[Senate Hearing 107-599]
[From the U.S. Government Printing 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

                               __________

         Printed for the use of the Committee on Appropriations


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




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                                 ______
                      COMMITTEE ON APPROPRIATIONS

                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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
                                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\
---------------------------------------------------------------------------
    \18\ Ornish D. Dr. Dean Ornish's Program for Reversing Heart 
Disease. New York: Random House, 1990; Ballantine Books, 1992.
---------------------------------------------------------------------------
                     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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
                               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\
---------------------------------------------------------------------------
    \28\ Pratt LA, Ford DE, Crum RM, et al. Depression, psychotropic 
medication, and risk of myocardial infarction. Circulation. 
1996;94(12):3123-9.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \31\ Gold PW, Chrousos GP. The endocrinology of melancholic and 
atypical depression. Proceedings of the Association of American 
Physicians. 1999;111(1):22-34.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
                                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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \37\ Blair SN, Kohl HW, Paffenbarger RS, et al. ``Physical fitness 
and all-cause mortality.'' JAMA. 1989;262:2395-2401.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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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