[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]
COMPLEMENTARY AND ALTERNATIVE MEDICINE IN GOVERNMENT-FUNDED HEALTH
PROGRAMS
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
FEBRUARY 24, 1999
__________
Serial No. 106-4
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.house.gov/reform
______
U.S. GOVERNMENT PRINTING OFFICE
56-145 CC WASHINGTON : 1999
COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida MAJOR R. OWENS, New York
JOHN M. McHUGH, New York EDOLPHUS TOWNS, New York
STEPHEN HORN, California PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida GARY A. CONDIT, California
THOMAS M. DAVIS, Virginia PATSY T. MINK, Hawaii
DAVID M. McINTOSH, Indiana CAROLYN B. MALONEY, New York
MARK E. SOUDER, Indiana ELEANOR HOLMES NORTON, Washington,
JOE SCARBOROUGH, Florida DC
STEVEN C. LaTOURETTE, Ohio CHAKA FATTAH, Pennsylvania
MARSHALL ``MARK'' SANFORD, South ELIJAH E. CUMMINGS, Maryland
Carolina DENNIS J. KUCINICH, Ohio
BOB BARR, Georgia ROD R. BLAGOJEVICH, Illinois
DAN MILLER, Florida DANNY K. DAVIS, Illinois
ASA HUTCHINSON, Arkansas JOHN F. TIERNEY, Massachusetts
LEE TERRY, Nebraska JIM TURNER, Texas
JUDY BIGGERT, Illinois THOMAS H. ALLEN, Maine
GREG WALDEN, Oregon HAROLD E. FORD, Jr., Tennessee
DOUG OSE, California ------
PAUL RYAN, Wisconsin BERNARD SANDERS, Vermont
JOHN T. DOOLITTLE, California (Independent)
HELEN CHENOWETH, Idaho
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Carla J. Martin, Chief Clerk
Phil Schiliro, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on February 24, 1999................................ 1
Statement of:
Berman, Brian, M.D., associate professor and director,
Program for Complementary Medicine, University of Maryland
School of Medicine, Baltimore, MD; and Ollie and Barbara
Johnson, Dean Ornish Lifestyle patient and spouse,
Columbia, SC............................................... 71
Kamerow, Douglas, M.D., Director, Center for Health Care
Technology, Agency for Health Care Policy Research,
Department of Health and Human Services; Thomas V. Holohan,
M.D., Chief, Patient Care Services Officer, Veterans Health
Administration; John F. Mazzuchi, Deputy Assistant
Secretary of Defense for Health Affairs, Clinical and
Program Policy, Department of Defense; and Jim Zimble,
M.D., president of the Uniformed Services University for
the Health Sciences........................................ 98
Ornish, Dean, M.D., president and director, Preventive
Medicine Research Institute, and clinical professor of
medicine, University of California, San Francisco, CA...... 46
Seymour, Jane, actress....................................... 26
Letters, statements, etc., submitted for the record by:
Berman, Brian, M.D., associate professor and director,
Program for Complementary Medicine, University of Maryland
School of Medicine, Baltimore, MD, prepared statement of... 75
Burton, Hon. Dan, a Representative in Congress from the State
of Illinois:
Information concerning saw palmetto...................... 143
Letter dated March 1, 1999............................... 140
Prepared statement of.................................... 6
Holohan, Thomas V., M.D., Chief, Patient Care Services
Officer, Veterans Health Administration, prepared statement
of......................................................... 125
Johnson, Barbara, Dean Ornish Lifestyle spouse, Columbia, SC,
prepared statement of...................................... 83
Johnson, Ollie, Dean Ornish Lifestyle patient, Columbia, SC,
prepared statement of...................................... 89
Kamerow, Douglas, M.D., Director, Center for Health Care
Technology, Agency for Health Care Policy Research,
Department of Health and Human Services, prepared statement
of......................................................... 101
Mazzuchi, John F., Deputy Assistant Secretary of Defense for
Health Affairs, Clinical and Program Policy, Department of
Defense; and Jim Zimble, M.D., president of the Uniformed
Services University for the Health Sciences:
Information concerning FY 98 breast cancer research
program................................................ 138
Prepared statement of.................................... 111
Ornish, Dean, M.D., president and director, Preventive
Medicine Research Institute, and clinical professor of
medicine, University of California, San Francisco, CA,
prepared statement of...................................... 54
Sanders, Hon. Bernard, a Representative in Congress from the
State of Vermont, prepared statement of.................... 23
Scarborough, Hon. Joe, a Representative in Congress from the
State of Florida, prepared statement of.................... 15
Seymour, Jane, actress, prepared statement of................ 29
COMPLEMENTARY AND ALTERNATIVE MEDICINE IN GOVERNMENT-FUNDED HEALTH
PROGRAMS
----------
WEDNESDAY, FEBRUARY 24, 1999
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:18 a.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the committee) presiding.
Present: Representatives Burton, Gilman, Morella, Davis,
Sanford, Hutchinson, Biggert, Chenoweth, Waxman, Maloney,
Norton, Kucinich, and Blagojevich.
Staff present: Kevin Binger, staff director; Daniel R.
Moll, deputy staff director; Beth Clay, professional staff
member; David Kass, deputy counsel and parliamentarian; John
Williams, deputy press secretary; Carla J. Martin, chief clerk;
Lisa Smith Arafune, deputy chief clerk; Jackie Moran,
legislative aide; Phil Schiliro, minority staff director; Phil
Barnett, minority chief counsel; Kristin Amerling, Jon Bouker,
and Sarah Despres, minority counsels; Karen Lightfoot, minority
professional staff member; Ellen Rayner, minority chief clerk;
Courtney Cook and Earley Green, minority staff assistants; and
Barbara Wentworth, minority research assistant.
Mr. Burton. The committee will come to order.
We have a Republican conference going on at this time and
we'll probably have Members coming in and out. I was going to
wait on them, but because we have a number of witnesses that
have time constraints, I thought we would go ahead and get
started.
A quorum being present, the committee will be called to
order. I ask unanimous consent that all Members and witnesses
written opening statements be included in the record and
without objection, so ordered.
Today, we continue our inquiry into American's access to
complementary and alternative medicine. Alternative medicine
continues to increase in popularity and use in the United
States. A 1997 survey in the Journal of the American Medical
Association revealed that over 42 percent of Americans used at
least 1 of 16 alternative therapies during the previous year.
Last year, we looked primarily at the research area. We
focused on the ability of seriously ill patients to get access
to FDA-approved clinical trials in alternative medicine. This
may be a relatively small percentage of the overall population,
but it is one that is desperately in need of our help.
There are millions of Americans who are suffering from
terminal or crippling diseases. For many of them, conventional
treatments like chemotherapy do not work, or may be fatal
themselves. For these people, alternative drugs and therapies
are the only ray of hope that they have. I believe in my heart
that we have an obligation to those people to invest the money
that's needed into research and clinical trials to find out
which treatments work and which ones do not. I believe that if
someone is seriously ill and wants to try an experimental drug
that safety has been established, the Federal Government has no
business in blocking them. After all, it's their life.
I have a special interest in this area because of how my
own family has been affected in just the last few years by
cancer. Last September and October, I lost both my mother and
my father to lung cancer. My wife struggled through breast
cancer 5 years ago, and thanks to an experimental alternative
cancer treatment, she has been in remission for 5 years. One of
the things that has really troubled me over the past 5 years is
this experimental program which has been so effective in
helping my wife. The Food and Drug Administration, because of
technicalities, tried to close the program down. I had about 70
women calling me who were crying on the phone and very upset
because the last ray of hope they had was Dr. Springer's
alternative therapy which stimulated the immune system. We had
to literally have a real hard talk with the Food and Drug
Administration because they were not going to relent.
Fortunately, they did review the situation, the problem was
solved and the program has been ongoing. So those 70-some women
who are in this experimental program are still happy and they
are doing well, but it is unfortunate that you have to fight
for a program like that when so many lives depend on it.
I'd be willing to bet that every member of this committee
has lost a family member to cancer, heart disease, or some
other serious illness. There is not anyone in this room whose
family has not been touched by cancer, heart disease or some
other devastating disease.
Last year, we began looking at the level of funding for
alternative medicine cancer research through the National
Institutes of Health. We learned that less than $20 million of
the $2.7 billion that is the budget for the National Cancer
Institute, was devoted to research in alternative medicine.
This is less than 1 percent of their total budget, and I think
that's deplorable.
This year, we are expanding our investigation to include
patient access to alternative medicine through Government-
funded health programs. Between 25 and 40 percent of Americans
receive at least part of their health care through federally
funded programs. This includes our active-duty military,
veterans, and their families. It also includes Americans who
receive medical care through Medicare, Medicaid, public health
clinics, and Indian Health Services.
Are research results translating into access to alternative
treatments by the average American? Well, the Health Care
Financing Administration estimates that national health care
expenditures for the United States will double by the year 2007
to exceed $2.13 trillion. Almost $1 trillion of those estimated
dollars will be public funds. It is imperative that the
Government reduce these healthcare costs while working to
improve the health and well being of the American people, and
that's where alternative therapy comes in.
With the epidemic-level increases of chronic conditions
such as heart disease, obesity, diabetes, arthritis, asthma,
and depression, as well as the high percentages of cancers such
as lung cancer, breast cancer, prostate cancer, colon cancer,
and melanoma, we have to be aggressive and open-minded in
looking for additional options in medical care. We have to find
effective and efficient ways to treat chronic and debilitating
illnesses. We have to find better ways to treat pain. We have
to find ways to reduce the use of antibiotics. We just read the
last week that many strains of viruses are becoming resistant
to antibiotics, and so there has to be alternatives looked at
very, very thoroughly. We have to find better ways to treat
pain. We also need to better care for the terminally ill. We
need to integrate the wisdom of the ages with the knowledge of
this century and move forward into the next millennium
expediently.
I remember when I was a State legislator, I had about 300
or 400 cancer patients who had been adjudged terminally ill
come down to the Indiana State Legislature when we were
debating an issue called Laetrile, and I know that's a very
controversial issue. But many of those people had been helped
because they had used alternative therapies and many had used
Laetrile with some success. And the thing that frustrated me
the most was the whole determination of those who opposed
Laetrile as well as any alternative therapy. And the way they
just ignored these people who were terminally ill, and it
seemed to me at the time and it seems to me today that if
somebody is adjudged terminally ill, they ought to be able to
do anything they wish to try to save their life. After all,
hope is one of the major ingredients in keeping people going.
And when you take away that hope and just say go home and die,
that's just what they are going to do.
Since a substantial portion of our population receives
their healthcare through these agencies, it's important to look
at the level of integration of complementary and alternative
medicine in these programs. We've heard the cry here in this
chamber of ``Show me the science'' in hearings of this
committee as the mantra of why alternative medicine should not
be used. Caution is important. Good scientific data is
important, and thousand of years of safe and effective use of
alternatives are also important.
We will hear today from two esteemed physician researchers.
Both Dr. Ornish and Dr. Berman have conducted clinical trials
in alternative medicine. Each hold teaching positions at highly
respected U.S. medical schools. Each has published in peer-
reviewed journals. Each has extensive experience and expertise
in their fields, and we'll hear that there is good scientific
research in alternative medicine and an ever-increasing amount
of that reported in peer-reviewed medical journals.
We'll also hear from the Department of Health and Human
Services, the Federal Government's principal agency for
protecting the health of all Americans. The Department of
Health and Human Services is responsible for providing
essential human services, especially for those who are least
able to help themselves. Among these services is the Medicare
program, the Nation's largest health insurer. Many of these
services are provided at the local level by State or county
agencies or through the private sector grantees.
For many Americans, especially those on Medicare and
Medicaid, the denial of coverage is a restriction of access and
in some cases, ultimately is a death sentence. The Department
of Veterans Affairs provides benefits and services to the
country's veterans. This is a population of over 25 million.
They also provide care for approximately 44 million family
members. Given the increased demand by patients to have access
to alternative therapies, in April 1998, the Veterans
Administration initiated a survey to determine the level of
alternative medicine availability and to assess what, if any,
alternative therapies should be offered with the Department.
That report was due out in December 1998 and it has still not
been released and we're going to find out why.
The Department of Defense provides health care to its
active-duty service members and active-duty dependants,
retirees and their dependants, and survivors of deceased
members and former spouses. There's an increasing number of
healthcare providers within the Defense Department that have
specialized training in complementary and alternative
therapies.
Today, we have one of the foremost actresses, Jane Seymour,
with us and she will present testimony regarding her
experiences in integrating natural healing approaches into her
life. Ms. Seymour has had numerous experiences with alternative
medicines that have helped her family. She will talk about her
father's cancer experience and her experiences of integrating
herbs, homeopathy, and other complementary methods with
conventional medicines.
Dr. Brian Berman is the Director of the NIH-funded
Complementary Medicine Program at the University of Maryland in
Baltimore. Dr. Berman has been a long-time advisor to the
Federal Government on alternative medicine and he has conducted
clinical research in acupuncture, mind-body and relaxation
techniques, and coordinates the complementary medicine field
group of the Cochrane Collaboration.
We are in a time of change in this country. Healthcare is
important to all of us. How can we, as a Government, provide
quality and effective care and not increase costs to the point
of crippling our system? Complementary and alternative medicine
may be a large part of the answer. As I have said before, we've
heard the mantra ``Show me the science'' and we are moving to
do that today. We will show that there is already scientific
data to validate the effectiveness of several complementary and
alternative therapies. We have moved to a point of looking at
broader availability to our armed-services families and their
veterans, and to those who rely on the Federal Government for
part or all of their health care. It is time that we assume and
assure that scientifically validated healthcare moves out of
the ivory towers of research community and into the lives of
the American people.
We look forward to hearing from today's witnesses. There
has been a great desire by many patients, healthcare providers,
associations, and researchers to speak to the committee on this
topic. And we're not able to bring them all in today, but we
will hold the record open until March 10 to allow for written
submissions to be included in the record. And I want to thank
all of our guests for being here today. I really appreciate it.
I know it takes a lot of time out of your busy schedule and we
really, really appreciate that.
I'll now turn to Mr. Waxman, our ranking minority member,
who just arrived for an opening statement.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Waxman. Thank you very much, Mr. Chairman.
There is no denying the growing popularity of alternative
medicines. They constitute a rising proportion of our
healthcare expenditures. The number and diversity of
alternative products and services in the healthcare marketplace
are increasing dramatically.
Today's hearing is focused on the right questions about
alternative medicines. It is important that we seek information
about therapies that can help improve our well being and to
encourage access to safe and effective treatments. At the same
time, we must promote thorough testing and review of therapies
to prevent unnecessary harm and expense to consumers.
I believe that a quote from a recent editorial in the
Journal of the American Medical Association provides the
appropriate framework for today's discussion. The Journal of
the American Medical Association recently wrote ``there is no
alternative medicine. There is only scientifically proven
evidence-based medicine supported by solid data or unproven
medicine for which scientific evidence is lacking.'' This is
the test to which we must hold alternative medicine. Medicine
of any kind must undergo the crucible of scientific
investigation from clinical trials to publications in reputable
peer-reviewed journals before it can gain a place in routine
practice. We must place our trust in credible evidence and not
mere speculation, or tradition, or popularity when we decide
how best to care for the sick.
The Federal Government and others have invested millions
into research on alternative medicines. Some research has had
promising results. For example, the Journal of the American
Medical Association recently reported on a preliminary study
indicating that yoga stretching can relieve some symptoms of
carpal tunnel syndrome.
On the other hand, other therapies have proven ineffective
or dangerous. For example in 1997, the deaths of three cancer
patients were linked to a Manassas physician who had been
treating them by injecting them with concentrated aloe vera, a
treatment that is not approved by the Food and Drug
Administration. Patients reportedly had learned about this
physician's treatment through the internet, word of mouth, or
an aloe vera supplier.
In highlighting ongoing research, examples of
scientifically validated forms of alternative medicine and
positive personal experiences with alternative treatments,
today's witnesses will help sift through the positive and the
negative aspects of this area of medicine.
I join my colleagues in welcoming the witnesses here today
and I just want to comment on the fact that we have a change of
the list of witnesses and their order which we were never
advised of until the very last minute. Not only were we not
advised, but the Government witnesses--and it would have been
helpful for them to know when they were to appear--were
suddenly put on a third panel. And, I think for the record, I
want to point out that we ought to be courteous to all of the
witnesses try to accommodate them and also discuss with our
colleagues, if we are going to have collegial hearings, how
we're trying to treat the witnesses so we can get the
opportunity to hear from them and not have them mistreated by
having the schedules changed on them.
Thank you very much, Mr. Chairman. I do appreciate the
hearing. I think the hearing is a worthwhile one and I will try
to be here as much as possible, but I certainly will review the
record for those witnesses where I am not present in the room
because of conflict of schedule.
Mr. Burton. Thank you, Mr. Waxman.
Let me just say that wherever possible, we always have our
agency and administration officials testify first. We do have
some time constraints which are a little unusual today. So, for
that reason we've changed our panel structure around a little
bit. So if that inconvenienced you, we apologize for that.
Mr. Hutchinson, do you have anything you would like to say?
Mr. Hutchinson. Thank you, Mr. Chairman.
I'm just delighted to participate in this hearing. I thank
you for conducting this and I look forward to the testimony.
And so in the interest of hearing the testimony, I yield back
the balance of my time.
Mr. Burton. Are you saying the chairman talked too long? Is
that what you're saying? [Laughter.]
Mr. Hutchinson. I would never say that, Mr. Chairman.
Mr. Kucinich.
Mr. Kucinich. Thank you very much, Mr. Chairman, Mr.
Waxman, fellow committee members, and members of the panel. I
appreciate the opportunity to participate in this hearing on
complementary and alternative medicine. I applaud the
chairman's willingness to address this issue and I thank him
for providing us with this forum.
As a witness to the theories and practice of alternative
medicine, I support the committee's efforts concerning this
issue. With this in mind I look forward to exploring
opportunities that will advance medical care and expand the
treatment options afforded to today's doctors.
I think that all of us in Congress are fully aware that our
healthcare system is on the verge of radical change. The
direction that we are going remains to be seen, but with rising
costs, with more and more Americans not having access to
adequate healthcare, and with more and more Americans
questioning whether they have any availability to healthcare, I
think there is becoming a greater and greater interest in
alternative methods.
This, in no way, is an attempt to denigrate allopathic
practice because I think that, at a minimum, many allopathic
practitioners would agree that alternative healthcare methods
and therapies are a proper adjunctive theory. I have great
respect for allopathic practice, but at the same time, I think
that you will find that allopathic practitioners who are candid
will admit that there are limitations to their own practice.
I think that we are fully aware that the United States
enjoys some of the most advanced health care in the world, but
yet we are unable to provide relief for a number of common
ailments. The current standards of practice occasionally fail
to recognize that medicine is an ancient art that encompasses
all methods of healing. Somewhere along the road to advance
medicine we sometimes forget that there are methods of treating
those who need help. It's time to help widen the vision of
modern medical doctrine and explore alternative medicine. We
have to let go of the fear that alternative medical practices
will replace and endanger standards and instead embrace the
idea that any method that is proven a safe form of treatment
ought to be available to the people.
American citizens have a right to health care and as
Members of Congress, we have a duty to ensure that they have
every available proven treatment option. Complementary and
alternative medical care encompasses numerous forms of studies
and tested procedures and practices and it is gaining support
from mainstream medicine. Unfortunately, there is some
unwillingness to support its practice and research. We must
ensure nonprejudicial disbursement of research funds to all
disciplines of medicine, including alternative medicine. We
must utilize this research not only to educate practitioners
and the public, but to provide them with access to proven
methods of alternative medicine.
I hope these hearings will broaden our understanding of
alternative medicine; will expose and end any bias that may
exist within our current system of medical doctrine. All
citizens deserve access to safe and proven methods of medical
care and I thank the chairman and the panel for expanding our
understanding of medicine that some would deem, unfortunately,
the alternative.
Finally, Mr. Chairman, these hearings present a wonderful
opportunity. We have to think creatively about healthcare; to
think dynamically; to draw new worlds toward us using a higher
consciousness of the potential we have within us to make this a
better world. I think that we need to urge Government officials
to keep an open mind on alternative therapies. Anyone who is
watching or listening knows that once an individual has
experienced a profound shift in his or her health as the result
of a new approach toward health care, it is important that the
story of the miracle of an individual's transformation be
available to study, certainly, and also to share.
So, I welcome Ms. Seymour and the other witnesses and I
thank you for participating in these hearings.
Thank you.
[The prepared statements of Hon. Joe Scarborough and Hon.
Bernard Sanders follow:]
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Mr. Burton. Thank you, Mr. Kucinich.
Well, we now finally are at the stage where we hear from
our witnesses and the first witness, Ms. Seymour, would you
come forward and sit in this chair right here in the middle,
and if you would like to have anybody with you, that's fine.
First of all, before you start your statement, let me just
say how much we appreciate you being here. I especially
appreciate you being here because I am one of your biggest
fans. I watched you in East of Eden and I thought you did
extremely well in that, and I saw you in ``Somewhere in Time,''
which is a very romantic movie. I saw your picture on the wall
in that movie theatre and just swooned. So I just want you to
know you have a big fan here in the chairman and----
Ms. Seymour. Thank you.
Mr. Burton [continuing]. Although we usually limit
testimony to 5 minutes, you can have all the time you want.
Ms. Seymour.
STATEMENT OF JANE SEYMOUR, ACTRESS
Ms. Seymour. Thank you very much, Chairman Burton, and
thank you all for giving me this opportunity. This is,
obviously, very unusual for me and something I am very excited
to be a part of.
My first experience with alternative medicine involved my
father, Mr. John Frankenberg, a fellow of the Royal College of
Obstetricians and Gynecologists in England. He specialized in
infertility and prided himself in being a good doctor, with
extraordinary results in his field, greatly due to the time he
would spend listening to his patients. When he himself was
diagnosed with lung and bone cancer and treated with radiation,
his oncologist told him that that was it. He had no more
options.
Distressed and desperate to find an answer, I found the
Virginia Livingston Clinic in San Diego, a complementary
medicine program which was heavily criticized by mainstream
medicine. I offered this option to my father not believing that
he would accept. However, after reading their brochure he did.
On his arrival in California, he was frail, gray, and
lifeless. Not the man I had always known, but rather a man who
appeared nearly dead, both physically as well as spiritually.
After only 1 week there undergoing complementary medicine
therapies and antibiotics, he regained his strength and his
spirit. He decided to visit Sea World. He walked out of this
wheelchair to look more closely at the exhibit. He was healthy
looking and happy and we were all, including his oncologist,
dumbfounded.
Many months later, he died of complications including heart
problems, but he had a much longer life than predicted and,
without question, a higher quality of life. He visited the
opera 2 days before his death. He was happy and comfortable
until the end. Before he died, I spoke with him asking if he
had any regrets in his life. And he said that his strongest
regret was his not knowing more about alternative medicine as
he felt he could have been a better doctor with that knowledge
to complement his own.
Since then, my sister Anne, who is with me today, has
trained as a homeopath in England. I have seen her help many
people. One was a woman with fibroid tumors declared unable to
conceive and told she needed surgery. Anne treated her
homeopathically, and she has just delivered a healthy child and
the doctors found no fibroids present in her body. When
alternative medicine finally arrives, how many surgeries like
this will be prevented?
My nephew with chronic Eczema has found relief at last with
homeopathy instead of steroids. My sister, Sally, had a brain
aneurysm and after surgery was given Arnica for the swelling
with the permission of her brain surgeon who admitted he didn't
really understand what Arnica was. He was then astounded, as
were all the nurses, who determined her swelling to be one-
tenth that of the other patients who had received the identical
surgery that day.
In my own life, I've used high-quality herbs, vitamins, and
homeopathy. During my 16-hour a day, 5 day-a-week job on Dr.
Quinn, I rarely got sick. Indeed, even pregnant with twins at
45, I was able to support my immune system with this regime and
not miss a single day of work.
I have recommended remedies to friends for headaches and
flu symptoms with amazing success, even to the non-believers.
My children, both teens and babies, routinely use alternative
medicine first. More often than not, it has solved their
problems. My pediatrician suggested homeopathy to avoid the
excessive use of antibiotics. One of my twins did so well with
this that he was antibiotic-free for over 6 months when all
around him were suffering from the flu.
Recently, both twins with ear infections received
antibiotics due to the severity of the case, but also took a
series of other therapies like herbal medicine to support their
immune systems. They sailed through this as if they were never
sick and needed far less antibiotics rounds. It was amazing.
Another friend with chronic migraines would vomit
uncontrollably and lie in a fetal position crying for help.
Medicine prescribed for her did little. Only Codeine gave her
some pain relief and sleep. The following day, she consulted a
naturopathic medicine practitioner who after the session gave
her a single remedy. She felt better within a half an hour and
has remained pain and headache free ever since.
About 9 years ago, I almost died of anaphalatic shock from
an injection of Cephliosporin prescribed for bronchitis.
Needless to say since that close call, I've been more inclined
to ask questions and seek options in my medical health. Do we
all need a severe wake-up call? I have managed to avoid
antibiotics on many occasions by catching early warning
symptoms of viral infections using proven herbs such as
echinacea, vitamins, and homeopathy.
Two years ago, I was very ill with Leptospirosis, a
bacterial infection contracted while filming in a swamp. I was
eternally grateful to have Tetracycline, which absolutely saved
my life. I am also positive that by my abstaining in the past
from antibiotics whenever possible and using complementary
medicines, the antibiotic worked more effectively in that
crisis.
The world of alternative medicine has become a major spark
in my life and I am here to suggest the integration of western
and alternative medicine within our medical establishments. It
would be an injustice to deny America the information about and
access to alternative medicine, particularly as it has now been
proven through laboratory and clinical research and has shown
to be cost effective with 100 to 500 years of reproducible
clinical results.
I am not standing here as a scientist, but as a concerned
member of the public who has had the privilege to try these
options which are supported by scientific evidence.
A recent article in JAMA estimated that there were 110,000
deaths annually from the use of medical drugs. It is the fourth
cause of death in America. That is not to say that miracles
have not been achieved with the use of prescription drugs, and
I am not here to vilify western medicine. I am looking for
inclusion, not exclusion. I propose every hospital in America
include a complementary medicine department consisting of two
or three licensed practitioners who direct the complement to
unassisted treatments such as chemotherapy side effects and
chronic, but not life-threatening, diseases. I propose the NIH
stop withholding its billions of dollars in research funds from
the implementation of natural medicines and protocols.
When I get sick, my children, or my friends, I want to know
that ``all'' has been done to protect their health. Everything!
I don't want to feel that I have to choose one medical system
over the other. Each of us can benefit from a portfolio of
medical choices and I want all the medical options available to
me, to my family, and to you. There must be room for all
remedies that bring health to the patient. Isn't this hearing
about healing? Alternative no longer needs to mean one or the
other. There should be no alternative other than the best
health care known to man.
Thank you.
[The prepared statement of Ms. Seymour follows:]
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Mr. Burton. Thank you very much, Ms. Seymour. That was a
very, very enlightening statement. We are going to ask you some
questions now.
Ms. Seymour. OK.
Mr. Burton. You didn't think you were going to get off
scott free, did you? [Laughter.]
I'd like to know a little bit more about your father's
situation. Do you know what kind of therapy they provided for
him when he became deathly ill with cancer and they gave up
hope?
Ms. Seymour. I have the data here somewhere that I can show
you. He had a number of therapies, but the main ones were
intravenous vitamin C, which many people have poo-pooed, which
I now believe is done all over the country. And a special
vaccine made that was also at that time not allowed. In fact,
he was very fortunate to get it. I believe the vaccine is now
being used elsewhere in the country routinely for cancer. He
also had an enormous amount of emotional counselling, which I
think was a very large factor, too.
In his case, of course, the cancer was not caught early
enough for him to go into remission. However, I think the point
I am trying to make here is that he was given the quality of
life, a comfort, and a sense of living until the end which I
think that every one who goes through cancer should be entitled
to, and especially if that exists.
And I think one of the reasons I am here today is because
he was an eminent surgeon who did not necessarily believe or
know anything about alternative medicine before. The fact that
his only regret in life was that he didn't get to know more
about these options until just before he died is really one of
the reasons I am here today. I meet an enormous number of
medical practitioners who really believe that there are holes
in what they are doing and that there really is a great need
for alternative medicine as a complement to what they are
doing, particularly as you mentioned, in cancer.
I have three friends who just went through breast cancer.
All three of whom were told at one point by their oncologist
that their white blood cells were at a level that they,
basically, were going to die. There was nothing more that could
be done for them. And they all said, ``well, what do you mean?
What do we do now?'' And their oncologists said, ``well, there
is nothing we can do now. We are finished. This is it. We've
done our best. That's all we can do.'' And my friends said
``well, are we supposed to walk out of door and die?'' And
their oncologists said, ``well, we don't like to put it that
way, but there is nothing more that we actually can do.''
In all three cases, they found alternative medicine and, in
fact in all three cases, it was Chinese herbal medicine that
brought back their immune system. All three of them are
incredibly healthy. All in remission and all of them would
swear by alternative medicine, and that is another reason I am
here.
Mr. Burton. Those are very impressive stories and it is not
unlike the situation that my wife went through 5 years ago.
They gave her less than a 50-percent chance to live 5 years and
she just celebrated her 5th year and she is very healthy.
So, I'd like to make just one more comment along the lines
of your father. He was a doctor and he was not enthralled with
alternative therapies until he became ill. For those who are
from HHS and FDA, I hope you listen to this story.
We had a Governor in Indiana who was deaf on alternative
therapies and he supported the AMA's position right down the
line. And I fought with him when I was a legislator and he was
Governor over some of these alternative therapies. His wife
became ill with cancer and he went and used every alternative
therapy he could possibly use to save her life and I do not
fault him for that. The only thing that bothered me was that
that is the way it ought to be for everybody. And he later
became the head of HHS, incidentally.
You mentioned in your testimony that you use alternative
treatments in your children. How do you decide what is safe for
your children?
Ms. Seymour. My pediatrician is actually the person who
started me out on this. She is a regular M.D. She does not
practice any alternative medicine. Her name is Dr. Lisa Stern,
a prominent pediatrician in Los Angeles. She said to me that
the use of antibiotics for small children was not safe to do on
a regular basis. That they were trying to find other options
and she suggested that I consult a homeopath. I consulted Dr.
Asa Hershoff in Los Angeles with my twins and we've been using
homeopathic and herbal remedies for them really pretty much
since they were born. We use, obviously, things like chamomile
for teething; Arnica for bumps and bruises; pulsatile for flu.
They really are incredibly healthy considering both of them
were on heart monitors. Both of them were born early; 6 weeks
early and being twins, you know, they are not as resistant
usually as other children to infections that are around them
because they had low birth weights.
I generally will go to the pediatrician first and then I
will take them to the homeopath and we'd look at what the
options are and, invariably, we'd try homeopathy for at least a
couple of days. Usually it works and, therefore, we don't end
up having to use the antibiotics.
Mr. Burton. Let me just ask one more question here. What
would you say right now to mothers all across America about the
use of antibiotics? You just talked about that. I presume you
would just tell them to be very careful; not to use them unless
it is absolutely necessary. I mean, how do you judge that and
what would you say to them?
Ms. Seymour. I think you go to your regular medical
practitioner and I personally believe you also have a homeopath
or someone like that, a naturopathic doctor that you can
consult. As a mother--for me, I would check their ears and make
sure there is no major ear infections or problems that way. And
most pediatricians will now agree and say that antibiotics
should be used very sparingly in small children and they are
very happy to have alternative means to try first.
Mr. Burton. Thank you. Mr. Waxman.
Mr. Waxman. Thank you very much, Mr. Chairman, and Ms.
Seymour. We are delighted to have you here and I appreciate
your testimony.
I think the important point that I get from what you had to
say is that we don't want one medicine here and another
medicine there. We want the best healthcare possible for all of
our people. And that means that everybody has to be open-minded
enough to reevaluate information, and if new information comes
out, we ought to accept it. I gather your father had a feeling
that as a medical person, he wasn't open to some of these
alternatives because he had been trained in a particular way
and didn't think about some of these other things that were
being suggested.
Is that a correct statement?
Ms. Seymour. Yes, I think the temperature has changed in
America today. I think people are aware now that they can take
health into their own hands and that preventive medicine is
probably a very important part of their lives. I think people
are very aware of how diet, nutrition, health, exercise, and
all kinds of protocols can really help them.
My father discovered rather late in life that this is an
area he wished he had known more about.
Mr. Waxman. Well, I'm not a scientist, but as a lay person
and a consumer, I want to be able to have more of a say over
what my family has in terms of healthcare and what decisions
they would make and I would make about whatever medicine that I
may or may not decide to pursue. But I also want the doctors to
be open to other--we call them alternatives--but other
indications of good health care.
To me, one of the shocking things is that how little in
medical schools they teach doctors about nutrition. Even though
now we are learning so much more about the value of nutrition.
Dr. Ornish will be testifying and I know his long record in
this area.
It's important that we not look at medicine as one sort or
another science--good science to me ought to be open to
alternatives and then those alternatives ought to be tested and
accepted wisdom ought to be retested as well so that we try to
get the best that we can for all of our people.
Have you had any obstacles or members of your family
encountered any difficulties in trying to get access to these
different remedies or different alternative practitioners?
Ms. Seymour. I have had no difficulty whatsoever. There
are--you know, we were talking about studies. There are 3,000
blind and double studies, you know, done worldwide on the
effects of herbal medicine and these studies comes from
countries like Germany, Japan, France, and England. So there
are studies that can be evaluated and I think it is rather
remarkable that we accept their studies on making fair Mercedes
or a German car and that is acceptable to us, but we disregard
what the Germans have to say about homeopathy and they are
really, probably, the foremost in the world in this area.
I, obviously, have had no problem in finding help. No, and
none of my friends. I would like to see the general public be
able to have this. My sister just brought with me a very
interesting report from England--from a part of England which
is close to a house that I own where the National Health did a
study to see the cost effectiveness and how it would affect the
general public in terms of health. And they took half of that
area of the National Health. They gave them regular medicine
and the other half they used homeopathy and natural medicine
and the results were astounding. The patient's response were as
that 90 percent of them were very happy with the alternative
medicine. Far less of them came back for repeated visits to the
doctor afterwards and the cost was so much less to the National
Health. So in England, they are taking this very seriously.
Mr. Waxman. And we should take it seriously here. There is
no question that if we can prevent disease, we are far better
off. And I'm encouraged by the amount of attention I see in the
press about encouraging people to exercise; watch their diet;
to take care of themselves; and to understand the value of
nutrition. This is, it seems to me, the direction that we ought
to go as we learn more information.
I am going to ask you one other question. Do you have any
suggestions on how the Government can help individuals obtain
access to alternative treatments that are safe and effective?
Ms. Seymour. I think that it would be very useful to have a
panel of maybe 200 to 300 practitioners that is decided within
alternative medicine--as you know, there is 40 or 50 different
forms of it--that they should decide who this panel is. And
they should be the people who should monitor amongst themselves
as to who is actually doing the right alternative medicine and
who isn't. And I would like to see in the hospitals when you go
to an oncologist, when you go to a hospital for cancer and you
are offered chemotherapy, that someone talks to you about how
you can support your immune system while you are going through
this.
It is very cost effective. In fact, I think you will find
less people becoming sick if we educate them in what they can
do with alternative therapies as a complement to, of course,
the brilliant remedies that we do have in allopathic medicine.
Mr. Waxman. I agree with you and----
Ms. Seymour. Thank you. I'm glad you do. [Laughter.]
Mr. Waxman. I was pleased that you mentioned the point
about spirituality because I think that is very important in
how people address their ailments because we don't know why,
but we do know that those who have an optimistic view of the
world often are able to heal themselves.
Ms. Seymour. It is called holistic medicine because
wellness is about the whole being. I personally have discovered
that homeopathy and Chinese herbs do work for me and for
everyone around me with remarkable results. So I do hope that
money will be spent to enable this to be shared with the rest
of the population.
Thank you.
Mr. Burton. Thank you, Mr. Waxman.
Mr. Gilman.
Mr. Gilman. Thank you, Mr. Chairman.
I want to commend you for bringing on this important issue
before our committee. The hearing should help to stress the
need for alternative and complementary treatments into the
mainstream of health care and provide patients with a variety
of treatment options. And I'm pleased that Dean Ornish is here
to tell us about how he's attacked the problems with regard to
heart situations.
And I want to thank Ms. Seymour for coming with her
examples of how homeopathic treatment has helped her. How did
you find the homeopathic physician that you needed? Were they
listed properly among physicians or were you just referred by
another patient?
Ms. Seymour. No, they are listed. They are quite easy to
find. In fact, there is a brilliant thing called the
Alternative Medicine Digest which is a phenomenal book that
will tell you where you can find any practitioner and how all
the different methods work. But homeopathy is quite easy to
find all over the world.
Mr. Gilman. One of the things I've found, Mr. Chairman, is
that there is so little education on pharmaceutical agendas at
the medical schools and I'm just wondering whether alternative
medicine has reached the training in the medical schools.
Would you know that Ms. Seymour?
Ms. Seymour. I do know that my homeopath teaches, I think--
is it at UCLA? Yes, he teaches at UCLA and I just recently, 2
nights ago, spoke to one of the top doctors at UCLA, Dr.
Becker, who said that they were about to instigate a program
there investigating the use of alternative medicine as a
complement to what they were doing.
Mr. Gilman. And maybe Dr. Ornish, in his testimony, can
tell us a little bit more about the kind of training that
exists in our Nation on alternative medicines.
Studies have found, Mr. Chairman, that more than 40 percent
of all of our people try alternative and complementary medical
treatments, seeking out the advice of physicians with regard to
these treatments. Many who have suffered through the agonizing
effects of traditional cancer treatment, such as chemotherapy
and radiation. We all know some of those examples are now
turning more and more to complementary and alternative
treatments like herbal therapy, meditation, and nutritional
therapy.
In a bill I introduced several years ago--and I'll keep
introducing it until we get some place--is a preventive
medicine to make certain we do more in prevention that can save
us more dollars on the cure if we apply prevention
appropriately. And I'm pleased that more and more nutritional
advice is finding its way into our medical system.
In our Nation, it is some sort of a stigma when we talk
about alternative medicine, and as a result, funding
alternative studies has been difficult for physicians and
researchers. Significant achievements are being made, though,
in the cures for cancer that are occurring overseas and in
Europe and Asia. I think it is long overdue that our Nation
works together with its foreign counterparts, sharing
information, sharing strategies and treatments, and to provide
our Nation with easy access to those treatments.
Some patients in our Nation have the ability to travel
overseas to receive alternative treatments, and we continually
hear about how they go to great lengths to try to find some
proper remedy. But all Americans should be afforded that
opportunity to access all forms of treatments, both traditional
and alternative. We should pool our resources to create
affordable, beneficial alternatives, to establish treatments in
an alternative form, from which all of our patients can
benefit.
So, Mr. Chairman, I thank you for focusing attention on the
studies that have shown that these alternative complementary
treatments create positive results. It is our hope that, with
hearings such as this, these treatments will be integrated into
our healthcare system.
I thank our panelists, Ms. Seymour and Dr. Ornish, for
coming before us.
Thank you, Mr. Chairman.
Mr. Burton. Thank you, Mr. Gilman. Mr. Kucinich.
Mr. Kucinich. Thank you again, Mr. Chairman. I want to
again state for the record that I think that the Chair is
performing a very valuable public service, as is Mrs. Seymour
for her participation. This is a subject that we are only
beginning to get into on a national level, and Congress has a
great ability here to coordinate a lot of knowledge. Again, it
needs to be said that Mr. Burton is doing something here that
is important for the country. I think that he should be
supported in his efforts. That is why I am here.
I also think that there is something about alternative
medicine which is uniquely symmetrical with democracy and
democratic tradition. We in this country believe in individual
responsibility. Alternative medicine certainly does that. Would
you agree, Ms. Seymour?
Ms. Seymour. Absolutely.
Mr. Kucinich. What would be your view as to how those who
you love and your family have had more control over their own
lives by being able to seek alternative therapies?
Ms. Seymour. Well, for example, it was pointed out to me
the other day that mammograms, which are routinely done on
women, are now shown to be causing cancer unnecessarily. There
are other ways of discovering the breast health with
thermography and ultrasound used together, and then the
mammogram used to bolster that, to make sure that the symptoms
are discovered.
There are other options in so many different areas. I think
the whole feeling of wellness, the whole concept of holistic
medicine is to want to be healthy and to want to be in a well
state, rather than constantly patching one's self up with
bandaids that will take away symptoms. Somebody once described
homeopathy to me as, if you drove a car and the oil light went
on to tell you that something was wrong with your oil, you
could have that light removed or you could actually go to the
garage and find out what part of your car, what part of the oil
system is not working. I think this is what we are talking
about in alternative medicine, that if we become in tune with
our health, then we may not get to such severe cases so often.
Mr. Kucinich. Would you say that is self-empowering?
Ms. Seymour. Yes, I think there's a lot of things we can do
for ourselves, and we can empower people to take care of their
own health. Rather than bandaiding it with things that take
away symptoms, I think they can listen to their bodies and
probably hear the symptoms and be able to notify the doctors as
to what is really happening in their bodies.
Mr. Kucinich. I think, Mr. Chairman, in conclusion, one of
the values of this hearing, and hearing from Ms. Seymour and
other witnesses, is that we start to shift our view of how
health is defined. One could almost ask at the beginning of
this hearing, alternative to what? Because as we broaden our
knowledge of healthcare, more things that appeared at one time
to be on the fringe or alternative suddenly become part of the
mainstream.
Ms. Seymour. I think also a huge issue today for all of us
is the support of the immune system. We never really thought of
the immune system until we had viruses and AIDS and hepatitis
C, which I believe is to be the next huge problem we have here.
I think we all have a responsibility to ourselves and to our
families to keep ourselves in as good health as we can, so that
we are able, our bodies are able to withstand these viruses.
Mr. Kucinich. Mr. Chairman----
Mr. Burton. If the gentleman will yield to me just for one
comment--years ago, when I was in the Indiana General Assembly
and we were working on the laetrile bill, I called Dr. Linus
Pauling--and I am sure you have all heard of him. He won two
Nobel Prizes. I think one was for cancer research or scientific
research. I was talking to him about laetrile, and he
interrupted me in mid-sentence and said, ``Well, that does have
some promising qualities to it,'' he said, ``but the thing that
I am convinced is going to save a lot of lives and prevent
heart attacks and cancer is megadoses of vitamin C.'' More and
more people today are agreeing with what Dr. Linus Pauling
said, and this was about 20 years ago.
I might add that he lived to be 92 years old and didn't
have cancer or heart trouble.
So thank you very much for yielding, Mr. Kucinich.
Mr. Kucinich. Just in conclusion, so that we can move on
here, what comes from any study of holistic medicine is an
understanding that healthcare is a profoundly personal matter.
In line with what I indicated previously about a symmetry with
democratic tradition and personal responsibility, we learn, as
we explore alternative practice, that there is something, a
process that begins inside of each of us.
Mr. Waxman referred to the potential for spiritual
considerations in that. Belief systems, faith, and hope are all
part of that process that, in effect, happens before we meet
that outside world, which offers us a variety of choices. So I
think that as we look at this, the many options which are
available to us begin, first, with our own decision to be open-
minded in approaching the possibilities of better healthcare,
which begin with ourselves.
Ms. Seymour. Yes, we don't want to be statistics. We want
to be considered as human beings, as people. You are very
right; if you believe that you are going to be well and that
you can be healthy, an enormous amount can be done. The mind
can override enormous symptoms.
Mr. Kucinich. Thank you again.
Ms. Seymour. Thank you.
Mr. Burton. Thank you, Mr. Kucinich. Mrs. Morella.
Mrs. Morella. Thank you, Mr. Chairman. Again, this is a
very informative hearing. Ms. Seymour, it is a delight to have
you here. You are a role model. So, therefore, what you say has
a tremendous effect on attitudes.
I just guess I want to try to synopsize your feeling, and
that is that attitude is altitude; as we approach something,
attitude is critically important; that balance is important and
openness. For instance, I think the American public has reached
the point where we are skeptical. We just don't know what to
believe. One day we hear about St. John's Wort or something
that is going to take the place of the antidepressants. We hear
about other possible medications or herbs that could be used
for arthritis. From one day to the next week, we find that
there are differences in approaches. So our confidence is kind
of eroded. We just don't know what to believe.
I guess what you are saying is you have got to continue to
use mammograms, using that just as an example, since you
mentioned it; you have got to continue to have co-rectal
examinations, but at the same time you should be open to the
totality or the homeopathy. Is this correct?
Ms. Seymour. To some degree. There are other options to
mammograms. I think the point I am saying is, rather than the
routine mammograms that we blithely all take without
considering the cost to ourselves healthwise in terms of the
radiation and the fact that it could cause cancer, there are
other ways of doing this which are far more cost-effective,
which are thermography. I tried it the other day, and it is
amazing how they can discover what is wrong with different
parts of your body and accurate they were. I had a blind test
done on me because I didn't believe in it. Sure enough, we
called up my internist and my dentist, and the findings were
absolutely agreed up. So there are other ways of detecting
disease like that, without necessarily hurting the human being.
So I guess it should be investigated anyway.
Mrs. Morella. It is an openness, that we look to the
various facets, the various aspects. I just don't want people
to think that they can't go off and get these examinations
regularly, or that they should not be part of their routine.
Ms. Seymour. No, but I do think that it would be nice if we
could spend some of those billions of dollars on looking at
thermography. There are only 30 people practicing that in this
country right now, whereas there are thousands in Europe, where
they are doing this very successfully. This would also be a
wonderful option for people in Third World countries, where
they could really detect what was wrong with patients very
inexpensively, very quickly. A lot of people could be helped.
Mrs. Morella. I want to thank you. Also, I want to thank
you, Mr. Chairman, for the articles that you have given us all,
too, that I think are very uplifting in terms of the number of
opportunities that are open with regard to alternative
medicine. Thank you. Thank you, Mr. Chairman.
Mr. Burton. Would you yield to me just real quickly?
Mrs. Morella. Indeed, yes.
Mr. Burton. I don't have the exact figure in front of me,
but I think $20 million is being used for alternative therapies
and alternative therapy research by the departments of health
in our country, and $2.3 billion is being used for conventional
medicine. I think one of the things that we need to do, and I
hope we are stressing today, is giving more funds for the
alternative therapy research and complementary research,
instead of just going ahead with the conventional approach that
we are taking.
We had a doctor named Dr. Barry Marshall. Dr. Barry
Marshall came up with a theory that stomach ulcers were not
caused by nerves; they were caused by a bacteria. Well,
conventional wisdom in the medical profession for years and
years and years and years was that it was caused by nerves.
They said that bacteria could not live in the acidity of your
stomach. Well, he did some research and found that it could. He
gave a speech--I think it was in Belgium--about this and he was
laughed off the stage, literally. He then went home and drank
the bacteria, became deathly ill, and cured himself with a
combination of bismuth and some antibiotics.
But the point is, there are billions of people in this
country that are suffering from stomach ailments that can be
cured because of his research. But he was ignored, not unlike
what Pasteur was, for a long time. He proved that the bacteria
does live in the stomach, and this alternative therapy research
that he did alone is going to save thousands, maybe millions,
of lives and millions of people from this kind of pain.
That is why I think, and I hope, these hearings that we are
going to continue to have will point out the fact to the
National Institutes of Health, to FDA, and everybody else, that
we need to have more funds used for research into alternative
therapies. Because if we do that, we are going to find, like
Ms. Seymour has said, that there are alternatives out there
that are not as dangerous that are going to help humanity.
I thank the gentlelady for yielding.
Mrs. Morella. Thank you. NIH is in my district, and I know
that they are moving ahead with alternative medicine.
I just wanted to point out there is no one panacea. So we
need to look at the entirety, and not just one little facet of
it.
Ms. Seymour. Yes, if I may quickly add--I didn't know if I
had time in my 5-minute speech, but we see incredible results
with acne, which a lot of people suffer from acne and adult
acne. Homeopathy can cure this within 4 days--it is amazing--
without the use of injections and steroids and antibiotics and
birth control pills and Accutane, which, of course, is very bad
for women.
There are options also with migraines and things like
these. These are huge issues for the American public that can
be helped very inexpensively and very quickly without any
adverse effects.
Mr. Burton. Thank you, Mrs. Morella. Ms. Norton, do you
have any questions?
Ms. Norton. Thank you, Mr. Chairman. Mr. Chairman, I think
these hearings are very important, and I appreciate that you
have called them.
And I appreciate your last statement about research,
because in a very real sense oppositional thinking about
alternative medicine and traditional medicine is very
unhealthy, is not good for your health. Hearings like this I
think are important for the way in which they--for particularly
the notion of what is necessary in order to have an informed
public.
Ms. Seymour, I think we are very fortunate that you have
been willing to come forward. By your own high profile, you
raise the profile of this very important subject.
Our country is abysmally behind on coming to grips with
alternative medicine. It is hard for me to criticize my country
in this regard when I realize what it has done in traditional
medicine; that in a real sense it is like being ahead in
soccer, and I think you neglect the other sports. We are so
ahead on what we have given to the world in everything from
AIDS to--that we let this slide. We are only now coming to
grips with it.
I have read books that--I must tell you, the only books
that convince me about anything are books that have been
written by people trained in medicine who have something to
compare it with.
I have a question about the way we go about this. I have to
confess that, without scientific evidence, I have myself often
been very open to alternative suggestions about what to do,
and, anecdoctally, have found some of them to be effective. I
am more inclined to insist upon the scientific medicine when it
comes to traditional medicine than I am to alternative
medicine. That is proper, because what the public kind of reads
in the newspaper, in the magazines, gets absorbed as what kind
of alternative medicine should be done.
That is why what the chairman said about research is no
less important for alternative medicine than it is for any
other kind of medicine--I want to just take issue with your
notion, for example, about mammograms. Some of us who are women
in this Congress have had a hell of a time getting women to be
sufficiently unafraid to get mammograms because of all this
stuff about radiation; that the whole notion that anybody
without research would say, ``Well, I think I am going to wait
until thermo-something''--look, all the scientific evidence now
tells us that there is not radiation danger, and that if there
is, it pales beside the danger of not getting a mammogram.
It is very important that there be research into
alternative methods. I would support that. But, again, the
public really is just left out there now. Whatever comes
through the microphones, including what we say here today,
becomes what you ought to go out and do. That is not the case
with traditional medicine, because there has been some
regulation.
I associate alternative medicine as well with preventative
medicine. That is one of the reasons why I am a great supporter
of it. I applaud what NIH is doing. I don't think it is enough,
and I think it came too late, but I think it is important to
do.
I don't agree that more training is necessary in order for
doctors to do this. I have a young doctor. Young doctors who
keep up with good medicine will prescribe alternative medicine.
If you go to a doctor who does not know anything about
alternative medicine, you ought not go to that doctor, because
if she is reading in the literature, she ought to know what is
effective and not effective. I don't think people should listen
to anybody except a doctor or a scientist about what is
effective or not effective, although I applaud the notion of
doing what I do. As an intelligent consumer, if you all don't
know yet, and nobody tells me that this is harmful to me, well,
I am going to do what I think is good for my health. That does
not stand in the place of research.
Now I have a question to ask you, because I found your
testimony very balanced. For example, you report in your
testimony 110 deaths annually from the use of medical drugs.
Well, you know, we can get to the point where somebody is going
to report, because there are no controls, because there is no
good information about deaths from alternative medicine. We are
already getting those kinds of reports.
The question for society for alternative medicine is the
same question society had when it had to decide whether or not
you ought to have x rays for your teeth or whether you ought to
listen to these people that say that, if you do, something will
happen; you will float into the universe.
You have to intelligently decide whether or not there has
been sufficient investigation, and there is no way for the
public to know now. Thus, the public does what I do. Look, if
you say a megadose of A, B, C vitamin will help me feel better
in some way, well, fine, let me do this because nobody told me
it will kill me. So I am going to use a megadose. It is not
very good, Eleanor, but that is what I do.
Now in your testimony you also said something very
important here. You said, ``I am not here to vilify western
medicine; I am looking for inclusion, not exclusion.'' And that
is where our country has failed--exclusion of alternative
medicine.
I would like to ask you whether or not--I noted that in
your breast cancer example these three women who used
alternative medicine had found that the doctors had said to
them, ``There is nothing more we can do for you.'' Now, of
course, there are women all over America, and these stories are
beginning to come out, for whom something can be done, who
believe that this kind of traditional medicine or that kind of
traditional medicine for breast cancer isn't what they should
do. So they are more likely to go into some alternative which
has not been scientifically shown.
I am asking you whether or not you would feel more
comfortable if there were far more--if our country engaged in a
regime of greatly increased controlled studies, so that the
public could make informed decisions, instead of anecdotal
decisions, about what is best for their health.
Ms. Seymour. There are studies, conclusive studies in----
Ms. Norton. I am not talking about where there are studies.
I am talking about where there are not studies.
Ms. Seymour. We should make studies, yes, and I would like
that. I think this is what we are asking for today. Let's
appropriate some of those funds and get onto it right away, and
have those tests done, maybe even blind testing, the way they
did it in England.
Ms. Norton. It must be blind testing.
Ms. Seymour. Do it in the hospitals, and allow the people
to have it, rather than waiting another 20 years and then find
out that what they were doing for 500 years did work.
I am certainly not saying that mammograms shouldn't be
done, and I am certainly not saying that in breast cancer you
should not have chemotherapy. What I am saying, and what I
testified--and I am sorry if I was misunderstood--is that we
are talking about inclusion here. We are talking about doing
chemo alongside Chinese herbal medicine, which will help the
patient to survive not only the cancer, but the chemotherapy.
We have seen countless stories of people where this has worked.
I guess while we are eventually, however this happens in
government, appropriating those funds, so we can investigate
these and find out who the true practitioners are, what the
real scientific data, and everyone gets happy about it.
Meanwhile, Americans are trying these things. You, indeed,
yourself are trying these things. You, indeed, are sort of
admitting that they do work for you.
Ms. Norton. Absolutely do.
Ms. Seymour. Absolutely.
Ms. Norton. I want to make sure that I am not having an
effect in my mind rather than in my mind.
Ms. Seymour. Well, the other people are the doctors, and
they will tell you, but, from what I have been told in my data,
maybe one or two people, if that, died last year from
homeopathy, from side effects of homeopathy. It is almost
impossible to die from a side effect from those forms of
alternative medicine, whereas it is very easy and has been
scientifically proven that over 110,000 people died last year
from adverse drug reactions. These are not people who took
drugs without being told by the doctors. These were people who
were specifically designated to take those drugs for those
specific things, and at the time it seemed to be appropriate
for them to take those things.
Ms. Norton. Thank you, Mr. Chairman.
Mr. Burton. Ms. Chenoweth.
Mrs. Chenoweth. Thank you, Mr. Chairman.
Mrs. Seymour, I can't tell you how very pleased I am that
you are here today.
John Kennedy, back in the 1960's, who was not the President
of my party, but I am deeply grateful to him for raising the
awareness of how important exercise is in our life. And perhaps
you will help supplement how important it is that we control
our own health and stay ahead of the power curve in terms of
boosting our immune systems and staying healthy. You may very
well be one who will take us on into the next century in
boosting the public awareness that we need alternative forms of
medicine.
You, like I, we are both very busy women. We shake a lot of
hands, and we see a lot of people. We fly on a lot of
airplanes. We are exposed to a lot of things. I find it
interesting, Mrs. Seymour, that I am 61, and my 30-something-
year-old staff have to follow me out to Idaho and back for a
weekend and take 2 days to recover. [Laughter.]
Now the only difference is that I believe in homeopathy and
I take massive doses of vitamin C. The reason I did, after
having worked for physicians for 18 years and really
appreciating all that they do for their patients and the love
they have for their patients, and how much they give--
nevertheless, there was such an entire freeze-out of other
alternative forms of medicine from the status quo institutional
form of medicine, that when someone suggested to me, when I had
a very severe case of Manieres disease, that I see a
naturopath, I thought they were crazy. Finally, when the
physician suggested surgery in the head for a shunt to relieve
the symptoms of the Manieres disease, I finally went to a
naturopath, who took a hair analysis and put me on zinc. The
symptoms disappeared.
I went out of obligation to the naturopath because of the
deep respect I had for the person who just begged me to do it.
Now not everybody can have a miracle cure like that, but it
certainly made me realize alternative forms of medicine are so
important to us being able to stay healthy and not ever have
to, hopefully, expend a lot of money as we reach the final
years of our life, which I don't expect will be for quite a
while for me, but I intend to stay healthy.
Thank you very, very much for your contribution. It is
deeply appreciated.
I want to share with you the fact that there was a recent
decision in the 10th circuit court of appeals involving two
litigants, Dirk Pearson and Sandy Shaw, who challenged the FDA
on the first amendment rights for people involved in homeopathy
to be able to talk about the results of their alternative
medicine. The court agreed with them that it is a first
amendment right. In fact, the court bifurcated the decision and
said, we will deal first with the constitutional issue of first
amendment rights, and then we will come down after with a
decision on the Administrative Procedures Act. That was
significant in the way the court did that. The court,
obviously, felt very compelled about first amendment rights in
this issue. I was thrilled to see the way the court dealt with
it. If you haven't seen that case, I recommend it to you.
I think that it is important, Mrs. Seymour, that the
government, the Congress recognize the importance of
alternative form of medicine. I think that we need to support
it in research. But, looking down the pike, if we give
government money for supporting research, I want to make sure
that those first amendment rights are guarded, and that
government does not exert undue control, to the point that,
again, we lose control of our own ability to stay healthy.
Thank you so much for what you are doing, and thank you
very much for being here.
Ms. Seymour. Thank you.
Mr. Burton. Thank you, Ms. Chenoweth. Ms. Norton has an
introduction, I think, real briefly here.
Ms. Norton. I thank you, Mr. Chairman, for allowing me to
introduce some youngsters who I am very glad have gotten to
hear this.
I do want to say to Ms. Chenoweth that the reason that the
young people who travel back are so much more tired than you
may be the same reason that you don't look 61. [Laughter.]
Good genes.
Mrs. Chenoweth. Very good genes.
Ms. Norton. Mr. Chairman, I am pleased that the youngsters
from the Knolle Elementary School had an opportunity to sit in.
They are part of a program that I run for D.C. youngsters, who,
after all, live in the District, called D.C. Students in the
Capital. I want to welcome them. I will take them out in the
hall now to say a few words to them.
Thank you, Mr. Chairman.
Mr. Burton. Thank you, Ms. Norton, and welcome to you,
students. It is nice that you are here learning more about your
government.
Mr. Davis.
Mr. Davis. Thank you very much.
I know it has been a long morning for you, Ms. Seymour, but
thank you very much, because I think what you have to say is
very important. Sometimes somebody of your stature coming up
here and saying it just wakes everybody up to something we have
been hearing anecdotally for some time.
My wife is an OB/GYN. She was a tenured professor of
obstetrics and gynecology, but I think she would agree with
everything that you have said today.
I don't think there is any reason we can't, up here in
Congress, direct some money for the complementary medicine
departments or courses in the medical schools, so at least
doctors will have some exposure to this. Right now they don't
seem to get it. In fact, conventional medicine, there is almost
a push on against some of this.
Your coming up here and speaking about it, and opening up
that a lot of us have anecdotal information, I think helps that
a lot.
The key here is that Washington and Congress, and even the
medical establishment, doesn't always know best. We are dealing
in some very changing areas where we are learning new things
every day. We want to enable consumers to make their best
choice. We best do that by the kind of things that you have
outlined here--giving them the full gamut of information, so
they can make intelligent choices, and letting our doctors and
medical community, NIH, and others do some exploration to see
why some of these things seem to work; that it is not
necessarily in somebody's head if it is working medi-physically
as well.
So you have done a great job. I appreciate your being here,
and I hope that we can followup legislatively to some of that.
I know it has been a long morning. I won't use all my time. But
thank you very much.
Ms. Seymour. Thank you.
Mr. Burton. Thank you, Mr. Davis. Ms. Biggert.
Ms. Biggert. Thank you, Mr. Chairman.
Mrs. Seymour, I was in Bolivia over our break on another
issue, but we had the opportunity to stop by a museum, which
was a museum of preventative medicine by the natives, Indians,
of Bolivia. It was quite interesting to see the bottles of
herbs and the way that they addressed--by looking at animals
and the organs, how they would determine whether somebody had
that illness.
I wondered if that really is a part of homeopathic
medicine. Has there been any movement to categorize what is
used in, well, Native American or other countries, the types of
medicines that they use that has been of help to us?
Ms. Seymour. Well, I think, obviously, the people to ask
about homeopathy are here today. You should address them on
that issue.
I always found it amusing, when I was playing Dr. Quinn,
that digitalis is what the Native Americans suggested as one of
the herbs that she used. Then, of course, the Native Americans
had herbs which, of course, are now used in synthesized form in
our regular medicines today.
So, yes, very much, I think these are things that we should
look into. I mean, we all now take echinacea, a large number of
the population. Not very long ago, everyone said ``echinacea
what?'' What is this stuff? As he said, Linus Pauling and
vitamin C, and I am sure Bolivia has a lot of things to offer
us and I am sure there are experts here who can answer you
exactly on that.
Ms. Biggert. Thank you, Mr. Chairman.
Mr. Burton. Thank you.
We now have a vote on. So what I think we will do is we
will have the committee break, go down and vote, and come back.
As soon as we return--and I apologize to the second panel--we
will have the second panel come forward.
Dr. Ornish, I understand you have limited time. You have
time constraints. So we will have you testify first and see how
we are going on time. Then, at around noon, we have food and
refreshments back there for the panelists. So we will break
around noon, and then we will come back and finish right after
we have lunch.
Ms. Seymour, you have been a lovely witness. We really
appreciate your being here. If you can stay around later, fine.
If not, we will see you later on today.
Ms. Seymour. Thank you.
Mr. Burton. Thank you very much.
We stand in recess to the fall of the gavel.
[Recess.]
Mr. Burton. Because of Dean Ornish's time constraints, I
would like to go ahead and get started with his testimony. Then
we will break shortly after that for about 20-25 minutes, so
everybody can get a bite to eat. Then we will come back and
finish with the second panel.
Would the second panel come forward.
So, Dean Ornish, welcome. We really appreciate your being
here. I have read a great deal about you. Since we want to save
some time and get you on your way in a timely fashion, we will
go ahead and let you testify now.
STATEMENT OF DEAN ORNISH, M.D., PRESIDENT AND DIRECTOR,
PREVENTIVE MEDICINE RESEARCH INSTITUTE, AND CLINICAL PROFESSOR
OF MEDICINE, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, CA
Dr. Ornish. Well, thank you, Mr. Chairman. I don't know how
much time you want, but I am available until 10 after 1, just
so you know.
Mr. Chairman, members of the committee, Ms. Clay, thank you
very much for the opportunity to be here today. My name is Dean
Ornish. I am a physician. I am founder, president, and director
of the nonprofit Preventive Medicine Research Institute and a
clinical professor of medicine at the University of California,
San Francisco, School of Medicine, where I am also one of the
founders of the new Osher Center for Integrative Medicine
there.
The theme of all of my work is simple, and that is, if we
don't treat the underlying cause of a problem, any problem--in
this case, heart disease--that more often than not, the same
problem comes back again. We get a new set of problems or side
effects that we hadn't counted, or on a social and health
policy level we are often faced with painful choices.
Whenever I lecture, I often start by showing a cartoon of
doctors mopping up the floor around a sink that is overflowing,
and nobody is turning off the faucet--a little like ignoring
the oil indicator light on the car that Ms. Seymour was talking
about.
During the past 22 years, my colleagues and I have
conducted a series of clinical trials demonstrating for the
first time that the progression of even severe coronary heart
disease often is actually reversible by making comprehensive
changes in diet and lifestyle. These include a low-fat
vegetarian diet, moderate exercise, stopping smoking, a variety
of stress management techniques, including stretching and
breathing and meditation exercises, and a lot of emphasis on
psyho-social and emotional support.
This was a radical idea when I began my first study 22
years ago. It has now become mainstream--the idea that heart
disease is often reversible. It has become generally accepted
by most cardiologists.
In my testimony and in my research I am going to focus on
heart disease, but I think it is also a much bigger issue. It
is an example of how powerful changes in diet and lifestyle can
be. We often think it has to be a new drug or a new laser or a
new surgical technique, or something really high-tech and
expensive to be powerful. We often have a hard time believing
that these simple choices that we make in our lives every day
can make such a powerful difference, but they do.
In the research that my colleagues and I have done, we have
used these very high-tech, state-of-the-art measures to prove
the power of these very ancient and low-tech, and low-cost
interventions.
Within a few weeks after making these changes, the patients
in these studies showed a 91 percent reduction in the frequency
of chest pain. Most of them became essentially pain-free,
including those who had been unable to work or even walk across
the street without getting severe chest pain. Within a month,
we found that those patients not only felt better, but in most
cases they were better in ways we could actually measure. We
found that the blood flow to the heart improved. We found that
the ability of the heart to pump blood was better. After a
year, we found that even severely blocked arteries began to
become measurably less blocked, became improved, in 82 percent
of the patients.
These research findings were published in the most
respected peer review medical journals, including the Journal
of the AMA, the Lancet circulation, the American Journal of
Cardiology, and others.
This research was funded in part by the National Heart,
Lung, and Blood Institute of NIH. Although it is very difficult
to get funding to do this kind of work, and early on, when I
began doing it, it was a bit of a catch-22, because it was
thought impossible to reverse heart disease. So it was hard to
get funding from the government and from the conventional major
foundations. Without the funding, we couldn't show it was
feasible. And since they didn't think it was feasible, they
didn't want to fund it. And then they said, well, where's the
evidence to show that we should fund it? It becomes a self-
fulfilling prophecy.
I might add, by the way, that in order to get the studies
underway, we said, let's just raise the money as we go along
and hope that we can do it. As we began to get more data
showing it was working, initially financed by just individuals
who thought this was an interesting idea, over time we later
got major foundation and much later NIH support.
In our latest report, which was published in the December
16, 1998 issue of the Journal of the AMA, we found that these
patients were able to stay with it for 5 years, not just for 1,
and, on average, they showed even more reversal of heart
disease after 5 years than they did after 1 year.
In contrast, the patients who were in the comparison or
control group, who were making more moderate changes, got worse
after 1 year, and even worse after 5 years. So moderate changes
don't go far enough even to stop heart disease from getting
worse. But the good news is that, if people are willing to make
bigger changes, they can stop and in most cases even reverse
it.
We also found that the incidence of cardiac events, like
heart attacks and strokes and operations, was 2\1/2\ times
lower in the patients who made these lifestyle changes than in
the control group.
There has been strong interest in the general public as
well, as Ms. Seymour has alluded to. A 1-hour documentary of
our work was broadcast on NOVA, the PBS science series, and was
featured in Bill Moyers' series, ``Healing in the Mind.''
I think these research findings have particular
significance for older Americans and the Medicare population.
One of the most meaningful findings was that the older patients
who made lifestyle changes in our research improved as much as
the younger ones. When I began doing this work, I thought that
the younger patients with milder disease would be more likely
to show reversal, but I was wrong. The major determinant of
improvement wasn't how old or how sick they were; it was how
much they changed. In fact, the oldest patient, who is now 83,
showed more reversal than anyone.
This is, I think, a very hopeful message for people in the
Medicare population, because it says, since the risk of bypass
surgery and angioplasty increase with age, that the benefits of
changing lifestyle occur at any age, I think that this has
particular benefit for older Americans and offers many of them
new hope and new choices that they didn't have before.
I think these findings have particular significance also
for women. This is by far the leading cause of death in women,
especially in the Medicare population. They have less access to
conventional treatments like bypass surgery and angioplasty. I
spoke for the Surgeon General's Conference a couple of years
ago on this very issue. When women do get operated on, they
don't do as well as men. They have higher rates of mortality
and morbidity following a bypass or an angioplasty. So that is
the bad news.
But the good news: Women seem to be able to reverse heart
disease easier than men can, whether through diet and lifestyle
or even through lipid-loren drug therapy. If you give a woman
estrogen to lower the risk of heart disease, you raise their
risk of breast cancer. But if you change lifestyle to lower the
risk of heart disease, you lower the risk of breast cancer and
osteoporosis. Here again, when you treat the cause, you don't
have to make these painful choices that often occur when we
literally or figuratively just bypass the problem without also
treating the cause.
The next research question, once we demonstrated that heart
disease was reversible, and that became generally accepted,
was: How practical is this? People said, well, sure, you can
reverse heart disease, but you live in California; they will do
anything there; no one else can do this. So we began training
hospitals around the country.
As you know, there has been bipartisan interest in finding
ways of controlling healthcare costs without compromising the
quality of care. Many people are concerned that the managed
care approach is simply shortening hospital stays and shifting
to outpatient surgery and forcing doctors to see more and more
patients in less and less time, while compromising the quality
of care, because, here again, they are not treating the cause.
It is frustrating for physicians, and it is frustrating for
patients as well.
Beginning 5 years ago, my colleagues and I established the
Multi-Center Lifestyle Demonstration Project, a nonprofit
institute. We wanted to find out: How practical is this? Can we
train other health professionals in other parts of the country
to do this? Can they motivate their patients to the same degree
that we did? Can this be not only a medically effective, but
also a cost-effective alternative to things like bypass surgery
and angioplasty?
In the past, lifestyle changes have been viewed as
prevention, but we are showing they can also be an alternative
treatment. I went to insurance companies and I said, ``Would
you pay for these kinds of interventions?''
They said, ``No, we don't pay for diet and lifestyle.''
``Why not?''
``We don't pay for that because that is prevention. We
don't pay for prevention.''
``What is wrong with prevention?''
``Twenty to thirty percent of people change companies every
year. It may take years to see the benefits. So why should we
spend our money today for some future benefit that may occur
years later, when chances are some other company will get it?''
And I said, ``It is the right thing to do.'' That wasn't
persuasive enough. So I said, ``It is not just prevention. It
can be an alternative treatment. For every patient, every man
or woman, who chooses to change lifestyle rather than, say,
undergoing bypass surgery, you save $50,000 immediately--real
dollars today, not just theoretical dollars years later.''
They replied, ``That sounds great in theory. We don't think
people can do it. So it is too hard to change lifestyles. So if
we pay for your program, most patients who can't follow it, we
will end up paying for their bypasses anyway. Now our costs
have gone up rather than down.''
So the missing links really were the data on adherence.
Then not only the immediate savings, but also the long-term
savings can occur because so many bypasses and angioplasties
clog up after just a few months or a few years; 40 to 50
percent of angioplastied arteries clog up again within just 4
to 6 months.
There is potentially a lot of money to be saved. In 1994,
over $15 billion in the United States was spent just on those
two operations. So that even if only 20 or 30 percent of the
people were willing to make these changes, it is a savings of
billions of dollars per year--real dollars today, because it is
a direct alternative to these treatments.
So we have trained a diverse selection of hospitals--
Alegeon Emmanuel Center in Omaha, and Mercy Medical Center in
Omaha, Beth Israel Medical Center in New York, Mercy Hospital
in Iowa, Broward General Hospital in Ft. Lauderdale--a whole
list of them that are in my written testimony. Also, High Mark,
which is western Pennsylvania Blue Cross/Blue Shield is both
providing the program as well as covering it. Over 40 other
insurance companies are covering this program as a defined
program at the sites that we have trained.
We have been approved by the Technology Assessment
Committees of Blue Cross and of Blue Shield of California
separately two separate times, and found to be reimbursable and
noninvestigational.
What we found, which we published in the American Journal
of Cardiology 3 months ago, was that 77 percent of men and
women who were eligible for bypass surgery were able to avoid
it by changing lifestyle, by going on our program.
Mutual of Omaha, which was the first insurance company to
cover this program, calculated savings almost $30,000 per
patient immediately. These patients reported reductions in
chest pain or angina comparable to what you can get with bypass
surgery or angioplasty, but without the costs and the risks of
going through that.
Now what about Medicare? Over half a million Americans die
annual from coronary heart disease, making it by far the
leading cause of death in both men and women. As I mentioned,
$15.6 billion was spent in 1994, more than for any other
surgical procedure. Not everybody is interested in changing
lifestyle, but a lot of people are, and billions could be saved
if people changed.
But, as you said in your opening remarks, Mr. Chairman, for
many Americans the denial of coverage is the denial of access.
Surgery is covered; angioplasty is covered, but lifestyle
changes are not.
Because of the success of our research and demonstration
projects, we asked HCFA, the Health Care Financing
Administration, to consider providing coverage for this
program, or ones like it, if they had the evidence to prove
that they were. I really believe that this can help provide a
new model for lowering Medicare costs without compromising the
quality of care or access to care. It is a new model that is
more caring and more compassionate and more cost-effective and
competent, because we are treating the cause; we don't have to
have these painful choices.
This approach empowers the individual. It can immediately
and substantially reduce healthcare costs by billions of
dollars, while improving the quality of care, rather than
limiting access to it. It offers the information and tools that
allow individuals to be individually responsible, personally
responsible, for their own healthcare choices and decisions,
and it provides access to quality, compassionate, and
competent, affordable healthcare to those who most need it.
Now, without going into the details--and I am happy to
elaborate in the question-and-answer period--I first began
meeting with officials from HCFA in June 1994, almost 5 years
ago, and I have had many, many meetings and conversations with
them since then. Then, as now, the concern was that, if we
start to pay for anything other than surgical procedures, and
so on, if we start to pay for anything that is, ``alternative''
medicine, then a Pandora's box would be opened. In other words,
anyone who had any kind of alternative medicine program would
say, well, you are covering this program; why don't you cover
ours? Or, even in a more limited way, people who had one for
treating heart disease would say that. I understand this
concern. It is a valid one.
In the first meeting almost 5 years ago with people from
HCFA, I was accompanied by the medical director at that time
with Mutual of Omaha. He said,
We have the same concerns and here is how we dealt with it:
We only pay for programs that have scientific data to support
them, whether they are traditional or nontraditional
approaches. And this right now is the only lifestyle
intervention that has scientific data from randomized control
trials showing that it can reverse heart disease. So we paid
for it. And when other people develop those data or they have
programs that are similar enough, we will pay for those, too.
I appreciate very much the leadership of Honorable Nancy-
Ann Min DeParle and her colleagues, Dr. Jeff Kans, Dr. Bob
Berenson, Dr. John Whyte, and others at HCFA. After going back
and forth with them for years now, during which a variety of
different options have been considered, including a
demonstration project, I am respectfully requesting that HCFA
now make a decision to cover this program for selective
patients.
Another demonstration project would, in effect, duplicate
largely what we have already done and what we have already
published in peer review journals. It would cost millions of
dollars. It would take years before a coverage decision could
be made, and I think the time is right to do it now because
Americans can benefit from this.
Coverage can be limited to those people who are choosing
this program as a direct alternative to a bypass or
angioplasty, because these are the patients for whom the cost
savings are the most dramatic and the most immediate. It, also,
can reduce the likelihood of fraud and abuse because you have
to get a letter from your doctor saying that this person is
sick enough to need a bypass. You have present test data from
angiography and other tests showing that this person really is
qualified to have a bypass or angioplasty. Because the program
is difficult, people who aren't interested in changing
lifestyle to this degree aren't going to do it, and they self-
select, which is good. Because the real question is not, how
many Americans are willing to change; the real question, if I
were at HCFA, would be, how likely is it, if we pay for
someone, that they are likely to succeed? If they self-select
for people who are likely to succeed, that is OK. That is part
of the reason why we found that almost 80 percent of people
were able to avoid these operations.
Then my colleagues and I would be happy to work with an
outside group. I am meeting in 10 days with the heads of the
American College of Cardiology at their annual scientific
meeting in New Orleans to say, you could be a credentialing
group to certify who has the scientific evidence--not just as
anyone who has the evidence to support that their program
works. That can meet HCFA's understandable need for
credentialing of programs, to make the program available to the
people who most need it.
In response to an earlier request from Bruce Vladeck,
Honorable DeParle's predecessor, Dr. Claude Lenfant, the
Director of the Heart, Lung, and Blood Institute at NIH,
evaluated this program, found it to be safe--actually, had to
go through a process saying it was safe for older Americans to
walk and meditate and quit smoking and eat vegetables, but we
have been through that process.
We also have strong bipartisan letters of support from some
of the most conservative Republicans, some of the most liberal
Democrats, and everyone in between. I think this committee is
an example of how this is a basic need that affects all
Americans. This is an area we can all come together, I think at
a time when our country really needs that kind of bipartisan
support.
We have support from some of the country's most eminent
medical authorities: Dr. Alexander Leaf, who was the chief of
medicine at Harvard; Dr. Christine Cassel, who is the immediate
past president of the American Board of Internal Medicine in
the American College of Physicians; Dr. Marion Nestle, the
chairman of nutrition at NYU, and so on.
We also appreciate very much a recent appropriation from
Congress to the Department of Defense to make this program
available at the Walter Reed Army Medical Center. I am very
grateful to Dr. James Simbol, who is the president of the
Uniformed Services University, and Dr. John Mazzuchi, in the
Office of the Secretary of Defense, who are here this morning.
Because if heart disease can be reversed, not only can it
save money in the military, but the implications for prevention
are even greater. As we have talked about, we focused on heart
disease as a model, but I think the same kind of lifestyle
interventions can reduce the likelihood of diabetes,
hypertension, obesity, breast cancer, prostate cancer, and
colon cancer.
I am directing a study now, in collaboration with Dr.
William Fair from Memorial Sloan-Kettering Cancer Center, who
has been the chief of urology there, and Dr. Peter Carroll, the
chairman of urology at UCSF, to see whether the progression of
prostate cancer might be stopped or reversed. It is the first
randomized control trial to look at that. Our preliminary data
are very encouraging, and if it is true for prostate cancer,
chances are it may be true for breast cancer as well.
A recent editorial by the editors of the New England
Journal of Medicine last year said, ``There can't be two kinds
of medicine, conventional and alternative.'' This is very
similar to what was said earlier about the JAMA editorial.
There is only medicine that has been adequately tested and
medicine that has not; medicine that works and medicine that
may or not work. Once a treatment has been tested rigorously,
it no longer matters whether it was considered alternative at
the outset. If it is found to be reasonably safe and effective,
it will be accepted.
Now this program, our lifestyle program, has been tested
rigorously. It has been found to be safe and effective. It
works. So, therefore, I respectfully submit that it should be
covered by Medicare for selective heart patients as an
alternative to a bypass or angioplasty.
Everyone benefits. Patients have access to new choices that
empower the individual. Health professionals have new options
to serve their patients. Medicare does something innovative to
lower healthcare costs without compromising the quality of
care, and Congress can demonstrate bipartisan leadership in an
area that is important to so many Americans.
I appreciate very much the opportunity to be here today. I
would be delighted to answer any questions you may have.
[The prepared statement of Dr. Ornish follows:]
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Mr. Burton. Thank you, Dr. Ornish.
Now HCFA has been unresponsive to your request, is that
correct?
Dr. Ornish. No, sir, I wouldn't put it quite like that. I
think Honorable DeParle has been very responsive, and I have
great admiration and appreciation for what she and her
colleagues are doing.
But I think that to make this a covered benefit will
require congressional statutory authority because it currently
isn't. They don't cover, just like many insurance companies
didn't cover, lifestyle interventions.
Mr. Burton. I wasn't aware of that. So, without
congressional authority, they can't expand the funding for this
kind of a program?
Dr. Ornish. Well, these are things we don't learn much
about in medical school, so I am not sure.
Mr. Burton. I will have to check into that. I will tell my
staff to check into that, but we will try to contact the people
at HCFA and HHS to see if we can have a dialog about that. We
may have some people from those agencies here today; I think we
do back there. I will be happy to talk to them about that as
well.
Dr. Ornish. Thank you.
Mr. Burton. I have a number of my colleagues and friends
who have had bypass surgery and have had angioplasty, and it is
depressing and surprising for me to hear you say that, within 4
to 6 months after angioplasty, the arteries can once again
close up.
Dr. Ornish. Yes, in 30 to 50 percent of the cases.
Mr. Burton. In 30 to 50 percent of the cases?
Dr. Ornish. Yes, sir.
Mr. Burton. Is that widely known? I was not aware of that.
Dr. Ornish. Well, there is a lot that isn't widely known.
This is widely known within the medical profession. But, you
know, it goes even further than that, sir.
Mr. Burton. If it is fairly wide known in the medical
profession, why is that not communicated to patients and the
public, because I don't think it has been? Angioplasty, at
least the people that I have talked to that have had it, is
seen as a panacea. Obviously, they ask them to have dietary
changes, and so forth, to try to keep it from coming back, and
they take an aspirin and all that sort of thing.
But the fact is, I don't think anybody I have ever talked
to that has had angioplasty knows that there is a good chance
it will reoccur within a short period of time.
Dr. Ornish. Well, that is the problem, getting the
information out, and that is part of why I write books and give
lectures and things, and why I appreciate the chance to be here
today.
But if you actually look at all the scientific data, if we
talk about we want evidence-based, randomized, double-blind--or
not double-blind, but placebo-controlled studies. There have
been three major randomized trials of bypass surgery, and in
every one of them they found that bypass surgery prolongs life
or prevents heart attacks in only about 2 percent of people.
Those are the most severe diseases.
Mr. Burton. Only in 2 percent of the people.
Dr. Ornish. Two point one percent, to be exact. These are
people with left main coronary artery disease and poor left
articular function.
No study has ever even been conducted that compares
angioplasty with just drug therapy to see whether it prolongs
life or prevents heart attacks. So for the vast majority of
Americans who get operated on for these two operations, for
which billions of dollars are spent every year, there is no
evidence that it prolongs their life or prevents heart attacks.
What it does do is relieve their chest pain or their angina. So
it has value. But we found in all of our studies a greater than
90 percent reduction in angina or chest pain within weeks when
people make bigger changes in diet and lifestyle than most
doctors recommend.
Mr. Burton. Within weeks, you say?
Dr. Ornish. Within weeks.
Mr. Burton. Usually, when people go in and they are
diagnosed with arteries that are closed or almost completely
closed, the doctors prescribe surgery or angioplasty within a
very, very short period of time.
Dr. Ornish. Yes, sir.
Mr. Burton. The danger is, somebody says, I have been
diagnosed with 90 percent closure in one artery and 100 percent
in another, and the doctor says, if we don't act pretty
quickly, you are going to have a heart attack. The fear factor
is very great.
Dr. Ornish. That is correct.
Mr. Burton. For them to talk to somebody like you, who
says, if you change your diet and change your lifestyle, in 4
to 6 weeks things will get better--they worry about being
around in 4 to 6 weeks.
Dr. Ornish. That is right.
Mr. Burton. So how does a person who goes in, they say you
have got closed arteries; you run the risk of a heart attack--
how does he get that information, when his doctor says you have
to have surgery; you have to have angioplasty?
Dr. Ornish. Well, it is a very important question. Let me
respond on two levels. The first is, how do you get the
information out? And the other is, what does the medical
science show us? In terms of how to get the information out, I
think you change reimbursement, you change medical practice,
and you change medical education. I used to think that good
science was sufficient, and I was naive. I think good science
is important, but generally sufficient to motivate lasting
changes in physician behavior. I think we have to change
reimbursement. And I want to make it clear, most doctors are
motivated by service, but if you are trained to do these things
and you get reimbursed to do these things, then that is what
people do.
So if Medicare were to cover this, it would have
implications that go far beyond this. It would change medical
education as well as medical practice.
Now it turns out that the 90 percent lesions are not as
dangerous as the 30 percent ones. That is the conventional
thinking now among some of the leaders in the field, like Dr.
Valentine Fuster at Harvard, and so on. It seems a little
counterintuitive because you think that, the more blocked it
is, the greater the danger. The more blocked it is, the more
likely it is to cause chest pain. But it is actually the more
mild lesions, the 30 to 40 percent, that are more likely to
cause heart attacks because they are more unstable.
Now no one is going to bypass the 30 percent blockage, and
yet, those are the ones that may be the most dangerous. But
when a person changes diet and lifestyle to the degree that we
do, or even when they go on cholesterol-lowering drug therapy,
the endothelium, the lining of the artery, stabilizes, and the
risk of a heart attack goes down dramatically.
Most patients don't know that the surgery is unlikely to
prolong their life, unless they are unstable, which is a
separate category, which most patients are not, or they are the
2.1 percent of patients. For most patients, the surgery is not
going to prolong their life or prevent a heart attack. They
don't know that, if they were willing to change their
lifestyle, they could accomplish the same reduction in angina.
Mr. Burton. Let me ask you two quick questions.
Dr. Ornish. Yes, sir.
Mr. Burton. If a person who normally would have a very
small chance of survival, like you said, it is not going to
change their life-and-death situation if they have the heart
surgery or the angioplasty. If they have the heart surgery or
if they took the alternative therapy, do you have any studies
or any figures that show how long their lives would be
extended, or do you have any kind of an average?
Dr. Ornish. Yes, sir. We found, in the study that came out
in the Journal of the American Medical Association 2 months ago
in December 1998, there were 2\1/2\ times fewer cardiac events
in people who changed their lifestyle compared to the control
group that made more moderate changes. So people not only feel
better, but in most cases they are better.
We used quantitative arteriography to measure the
blockages. We used cardiac PET scans, positron emission
tomography, to measure blood flow to the heart. The state-of-
the-art showed these patients got better and better over time.
Now not everybody wants to change lifestyle. I don't even
tell my own patients to change. But I do believe in freedom of
choice. I think it is a very American idea. For those people
who don't want to change, I find a good surgeon or a good
interventional cardiologist or I put them on drugs. But for
that subset of patients who are willing and who are motivated
to change--and that subset is a lot bigger when people really
know what the facts are--I think it would be nice to give them
the freedom of choice, too, by covering programs like this.
Mr. Burton. Thank you.
Ms. Norton, do you have any questions?
Ms. Norton. Yes, Mr. Chairman. This hearing is very well-
structured, Mr. Chairman, I think, because we are going to get
to questions of representatives of the Federal Government to
establish responsibility here. I am glad we heard of your own
testimony beforehand, Dr. Ornish. I think it is very valuable
testimony, precisely because you are a credentialed and
experienced physician.
Dr. Ornish. Thank you.
Ms. Norton. The balance that you bring to the table is very
important, particularly as we try to play catch-up, it seems to
me, on making available these approaches. What you have spoken
about is hard to call an alternative approach because it is
also a preventive approach.
Dr. Ornish. Yes.
Ms. Norton. It is what most fascinates me about homeopathic
medicine. I appreciate the full information you have given us.
For example, the chairman asked an important question: Well,
how in the world, if 30 to 50 percent close back up again, as
it were, but you indicate that they do bring some relief.
Obviously, a physician wants to bring some relief to the chest
pains. So he wants to do whatever he can; he wants to do it
quickly. So he has something that works and he hopes that the
next thing will work. I want to ask a question about that.
I do believe what you say about, well, let those who will;
most people won't. Well, let's do it for those who will. I do
think there is a very strong case to be made, since I do
believe--and here you are talking about what we do have
evidence about--that these changes, if you are willing to make
them--can both prevent heart disease and help retard it once
you have had a heart attack.
This morning there was a report--I heard it on the National
Public Radio; it was a very informative report--about autopsies
that were done on young men. I think it was young men from the
Korean War. Now they have done all of the studies.
Dr. Ornish. Yes, ma'am.
Ms. Norton. It was quite amazing. Essentially, it is not
about old fogies like me. It is about how young people like my
legislative assistants are getting their arteries all clogged
up, as I speak----
Dr. Ornish. Yes.
Ms. Norton [continuing]. And won't pay any attention to it
until they get to be middle age, and then they have found that
these people in their twenties are showing signs, significant
signs, of heart disease. By the time they got as old as 35,
they just had it. Nobody even thinks about heart disease at
those ages.
Two questions: One is, if this information is available, so
that physicians, who also don't concentrate on young people, in
part, because they don't go to the doctor, if physicians look
to young people as a way of dealing with heart disease, a
runaway problem in this society, won't this, in turn, get us to
the point that you want to get, which is the change in the
lifestyle will become more automatic?
I ask this question because young people became
environmentalists when it took old people, who had been so used
to being wasteful, to understand it. So they became teachers,
as it were, for older people.
Is there a way, now that we know that heart disease it not
simply a disease of middle and old age, to get to where you
want to get simply by changing our focus from the pool that has
been the target to a younger pool, in which case some of the
problems get prevented and the others, it seems to me, we are
able to deal with in a lifestyle you indicate. I would like to
hear you discuss how this might be done, if it could be done,
if it would be effective. Second, how it might be done, given
the fact that young people not only believe they are immortal,
but have no reason to seek the help of physicians, for the most
part?
Dr. Ornish. Well, Ms. Norton, I appreciate so much the
question. You are absolutely right; studies have shown that
American soldiers killed in Korea, Vietnam, the Persian Gulf,
even at the age of 19, had significant plague in their coronary
arteries. A study done by Dr. Gerald Berenson in Louisiana
found that children who died in accidents, that half of them
had severe plaque, and all of them had blockages in their
aortas. So this is a problem that begins in childhood and
progresses over a period of decades. So you are quite right;
that is where we have to begin.
Now the old joke is, if I change my lifestyle, if I eat
this way, am I going to live longer or is it just going to seem
longer? You know, that is what a lot of young people think,
that lifestyle changes----
Ms. Norton. Either will do.
Dr. Ornish. Pardon me?
Ms. Norton. Either will do at this point. [Laughter.]
Dr. Ornish. Well, there is this myth that the good life is
eating a high-fat diet and getting drunk and using cocaine and
smoking and getting under a lot of stress, and that it is
boring to have a healthy lifestyle. Part of what I have learned
is that telling a young person they are going to live to be 86
instead of 85 does not motivate them. In fact, it hardly
motivates people who are 85--[laughter]--because people want to
feel better.
The paradox I have found is that it is actually easier to
make big changes than to make small ones. That is why I began
changing when I was 19, growing up in Texas, eating meat a lot,
because I found I felt better. I had more energy. I could think
more clearly.
Now you know Viagra came out last year at the same time the
Nobel Prize was awarded to the doctors who discovered a
compound called nitric oxide, which dilates blood vessels. One
of the things that happens when people change their diet is
that their sexual function often improves, particularly in
older men, because it is not just your heart that gets more
blood flow. People find that they think more clearly. They have
more energy. Now, as a scientist, those are harder things to
measure than arteries in coronary blood vessels getting better,
but from the motivational standpoint, one of the most effective
anti-smoking ads was not ``smoking causes cancer,'' but ``do
you want to taste like you have been licking an ashtray when
someone kisses you?'' It puts it into the here and now.
That is what younger people really respond to, changes that
affect their quality of life in the short run. We doctors like
to talk about risk factor reduction and prevention, but most
young people find that boring. I have found that we need to
talk about changes in lifestyle that improve the quality of
your life very quickly. That is what happens when you make
changes. I think it is never too early to begin making these
changes, and it is never too late to begin making them.
Ms. Norton. Thank you. Thank you, Mr. Chairman.
Mr. Burton. Thank you. Thank you, Doctor.
Mrs. Chenoweth.
Mrs. Chenoweth. Thank you, Mr. Chairman.
Dr. Ornish, I was fascinated as you gave your testimony
because you almost gave it word for word with rarely looking at
your notes. [Laughter.]
Interesting observation.
I wanted to ask you, it seems that the dog in the manger
seems to be the insurance companies. You said it better than I
did. You were more politically correct. You said, once
reimbursements get in line, then the rest of the policy will
follow. I couldn't agree with you more.
On page 4 of your testimony, you mention that 77 percent of
the patients who were candidates for bypass surgery or
angioplasty responded very positively to your recommendations
or those types of recommendations, and that Mutual of Omaha
said that it saved $30,000 per patient.
Dr. Ornish. Immediately.
Mrs. Chenoweth. Immediately. These guys look at the bottom
line--why aren't they responding to this? What is wrong? That
startled me.
Dr. Ornish. Well, they are responding. That is why 40
insurance companies are now covering this program in the
hospitals that we have trained. But if HCFA, if Medicare were
to cover this, then most of the other insurance companies would
follow suit. That is really the Rosetta Stone. That is where
the leverage point is. That is where the opportunity for change
is the greatest.
If we can focus on the area where the cost savings were the
most immediate and the most dramatic, then I am hoping it will
be a much smaller step for them to see that there is value in
paying for preventive services as well. But let's start in an
area that I think is where the cost savings can really be shown
the most quickly and the most dramatically. That is why we
focused on that area, but it is by no means limited to that in
terms of the benefits.
Mrs. Chenoweth. I have been frustrated because other
alternative forms of medicine, such as the practice of
chiropracty and naturopathy, and so forth, there seems to be so
much manipulation in terms of what will be paid for and what
won't be paid for, and what takes certain approvals, and so
forth. So I hoping that shortly we will see people working
together--MD's working in consultation with other people who
have an expertise in an area that they could offer great
advice. That is my hope.
In following up with the chairman's comments, this 77
percent figure fascinated me. Doctor, does that mean that 23
percent of the people would be eligible and would need bypass
or angioplastic surgery because they were the unstable
candidate, those that may not live for the next week or so?
Dr. Ornish. The patients, for whatever reason, 23 percent
ended up getting operated on during that 3-year period. It was
a 1-year program. We followed them for 3 years.
Now an interesting fact is that, because the cost
differential between a bypass and paying for lifestyle
intervention is so great--it is, say, maybe $50,000 for a
bypass and, say, $7,000 for a year of lifestyle training--if we
just delayed surgery for a year and a half, and then 100
percent of people failed, the interest saved on that $50,000
would more than cover the cost of a lifestyle program. We have
certainly done a lot better than that.
So from an economic, hard-dollars standpoint, this makes
sense. I would love to see coming out of these hearings two
things. One has already been discussed, which is increased
funding for research. I am a scientist. That is what I do. I
have great appreciation for the value of science to help sort
out what works and what doesn't work, and for whom and under
what circumstances, so we can cut through a lot of the hype and
say, what really is the science here?
The other thing that I would like to come out of this is
that there are a few so-called alternative approaches, like
what we have done, that have been proven to work, that are both
medically effective and cost-effective. Let's now take them to
the level of reimbursement, which is where change really can
happen. Then I think you will find it will affect medical
education, as well as medical practice, as well as medical
research.
Mrs. Chenoweth. Thank you, Doctor.
Mr. Burton. We are going to break for lunch for about 20-25
minutes because I can hear people's stomachs growling, and we
have some food for the panelists along with some refreshments.
But I would like to end up by asking you just one really
hard question.
Dr. Ornish. Yes, sir.
Mr. Burton. Do you believe, as a scientist and a doctor,
that there is resistance from some areas of government and
medicine because of the profit that is to be made by
pharmaceutical companies and the medical profession in
performing these types of operations and prescribing these
types of medicines?
Dr. Ornish. Well, time for lunch. [Laughter.]
Mr. Burton. I don't want to take too much time, but this is
very serious, because there has been some suspicion among some
of us in Congress that people who work at the Food and Drug
Administration and at Health and Human Services have been
influenced unduly by pharmaceutical companies, for instance.
Many of them have been paid fees for some forms of research.
They have put on boards by some of the pharmaceutical
companies, and that tie kind of concerns us, because what we
want, as Members of the Congress, is the best quality of
healthcare, whatever it is, for the American people. That
emanates, in part, from the pharmaceutical companies and the
research they do, but it also emanates from holistic
approaches. So I am concerned that maybe our health agencies in
the Federal Government might be unduly influenced, and that is
why I would like to have your opinion about that.
Dr. Ornish. Well, let me put it in a slightly different
context. I think most doctors are genuinely interested in doing
what is best for their patients. I believe the vast majority of
doctors are generally interested in service. But, at the same
time, having been trained very conventional--you know, I went
to medical school at Baylor and did my course surgery medical
surgical rotation with Michael DeBakey, the eminent heart
surgeon. I did my post-graduate training at Harvard and Mass.
General, and I am at UCSF now.
I understand that training process, and I also understand
how hard it is to be a doctor these days, when you are getting
squeezed from all sides. If managed care says you have to see a
new patient every 7 minutes, even if you are interested in
nutrition or dealing with the psychosocial and the emotional
and spiritual dimensions of health and well-being, you don't
have time to do it. In 7 minutes, you don't have time to talk
to about the problems with the marriage or the problems at work
or the problems with the kids on drugs, whatever it happens to
be. You, basically, have time to listen to the heart and lungs.
You write a prescription for a cholesterol-lowering drug. You
are on to the next patient.
It is profoundly unsatisfying for most physicians and for
most patients. Most physicians, according to the latest
surveys, which I am sure you have seen, wouldn't recommend
medicine as a career for their sons or daughters because it is
not fun.
Now we are trying to say, look, if you treat the cause of
the problem, if we change reimbursement, we offer different
approaches. Of course, there is an economic incentive the way
things are set up now, but why can't there be an economic
incentive to do things differently. We always have the money to
pay the $50,000 for a bypass. Why not the $7,000 for a year of
lifestyle training, which is a whole team of people, not just a
physician, but a dietician, an exercise physiologist, a stress
management instructor, a psychologist, and so on, to deal with
the cause of the problem?
If we can make it economically reimbursable, then we change
those other incentives. Some patients do need surgery. Some
patients do benefit from drugs. But I think we also need to
include these other approaches which are of permanent benefit,
which can really empower the individual and make such a huge
difference in both their quality of lives and in their
survival.
Mr. Burton. Thank you, Dr. Ornish. That was a great
statement, and it had some real political overtones. Have you
thought about entering politics? [Laughter.]
Dr. Ornish. Well, I am trying to build bridges here.
Mr. Burton. Yes, I know you are, and I appreciate that.
We have some people from HCFA here, don't we? Do we not?
Don't we have somebody from the Department here? Can you come
back and have lunch with us? I would like for Dr. Ornish and
you and I to talk a little bit.
OK, I think we will break now for about a half an hour and
have a little bite to eat. You have to leave at 10 after 1?
Dr. Ornish. Yes, sir, but I just want to say, in closing,
how grateful I am to you for organizing these hearings and for
the opportunity to be here today.
Mr. Burton. Thank you, Doctor.
We will reconvene in about 30 minutes.
[Recess.]
Mr. Burton. We will reconvene.
We will have other Members, I believe, coming back here
shortly. They are running all over the place because there's a
number of hearings going on today. So I apologize for the
people coming in and out.
But I would like to have Dr. Brian Berman of the University
of Maryland and Mr. Ollie Johnson and his lovely wife, Barbara,
come forward. We will have your testimony now.
I appreciate very much your patience and hope you did get
something to eat. We normally don't provide that service, but
today we did.
Why don't we start with Dr. Berman? Dr. Berman, do you want
to start and give us an opening statement? If you want to, you
can submit your statement for the record, and then summarize.
STATEMENTS OF BRIAN BERMAN, M.D., ASSOCIATE PROFESSOR AND
DIRECTOR, PROGRAM FOR COMPLEMENTARY MEDICINE, UNIVERSITY OF
MARYLAND SCHOOL OF MEDICINE, BALTIMORE, MD; AND OLLIE AND
BARBARA JOHNSON, DEAN ORNISH LIFESTYLE PATIENT AND SPOUSE,
COLUMBIA, SC
Dr. Berman. Thank you very much. Mr. Chairman, members of
the committee, I am extremely honored to be here today and
given the opportunity to provide testimony to the Committee on
Government Reform.
I am a board-certified family physician and pain management
specialist, and I am also trained in acupuncture and homeopathy
at the Royal London Homeopathic Hospital. I went on to look at
some of these therapies and incorporate those into my practice
because I was frustrated that I didn't have all the answers for
my patients--excellent training for acute care, trauma, but not
for a lot of the chronic diseases that we see every day.
I have been practicing integrated medicine for the past 17
years. I am also associate professor at the University of
Maryland School of Medicine and director of the complementary
medicine program there, and principal investigator on the
National Institute of Health-funded Center for Alternative
Medicine Pain Research and Evaluation, as well as CAM research
grants from the NIH and the Department of Defense. So I have
been asked to present today from the three perspectives as a
clinician, as a researcher, and as an advisor to the government
for the past 6 or so years.
Our center was started in 1991, and we really started it
because of some of the remarks that were made today. Back then,
I really felt that these types of therapies weren't going to be
brought into the mainstream of medicine unless there was a
proven scientific base to these therapies. So we started back
then, in a time when there was a great deal of public interest,
but the medical community's interest was low, if not hostile.
As we all know, and it has been said today by you, there has
been a great sea of change over the past 7 or 8 years. It has
gone from 3 in 10 to 4 in 10 Americans using these therapies,
and worldwide 75 percent of the world uses these forms of
therapy as their primary form of healthcare. In this country,
we see that there has been an increase in expenditures to $21
billion just for the providers' side, and another $13 billion
for the other out-of-pocket expenses of herbs, vitamins, books,
and so forth.
What has also changed over this period of time has been the
government's support, and that started really with the opening
of the Office of Alternative Medicine at the NIH in 1992,
through the support of Senator Harkins and others. Thanks to
the efforts of this Congress, now it has become a center with
increased autonomy, increased budget, which has brought the
much-needed funding or the start of the much-needed funding to
an area that does not have access to the deep pockets of an
industry, the sort of research and development industry, of a
pharmaceutical industry that we have with modern medicine.
So I became involved with the Office of Alternative
Medicine at its start through chairing the Ad Hoc Advisory
Committee, the consensus meetings in Chantilly and then the
report for the NIH ``Alternative Medicine: Expanding Medical
Horizons Report,'' and as an advisory council member. Over
these years, I have seen tremendous progress in the field. One
has been the Office of Alternative Medicine's funding 11
centers of research, and that has started the infrastructure.
Over the past 2 days, I was at meetings of the principal
investigators, and the excitement to see people representing
the field of cancer, heart disease, pediatrics, pain, many
areas, women's health, and having from 7 to 10 projects, really
getting out information that the Congress and the public really
wanted to see.
Pilot projects have been funded, and now definitive studies
in several promising areas are underway, such as osteoarthritis
or acupuncture in the use of osteoarthritis in the elderly, St.
John's Wort clinical trial, and some of these definitive
studies that we have all been wanting to see happen.
At the University of Maryland we focus on the area of pain,
and particularly the modalities of acupuncture and mind/body
therapies. I would like to use these right now as an example of
the progress that has been made in some areas of complementary
medicine, and then give a picture of where they stand as
regards the government policy.
We at our place are building a mosaic of information, of
evidence, basic science information, looking at how does
acupuncture actually work, studies ongoing there; randomized
controlled trials. Is acupuncture and mind/body therapy safe,
effective for acute pain conditions such as post-operative
dental pain, as well as chronic pain problems like
osteoarthritis in the elderly, lower back pain, fibromyalgia?
Also, what is going on in the actual clinical setting, tracking
the outcomes and the real-life experience of patients?
We are also collecting and evaluating the existing
literature. One of the criticisms of complementary medicine, as
we heard alluded to today, is the general lack of scientific
evidence. We have found and collected over 11,000 citations in
complementary medicine and pain alone. The difficulty, in part,
has been finding this literature, that it is in either foreign
journals or nonmainstream journals.
So our investigations to date, they paint the picture that
acupuncture and mind/body therapies, part of which we heard
earlier by Dean Ornish, mind/body therapies and acupuncture
have great potential, whether alone or as adjunct to therapies,
for many of the pain problems. More research is needed to
complete this picture and fill in the gaps.
While this research is important and the building block for
practicing evidence-based healthcare, how is it being brought
into the public arena, where it can be useful in setting
clinical guidelines and affecting healthcare policy? Some of
the things that have occurred--back in 1994, the NIH and the
FDA held a joint conference looking at acupuncture. The outcome
of that meeting was that they determined there was enough
evidence to say that acupuncture was no longer going to be
listed as an experimental device.
The NIH Acupuncture Consensus Conference was held in 1997.
The outcome there was they found there was sufficient evidence
to expand its use into conventional medicine and to conduct
future studies. They listed a whole range of conditions, from
addiction, to asthma, to pain conditions, where there was
fairly good evidence.
There was also a Technology Assessment Conference in Mind/
Body Therapies for Pain and Insomnia, held through the National
Institutes of Health, for which I was a panel member. There the
findings were that there was strong evidence for treating a
wide range of chronic pain conditions.
Both conferences recommended these therapies be covered by
healthcare payers. This is far from the reality today. So the
recurring theme of coverage comes up. Insurers and healthcare
companies, they put them on today sometimes as additional
riders or reduced rates. Over the 7-year increase in patients
usage that we saw from those surveys, there wasn't any change
in the coverage.
What about the government-funded healthcare programs? I
would like to just give you a quick story about one of my
patients. Before I came here, last week when I was preparing
for this testimony, one of my patients, an elderly gentleman
with chronic back pain, whose insurance is Medicare, called me,
and he said, ``I won't be able to come for treatment any
longer.'' Now he had tried all the conventional treatments for
his chronic back pain without success. He came to me. We
treated him with acupuncture. Maryland has acupuncture
licensing laws. I am licensed in the State of Maryland to
practice acupuncture. He benefited greatly over the course of
about 4 months' time. Now he has to come back and say, it is
not going to be covered, so he has to go back to the treatment
which he had before, physical therapy, which really didn't
benefit him. And as a side, there isn't much in the way of
strong evidence to show the efficacy of physical therapy for
chronic back pain.
At the end of the day, who is being served by this?
Certainly, not the patient, who now has to give up an effective
treatment for him, and certainly not Medicare. I think it is
time to start considering complementary and alternative
medicine as viable healthcare options in our healthcare system.
So how do we do this? With over 200 modalities under this
broad umbrella ``complementary medicine,'' it could seem an
overwhelming task to know what information there is, which
treatments merit consideration based on solid evidence. At our
university, part of our program, one of our main efforts has
been in gathering the best information and trying to
disseminate that.
Part of that effort is through the Cochrane Collaboration,
which is an international organization dedicated to evaluating
all medical therapies. So we are coordinating this
international field for complementary medicine as part of the
Cochrane Collaboration, and through these efforts, there now
exists a specialized registry of randomized controlled trials
that is available worldwide of about 4,000 clinical studies and
another 4,000 we are considering.
We and others worldwide are involved with reviewing this
evidence with a systemic review and then drawing conclusions
that can help guide clinical decisions and future research.
There have been 164 of these reviews completed, and it is this
type of information that can help guide the integration of
complementary medicine into the mainstream.
So, in conclusion Mr. Chairman, I offer the following: We
need continued proactive funding by the government. Most
complementary alternative medicine therapies are not
patentable, and therefore, of little interest to industry. We
need to continue to investigate the safety, efficacy, cost-
effectiveness, and use the full range of methodologies from
randomized controlled trials to basic sciences to health
services research.
No. 2, we need quality information that is succinct and
evidence-based made available to the public, to researchers,
payers, and policymakers.
No. 3, based on this research and quality information, we
need to make complementary therapy more accessible, especially
to those with little disposable income. I think this can be
accomplished, one, through coverage, through Medicaid/Medicare,
and, two, through setting up demonstration programs at places
like the VA system, military medicine, the Bureau of Primary
Health Care.
Then, last is setting up the President's commission. There
was language to set up the President's commission. I think we
should go forward with that. I think that will help us
facilitate other government agencies become involved in this
field.
I think the continued interest and support of your
committee and other government programs will help ensure that
ours and future generations benefit from the availability of
effective healthcare approaches, regardless of whether they are
labeled alternative, complementary, or conventional.
Thank you very much.
[The prepared statement of Dr. Berman follows:]
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Mr. Burton. I have some questions, but we will go ahead and
hear the other panelists, and I will ask you about those in
just a moment.
Mrs. Johnson, ladies before gentlemen.
Ms. Barbara Johnson. Thank you.
Mr. Burton. Would you pull the microphone pretty close?
Thank you very much.
Ms. Barbara Johnson. Mr. Chairman, members of the
committee, thank you for the kind invitation to allow me to
testify at this hearing today. My name is Barbara Johnson, and
I have been my family's caregiver for 42 years. I appreciate
the opportunity to share with you mine and Ollie's journey to
the Dr. Dean Ornish's Program for Heart Disease Reversal.
In 1987, my husband, Ollie Johnson, was diagnosed with
heart disease. He had a heart catheterization at Richland
Memorial Hospital in Columbia, SC, which showed that he had a
70 percent blockage in one artery and a 90 percent blockage in
another. His doctor did not think that he was a candidate for
any kind of surgery, so he prescribed medication for him. All
of the medication was provided by the pharmacy at Moncrief Army
Hospital at Ft. Jackson, SC, since Ollie is retired from the
Air Force.
At my insistence, the doctor also provided a way for Ollie
to go to the cardiac rehab program at the University of South
Carolina. On my own, I bought cookbooks which were recommended
by the American Heart Association, because we didn't really get
any nutritional information from the doctor, and started
cooking, ``heart healthy.'' We stopped eating beef and ate
chicken, pork, and fish. We stuck to this regimen for several
years. He exercised periodically by walking 3 to 5 miles a
week.
In 1991, I began to see Dr. Dean Ornish on various talk
shows and became intrigued with his program. I bought his book,
``Dr. Dean Ornish's Program for Reversing Heart Disease,'' and
knew that the program would work for us.
When Ollie had his next regularly scheduled appointment
with his cardiologist, we mentioned the book and program to
him, and expressed a keen interest in trying it. The doctor
quickly dismissed us and said, ``You can't do that program.
It's too harsh.'' I did not believe this, but was powerless
against his suggestion. So for the next 4 years, we followed
the American Heart Association diet with a 30 percent fat
intake.
By June 1995, when Ollie had his yearly checkup, it was
discovered that his heart disease had gotten worse, and now a
third artery had significant blockage. Knowing that the Dean
Ornish program would stop the progression of the disease, I
asked the doctor what did we need to do to stop the disease
from getting any worse. By this time, the Richland Memorial
Hospital offered the program. The doctor said that the only way
that he knew of to get the disease to stop was to enroll in the
Ornish program. So I asked him to please get us in the next
class, and he did.
We started the program in July 1995. For the first 3
months, we were required to go to the hospital 3 nights a week
for lectures, exercise, stress management, and supper. This is
how we learned to live the program.
At one point, our family members were invited to the
hospital and they were given information on the program. Their
questions were answered, and we all had a meal together. This
event was invaluable to us because it emphasized the value of
staying with the program and how family support was so
important.
I do not have heart disease, but I entered the program to
support my husband and to ensure his success. In our home we
eat and live the Ornish lifestyle. When we started the program
in July, we were told that Ollie's insurance, Blue Cross/Blue
Shield, would not pay for our participation. We had to pay
$5,000 for Ollie and $1,000 for me. We paid $3,000 down and
were given 2 years to pay off the remaining $3,000. We paid a
monthly payment to the hospital.
During the first year in the program, we faithfully stayed
in compliance with all of the dietary, exercise, and stress
management requirements. We filled out program compliance
sheets daily and mailed them to the hospital monthly. We
actually filled out these forms for 3 years. The first year was
a year of learning--learning how to cook so that meals were
tasty and satisfying.
We also had to give ourselves time to adjust to the new
lifestyle. Travel and eating out were challenges that we were
up to and slowly but surely mastered. During the first 2\1/2\
years, whenever we traveled, we took an electric cooler and a
two-burner stove and all of our food with us. If we couldn't
find a restaurant to serve us, we would cook in our hotel room.
We made this fun and never saw it as a hardship.
After 3 years, I am very good at preparing our meals and we
are both energetic and healthy. Ollie walks 15 to 20 miles a
week and lifts weights three times a week. I walk 30 to 35
miles a week, work out at the gym on weight machines three
times a week, and take an aerobics class twice a week. And by
the way, I am in training for the Cooper River Bridge Race.
Another plus of this program is that our food bill has gone
down dramatically. When you do not have to buy meat, you
realize a substantial savings at the grocery store.
When Ollie had the thallium stress test and blood work
after 1 year, his test results were so favorable that his
doctor took him off the Procardia and reduced the Tenormin from
50 milligrams to 25 milligrams daily, and the doctor tells us
on the side that he doesn't really think Ollie needs the
Tenormin, but he is scared to take him off of it.
Eliminating the Procardia amounted to a savings of $40 a
month to the U.S. Army. The current cost of Tenormin is less
than 1 cent per day. Every thallium stress test that he has had
since then has been more favorable each year.
The hospital had been sending Ollie's medical test results
and our compliance sheets to the insurance provider. After we
had paid on the remaining $3,000 for 13 months, the insurance
company paid off the balance. The insurance provider currently
pays for some patients to participate in the program. However,
when we entered the program, the insurance provider would only
pay if the participant had previously had a heart attack,
bypass surgery, angioplasty, or stints.
We are fortunate and grateful that the Dr. Dean Ornish
program is available in Columbia. In July 1995, Columbia was
one of only seven locations in the United States. However,
there is a need for this program to be available throughout the
United States. I believe that participation in this program has
eliminated the potential of my husband having a heart attack or
bypass or some other kind of invasive measure. I wholeheartedly
recommend that this, the Dean Ornish program, be authorized
under Medicare.
I thank you for your attention, and I will be glad to
answer any questions.
[The prepared statement of Mrs. Johnson follows:]
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Mr. Burton. Mr. Johnson, would you care to comment?
Mr. Ollie Johnson. Thank you, Mr. Chairman. I'm Ollie
Johnson, and I am the patient here. I appreciate the
opportunity to share with you my experiences overcoming my
heart disease and also my thoughts as a taxpayer.
It is very sobering when one is told, ``You are going to
have a heart attack.'' I was told that by my cardiologist, and
later by a nurse while I was in the cardiac rehab. unit at the
University of South Carolina. Fortunately, at this time in my
life I feel very certain that it is not going to happen.
My initial attempt to seek treatment in 1987 was at the
Moncrief Army Hospital at Ft. Jackson. I was seen by a clinical
nurse who administered an at-rest EKG. There were no visible
symptoms since I was not put under stress. Consequently, I was
told that I had no problem.
We were not satisfied with this diagnosis, and
subsequently, saw my current cardiologist, who at that time
diagnosed blockage after a more thorough examination and
verification by cardiac catheterization. After completing the
cardiac rehabilitation in 1987 and changing my lifestyle, the
possibility of a heart episode still remained. When I started
the Dean Ornish program to reverse heart disease in 1995,
initial tests showed that my heart disease had progressed, but
simply at a slower pace.
After the first 6 months in the Ornish program, tests
showed a significant lowering of my cholesterol levels,
favorable levels of my HDL, LDL, and triglycerides. This was
viewed by the Heart Center staff as the environment in which
reversal takes place.
After 1 year, the progression of my disease completely
stopped. After the second year, there was evidence that the
area served by the blockage was getting more blood. After the
third year, even more blood flow was noted. In addition, my
ischemia had disappeared.
My cardiologist commented that, if you didn't know that I
had heart disease, he could not tell from my electrocardiogram
stress test. I feel confident that my disease is being cured,
and that I will not require a catastrophic heart procedure. I
am healthy and energetic. I walk 15 to 20 miles a week. I
meditate for 1 hour 4 to 6 days each week, and I adhere to the
Ornish diet.
My wife and I are involved in our community. I do part-time
consulting work. We travel, occasionally visit and enjoy our
grandchildren, and enjoy our lifestyles.
I would be remiss if I did not thank the many people who
have helped save my life. Dr. Dean Ornish, who invented and
developed this program, and weathered the rocky road to get
this program widely accepted; the Heart Center at Palmetto
Richland Memorial Hospital for making this program available in
South Carolina; the medical directors, Drs. Don Sanders and Joe
Collins; my cardiologist, Dr. Stephen Humphrey; the wonderful
staff at the Heart Center: Susan Bevron, who coordinated the
Ornish program when we entered it; Colleen Wracker, a nutrition
specialist who patiently taught us how to eat Ornish and
answered all of our many questions; Brent Schell, our stress
management specialist, and Jean Humphrey, our group support
volunteer--and last, but by no means least, my wife, Barbara
Johnson, who determined long before I knew that this was the
program that would save my life. She is my advocate, my cook,
my motivator, my caregiver, and she is the mother of my
children. I am truly blessed, and I am grateful for this
program.
I just want to share with you as a taxpayer that I feel
very strongly that when the government invests in the health
and well-being of its citizens, there should be specific
outcomes. The program should have a favorable impact on the
society that it serves. It should be cost-effective, and it
should be measurable.
I believe that the Dr. Dean Ornish Lifestyle Program meets
these outcomes. I am healthier. There is evidence that my
blockage is regressing, and I am avoiding a catastrophic bypass
procedure cost of about $45,000 to me and my insurance carrier.
I have some data from the South Carolina Budget and Control
Board, Office of Research and Statistics. These figures show
cardiac procedures, angioplasty and bypass, and their average
costs for the period October 1997 through September 1998. There
were 6,587 procedures at a cost of more than $228 million. If
one-fourth of that population had early access to, and
embraced, the Dean Ornish Heart Disease Reversal Program, there
was a potential savings of more than $57 million in medical
costs within South Carolina; and, 1,646 people might have
avoided catastrophic invasive procedures.
I would certainly urge this distinguished panel to support
Medicare coverage of this program. I thank you for allowing me
to participate. I will answer any of your questions.
[The prepared statement of Mr. Johnson follows:]
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Mr. Burton. Thank you, Mr. Johnson. Your wife must be an
extraordinary woman, as well as a good cook.
Mr. Ollie Johnson. Yes, she is.
Mr. Burton. Mr. Sanford ought to be very proud of you as
constituents, because you make a very strong case, and you are
examples of what people ought to do to make sure their
lifestyles are enhanced. So congratulations.
Let me just ask you a couple of questions, and then I will
yield to Mr. Sanford.
What is your cholesterol level now?
Mr. Ollie Johnson. 196 or 195.
Mr. Burton. Is that right, below 200?
Mr. Ollie Johnson. Oh, yes, it has been down to 170, but I
had some tests last week and it was about 195 or 190, somewhere
in there.
Mr. Burton. Your LDL and HDL are at acceptable levels as
well?
Mr. Ollie Johnson. They are all in acceptable levels, yes.
Mr. Burton. What were they before? Do you recall?
Mr. Ollie Johnson. I don't know because I didn't pay too
much attention to it until I got them, and when I first was
checked, it was 3 or 4 months into the program; they had all
just kind of gotten into compliance.
Mr. Burton. What about your blood pressure? Is it pretty
good?
Mr. Ollie Johnson. Yes, my blood pressure--they have to
sort of wake me up.
Mr. Burton. 120 over 80 or----
Mr. Ollie Johnson. Yes, it is usually somewhere at 120 over
80, 78.
Mr. Burton. But it was higher than that when you first
started taking Tenormin, I guess?
Mr. Ollie Johnson. Yes. Yes, it was higher than that. But I
haven't had a problem in 3\1/2\ years.
Mr. Burton. Did you take Zocor or any of the cholesterol-
controlling drugs at any time?
Mr. Ollie Johnson. No. I took Procardia that dilutes your
blood vessels. They took me off that medication and they
reduced my Tenormin from 50 milligrams to 25 milligrams. Right
now I am taking 25 milligrams of Tenormin and a baby aspirin,
and I take a multiple vitamin.
Mr. Burton. But the doctor really doesn't even think you
need those; it is just a precaution?
Mr. Ollie Johnson. That is correct. He doesn't really think
I need that, but he won't take me off of it.
Mr. Burton. OK, very good. Well, I can tell you right now
that we are going to be having meetings with Dean Ornish and
people at HCFA. I have already talked to some of the people
over there about that. It sounds like to me that there is not a
lot of opposition over at Health and Human Services and HCFA to
the Ornish program. The problem, I guess, it looks like to me,
is that we need some legislation to enable them to approve this
program being paid for by the Medicare system. If we can get
HCFA and Health and Human Services, FDA, and everybody onboard,
then it seems to me we ought to be able to get the Congress to
go along with that. We should be able to get that done. So
maybe your wish and Dr. Ornish's wishes, will be realized
before too long. Anyhow, we are going to be meeting with them
in the not-too-distant future.
I would like to ask Dr. Berman a couple of questions about
the acupuncture. You said in your testimony that--I may be
paraphrasing what you said--but, because it is not profitable,
a lot of the companies are not interested in this, or a lot of
the providers are not interested in this. Maybe you could
clarify that. I might have----
Dr. Berman. I think what I was saying was that a lot of
these therapies or complementary alternative medicines are not
patentable. So because there is no patent, there is no great
incentive for a drug company to put the amount of money that it
takes to go through the steps to have it. So, therefore, they
don't really get evaluated and taken to that sort of stage from
people's observations--yes, it seems to work anecdotally--all
the way through to the clinical trials that we need.
I was more talking about that research dollars are really
needed, and it is not going to come from--a lot of our research
is from the drug industry, and that is where a lot of the
dollars come from.
Mr. Burton. Do you think that some of the opposition to the
procedures that you provide comes from pharmaceutical companies
because there is no real profit incentive?
Dr. Berman. We are back to that question again.
Mr. Burton. Well, you know, I ask that question, and I
asked it of Dean Ornish, and the reason I ask it is because it
is very important that we get that out in the open. That is not
something you can hide behind, because if agencies of the
Federal Government are being controlled, in part even, by
pharmaceutical companies, because they invest large amounts of
moneys in research, and they are afraid their research dollars
are going to go down the tube because somebody finds bark off a
tree that is going to cure cancer, instead of their product,
then if they have that kind of influence, it is unseemingly.
I think in the process--and I am going to go off on a
little tirade here--I think in the process of getting
alternative therapies accepted, we may have to, as a
government, figure out some way to protect pharmaceutical
companies against making great investments in scientific
research, and then have something come along that didn't cost
anything that knocks their research out of the box, and there
is maybe $2 or $3 billion that has gone down the tubes.
I am sympathetic to the problem that they face. If they
patent something, they go through all the research; they come
up with a compound that works, and then somebody comes up with
something that is homeopathic that works just as well, but
doesn't cost anything. So they are out all that money. So I am
sympathetic to that.
But, at the same time, I think we need to know in the
Congress if pharmaceutical companies, if medical facilities in
this country are using their influence to keep a lid on
alternative therapies, so that they can still make the almighty
dollar.
Dr. Berman. I think that does exist. I think we would have
to say straight that there is a great profit motive, and it is
not there for many of these therapies. So while some of them
are now--quite a few of the big pharmaceutical companies are
starting to look at this field, they are coming along with a
big net to see where is the market, and beginning to start
their own lines of vitamins and minerals, and have not yet gone
the other way to say, let's put in the research dollars,
because of these concerns: Where is that patent going to be,
and their payout at the end of the line.
Mr. Burton. Well, perhaps we can wade through that and
figure out some way to be able to encourage them, so that they
can make money and still get to the final conclusion we all
want.
Let me ask you a little bit about acupuncture, because I am
not that familiar with it. How does it work on joints and pain?
If you use acupuncture, for instance, if you have knee problems
or tennis elbow or shoulder problems or back problems, does it
give long-lasting relief or is it just a temporary thing, like
aspirin or acetaminophen or something?
Dr. Berman. What we have found is that it generally, in the
beginning, the treatments are maybe--if somebody has a chronic
problem--if it is an acute problem, often it lasts. But if it
is a chronic disease, let's say, like somebody with
osteoarthritis of the knees, and they have had this for many,
many years. Initially, you may find that the treatments last
for just a couple of days, and then as you go along, if this
treatment is working for this particular patient, they tend to
last longer and longer, and there is more of a carryover
effect. From some of our studies, it has lasted sort of for 12
weeks before we saw any decrease in the effects from the
treatment.
Mr. Burton. Does it ever provide a complete cure or is it
just like some kind of pharmaceutical that would provide a cure
for a short period of time, and you have to take it again?
Dr. Berman. Well, in the traditional way of looking at it,
they would say the cure might be that you come in once a season
eventually, and it has to do with not just your local knee
pain, but your general health. Whether or not it can--it really
depends on which problem. I mean, I have seen it cure tennis
elbow quite effectively and some problems of chronic headaches.
But something where it is really--looking at
osteoarthritis, part of the joint is gone, and they are waiting
to have joint replacement, it is not going to regenerate that
joint. There is some evidence that glucosamine and some of the
other compounds might have some effect there, but for
acupuncture you are not going to regenerate it, but you will
decrease the inflammation around that joint. You will decrease
the pain, and you will increase the quality of life, so that
the person is really perhaps able to not have the surgery or
avoid having the surgery.
Mr. Burton. Very good.
Mr. Sanford.
Mr. Sanford. I guess I would ask this of my fellow South
Carolinians. We grew up not only in the Sunbelt, but in the
stroke belt as well. Growing up where we did, I have a
particular love of fried chicken, country fried steak, fried
okra. My hope that is, as you look at the Ornish program, a
part of it is what you eat; a part of it what you do in terms
of exercise, and a part of it, I suppose, is what you think
with meditation, and maybe there are other elements in terms of
herbs.
How much of it is the nutrition part? Can I skip out on the
nutrition part and still be OK, or, no, it is all three?
Mr. Ollie Johnson. It is all of them. We asked that
question. It is like we can only have one drink a day. I asked,
could I save them up until Saturday? They said, no, you can't.
[Laughter.]
But the food part, we don't eat meat; we don't eat seafood.
We go to a restaurant and we talk to the cook or we say,
``Look, can you fix up the meal?'' They will say, ``We can fix
you a vegetarian meal.'' But if they are going to put ``fat-
back'' into it, we have a problem there. So we actually just
leave.
Mr. Sanford. So is it equal, a third, a third, a third, or
is it really more relying on what you eat than anything else?
Mr. Ollie Johnson. No, sir. I don't know that they have an
answer for that, because we never got one that is one-fourth
exercise, one-fourth meditation, one-fourth diet, and one-
fourth group support. I don't believe they have any evidence to
say which is the most influential. We have not at this point.
So we do all of it. We do all of it, and it is working.
Mr. Sanford. What would you say to folks that say--
detractors, in essence, of alternative medicine who say, wait a
minute, the Federal Government can only fund so many things.
This is not magic. I know that fried okra probably isn't the
best thing in the world for me, but I grew up eating it; I love
eating it.
In other words, since it is not magic, since I know it is
not good for me, therefore, you could have figured this out
earlier. What shouldn't government involvement be reserved for
the very end of things? In other words, what would you say to a
detractor that said, only so many dollars; save it for the end
because people, if they are really disciplined, could be doing
this stuff without having government involved in a program of
Dean Ornish or others?
Mr. Ollie Johnson. Well, I think the evidence of it, good
or bad, is the cost in South Carolina right now, $228 million,
just last year alone. All of those people--I didn't have any
figures on what their ages were, but I would suspect that they
are maybe older people. I sort of crossed that bridge. I have a
lot of friends who still eat Kentucky Fried Chicken, or ``KFC''
now--we don't say, ``fried'' anymore. [Laughter.]
And we don't perceive it as being a hard thing. It is
really very difficult to convince another person that this is a
good way that is not so bad. Most of my friends do not eat
Ornish, and they know I eat Ornish. We go to a restaurant, and
I may end up eating a salad, but that is it. Every now and
then, when they say, ``Your weight, you look pretty good,'' I
say, ``Well, it is part of the program that I am in.'' They
will ask me a few more questions. I know that they are eating
better. They probably gave up the double hamburgers and stuff
like that, and they are eating more turkey, because they see me
every day and they believe that something is happening with
that guy; he is a better person because I know he is
meditating. He is a little bit better to get along with.
So I don't criticize their lifestyle. I am willing to tell
them about mine.
Mr. Sanford. Right.
Mr. Ollie Johnson. I have had that question, ``Well, I
can't do that because I am enjoying this lifestyle,'' but we
are both at the concert or the theater, you see.
Mr. Sanford. I would ask the question, I suppose, to Mr.
Berman, unless you want to throw in your thoughts. That is, how
would you guard against quackery, though? In other words, if
you open up government to doing a lot of other things, surely,
there would be a lot of folks that maybe--AMA has pretty strict
guidelines. How you have an AMA-like control over who does or
doesn't do acupuncture or herbal remedy?
Dr. Berman. There is a lot of efforts in that way. There is
certification. You look at certification, regulation,
licensing, education, experience, and there are the
acupuncturists, the chiropractors, massage therapists, they do
have national--and many of the States have their own
regulations. So you would go look at that. I think that is very
important.
You could set up many things. You could set up looking at
the adverse reactions of many of these therapies, so you could
look at what goes on with them adversely. And you would also
continue to do the research, so you could separate out what
doesn't work and discard those, and then keep in the ones that
do work.
So I think there are many ways that we could really
improve, both from a conventional as well as a complementary
medicine side, to separate out the quackery.
Mr. Sanford. Mr. Chairman, thank you.
Mr. Burton. Thank you. I would just like to say, Mr.
Sanford, that we had Dean Ornish in earlier, and, of course, I
think you were in other committee meetings or something. I hope
that you and some of the other members will take advantage of
an invitation Dean Ornish made, and that was that he said he
would be willing to come back from San Francisco to meet with a
number of Congressmen to tell them about his specific program,
and if you are interested, get you on it, because it has had
substantial results.
In addition to that, they have scientific research in his
program that backs up, in Dean Ornish's case, what these people
have said here today, that it does eliminate in many cases, but
certainly reduces the necessity for heart surgery and bypass
surgery and also angioplasty. They estimated that it would save
$30,000 to $35,000 for each case. When you put a pencil to
that, if we could get Health and Human Service, HCFA, and all
the health agencies to incorporate this into Medicare, it would
probably save billions of dollars for the Medicare program that
could be well used elsewhere. It is one of the things that I
know that you will want to work with us, and I will talk to you
about that.
Let me just thank you very much. I am going to have to find
out, Mrs. Johnson, what you cook that tastes so good that
doesn't have cholesterol in it. [Laughter.]
Maybe I can get you to come to Indiana and teach me and my
family. But, anyhow, I am just teasing you.
Thank you very much for being here, and I am sorry you had
to wait so long. We will take to heart what you said. We are
going to meet with Dean Ornish. What you are requesting is
going to be looked into very thoroughly and, hopefully, we will
get some results on it. So thank you very much.
Thank you, Dr. Berman. We are going to check into the
acupuncture. I may be talking to you about acupuncture myself.
Dr. Berman. OK.
Mr. Burton. Why don't we have the next panel come forward?
We will get started with the next panel.
We are going to have a vote coming up here right now.
The next panel is Dr. Kamerow, Dr. Holohan, and Dr.
Mazzuchi.
Dr. Kamerow, we talked earlier today. You know, Dr.
Kamerow, I only wish the Army had as nice of uniforms as you
guys. I was in the Army and our uniforms never could measure up
to you or the Marines.
Why don't we start with Dr. Kamerow, since we will just go
from left to right? Did I mention everybody or did I leave
someone out?
Mr. Mazzuchi. Dr. Zimble is here with me, sir. He is the
president of the Uniformed Services University of the Health
Sciences.
Mr. Burton. Oh, Doctor, well, I apologize for that. OK.
Dr. Kamerow.
STATEMENTS OF DOUGLAS KAMEROW, M.D., DIRECTOR, CENTER FOR
HEALTH CARE TECHNOLOGY, AGENCY FOR HEALTH CARE POLICY RESEARCH,
DEPARTMENT OF HEALTH AND HUMAN SERVICES; THOMAS V. HOLOHAN,
M.D., CHIEF, PATIENT CARE SERVICES OFFICER, VETERANS HEALTH
ADMINISTRATION; JOHN F. MAZZUCHI, DEPUTY ASSISTANT SECRETARY OF
DEFENSE FOR HEALTH AFFAIRS, CLINICAL AND PROGRAM POLICY,
DEPARTMENT OF DEFENSE; AND JIM ZIMBLE, M.D., PRESIDENT OF THE
UNIFORMED SERVICES UNIVERSITY FOR THE HEALTH SCIENCES
Dr. Kamerow. Thank you, Mr. Chairman, members of the
committee. I am Dr. Douglas Kamerow, testifying on behalf of
the Department of Health and Human Services. Our Department,
HHS, has a number of roles related to complementary and
alternative medicine. NIH, the National Institutes of Health,
facilitates research into new health therapies that may someday
be options for the treatment of illnesses. FDA, the Food and
Drug Administration, is responsible for approving new medical
devices or drugs that are safe and effective in the treatment
and prevention of disease.
I work in another public health service agency, the Agency
for Health Care Policy and Research, AHCPR. Unlike my
colleagues on the panel here today, we at AHCPR neither deliver
care nor regulate care. Our mission is to access the evidence
for what works and what does not work in healthcare.
We support and conduct research that improves the quality,
the outcomes, and the appropriate use of healthcare services.
We provide the scientific foundation that is necessary for
informed healthcare decisions. We want those decisions, which
are being made every day by patients, by clinicians, by
purchasers, healthcare system leaders, and policymakers, to be
based on solid evidence about what works, when it works, and
for whom it works.
The study of complementary and alternative medicine is
squarely within AHCPR's mission. While we have done some work
in this area, we have really just begun to look at it. Let me
tell you a little, about 3 minutes' worth, of what it is that
we have done and what we are doing.
First, we are working to provide accurate statistics about
the use of complementary and alternative medicine in the United
States. One of our surveys, the Medical Expenditure Panel
Survey, has collected information on persons who consult with
complementary and alternative medicine providers. This is the
largest available survey of persons who have used alternative
care, and when we release results, they will provide the most
accurate estimates yet about the use of complementary and
alternative care providers.
Second, we supported a number of early studies on the
effectiveness and cost-effectiveness of alternative therapies
for treatment of low back pain, including chiropractic,
acupuncture, and spinal manipulation. We have also evaluated
patient satisfaction with their care compared to patients
treated with conventional therapies.
Third, we are working closely with our colleagues at NIH,
at the National Center for Complementary and Alternative
Medicine, to co-sponsor two studies on acupuncture: one looking
at the effectiveness of acupuncture on back pain and, second,
in treating depression during pregnancy.
Fourth and finally, we are helping to document and
synthesize the scientific and clinical evidence that supports
complementary and alternative medicine. In 1997, we established
12 evidence-based practice centers around North America to
systematically analyze important clinical topics. Let me give
you one example.
I am a family physician. A patient recently asked me about
using garlic preparations to help reduce his blood pressure and
his cholesterol. I was frustrated because there really was
nowhere I could turn for reliable information about this
substance, which is commonly used in this country and abroad. I
am pleased to say that now we at AHCPR have commissioned what
we call an evidence report on garlic. One of our EPCs will
scour the world's literature about it, systematically review
that research, and authoritatively tell us what is known about
what works and what doesn't work about garlic.
In addition to this report, we are also reviewing other
complementary and alternative medicine topics for future
reports, and we are discussing further collaboration with our
colleagues at NIH.
Now AHCPR is a small agency, and therefore our investment
in this area only scratches the surface. What is needed to
create the scientific foundation for CAM, for complementary and
alternative medicine? We need to develop better, more reliable
methods for studying and evaluating these therapies, and much
more research is needed on their effectiveness and outcomes. We
need to increase the available data on their use, and we need
to know how patients feel about the care they receive and why.
We at AHCPR believe that the best evaluation of medical
care is one that measures the impact on the outcomes that
patients care about and what they care about most. The bottom
line is that all of us--doctors, other health professionals,
patients, health systems, and payers--need evidence. We need to
know what works and for
whom. It is our job at AHCPR to provide this evidence. These
efforts will allow us to identify complementary and alternative
therapies that improve health, improve health care, and enhance
the quality of life of our patients.
Thank you.
[The prepared statement of Dr. Kamerow follows:]
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Mr. Burton. Thank you, Doctor.
We have 5 minutes before this vote expires. So I apologize
to the panelists. I mean, how would you like to live this life
where you run back and forth? The only good thing about it----
Dr. Kamerow. Exercise.
Mr. Burton [continuing]. Is exercise, yes. We will be back
in 5 or 10 minutes.
[Recess.]
Mr. Burton. We will reconvene.
Thank you, Dr. Kamerow, for your testimony.
We will hear from Dr. Mazzuchi now.
Mr. Mazzuchi. Yes, thank you, Mr. Chairman. I will just
highlight some pieces of my testimony for you, in the interest
of time.
Mr. Burton. Thank you, Doctor.
Mr. Mazzuchi. One of the questions that you had asked that
I cover in my testimony, and I have covered it in some detail
in the written testimony, deals with a chiropractic
demonstration program that the Department of Defense is
operating in response to the Defense Authorization Act of 1995.
We now have 13 sites. We use two different models: a patient
choice model and a managed care model. In addition to those 13
sites, we have 3 comparison-sites where we also ask similar
questions to patients who are undergoing care, but from
traditional providers, and not the chiropractic providers. The
data-gathering phase of that will continue through September
30, 1999, and then we will report to Congress, which we are
required to do by the act, which requires us to report on both
the feasibility and the advisability of adopting the
chiropractic care into the military health system.
We don't have enough data for me to give you the answer to
that yet, but I can say, from the information that we have
gathered, that the patients who are receiving chiropractic care
are quite pleased with that care.
In my opinion, one of the most beneficial aspects of
complementary and alternative medicine is that these therapies
tend to focus on self-care and stress a balance in living. We
in the DOD continue to initiate and implement programs that
recognize that personal health behaviors are extremely
important in reducing the incidence and severity of disease,
injury, and disability.
The first step in any comprehensive healthcare plan to
promote a healthy lifestyle is to evaluate current health
status. The Health Enrollment Evaluation Assessment Review
[HEAR], is an age-appropriate tool that surveys the general
health status of each of our beneficiaries. The HEAR gathers
information on current health status, family medical history,
currency of immunizations, prevention screenings, mental
health, use of alcohol and drugs, et cetera, and has become a
very important instrument to us as we look at lifestyle, so
that we can initiate prevention programs that meet the needs of
our population both individually and our population as a whole.
Let me address the fact that you asked about training of
our DOD providers. Overall, there are many elements of CAM
offered in DOD facilities throughout our Department. Our
physicians have been trained in acupuncture techniques. They
have been appropriately credentialed and now treat patients
with acupuncture in DOD facilities.
For example, selected providers at both Walter Reed Army
Medical Center and Andrews Air Force Base, both here in
Washington, at the Family Practice Clinic, treat patients who
have chronic pain with acupuncture.
Another example: a radiation oncologist assigned to Edwards
Air Force Base conducts an acupuncture practice every morning
in his practice and has accommodated about 1,200 visits for the
treatment of pain, smoking cessation, and obesity.
Many of our hospitals and clinics offer stress management
programs that include relaxation training, visualization,
breathing techniques, exercise information, and cognitive
therapies. Our psychology clinics within the Department offer
biofeedback and other behavioral modification services. Some
mental health professionals and other staff use meditation
techniques with our patients. T'ai Chi, for instance, is used
by some of our facilities as a routine for relaxation therapy.
Many therapies considered to be complementary or
alternative have not been adopted as mainstream medicine
because of the current lack of evidence for their scientific
support for their efficacy and safety. We are held accountable
to a particular standard for the services we cover outside of
our medical treatment facilities.
And just so that you understand, we have a military health
system that involves not only the MTFs, or the medical
treatment facilities, that we ourselves run and operate, but we
also have a managed care program as well as the standard
CHAMPUS program, which is a piece of that program, that offers
care outside of our facilities.
So what we can cover on the outside is governed by a
standard that requires us to show the cost-effectiveness and
scientific efficacy and safety of those products. Inside the
house, we do have our physician community who are trained in
many CAM techniques. They do actually provide those techniques
within our healthcare system, but we do not pay for them
outside of our system.
To uphold our accountability, we have regulations and
program policies that restrict covered benefits. However, the
DOD will follow very carefully the research done through
institutions such as the Office of Alternative Medicine within
the National Institutes of Health, the Uniformed Services
University of the Health Sciences, and programs of other
medical schools, such as the one we heard about at the
University of Maryland's Complementary Medicine Center, for
answers to the questions that CAM therapies pose to us.
Many of our beneficiaries are interested in complementary
and alternative medicine, and our providers realize that within
each person there is the natural recuperative power that is the
key to all healing, and that taking charge of one's own health
and well-being, both physically, mentally, emotionally, and
spiritually, is within the grasp of each of us.
Moreover, the Department does not restrict the practice of
providers who are knowledgeable, willing, and able to provide
alternative medicine therapies to their patients. The spectrum
of CAM, however, is broad, involving many things, and the truth
is that there is no one single definition that can clearly
define what is alternative medicine. Moreover, the line between
what is alternative medicine and mainstream therapy is not
consistently clear in the minds of patients and providers
alike.
We remain a society that is built upon science and depended
upon science to solve many of the problems that we, as well as
our future generations, will be facing. As therapies which are
currently considered complementary or alternative are tested
and shown to be safe, efficacious, and cost-effective, they
will be integrated into the DOD health system.
Dr. Zimble is with me here today. He is the president of
the Uniformed Services University and is here to talk about two
particular aspects that you asked in your program, mainly,
medical school training, since he operates our military medical
school, as well as the Dean Ornish Demonstration Project, which
funds were just transferred this week, so we can move on with
that--if Dr. Zimble would like to do that.
Dr. Zimble. Mr. Chairman, I want to thank you very much for
allowing me to be a strap-hanger with Dr. Mazzuchi. I have
learned a great deal here today about the sense of this
committee and, also, some of the great contributions that are
being toward the integration more and more into mainstream
medicine.
We have started at the Armed Services University interest
in CAM in 1994, when we began seminars for the complementary
and alternative medicine. We have had about 64 seminars since
that time in 1994.
Also, in 1996, we had what I consider to be a really good
beginning in getting involvement of other medical schools and
schools of nursing into an interest in CAM. We held a 3-day
Consensus Conference with representation from about 33
different institutions, looking at various aspects of all types
of alternative/complementary medicine, including workshops by
many of the practitioners.
Now we are beginning an elective 4th-year curriculum to
teach complementary medicine and then alternative medicine. We
have about 13 research projects, protocols, currently underway
within our school of basic sciences and clinical sciences that
deal with various aspects of complementary medicine. Now we
want to do more of this, and, as I listen to the Ornish that is
described, I have a great deal of difficulty in accepting this
as an alternative medicine. I think this is mainstream medicine
that is currently underfunded and under-recognized.
As the evidence accrues, we need to learn how to integrate
that into the practice of medicine. We try to teach that to our
students. By the way, one out of every five physicians in on
active duty today is a graduate of your Uniformed Services
University. So we are a growing enterprise, and we are part of
the academic health center of the military health system.
I am very pleased that the first Director of the Office of
Alternative Medicine, Dr. Wayne Jonus, is now a member of our
facility. He is a lieutenant colonel, family medicine physician
in our Department of Family Medicine. I was very pleased when
Mr. Waxman
quoted him from his editorial in the November 11th Journal of
the American Medical Association.
I have a full statement that is included in the written
report to you, and I stand by to answer any questions you might
have.
[The prepared statement of Drs. Mazzuchi and Zimble
follows:]
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Mr. Burton. Thank you. We will get back to questions in
just a moment.
Dr. Holohan.
Dr. Holohan. Thank you, Mr. Chairman. I am glad to be
sitting next to the president of USUHS, which has a superb
faculty, I am told, as well.
First, permit me to note that Dr. Kizer, the Under
Secretary for Health, yesterday sent letters to the committee
Chair and ranking member in which he emphasized some points
that we made in our written testimony, and complimented the
committee for addressing this topic. A conflict in his schedule
prevents him from being present to testify today.
Public interest in alternative medical practices is
increasing, and there are likely many reasons for this,
including dissatisfaction with limitations of conventional
medicine, desire for treatment directed toward the whole
person, distrust of drugs and side effects, and some
understandable frustration in search for a cure on the part of
patients afflicted with chronic or serious disorders.
Conventional medicine's interest is evidenced by the fact
that an entire recent issue of the Journal of the American
Medical Association was devoted to this topic. Of note, VA
participated in one of the trials that was reported in that
issue.
Alternative medicine is a very nonspecific term that has
been used to describe a heterogeneous group of practices. While
their underlying philosophies and the manner in which their
agents and techniques are employed diverge from mainstream
medical principles and practices, that separation is not
distinct and absolute, as we shall later discuss and as has
been mentioned several times by previous witnesses.
VA recently awarded a contract to evaluate alternative
practices as they might apply to our system of healthcare in
VA. At present, that report hasn't been completed, but we do,
however, have some preliminary survey data regarding the state
of alternative practices in VA facilities.
While knowledge and even awareness of alternative practices
varied widely among providers and facilities, most of the 131
facilities surveyed provide some such treatments. These
practices usually reflected the presence of a practitioner or
practitioner advocates and managerial willingness to accept the
implementation of those programs. Most of the facility
management teams were reported as pragmatically oriented and
described as having no biases for or against alternative
treatments.
The main concerns VA personnel expressed related to the
highly variable training and credentialing of practitioners,
the lack of sound scientific evidence supporting the use of
many alternative therapies, and uneasiness about the budgetary
impact of alternative practice in an environment of constrained
resources.
We note that many practices often considered as alternative
have been or are also used by conventional medicine. For
example, physical and manual treatment significantly overlap
with modalities that are widely used in the current practice of
physical medicine and rehabilitation. Many nutritional therapy
models have counterparts in allopathic medicine, such as the
use of hyperalimentation as an adjunct to conventional cancer
treatment.
The mainstream medical literature contains numerous studies
of vitamin supplementation, the use of zinc and antioxidants,
among many others. Many drugs that are used by conventional
practitioners are, in fact, botanical preparations which have
been evaluated in clinical trials and approved for marketing by
FDA. These include vincristine from the periwinkle plant,
digitalis from foxglove, and taxol, which was originally
extracted from the Pacific yew tree bark.
Moreover, mind/body interaction is not a phenomenon that is
only recognized by alternative practitioners, as there is, in
fact, a long history in medicine of appreciation of those
mutual effects. A significant body of mainstream research has
provided data that indicate the prognosis for coronary disease
patients with depression is worse than for those without; that
breast cancer patients who attended a support group had
measurably better outcomes than those who did not, and that
single male cancer patients had poorer prognoses than married
patients.
Many similar findings are published, and currently, in VA
we are developing a formal systemwide strategy to fully
integrate mental health and medical services throughout our
system of care, based upon our belief that all diseases or
disorders exist within an individual who is the unit of the
care.
At the same time, one cannot ignore alternative or
unconventional care that may be extreme. There are a number of
therapies whose advocates have proposed unreasonably optimistic
claims and whose treatments have been ineffective and often
harmful. Our written testimony provided specific examples of a
number of such regimens.
Indeed, in the early 1980's, a committee chaired by the
late Congressman Claude Pepper published a comprehensive,
sobering, yet remarkable, report on the wide variety of
ineffective treatments being sold to the public. We do not mean
by imply that all unconventional treatments are ipso facto
suspect. The critical point to be made is that the advocate of
any treatment, conventional or unconventional, allopathic or
homeopathic, surgical or psychological, has an ethical and
moral obligation to provide high-quality evidence that
satisfactorily demonstrates the treatment is effective, and
that the benefit is clearly proportionate to the risk. This is
true for conventional treatment, and it is true for alternative
practices.
Claims that assert that scientific research standards are
inappropriate or irrelevant to alternative practices are wrong.
Science is not a belief system, but merely a disciplined method
of investigation that enables one to test the hypothesis, and
its applicability is virtually universal, we feel.
The scientific method is the only instrument that permits a
mathematically sound statement of the probability that a
particular cause will result in a specific effect. A casual and
an unsystemic linkage of cause and effect is too often
erroneous, and for those reasons, prudent clinicians are loathe
to accept anecdotal evidence, a few cases, or subjective
judgments as proof of efficacy.
VA believes we have a serious responsibility to demand
evidence of benefit and safety for treatments we provide to
veteran patients, and we have invested considerable resources
to that end. We also believe that opinion or beliefs do not
constitute scientific evidence and that anecdotes or small
series studies represent the weakest forms of evidence and only
serve to provide a hypothesis that can be tested in a well-
designed trial.
While such positions are not in accord with the opinions of
some in both the conventional and alternative medical fields,
they are ratified by how most of us, tacitly or overtly, rely
on the scientific method in our daily lives. When we step into
an airplane, we are aware of our dependence upon the research
and experimentation underlying the engineer's theories and upon
the repeated testing of materials and design of the airframe,
engines, and controls. We expect the Federal Aviation
Administration to provide serious oversight of aircraft
manufacture, and that design and construction will rely in the
application of scientific investigation. We also expect that
production will be accomplished by technical experts qualified
by training and experience, and certified as competent by
reliable and responsible authorities.
It is dangerous to assume that so-called natural or
nonpharmaceutical products are by nature safe. In our written
testimony, we noted the recent recall of a dietary supplement,
gamma butyrolactone, or GBL, which has caused comas, seizures,
cardiac and respiratory arrest, and death. Undoubtedly, most
consumers made ill or killed by GBL assumed its production and
sale implied at least some research demonstrating safety, if
not effectiveness. Sadly, they were mistaken.
At present, there is a paucity of rigorous, reliable, and
valid clinical trial data supporting many alternative
interventions. Indeed, that was identified as a major concern
of VA personnel in our contractors' survey. We believe that
evidence is critical in our determination as to the role
alternative medicine may play in the care of our patients. To
that end, our research and development program will continue to
fund scientifically meritorious investigator-initiated research
related to alternative practice at all levels.
Inconsistent alternative provider credentialing, licensing,
and regulation pose serious problems in the utilization of
those practitioners and techniques. And, Mr. Chairman, you
asked a question about this a minute ago of Dr. Berman.
Acupuncturists are licensed in 35 States; massage therapists in
27; naturopaths in 4, and homeopaths in 14 States.
I did some surfing of the internet on naturopathy and found
an internet site that provided naturopathy information--
actually, two sites--that made a statement that, ``Certified
naturopaths may complete a 4-year program of study or they may
be someone with nothing more than a diploma from a diploma mill
or a correspondence school.''
VA has set high standards for practitioner education,
credentialing, and certification. All newly hired VA physicians
must be licensed and board-certified. Advanced practice nurses
must possess licensure, national certification, and a graduate
degree; and registered nurses, licensure and a bachelor's
degree. We believe that all providers in VA should meet
appropriate comparable standards, irrespective of their
practice focus.
In closing, VA is investigating alternative medicine
practices and is presently gathering data to address the
interest of our clinicians and the extent of alternative
medicine use in our system. We expect to be reviewing
information developed from the literature base for alternative
practices, the appropriateness of employment for our
population, and information on cost and cost-effectiveness.
VA expects that any treatment offered to veteran patients,
whether conventional or alternative, and provided outside the
context of a clinical trial, will be chosen on the basis of
objective evidence sufficient to permit the conclusion that it
is both safe and effective.
Thank you.
[The prepared statement of Dr. Holohan follows:]
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Mr. Burton. Thank you, Dr. Holohan.
Dr. Kamerow, why is it that, if there is a program like Dr.
Ornish's that has substantial evidence that shows that it is
effective in reducing conventional therapies, such as open
heart surgery and--what is the balloon thing again--
angioplasty, why is it that there is not some mechanism for the
Department of Health and Human Services to contact Congress and
suggest to us that we take legislative action that will enable
you to put that under the Medicare program?
I guess the point I am trying to make is this: We are
finding out today that most of the people here agree that that
program has merit, is effective, and is going to save a lot of
money in the area of reduced heart surgeries and angioplasties.
If that is the case, we are finding out about it, and we are
going to be getting together with you and others at the
Department of HHS, along with the doctor, to figure out some
way to provide the passage of legislation, so that you can put
that into the Medicare program.
My question is, why is it, when something like this
happens, do you have to wait for Congress to come to you and
take the initiative? Wouldn't it be better, if you know that
there is something that works, for you to tell people in
Congress about it, so that we could start the wheels rolling
that will enable you to incorporate it into your procedures?
Dr. Kamerow. I think that is a good idea, Mr. Chairman. I
will certainly check with the Health Care Financing
Administration and suggest that to them.
I think that in this particular case it is only really
recently--and I mean quite recently, such as the last several
months--that there have been good randomized control studies in
fairly large populations of the kinds of interventions that Dr.
Ornish is talking about. It is a very intensive regimen----
Mr. Burton. I understand.
Dr. Kamerow [continuing]. And it has been done successfully
in small numbers of people. My understanding is that the people
at HCFA are looking at it closely and would be glad to talk to
you about it.
Mr. Burton. I understand it takes a lot of discipline.
I wish you would suggest to them--I know that the agencies
are not supposed to lobby Members of Congress. However, I can
tell you, as one Member of Congress and chairman of one
committee, that I would not consider it lobbying if, for
instance, the Department of HHS came to us and said, ``Here is
a procedure that will help people, reduce medical costs, and
one that we could use in the Medicare program with great
efficiency and effectiveness, if Congress would allow us to do
it, but right now we are prohibited from doing it because there
is a legislative prohibition against it.''
Dr. Kamerow. I will be glad to take that message----
Mr. Burton. And, really, I don't think anybody would
consider that lobbying--it is that you gave us some ideas or
suggestions--and I certainly wouldn't. I wish you would tell
them that over there, because there may be other things that we
don't know about besides this program that might be very
advantageous to the Medicare program, to HHS, and to the
populace in general.
Dr. Kamerow. I would he happy to do that.
Mr. Burton. Let me ask you just a couple more questions. I
know that you are pinch-hitting for the Secretary, since there
is no one on her staff that covers alternative medicine. Do you
think that it would be helpful for HHS to have an Associate
Secretary for Complementary or Alternative Medicine?
Dr. Kamerow. I think that the Department is working to
coordinate these issues at multiple levels, and that they would
be glad to consider those kinds of suggestions from you. As I
said in the testimony, there certainly are a number of
activities going on throughout the Department and a number of
agencies. I think they are working together to try to
coordinate them. The Director of NIH, Dr. Varmus, does have a
committee that he convenes across the Public Health Service,
with representatives from the different agencies, to talk about
research in complementary and alternative medicine. So I think
there are some mechanisms that are in place now to coordinate
the different activities.
Mr. Burton. I guess the question I am posing is--I am not
talking about a person who is an advocate for alternative
therapy, but someone who would constantly peruse the medical
journals and check to see if there are new alternative ways
that are coming online that have been proven effective that
they could point out to the people who are in charge of HHS,
who will be making decisions on whether or not to move into
different areas or new areas that might help the population.
So you might throw that out to them, as well as some idea
on how to keep Congress informed, as well as the upper echelons
of HHS, on new therapies that may be coming along of an
alternative nature.
Dr. Kamerow. I would be happy to do that.
Mr. Burton. In 1997, the NIH consensus panel, their
consensus was that acupuncture was effective in the treatment
of post-operative and chemotherapy nausea. Why is it that they
are still not allowing acupuncture to be utilized through the
Medicare program?
Dr. Kamerow. My understanding about acupuncture and
Medicare is that there is a national noncoverage statement and
policy, and that, in light of the recent Consensus Conference
and other evidence, that they are looking at this, and when
they feel that the evidence is strong enough, that they will
change that.
It is important to point out that evidence from one source,
such as an NIH Consensus Conference, may not be all that is
necessary. It may be the opinion of some experts, and HCFA
often requires that there be the kinds of randomized control
trials that Dr. Ornish talked about before they will cover
interventions. But that is one kind of evidence, and they
certainly are taking that under consideration.
Mr. Burton. Well, I have some personal experience. My wife
had chemotherapy. My mother and father, who both died last
September and October, had chemotherapy. And I know the kinds
of problems that you have when you take that after a period of
time. You regurgitate. You have all kinds of complications. It
just seems to me if acupuncture has been helpful--even though
they took medication, they still had these kinds of problems.
If acupuncture relieves those kinds of symptoms, and it has
been proven to do so, as we believe it has, it seems to me that
that ought to be something that is seriously considered. You
might want to put some limitations on acupuncture until other
things are proven, but if it is helping in those areas, I wish
that you would at least talk to them about that and look into
that.
Dr. Kamerow. I certainly will.
Mr. Burton. How much money has VA invested in alternative
medicine research?
Dr. Holohan. I will pass that question over to our
representative from the Office of Research, Dr. Burris.
Mr. Burton. Doctor, why don't you come over to the
microphone, so that I can hear you?
Do you know how much they have spent?
Dr. Burris. In fiscal year 1998, there were over 100
individual research products in the area of complementary and
alternative medicine being conducted in VA facilities. They
were funded at approximately $5.5 million by VA, and an
additional over $9 million from all other sources of funding
combined, other Federal agencies as well as nonprofit
organizations.
Mr. Burton. So the total for VA as well as other Federal
agencies was about $14, $15 million?
Dr. Burris. In fiscal year 1998, that is correct.
Mr. Burton. What percentage of that would be the total
expenditure for conventional healthcare therapies?
Dr. Burris. It would be a little less than 2 percent of the
VA research budget for that fiscal year.
Mr. Burton. As well as the other agencies you were talking
about?
Dr. Burris. No, I don't know what the figure would be of
the other agencies.
Mr. Burton. OK. But it is about 2 percent?
Dr. Burris. Of the VA budget.
Mr. Burton. In the area of cancer research, didn't you say
that it was about 1 percent, that we are putting $2.3 billion
into conventional cancer research and about $20 million into
alternative therapies? So we are looking at somewhere between 1
and 2 percent for alternative therapies.
Is there any suggestion that VA or the Department of
Defense or at HHS that we increase that percentage? Because
some of these alternatives have been very, very effective. Dr.
Mazzuchi?
Mr. Mazzuchi. Well, there is a way of doing that, I think,
without necessarily increasing the percentage. I wish I had
better data for you, and I can get it for you. As part of the
DOD's breast cancer research program, where the Congress has
appropriated considerable amount of money to the Department for
breast cancer research, some of those moneys are set aside for
IDEA grants. I have forgotten what the IDEA acronym stands for,
but, basically, it is research moneys given to researchers who
do not have a proven track record in the business; they have
not been in the business of cancer research, or who are looking
at alternative therapies or new techniques. It is basically
meant to stimulate research in areas from people who have not
been in this area before and with ideas that are different from
some of the more mainstream research ideas. I think that is a
good way to go with alternative medical research, is that you
open the door, not necessarily setting out a certain
percentage, but you certainly encourage, as part of your
overall grant, that some areas would be in places that were
not----
Mr. Burton. See, the concern I have is that to encourage is
kind of a nebulous thing. If there are specific funds that are
allocated for a project or an area, that money is going to be
used for that specific area. If you do it any other way, then
the money, in all probability, won't get to that.
Mr. Mazzuchi. Our IDEA grants actually are a certain amount
of money that is set aside. It is not really percentage, but I
guess you could make it a percentage of the money.
Mr. Burton. OK, what amount of money is set aside for that?
Mr. Mazzuchi. I have to get the number for you. It is quite
large. It is about a quarter of the research grants are done
with IDEA grants. Now all the IDEA grants aren't alternative
medicine. They are simply with people who have not done this
kind of research in the main or are trying to attract both new
scientists and new methodologies, which some of that would go
into.
[The information referred to follows:]
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Mr. Burton. Well, we know that in the area of HHS and
cancer it was about 1 percent, and we know now that at VA it is
about 2 percent. So that is a very, very small percentage of
the overall spending. There is a growing sense in the country
among people who are veterans, at the VA, people in the Defense
Department, and the general population that alternative
therapies are something that they really want to take a hard
look at before they go with conventional therapies. So it seems
to me that there ought to be more money spent in that area
instead of just a mere pittance; 1 or 2 percent is not going to
cut it.
Yes, sir?
Dr. Zimble. Mr. Burton, I just wanted to mention, I
overlooked one fairly important fact, and that is that, in the
1999 appropriation to the Department of Defense, $2.5 million
was appropriated to our university to support the Ornish
program. We will be bringing that to Walter Reed Army Medical
Center, which will be doing some work specifically for that.
Mr. Burton. So you are very supportive of that program?
Dr. Zimble. Oh, yes, sir.
Mr. Burton. What I would like for you to do, if you would,
for me--because we are going to be meeting with the people at
the HHS about that program, and we are going to have Dr. Ornish
come back from San Francisco to meet with us, to try to figure
out some way to legislatively get that program online, so we
can incorporate it into the Medicare program. If you are
sympathetic toward that end with the VA and the Department of
Defense, if you could send me a letter to that effect, I would
sure like to have that, just saying that you think it has
worked; it has been effective.
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Mr. Burton. Let me ask you one more question regarding the
veterans. Is saw palmetto available to veterans? We understand
that that has had a positive impact on prostate problems.
Dr. Holohan. Frankly, Mr. Chairman, I don't know.
Mr. Burton. Well, could somebody maybe check into that and
let me know? Because that is one thing that there is some
evidence that has been helpful in a number of prostate problems
in men.
[The information referred to follows:]
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Mr. Burton. You mentioned that the Defense Department will
begin integrating alternative therapies when they have been
tested and shown to be safe and cost-effective. Since
acupuncture has been shown by an NIH consensus panel to be
effective for post-operative and chemotherapy nausea, as well
as dental pain, when will the Defense Department begin making
acupuncture in certain cases available systemwide?
Mr. Mazzuchi. We have begun the process to do that. Based
on the Consensus Conference at NIH, we communicated that
information to the office in Aurora, which is the benefits
office, which tends to look at new technologies and does
technology assessment with us. That office is looking at the
literature right now, and is looking at perhaps doing some
clinical trials to determine whether this should be a covered
benefit. It is a process that takes between 1 and 2 years. We
are about 8 or 9 months into that process now. My expectation
is that, based on the literature we have seen so far, it looks
fairly favorable that at least in some circumstances it would
be covered. Now, as I have said, we do cover it inside the
MTFs, our medical treatment facilities, like Walter Reed, and
so forth. But in terms of being paid for, if you receive your
care external to our military hospitals, that we still do not
do, but that is where we are heading.
Mr. Burton. Let me just make one more comment, and then we
will let you folks go. I am sorry you had to wait all day. I
really appreciate your patience.
One of the things that I believe Dr. Ornish mentioned was
that they had a very difficult time--I think it was Dr.
Ornish--they had a very difficult time getting the funds to get
the body of evidence that was necessary to show that the
program was effective. He said he had to go to private
foundations to get the money, which was very difficult. He
could not get any from the Federal Government, even though we
now know, in retrospect, that the program does work and it does
have real benefits.
Are any of the funds that you are allocated being used to
look into these alternative therapies, so that people like Dr.
Ornish can get the results that you require, so that they can
be incorporated into your programs? Do you see what I am
saying? I mean, if a very small percentage is dedicated for
alternative therapy research, and somebody like Dr. Ornish
comes up with a new procedure that is going to be very
effective and save money and help save lives, and everything
else, how can we allocate more of our resources so that they
can get that kind of testing result finalized, so that you can
have it for your review, and, ultimately, for getting the
procedure into your practices and your policies? Did I make
myself clear? Maybe I didn't.
Dr. Zimble. At the Uniformed Services University, we work
with a statutorily created 501(3)(c) foundation, the Henry M.
Jackson Foundation for the Advancement of Military Medicine.
Mr. Burton. Who puts the money into that? Is that a
government funded----
Dr. Zimble. That can come through government. It comes from
both the private sector and can come from the government. The
$2.5 million I mentioned to you previously will go from me to
the foundation. The foundation will give some of that to the
Walter Reed Army Medical Center. Some of that will go to Dr.
Ornish for his preventive medicine research.
Mr. Burton. I am not just talking about Dr. Ornish. I am
talking about the other----
Dr. Zimble. Right, but we can use that--that paradigm can
be used for other methodologies.
Mr. Burton. OK. So the Department of Defense, even though
the funds are not high----
Dr. Zimble. Right.
Mr. Burton [continuing]. It is a very small amount--you do
have a way of doing that. How about NIH and HHS?
Dr. Kamerow. HHS has a number of mechanisms for either new
investigators or small grants for novel ideas, sometimes more
off-the-wall ideas, that they can use. I know that AHCPR, we
have a small grants program for just those kinds of pilot
programs or early research, where people can apply if they
don't have the credentials that Dr. Ornish was talking about
before to get funding for these kinds of projects.
Mr. Burton. How do they make the judgment on who gets those
grants?
Dr. Kamerow. They are reviewed in study sections, which is
typical.
Mr. Burton. By whom?
Dr. Kamerow. By peers. Peer review.
Mr. Burton. Peer review, doctors. Are any of those doctors
on any boards of any pharmaceutical companies, or have they
ever been employees of any pharmaceutical companies?
Dr. Kamerow. I believe that is a pretty----
Mr. Burton. Broad question?
Dr. Kamerow [continuing]. Pretty broad question. I am sure
somewhere there is, but they are generally university and other
researchers.
Mr. Burton. Well, I think you know why I asked that
question. There is a concern that, if an alternative therapy or
alternative vitamin or drug, or whatever it might be, comes on
the market, that there might be some impediments to them
getting that approved or even getting a grant to have it tested
thoroughly because of influence being exerted by people who
have a vested interest.
Dr. Kamerow. I think that this is an important point that
you have made a couple of times during the hearing, and my
response would be that I think it is through the government
research where this kind of nonprofitable, if you will,
research gets a chance, because the R&D that gets paid for by
the drug companies won't pay for this kind of work. So really
it is very important for us in the public sector to fund this
research in the most impartial way possible.
Mr. Burton. Toward that end, if we can be of any help at
all, and if you think that there is any way, any of your
agencies, that we could be of help, I wish you would let me
know.
Dr. Kamerow, I look forward to talking with you further
about HHS and Dr. Ornish's program and some legislation that we
might be able to put together, together, that might get that
thing into the overall Medicare program.
Dr. Kamerow. Yes, sir.
Mr. Burton. Well, thank you very much for being here. I
really appreciate it.
Thank you very much.
We stand adjourned.
[Whereupon, at 3:16 p.m., the committee was adjourned.]
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