary artery disease. American Journal of Cardiology. 1981;48,
765-777.
\10\ Coronary Artery Bypass Surgery Cooperative Study Group.
Eleven-year survival in the Veterans Administration randomized trial of
coronary bypass surgery for stable angina. The New England Journal of
Medicine. 1984;311:1333-1339.
---------------------------------------------------------------------------
Angioplasty was developed with the hope of providing a less
invasive, lower risk approach to the management of coronary artery
disease and its symptoms. Though widely utilized, there has never been
a randomized trial comparing angioplasty to medical therapy in stable
patients with coronary artery disease, therefore the mortality and
morbidity benefits of angioplasty are unknown. In low-risk patients
with stable coronary artery disease, aggressive lipid-lowering therapy
is at least as effective as angioplasty and usual care in reducing the
incidence of ischemic events.\11\
---------------------------------------------------------------------------
\11\ Pitt B, Waters D, Brown WV, et al. Aggressive lipid-lowering
therapy compared with angioplasty in stable coronary artery disease.
Atorvastatin versus Revascularization Treatment Investigators. N Engl J
Med. 1999;341(2):70-6.
---------------------------------------------------------------------------
The use of various types of stents during angioplasty may slow the
rate of restenosis, but there are no randomized controlled trial data
supporting the efficacy of these approaches. Compared to balloon
angioplasty patients, coronary stent patients have no statistically
significant differences in regard to additional percutaneous coronary
intervention or coronary artery bypass during a six-month follow-up
period, although they did have fewer heart attacks.\12\ The use of the
left internal mammary artery in bypass surgery may reduce reocclusion,
but vein grafts also must be used when patients have multivessel
disease. Thus, in addition to the costs of the original bypass or
angioplasty there are often costs of further procedures when restenosis
and reocclusion occur.
---------------------------------------------------------------------------
\12\ Heuser R, Houser F, Culler S, et al. A Retrospective Study of
6,671 Patients Comparing Coronary Stenting and Balloon Angioplasty. J
Invas Cardiol. 2000;12(7):354-362.
---------------------------------------------------------------------------
The majority of adverse events related to coronary artery disease,
MI, sudden death and unstable angina are due to the rupture of an
atherosclerotic plaque of less than 40-50 percent stenosis (blockage).
This often occurs in the setting of vessel spasm and results in
thrombosis and occlusion of the vessel.\13\ Bypass surgery and
angioplasty usually are not performed on lesions < 50 percent stenosed
(blocked) and do not affect non-bypassed or non-dilated lesions,
whereas comprehensive lifestyle changes (or lipid-lowering drugs) may
help stabilize all lesions, including mild lesions (< 50 percent
stenosis). Also, mild lesions that undergo catastrophic progression
usually have a less well-developed network of collateral circulation to
protect the myocardium than do more severe stenoses.
---------------------------------------------------------------------------
\13\ Fuster V, Badimon L, Badimon JJ, Chesebro JH. The pathogenesis
of coronary artery disease and the acute coronary syndromes. New
England Journal of Medicine. 1992;326, 242-318.
---------------------------------------------------------------------------
Bypass surgery and angioplasty have risks of morbidity and
mortality associated with them, whereas there are no significant risks
from eating a well-balanced low-fat, low-cholesterol diet, stopping
smoking, or engaging in moderate walking, stress management techniques,
and psychosocial support.
COMPARISON OF INTENSIVE LIFESTYLE CHANGES (ILC), ANGIOPLASTY (PTCA), AND
BYPASS SURGERY (CABG)
------------------------------------------------------------------------
ILC PTCA CABG
------------------------------------------------------------------------
Rapid angina....... X X X
Rapid myocardial X X X
perfusion...................
cardiac events..... X .......... \1\ X
Continued in X .......... .................
stenosis over time..........
Continued in X .......... .................
perfusion over time.........
Improvements in non-dilated X .......... .................
lesions.....................
Improvements in non-bypassed X .......... .................
lesions.....................
Costs........................ + +++ +++++
------------------------------------------------------------------------
\1\ Subset.
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 via Lifestyle
Advantage. 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.
A total of 333 patients completed the Multicenter Lifestyle
Demonstration Project (194 in the experimental group and 139 in the
control group). We found that almost 80 percent of experimental group
patients were able to safely avoid bypass surgery or angioplasty for at
least three years by making comprehensive lifestyle changes at
substantially lower cost without increasing cardiac morbidity and
mortality. These patients reported reductions in angina comparable to
what can be achieved with revascularization. Mutual of Omaha calculated
an immediate savings of almost $30,000 per patient. At Highmark Blue
Cross Blue Shield/Lifestyle Advantage, 348 of 350 patients were able to
safely avoid revascularization by making comprehensive lifestyle
changes. Patients reported reductions in angina comparable to what can
be achieved with bypass surgery or angioplasty without the costs or
risks of surgery.
Several patients with such severe heart disease that they were
waiting on the heart transplant list for a donor heart (due to ischemic
cardiomyopathies secondary to coronary heart disease) 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 $500,000 per patient as well as significant
physical and emotional trauma. Also, up to one-half of patients waiting
for a heart transplant die before a donor becomes available.
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.\14\
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\14\ Ornish D. Concise Review: Intensive lifestyle changes in the
management of coronary heart disease. In: Harrison's Principles of
Internal Medicine (online), edited by Eugene Braunwald et al., 1999.
Also to be published in hardcover in 2002.
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medicare
Good science is very important but not always sufficient to
motivate lasting changes in medical practice. When reimbursement
changes, then medical practice and medical education often follow.
Over 550,000 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 700,000
coronary angioplasties were performed in the United States last year at
a combined cost of over $30 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 Centers for Medicare
and Medicaid Services (CMS) 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, CMS conducted their own internal peer review of our program.
After seven years of discussions and review, CMS is now conducting 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.
Also, Congress appropriated funds via the Department of Defense for
us to train the Walter Reed Army Medical Center in our program for
reversing heart disease. This program began three years ago.
can prostate cancer be slowed, stopped, or reversed by changing
lifestyle?
The significant benefits of stress management techniques and other
lifestyle changes extend beyond reversing and helping to prevent
coronary heart disease. Other illnesses that may benefit include
diabetes, hypertension, obesity, and cancers of the prostate, breast,
and colon.
Five 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-five 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 United States who eat this diet also have much lower
rates of prostate cancer and breast cancer than those eating a typical
American diet.
This study has been conducted in collaboration with Peter Carroll,
M.D. (Chairman, Department of Urology, UCSF School of Medicine) and the
late William Fair, M.D. (Professor and 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.
We enrolled 84 men with biopsy-proven prostate cancer who had
elected not to undergo conventional treatment for reasons unrelated to
the study. This unique design allowed us to have a non-intervention
control group to study the effects of diet and lifestyle alone on
cancer without confounding interventions such as chemotherapy,
radiation, and surgery.
These prostate cancer patients were randomly assigned into an
experimental group who were asked to make comprehensive lifestyle
changes or to a non-intervention control group. The comprehensive
lifestyle changes were very similar to the program that we documented
could reverse the progression of heart disease, including a very low-
fat plant-based diet (predominantly fruits, vegetables, whole grains,
beans, and soy products), moderate exercise, stress management
techniques (including yoga and meditation), and a weekly support group.
During the first year, none of the experimental group patients and
seven of the control group patients underwent conventional treatments
such as surgery or radiation.
After three months, PSA levels decreased in the experimental group
but remained about the same in the control group. These differences
were statistically significant. After one year, PSA levels increased
(worsened) in the control group but decreased (improved) in the
experimental group. These differences also were statistically
significant after one year. This rise in PSA in the control group would
have been even greater if they had not also made significant changes in
diet and lifestyle. When we examined a different control group of
patients at the Walter Reed Army Medical Center with similar disease
severity who had not made such significant changes in diet and
lifestyle, we found their PSA rose substantially more.
Of particular interest was the strong and statistically significant
correlation between adherence to the lifestyle program and changes in
PSA across both groups after three months. The more people changed, the
more their PSA decreased. We found a similar strong and statistically
significant correlation between adherence to the lifestyle program and
changes in PSA across both groups after one year. This correlation
between adherence to the lifestyle program and changes in PSA was very
similar to what we found in our earlier studies when we found a strong
correlation between adherence to the lifestyle program and changes in
coronary artery disease.
Thus, it appears that comprehensive lifestyle changes may stop or
even reverse the progression of both heart disease and prostate cancer.
However, adherence needed to be very high (>88 percent) in order to
stop the disease from progressing.
how does emotional stress affect the heart?
Emotional stress, in addition to diet and exercise, is one of the
underlying causes of coronary heart disease. During the past ten years,
increasing scientific evidence has provided a more complete
understanding of the mechanisms of coronary heart disease (CHD). This
understanding provides increasing justification for using intensive
lifestyle changes in managing CHD.
Coronary heart disease is a much more dynamic process than had once
been thought. While coronary atherosclerosis (arterial blockages)
contributes to myocardial ischemia (reduced blood flow to the heart),
so do other mechanisms that may change rapidly--for better and for
worse. These include variations in coronary artery vasomotor tone,
platelet viscosity, endothelial stability, inflammation, and collateral
circulation.
Each of these mechanisms may be directly influenced by lifestyle
factors, including cigarette smoking, diet, emotional stress,
depression, and exercise. These changes can occur--for better and for
worse--much more quickly than had once been believed.
The most common cause of myocardial infarction, sudden cardiac
death, or unstable angina is rupture of an atherosclerotic plaque,
often associated with localized coronary thrombosis and/or coronary
artery spasm.\15\ \16\ Research publications since 1990 have
consistently shown that intensive risk factor modification can reduce
cardiac events quite rapidly by stabilizing the endothelium within a
relatively short period of time, whether via comprehensive changes in
diet and lifestyle or with lipid-lowering drugs, or both, even before
there is time for meaningful regression in coronary
atherosclerosis.\17\
---------------------------------------------------------------------------
\15\ Brown BG, Zhao XQ, Sacco DE, Albers JJ. Lipid lowering and
plaque regression: new insights into prevention of plaque disruption
and clinical events in coronary artery disease. Circulation.
1993;87:1781-1791.
\16\ van der Wal AC, Becker AE, van der Loos CM, Das PK. Site of
intimal rupture or erosion of thrombosed coronary atherosclerotic
plaques is characterized by an inflammatory process irrespective of the
dominant plaque morphology. Circulation. 1994;89:36-44.
\17\ Gould KL. Clinical Cardiology Frontiers: Reversal of Coronary
Atherosclerosis. Circulation. 1994;90(3):1558-1571.
---------------------------------------------------------------------------
In addition to these mechanisms, emotional stress often motivates
people to overeat, drink too much alcohol, abuse drugs, work too hard,
and engage in other self-destructive behaviors. In addition, people who
are lonely, depressed, and isolated are many times more likely to get
sick and die prematurely than those who feel love, connection, and
community. The mechanisms for this understanding are not completely
understood: we know that it is true even though we do not always know
why it is true.
In this testimony, I will discuss some of these mechanisms,
describe the evidence from lifestyle intervention trials, and summarize
strategies that may be helpful in motivating patients to make and to
maintain beneficial changes in diet and lifestyle.\18\
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\18\ Ornish D. Dr. Dean Ornish's Program for Reversing Heart
Disease. New York: Random House, 1990; Ballantine Books, 1992.
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emotional stress and hostility
Emotional stress may lead to chest pain and heart attacks both via
coronary artery spasm and by increased platelet aggregation (blood
clots) within coronary arteries.\19\ Stress may lead to coronary spasm
(constriction of coronary arteries) mediated either by direct alpha-
adrenergic stimulation (i.e., direct connections between the brain and
the heart) or secondary to the release of hormones such as thromboxane
A2 from platelets, perhaps via increasing circulating stress hormones
or other mediators.\20\ Both thromboxane A2 and catecholamines (stress
hormones) are potent constrictors of arterial smooth muscle and
powerful endogenous stimulators of platelet aggregation.\21\
---------------------------------------------------------------------------
\19\ Oliva, P. B. (1981). Pathophysiology of acute myocardial
infarction. Annals of Internal Medicine, 94, 236-250.
\20\ Schiffer, F., Hartley, L. H., Schulman, C. L., & Abelman, W.
H. (1980). Evidence for emotionally induced coronary arterial spasm in
patients with angina pectoris. British Heart Journal, 44, 62-66.
\21\ Moncada, S., & Vane, J. R. (1979). Arachidonic acid
metabolites and the interactions between platelets and blood vessel
walls. New England Journal of Medicine, 300, 1142-1147.
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Personally relevant mental stress may be an important precipitant
of reduced blood flow to the heart--often silent--in patients with
coronary artery disease.\22\ Acute mental stress may be a frequent
trigger of transient reductions in blood flow to the heart, heart
attacks and sudden cardiac death.\23\
---------------------------------------------------------------------------
\22\ Rozanski A. Bairey CN. Krantz DS, et al. Mental stress and the
induction of silent myocardial ischemia in patients with coronary
artery disease. New England Journal of Medicine. 318(16):1005-12, 1988
Apr 21.
\23\ Bairey CN. Krantz DS. Rozanski A. Mental stress as an acute
trigger of ischemic left ventricular dysfunction and blood pressure
elevation in coronary artery disease. American Journal of Cardiology.
66(16):28G-31G, 1990 Nov 6.
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Women of postmenopausal age may have greater cardiovascular
responses to stress than men or premenopausal women.\24\
Atherosclerotic monkeys with chronic psychosocial disruption had
coronary artery constriction in response to acetylcholine, whereas
atherosclerotic monkeys living in a stable social setting had coronary
artery vasodilation in response to acetylcholine, even though both
groups of monkeys were consuming a cholesterol-lowering diet.\25\
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\24\ Bairey Merz CN. Kop W. Krantz DS, et al. Cardiovascular stress
response and coronary artery disease: evidence of an adverse
postmenopausal effect in women. American Heart Journal. 135(5 Pt
1):881-7, 1998 May.
\25\ Williams JK. Vita JA. Manuck SB. Selwyn AP. Kaplan JR.
Psychosocial factors impair vascular responses of coronary arteries.
Circulation. 1991;84(5):2201-2.
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In an analysis of over forty-five studies, hostility has emerged as
one of the most important personality variables in coronary heart
disease.\26\ The effects of hostility are equal to or greater in
magnitude to the traditional risk factors for heart disease.\27\
Hostility and cynicism appear to be the primary toxic components of the
Type A behavioral pattern. Other aspects of Type a behavior do not seem
to be harmful.
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\26\ Miller TQ, Smith TW, Turner CW, et al. A meta-analytic review
of research on hostility and physical health. Psychological Bulletin.
1996;119:322-348.
\27\ Review Panel on Coronary-Prone Behavior and Coronary Heart
Disease. Coronary-prone behavior and coronary heart disease: a critical
review. Circulation. 1978;65:1199-1215.
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depression
Several studies have shown that depression significantly increases
the risk of developing coronary heart disease. One study of 1,551
people in the Baltimore area who were free of heart disease in 1981
found that those who were depressed were more than four times as likely
to have a heart attack in the next 14 years. Depression increased risk
as much as did hypercholesterolemia.\28\
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\28\ Pratt LA, Ford DE, Crum RM, et al. Depression, psychotropic
medication, and risk of myocardial infarction. Circulation.
1996;94(12):3123-9.
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Depression also increases the risk of subsequent myocardial
infarction in patients with existing coronary heart disease.
Unfortunately, depression often goes untreated.
One study examined the survival of elderly men and women
hospitalized for an acute heart attack who had emotional support
compared with those patients who lacked such emotional support. More
than three times as many men and women died in the hospital who had no
source of emotional support compared with those with two or more
sources of support. Among those who survived and were discharged from
the hospital, after six months 53 percent of those with no source of
support had died compared with 36 percent of those with one source and
23 percent of those with two or more sources of support. These figures
did not change significantly after one year. When they looked at all
patients and controlled for other factors that might have influenced
survival (such as severity of the heart attack, age, gender, other
illnesses, depression), men and women who reported no emotional support
had almost three times the mortality risk compared with those who had
at least one source of support.\29\
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\29\ Berkman LF, Leo-Summers L, Horwitz RI. Emotional support and
survival after myocardial infarction. A prospective, population-based
study of the elderly. Annals of Internal Medicine. 1992;117(12):1003-9.
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In another study, researchers followed 222 patients who had
suffered myocardial infarction and found that those who were depressed
were four times as likely to die in the next six months as those who
were not depressed.\30\
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\30\ Lesperance F, Frasure-Smith N, Talajic M. Major depression
before and after myocardial infarction: its nature and consequences.
Psychosomatic Medicine. 1996;58(2):99-110.
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Many depressed patients are, paradoxically, in a constant state of
hyperarousal, causing sustained hyperactivity of the two principal
effectors of the stress response, the corticotropin-releasing-hormone,
or CRH, system, and the locus ceruleus-norepinephrine, or LC-NE,
system. Norepinephrine may precipitate vasoconstriction, platelet
aggregation, and arrhythmias. Cortisol may accelerate
atherosclerosis.\31\ When patients are treated for depression, these
changes in CRH and LC-NE may return to normal. Beta-blockers help blunt
the hyperarousal state but may exacerbate depression, whereas
meditation may reduce hyper-reactivity without causing depression.
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\31\ Gold PW, Chrousos GP. The endocrinology of melancholic and
atypical depression. Proceedings of the Association of American
Physicians. 1999;111(1):22-34.
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Social factors, including social support, play an important role in
both adherence to comprehensive lifestyle changes and may have powerful
effects on morbidity and mortality independent of influences on known
risk factors. An increasing number of studies has shown that those who
feel socially isolated have three to five times the risk of premature
death not only from coronary heart disease but also from all causes
when compared to those who have a sense of connection and
community.\32\ \33\
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\32\ House JS, Landis KR, Umberson D. Social relationships and
health. Science. 1988; 241(4865):540-5.
\33\ Ornish D. Love & Survival: The Scientific Basis for the
Healing Power of Intimacy. New York: HarperCollins, 1998.
---------------------------------------------------------------------------
For example, researchers at Duke studied almost 1,400 men and women
who underwent coronary angiography and were found to have had at least
one severe coronary artery stenosis. After five years, men and women
who were unmarried and who did not have a close confidante--someone to
talk with on a regular basis--were over three times as likely to have
died than those who were married, had a confidant, or both. These
differences were independent of any other known medical prognostic risk
factors.\34\
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\34\ Williams RB, Barefoot JC, Califf RM, et al. Prognostic
importance of social and economic resources among medically treated
patients with angiographically documented coronary artery disease.
Journal of the American Medical Association. 1992;267(4):520-524.
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exercise
One of the benefits of exercise is to help reduce stress and combat
depression. The role of exercise in the prevention and treatment of
coronary heart disease is well-known and is supported by several
reviews of the literature. Two meta-analyses indicate that the risk of
death was doubled in those who were physically inactive when compared
with more active individuals.\35\ \36\ Rehabilitation programs
incorporating exercise also show modest benefits of exercise in
preventing recurrent CHD events. None of 22 randomized trials in the
meta-analysis had the power to show a significant treatment effect, but
in a meta-analysis employing the intention-to-treat analysis, there was
a significant reduction of 25 percent in 1- to 3-year rates of CHD and
total mortality in the patients receiving cardiac rehabilitation when
compared with control patients.
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\35\ Berlin, J. A., & Colditz, G. A. A meta-analysis of physical
activity in the prevention of coronary heart disease. American Journal
of Epidemiology, 1990;132, 612-628.
\36\ Powell, K. E., Thompson, P. D., Caspersen, C. J., & Kendrick,
J. S. Physical activity and the incidence of coronary heart disease.
Annual Review of Public Health. 1987;8, 253-287.
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Moderate exercise provides most of the improvement in longevity as
more intensive exercise while minimizing the risks of exercising. In
one study, investigators performed treadmill testing on 10,224 men and
3,120 women who were apparently healthy. Based on their fitness level,
these participants were divided into five categories, ranging from
least fit (group 1) to most fit (group 5). The researchers followed
these people to determine how their level of physical fitness related
to their death rates. After eight years, the least fit (the sedentary
group 1) had a death rate more than three times greater than the most
fit (the very active group 5). More important, though, was the finding
that most of the benefits of physical fitness came between group 1 and
group 2, particularly in men.\37\
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\37\ Blair SN, Kohl HW, Paffenbarger RS, et al. ``Physical fitness
and all-cause mortality.'' JAMA. 1989;262:2395-2401.
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Even substantial decreases in cardiovascular fitness resulting from
decades of inactivity can be substantially reversed with modest
endurance training.
practical considerations
Lifestyle factors such as diet, smoking, and emotional stress often
interact. For example, people are often more likely to overeat, smoke,
work too hard, or abuse drugs and alcohol when they feel lonely,
depressed, or isolated. As one patient told me, ``I've got 20 friends
in this package of cigarettes and they're always there for me. Are you
going to take away my 20 friends? What are you going to give me
instead?''
Providing health information is important but not usually
sufficient to motivate lasting changes in behavior unless the
underlying psychosocial issues are also addressed. Thus, stress
management techniques and group support may address some of these
deeper concerns, thereby making it easier for patients to change diet
and quit smoking.\38\ \39\ Sometimes, patients also may benefit from
referral to a psychotherapist for treatment of depression with
counseling and/or antidepressants.
---------------------------------------------------------------------------
\38\ Ornish D. Love & Survival: The Scientific Basis for the
Healing Power of Intimacy. New York: HarperCollins, 1998.
\39\ Ornish D, Hart J. Intensive Risk Factor Modification. In:
Hennekens C, Manson J, eds. Clinical Trials in Cardiovascular Disease.
Boston: W.B. Saunders, 1998.
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The conventional medical thinking is that taking a statin drug is
easy and most patients will comply, but making comprehensive lifestyle
changes is virtually impossible for almost everyone. In fact, less than
50 percent of patients who are prescribed statin drugs are taking them
as prescribed just one year later.\40\
---------------------------------------------------------------------------
\40\ Rogers PG, Bullman WR. Prescription medication compliance: a
review of the baseline of knowledge. A report of the National Council
on Patient Information and Education. J Pharmacoepidemiology. 1995;2:3-
36.
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One might think that compliance to lipid-lowering drugs would
always be much higher than to comprehensive diet and lifestyle changes,
since taking pills is relatively easy and the side-effects are minimal
for most patients. However, cholesterol lowering drugs do not make most
patients feel better. They are taken today in hopes that there may be a
long-term benefit by reducing the risk of a myocardial infarction or
sudden cardiac death.
To many patients, concepts such as ``risk factor modification'' and
``prevention'' are considered boring and they do not initiate or
sustain the levels of motivation needed to make intensive lifestyle
changes. ``Am I going to live longer, or is it just going to seem
longer?''
Also, the prospect of a heart attack or death is so frightening for
many patients that their denial often keeps them from thinking about it
at all. Because of this, adherence becomes difficult for them to
maintain. (Patients often will adhere very well for a few weeks after a
heart attack until the denial returns.) Fear is a powerful motivator in
the short run but not in the long run, for when it's too scary to think
about something, many people simply don't.
While fear of dying may not be a sustainable motivator, joy of
living often is. In our experience, paradoxically, it may be easier for
some patients to make comprehensive changes all at once than to make
small, gradual changes or even to take a cholesterol-lowering drug.
For example, when patients follow a Step 2 diet, they often have a
sense of deprivation but not much apparent benefit. LDL-cholesterol is
reduced by an average of only 5 percent,\41\ frequency of angina does
not improve much, lost weight is usually regained, and coronary artery
lesions tend to progress. However, patients who make comprehensive
lifestyle changes often experience significant and sustained reductions
in frequency of angina, LDL-cholesterol, and weight; also, coronary
artery lesions tend to regress rather than progress.
---------------------------------------------------------------------------
\41\ Hunninghake DB, Stein EA, Dujovne CA, et al. The efficacy of
intensive dietary therapy alone or combined with lovastatin in
outpatients with hypercholesterolemia. N Engl J Med. 1993;328(17):1213-
9.
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Patients usually report rapid decreases in angina and often
describe other improvements within weeks; these rapid improvements in
angina, well-being, and quality of life sustain motivation and help to
explain the high levels of adherence in these patients. Instead of
viewing lifestyle changes solely in terms of risk factor reduction in
hopes of future benefit, patients began to experience more immediate
benefits, thereby reframing the reason for making these changes in
behavior from fear of dying to joy of living.
This is a particularly rewarding and emotionally fulfilling way to
practice medicine, both for patients and the physicians and other
health professionals who work with them. Much more time is available to
spend with patients addressing the underlying lifestyle factors that
influence the progression of coronary artery disease, yet costs are
substantially lower.
As discussed earlier, the major reason that most stable patients
undergo bypass surgery or angioplasty is to reduce the frequency of
angina, and comparable results may be obtained by making comprehensive
lifestyle changes alone. Instead of pressuring physicians to see more
patients in less time, this is a different approach to reducing medical
costs that is caring and compassionate as well as cost-effective and
competent.
The physician, who is often pressed for time, need not provide all
of the training in changing diet and lifestyle. He or she can act as
the ``quarterback,'' providing direction and supervision. My colleagues
and I at the non-profit Preventive Medicine Research Institute and at
Lifestyle Advantage have trained teams of health professionals at
clinical sites around the country in this program of comprehensive
lifestyle changes. These include cardiologists, registered dietitians,
exercise physiologists, psychologists, chefs, stress management
specialists, registered nurses, and administrative support personnel.
These teams, in turn, work with their patients to motivate them to make
and maintain comprehensive lifestyle changes.
In practice, patients with coronary heart disease should be offered
a range of therapeutic options, including comprehensive lifestyle
changes, medications (including lipid-lowering drugs), angioplasty, and
bypass surgery. The physician should explain the relative risks,
benefits, costs, and side-effects of each approach and then support
whatever the patient decides. Whether or not a patient chooses to make
intensive lifestyle changes is a personal decision, but he or she
should have all the facts in order to make an informed choice.
Emotional stress affects the health and productivity of almost all
Americans. 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 effects of emotional
stress on health and disease.
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 regardless of socioeconomic and demographic background. 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.
Thank you very much for the opportunity to share these thoughts
with you today.
STATEMENT OF KAREN MATTHEWS, Ph.D., DIRECTOR,
CARDIOVASCULAR BEHAVIORAL MEDICAL RESEARCH
TRAINING PROGRAM, UNIVERSITY OF PITTSBURGH
SCHOOL OF MEDICINE
Senator Specter. Thank you very much, Dr. Ornish. We now
turn to Dr. Karen Matthews. We kind of skipped in our order,
but we are now coming back to alphabetical order. She is the
program director of the Cardiovascular Behavioral Medicine
Research Training program at the University of Pittsburgh,
director of the Pittsburgh Mind Body Center, professor of
psychology, psychiatry and epidemiology at the University of
Pittsburgh. She received her bachelor's degree in psychology at
University of California at Berkeley and her Ph.D. in
psychology at the University of Texas. So welcome, Dr.
Matthews, and we look forward to your testimony.
Dr. Matthews. Thank you for including me in this panel
today. I want to thank you for your past support of the
mechanisms supporting the Mind Body Centers as well as your
efforts and the efforts of the committee in increasing
financial support for biomedical research. It is much
appreciated.
I want to make three points in my testimony today. The
first point is that psychological stress can trigger a heart
attack and lead to premature death. It may also accelerate the
rate of atherosclerosis in the coronary arteries prior to the
first heart attack. So theoretically then, it makes a lot of
sense in stress management techniques to reduce the risk of
first or second heart attack.
The second point is that there are relatively few clinical
trials of stress management that meet standard criteria for
clinical trials with heart disease patients, but combining the
data from smaller scale clinical trials does show that
psychosocial interventions are a useful adjunct to standard
care.
The third point I would like to make is that the science of
behavior change and practical knowledge of how to conduct
clinical trials has advanced sufficiently now so that I think
it really is a good time for larger scale studies to evaluate
how we can best promote health in coronary patients as well as
prevent the first occurrence of heart disease.
So let me go over the points in a little more detail. First
of all, regarding the role of stress in heart disease, risk
factors for heart disease can be subdivided into those that are
related to the development of disease prior to the symptoms as
well as those that can be important after the onset of
symptoms, like a heart attack. So we really think about the
risk factors as having two major stages, I guess you would say.
Development of atherosclerosis begins in adolescence and
young adulthood, that early, whereas alterations in plaque
readings, rupture and heart attack usually is seen in men
beginning in the 50s and in women beginning in the 60s.
Typically the first presentation of symptoms is angina for
women, or chest pain, and for men is a heart attack, but if
women have a heart attack it is actually worse for them than it
is for men, and they are more likely to have a recurrent event
and they are more likely to die relative to men.
Evidence shows that stressful events such as things like
earthquakes or the death of a spouse or child, or missile
attacks during war do lead to plaque, rupture and heart attack.
Accumulation of stressors at home or at work may also be
related to earlier development of atherosclerosis. We haven't
had simple measures of subclinical or silent atherosclerosis
until rather recently for research purposes, because the
techniques that we have had available to us have not been safe
or recommended for people unless we know that they have serious
disease.
Thus, at this point we are really accumulating the data on
what's important in terms of stress and early disease markers.
Nonetheless, at this point it appears that individuals at
higher risk for subclinical atherosclerosis experience economic
hardship, are employed in stressful jobs, and have negative
emotions such as depression or feeling isolated from others. So
to the extent that stress management interventions do lower
stress, interventions should be able to assist in lowering the
risk of initial or a second event in individuals under high
stress.
Regarding the second point, which is the current status of
intervention research, clinical trials evaluating any
intervention should include random assignment to an
intervention or an appropriate comparison group, a
representative sample of the target population, and a
sufficient sample size relative to the health outcomes to allow
accurate statistical tests. These features are true for any
evaluation of treatment, whether it be behavioral treatment or
a pharmacologic treatment.
There are relatively few studies of stress management of
heart disease patients that have met these three criteria. One
study found that very long term behavioral treatment, which
included stress management, reduced type A behaviors and
reduced rates of a second heart attack compared to those in a
comparison group. But two large scale trials, one conducted in
England and one conducted in Canada, did not find that stress
management reduced either the stress in individuals or patients
or the rates of recurrent events. Now those studies were very
short in duration and probably not effective enough to get the
kind of changes that we need to see in order to promote health
in heart disease patients.
The third point that I wanted to make is that we really
need further studies at this point on the impact of behavioral
interventions on reversing heart disease. I think adaptations
to standard stress management interventions may be necessary to
make them more effective for our heart attack patients,
especially since many of these individuals are getting their
behavioral counseling while they are in the hospital and under
a lot of distress, and their families of course are panicked as
well.
Women I think deserve special consideration, given their
high risk following a heart attack as well as in one of those
three large scale studies, the efforts to reduce stress in
women actually led to an increase in heart attack rates
compared to usual care. It's not really understood why that's
the case, but the timing is extremely important and very
striking, and we need to understand that.
Studies on behavioral interventions to prevent heart
disease are worth looking at. We know that a combination of not
smoking, having a healthy diet, and higher levels of physical
activity, moderate alcohol consumption and not being overweight
is associated with very low risk of heart disease in the nurses
health study, a very large scale study of nurses throughout the
United States. But unfortunately, only 3 percent of the nurses
were in this category and if anyone should know about healthy
life style, it should be nurses.
prepared statement
Very few people in the United States have adopted life
styles that are associated with very low risk for heart
disease, in part because of the difficulty in changing well
practiced behaviors later in life and in part because stress
may interfere with the ability to adopt health promoting
behaviors. We need studies to better understand how the role of
stress accelerates heart disease risk early in life and to
evaluate how stress management interventions might impact
earlier risk conditions. Thank you.
[The statement follows:]
Prepared Statement of Dr. Karen A. Matthews
It is a pleasure for me to participate in the hearing today on the
impact of stress management in reversing heart disease. I am Professor
of Psychiatry at the University of Pittsburgh and Director of the
Pittsburgh Mind-Body Center, one of five scientific centers established
by the National Institutes of Health in 1999 at the encouragement of
this committee. My own research is on the role of stress in the
development of heart disease, with an emphasis on young adults and on
women during the menopausal transition. Our Center is dedicated to
understanding how stress and other psychological factors translate into
risk for diverse diseases, including heart disease.
Today I would like to make four points:
1. Psychological stress is typically considered to be a process and
not a single event. Stress management techniques can intervene in
multiple ways in the stress process.
2. Psychological stress can trigger ischemia, heart attack, and
premature death. It may also accelerate the rate of atherosclerosis
prior to the first heart attack or other clinical event, especially
among those who already have high levels of ``subclinical or silent
disease.'' Thus, effective stress management techniques should
theoretically be able to prevent a first or second heart attack.
3. Adequate tests of the impact of stress management interventions
in heart disease patients have been few in number, but combining
together the data from small clinical trials shows that psychosocial
interventions can be a useful adjunct to other therapies.
4. The science of behavior change and practical knowledge of how to
conduct clinical trials have advanced sufficiently so that now is an
opportune time to conduct high quality studies on the impact of stress
reduction on preventing or reversing heart disease.
Psychological Stress as a Process
Psychological stress is defined as an individual's perception that
environmental demands exceed or tax the resources that s/he has to deal
with those demands. It starts with an awareness of an anticipated or
acute event in which an individual appraises the event as potentially
exceeding the resources that can be brought to be bear to deal with the
event. When a person is unable to deal with the event, then the person
feels a reduction in physical and psychological well being, e.g.,
reduced energy and increased anxiety. Ways of coping with stress are
typically categorized according to whether the aim is to alter the
event in some way or to mitigate one's reaction to the event. Examples
of events that most people would consider stressful are work overload,
marital conflict, children's school failure, and job insecurity. Coping
with work overload, for example, could take the form of renegotiating
work objectives and reducing the arousal associated with fast paced
work through stress management techniques.
Psychological stress rarely is a single event. Rather the events
are chained together and can be cumulative in their impact. For
example, work overload can reduce the time for high quality
interactions with spouse and family, which, in turn, can lead to both
neglect and greater conflict, which in turn could lead to marital
dissolution. Even when events are not chained together, an event can
have a different impact depending on other life circumstances. For
example, the death of one's dog may have a more substantial impact if
it co-occurs with children leaving the home. The perspective of
psychological stress as a process suggests that stress management
techniques can intervene in the sequences of stressful events in many
different ways depending on the specific circumstances.
Psychological Stress as a Risk Factor for Heart Disease
Risk factors for heart disease can be subdivided into those related
to the development of atherosclerosis and those related to changes in
atherosclerotic plaque, thrombosis, and fibrinolysis (the latter two
being clotting and dissolution of clots). The development of
atherosclerosis can be traced to adolescence and young adulthood,
whereas alterations in plaque leading to rupture and a heart attack
begin in the fifties for men and in the sixties for women. The initial
presentation of symptoms for heart disease tends to be angina for
women, whereas it is a heart attack for men. However, if women
experience a heart attack, their prognosis is worse relative to men.
Evidence shows that stressful events can trigger plaque rupture and
a heart attack. For example, on the day of the North ridge earthquake,
the Los Angeles coroner's office increased five-fold in the number of
deaths from cardiac causes, compared with the previous week. Most of
these deaths occurred within the first hour of the earthquake. During
the 1991 Iraqi missile crisis, the number of heart attacks increased in
the areas of Tel Aviv, Israel, that were attacked, compared to numbers
in the prior year. Most victims of a heart attack, especially male,
have significant underlying atherosclerosis. It is thought that the
emotional distress associated with stressful events leads to vasospasm
or ventricular arrhythmia in those with significant underlying disease.
Accumulation of stressors, i.e. chronic stress, may also be related
to the development of atherosclerosis. However, the data are not
definitive because we have not had suitable measures of subclinical
atherosclerosis for use in ostensibly healthy people. A common method
of measuring coronary atherosclerosis, e.g., angiography, has some risk
and is not used unless individuals are strongly suspected of having
heart disease. More recently, new measures of subclinical carotid
atherosclerosis and calcified plaque have come available for research
and clinical purposes and are being used in ongoing studies. The
availability of these measurements has increased enormously the
potential for understanding the development of disease, long before
heart damage is permanent and when prevention is possible.
Thus far, evidence based on subclinical measures of atherosclerosis
suggest that individuals who experience economic hardship, who are
employed in demanding jobs and are physiologically reactive to stress,
who are depressed, mistrustful of others, hold their anger inwardly,
and anxious are at higher risk for subclinical atherosclerosis. Primate
studies also find that the combination of the usual American high fat
diet and psychosocial stress leads to the development of
atherosclerosis in the large coronary vessels, the inability to dilate
coronary arteries when oxygen demand is increased, and adverse changes
in reproductive hormones in females. Taken together, these findings
suggest theoretically that effective stress management techniques
should be able to reduce the risk of a first or second heart attack.
Status of Stress Management Interventions in Reversing Heart Disease
Stress management interventions typically have a number of
components. These include training people to recognize the kinds of
circumstances that lead them to be emotionally aroused, to practice
skills to reduce the affective, behavioral, and physiologic components
of stress, and to reinterpret arousing circumstances in a more benign
way, e.g., to look for the potential for good and not just harm. Often
stress management interventions are combined with other interventions,
including modification of diet and exercise patterns.
Ideally studies that evaluate any intervention should include
random assignment to the intervention vs. an appropriate comparison
group, a representative sample of the target population, and sufficient
sample size in relation to the number of health outcomes to allow
adequate statistical power to test the study hypothesis. There are
relatively few stress management studies that meet these criteria.
Friedman and colleagues evaluated a long-term intervention to reduce
Type A behavior (being hard driving, competitive, and easily annoyed)
among 862 heart attack patients, almost all men; diabetics and smokers
were excluded The behavioral treatment included training in progressive
muscle relaxation, changes in belief systems that support Type A
behavior, behavioral alterations, practicing specific drills, and
health education; the comparison group had only health education
delivered by cardiologists. The treatment successfully reduced Type A
behavior. Patients who were in the behavioral treatment group had
reduced rates of a second heart attack, compared to those in the
comparison group.
Jones and West studied 2,315 MI patients who were randomized to
seven weeks of stress management or usual care after hospital
discharge. The intervention included teaching relaxation training,
skills to recognize stressful circumstances and how to respond to them.
Those in the intervention group experienced neither a reduction in
anxiety and depression nor a reduction in risk of heart attack or other
clinical complications or death in the following year. Frasure-Smith
evaluated a home-based intervention designed to reduce distress among
1,376 heart attack patients who reported high stress scores. The
intervention included emotional support, practice advice, education,
and referral as appropriate offered by nurse clinicians; the comparison
group was usual care. This intervention neither reduced anxiety and
depression nor lead to a reduction in the mortality among men. Women
had higher distress scores, had more intensive intervention, and also
experienced higher mortality rates in the intervention group than in
the usual care group. The authors speculated that the monthly screening
for signs of distress may have had an untoward effect on the patients.
Given that few individual studies meet standard study criteria for
evaluating intervention effectiveness, combining the results of small
scale trials via a statistical technique called meta-analysis is useful
to address the subject of this hearing. Linden et al summarized the
results of 22 studies that in combination evaluated the benefits of
psychosocial interventions added to standard care among a total of
2,024 patients as compared to 1,156 standard care participants. The
interventions were quite varied and included relaxation training, group
psychotherapy, and individual counseling, whereas standard care
included medical management, exercise and diet information and
sometimes active intervention. In the aggregate, these studies were
successful in reducing psychological distress. Among the participants
in the 10 fully randomized clinical trials, those assigned to the
psychosocial intervention had lower morbidity rates throughout the
reporting period and lower mortality rates during the first two years
of follow-up in relation to the rehabilitation comparison groups. Those
comparison groups typically included exercise and diet intervention and
medical management. These authors commented on the cost-effectiveness
of adding psychosocial intervention to standard care.
The latter point is underscored by Blumenthal et al. A small group
of men with coronary artery disease and exercise-induced ischemia were
randomized to either four months of aerobic exercise or weekly classes
on stress management and were followed for five years. Another group
was followed for comparison purposes. Results showed that patients who
experienced the stress management intervention had reduced rates of
ischemia during mental stress and throughout the day, reduced numbers
of clinical coronary events, and reduced medical costs as compared to
patients in usual care.
opportunities for behavioral interventions in preventing or reversing
heart disease
Economic costs of treating heart disease are enormous. For example,
coronary bypass surgery with cardiac catheterization costs about $42K
and coronary angioplasty about $11K. Societal costs of heart disease in
terms of reduction in work capacity, increased distress and pain, and
reduction in ability to carry out everyday activities, are difficult to
estimate, but substantial. Therefore, it makes sense to use all the
tools at our disposal to reduce the likelihood of additional adverse
events in those at highest risk. Psychosocial interventions may be an
important part of the therapeutic prescription along with pharmacologic
therapy, weight reduction, and exercise. Large scale stress management
studies are few in number and several are inconclusive because they
have not reduced emotional distress, perhaps because the interventions
were quite short. It is most likely that stress management
interventions will be clinically effective when they improve
psychosocial functioning and are targeted at those individuals at
increased risk for adverse events. Stress management interventions have
been used frequently in other contexts, are standardized, and have
demonstrated effects on distress and physiologic responses. Adaptations
may be necessary to make them effective for heart attack patients,
especially those treated early after a heart attack. Women deserve
special consideration, given their adverse response to the home-based
nursing intervention described above, and their high risk following a
heart attack. It is important to conduct behavioral intervention
studies to try to reverse heart disease.
Studies on behavioral interventions to prevent heart disease may be
worthwhile. Stress may accelerate the rate of atherosclerosis and early
signs of heart disease can be observed in adolescents and young adults.
We know that the combination of not smoking, having a healthy diet,
higher levels of physical activity, moderate alcohol consumption, and
not being overweight is associated with very low risk of heart disease
in the Nurses' Health Study. Unfortunately, only 3 percent of the
nurses were in this category. Very few people in the United States have
adopted life styles that are associated with very low risk for heart
disease, in part because of the difficulty in changing well-practiced
behaviors later in life and in part because stress may interfere with
altering behaviors to more health-promoting forms. We need a better
understanding of the role of stress in accelerating disease risk early
in life and how stress management interventions might impact early risk
trajectories. Stress management combined with promoting healthy life
styles in adolescence and young adulthood may have long term economic
and social advantages.
STATEMENT OF COLONEL MARINA VERNALIS, MC, USA, D.O.,
MEDICAL DIRECTOR, CARDIAC RISK PREVENTION
CENTER, WALTER REED ARMY MEDICAL CENTER
Senator Specter. Thank you very much, Dr. Matthews. Our
next witness is Dr. Marina Vernalis, a Colonel in the Medical
Corps of the U.S. Army, medical director of the Cardiac Risk
Prevention Center at Walter Reed Army Medical Center, and
associate professor of clinical medicine at the Uniformed
Services University of Health Sciences. Dr. Vernalis has been
very helpful to the subcommittee in structuring these hearings
and she met with me yesterday to discuss quite a number of
aspects of stress reduction.
She is accompanied by Ms. Maureen Miller, RN, who is a
participant in the Walter Reed program. Ms. Miller is a
healthcare consultant currently working on the White House
report on complementary and alternative medicine policy. From
1978 to 1998 she was a nurse officer in the U.S. Public Health
Service. She has a BS in nursing from St. Louis University and
a master's in public health from Tulane University.
Thank you for joining us, Dr. Vernalis and Ms. Miller. We
look forward to your testimony.
Colonel Vernalis. Good morning, Mr. Chairman. For years, I
have had a strong commitment to study strategies in reversing
heart disease and feel very privileged to be on this panel. I
would like to address the issue of stress management in
reversal of heart disease not only from my perspective as a
clinical cardiologist but also as a military officer who knows
that stress is part of military life, especially in times like
these. The Department of Defense has a strong interest in
stress as it affects cardiac health, and the role of stress
management in reversing heart disease. The Department is
interested in identifying these issues early in military
careers to help maintain a healthy force and a healthy
beneficiary population.
If early interventions can indeed play a role in reversing
heart disease and improving outcomes, we need to partner in
this effort. Over the past 25 years we have reduced
cardiovascular mortality by over 50 percent and improved the
quality of life, but most of our science efforts have been
directed at drug therapy and invasive technology, such as
balloon angioplasty and bypass surgery. These interventions are
wonderful lifesaving methods, but our efforts are directed to
the treatment of disease where it's already advanced and
necessitates costly procedures, invasive procedures that have
taken a costly toll on our patients and to their families.
Just ask anyone who has coronary disease or a relative with
coronary disease. I know. Both of my parents had two bypass
operations each, and my brother has suffered a heart attack and
has had a bypass operation. Mental stress has long been
implicated as a trigger of adverse cardiac events. Studies have
been conducted on the use of psychosocial interventions. Much
of the existing data suggests that these interventions are
additive components to usual care. However, the evidence for
using psychosocial treatment methods to not only reduce mental
stress but to prevent stress induced cardiac events is not as
well established. Further, to my knowledge, there are no
differentiating measures to determine which method of stress
management has the greatest benefit or which method is most
beneficial to either gender or ethnic differences.
For example, a recent abstract that Dr. Matthews alluded to
which was presented at the American Heart Association meeting
last fall, suggests that the use of group intervention
positively impacts white men but the finding did not hold true
for minorities or women.
At Walter Reed we have a comprehensive life style
modification program that we call the coronary artery disease
reversal program, or CADRe. It is modeled after Dr. Ornish's
work.
Two of the four components include group support and stress
management using the techniques of yoga, relaxation,
meditation, and imagery. The other components include an
individualized exercise prescription and a plant based
vegetarian diet. Right now we believe these components are
synergistic. There is a need for an improved understanding of
the individual components of the CADRe program and how they
contribute to the overall positive outcomes or benefit of the
program.
Currently we have 122 military beneficiaries enrolled in
our program, ranging in age from 31 to 80. Most are retired
military, 15 percent are active duty. A third are women, 20
percent are minorities, and the majority of them have coronary
disease. In our patient population, the results of the program
is remarkably wide. We have seen a reduction in stress, a
reduction in symptoms, improvement in functional capacity and
exercise time, as well as improvement in lipids, their blood
pressure, their weight and their body fat composition.
Most of the patients who were limited by their heart
disease before they started the program within 3 months were
able to bathe, walk, shop, and do ordinary day-to-day
activities without any difficulty. And this is coupled with
significant overall improvement in their cardiovascular fitness
which increased to an average pace increase of 4.8 miles per
hour to 6.2 miles per hour on a flat surface.
You often hear people comment that they just can't handle a
vegetarian diet. However, the overall adherence to the diet at
1 year is 92 percent. The average weight loss at 3 months is 11
pounds with a 4 percent reduction in body fat, and they seem to
maintain this after 1 year.
We recommend 60 minutes of stress management every day,
very much like Dr. Ornish, and overall the stress management
adherence is approximately 62 percent. It's ironic that people
say they just can't carve out 1 hour per day to relax, meditate
or de-stress, or prefer exercise as a way of managing stress.
Regardless, we have been able to document a significant
reduction in stress and depression and hostility. However, it's
interesting to note that when scores on psychosocial change are
compared by gender, the males seem to benefit most.
I believe that the preliminary data from our program is
quite impressive and I believe it will produce outcomes for the
day that we will make a difference in the way we care for
military beneficiaries in the future and maybe the general
population as well.
Of great interest is the fact that our data validates the
gender different response in psychosocial measures, raising the
question, we need to develop new ways to treat women with
stress. We need to explore and identify psychosocial
interventions that are specifically gender and minority
relevant, as well as clinically efficacious through controlled
research trials, and I believe there is an urgent need to
further study the healing potential of the spiritual and
emotional relations within each human life.
prepared statement
And in closing, I would like to say some words from one of
our participants that describe the value of our program. I
started this program thinking I would get a head start on being
healthy only to find out that I should have done this life
style change 20 years ago. I certainly feel better in this life
style than any other I have tried.
Thank you very much for the opportunity to testify today.
[The statement follows:]
Prepared Statement of Col. Marina N. Vernalis
For years, I have had a strong interest and commitment to study
strategies on reversing heart disease and feel privileged to
participate on this panel. I would like to address the issue of stress
management and reversing heart disease not only from my point of view
as a clinical cardiologist but also as a military officer who knows
that stress is part of military life, especially in times like these.
The military health care system has a very large number of
beneficiaries both active duty and retired who are at risk for
cardiovascular disease or already have heart disease. It has a strong
interest in stress induced cardiac events and the role of stress
management measures for heart disease prevention and reversal. And it
makes sense to identify these issues early in military careers to help
maintain a healthy force. If early interventions can play a role in
reversing cardiovascular disease and improving outcomes, and I think
they can, then we need to be partners in this effort. I believe there
is an urgent need to further study the use of psychosocial
interventions and other lifestyle modifications for preventing cardiac
events and reversing coronary artery plaque in the military population.
Mental stress has long been implicated as a trigger of adverse
cardiac events in the literature. The evidence regarding the use of
psychosocial measures for preventing stress induced cardiac events is
not as clear. To my knowledge, there are no differentiating measures to
determine which type of stress management measures has the greatest
benefit. Until recently the existing data suggests that psychosocial
interventions are an additive component to coronary artery disease
outcomes. However, a recent abstract presented at the American Heart
Association meeting last fall suggests that the use of group
intervention positively impacts white men but doesn't hold true with
minorities or women (ENRICH study). Our program, like the traditional
Ornish model, has four separate core components. Two of the core
components include group support and stress management using the
techniques of yoga poses, deep relaxation, imagery, and meditation. The
other components include individualized exercise prescriptions, and a
plant-based vegetarian diet. It makes sense that exercise and diet
result in an improvement in self-image and a generalized feeling of
well being that enables people to manage life stressors better. It is
believed the program components are synergistic and are directly
related to adherence. A single component effect on cardiac outcomes
cannot be determined. This needs further exploration. With this
background, I wish to share with you some of the preliminary data in
our Coronary Artery Disease Reversal program which we call CADRe at
Walter Reed Army Medical Center.
In 1999, we initiated a federally funded program to study coronary
artery disease reversal and prevention non-invasively. It is modeled
after Dr. Dean Ornish's lifestyle modification program. It is open to
TriService military beneficiaries who are at risk for heart disease as
well as those patients with coronary artery disease. We measure a wide
range of clinical, physiologic and quality of life outcomes which
ultimately will serve as benchmarks for optimal cardiovascular care
strategies not only for military beneficiaries but hopefully, the
entire health community. We also integrated innovative technology such
as carotid intima media thickness (CIMT), which is a validated way to
measure plaque regression. We are encouraged by our ability to enroll
participants and we believe our research study may have the largest
cohort of patients longitudinally followed in this model.
The program began enrolling its first participants in February of
2000. Currently 122 military health care beneficiaries are enrolled.
All branches of the federal services are represented in the population.
All are at least are high school educated. All of the participants are
highly motivated to participate in their own health care. Forty-seven
have completed one year and the rest are actively participating in the
maintenance program. Participants span the age spectrum of 31 to 80
years old, 34 percent are female, and 20 percent are from minority
groups. Sixty-six percent have documented coronary artery disease
(CAD). Of those with CAD, 57 percent have had at least one
revascularization procedure (bypass surgery or angioplasty).
Additionally, 66 percent of the participants suffer from hypertension,
18 percent with diabetes and 71 percent are taking cholesterol-lowering
medications. Of the enrolled participants, 19 are active duty, 71 are
from the retired ranks, 31 are eligible family members and one is a
Secretary of Defense designee. Twenty participants (16 percent dropout
rate) have either voluntarily withdrawn or have been medically
withdrawn from this study. Reasons for withdrawal are varied and
include lack of commitment to continue the program, co-morbid health
factors, and military duties. There also have been no serious adverse
events as a result of program participation.
Outcome variables include: (1) reduction in symptoms; (2)
improvement in functional capacity and exercise tolerance; (3)
compliance; (4) evidence of atherosclerotic regression; (5) reduction
of stress, and; (6) improvement in lipids, blood pressure, and weight
and body composition. We are also monitoring other CAD associated
``markers'' such as homocysteine, C-reactive protein, fibrinogen,
lipoprotein-a.
At enrollment, one third of those with known CAD had significant
functional limitations upon enrollment. After 3 months, over 75 percent
of those same patients significantly improved their functional ability.
This means they were able to bathe, walk, shop, and do other ordinary
day-to-day activities without difficulty.
Each of our participants has a tailored exercise prescription. Both
aerobic (exercise in target heart rate) and non-aerobic exercise has
been measured. Our participants exercise for an average of 3.6 hours
per week. Treadmill exercise testing data is available on 60
participants who have completed 3 months of program participation.
Preliminary results on those who have completed 12 months of program
participation shows that 55 percent of the total exercise time is
attributable to non-aerobic exercise because of limiting
musculoskeletal conditions or symptoms due to panvascular disease.
Despite the latter, preliminary results show a significant improvement
in treadmill exercise time since enrollment and suggests the duration
and not necessarily the type of activity plays a role in the
sustainment of the improved function. This is coupled with a
significant overall improvement in cardiovascular fitness as defined by
METS (metabolic equivalent) or the power output of the human body, much
like the horsepower of an engine. This power is enhanced by
improvements in the entire cardiovascular system from the heart's
pumping ability to the size and number of blood vessels to the cellular
level improvements. After 3 months, our patients increased their
fitness level by 1.7 METS. This equates to an increase in walking from
1.8 miles per hour (mph) to 3.4 mph on a flat surface. Twelve-month
preliminary data shows sustainment of both exercise time and workload
at a significant level. This is very encouraging since there is
evidence-based data that an increase of 1-MET in functional capacity
may convey a 12 percent increase in survival. In addition, blood
pressure is reduced and some patients require less medication.
Functional health improvement has also been validated in this
population through the use of the Health Status Survey (SF-36), which
is a widely used tool for measuring health status and outcomes.
Improvements have been seen in both the physical and mental components
of this tool. The overall mean compliance with the plant-based
vegetarian dietary guidelines after 12 months of participation is 92
percent. Participants have done remarkably well in integrating this
ultra-low fat diet into their daily routine. Although Dr. Ornish did
not design this program for weight loss, reduction in weight and body
fat is a natural by-product. The average weight loss at 3-month is 11
pounds with almost 4 percent reduction in body fat and seems to hold
steady at one year.
After 3 months, there is a mean reduction in total cholesterol for
the 85 participants of 21 points and the LDL by 19 points. This is seen
in patients on statin therapy as well. High-density lipoprotein (HDL)
levels decrease by 8 points and triglycerides increase slightly. The
decrease in HDL and increase in triglycerides are similar to the
findings of Dr. Dean Ornish in both his initial Lifestyle Heart Trial
as well as the Multicenter Lifestyle Demonstration Project. Although
the Lifestyle Heart Trial showed plaque regression, there appears to be
competing effects of the program on the HDL and triglycerides. The
importance of the latter is not clear and needs further clarification.
We adopted the Ornish Program model which recommends 60 minutes of
stress management every day. Overall stress management adherence is
highest during the first 12 weeks (69 percent or 41 minutes/day) and
decreases to 37 minutes/day at 12 months. This has been a difficult
component for this population to integrate into their lives. It is
ironic that people can't seem to carve out one hour per day to relax,
de-stress or meditate. Some prefer exercise as a way to manage their
stress. Regardless, reduction in stress as measured by the Perceived
Stress Scale (PSS) is significant at both 3 month and 12 month time
periods. However, when the data is compared by gender, the benefit is
only seen in men at both 3-months and 12-months.
Group support is the other psychosocial interventional component of
the program. The Center for Epidemiological Studies Depression Scale
(CESD) and the Modified Cook Medley Hostility Scale (CMHS) are reliable
tools that we use to measure the value of group support. Both these
instruments have shown a decrease of depression and hostility. Again,
when groups are compared by gender, only males seem to benefit.
In conclusion, the short-term data we have achieved in our program
is impressive by way of emotional and physiologic measures. These
changes argue well for being able to demonstrate long-term success with
respect to more definitive outcomes such as adverse clinical CV events
including hospitalization for an acute coronary syndrome or the need
for future coronary revascularization procedures. In addition, the
effects of the core components on carotid intima media thickness, a
validated measure of atherosclerosis burden, will shed important
information on the regression or stabilization of plaque. We hope to
identify psychosocial interventions that are specific, gender and
minority relevant as well as clinically efficacious and resource
prudent via controlled research studies.
Our program has the potential to operationalize bench research and
to identify what is clinically applicable not only to the military
population but the general population as well. Future program goals
include a randomized, prospective study to tease out the relevance of
the core components especially as it relates to psychosocial
interventions. It will also be important to identify the additive
effects of lifestyle modification to pharmacoprevention of
atherosclerotic cardiovascular disease.
In closing, these words from one of the participants describe the
value of this program:
``I started this program thinking I would get a head start on being
healthy only to find that I should have done this lifestyle change 20
years ago. I have gotten more out of CADRE than reversing heart
disease. I have learned a lot about myself. I have learned that I have
physical problems that contribute to heart disease but can do something
about them. I am in control of what goes in my mouth and how far I push
my body for training and for accomplishing relaxation. However, it
takes every part of the program to make it work. I certainly feel
better in this lifestyle than any other I have tried.''
Thank you for this opportunity to testify about our program.
Note.--The opinions or assertions herein are the private views of
the author and are not be construed as reflecting the views of the
Department of the Army or the Department of Defense.
Senator Specter. Thank you very much, Dr. Vernalis. It is
interesting to comment that it should have begun 20 years ago.
I think Dr. Eisenberg would put a larger figure than the 20
years, so we will have to do the best we can now.
We have a very unique State senator from Pennsylvania named
Marvin Taylor, in his 90s, who said if he had known that he was
going to live so long, he would have taken better care of his
health.
FUNDING FOR BEHAVIORAL RESEARCH
On to the subject matter. Dr. Kaufmann, I want to address
the first question to you concerning NIH funding. There has
been an enormous increase in NIH generally, from $11 or $12
billion to $23 billion, and now the President is asking for an
additional $3.4 billion. So, we will be more than doubling the
funding. We have increased heart research from fiscal year
2000, under $1.4 billion to now almost $1.9 billion. Behavior
and cardiovascular disease in fiscal year 1999, $75 million, to
now almost $92 million. Also, mind body has gone up
proportionately the same.
Perhaps the greatest increase came in the National Center
for Complementary and Alternative Medicine. My wife took a
serious interest in this a number of years ago when I was
chairman of the subcommittee. The funding was at $7 million in
fiscal 1996, and now it's in excess of $113 million.
I know you have some limitations within the protocol at
NIH, but is there an adequate allocation to do research on the
kinds of subjects we're discussing here today?
Dr. Kaufmann. There is. We have a very complicated issue
because at one level, of course, the amount that is expended in
any particular area, whether it be behavioral prevention
research, et cetera, or technological developments as we have
seen here today or other matters, is determined to a large
extent by the scientific community in the sense that better
than 80 percent of our budget is spent on research that is
unsolicited. In other words, the scientific community proposes
it, and this is particularly true for the behavioral research
community.
And we have the same pay line and the same criteria for
paying behavioral research and intervention research as we have
for all other areas within our system without making a
distinction. So that, given that particular applications go
through our peer review process and are deemed acceptable and
are deemed worthy of our support after our review process, they
go to our advisory council and they are funded.
I think we have been very successful in doing so. I think
also, it's fair to say, that over the last 20 years or close to
20 years that I have been associated with NHLBI, I have seen
tremendous progress in the capacity of the behavioral research
community to advance the science and advance the knowledge, and
we are in a much better position to do some of the things that
we are talking about today than we were 10 years ago or even 5
years ago.
So I think that the financial support is not the only
measure, but I think the scientific productivity is another
measure, and I think also the activity and the proactive stance
in the scientific community itself in proposing cutting edge
science also drives much of what we do.
Senator Specter. I would like to have the views of the
participants on the panel as to where you would like to see NIH
go beyond where NIH is today. NIH makes its own allocations and
we do not, the Congress does not allocate NIH's money. We do
express an opinion and then NIH makes the final decision.
I wonder if you could respond, perhaps in alphabetical
order, and you may want to supplement this in writing, because
we will pay close attention to what you say. Dr. Abrams, what
would you like to see NIH do with the billions that it is now
allocated?
Dr. Abrams. Two things. I do think we need a better
understanding of the basic mechanisms and especially the
interactions between stress, the other life style factors, and
disease. So I would like to see more research done in that
domain that will form more effective and more cost efficient
treatments down the line in the future, so that would be the
fundamental science recommendation.
I also think critically, we don't have enough research on
how to put what we know today, which is substantial, into
practice, and how to diffuse it effectively to what I call
every nook and cranny of every community in the United States,
paying particular attention to tailoring the treatments to the
unique needs of populations at disproportionate risk, women,
and I think we do have technologies to begin to do that, but
the research isn't there on the diffusion and dissemination to
large populations. So, I would like to see more research on how
we can do that effectively.
And then I think finally, we don't have enough research
into health policy and health economics now, because unless you
charge the larger environment of policy and economics in our
society, it's very hard for individuals to sustain individual
change. The image that comes to mind is that you're rowing a
boat against the current, and no matter how much personal
conviction and motivation you have, if you're living in a
society where all the incentives and temptations are to do fast
foods or to use tobacco as a means of helping you get through a
busy workday, and if you don't attend to stress and balancing
your life style in a way that Dr. Ornish, Benson and others
have said, you can't really do it at an individual level.
So I think the Public Health Service needs a different
infrastructure to disseminate and diffuse information, much
like we could do and are doing to revamp the Public Health
Service for bioterrorism. I think that would require
significant effort, to take what we know from behavioral
biomedical science, the state of the art, and evaluate it in a
scientific way in large scale diffusion and dissemination.
Senator Specter. I would like to ask for briefer answers,
if you can. As I said, you may supplement in writing, so that
we can have some more background. Dr. Benson.
Dr. Benson. Thank you. I would view health and well being
as being akin to a three-legged stool being held up by one leg
of pharmaceuticals, a second leg of surgery and procedures.
Most of our, the direction in research is really being spent,
money is being spent on these first two legs, pharmaceuticals
and surgery. We haven't paid attention to a third leg, and that
is self care, because within that third leg we have over 60
percent of physicians that are poorly treated by both drugs and
surgery.
And I think the way to do this is to follow almost exactly
what Dr. Abrams just said. We must first identify the basic
mechanisms involved. That will lead to an efficiency in the way
the work is disseminated. Second, we have to look to the
dissemination to the population, and this will take long term
behavioral change that will go beyond, I believe, health care,
and we should be in the educational system teaching children
early in life how to do appropriate behaviors of stress
management. And third, we must then disseminate these programs
widely throughout the nation in a concerted effort to define
how important self care is. And many of the people at this
table are speaking to self care mechanisms and I endorse them
and would add more emphasis on them.
[The information follows:]
As I testified on May 16, 2002, stress is a significant component
in the genesis of heart disease and should be treated in programs
designed to reverse cardiac disease. In addition to stress management
approaches, diet modifications and exercise programs should also be
offered. Stress management, dietary changes and exercise should and can
be effectively integrated with each other as well as with
pharmacological and surgical treatments.
The Cardiac Wellness Programs of the MBMI are efficient and so
readily accepted and maintained as a part of lifestyle changes by
patients after they are learned. They consist of:
--A safe, supervised exercise program
--An individualized nutrition plan
--Comprehensive stress management with an emphasis on learning
relaxation response techniques, and
--Group discussion series designed to provide information necessary
to support lifestyle changes
The Cardiac Wellness Programs of the MBMI were directly compared to
other more demanding cardiac reversal programs in a pilot project of
the Commonwealth of Massachusetts General Insurance Commission (GIC) in
1994.
In 1994, the Group Insurance Commission (GIC) of Massachusetts
supported a pilot project designed to provide patients with coronary
artery disease opportunity to participate in a comprehensive lifestyle
modification program that compared the MBMI program to that of a more
demanding program.
Both programs were of 12-month duration and included supervised
exercise, nutrition, yoga/relaxation response/stress management and
group support. The major differences between the programs were: 1. The
frequency, the length and the total number of sessions over the 12-
month period: The total number of hours spent in the MBMI program
totaled 126, whereas 264 hours were required in the more extensive
program. 2. Emphasis on diet: MBMI utilized a 15 percent fat diet
emphasizing soy, in comparison to the more restrictive program that
promoted a 10 percent fat, vegetarian diet. 3. Drug management of blood
lipids: The MBMI program included drugs in its lipid management when
necessary. The other program did not utilize drugs. 4. Cost: The cost
of the MBMI program was about $5,000 compared to the other program
which cost between $7,000 and $8,000.
Both programs demonstrated similar success in clinical outcomes
that included weight loss, lipid and blood pressure reduction,
improvement in clinical symptoms and exercise tolerance as well as
reduction in psychological distress. However, the MBMI program had more
people not only choosing it, but also remaining in it. In other words,
it was more readily accepted and once chosen, better adhered to in the
long run. Therefore, a coronary artery disease patient in the MBMI
program got the same results for less time and less money that with the
more demanding program.
As a result of this pilot study, the GIC and several other major
third party payers (Unicare, Harvard Pilgrim Health Plan, Tufts Health
Plan and Neighborhood Health Plan) now cover the MBMI program for state
employees.
Further, the Centers for Medicare and Medicaid Service (CMS)
project is underway to test further the efficacies and costs of these
two cardiac approaches. Titled, Medicare ``Lifestyle Modification
Program Demonstration'', its results should be available in several
years.
prevention-stress management programs for the schools of america
As I also testified on May 16, 2002, stress is a factor in 60
percent to 90 percent of visits to health care professionals. It
contributes not only to cardiac symptoms, but also to many other
diseases.
Stress is an all too prevalent component of childhood in the United
States today made even worse by the necessity to cope with fears of
terrorism. Our educational system should be offering stress management
programs in their curricula for its short-term beneficial effects in
young life and for its long-term effects on adult health and well-
being.
The MBMI has addressed the need for stress management programs in
schools since 1989 through its Educational Initiative. The Institute
offers a relaxation-response based curriculum that teaches coping
skills to students and educators for life-long use. The programs have
been scientifically demonstrated to improve students' self-esteem,
self-efficacy, loss of control, grade point average, work habits,
memory and cooperation. The results are presented in three articles
entitled ``Increases in Positive Psychological Characteristics with a
New Relaxation-Response Curriculum in High School Students;'' \1\
``Academic Performance Among Middle School Students After Exposure to a
Relaxation Response Curriculum;'' \2\ and ``The Evaluation of a Mind/
Body Intervention to Reduce Psychological Distress and Perceived Stress
in College Students.'' \3\
---------------------------------------------------------------------------
\1\ Benson H, Kornhaber A, Kornhaber C, LeChanu MN, Myers P,
Friedman R. Increases in Positive Psychological Characteristics with a
New Relaxation-Response Curriculum in High School Students. Journal of
Research and Development in Education 1994; 27:226-231.
\2\ Benson H, Wilcher M, Greenberg B, Higgins E, Ennis M,
Zuttermeister PC, Myers P, Friedman R. Academic performance Among
Middle School Students after Exposure to a Relaxation-Response
Curriculum. Journal of Research and Development in Education 2000;
33:156-165.
\3\ Deckro GR, Ballinger KM, Hoyt M, Wilcher M, Dusek J, Myers P,
Greenberg B, Rosenthal DS, Benson H. The Evaluation of a Mind/Body
Intervention to Reduce Psychological Distress and Perceived Stress in
College Students. Journal of American College Health 2000; 50:281-287.
---------------------------------------------------------------------------
These results are especially important, as the curriculum was
successful in two of the studies with ethnically diverse students who
live in economically disadvantaged neighborhoods. Children in these
environments are at risk of developing psychological disabilities such
as depression and post-traumatic-stress disorder, in addition to an
increase in their chances of becoming victims or perpetrators of
violence themselves.
It has been documented that children are better able to cope with
demanding situations if they have an internal locus of control and a
sense of self-efficacy. The goal of the Education Initiative is to
support the nation's schools by teaching children and their educators
to recognize their inherent capabilities to effectively shape their
world. By using the simple, easily implemented interventions taught in
the Education Initiative's relaxation response based curriculum, we are
creating more self-aware children, as well as more effective, safer
schools. The long term health benefits of being better able to handle
stressful circumstances are yet another reason to start the relaxation
response early in life.
suggested next steps
1. Stress management programs such as the Mind/Body Medical
Institute's relaxation response curriculum should be offered to schools
across the United States. Funding should be supplied for a ``train the
trainer'' Demonstration Project through the Department of Education to
teach teachers of students how to impart these proven, stress
management courses.
2. The Walter Reed Medical Center should conduct a controlled,
prospective, randomized trial to compare the outcomes of utilizing a
demanding vegetarian diet with a more liberal diet that would also
utilize lipid-lowering drugs. Both groups would either be exposed to a
relaxation-response based stress management program to a control
condition. Such a trial should take place over a ten-year period to be
able to assess long-term outcomes. A competent leader of this project
could be Marina Vernalis, D.O., Medical Director of the Cardiac Risk
Prevention Center, Walter Reed Medical Center. This would be a
Department of Defense project.
Senator Specter. I would broaden the question beyond NIH
and CDC, and for you, Dr. Eisenberg, even beyond that to the
Department of Defense. We had the three Surgeon Generals in
this room about a week ago, and I brought up the matters that
you had told me about. I don't know if you got a copy of that
hearing transcript, but I would be interested for you to
include DARPA and CDC in your response.
Dr. Eisenberg. I was part of the presentation in 1994
called reengineering healthcare, where we were laying out how
the entire healthcare delivery system could be dramatically
overhauled, including advances in technology that are within
our grasp, but need a lot of help, because we haven't really
seen these things happen on their own in medicine.
I have been a consultant to industry for 35 years,
including the military-industrial complex, and trying to get
risk research done at the core of technology advancement has
been almost impossible. The only place we've seen that happen
is at agencies like DARPA, the Defense Advanced Research
Projects Agency, who developed the Internet and where we began
telemedicine and moved over now to additional participation by
Fort Detrick and the Army Medical Research Command.
So we feel the Defense Department, which of course has the
interest in this because it is the largest managed care system
in the country, as well as the battlefield care that we need,
but the fundamental issue is technology advancement and it
needs a lot of help, and at many levels.
The imaging technologies are expensive and at their core we
need the risk research to develop new materials. X-rays using
electron microscopy, we don't even come close to that in a
human being, largely because we haven't gone far enough in
research that really isn't that difficult or even that far
beyond our grasp to be able to achieve the kind of high
resolutions of imaging the human body and even simultaneously
imaging the physiology and the biochemistry so we get a fused
image. All pathology is defined around the anatomy, physiology
and chemistry, and electroactivity, and we are now ourselves
building a device that will fuse all of these.
But, there are so many spin-off opportunities. Early
diagnosis, as we've talked about here, compacting the
diagnostic process. We have a huge problem in this country
right now where diagnostic imaging is on a rapid rise, and a
baby boomer is turning 50 every 69 seconds, and it's going to
escalate beyond our capability to handle it economically, and
we're trying to create a single device which could potentially
replace $80,000 worth of testing with a single $1,500
noninvasive test.
These types of technologies are within our grasp. They also
are the core of changing the whole way we do therapies. We need
assimilation of training, assimilation before we do procedures,
imaging and computers guiding procedures so that they can be
done far more precisely. The powerful electronics that are
developed for the computation and even the transmission of this
data can be translated into new types of information systems.
Even a new type of doctor's bag which allows a physician
individually far more powerful levels of information access,
artificial intelligence decision making, and all of this can be
wrapped up into a system that can go into the home, much as
we're trying to take it to the forward battlefield for
peripheral care or telepresent healthcare.
So these are major opportunities that are here and now,
they are not years in the future, they are within our grasp,
but they absolutely need support. They're not going to happen
within industry, which is driven by a profit potential and is
not going to do the risk research, so we need this help from
the government, and the payoff would be extraordinary.
Senator Specter. Dr. Eisenberg, I would like you to
supplement that with a written follow-up. I serve on the
Defense Appropriations Subcommittee, and the committee directs
or suggests specifically what we would like DOD to do.
Dr. Eisenberg. I will.
Senator Specter. Dr. Matthews.
Dr. Matthews. I would like to make two points and I will
respond and write them in more detail, but I would like to take
advantage of some of these new techniques that are being
developed to understand the role of stress in the early phases
where the potential of prevention of progression of
atherosclerosis is at its highest.
And second, I think there are many many talented
investigators who have worked very hard to develop stress
management programs and techniques that clearly work in small
scale studies, but we haven't yet been able to take what they
have been able to do in the small scale studies and translate
that into the larger clinical trial, which would be very
helpful to have. Developmental work in how to take those
studies and make them able to be used for general population
studies.
Senator Specter. Dr. Ornish.
Dr. Ornish. Senator, I appreciate the question. I just want
to mention that Dr. Vernalis, when she explained to the
adherence to the meditation and diet is so great, is because
she can order people to follow the program at Walter Reed.
BUDGET ALLOCATED TO BEHAVIORAL APPROACHES
May I ask a question of Dr. Kaufmann? I'm just curious to
know what the percentage of NIH funding that goes to these
kinds of approaches is.
Dr. Kaufmann. Well, I can speak for NHLBI. I think within
the heart program, I think our data shows that we spend about 6
percent of our budget on behavioral research concerning
cardiovascular disease.
Dr. Ornish. Six percent? I guess one of the two points I
would make would be that that percentage could be increased,
since this clearly affects so many people. But I also, even
though I spend most of my time with the science, I have come to
learn over many years that the problem is not a lack of
science, there is already so much science out there, the
problem is one of reimbursement. And that we doctors tend to do
what we get reimbursed to do and what we get trained to do what
we get paid to do.
And so, that's why we have put so much effort in trying to
have Medicare do a demonstration project, because ultimately if
Medicare begins to fund and cover programs like this, even in a
generic way, that more than anything will change the practice
of medicine and medical education.
And yes, we do need to better understand the mechanisms by
which stress affects the heart and affects other organ systems,
but there is so much information already out there that has not
been implemented as everyone here has indicated, that to
whatever degree you and your colleagues can help influence CMS
to not just cover surgical interventions but approaches that
involve empowering the individual, personal responsibility,
freedom of choice, I think this more than anything can really
give people the multiple choices that are currently available
to most people now.
Senator Specter. Dr. Vernalis, here's your chance to direct
the Chairman of the Joint Chiefs of Staff and the Secretary of
Defense on how they ought to spend almost $400 billion a year.
Colonel Vernalis. We need to seize the opportunity to be
more focused on prevention and develop the strategies that we
know will work, and we need to further explore the mechanisms
of stress and the need for psychosocial interventions,
particularly as it refers to gender and minorities.
As you know, we do our work at Walter Reed through a
federally funded grant, and if there is in fact room in the
President's budget, we would be more than happy to partner this
effort and enlarge the program we're conducting right now.
STRESS MANAGEMENT MESSAGES FOR THE PUBLIC
Senator Specter. I would like to hear from each of you as
to an abbreviated suggestion on the issue of stress management.
Focusing on that alone, what would you say to the man on the
street, succinctly and in common jargon, as to what he or she
should do as a first step if they can't undertake one of the
wonderful programs available or spend a week with Dr. Ornish or
a week with Dr. Vernalis. Dr. Kaufmann, we start with you.
Dr. Kaufmann. I think that is probably the crux of the
matter here.
Senator Specter. Occasionally we get there.
Dr. Kaufman. Yes. Basically, it is clear certainly from
anecdotal evidence and certainly all of my friends and
certainly everyone that I associate with, everyone agrees that
stress is something that is very much a factor in their lives.
From the research perspective, and I will put on my
research hat, I have to recognize that we don't have----
Senator Specter. Just to let you know, they started a vote,
which means we have to conclude in about 14 minutes. So I would
ask you to focus directly when you're talking to a man or woman
in the street, stress management. What do you say?
Dr. Kaufmann. I would say that setting one's priorities and
making choices that are realistic within the time frame that
people have, and spending time in reflection and in some of the
pursuits that matter with individuals around them, and people
close to them, are things that are worth practicing that will
enrich their lives and foster health.
Senator Specter. Dr. Abrams.
Dr. Abrams. I would say step back and don't let your
environment control you. Try to take charge and control your
environment.
Senator Specter. Dr. Benson.
Dr. Benson. Stress evokes a fight or flight response. You
have within yourself the ability that's opposite the stress
response that's called a relaxation response. Put aside 10 to
20 minutes once or twice daily to either pray, meditate, do
yoga or what have you, to bring about this response which will
counteract the harmful effects of the stress.
Senator Specter. Dr. Eisenberg.
Dr. Eisenberg. I would say to my patients, you do want to
know what's happening with your body. And while looking inside
your body is potentially an intimidating process, we have
actually found it to be an extraordinarily empowering process
and even when people are very fearful of it, finding what is
and isn't going on to a large extent is indeed very empowering,
and pushes people into the act of being proactive rather than
fear based, not knowing is a fear of death in a way, and that
is not a good way to live your life. So pushing people into a
proactive place where they are empowered by knowledge, to me
this is the basis for moving forward and moving into behavioral
changes.
Senator Specter. Dr. Matthews.
Dr. Matthews. If I may reframe the question, because of my
interest in the early development of atherosclerosis, I will
say what I would say to a young adult and that would be to get
the best education possible, because we know the higher the
education the lower the risk of coronary disease.
And I would also suggest for the more average person on the
street to anticipate stress and plan for it.
Senator Specter. Dr. Ornish.
Dr. Ornish. I would try to help the person understand that
the stress, you have to know that the stress is out there, so
either you choose to treat this really interesting and
productive life that is filled with stress and you die early,
or you sit under a tree and watch your life go by, and that
isn't your choice. The stress isn't so much in what you do,
it's how you react to what you do. Practicing even a minute a
day of meditation or prayer, or self imaging as others have
said, on a regular basis can allow you to be in the same job,
the same environment, even the same family, and not react in
the same way.
Sometimes patients say things like I used to have a short
fuse and I'd explode easily. Now my fuse is longer, things
don't bother me as much. And so, one thing I would add to what
Dr. Eisenberg just alluded to, it's not about just preventing
something bad from happening. It's not about risk factor
reduction and prevention that's the most important, it's about
feeling better, and accomplishing more and enjoying life.
And it's even more than just stress management. It's really
about reacquainting yourself with inner peace and what it feels
like to be peaceful and to realize that that doesn't come about
because of something you need to do but rather, that's our
natural state until we disturb it, so, there is a lot people
can do.
Senator Specter. We have a colleague here who was accused
of having a short fuse, that I was asked about recently and I
said he was wrong, he had no fuse.
Dr. Vernalis.
Colonel Vernalis. We need to educate our patients so they
are actively involved in their own healthcare and their
outcomes.
EDUCATION AND DISSEMINATION
Senator Specter. The next question that I would like your
comments on is how we educate the people as to these issues.
Dr. Eisenberg has a marvelous method of showing them a picture
that illustrates the body, showing the lungs of a smoker. It's
an integral, but terrifying experience to see it all black. I
have had some terrors of my own with that particular one. You
can't hear everything that's been written in Dr. Ornish's books
or Dr. Benson's books. You may want to supplement this answer,
but I would be interested in your views as to what NIH or CDC
might be doing, or perhaps the Department of Education, this
subcommittee has jurisdiction over the Department of Education,
in carrying this message directly to the people.
Dr. Abrams talks about reeducating society on fast food.
That's a pretty tough order because of the competition with
Burger King, McDonald's and all the rest of those agencies. It
would be a big line for undertaking, but I would be interested
in your succinct views, and as I say, you can supplement it in
writing, how to communicate this message. Dr. Kaufmann.
Dr. Kaufmann. Well, at NHLBI we actually have a very active
program called education and dissemination. We have, for
example, the blood cholesterol program, the high blood pressure
prevention program, as an education, and several initiatives
along those lines and others being planned to disseminate this
work. It is one of the most important aspects of our work.
I think that the greatest challenge, however, today is the
area of health disparities, and reaching individuals at all
levels of our society is really a challenge that we have in
this country.
Senator Specter. Dr. Abrams, you have 1 minute.
Dr. Abrams. I would say the most important thing is to get
away from simple brochures and pamphlets, but try to teach
people some simple behavioral skills and spread that into
communities through role models and to perhaps training a new
cadre of public health workers in the techniques of behavior
change to get into some of those things.
Senator Specter. We have 7 minutes left on the vote, so we
have 1 minute for you, Dr. Benson.
Dr. Benson. I would get into education very quickly. We
have done this work at preschool levels and to affect change
throughout our Nation, what is needed is for people to learn
early how to manage stress. This can be approached throughout
our school system and I would start there.
Senator Specter. Dr. Eisenberg.
Dr. Eisenberg. One area is teaching physicians how to talk
to patients, which Dr. Abrams has been fortunately able to
teach me how to do. I think the other area of course, is that
technology has great power. The use of graphics is an extremely
powerful tool that is not only done in my office, but taken
directly into the patient's home for a very advanced and
continuing form of education and reinforcement.
Senator Specter. Dr. Matthews.
Dr. Matthews. Improving education both in terms of medical
school training as well as high schools on this topic.
Adolescence is a very important time for forming health habits
that last the rest of their lives.
Senator Specter. Dr. Ornish.
Dr. Ornish. Well, actually having consulted with
development of these programs, I am encouraged that there is
more interest in it, and I would agree with everyone who says
that we should look to education. We can teach meditation in a
secular way, school lunch programs can serve healthier food.
They are cutting back on physical education programs
nationwide, and I think this mortgaging our kids future, so
there is a lot through the Department of Education that can be
done. And if you start early, it is so much easier. You don't
have to make such big changes early on; an ounce of prevention
is really worth the pound of cure if you start earlier.
Senator Specter. Soy burgers?
Dr. Ornish. Soy burgers, kids love it.
Senator Specter. Do you counsel McDonald's?
Dr. Ornish. I have been talking with McDonald's about
serving, and not just serving, but including healthier items in
their line, and I think there is a receptivity to that now that
there wasn't 5 years ago.
Senator Specter. Dr. Vernalis.
Colonel Vernalis. Education needs to start earlier, and I
agree with my colleagues with what they said. One in three of
our children are obese now and the ACC projects that
cardiovascular disease is going to double over the next 10 to
20 years. We are going to be seeing people having events in
their 30s instead of their 50s, so we need to start something
earlier.
Senator Specter. Miss Miller, let me turn to you to ask you
about the Walter Reed program, your experience there, and how
you're finding it.
Ms. Miller. Well, we start out the program where we gather
for a week, we stay at a facility on the site and we learn
everything we need to know about each one of the four
components of the program. And then we spend 3 months going
twice a week, for 4 hours twice a week, and we complete all,
again, together as a group, all four aspects. And then we move
to once a week for 6 months, and then the last 3 months we're
on our own. That's the methodology for the program.
And we do the diet, we do a low fat plant-based diet. We
exercise 180 minutes a week, at least that much, in our
appropriate zone. We have group support and then we have the
stress management which combines yoga, meditation, guided
imagery and relaxation.
Senator Specter. Thank you all very much. We're going to
continue this discussion informally. The panelists are invited
to be my guests at lunch. We have a big round table in the
center of the dining room.
I would like you to supplement your oral testimony in two
respects. I would like you to give the subcommittee in writing
what you think NIH should be doing that NIH is not currently
doing, and feel free to specify your own pet projects that you
might want to apply for grants. Don't be bashful about a little
self interest regarding what you know about and would like to
happen. And as I said earlier, broaden it actually beyond NIH
to CDC, or DARPA, because we have a fair amount of persuasion
when we put up the money.
The other item I would like your written views on would be
the communications line. How does this message get out to the
man on the street? I do not think that this hearing is going to
be widely communicated to the media, but we do have resources
at our disposal to get the message out with some direction to
NIH, CDC, DARPA or the Departments of Education, Health and
Human Services. Dr. Ornish, you made the comment about what is
reimbursed and that could be included in part one, because we
have some influence with Medicare through the Department of
Health and Human Services.
Everyone is invited back for the health fair in this room
at 1:00 to 3:00, where we will have displays at the suggestion
of Dr. Eisenberg, and we are prepared to let people take a
look. President Kennedy had a very famous statement when he
asked a group of Nobel laureates and high-powered scientists,
and he said, ``there was more talent in the White House tonight
at any time since Jefferson died alone.''
I think we have more talent here even than when Kennedy was
commenting. See you all at lunch.
CONCLUSION OF HEARING
Thank you all very much for being here, that concludes our
hearing.
[Whereupon, at 11:38 a.m., Thursday, May 16, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
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