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THE PRESIDENT SEEM
4-7-99
Coming
outerwing P/s get mu Lawis acticle
I
capied
Jennings
Podesta
David S. Broder
Health Care:
The Cold Truth
Consider Medicare. Those over 65 are the only large class of
Americans with guaranteed health benefits. A bipartisan commis-
When Congress returns next week, it will face a debate on
sion's effort to slow the cost spiral that threatens bankruptcy of
health care that has started on a partisan note and may well end in
that program foundered on insistence by the White House and
frustration. For anything useful to be salvaged, politicians will have
most congressional Democrats that every existing benefit be
to recognize a truth few of them are willing to face.
guaranteed. President Clinton even endorsed a politically popular
It is defined succinctly in the headline of an article in the April
move to add prescription drug benefits to the menu. No one, least
issue of the monthly magazine of the National Conference of State
of all the president, has proposed a way of financing that level of
Legislatures: "Government Does, Indeed, Ration Health Care."
services-without new cost-sharing measures-for the growing
The author is a man known for disgorging uncomfortable
ranks of senior citizens, whose voting power intimidates politi-
truths, former Colorado governor Richard Lamm. Speaking of
cians of both parties.
American medicine, Lamm says, "We are inventing the unafforda-
Or take the "patient's bill of rights" legislation tabbed as a high
ble and spending the unsustainable. We need to focus limited
priority by the White House and Republican congressional leaders.
resources where they will buy the most health for society."
The basic provision would guarantee every patient in managed
He cites some of the evidence. In this age of medical
care all "medically necessary" treatments, determined by his or her
breakthroughs, health care has overtaken housing as the most
physician or, on appeal, by an independent arbiter.
expensive item in the family budget-and health care spending is
The legislation is being propelled by a flood of emotional
growing faster than anything else in state and federal budgets as
anecdotes about individual patients whose lives were jeopar-
well. The trillion-dollar annual medical bill represents one-seventh
dized-or even lost-by the cost-conscious regulations of a
of the nation's economy.
managed care company or insurer. The individual stories are so
And yet, the United States has by far the largest share of
compelling that the social costs are ignored. If every patient is
uninsured citizens of any advanced nation, with 43 million having
guaranteed every service that could provide even a marginal
no coverage now. Of 29 industrial countries, we rank 21st in infant
benefit in someone's judgment, then what will the economic
mortality, 17th in life expectancy for women and 21st for men.
consequences be? The answer, Lamm writes, is that "the dollars
Lamm is far from alone in arguing that the current health care
we spend on marginal and futile care are no longer available to
system is unsustainable. Health and Human Services Secretary
spend on needed care for someone else in the system or some other
Donna Shalala says the same thing. So do many other experts.
equally important social need."
He adds: "The health care system can no more afford to do
The question, as Lamm writes, is not if we ration-but how. So
everything 'beneficial' for every patient than the education system
far, we have chosen to ration by leaving one-sixth of our population
can do everything 'beneficial' for every student
or the police
uninsured and, increasingly, by trying to let medical organizations
department for every citizen
"manage" the health care of those with insurance. Since the failure
We are funding health care by an
of the Clinton administration's bill for universal health insurance in
unsustainable yardstick."
Writing in this vein sounds coldhearted. But the real cruelty is
1994, efforts to expand coverage have been sporadic, and the
ignoring these truths. Until we insist that all Americans of all
number of uninsured has grown by roughly a million a year.
ages-including the retired-contribute to the costs of their health
What is almost as worrisome is the fact that the major health
care as far as they are able, until we acknowledge that additional
care reforms being considered in Washington ignore the fact that
benefits for those with insurance are less vital than providing
society must make hard choices about what it can afford-and
access to basic care for the uninsured, the political finagling over
how those dollars can best be used. Indeed, they threaten to
health care in Washington is likely to do more harm than good.
exacerbate the problem by promising that the privileged will be
even better protected.
the Washington Post
7, 1999
Government Does, Indeed, Ration
Health Care
Doctors make decisions based on the good of the individual. When it comes to health care
states must make policy based on what is good for the whole population.
By Richard D. Lamm
T
he largest purchase the average American family will make in
But every state "rations" taxpayers' money in a process called budget-
their lifetime is no longer their house, but their health care.
ing. Whenever demand for tax dollars exceeds the supply of those
Over the last 30 years, health care also has been the fastest growing
dollars (which is always), a state prioritizes and "rations" the money
part of the average state, federal, corporate and household budget.
and services it buys. A state must ask not "If" it rations, but "how."
National spending on health care averages close to $4,000 per per-
A state's role and obligations in the health area vary considerably
son, more than the per capita earnings of over half the people in
from the role and obligations of health providers. Consider that poli-
the world.
cymakers view the big picture while providers consider the individual
Taxpayers now fund approximately 50 percent of the $1 trillion
patient: policymakers always consider cost, providers believe cost is
cost of the American health care system. The funding comes through
not a consideration; policymakers try to maximize good while
Medicare and Medicaid, plus state and federal funding of medical
providers must "do no harm."
schools, public health, employee benefits, etc.
Doctors and other medical providers are patient
One dollar out of every $7 spent in America is for
advocates and don't have to deny needed care, but
health care.
public policymakers' moral universe is not the indi-
Yet for all our spending, we still have approxi-
vidual, but all citizens. As Oregon Governor John
mately 43 million Americans without health
Kitzhaber, a physician, maintains, "The legislature
insurance, and the state of our health is not equal
is clearly accountable not just for what is funded in
to many other developed countries. Surprisingly,
the health care budget, but also for what is not
we have spent little time discussing the govern-
funded. Accountability is inescapable
ment's role in health care or what we get for our
Whoever pays for health care rations medi-
money. What should a state's role and goal
cine. An insurance contract is a rationing docu-
be in funding health care? How do we
ment in that it limits what is covered and not cov-
hold the system accountable for public
ered (tattoo removal? Viagra? bone marrow
dollars? Who should the state cover and
transplants?) and who is eligible for reimbursement
for what benefits?
(naturopaths? chiropractors?). Rationing is inher-
ent every time we make up a budget.
PUBLIC POLICY vs. PROVIDERS
Policymakers have not done enough to assert the broader public
INFINITE NEEDS, FINITE RESOURCES
interest in achieving a healthy state or nation. The public policy of a
Are health professionals in the best position to judge how to keep
nation cannot be judged solely by the quality of its medicine or
a state healthy? Clearly they are not. One thoughtful observer points
driven simply by the ethics of health providers. Medicine is a key
out why this is so:
part, but not the only part, of a health care system. Policymakers
"Professionals tend to believe that they are the only ones able to
mostly fund health providers to deliver all "reasonable and necessary"
make informed choices. In fact, many of them are not trained to see
care to covered categories of citizens, and we ask few questions about
the overall health situation of the whole population, but only the
what is delivered or if we have a just system.
problems of the individual patients. The devotion of the physician to
We leave large numbers of medically indigent without health insur-
her patient may make it difficult for her not to seck an excessive.
ance, yet we tell ourselves proudly that we don't "ration" medicine.
share of the available resources and to overlook the resulting loss to
other patients," says E.O. Attinger, an official with the World Health
Richard D. Lamm, " former governor of Colorado, is director of the Center for Public
Organization.
Policy and Contemporary issues at the University of Deriver.
Health providers, as patient advocates, understandably have diffi-
26
APRIL 1992 STATE LEGISLATURES
P.02/04
FAX NO. 3038638003
LEG.
ST.
30
CONF.
,JVN
APR-08-99 WED 10:25 AM
culty looking at the social context of d
:. They are experts in the
all, that resources are limited. It's the limitation on resources that
human body and disease, but not necessarily in health policy. Gov-
both necessitates and justifies the strategy of getting more for less."
emment must look at the social context of all problems and decide
This is painful but unavoidable. We are inventing the unaffordable
how to allocate limited funds to buy the most health for those it cov-
and spending the unsustainable. We need to focus limited resources
ers. Doctors can say yes without saying no. In public policy, every-
on where they will buy the most health for society.
thing we do prevents us from doing something else. Government
The price of modern medicine in a high technology society is to
can't meet the Hippocratic oath's standard of "do no harm," it must
decide what and whom to cover. We must find a way to do so and at
maximize good with always limited money.
the same time articulate the trade-offs involved. I suggest that when
As Victor Fuchs has wisely observed, paraphrasing Abraham Lin-
we deliver futile and marginal care, we are actually being unethical. In
coln, "A nation can provide all of its people with some of the care
the new world of health care, when we overtreat A we take needed
that might do them good; it can provide some of its people with all of
care away from B. The unintended end result of current medical
the care that might do them some good, but it cannot provide all of
ethics is unethical public policy and unethical macro decision mak-
its people with all of the care that might do them some:good."
ing. The dollars we spend on marginal and futile care are no longer
How do we decide who is covered for what?
available to spend on needed care for someone else in the system or
some other equally important social need.
ASKING THE HARD QUESTIONS
Philosopher Haavi Morreim of the University of Tennessee School
Ethical health policy must not be the sum total of all individual
of Medicine writes of a new concept, "contributive justice," which
citizens' "bencficial" medicine. Government could never underwrite
changes the rules when making choices for those who contribute to a
the open-ended commitment for reimbursement for every service
limited pool. From this viewpoint, my irrational or excessive use of
that the doctor and patient thought "beneficial" to an individual
limited funds prevents you or others from getting necessary care.
patient. Public policy today has no way to weigh and balance health
Herein lies a yet undeveloped challenge to society for evaluating
care spending either within the health care system: or against other
modern medicine by a new ethical perspective.
important priorities.
In a world that cannot deliver all the "beneficial" care to everyone,
My generation of public policymakers did not ask enough hard
the existing ethics are inadequate to judge a health delivery system.
questions of the health care system. We lacked proportion and
If a system produces more health for a group, should we turn against
allowed health care spending to grow out of control. Consequently,
it because it violates ethical standards applicable to an individual
we have today many badly maintained public buildings; yet
(and one which we admit is unsustainable)? In a world of limited
approximately half the hospital beds in America are empty. Wc
resources, what if a group is better off not giving all the marginal care
have too many doctors (unevenly distributed) and too few teach-
to individuals but instead maximizes the health of the group?
ers. Most American cities have duplicative and redundant medical
technology near schools that are without computers for students.
HOW DO WE JUDGE A HEALTH CARE SYSTEM?
We keep people alive in a permanent vegetative state in cities
Does America really have "the best health care system in the
where 20 percent of the population are uninsured, and many kids
world?" It is clear that America has the most technologically
don't have vaccinations. We pay for marginal end of life care for
advanced medicine, but brilliant medicine does not necessarily make
people, while others don't have meals on wheels, long-term care,
a brilliant health care system. While there is virtually no question
respite care or emergency response systems and have no handy
that in research, training, facilities and technology no nation tops the
senior citizen centers.
United States, most experts agree with Professor Robert Blank's con-
The health care system can no more afford to do everything "ben-
cise analysis of our total system in his book The Price of Life: The Future
eficial" for every patient than the education system can do everything
of American Healthcare:
"beneficial" for every student, nor the police department do every-
"Although there is no doubt that Americans have the most exten-
thing "beneficial" for every citizen, nor every parent do everything
sive range'of sophisticated medical technology in the world, we fall
"beneficial" for their children. We are funding health care by an
well short of most other nations in health promotion, preventive
unsustainable yardstick.
medicine and access to primary care. Health outcomes as measured by
Nor can a public policymaker "do no harm." Someone must locate
morbidity and mortality rates fail to reflect the vast expenditure dif-
the garbage dumps and the one-way streets, must parole prisoners (to
forential with other nations. Something, therefore, is dreadfully wrong."
make room for this year's crop of new inmates), set speed, limits and
(emphasis added)
myriad other tasks which inevitably cause "harm" because public pol-
It is important to recognize that brilliant doctors and advanced
icy can't help but inadvertently do some harm. No public policy.
technology alone are not enough to produce an excellent system.
maker should ever sign the Hippocratic oath.
Why? Because a system is the sum of its parts, and a weak part any-
What can we not do? We need to start now to discuss what we can
where weakens the system overall. What if we were to claim that we
morally leave undone. This is dilemma so new that neither our
had the "best road system in the world," with beautiful, modern free-
social, legal and religious institutions, nor our health care providers or
ways, yet traffic movement was paralyzed by congestion, highways
consumers, have developed a satisfactory way of coping," says Lau-
missed a significant part of the state and our traffic deaths were
rene Graig in Health of Nations: An International Perspective on U.S.
among the highest in the world?
Health Reform. Yet cope we must.
A health care system should be evaluated by three criteria: 1) tech-
As Dr. David Eddy, policy expert with the Kaiser Permanente
nology and training; 2) access by the entire population; and 3) out-
Health Care Program has said, "Wc will need to accept, once and for
comes and results. While the United States unquestionably excels in
STATE LEGISLATURES APRIL 1993
27
03/04
FAX NO. 3038638003
NAT' CONF. OF ST. LEG.
WV
10:26
DED
APR-08-99
technology and training, in the other two categories it falls far short
of other developed nations.
NGS
Despite the enormous amount of resources and talent expended on
health care, 50 percent more than any other developed country, Amer-
ica has the most uninsured citizens and the most underinsured citi-
zens in the developed world: Equally upsetting, our citizens are less
issembly
healthy than those in Europe, Canada or Japan. We are even losing
ground compared with other nations. The United States ranks 21 out
of 27 countries in infant mortality; 17th for life expectancy of women;
Issues
and 21st for life expectancy of men of the 29 developed countries.
Health providers can rightly say that those statistics are not their
Meeting
fault, but public policy must take responsibility for them. A doctor
can rightly point out that these flow from unhealthy lifestyle, not
inadequate medicine, but public policy does have an impact on
smoking, alcohol, seat belts, illicit drugs and other non-medical
causes of poor health.
ency Washington
Capitel Hill
CHANGING THE HEALTH ETHIC
If this reasoning is correct, it changes many of our standard yard-
sticks. We no longer should approve a drug, a new technology or a
procedure if it offers only marginal benefits.
seting is your State Federal
Health expert Reinhard Priester at the University of Minnesota
this meeting, nine AEI committees will
says, providers should not do everything that maximizes benefit in
an individual patient, since doing $0 may interfere with the ability of
ederat that affect
other patients to obtain basic services; rather, providers should treat
tates
each patient with a full range of resources as is compatible with treat-
the adminis
ing patients yet to come. That is an ethical earthquake. "
We must revise our unsustainable health care culture. We are indi-
viduals with certain defined rights and duties and also we are mem-
this opportunity to discuss
bers of a society which itself has rights. But when an individual con-
be.issues:
tributes to a limited pool of resources, he enters a new contractual
arrangement that cannot be evaluated by the normal standards.
Social security reform
Here the system has an ethical duty to the other members of our
Electric utility deregulation
group not to use limited resources on procedures that have a certain
degree of marginal effectiveness: I submit that not only is Oregon's
Managed care
health prioritization ethical, but that it may be unethical not to have
Federal recoupment of tobacco settlement money
some system that sets priorities for limited funds. As Governor
Kitzhaber has said so often, we must decide both who and what. It
Federal budget
must occasionally consider the health of the group before consider-
ing the health of the individual.
Interested in serving on a committee? Ask your
A modern system, looking beyond the individual patient, may find
leader to appoint you to the Assembly on Federal
as Kaiser has in Southern California that they can save twice as many
Issues. Or, just register to attend the 1999 Assembly
women for two-thirds of the money by concentrating mammography
on women between 50 and 70. Isn't that better than giving mammo-
on Federal Issues Spring Meeting if you'd like to help
grams indiscriminately, especially if we use the money saved for other
guide NCSI's lobbying efforts.
more health producing strategies?
No nation leaves its total defense policy to its generals, nor its edu-
For more information, call Carl Tubbesing or
cational policy to its teachers, nor its concept of justice to its lawyers.
Renae Sicdge in the NCSL Washington office at
While the state cannot decide what medical care an individual needs,
it can and must decide what policies produce the most health, and
(202) 624-5400.
additionally set up a system to make the best use of the funds it does
spend on health care.
Public policy has a broad responsibility and demands a panoramic
view. We "ration" health care whenever we leave someone or some-
NCSL
thing out of our health coverage. We can (and have) run from
rationing, but we can't hide. Wc must, sooner or later, better assert
the public interest in funding health care.
28
APRIL 1999
STATE LECISLATURES
P. 04/04
FAX NO. 3038638003
LEG.
'IS
OF
CONF.
NAT'
APR-08-99 WED 10:27 AM
THE PRESIDENT HAS SEEN
3-22-99
APTA's Exclusive PT Weekly
ULLETIN
American Physical Therapy Association
MARCH 15, 1999
NATIONAL WEEKLY
VOL. 14 NUMBER 11
Legislation Would Allow Exceptions
To Annual Cap on Physical Therapy
Sen. Charles Grassley (R-lowa). chair of the Special
therapy and speech-lan-
Committee on Aging, has introduced legislation to
guage pathology ser-
ease the cap on Medicare coverage for outpatient
vices, and a $1.500 cap
physical therapy and other rehabilitative services.
on occupational ther-
have Minie? The
While APTA maintains its opposition to arbitrary
apy services.
caps on care and supports repeal of the $1,500 cap on
"The cap is arbi-
outpatient physical therapy services, the association
trary." Grassley said. TIt's
believes this new legislation would provide reason-
based on the bottom
able relief to seniors and individu-
line. not on what the
als with disabilities who are con-
patient needs. This leg-
Insid
fronted with the current limitation
islation would make the
on coverage.
patient the priority. It
Physical therapists across the
would allow seniors to
Sen. Charles Grassley (R-lowa)
nation commend Sen. Grassley for
receive rehabilitative
his leadership on this important
therapy based on their medical conditions. not on ar-
issue," said APTA President Jan K.
bitrary payment limits."
5
Richardson. PT, PhD, OCS. Passage
The caps were imposed as a well-intended. cost-
of this legislation would help en-
saving step to help preserve Medicare's solvency,
sure that patients who are in need
Grassley said, but Congress failed to recognize the po-
Rep. Adam
of outpatient physical therapy ser-
tentially devastating effects.
Speaks At
vices receive appropriate care in
The Medicare Rehabilitation Benefit Improvement
PT PAC Breakfas
the setting of their choice, without
Act, co-sponsored by Sen. Harry Reid (D-Nev.). would
fear of exceeding an arbitrary limit
establish exceptions to the $1,500 limit.
Feature Story
3
on coverage."
Providers would be required to demonstrate med-
An annual cap of $1,500 on
ical necessity and the Department of Health and
physical therapy and all outpatient
Human Services would implement the exceptions.
rehabilitation services except
Just 31 days after the caps went into effect. Grass-
those provided in hospital outpa-
ley said, an estimated one in four beneficiaries had
tient departments was imposed, ef-
exhausted half their yearly benefit. According to a re-
fective Jan. 1, 1999, under the Bal-
cent study, he said. almost 13 percent of Medicare
anced Budget Act of 1997.
beneficiaries - 750,000 people - will exceed the
Currently, there are two separate
cap each year.
limits: a $1,500 cap on physical
"Medicare beneficiaries with conditions that re-
quire extensive rehabilitation. such as stroke. hip frac-
NEWSPAPER: Postmaster please
copied
ture, Parkinson's Disease or cerebral palsy. easily meet
AUTO
Jennings
and exceed this arbitrary $1,500 limit on coverage
that Congress has imposed on outpatient physical
PTB 0045740 S 1 2
JANICE ANDERSEN
Podesta
therapy services," Richardson said. Enactment of this
legislation would restore reasonable rehabilitation
PO BOX 39
benefits to beneficiaries with illnesses. injuries or dis-
PRESTON MD 21655 0039
abilities that might typically exceed the $1.500 cap.
APTA applauds introduction of this legislation."
(See GRASSLEY on page 6)
GRASSLEY (Continued from page 1)
The bill establishes certain criteria in order for Medicare beneficiaries to be
eligible for an exception to the cap and allows HHS to establish additional crite-
ria if necessary.
The bill's criteria says the beneficiary must:
Be diagnosed with an illness, injury or disability that requires additional physi-
cal, occupational or speech therapy services that are medically necessary in a
calendar year; or
Have a diagnosis that requires such services and an additional diagnosis or incident
that exacerbates his condition (such as diabetes) and requires more services: or
Meet other requirements as determined by HHS.
The legislation also requires HHS to conduct a study and report to Congress two
years after enactment of the bill.
The study will include:
The number of Medicare beneficiaries who received exemptions to the cap:
The diagnoses of the beneficiaries;
The types of therapy services that are covered due to such exemptions;
The settings in which services are provided; and
The number of beneficiaries who reach the $1,500 cap.
"I hope this bill will assure seniors that Congress wants to preserve their access to
medical care," Grassley said. "Physical therapy, occupational therapy and speech ther-
apy aren't luxuries. They're necessary for getting well after someone suffers a stroke
or broken hip. Medicare should recognize this with coverage that makes sense."
Richardson agrees.
"As long as services are medically necessary, APTA believes that beneficiaries should
not have to fear denial of coverage if they happen to require physical therapy in the
spring and then again in the winter of the same year for another condition," she said.
MAR-30-1999 17:21
HCFA LEGISLATION
410 205 5157 P.01/02
TOTAL SERVICES
4
BETWER
HOFA
of
FAX COVER SHEET
MEDICARE MEDICAID
Health Care Financing Administration
OFFICE OF LEGISLATION
Number of Pages: 1 traves
Date: 3/30/99
From:
To: Devorah
Anne Scott
Fax: 456-5557
Fax: 202-690-8168 or 205-5157
Phone: 456-5707
Phone:
REMARKS: Here is a draft fact sheet on
the therapy caps
In addition, when CBO did an analysis
last years they estimated that the limits would
cause Medicare payments for theopy to be reduced
by about 50%, with over 400,000 people att ected
annually by the limit.
HEALTH CARE FINANCING ADMINISTRATION
200 Independence Ave., SW
Room 341-H, Humphrey Building
Washington, DC 20201
MAR-30-1999 17:21
HCFA LEGISLATION
410 205 5157
P.02/02
URAFI
Outpatient Therapy Caps
UNCLEARED
BBA Provision
Section 4541 of the Balanced Budget Act (BBA) established an annual per beneficiary limit of
$1500 for all outpatient physical therapy (PT) services (including speech-language pathology
services), except for services furnished by hospital outpatient departments. A separate $1500
limit was also established for all outpatient occupational therapy (OT) services except for services
furnished by hospital outpatient departments. Therapy services furnished by a physician or
incident to a physician's professional services are also subject to the limits. These limits, effective
January 1, 1999, replace the current $900 limits, which apply only to services furnished by
therapists in independent practice.
Partial Implementation of Policy in 1999
Full implementation of the $1500 limits in 1999 was not possible due to the considerable new
programming that would be required, which HCFA cannot undertake simultaneously with the
Year 2000 Conversion efforts. HCFA will implement this provision on a limited basis in 1999
with full implementation to begin sometime in 2000.
In 1999, with the exception of therapists in independent practice and SNFs, the limits will be
implemented on a per provider basis. That is, each provider, physician, or nonphysician
practitioner will be held accountable for tracking incurred expenses for each beneficiary and not
billing Medicare for patients who have met the annual $1500 limitation at their facility for each
separate limit.
For SNF residents, however, the limits are being fully implemented since SNFs are responsible for
billing for all Part B outpatient rehabilitation services for residents no longer covered under a Part
A SNF stay. This prevents a beneficiary from getting the services from more than one provider if
the cap is exceeded.
For therapists in independent practice, the $900 limits that applied prior to 1999 were increased to
$1500. They continue to be applied on an annual per beneficiary basis rather than a provider
basis.
Impact on Beneficiaries
HCFA is concerned about the limits and will be monitoring the impact of this provision in the next
year, particularly in SNFs, which is where the limits will be most widely felt. The American
Physical Therapy Association has estimated the average number of visits required for various
diagnoses, indicating that the $1500 caps will leave many beneficiaries without Medicare coverage
for medically necessary therapy. Some of the examples of the average number of visits needed
are: 35 visits for stroke; 35 visits for brain tumor; 25 visits for fractures with surgery; and 30 visits
for lower extremity amputation.
intent is good don't have cost
estimates now. or regulatory cuteria
TOTAL P.02
Bill Clinton 3-4-99
C Jewing
I have souce
iseas about our
we Murud
direcce
Be
copied
C. Jennings
COS
President of the United States
UNINSURED IN U.S.
Shift in
SPAN MANY GROUPS
All of the I
made the Sat.
Motors one
prominent ex
tions have bei
Health Coverage Experts Take
union membe
Further Look at Solutions
ers chose nev
vocated a me
close relation:
er's managen.
By PETER T. KILBORN
WASHINGTON, Feb. 25 - Who
Busine
are all these 43.4 million Americans,
at the Census Bureau's last count,
who do not have health insurance?
Who runs the least risk in going
without it? (Children.) Who runs the
most, medical and financial? (Sick
people approaching 65.) Who is most
likely to have it? (People over 65.)
Not to have it? (Adults who work for
low wages.) Who doesn't care? (In-
vincible youth.)
For more than a decade, an aver-
age of a million Americans a year
have either lost their health insur-
ance or failed to obtain insurance for
which they became eligible. The rea-
sons vary: prohibitively priced pre-
miums, reduced employer coverage,
the welfare overhaul.
But whatever the causes, the
growth in the number of uninsured is
a startling anomaly in an economy
that has been able to subdue infla-
tion, unemployment and budget defi-
cits. Much to the dismay of advo-
cates for the uninsured, the United
States, despite its bounty, stands al-
most alone among industrial nations
in not providing free basic health
care for all.
"The number is going in absolute-
An Unexp
ly the wrong direction," said Grace-
A storm just 0
Marie Arnett, president of the Galen
coasts. By yes'
Institute, a conservative health and
tax policy organization. "It shows
something is wrong with the sys-
tem."
And with the rise in the cost of
Strugg
insurance and health care outrun-
ning wage gains, said Paul Fronstin,
By MIC)
Continued on Page A14
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"Either we fir
Byrd, prosecutors said, was
Americans Without Health Insurance Run the Gamut
SNAPSHOT
Continued From Page Al
ance. They just don't think about the
Health System Change, a group sup-
share to 22 percent on average by
The Uninsured
risks."
ported by the Robert Wood Johnson
1996, from 13 percent in 1988.
The income of many is so low that
Foundation. The study found that
As a result, a survey by the Fed-
Percentage of Americans without
an analyst at the nonpartisan Em-
they cannot afford to buy insurance,
16.3 percent of uninsured people un-
eral Agency for Health Care Policy
health insurance in 1997, by
ployee Benefit Research Institute,
Professor Swartz said, but not so low
der 65 were in fair to poor health,
and Research found, one in four
SEX
"this is going to get worse unless
that they qualify for Medicaid. Oth-
compared with 10.6 percent of all
workers who were offered employer-
Men
18%
something is done about it."
ers may qualify but fail to apply,
people under 65.
subsidized insurance in 1997 declined
The what to do about it, long pri-
because of ignorance, language bar-
One explanation for the rise in the
to sign up. A decade ago, only one in
Women
15
marily the concern of liberals, is now
riers or a general sense of intimida-
uninsured is the shift of people from
ten declined.
being weighed by officials across the
AGE
tion.
welfare to work. More than six mil-
These changes, analysts say, have
political spectrum. The proposals,
Most of the uninsured in the great-
lion have left the welfare rolls in the
spawned the largest segment of the
Under 18
15
still evolving, range from expansion
est need of coverage "are working
last five years, many for low-wage
uninsured, the working poor.
18 to 24
30
of government insurance programs
adults who are not quite in the mid-
jobs with employers that do not offer
Young adults - some poor, some
25 to 34
23
to tax breaks helping more people
dle class," said David B. Kendall,
any insurance or that charge a lot for
not - are another large group of the
35 to 44
17
buy coverage.
health policy analyst at the Progres-
it. For these workers, there is help
uninsured. Of 65 million up to 34
But while there is debate on how to
sive Policy Institute. "They are the
for a while from Medicaid, the Fed-
years old, nearly 25 percent are unin-
45 to 64
14
help the uninsured, few experts dis-
folks who don't have a job that's
sured (compared with 13 percent of
65 and
1
agree on who they are.
going to be there for a lifetime."
the rest of the population), and they
over
To begin with, not many are
Minority groups account for a dis-
account for nearly 40 percent of all
among the elderly or the seriously
proportionate number of the unin-
A trend 'going in
the uninsured.
RACE AND ETHNICITY
disabled, most of whom are covered
sured, Mr. Kendall said. Hispanic
Of the youngest among them, those
White
15
by Medicare. Another group, some
Americans, nearly half of whom un-
absolutely the
19 to 24, the Center for Studying
Asian
21
five million to six million, have fam-
der 65 lack insurance, are only 11
Health System Change says, 30 per-
ily incomes exceeding $75,000 a year
percent of the population but 21 per-
wrong direction.'
cent are not offered insurance
Black
22
and can usually afford the insurance
cent of all the uninsured. Experts say
through their jobs. Of those who are
Hispanic*
34
that, for any number of reasons, they
there are several reasons, among
offered it, typically for a few hundred
do without.
them that Hispanic immigrants tend
dollars a year, 30 percent turn it
WORK
Almost 11 million are children,
to be healthy and in addition may be
eral-state insurance program for the
down. Some who reject it are work-
All full-time workers
from families that range from indi-
intimidated by language and cultural
poor, which is automatically granted
ing poor and cannot afford it. Others,
gent to well off. But children are a
barriers from applying for Medicaid
welfare recipients. In most states,
17
feeling invincible, simply spend the
less compelling concern to many
or other assistance.
families can remain on Medicaid for
money on something else.
Full-time workers with incomes below
health system analysts than are
The travails of the uninsured are
a year after leaving the cash-assist-
However much some young adults
the poverty line
large numbers of the other unin-
often dismissed because the law as-
ance rolls.
feel they can do without insurance,
49
sured. First, they are generally
sures them the last-resort, safety-net
But then, said Ronald F. Pollack,
the nation has an incentive to help
healthier than adults and less expen-
care of emergency rooms, says
executive director of Families
them buy it, analysts say. Like safe
sive to treat. And second, alone
Drew E. Altman, president of the
U.S.A., a consumer advocacy group,
drivers who never have accidents
All people who did not work
among the uninsured, they have al-
Kaiser Family Foundation. But by
"their reward is the loss of health
and yet are required to buy car
26
ready been singled out for help, un-
the time they call the ambulance,
insurance."
insurance, these young people, by
der a $24 billion, five-year program
Mr. Altman notes, many have gone
Another reason for the swelling in
paying health insurance premiums,
"May be of any race.
for non-Medicaid-eligible children
without the preventive care that
the number of uninsured is the rising
would help defray the cost of care for
approved by Congress in 1997.
might have averted the crisis.
cost of health care - for hospital
people who are frailer and older.
Source: Census Bureau
That leaves the rest of the unin-
A survey of adults under 65 by
stays, visits to the doctor and pre-
This process of subsidizing one group
sured, those who need coverage
Kaiser and the Commonwealth Fund
scription medicine alike. It is climb-
whose purchases then serve to subsi-
The New York Times
most: 25 million to 30 million people
found that in a single year, 24 percent
ing faster than workers' wages, and,
dize others is called cross-subsidiz-
who have the greatest chance of be-
of the uninsured declined to fill a
on top of the general increase in the
ing.
families and enough to permit nearly
coming ill and cannot pay for care
prescription that had been given
cost of care, employers are asking
Among the beneficiaries of cross
90 percent of them to pay the age
when they do. Demographically, they
them by a doctor, compared with 6
workers to pay a larger share of that
subsidies would be a not so obviously
group's high premiums of close to
run the gamut.
percent of those who had insurance.
cost.
needy group of the uninsured: the
$3,000 a year, even if the employer
"Some work, and some don't,"
Fifty-one percent had encountered
In 1985, nearly two-thirds of all
poorer and sicker, often retired and
pays no share.
said Katherine Swartz, an associate
difficulty obtaining care, as against
businesses with 100 or more employ-
homebound, among the 23 million
But the three million among them
professor at the Harvard School of
10 percent of the insured. And 42
ees paid the full cost of a worker's
Americans who, age 55 to 64, are not
who are uninsured earn an average
Public Health. "Some don't work be-
percent had not seen a doctor during
care, a study by the Kaiser Family
yet eligible for Medicare.
of only $18,000. The center reports
cause they're sick. Some are very
the prior year, compared with 17
Foundation found. A decade later
According to the Center for Study-
that a third of them are in particular-
young adults not covered by their
percent of the insured.
only a third did SO. Kaiser also says
ing Health System Change, people in
ly perilous straits: these one million
parents' health insurance. They take
As a result, the uninsured are sick-
employers who ask workers to pay
that age group have average family
are in ill health and have average
jobs serving latte in coffee shops that
er than others, according to research
part of the cost through payroll de-
incomes of $45,800 a year, about
incomes of just $9,600, which puts
are not likely to have health insur-
last year by the Center for Studying
ductions had raised the workers'
$4,000 more than the average for all
private coverage far out of reach.
Thurs.
PREVENTIVE MEDICINE
RESEARCH INSTITUTE
900 BRIDGEWAY, SUITE 1
co
SAUSALITO, CA 94965
Jee
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To CJenning - callum this
President Olinton Hisayiyan
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FIRST CLASS MAIL
THE PRESIDENT HAS SEEN
3-2-99
Preventive Medicine Research Institute
A non-profit public institute dedicated to research, education, and service
Dean Ornish, M.D.
Founder, President & Director
Preventive Medicine Research Institute
Clinical Professor of Medicine
School of Medicine, University of California, San Francisco
900 Bridgeway, Suite 1, Sausalito, California 94965
phone: 415/332-2525 x222; FAX: 415/332-5730
e-mail: [email protected]
Testimony of Dean Ornish, M.D.
Committee on Government Reform
Congress of the United States
House of Representatives
Hearing:
"Opening the Mainstream to Complementary and Alternative Medicine:
How Much Integration is Really Taking Place?
An Inquiry into Access to Complementary and Alternative Medicine in
Government-Funded Programs"
February 24, 1999
2154 Rayburn House Office Building
Washington, D.C.
Roole
to
H. is to
2
INTRODUCTION AND BACKGROUND
Mr. Chairman, members of the Committee, thank you very much for the opportunity to
be here today. My name is Dean Ornish, M.D. I am Founder, President, and Director of the
non-profit Preventive Medicine Research Institute and Clinical Professor of Medicine at the
School of Medicine, University of California, San Francisco (UCSF), where I am also one of the
founders of the new Osher Center for Integrative Medicine at UCSF.
The theme of all of my work is simple: if we do not treat the underlying causes of a
problem-in this case, heart disease-then the same problem may recur, new problems may
emerge, or we may be faced with painful choices. Whenever I lecture, I often show a cartoon of
doctors mopping up the floor around an overflowing sink without also turning off the faucet.
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 can be reversed by making comprehensive changes in diet and lifestyle, without coronary
bypass surgery, angioplasty, or a lifetime of cholesterol-lowering drugs. These lifestyle changes
include a very low-fat, low-cholesterol diet, stress management techniques, moderate exercise,
smoking cessation, and psychosocial support. This was a radical idea when I began my first
study; now, it has become mainstream and is generally accepted as true by most cardiologists and
scientists.
Within a few weeks after making comprehensive lifestyle changes, the patients in our
research reported a 91 percent average reduction in the frequency of angina. Most of the patients
became essentially pain-free, including those who had been unable to work or engage in daily
activities due to severe chest pain. Within a month, we measured increased blood flow to the
heart and improvements in the heart's ability to pump. And within a year, even severely blocked
coronary arteries began to improve in 82% of the patients.
These research findings were published in the most well-respected peer-reviewed medical
journals, including the Journal of the American Medical Association, The Lancet, Circulation, The American
Journal of Cardiology, and others. This research was funded in part by the National Heart, Lung,
and Blood Institute of the National Institutes of Health.
THE LIFESTYLE HEART TRIAL
In our latest report, published in the December 16, 1998, issue of the Journal of the
American Medical Association, we found that most of the study participants were able to maintain
comprehensive lifestyle changes for five years. On average, they demonstrated even more
reversal of heart disease after five years than after one year. In contrast, the patients in the
comparison group who made only the moderate lifestyle changes recommended by most
physicians (i.e., a 30% fat diet) worsened after one year and their coronary arteriès became even
more clogged after five years. Also, we found that the incidence of cardiac events (e.g., heart
attacks, strokes, bypass surgery, and angioplasty ) was 2.5 times lower in the group that made
comprehensive lifestyle changes after five years. There has been strong interest in this research in
the general public as well. A one-hour documentary of this work was broadcast on NOVA, the
PBS science series, and was featured on Bill Moyers' PBS series, Healing & The Mind.
3
These research findings have particular significance for Americans in the Medicare
population. One of the most meaningful findings in our research was that the older patients
improved as much as the younger ones. When I began the research, I believed that the younger
patients with milder disease would be more likely to show regression, but I was wrong. Instead,
the primary determinant of change in their coronary artery disease was neither age nor disease
severity but adherence to the recommended changes in diet and lifestyle. No matter how old
they were, on average, the more people changed their diet and lifestyle, the more they improved.
Indeed, the oldest patient in our study (now 83) showed more reversal than anyone. This is a
very hopeful message for Medicare patients, since the risks of bypass surgery and angioplasty
increase with age, but the benefits of comprehensive lifestyle changes may occur at any age.
These findings also have particular significance for women. Heart disease is, by far, the
leading cause of death in women in the Medicare population. Women have less access to bypass
surgery and angioplasty. When women undergo these operations, they have higher morbidity and
mortality rates than men. However, women seem to be able to reverse heart disease even easier
than men when they make comprehensive lifestyle changes.
MULTICENTER LIFESTYLE DEMONSTRATION PROJECT
The next research question was: how practical and cost-effective is this lifestyle program?
As you know, there is bipartisan interest in finding ways to control health care costs
without compromising the quality of care. Many people are concerned that the managed care
approaches of shortening hospital stays, shifting from inpatient to outpatient surgery, forcing
doctors to see more and more patients in less and less time, etc., may compromise the quality of
care because they do not address the lifestyle factors that often lead to illnesses like coronary
heart disease.
Beginning five years ago, my colleagues and I established the Multicenter Lifestyle
Demonstration Project. It was designed to determine (a) if we could train other teams of health
professionals in diverse regions of the country to motivate their patients to follow this lifestyle
program; (b) if this program may be an equivalently safe and effective alternative to bypass
surgery and angioplasty in selected patients with severe but stable coronary artery disease; and
(c) the resulting cost savings. In other words, can some patients avoid bypass surgery and
angioplasty by making comprehensive lifestyle changes at lower cost without increasing cardiac
morbidity and mortality?
In the past, lifestyle changes have been viewed only as prevention, increasing costs in the
short run for a possible savings years later. Now, this program is offered as a scientifically-proven
alternative treatment to many patients who otherwise were eligible for coronary artery bypass
surgery or angioplasty, thereby resulting in an immediate and substantial cost savings.
For every patient who chooses this lifestyle program rather than undergoing bypass
surgery or angioplasty , thousands of dollars are immediately saved that otherwise would have
been spent; much more when complications occur. (Of course, this does not include sparing the
patient the trauma of undergoing cardiac surgery.)
4
Also, providing lifestyle changes as a direct alternative for patients who otherwise would
receive coronary bypass surgery or coronary angioplasty may result in significant long-term cost
savings. Despite the great expense of bypass surgery and angioplasty, up to one-half of bypass
grafts reocclude after only five to seven years, and 30-50% of angioplastied arteries restenose
after only four to six months-an example of mopping up the floor around the overflowing sink
without also turning off the faucet. When this occurs, then coronary bypass surgery or coronary
angioplasty is often repeated, thereby incurring additional costs.
Through our non-profit research institute (PMRI), we trained a diverse selection of
hospitals around the country. The initial sites were Alegent Immanuel Medical Center/Alegent
Heart Institute, Omaha, NB; Alegent Bergen Mercy Medical Center, Omaha, NB; Beth Israel
Medical Center, New York, NY; Mercy Hospital Medical Center/Iowa Heart Center,
Des Moines, IA; Broward General Medical Center, Fort Lauderdale, FL; Palmetto Richland
Memorial Hospital, Columbia SC; Mt. Diablo Medical Center, Concord, CA; Beth Israel
Deaconess Medical Center/Harvard Medical School, Boston, MA; Scripps Hospitals and Clinics,
La Jolla, CA. Additional program sites included the School of Medicine, University of California,
San Francisco; California Pacific Medical Center, San Francisco; Franciscan Health System of the
Ohio Valley, Cincinnati Ohio; Swedish American Health System, Rockford, IL; and Swedish
Medical Center/First Hill, Seattle, WA.
Also, Highmark Blue Cross/Blue Shield of Western Pennsylvania was the first insurer to
both cover and to provide this program to its members. Over 40 other insurance companies are
covering this approach as a defined program either for all qualified members or on a case by case
basis at the sites we have trained. The Technology Assessment Committees of both Blue Cross
of California and, separately, Blue Shield of California have evaluated this program and
determined it to be reimbursable and non-investigational.
In brief, we found that 77% of people who were eligible for bypass surgery or angioplasty
were able to avoid it safely by making comprehensive lifestyle changes in the hospitals we trained.
Mutual of Omaha calculated an immediate savings of $29,529 per patient. These patients
reported reductions in angina comparable to what can be achieved with bypass surgery or
angioplasty without the costs or risks of surgery. These findings were published in the
American Journal of Cardiology in November 1998. We also found that patients who needed bypass
surgery or angioplasty were able to reduce the likelihood of needing another operation by making
comprehensive lifestyle changes after surgery.
MEDICARE
Over 500,000 Americans die annually from coronary artery disease, making it the leading
cause of death in this country. Approximately 500,000 coronary artery bypass operations and
approximately 600,000 coronary angioplasties were performed in the United States in 1994 at a
combined cost of approximately $15.6 billion, more than for any other surgical procedure. Much
of this expense is paid for by Medicare. Not everyone is interested in changing lifestyle, and some
people with extremely severe disease need surgery, but billions of dollars per year could be saved
immediately if only some of the people who were eligible for bypass surgery or angioplasty were
able to avoid it by making comprehensive lifestyle changes instead.
5
Unfortunately, for many Americans on Medicare, the denial of coverage is the denial of
access. Because of the success of our research and demonstration projects, we asked the Health
Care Financing Administration to consider providing coverage for this program. We believe that
this can help provide a new model for lowering Medicare costs without compromising the quality
of care or access to care. In short, a model that is caring and compassionate as well as
cost-effective and competent.
This approach empowers the individual, may immediately and substantially reduce health
care costs while improving the quality of care, and offers the information and tools that allow
individuals to be responsible for their own health care choices and decisions. It provides access
to quality, compassionate, and affordable health care to those who most need it.
I first met with officials from HCFA on June 9, 1994, almost five years ago, and many
times since then. Then, as now, concern was expressed that if HCFA were to cover an
"alternative medicine" program, then a "Pandora's Box" would be opened. In other words, if
HCFA covered this program, then everyone who had any kind of alternative medicine program
would demand coverage. Or, even in a more limited way, everyone who had an alternative
program for treating coronary heart disease would demand coverage from HCFA.
I understand this concern. In the first meeting with HCFA in 1994, I was accompanied by
the medical director of Mutual of Omaha. In response to this issue, he replied that Mutual of
Omaha made a decision to provide coverage for this program because it has the scientific data
from many years of randomized controlled trials demonstrating safety and efficacy. If other
programs develop this scientific evidence of safety and efficacy, then Mutual of Omaha would
consider providing coverage for those programs as well. Other insurance companies that are
providing coverage for this program in the sites we have trained have expressed similar ideas.
I appreciate very much the leadership and vision of Hon. Nancy-Ann Min DeParle at
HCFA. After going back and forth with HCFA for several years during which a variety of
options have been considered (including a demonstration project), I am respectfully requesting
that HCFA now make a decision to cover this program for selected patients. Another
demonstration project would largely duplicate the demonstration project that we have already
conducted, it would cost millions of dollars, and it would delay this program for several more
years to Americans who may benefit from it.
Coverage from HCFA could be limited to people who are choosing this program of
comprehensive lifestyle changes as a direct alternative to bypass surgery or angioplasty. These are
the patients in whom the cost savings are the most dramatic and immediate, and it would be the
easiest group in which to prevent fraud or abuse. My colleagues and I would be happy to work
with an outside group (e.g., the American College of Cardiology) that could provide certification
for any comprehensive lifestyle program that has sufficient scientific evidence of medical
effectiveness and cost effectiveness to justify coverage. This certification could be offered on a
non-exclusive basis and would meet HCFA's understandable need for credentialing of programs
to avoid fraud and abuse, thereby making the program available to the people who most need it.
In response to an earlier request from Hon. DeParle's predecessor, Bruce Vladeck,
Dr. Claude Lenfant (Director, National Heart, Lung, and Blood Institute, National Institutes of
Health) evaluated this program and found it to be safe for Americans in the Medicare population.
6
Also, bipartisan letters of support were written from President Clinton, former Speaker
Gingrich, and ten other U.S. Senators (Republican and Democrat), as well as AARP executive
director Horace Deets, former Surgeon General C. Everett Koop, and other medical authorities
including Christine Cassel, M.D. (Professor and Chairman, Department of Geriatrics and Adult
Development, The Mount Sinai Medical Center, Immediate Past President, American College of
Physicians, Chair, American Board of Internal Medicine), Alexander Leaf, M.D. (Jackson
Professor of Clinical Medicine, Emeritus, Chairman, Department of Medicine, Emeritus,
Chairman, Department of Preventive Medicine & Clinical Epidemiology, Emeritus, Harvard
Medical School and Massachusetts General Hospital), Marion Nestle, Ph.D. (Professor and Chair,
Department of Nutrition and Food Studies, New York University), and others.
We appreciate very much a recent appropriation from Congress to the Department of
Defense to make this comprehensive lifestyle change program available at the Walter Reed Army
Medical Center. If heart disease can be reversed, then the implications for prevention are even
more important. Increasing evidence links a low-fat plant-based diet with a lower incidence of
diabetes, hypertension, obesity, and cancers of the prostate, breast, and colon.
A recent editorial by the editors of The New England Journal of Medicine (1998;339(12),
p. 839-841) stated, "There cannot be two kinds of medicine-conventional and alternative.
There is only medicine that has been adequately tested and medicine that has not, medicine that
works and medicine that may or may not work. Once a treatment has been tested rigorously, it
no longer matters whether it was considered alternative at the outset. If it is found to be
reasonably safe and effective, it will be accepted." This program has been tested rigorously and
was found to be reasonably safe and effective. It works. Therefore, I respectfully submit that it
should be covered by Medicare for selected heart patients as an alternative to bypass surgery or
angioplasty.
Everyone benefits: patients have access to new choices, health professionals have new
options to serve their patients, Medicare offers an innovative approach to lowering health care
costs without compromising the quality of care, and Congress can demonstrate bipartisan
leadership in an area that is important to so many Americans.
Thank you very much for this opportunity to be here today. My colleagues and I are very
grateful for your interest in our work.
7
SELECTED REFERENCES
Original Reports
1.
Ornish DM, Scherwitz LW, Doody RS, et al. Effects of stress management training and
dietary changes in treating ischemic heart disease. JAMA. 1983;249:54-59.
2.
Sacks FM, Ornish DM, Rosner B, McLanahan S, Castelli WP, and Kass EH. Dietary
predictors of blood pressure and plasma lipoproteins in lactovegetarians.
JAMA. 1985;254:1337-1341.
3.
Ornish DM, Brown SE, Scherwitz LW, et al. Can lifestyle changes reverse coronary
atherosclerosis? The Lifestyle Heart Trial. The Lancet. 1990; 336:129-133.
4.
Ornish D. Lessons from the Lifestyle Heart Trial. Choices in Cardiology. 1991;1(5):1-4.
5.
Gould KL, Ornish D, Kirkeeide R, Brown S, et al. Improved stenosis geometry by
quantitative coronary arteriography after vigorous risk factor modification.
American Journal of Cardiology. 1992; 69:845-853.
6.
Barnard N, Scherwitz L, Ornish D. Adherence and acceptability of a low-fat, vegetarian diet
among cardiac patients. Journal of Cardiopulmonary Rehabilitation. 1992; 12:423-431.
7.
Gould KL, Ornish D, Scherwitz L, et al. Changes in myocardial perfusion abnormalities by
positron emission tomography after long-term, intense risk factor modification.
JAMA. 1995;274:894-901.
8.
Ornish D. Avoiding Revascularization with Lifestyle Changes: The Multicenter Lifestyle
Demonstration Project. American Journal of Cardiology. 1998;82:72T-76T.
9.
Ornish D, Scherwitz L, Billings J, et al. Can intensive lifestyle changes reverse coronary heart
disease? Five-year follow-up of the Lifestyle Heart Trial. JAMA. 1998;280:2001-2007.
Review Articles
1.
Ornish D. Reversing heart disease through diet, exercise, and stress management.
Journal of the American Dietetic Association. 1991; 91:162-5.
2.
Ornish D. Can life-style changes reverse coronary atherosclerosis? Hospital Practice,
May 1991.
3.
Ornish D. Can you prevent-- and reverse-- coronary artery disease? Patient Care.
1991;25:25-41.
4.
Ornish D. Can atherosclerosis regress? Cardiovascular Risk Factors. 1992; 2(4):276-281.
8
5.
Dienstfrey H. What makes the heart healthy? A talk with Dean Ornish. Advances.
1992:8(2), 25-45.
6.
Ornish D. Can lifestyle changes reverse coronary heart disease? World Review of Nutrition and
Dietetics. 1993;72:38-48.
7.
Orth-Gomér K, Burell G, Perk J, Ornish D, Benesch L, Roquebrune JP. Börja Pa Nytt
Efter Hjärtfel [Fresh start after heart disease. Changed life style is an important part of
rehabilitation.] Läkartidningen. 91:379-384.
8.
Ornish D. Dietary treatment of hyperlipidemia. Journal of Cardiovascular Risk.
1994;1:283-286.
Books
1.
Ornish D. Stress, Diet, & Your Heart. New York: Holt, Rinehart and Winston, 1982;
New American Library (Signet Books), 1983.
2.
Ornish D. Dr. Dean Ornish's Program for Reversing Heart Disease. New York: Random House,
1990; Ballantine Books, 1992.
3.
Moyers, Bill. "Changing Life Habits: A Conversation with Dean Ornish." In:
Healing and the Mind. New York: Doubleday, 1993.
4.
Ornish D. Eat More, Weigh Less. New York: HarperCollins Publishers, 1993.
5.
Ornish D. "Can lifestyle changes reverse coronary heart disease?" In: Multiple Risk Factors in
Cardiovascular Disease, 2nd Symposium Proceedings. Tokyo: Churchill Livingstone Japan, 1994.
6.
Ornish D. Everyday Cooking with Dr. Dean Ornish. New York: HarperCollins Publishers,
1996.
7.
Billings J, Scherwitz L, Sullivan R, Ornish D. Group support therapy in the Lifestyle Heart
Trial. In: Scheidt S, Allan R, eds. Heart and Mind: The Emergence of Cardiac Psychology.
Washington, DC: American Psychological Association; 1996:233-253.
8.
Ornish D, Hart J. Intensive Risk Factor Modification. In: Hennekens C, Manson J, eds.
Clinical Trials in Cardiovascular Disease. Boston: W.B. Saunders, 1998. (companion to the
Braunwald standard cardiology textbook).
9.
Ornish D. Love & Survival: The Scientific Basis for the Healing Power of Intimacy.
New York: HarperCollins, 1998.
9
Letters
1.
Ornish D. "Dietary saturated fatty acids and low-density or high-density lipoprotein
cholesterol." The New England Journal of Medicine. 1990;322:403.
2.
Ornish DM, Brown SE, Scherwitz LW, et al. Lifestyle changes and heart disease.
The Lancet. 1990; 336:741-2.
3.
Ornish D. What if Americans ate less fat? JAMA. 1992; 267(3):362.
4.
Ornish D, Brown SE. Treatment of and screening for hyperlipidemia. The New England
Journal of Medicine. 1993; 329(15): 1124-5.
5.
Ornish D. Should a Low-Fat, High-Carbohydrate Diet Be Recommended for Everyone?
The New England Journal of Medicine. 1998;338(2):127-129.
6.
Ornish D. Serum lipids after a low-fat diet. JAMA. 1998;279(17):1345-6.
7.
Ornish D. Dietary fat and ischemic stroke. JAMA. 1998;279(15):1172.
8.
Ornish D. More on low-fat diets. The New England Journal of Medicine.
1998;338(22):1623-1624.
(copy)
PREVENTIVE MEDICINE RESEARCH INSTITUTE
Deant )mish. MD.
President & Director
900 Bridgeway. Suite !
Sausalito, CA 94965
Tel. 115/332-2525 x222
FAX 415/332-5730
E-mail Dean( [email protected]
February 25, 1999
Flt. Lt. Jerry John Rawlings
President of the Republic of Ghana
Mrs. Nan Konadu Agyeman-Rawlings
c/o Blair House
702 Jackson Place
Washington, DC 20503
attention: Mr. Randy Bumgardner
Your Excellencies,
It was a great pleasure and honor to meet you last night in the receiving line of the
State Dinner honoring you, hosted by President Clinton and Mrs. Hillary Rodham Clinton at
The White House.
Please accept the enclosed copies of my books. I would be honored to be of service to
you at any time.
With best wishes and warm personal regards,
Sincerely,
Dean Ornish, M.D.
Clinical Professor of Medicine
School of Medicine
University of California, San Francisco
\ non-profit, public institute dedicated to research, education, and service
American Medical Association
Physicians dedicated to the health of America
MEDICAL
WEDICAL
News Release
EMBARGOED FOR RELEASE: 3 p.m. (CT) Tuesday, December 15, 1998
Media Advisory: To contact Dean Ornish, M.D., call 800/775-7674, ext. 222.
Long-Term Lifestyle Changes Increase Regression of Coronary Heart Disease
Coronary atherosclerosis continued to progress in those with conventional lifestyle
CHICAGO--Patients in an experimental group who made intensive changes in diet, exercise, stress
management, and other lifestyle factors showed greater reversal of coronary heart disease after five years
than after one year in the Lifestyle Heart Trial, according to an article in the December 16 issue of The
Journal of the American Medical Association (JAMA).
In contrast, the authors found that control group patients showed much more progression (continued
worsening) in average percent diameter stenosis after five years than after one year, even though more than
half of the control group patients were prescribed lipid-lowering medications during the course of the study.
Dean Ornish, M.D., of the Preventive Medicine Research Institute, Sausalito, Calif., and the University of
California at San Francisco School of Medicine, and colleagues conducted a five-year follow-up of the
Lifestyle Heart Trial. The original trial found that after one year, heart patients who made intensive lifestyle
changes had a 37.2 percent reduction in LDL cholesterol, less frequent angina, and a reduction in stenosis.
By contrast, patients who made moderate changes reduced LDL cholesterol by only 6 percent, had more
frequent angina, and greater narrowing of the blood vessels. Among the 48 patients from the original study,
35 agreed to take part in the follow-up and continued through the entire five years.
Patients in the experimental group were prescribed an intensive program that included a 10 percent fat
vegetarian diet, moderate aerobic exercise, stress management training, smoking cessation, and group
psychosocial support. Control group patients were asked to follow the advice of their personal physicians
regarding lifestyle changes, consistent with the American Heart Association's Step II diet guidelines. No
experimental group patients took lipid-lowering drugs, while 60 percent of control patients received lipid-
lowering medication. Angiograms were done at the end of five years for the 20 experimental group and 15
control patients who completed the follow-up.
Jeff Molter, Director
515 North State Street
312 464 5374
Department of Science News
Chicago, Illinois 60610
312 464 5839 Fax
--more--
(LIFESTYLE CHANGES)
Among the findings of the study:
Experimental group patients had a 91 percent reduction in frequency of angina after one year, and a
72 percent reduction after five years. Control patients had a 186 percent increase after one year, and
a 36 percent decrease after five years. Three of the five control patients who reported an increase
from baseline to year one underwent coronary angioplasty before year five.
The reduction in LDL cholesterol levels in the experiment group was comparable with results
achieved by lipid-lowering drugs for ambulatory patients.
In the experimental group, the average percent diameter stenosis (narrowing of the blood
vessels)showed a 7.9 percent relative improvement after five years, while the control group showed a
27.7 percent relative worsening.
The researchers also found more than twice as many cardiac events in the control group (45 events, 2.25
events per patient) than in the experimental group (25 events, 0.89 events per patient). Events included
heart attacks, coronary angioplasty, coronary bypass surgery, cardiac-related hospitalizations, and
cardiac-related deaths.
The authors write: "These findings support the feasibility of intensive lifestyle changes in delaying,
stopping, or reversing the progression of coronary artery disease in ambulatory patients over prolonged
periods."
The authors conclude: "In summary, these ambulatory patients were able to make and maintain
comprehensive changes in diet and lifestyle for five years and showed even more regression of coronary
atherosclerosis after five years than after one year as measured by percent diameter stenosis. In contrast,
patients following more conventional lifestyle recommendations showed even more progression of
coronary atherosclerosis after five years than after one year, and had more than twice as many cardiac
events as patients making comprehensive lifestyle changes."
(JAMA. 1998;280:2001-2007)
Editor's Note: The Preventive Medicine Research Institute is a non-profit organization. Major support for this
study was provided by grants from the National Heart, Lung, and Blood Institute of the National Institutes of
Health, Bethesda, Maryland and numerous other organizations. For a complete listing, please see the JAMA
article.
#
For more information: contact the AMA's Science News Department at 312/464-5374.
http://www.ama-assn.org/jama
Intensive Lifestyle Changes for Reversal
of Coronary Heart Disease
Dean Ornish, MD; Larry W. Scherwitz, PhD; James H. Billings, PhD, MPH; K. Lance Gould, MD;
Terri A. Merritt, MS; Stephen Sparler, MA; William T. Armstrong, MD; Thomas A. Ports, MD;
Richard L. Kirkeeide, PhD; Charissa Hogeboom, PhD; Richard J. Brand, PhD
Context.-The Lifestyle Heart Trial demonstrated that intensive lifestyle
THE LIFESTYLE Heart Trial was the
changes may lead to regression of coronary atherosclerosis after 1 year.
first randomized clinical trial to investi-
Objectives.-To determine the feasibility of patients to sustain intensive lifestyle
gate whether ambulatory patients could
changes for a total of 5 years and the effects of these lifestyle changes (without
be motivated to make and sustain com-
lipid-lowering drugs) on coronary heart disease.
prehensive lifestyle changes and, if so,
Design.-Randomized controlled trial conducted from 1986 to 1992 using a
whether the progression of coronary
randomized invitational design.
atherosclerosis could be stopped or re-
versed without using lipid-lowering
Patients.-Forty-eight patients with moderate to severe coronary heart disease
drugs as measured by computer-as-
were randomized to an intensive lifestyle change group or to a usual-care control
sisted quantitative coronary arteriogra-
group, and 35 completed the 5-year follow-up quantitative coronary arteriography.
phy. This study derived from earlier
Setting.-Two tertiary care university medical centers.
studies that used noninvasive mea-
Intervention.-Intensive lifestyle changes (10% fat whole foods vegetarian diet,
sures.
aerobic exercise, stress management training, smoking cessation, group psycho-
After 1 year, we found that experi-
social support) for 5 years.
mental group participants were able to
Main Outcome Measures.-Adherence to intensive lifestyle changes, changes
make and maintain intensive lifestyle
in coronary artery percent diameter stenosis, and cardiac events.
changes and had a 37.2% reduction in
Results.-Experimental group patients (20 [71%] of 28 patients completed
low-density lipoprotein (LDL) choles-
terol levels and a 91% reduction in the
5-year follow-up) made and maintained comprehensive lifestyle changes for 5
frequency of anginal episodes.³ Average
years, whereas control group patients (15 [75%] of 20 patients completed 5-year
percent diameter stenosis regressed
follow-up) made more moderate changes. In the experimental group, the average
from 40.0% at baseline to 37.8% 1 year
percent diameter stenosis at baseline decreased 1.75 absolute percentage points
later, a change that was correlated with
after 1 year (a 4.5% relative improvement) and by 3.1 absolute percentage points
the degree of lifestyle change. In con-
after 5 years (a 7.9% relative improvement). In contrast, the average percent diam-
trast, patients in the usual-care control
eter stenosis in the control group increased by 2.3 percentage points after 1 year
group made more moderate changes in
(a 5.4% relative worsening) and by 11.8 percentage points after 5 years (a 27.7%
lifestyle, reduced LDL cholesterol lev-
relative worsening) (P= .001 between groups. Twenty-five cardiac events occurred
els by 6%, and had a 165% increase in the
in 28 experimental group patients vs 45 events in 20 control group patients during
frequency of reported anginal episodes.
Average percent diameter stenosis pro-
the 5-year follow-up (risk ratio for any event for the control group, 2.47 [95% con-
gressed from 42.7% to 46.1%.
fidence interval, 1.48-4.20]).
Given these encouraging findings,
Conclusions.-More regression of coronary atherosclerosis occurred after 5
we extended the study for an additional
years than after 1 year in the experimental group. In contrast, in the control group,
4 years to determine (1) the feasibility
coronary atherosclerosis continued to progress and more than twice as many car-
of patients sustaining intensive changes
diac events occurred.
in diet and lifestyle for a much longer
JAMA 1998;230:2001-2007
time, and (2) the effects of these changes
on risk factors, coronary atherosclero-
sis, myocardial perfusion, and cardiac
From the Department of Medicine (Dr Ornish). and
Division of Cardiology. University of Texas Medical
events after 4 additional years.
the Division of Cardiology (Dr Armstrong), California
School, Houston (Drs Gould and Kirkeeide); and the
Pacific Medical Center, San Francisco: the Department
Preventive Medicine Research Institue, Sausalito. Calif
of Medicine (Dr Omish), the Division of Cardiology,
(Drs Omish Scherwitz. and Billings. Mr Sparler, and
METHODS
Cardiac Catheterization Laboratory. Cardiovascular
Ms Merritt).
Research Institute (Dr Ports), and the Division of
Reprints: Dean Omish, MD. Preventive Medicine Re-
The design, recruitment, and study
Biostatistics (Drs Brand and Hogeboom), School of
search Institute, 900 Bridgeway, Suite 1. Sausalito. CA
population were previously described.³⁵
Medicine, University of California, San Francisco: the
94965 (e-mail: [email protected]).
In brief, we recruited men and women
JAMA, December 16, 1998-Vol 280, No. 23
Lifestyle Heart Trial-Omish et al 2001
Table 1.-Baseline Characteristics of Experimental and Control Groups
form after being fully informed of the
Experimental
Control
P
study requirements.
Characteristic
(n 20)
(n 15)
Value
Patients completed a 3-day diet diary
Men. No.
20
12
at baseline and after 1 and 5 years to
.07
Women, No.
0
3
assess nutrient intake and dietary ad-
Age, mean (SD), y
57.4 (6.4)
61.8 (7.5)
.08
herence.6 Methods of lipid assays were
Education. mean (SD). y
15.5 (2.7)
14.5 (3.4)
.29
the same as previously reported.³ These
Employed. No.
14
6
.10
3-day diet diaries were analyzed with a
mass index. mean (SD). kg/m2
28.4 (4.1)
25.4 (3.5)
03
software package (CBORD Diet Ana-
No. with history of myocardial infarction
12
5
.17
lyzer; CBORD Group Inc; Ithaca, NY)
Average No. of lesions studied. mean (SD)
(2.7)
5.3 (3.2)
.93
using the US Department of Agricul-
No. with history of percutaneous transluminal
5
4
>.99
ture database. Also, patients were asked
coronary angioplasty
to complete a questionnaire reporting
No. with history of coronary artery bypass graft
1
0
>.99
the frequency and duration of exercise
Reported angina. No. (%)
11 (55)
6 (40)
.49
and of each stress management tech-
*Values are statistics unless otherwise indicated. P values are 2-tailed.
nique. Information from these sources
was quantified into continuous scores us-
with coronary atherosclerosis docu-
to 5-year comparisons.
ing an a priori determined formula. The
mented by quantitative coronary arte-
Four experimental and 4 control pa-
adherence measure was a continuous
riography.
tients who had an angiogram at 1 year did
score reflecting daily intake of choles-
We identified 193 patients as poten-
not have a third angiogram after 5 years.
terol (in milligrams), fat (in grams),
tially eligible for our study who agreed
Three of these 4 patients in the experi-
frequency and duration of exercise, fre-
to undergo quantitative coronary angi-
mental group refused a third angiogram
quency and duration of stress manage-
ography. Following angiography, 93
(patients only volunteered for a 1-year
ment techniques, and smoking. A score
patients remained eligible and were ran-
study that was subsequently extended),
of 1.0 equalled 100% adherence but
domly assigned to experimental or con-
and 1 died between years 1 and 4; of the 4
scores could be greater than 1.0 if par-
trol groups using a randomized invita-
control group patients who did not un-
ticipants exceeded the recommended in-
tional design to minimize crossover,
dergo a third angiogram, 1 died, 2 under-
tensive lifestyle changes.
ethical concerns, nocebo effects, and
went revascularization of the arterial
The technicians responsible for per-
dropout. Of these 93 patients who were
lesions under study, and 1 developed
forming all medical tests were blinded to
eligible, 53 were randomly assigned to
Parkinson disease and became too ill to
patient group assignment. Also, different
the experimental group and 40 to the
be safely tested. Cine arteriograms made
personnel implemented the lifestyle in-
usual-care control group. Patients were
in San Francisco, Calif, were sent to the
tervention, conducted the tests, and com-
then contacted and invited to participate
University of Texas Medical School,
puted statistical analyses, although the di-
in the study; 28 (53%) and 20 (50%)
Houston, for blinded quantitative analy-
etitian was made aware of the nutrient
agreed to participate in the experimen-
ses as previously described in detail.
analysis to monitor patients' safety and
tal and control groups, respectively. The
All results, except lesion changes at 1
adherence. Quantitative coronary arte-
primary reason for refusal in the experi-
year (18 experimental and 15 control
riograms were blindly analyzed without
mental group was not wanting to un-
subjects) and cardiac events after 5
knowledge of group assignment.
dergo intensive lifestyle changes and/or
years (all 28 experimental and 20 control
not wanting a second coronary angio-
subjects), are based on the total of 35
Program Intervention
gram; control patients refused primarily
patients (20 experimental and 15 control
Experimental group patients were
because they did not want to undergo a
subjects) who had both baseline and 5-
prescribed an intensive lifestyle pro-
second angiogram. To detect possible se-
year angiograms. From these 35 pa-
gram that included a 10%-fat vegetarian
lection biases, we collected data on age,
tients, there were 224 lesions studied at
diet, moderate aerobic exercise, stress
marital status, reported angina, history
baseline, of which 24 were 100% occluded
management training, smoking cessa-
of myocardial infarction, height, weight,
and were excluded a priori from the le-
tion, and group psychosocial support
number of diseased lesions, and stenosis
sion-change analyses per the study pro-
previously described in detail. 3,7-10 Pa-
severity for all patients who were ran-
tocol. Of the remaining 200 lesions, 14
tients were encouraged to avoid simple
domized into the study but refused to
were lost to the 4-year follow-up, as fol-
sugars and to emphasize the intake of
participate. We did not exclude any ex-
lows: in the experimental group, 2 le-
complex carbohydrates and other whole
perimental group patients who volun-
sions were excluded due to technical fail-
foods. Only 1 patient in the experimental
teered even if we doubted their ability to
ure during the angiogram and 2 had
group was actively smoking at baseline,
adhere to the lifestyle program. All pa-
views that did not match; in the control
and she quit at entry. Control group pa-
tients who volunteered were followed up
group, views did not match for 3 lesions,
tients were asked to follow the advice of
using the intention-to-treat principle.
3 lesions were excluded due to technical
their personal physicians regarding life-
After 1 year, 7 patients did not pro-
failure, 1 was excluded due to angio-
style changes.
ride angiographic data, and the reasons
plasty, and 3 were excluded due to coro-
or loss to follow-up have been reported.³
nary artery bypass surgery. Of the 1S6
Statistical Methods
)f the remaining 41 patients at baseline
lesions available for analysis at 4 years,
We decided a priori to use percent di-
nost had severe coronary atherosclero-
109 were from the experimental group
ameter stenosis as the primary depen-
is: 28 had 3-vessel disease, 12 had
and 77 were from the control group.
dent variable. Statistical methods to
-vessel disease, and 1 had 1-vessel
The 1-year original study and the 4-
compare the 2 groups were previously
isease. Two of these patients whose
year extension were approved by the
described. Analysis of adherence vari-
ngiographic data were not usable after
committees on human research at Cali-
ables and risk factor levels used time-
y agreed to undergo quantitative
fornia Pacific Medical Center and Uni-
structured repeated measures in which
bronary arteriography after 5 years;
versity of California, San Francisco, and
levels from all 3 measurement times
nese results are included in the baseline
each patient signed a written consent
(baseline, 1 year, and 5 years) were in-
02 JAMA. December 16. 1998-Vol 280. No. 23
L
le
Trial-Omish et at
Table 2.-Adherence to Exercise. Stress Management. and Dietary Guidelines
(SEM) at e
(SEM) at 1 Year
Mean (SEM) at 5
Experimental
Control
Experimental
Control
P Value*
Experimental
Control
P Value*
(n 20)
(n 15)
(n 20)
(n = 15)
Baseline-1 Year
(n 20)
(n a 15)
Baseline-5 Years
Exercise
Times per week
2.66 (0.84)
2.38 (0.77)
4.97 (0.35)
2.87 (0.70)
.06
4.34 (0.49)
3.57 (0.56)
.64
Hours per week
2.26 (0.85)
2.42 (0.99)
5.02 (0.61)
2.52 (0.70)
.12
3.56 (0.56)
2.90 (0.65)
.50
Stress management
Times per week
0.70 (0.41)
0.15 (0.10)
8.22 (0.73)
0.49 (0.25)
<.001
4.93 (1.02)
0.74 (0.39)
<.001
Minutes per day
6.01 (3.56)
1.71 (1.19)
(7.85)
4.47 (2.79)
<.001
48.53 (10.36)
8.44 (6.11)
.001
Fat intake
Grams per day
63.67 (4.35)
57.42 (5.94)
12.71 (1.06)
52.38 (5.31)
<.001
17.34 (2.30)
44.09 (6.66)
<.001
% of Energy intake
29.71 (1.8)
30.52 (2.9)
6.22 (0.3)
28.76 (2.3)
<.001
8.51 (1.0)
25.03 (2.7)
<.001
Dietary cholesterol, mmoVL [mg/dL]
5.47 (0.672)
5.49 (0.908)
0.08 (0.002)
4.69 (0.636)
<.001
0.48 (0.140)
3.59 (0.641)
.002
[211.4 (26.0)]
[212.5 (35.1)]
(3.3 (0.8)]
[181.3 (24.6)]
(18.6 (5.4)]
[138.7 (24.8)]
Energy intake, J/d
8159 (473)
7159 (489)
7623 (473)
7004 (489)
.64
7724 (485)
6581 (489)
.86
Total adherence scoret
0.62 (0.08)
0.60 (0.07)
1.29 (0.08)
0.64 (0.07)
<.001
1.06 (0.08)
0.72 (0.07)
<.001
"All P levels are 2-tailed and each is a result of a test of the null hypothesis that the change between 2 particular visits (eg, baseline and 1 year) does not differ between
the experimental and control groups.
Percentage of minimum recommended level of combined litestyle change: includes all the above plus smoking cessation.
Table 3.-Baseline Levels, 1-Year, and 5-Year Change Scores in Coronary Artery Lesions*
Mean at Baseline (95% CI)
Change Scores at 1 Year (95% CI)
Change Scores at 5 Years (95% CI)
Experimental
Control
Experimental
Control
P Valuet
Experimental
Control
P Valuet
(n 20)
(n 15)
(n 18)
(n 15)
Baseline-1 Year
(n 20)
(n 15)
Baseline-5 Years
Diameter stenosis. %
38.92
42.50
-1.75
2.28
.02
-3.07
11.77
.001
(35.29 to 42.54)
(38.18 to 46.31)
(-4.08 to 0.58)
(-3.0 to 4.86)
(-5.91 to -0.24)
(3.40 to 20.14)
Minimum diameter, mm
1.64
1.74
0.01
-0.12
11
0.001
-0.34
.05
(1.44 to 1.84)
(1.50 to 1.97)
(-0.10 to 0.12)
(-0.25 to -0.001)
(-0.11 to 0.11)
(-0.66 to -0.02)
Normal diameter, mm
2.65
2.96
-0.06
-0.10
.68
-0.13
0.045
.01
(2.39 to 2.92)
(2.64 to 3.27)
(-0.16 to 0.03)
(-0.27 to 0.06)
(-0.26 to 0.01)
(0.017 to 0.072)
"CI indicates confidence interval.
tAll Plevels are 2-tailed and each is a result of a test of the null hypathesis that the change between 2 particular visits (eg. baseline and 1 year) does not differ between
the experimental and control groups.
cluded in a single regression model. Sta-
volunteered in all available data except
by the square of the height in meters)
tistical significances of group differences
those who volunteered were more likely
(23.4 vs 25.4 kg/m²; P = .03) and had lower
were obtained for baseline levels, 1-year
to have a history of angina (87% vs 65%;
high-density lipoprotein (HDL) choles-
changes, and 5-year changes using F
P = .02), a greater number of lesions (4.5
terol levels (1.04 mmol/L [40.1 mg/dL] vs
tests. All repeated measures analyses
vs 3.5; P = .04), and slightly more se-
1.36 mmol/L [52.4 mg/dL]; P = .04),
were implemented using PROC MIXED
verely stenosed lesions (2.3 vs 2.0 on a
which was also reflected in lower apoli-
under SAS version 6.08." Analysis of le-
3-point scale; P = .05).
poprotein A-I levels (3.45 mmol/L [133.1
sion data used a repeated measures
mg/dL] vs 4.08 mmol/L [157.5 mg/dL];
model in which the repeated measures
Baseline Comparisons
P = .03). The lower body mass index in
were baseline or change values for mul-
of Experimental Group
the control group may be due to the
tiple lesions within each subject. Change
With Control Group
larger number of women in the control
scores were used for the baseline to 1-
Analyses across the 35 volunteers at
group. Other lipid values, including ra-
year and baseline to 5-year follow-up pe-
baseline for whom 4-year lesion data
tios of total cholesterol to HDL and LDL
riods, and analysis of baseline levels, 1-
were available showed no significant dif-
to HDL, did not differ significantly at
year changes, and 5-year changes were
ferences between the experimental
baseline (Table 4).
done separately. Again, F tests provided
group and the control group in demo-
by SAS PROC MIXED were used to test
graphic characteristics, history of myo-
Program Adherence
significance of differences between
cardial infarction, angioplasty, bypass
In the experimental group, adherence
groups with respect to baseline levels,
surgery, lesion number, lesion stenosis,
to all aspects of the program was excel-
1-year changes, and 5-year changes. The
dietary fat or cholesterol intake, exer-
lent during the first year and good after 5
SAS PROC MIXED linear regression,
cise and stress management practice,
years, whereas control group patients
which allowed for dependence in data,
blood pressure, exercise capacity, and
maintained more moderate changes dur-
was used to determine the relationship
psychosocial measures (Tables 1-3).
ing the 5 years consistent with conven-
between adherence-and percent diam-
Among the many comparisons, only a
tional guidelines (Table 2). The percent-
eter stenosis changes. Relative rates for
few differed significantly (P<.05). More
age of daily energy (calories) provided by
cardiac events were analyzed and tested
women were randomly assigned to the
fruits, vegetables, whole grains, soy,
by Poisson regression using exact tests
control group (4) than to the experimen-
other legumes, nonfat dairy, and alcohol
(Stata 5.0, College Station, Tex).
tal group (1); this fact accounted for half
was comparable at 1 year and at 5 years.
the weight difference (10 kg) between
In the experimental group, fat intake
RESULTS
the 2 groups and most of the height dif-
decreased from approximately 30% to
Baseline Comparisons
ference (6 cm).
8.5%, cholesterol from 211 to 18.6 mg/d,
of Volunteers With Refusals
Experimental group patients had a
energy from 8159 to 7724 J (1950-1846
Those who declined the invitation to
slightly larger body mass index (mea-
cal), protein from 17% to 15%, and carbo-
be in the study were similar to those who
sured as the weight in kilograms divided
hydrates increased from 53% to 76.5%. In
JAMA, December 16, 1998-Vol 280, No. 23
Lifestyle Heart Trial-Omish et al
2003
Table 4.-Changes in Risk Factors
Mean (SEM) at Baseline
Mean (SEM) at 1 Year
Experimental
Control
Experimental
Control
Risk Factor
(n = 20)
(n 15)
(n 20)
(n 15)
Serum lipids. mmol/L [mg/dL]
Total cholesterol
5.83 (0.31) (225.1 (11.9))
6.42 (0.24) (247.9 (9.4)]
4.22 (0.22) [162.9 (8.4)]
6.33 (0.38) [244.3 (14.7)]
Low-density lipoprotein
3.72 (0.29) [143.80 (11.21)]
4.30 (0.19) [166.40 (7.46)]
2.24 (0.24) [86.56 (9.41)]
4.25 (0.38) [164.13 (14.85)]
High-density lipoprotein
1.04 (0.07) (40.05 (2.78)]
1.36 (0.14) (52.36 (5.54)]
0.94 (0.10) [36.28 (3.81)]
1.34 (0.10) (51.87 (3.81)]
Triglycende
5.90 (0.69) [227.8 (26.5)]
5.78 (1.63) (223.3 (63.0)]
6.69 (0.75) [258.2 (29.1)]
4.30 (0.40) (166.1 (15.5)]
Apolipoproteins, g/L
A-I
1.331 (0.046)
1.575 (0.092)
1.308 (0.057)
1.761 (0.121)
B
1.000 (0.054)
1.024 (0.062)
0.7685 (0.046)
1.085 (0.053)
Blood pressure. mm Hg
Systolic
135.3 (4.0)
137.2 (4.5)
126.4 (3.9)
128.8 (4.5)
Diastolic
81.70 (2.05)
80.27 (3.15)
77.03 (2.01)
75.07 (8.15)
Weight. kg
91.40 (3.42)
75.74 (4.37)
80.64 (2.48)
77.18 (4.73)
"All levels are 2-tailed and each is a result of a test of the null hypothesis that the change between 2 particular visits (eg, baseline and 1 year) does not differ between
the experimental and control groups.
Table 5.-Reported Angina Symptoms
Mean (SD) at Baseline
Mean (SD) at 1 Year
Mean (SD) at 5 Years
Experimental
Control
Experimental
Control
P Value*
Experimental
Control
P Value*
(n 18)
(n 14)
(n 18)
(n 14)
Baseline-1 Year
(n 18)
(n 14)
Baseline-5 Years
Chest pain frequency, times per week
5.8 (14.7)
1.4 (1.8)
0.5 (0.8)
4.0 (9.3)
.08
1.6 (2.7)
0.9 (1.9)
.32
C
pain duration, min
3.1 (4.8)
3.2 (8.4)
1.8 (4.7)
7.6 (15.9)
.11
0.9 (1.3)
1.0 (2.7)
.93
C
pain severity (1-7 scale)
1.5 (1.5)
0.6 (0.8)
0.7 (1.2)
1.4 (1.2)
<.001
0.9 (1.4)
0.6 (1.1)
.29
*All P levels are 2-tailed and each is a result of a test of the null hypothesis that the change between 2 particular visits (eg. baseline and 1 year) does not differ between
the experimental and control groups.
the control group, fat intake decreased
A-I did not change in the experimental
4.5% relative improvement) and by 3.1
from 30% to 25%, cholesterol from 212.5
group, but it increased in the control
absolute percentage points after 5 years
to 138.7 mg/d, energy from 5.49 to 3.59 J
group (P = .04). High-density lipoprotein
(a 7.9% relative improvement). In con-
(1711-1573 cal), protein from 19% to 18%,
levels and blood pressure did not differ
trast, the average percent diameter ste-
and carbohydrates increased from 51% to
between the 2 groups.
nosis in the control group increased by
52%. Since patients. volunteered origi-
2.3 percentage points after 1 year (a5.4%
nally only for a 1-year study, there was a
Angina Pectoris
relative worsening) and by 11.8 percent-
significant decrease in meeting atten-
Experimental group patients had a
age points after 5 years 27.7% relative
dance after 1 year for 4 of the patients.
91% reduction in reported frequency of
worsening). These between-group dif-
Walking was the recommended form of
angina after 1 year and a 72% reduction
ferences were statistically significant af-
exercise, but some patients jogged or did
after 5 years (Table 5). In contrast, con-
ter both 1 year and 5 years (P = .02 and
more strenuous exercise.
trol group patients had a 186% increase
P = .001, respectively, Figure 1).
in reported frequency of angina after 1
Figure 2 shows the experimental
Risk Factor Changes
year and a 36% decrease in frequency
group changes in percent diameter ste-
Patients in the experimental group
after 5 years. The decrease in angina in
nosis from baseline to 5 years according
lost 10.9 kg (23.9 lbs) at 1 year and sus-
the control group after 5 years was in
to tertiles of adherence to the lifestyle
tained a weight loss of 5.8 kg (12.8 lbs) at
large part because 3 of the 5 patients
intervention. As seen at 1 year,3 there
5 years, whereas weight in the control
who reported an increase in anginal epi-
was also a strong correlation between
group changed little from baseline. In
sodes from baseline to 1 year underwent
adherence and percent diameter steno-
the experimental group, LDL choles-
coronary angioplasty between years 1
sis after 5 years in a dose-response rela-
terol levels decreased by 40% at 1 year
and 5. Because of this reduction in angina
tionship; the tertile of patients that was
and remained 20% below baseline at 5
in control group patients who under-
most adherent to the program had the
years. In the control group, LDL choles-
went revascularization, the between-
most regression, the tertile with inter-
terol levels decreased by 1.2% at 1 year
group differences were no longer signifi-
mediate adherence had less regression,
and by 19.3% at 5 years. There were no
cant after 5 years (Table 5).
and the tertile with the least adherence
statistically significant differences in
halted the progression of disease with-
LDL levels between the 2 groups at 5
Angiographic Changes
out regression (P = .04). Of interest is
years, primarily because 9 (60%) of
All detectable lesions that matched at
that this relationship was not related to
15 control patients took lipid-lowering
baseline and 5-year follow-up and were
age or disease severity. There was no
drugs between year 1 and year 5 of the
not 100% occluded at baseline were in-
significant relationship between adher-
study. None of the experimental group
cluded in the analyses (n = 186). At base-
ence and lesion changes in the control
patients took lipid-lowering drugs dur-
line, there were no significant differ-
group, perhaps because many of these
ing the 5 years of the study. Fourteen
ences between the experimental and
patients began taking lipid-lowering
patients in the experimental group and
control groups in any measure of lesion
drugs, which may have confounded the
11 patients in the control group took as-
severity (Table 3). In the experimental
ability to detect a possible relationship.
pirin during the study.
group, the average percent diameter
Indeed, we found significant correla-
Triglycerides did not change signifi-
stenosis at baseline decreased 1.75 ab-
tions between changes in lipid levels
cantly in either group. Apolipoprotein
solute percentage points after 1 year (a
(LDL and total cholesterol) and changes
2004 JAMA, Decem
16, 1998-Vol 280. No. 23
Lifestyle Heart Trial-Omish et al
60
Mean (SEM) at 5 Years
P Value*
Experimental
Control
P Value*
Baseline-1 Year
(n 20)
(n 15)
Baseline-5 Years
55
.004
4.87 (0.20) (188.0 (7.8))
5.62 (0.20) (217.0 (7.9)]
.60
51.9
.003
2.99 (0.20) (115.35 (7.59)|
3.47 (0.21) [133.80 (8.25)]
.76
50
.35
0.90 (0.05) (34.75 (2.03)]
1.28 (0.12) [49.27 (4.47)]
.54
Control
.17
6.11 (0.59) [236.1 (22.9))
5.48 (0.78) [211.5 (30.2)]
.78
.11
1.302 (0.092)
1.839 (0.139)
.04
.004
1.014 (0.072)
0.991 (0.083)
.63
Diameter Stenosis,
45
41.3
42.3
.96
130.0 (3.9)
123.3 (4.7)
.19
40
40.7
H
.91
76.63 (2.01)
73.61 (3.25)
.74
38.5
37.3
.001
85.64 (2.88)
77.09 (4.5)
.001
35
Treatment
in lesions in both groups. These correla-
duction (continued improvement) after
30
Baseline
1 y
5 y
tions remained significant when exam-
5 years than after 1 year in experimental
ining either the lipid values at 5 years or
group patients who were asked to make
the change in lipid values from baseline
intensive lifestyle changes. In contrast,
Figure 1.-Mean percentage diameter stenosis in
treatment and control groups at baseline, 1 year.
to 5 years.
control group patients showed much
and 5 years. Error bars represent SEM: asterisk.
As a secondary analysis, we examined
more progression (continued worsening)
P=.02 by between-group 2-tailed test: dagger,
the results in control group patients who
in average percent diameter stenosis af-
.001 by between-group 2-tailed test.
began taking lipid-lowering drugs during
ter 5 years than after 1 year, even though
the study. Percent diameter stenosis pro-
more than half of the control group pa-
gressed from 45.7% to 51.7%, a change of
tients were prescribed lipid-lowering
do
6.0 absolute percentage points. In the con-
medications during the course of the
trol patients who did not take lipid-low-
study. Although the sample size was
-7
-6.81
ering drugs the disease progressed from
relative small, 12 these differences were
40.7% to 59.7%, a much greater change of
statistically significant at both 1 year
-6
19.0 absolute percentage points. (No ex-
and 5 years. These findings support the
perimental group patients took lipid-low-
feasibility of intensive lifestyle changes
Changes in Diameter Stenosis (Baseline to 5
-5
ering drugs during the study.)
in delaying, stopping, or reversing the
1
The change in body mass index from
progression of coronary artery disease
-3.02
baseline to 1 year (r = -0.85; P<.001)
in ambulatory patients over prolonged
-3
and from baseline to 5 years = -0.72;
periods.
P = .001) was significantly correlated with
We found more than twice as many
-2
the change in percent diameter stenosis
cardiac events per patient in the control
-1
in the control group only. In other words,
group than in the experimental group.
-0.37
those who gained weight were more likely
These findings are consistent with other
0
to show progression of atherosclerosis.
clinical trials showing that even small
changes in percent diameter stenosis are
1
Cardiac Events
Most
Medium
Least
often accompanied by marked reduc-
Adherence
Adherence
Adherence
Data on cardiac events were obtained
tions in cardiac events. 13-10 Other studies
(1.60-1.20)
(1.18-0.83)
(0.73-0.47)
from all 48 patients. Cardiac events in-
have demonstrated how quickly the
(n 6]
(n = 7]
(n 6]
cluded myocardial infarction, coronary
coronary artery endothelium stabilizes
angioplasty, coronary artery bypass sur-
in response to lipid-lowering drugs. 17.18
Figure 2-Changes in percentage diameter steno-
gery, cardiac-related hospitalizations,
Although there was some reduction in
sis by 5-year adherence tertiles for the experimen-
and cardiac-related deaths. At 5 years,
adherence to the intensive lifestyle in-
tal group.
there were more cardiac events in the
tervention between years 1 and 5 in the
control group (45 events for 20 patients,
experimental group, long-term adher-
population. 19 In contrast, the Step II diet
or 2.25 events per patient) than the ex-
ence remained remarkably high in this
reduces LDL cholesterol by only 5% or
perimental group (25 events for 28 pa-
sample of self-selected patients. The
less.
20.21
tients, or 0.89 events per patient) (Table
level of lifestyle change, even at 5 years.
High-density lipoprotein levels de-
6). Control group patients were more
is greater than in any other published
creased and triglycerides increased in
likely to have undergone coronary angi-
study of ambulatory populations. These
experimental group patients overall, al-
oplasty and bypass surgery and/or to
results are especially encouraging be-
though the ratio of LDL to HDL was
have been hospitalized for cardiac-re-
cause these patients initially volun-
improved. Recent reports assert that
lated problems than were experimental
teered to participate for only 1 year
this phenomenon, which is often seen in
group patients.
when they entered the study.
very low-fat diets, may be harmful. 22.23
The experimental group reduced LDL
However, patients in the Lifestyle
COMMENT
cholesterol levels by 40% at 1 year and by
Heart Trial showed even more regres-
The primary end point of this study,
20% after 5 years; these reductions are
sion of coronary atherosclerosis after 5
chosen a priori, was percent diameter
comparable with those achieved with
years than after 1 year as well as signifi-
stenosis. On average, there was more re-
lipid-lowering drugs in an ambulatory
cantly decreased cardiac events. Low
JAMA, December 16, 1998-Vol 280, No. 23
Lifestyle Heart Trial-Omish et al
2005
Table 6.-Cardiac Events During 5-Year Follow-up
et al29 reported that a similar diet plus
lipid-lowering drugs in 11 patients caused
No. of Events
regression of 11 lesions and stabilization
Experimental
Controlt
Risk
95% Confidence
P
in the remaining 14 lesions after 5.5 years.
(n 28)
(n 20)
Ratio
Interval
Value
Although there was no control group,
Myocardial infarction
2
4
2.74
0.393-30.3
.26
those who were adherent to the diet re-
Percutaneous transluminal
8
14
2.40
0.939-6.60
<.05
coronary angioplasty
ported substantially fewer cardiac events
Coronary artery bypass graft
2
5
3.43
0.561-36.0
than those who were not adherent.
.14
Cardiac hospitalizationst
23
44
2.62
1.55-4.55
<.001
Like all clinical trials, our study has
Deaths
2
1
0.685
0.012-13.2
.81
limitations. Although the study partici-
Any event
25
45
2.47
1.48-4.20
<.001
pants were a diverse group, they may
not be representative of the general
*Person-years of observation was 108.04.
population of patients with coronary
+Person-years of observation was 78.81.
Includes myocardial infarction, percutaneous transluminal coronary angioplasty. and coronary artery bypass
heart disease. Half of the patients who
graft.
underwent quantitative coronary arte-
riography in the participatory hospitals
HDL cholesterol levels due to reduced
eter remained stable in the experimental
did not meet all of the inclusion and ex-
fat intake are the result of a decreased
group but markedly narrowed in the con-
clusion criteria and were not invited to
transport rate rather than the increased
trol group during the 5 years of the study.
participate in the study. Also, half of the
catabolism that is responsible for most
At 5 years, the differences between the
patients who were invited declined to
cases of low HDL cholesterol levels in
experimental and control groups were
enroll in the study. Nevertheless, it is
persons consuming a typical Western
statistically significant for both percent
encouraging that 50% of the patients who
diet.24 Populations consuming low-fat,
diameter stenosis and minimum diam-
were contacted agreed to volunteer de-
plant-based diets have low HDL choles-
eter, even though control group pa-
spite the requirement for repeated arte-
terol levels and low rates of coronary
tients reported risk reduction behavior
riography and that experimental group
heart disease. Our data provide evidence
consistent with a Step II diet of the Na-
patients were able to make and maintain
using quantitative coronary arteriogra-
tional Cholesterol Education Program
comprehensive lifestyle changes. The
phy in this population that diet-induced
and the American Heart Association:
angiographic measures lost to follow-up
lowering of HDL cholesterol does not
they consumed an average of 25% of en-
may have affected the treatment and con-
confer the same risk of atherosclerosis
ergy (calories) from fat and exercised an
trol groups differently, although there
as do low HDL cholesterol levels in
average of 3.5 times per week. These data
are no data to suggest that this occurred.
Americans consuming a high-fat diet.
are consistent with other studies indi-
In addition, there is a possibility of dif-
Experimental group patients whose tri-
cating that moderate changes in diet and
ferential loss of lesions in patients, al-
glycerides increased during the first
lifestyle may not be sufficient to stop the
though no evidence indicates that this oc-
year were asked to minimize their in-
progression of coronary atherosclerosis
curred; in both groups, there were 14 le-
take of simple carbohydrates, and tri-
unless combined with lipid-lowering
sions that were lost to follow-up. Also, 4
glyceride levels decreased between year
drugs.²⁷
lesions were lost in the control group to
1 and year 5.
After 5 years, the normal diameter
bypass surgery or angioplasty; since
The experimental group's marked re-
(the segment of least narrowing proxi-
these lesions were worsening sufficiently
duction in frequency, severity, and du-
mal to the minimum diameter) de-
to require revascularization, the exclu-
ration of angina after 1 year was sus-
creased slightly in the experimental
sion of these lesions from analysis would
tained at similar levels after 5 years. This
group but widened slightly in the control
make between-group differences more
long-term reduction in angina is compa-
group. A slight decrease in normal diam-
difficult to detect. We recently completed
rable with that achieved following coro-
eter, at least up to a point, may improve
a multicenter demonstration project to
nary artery bypass surgery or angio-
myocardial perfusion by streamlining
assess the practicality and cost-effective-
plasty and helps to maintain long-term
flow-decreasing the forward flow
ness of this intervention in a larger
adherence.² Between-group differences
losses that occur when going from a
sample of economically and geographi-
in most measures of chest pain were not
larger to a sharply reduced lumen diam-
cally diverse patients with coronary
statistically significant after 5 years be-
eter.⁴ Conversely, the slight increase in
heart disease.*0
cause there was a large variability in an-
the normal diameter and reduction in the
Although we did not use lipid-
gina and control group patients who
minimum diameter seen in control group
lowering drugs in the experimental
were the most symptomatic underwent
patients increased the entry angle, fur-
group, their value has been demon-
revascularization.
ther reducing blood flow. These theoreti-
strated in studies that have been pub-
When we began this study, we be-
cal considerations are consistent with
lished since the Lifestyle Heart Trial be-
lieved that the younger patients with
the substantially increased myocardial
gan. We do not know if experimental
milder disease would be more likely to
perfusion in the experimental group and
group patients may have demonstrated
show regression, but we did not find this
decreased myocardial perfusion in the
even more improvement by including
0 be true. Instead, we found that the pri-
control group that we measured using
lipid-lowering drugs. 14-16 Patients in the
nary determinant of change in percent
cardiac positron emission tomography
control group who were not prescribed
liameter stenosis in the experimental
scans.⁵
lipid-lowering drugs during the study
group was neither age nor disease se-
A much earlier study by Morrison3
showed more than 3 times as much pro-
verity but adherence to the recom-
found that moderate reductions in fat and
gression in percent diameter stenosis as
nended changes in diet and lifestyle. This
cholesterol intake improved cardiac sur-
those who were. No experimental group
elationship of adherence to percent di-
vival: after 12 years, all of the control
patients took lipid-lowering drugs dur-
meter stenosis in the experimental
group patients had died compared with
ing the study, yet they showed better re-
roup was found after 1 year3 and also af-
only 62% of experimental group pa-
sults than control group patients who
er 5 years in a dose-response relation-
tients in a nonrandomized trial. More re-
were taking these drugs. Lipid-
hip. Coronary artery minimum diam-
cently, an important study by Esselstyn
lowering drugs are expensive, compli-
006 JAMA, December 16, 1998-Vol 280. No. 23
Lifestyle Heart Trial-Omish et al
ance is difficult to achieve," and long-
many cardiac events as patients making
Glenn Foundation, Santa Barbara, Calif, Corporate
term safety is unknown. In practice,
comprehensive lifestyle changes.
Property Investors, New York, NY, the Seretean
Foundation, Boca Raton, Fla, the Weatherhead
patients may be offered a range of thera-
Foundation, Cleveland, the Texas Commerce Bank
peutic options, including comprehen-
Major support for this study was provided by
Foundation. Houston, and Arthur Andersen & Co,
grants from the National Heart, Lung, and Blood
sive lifestyle changes, lipid-lowering
Houston.
Institute of the National Institutes of Health,
therapy, and revascularization, either
We are indebted to the following who performed
Bethesda, Md (RO1HL42554). the Department of
quanitative coronary arteriography for this study:
separately or in combination.
Health Services of the State of California, Sacra-
Robert Bernstein, MD. Craig Brandman, MD.
In summary, these ambulatory pa-
mento (1256SC-01). The Henry J. Kaiser Family
Bruce Brent, MD. Ralph Clark. MD. Keith Cohn.
Foundation, Menlo Park. Calif. Gerald D. Hines In-
tients were able to make and maintain
MD. James Cullen. MD, Richard Francoz, MD. Kent
terests. Houston, Tex. Houston Endowment Inc,
comprehensive changes in diet and life-
Gershengorn, MD. Gabriel Gregoatos, MD, Lester
Houston, The John E. Fetzer Institute, Kalamazoo.
Jacobsen. MD, Myron Marx, MD. Patricia McK-
style for 5 years and showed even more
Mich. The Nathan Cummings Foundation. New
enna, MD, Roy Meyer, MD. Gerald Needleman, MD,
regression of coronary atherosclerosis af-
York, NY, The Bucksbaum Foundation. Des
Gene Shafton, MD. Brian Strunk. MD, Anne
Moines. Iowa, Gross Foundation, Houston. Pritzker
ter 5 years than after 1 year as mea-
Thorson, MD. and John Wack, MD. as well as the
Foundation, Chicago, III. The Enron Foundation.
sured by percent diameter stenosis. In
head angiography nurses Georgie Hesse, RN, and
Houston. the Milken Family Foundation. Los An-
LaVeta Luce. RN. Dale Jones, RT, and Yvonne
contrast, patients following more con-
geles, Calif, The Bomer Foundation, Houston, Con-
Stuart. RT. provided technical support for the arte-
ventional lifestyle recommendations
tinental Airlines, Houston, the Credit Suisse First
riographic analyses. Special appreciation to Jean-
showed even more progression of coro-
Boston Foundation, New York, the Groppe Foun-
Marc Fullsack for food services and to Marjorie
dation, Houston, the Ray C. Fish Foundation. Hous-
nary atherosclerosis after 5 years than
McClain and Myrna Melling for administrative
ton, the Moldaw Philanthropic Fund, Atherton,
support.
after 1 year, and had more than twice as
Calif, the Dawson Foundation, Cleveland, Ohio, the
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fects of diet and exercise in men and postmenopausal
lipid-lowering drugs. JAMA 1996;275:55-60.
JAMA, December 16, 1998-Vol 280, No. 23
Lifestyle Heart Trial-Omish et al 2007
The
American
Journal
of
Cardiology
NOVEMBER 26, 1998
A Symposium:
Summit on Cholesterol and
Coronary Disease
2ND NATIONAL CONFERENCE ON LIPIDS IN THE
ELIMINATION AND PREVENTION OF CORONARY DISEASE
GUEST EDITOR:
Caldwell B. Esselstyn, Jr., MD
Department of General Surgery
The Cleveland Clinic Foundation
Cleveland, Ohio
CME ISSUE SPONSORED BY THE CLEVELAND CLINIC FOUNDATION
Avoiding Revascu arization with
Lifestyle Changes: The Multicenter
Lifestyle Demonstration Project
Dean Ornish, MD, for the Multicenter Lifestyle Demonstration Project Research Group
The Multicenter Lifestyle Demonstration Project was de-
were able to avoid revascularization for at least 3 years
signed to determine if comprehensive lifestyle changes
by making comprehensive lifestyle changes at substan-
can be a direct alternative to revascularization for se-
tially lower cost without increasing cardiac morbidity
lected patients without increasing cardiac events. A total
and mortality. These patients reported reductions in on-
of 333 patients completed this demonstration project
gina comparable with what can be achieved with
(194 in the experimental group and 139 in the control
revascularization. ©1998 by Excerpta Medica, Inc.
group). We found that experimental group patients
Am J Cardiol 1998;82:72T-76T
T
he idea that the progression of coronary artery
These lifestyle changes include a very low-fat, low-
disease is often reversible was once a radical con-
cholesterol diet (approximately 10% fat, <10 mg/day
cept but now has become mainstream. as these pro-
dietary cholesterol, a whole-foods vegetarian diet high
ceedings clearly demonstrate. A number of interven-
in complex carbohydrates and low in simple sugars),
tions have been shown to arrest or reverse the pro-
stress management techniques, moderate exercise, and
gression of coronary atherosclerosis, many of which
psychosocial support. Endpoint measures included
have been detailed in this symposium. These include
quantitative coronary arteriography to assess coronary
comprehensive changes in diet and lifestyle 1-3 lipid-
artery stenosis and cardiac positron emission tomog-
lowering drug therapy.4 partial ileal bypass sur-
raphy to assess myocardial perfusion. 2.10
gery.⁷ and parenteral nutrition.⁸
In the past, insurance companies, managed care
Approximately 500,000 coronary artery bypass
organizations, and Medicare have been reluctant to
graft (CABG) operations and approximately 600,000
pay for lifestyle interventions, in part because these
percutaneous transluminal coronary angioplasties
have been viewed as prevention-increasing costs in
(PTCAs) were performed in the United States in 1994
the short run for a possible savings years later. Also,
at a combined cost of approximately $15.6 billion,
since approximately 20-30% of patients change their
more than for any other surgical procedure. The cost
insurance plans each year, even if cost savings result
of treatment of coronary artery disease (CAD) in the
from lifestyle interventions, they may accrue to an-
United States was estimated to be $56.3 billion
other insurance company.
in 1994.9 Thus, there is a potential for significant cost
However, a program of comprehensive lifestyle
savings if safe and comparably effective, but less
changes may be offered as a much less costly alter-
expensive, alternative interventions can be imple-
native treatment to revascularization for selected pa-
mented.
tients who are eligible for CABG or PTCA (under the
The Multicenter Lifestyle Demonstration Project
supervision of the referring physician), thereby result-
was designed to determine (1) if we could train other
ing in immediate and substantial cost savings.
teams of health professionals in diverse regions of the
Also, providing lifestyle changes as a direct alter-
country to motivate their patients to follow a program
native for patients who otherwise would receive
of comprehensive lifestyle changes; (2) if this lifestyle
CABG or PTCA may result in significant long-term
program may be an equivalently safe and medically
cost savings. Despite the expense of bypass surgery
effective but more cost-effective alternative to revas-
and angioplasty, 30-50% of bypass grafts reocclude
cularization in selected patients with severe but stable
after only 5-7 years, and 30-50% of angioplastied
coronary artery disease; and (3) what the resulting cost
arteries restenose after only 4-6 months. 11.12 When
savings might be. In other words, can patients avoid
this occurs, then bypass surgery or angioplasty is often
revascularization by making comprehensive lifestyle
repeated, thereby incurring additional costs.
changes at lower cost without increasing cardiac mor-
CABG is effective in decreasing angina and im-
bidity and mortality?
proving cardiac function. However, when compared
Earlier studies demonstrated that the progression of
with medical therapy and 16 years of follow-up.
even severe coronary artery disease often can begin to
CABG improved survival only in a very small sub-
reverse in many patients by an intensive, multifacto-
group of patients: those with decreased left ventricular
rial program of comprehensive lifestyle changes.
function and stenotic lesions of the left main coronary
artery of >59%. Median survival was not prolonged
in patients with left main coronary artery stenosis
From the Preventive Medicine Research Institute, Sausalito, Califomia.
Address for reprints: Dean Omish, MD, University of California-
<60% and normal left ventricular function, even if a
San Francisco School of Medicine; Preventive Medicine Research
significant right coronary artery stenosis 70% was
Institute, 900 Bridgeway, Suite 1, Sausalito, California 94965.
also present. 13-16
72T
1998 by Excerpta Medica, Inc.
0002-9149/98/$19.00
All rights reserved.
Pfl 0002-9149(98)00744-9
PTCA was developed with the hope of providing a
turally diverse. Approximately 40 insurance compa-
less invasive, lower-risk approach to the management
nies are now reimbursing at least part of the cost of
of coronary artery disease and its symptoms. Although
this program at these sites for selected patients.
widely utilized, PTCA has never been compared with
We trained teams of health professionals at each of
medical therapy in a randomized trial in stable patients
these clinical sites. including cardiologists. registered
with coronary artery disease: therefore. the mortality
dietitians. exercise physiologists. psychologists. chefs,
and morbidity benefits of PTCA are unknown.
stress management specialists, registered nurses, and
The use of various types of stents (the insertion of
administrative support personnel. These teams, in
a mesh brace into the lumen of the coronary artery
turn. worked with their patients to motivate them to
during angioplasty) may slow the rate of restenosis.
make and maintain comprehensive lifestyle changes.
but there are no randomized controlled trial data sup-
Patients were selected who had angiographically
porting the efficacy of these approaches. The use of
documented coronary artery disease severe enough to
the left internal mammary artery in bypass surgery
warrant revascularization and who were approved for
may reduce reocclusion, but vein grafts also must be
insurance indemnity to undergo a procedural interven-
used when patients have multivessel disease. Thus. in
tion.
addition to the costs of the original bypass or angio-
In addition, patients were excluded for any of the
plasty, there are costs of further procedures when
following: (1) >50% stenosis in the left main coro-
restenosis and reocclusion occur.
nary artery; (2) CABG within 6 weeks or angioplasty
The majority of adverse events related to coronary
within 6 months: (3) chronic unresponsive congestive
artery disease, myocardial infarction, sudden death,
heart failure; (4) malignant uncontrolled arrhythmias;
and unstable angina are due to the rupture of an
(5) myocardial infarction within 1 month: (6) homozy-
atherosclerotic plaque of <40-50% stenosis. This of-
gous hypercholesterolemia: (7) psychosis; (8) hypo-
ten occurs in the setting of vessel spasm and results in
tensive response to exercise: (9) alcohol or drug
thrombosis and occlusion of the vessel. 17 CABG and
abuse; and (10) life-threatening comorbidity.
PTCA usually are not performed on lesions <50%
Patients and staff met 3 times per week for 12
stenosed and do not affect nonbypassed or nondilated
weeks plus once per week for the remaining 9 months.
lesions. whereas comprehensive lifestyle changes (or
Most sessions were 4 hours long: 1 hour of exercise.
lipid-lowering drugs) may help stabilize all lesions,
1 hour of stress management techniques, 1 hour of
including mild lesions (<50% stenosis). Also, mild
group support, and a 1-hour meal. The cost of the
lesions that undergo catastrophic progression usually
1-year program averaged $7,000 per person. (Shorter
have a less well-developed network of collateral cir-
and less-expensive versions of the program are now
culation to protect the myocardium than do more
available for people with less severe coronary artery
severe stenoses.
disease.)
Bypass surgery and angioplasty have risks of mor-
All hospitals sent data directly to the independently
bidity and mortality associated with them, whereas
funded data coordinating center at the Massachusetts
there are no significant risks from eating a well-bal-
General Hospital. Matched control-group patients
anced low-fat, low-cholesterol diet, stopping smoking,
were provided by Mutual of Omaha. Patients were
or engaging in moderate walking, stress management
matched for age, gender. left ventricular ejection frac-
techniques, and psychosocial support.
tion (<25%, 25-40%, or >40%), and cardiac score
defined as the sum of the severity score for each of the
ASSESSING COSTS OF LIFESTYLE
3 main coronary arteries rated as 0 (<50% stenosis).
CHANGE
0.5 (50-75% stenosis), or 1.0 (>75% stenosis). All
Thousands of dollars are saved immediately for
control group patients were within 1 month of having
every CABG candidate who can avoid the procedure
undergone revascularization.
by making intensive changes in diet and lifestyle.
Although a randomized controlled trial interven-
However, cost savings in avoided revascularization
tion comparing comprehensive lifestyle changes with
will occur only if patients who are trained in this
revascularization may seem ideal, it is not feasible in
lifestyle program adhere to it over time. If patients do
practice. The attitude of someone willing to make
not adhere, costs would increase rather than decrease
comprehensive lifestyle changes is often quite differ-
because insurers would end up paying for both life-
ent from that of someone who wants to undergo re-
style training and subsequent revascularization. The
vascularization. The decision to make comprehensive
missing link, therefore. are the data to demonstrate
lifestyle changes requires commitment, discipline, and
whether patients will adhere to this intensive lifestyle
a willingness to assume personal responsibility for
program. We wanted to determine whether patients
one's health. The decision to undergo revasculariza-
who are motivated to make comprehensive lifestyle
tion is often made by patients who want the doctor to
changes can maintain these changes in an ambulatory
"fix" them-the other end of the personal responsibil-
setting if given the proper support.
ity spectrum. This is not a value judgment, only a
To address this question, we began the Multicenter
reflection of different approaches, both of which may
Lifestyle Demonstration Project in 1993 at 8 sites.
be valid. To be randomized, a patient has to be willing
Also, we have trained practitioners at.0001 additional
to undergo either treatment (revascularization or com-
sites whose data are not included here. These sites are
prehensive lifestyle changes). Since the mindset is so
geographically, socioeconomically, racially, and cul-
different, it would be very difficult to find patients
A SYMPOSIUM ON CHOLESTEROL AND CORONARY DISEASE 73T
who were willing to accept either choice determined
years (p <0.0001), and 101.7 mg/dL after 3 years
by someone else; most patients want to choose one or
(p <0.0001). Total cholesterol decreased from a mean
the other for themselves.
of 202.0 mg/dL at baseline to 183.7 mg/dL after 3
Baseline demographics: A total of 333 patients
months (p <0.0001), 182.6 mg/dL after 1 year
completed this demonstration project. Of these, 194
(p <0.0001), 187.3 mg/dL after 2 years (p <0.0001),
were in the experimental group and 139 were in the
and 183.4 mg/dL after 3 years (p <0.0001). Thus,
control group.
reductions in LDL and total cholesterol levels were
At baseline, there were no significant differences
maintained throughout the 3-year interval. although
between the experimental group and control group in
the lifestyle intervention was only 1 year long.
age, gender, marital status, employment status, or
High-density lipoprotein (HDL) cholesterol levels
history of hypertension, hypercholesterolemia, diabe-
initially decreased from 36.7 mg/dL to 32.8 mg/dL
tes, smoking, or family history of heart disease. In the
after 3 months (p <0.0001) and to 36.1 mg/dL after 1
experimental group. the average age was 58 years.
year (p = 0.120) but increased to 40.1 mg/dL after 2
79% were male, and 77% were married. Of particular
years (p <0.005) and increased to 42.2 mg/dL after 3
note is that 63.5% of these patients were currently
years (p = 0.001). Triglycerides initially increased
working yet were able to find time to adhere to the
nonsignificantly from 229.8 mg/dL to 235.7 after 3
intervention of comprehensive lifestyle changes. Fur-
months (p = 0.494), but stabilized after 1 year to
thermore, 50% were hypertensive, 62% had hyperlip-
228.8 (p = 0.946) to 213.0 (p = 0.607) to 200.8 after
idemia, 19.6% had diabetes, 66% had smoked ciga-
3 years (p = 0.339). These changes in HDL-choles-
rettes, and 58% had a family history of heart disease.
terol and triglyceride levels are particularly relevant in
Finally, 54% of the experimental group patients and
light of recent controversies in this area. 18
32% of control group patients were taking lipid-low-
Mean weight decreased from 187.3 lb at baseline
ering drugs.
to 178.0 lb after 3 months (p <0.0001), to 177.0 lb
Angiographic severity of coronary artery disease
after 1 year (p <0.0001), to 176.6 after 2 years
was comparable in both groups. However, 55% of
(p <0.0001), to 179.9 lb after 3 years (p = 0.007).
experimental group patients had a prior myocardial
Long-term reductions in weight are unusual. 19 Percent
infarction compared with only 28% in the control
body fat decreased from 25.7% at baseline to 22.9%
group: also, experimental group patients had a longer
after 3 months (p <0.0001), to 21.3% after 1 year
history of coronary artery disease than those in the
(p <0.0001), to 22.4% after 2 years (p <0.0001), to
experimental group. Taken together, these factors may
23.4% after 3 years (p = 0.134).
bias toward higher morbidity for the experimental
Exercise capacity increased from 9.59 METS at
group than the control group during the demonstration
baseline to 11.15 after 3 months (p <0.0001), to 11.66
project.
after 1 year (p <0.0001), to 10.88 after 2 years
Adherence and changes in risk factors: These adher-
(p <0.0001), to 11.03 after 3 years (p <0.0001).
ence data, changes in risk factors, and a more detailed
description of the demonstration project will be de-
CAN PATIENTS SAFELY AVOID
scribed in greater detail in a forthcoming article. Not
REVASCULARIZATION?
all patients completed adherence questionnaires; the
We found that 150/194 of experimental-group pa-
validity of our adherence data depends on the assump-
tients were able to avoid revascularization and the
tion that the patients who did not provide follow-up
frequency of adverse cardiac events was not in-
data had the same adherence as those who did. If
creased. The number of cardiac events per patient-
patients who had low adherence were more likely to
year of follow-up when comparing the experimental
avoid follow-up, then the adherence rates that we
group with the control group was as follows: 0.012
estimated would be overly optimistic.
versus 0.012 for myocardial infarction (p = not sig-
nificant). 0.014 versus 0.006 for stroke (p = not sig-
RESULTS
nificant), 0.006 versus 0.012 for noncardiac deaths
In brief, patients exercised an average of 1.6 hours/
(p = not significant), and 0.014 versus 0.012 for car-
week at baseline, increasing to 3.9, 3.5, 2.9, and 2.7
diac deaths (p = not significant).
hours/week at 3 months, 1 year, 2 years, and 3 years,
As described above, a primary benefit of revascu-
respectively. Patients practiced stress management
larization is reduction of angina. In the Multicenter
techniques an average of 0.19 hours/week at baseline
Lifestyle Demonstration Project, we used a very con-
and 4.5, 2.6, and 2.0 hours/week at 1 year, 2 years, and
servative measure of angina: no angina at all in during
3 years, respectively.
the prior 30 days. For example, if a patient who had
Based on the results of 3-day diet diaries, the
frequent angina at baseline-as many as 10 episodes
percentage of total calories as dietary fat was 6.5%,
per day-had even 1 episode in the prior 30 days, then
6.8%, 7.4%, and 8.3% after 3 months, 1 year, 2 years,
the patient was still considered to have angina.
and 3 years. The cholesterol intakes for these 4 time
Of the experimental group patients who reported
periods were 14.1, 19.0, 22.7, and 25.7 mg/day.
angina at baseline, 49% had no chest pain during the
Low-density lipoprotein (LDL) cholesterol levels
prior 30 days after 3 months, 65% had no chest pain
decreased from a mean of 122.9 mg/dL at baseline to
during the prior 30 days after 1 year, 61% had no chest
106.1 mg/dL after 3 months (p <0.0001), 104.2
pain during the prior 30 days after 2 years, and 61%
mg/dL after 1 year (p <0.0001), 107.5 mg/dL after 2
had no chest pain during the prior 30 days after 3
74T THE AMERICAN JOURNAL OF CARDIOLOGY®
VOL
82
(108)
NOVEMBER
26,
1998
years. These reductions in angina are comparable with
of each approach and then support whatever the pa-
what can be achieved with revascularization but with-
tient decides. 20 At this time. however, most third-party
out the morbidity and costs.
payers will cover most of the costs of drug therapy and
As noted above, the average cost of the 1-year
revascularization but not the costs of training patients
intensive lifestyle intervention was $7,000. The aver-
in a program of comprehensive lifestyle changes. Ap-
age cost for PTCA (with cardiac catheterization) was
proximately 40 insurance companies are covering this
$31,000 and for CABG was $46,000. All of the ex-
lifestyle program in the sites we have trained. but this
perimental group patients were eligible for revascu-
is still a relatively small number.
larization both by medical criteria and by reimburse-
Comprehensive lifestyle changes are not for every-
ment criteria from Mutual of Omaha. However, only
one. We do not know how many patients with coro-
31 PTCAs were performed on the 194 experimental
nary artery disease in the United States would be
group patients (0.064 events per patient-year of fol-
interested in choosing to make comprehensive life-
low-up) and 26 CABGs were performed on the 194
style changes rather than undergo revascularization. In
experimental group patients (0.053 events per patient-
practice, however. the primary limiting factor has
year of follow-up) after entry. Thus. the costs in the
been the lack of widespread insurance coverage rather
experimental group were: (31 $31.000) +
than a shortage of motivated patients.
(26 X $46,000) + (194 $7,000) = $3.515,000, or
This is a particularly rewarding and emotionally
an average cost of $18.119/patient.
fulfilling way to practice medicine, both for patients
All of the 139 control group patients were selected
and the physicians and other healthcare professionals
for having had a recent PTCA or CABG before entry:
who work with them. Much more time is available to
66 underwent PTCA, and 73 underwent CABG. In
spend with patients addressing the underlying lifestyle
addition, there were 23 PTCAs and 11 additional
factors that influence the progression of coronary ar-
CABGs in the control group after entry. Thus, the
tery disease, yet costs are substantially lower. Patients
costs in the control group were: (66 X $31,000) +
usually show rapid decreases in angina and often
(23 X $31,000) + (73 X $46,000) + (11 X $46,000) =
report other improvements within weeks: these rapid
$6,623,000. or an average cost of $47,647/patient.
improvements in well-being sustain motivation and
The average savings per patient, therefore, were:
help to explain the high levels of adherence in these
$47,647 - $18,119 = $29,529. This number is a con-
patients. The major reason that most stable patients
servative estimate, since 8 experimental group pa-
undergo CABG or PTCA is to decrease the frequency
tients who had a PTCA after enrolling had ≥1 addi-
of angina, and comparable results may be obtained by
tional PTCAs or CABGs during the study. Restenosis
making comprehensive lifestyle changes alone. In-
within 6 months following PTCA is a failure of the
stead of pressuring physicians to see more patients in
angioplasty rather than intensive lifestyle changes, yet
less time, this is a different approach that is caring and
we counted all procedures in this cost analysis, even
compassionate as well as cost-effective and compe-
PTCAs occurring within 6 months after a prior PTCA.
tent.
There is no way to know with certainty how many
of the patients who were eligible for revascularization
CONCLUSION
actually would have undergone revascularization in
In summary, in the Multicenter Lifestyle Demon-
the absence of the lifestyle program. Whether or not a
stration Project, we found that experimental group
patient undergoes revascularization is a function of
patients were able to avoid revascularization for at
many factors. including disease severity, patterns of
least 3 years by making comprehensive lifestyle
practice in the local community, individual prefer-
changes at substantially lower cost without increasing
ences among cardiologists and cardiac surgeons, and
cardiac morbidity and mortality.
method of reimbursement. Revascularization rates
tend to be much higher when reimbursed on a fee-for-
Acknowledgment. Special appreciation to Marjorie
service basis than on a capitated basis. One of the sites
McClain, Sam Lind. Zanse Smith and Bob Finkel for
in our demonstration project, for example, performed
their invaluable assistance.
more angioplasties (17) than the other 7 hospital sites
combined (14).
APPENDIX
Given the large cost differential between the cost
Multicenter Lifestyle Demonstration Project Research Group: Preventive
of revascularization and the cost of the year-long
Medicine Research Institute. Sausalito, CA: Dean Omish. MD. President and
lifestyle intervention program, it would have been
Director: James H. Billings, PhD. MPH. Director, Clinical Services: Lee
cost-effective to offer comprehensive lifestyle
Lipsenthal. MD. Medical Director. Melanie Elliot-Eller. MSN. RN. Director of
Nursing Services: Terri Merritt-Worden. MS. Director of Exercise Science Ser-
changes even if only 18% of patients who were eligi-
vices: Nischala Devi. Director of Stress Management Services: Sarah Ellis, RD.
ble for revascularization actually would have had it in
Director of Nutrition Services: Helen Roe. RD. Former Director of Nutrition
Services: Larry Scherwitz. PhD. Director of Research: Jean-Marc Fullsack.
the absence of this program.
Director. Food Services: Glenn Pereison. Director. Network Development Patty
In practice, we believe that patients with coronary
McCormac, RN. Hospital Liaison: Ruch Marlin. MD. Hospital Liaison, Ana
artery disease should be offered a range of therapeutic
Regalia. CPA. Director. Grants & Contracts: Bryce Williams, MS. Controller.
Massachusens General Hospital Data Coordinating Center. Charlestown MA:
options, including comprehensive lifestyle changes,
Alexander Leaf. MD. Director, Judy Scheer, MPH. RN. Center Coordinator:
medications (including lipid-lowering drugs), angio-
David Schoenfeld. PhD. Consulting Statistician.
Program Sites: Alegens Immanuel Medical Censer/Alegens Heart Institute.
plasty, and bypass surgery. The physician should ex-
Omaha, NE: Richard Collins, MD. Medical Director: Sheila McGuire, Program
plain the relative risks, benefits. costs, and side effects
Director, Alegens Bergen Mercy Medical Center. Omaha. NE: Dennis Tierney.
A SYMPOSIUM ON CHOLESTEROL AND CORONARY DISEASE 75T
MD. Medical Director: Steve Luppes, Program Director, Beth Israel Medical
d. Blankenhom DH. Nessim SA. Johnson RL. Sanmarco ME. Area SP. Cashin-
Center. New York NY: Steven Horowitz, MD. Medical Director: R
Roberti,
Hemphill L Beneficial effects of combined colestipol-aiacin therapy on coronary
MD. Co-Medical Director. Laurie Jones. Program Director. Mercy Hospital
atherosclerosis and coronary venous bypass grafts. JAMA 1987;257:3233-3240.
Medical Center/lowa Heart Center. Des Moines, LA: William Wickemeyer. MD.
7. Buchweld H. Varco RL Matts JP. Long JM. Fitch F Campbell GS. Pearce
Medical Director. Philip Bear, MD. Co-Medical Director. Shakun Advani, MD.
MB. Yellin AE, Edmiston WA. Smink RD Jr. et al. Effect of partial ileal bypass
Co-Medical Director, Diane Mcflhon, RD. Program Director. Broward General
surgery on mortality and morbidity from coronary heart disease in patients with
Medical Center. Fort Lauderdale, FL: Brenda Sanzobrino. MD. Medical Direc-
hypercholesterolemia. N Engl / Med 1990;323:946-955.
tor. Caroll Moody. MD. Co-Medical Director: Michael Chizner. MD. Co-Med-
8. Gould KL Martucci JP. Goldberg DI. Hess MJ. Edens RP. Latiff R. Dudrick
ical Director: Terry Ray. RN. Program Director: Palmetto Richland Memorial
SJ. Short-term cholesterol lowering decreases size and severity of perfusion
Hospital, Columbia. SC: Donald Saunders, MD. Medical Director: Joseph Hol-
lins. MD. Co-Medical Director: Donna Greenwold. RN. Program Director: Mt.
abnormalities by positron emission tomography after dipyridamole in patients
Diable Medical Center/Heart Health Center. Peter Kunkel. MD. Medical Direc-
with coronary artery disease: a potential noninvasive marker of healing coronary
tor. Lynn Olison. PhD. Program Director: Beth Israel Deaconess Medical Center/
endothelium. Circulation 1994;39:1530-1538.
Harvard Medical School. Boston. MA: Jackie Hart. MD. Medical Director.
9. American Heart Association. Heart and Stroke Facts. 1995 Statistical Supple-
Caidin Hosmer. RD. Program Director. ScrippsHealth Shiley Sports & Health
ment. Dallas: American Heart Association. 1994.
Center. La Jolla CA: Erminia Guarneri MD. Medical Director: Betty Chris-
10. Gould KL. Omish D. Scherwitz L Brown S. Edens RP. Hess MJ. Mullani N.
tensen. Program Director.
Bolomey L Dobbs F. Armstrong WT. et al. Changes in myocardial perfusion
Additional Program Sites: University of California San Francisco/Culifor-
abnormalities by positron emission tomography after long-term intense risk factor
nia Pacific Medical Center. San Francisco, CA: Anne Thorson. MD. Medical
modification. JAMA 1995:274:394-901.
Director: Kevin Worth. RN. Program Director. Highmark Blue Cross/Blue Shield
11. Bourassa MG. Long-term vein graft patency. Curr Opin Cardiol 1994:9:685-
of Western Pennsylvania, Pittsburgh, PA: Howard Grill. MD. Medical Director:
691.
Anna Silberman, MPH. Vice President: Tina Palaggo-Toy, MS. Director. Health
12. Hirshfeld JW Jr. Schwartz JS. Jugo R. MacDonald RG. Goldberg S. Savage
Place: Amy Wilhelm, MEd. Program Administrator: Franciscan Health System
MP. Bass TA. Vetrovec G. Cowley M. Taussig AS. et al. Restenosis after
of the Ohio Valley. Cincinnati OH: Freidoon Ghazi, MD. Medical Director. Roy
coronary angioplasty: a multivariate statistical model to relate lesion and proce-
Jacobsen. MD. Co-Medical Director: Judy Steele. RN. Program Director. Mi-
dure variables to restenosis. J Am Coll Cardiol 1991;18:647-656.
chael Wizer. PhD. Co-Program Director. SwedishAmerican Health System. Rock-
ford. IL: Dean Thomas. MD. Medical Director: Roger Greenlaw, MD. Co-
13. Alderman EL Bourassa MG. Cohen LS. Davis KB. Kaiser GG. Killip T.
Medical Director: Carol Klint. RN. Program Director: Nancy Halberstadt-Dag-
Mock MB. Pettinger M. Robertson TL. Ten year follow up of survival and
erfoerde. RN, Co-Program Director: Swedish Medical Center/First Hill, Seattle.
myocardial infarction in the randomized Coronary Artery Surgical Study. Circu-
WA: Anne Kinnaman, Program Director, Suzanne Westcott, Program Coordina-
lation 1990:82:1629-1646.
tor.
14. Varnauskas E. for the European Coronary Surgery Study Group. Twelve-year
follow-up of survival in the randomized European Coronary Surgery Study.
N Engl J Med 1998:319:332-337.
15. Chaitman BR. Fisher LD. Bourassa MG. Davis K, Rogers WJ. Maynard C.
1. Esselstyn CB Jr. Ellis SG. Medendorp SV, Crowe TD. A strategy to arrest and
Tyras DH. Berger RL. Judkins MP. Ringqvist L Mock MB. Killip T. Effect of
reverse coronary artery disease: a 5-year longitudinal study of a single physician's
coronary bypass surgery on survival patterns in subsets of patients with left main
practice. J Fam Pract 1995;41:560-568.
coronary artery disease. Am J Cardiol 1981;48:765-777.
2. Omish D. Brown SE. Scherwitz LW. Billings JH. Armstrong WT. Ports TA,
16. Coronary Artery Bypass Surgery Cooperative Study Group. Eleven-year
McLanahan SM. Kirkecide RL Brand RJ. Gould KL Can lifestyle changes
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