PWC - Impact of Personalized Medicine

April 2010
BREAKTHROUGHS:
The Impact of
Personalized
Medicine
Today
The Big Picture 2 Partners
In the Middle of a Personalized Bridge
HealthCare 24
Beth Israel Deaconess Case Study 3
Medical Center 11 Vanderbilt University

Case Study 1 Medical Center 28
The Ohio State Case Study 4
Click to launch
University Roundtable 33 full screen
The Promise of Personalized Medicine
Medical Center 18
Case Study 2 Executive 45
Summary In collaboration with
2
In the Middle of a
Personalized
Bridge
T
BY JIM MOLPUS
The ultimate aspiration of the practice of medicine Healthcare has been through an assortment of
is to be truly personalized, with targeted treatments global buzzwords that are supposed to create a
based on evidence that perfectly fit a patient’s genetic convergence of science, healing, and cost-effective-
markers. Perhaps it is that vision of personalized ness. If the foundations being laid today follow their
medicine that made it sound intimidating rather than current course, personalized medicine may indeed be
inviting for many providers. that disruptor.
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THE BIG PICTURE 3
Personalized Medicine 2009 TOTAL MARKET: 2015 TOTAL MARKET:

Market Size, $225–$232 Billion $344–$452 Billion
2009 and 2015
Roll over each category

to reveal dollar costs.
Totals may differ due to rounding.

Source: PricewaterhouseCoopers analysis.
I
n a not-too-distant era in which genomics and proteomics give The potential of personalized medicine belies its current state,
a multidimensional map of a patient’s triggers for genetic reac- where, in service lines such as pediatrics and cancer, the science has
tion, treatment is based on particular science, not general guess- already moved from bench to bedside. Barriers remain, not the least
work. Patients do not suffer through trial and error, or retrospective of which are reimbursement systems, data, privacy and regulatory
medicine. Payers and employers, and the patients themselves, are not hurdles, and a paradigm shift for how a physician looks at diagnostics.
saddled with the bill for countless tests that later prove unnecessary. Proponents believe those hurdles will be crushed by the potential.

THE BIG
? PICTURE 4
“Personalized medicine is going to revolutionize the practice of The cost curve of genetic diagnostics is bending down rapidly.
medicine; there is absolutely no doubt about it,” says Raju Kucherlapati, Kucherlapati says tests that cost $10,000 just a few years ago are now
PhD, Paul C. Cabot professor of Genetics at Harvard Medical School less than $3,000. Much of the current cost is because genetic analysis
and one of the researchers behind the Human Genome Project. has to be run episodically. When a person’s entire genome has already
“Implementation of personalized medicine is going to result in better been sequenced, the underlying data has already been gathered. The
outcomes for patients, and I truly believe there is going to be reduced first genome cost $2.7 billion in 1991 dollars.
cost. It’s happening today, it’s not some time in the future. This is going
Now that test is less than $50,000 and with acceleration in
to be the normal practice as we move forward.”
biomedical computing the so-called $1,000 genome “is truly near,”
Gerald McDougall, principal and U.S. Health Sciences Leader Kucherlapati says. Richard Hamermesh, professor of management
for PricewaterhouseCoopers, says it’s no longer a question of “if” practice at Harvard Business School, says the rapidly downward bend-
personalized medicine is coming. ing cost curve in genetics is like “Moore’s law on steroids,” a reference
to a model in transistor and microchip development that saw their
“It’s how and when those throughout the entire healthcare
capacity double every two years.
continuum will embrace personalized medicine,” McDougall says.
“Academic medical centers are doing research and development “Healthcare is not a normal market,” Hamermesh says. Regulation
around molecular and personalized medicine and pushing the creates an impact on growth, he says, and the entire field of diagnostics
boundaries. What is really compelling right now is that the has not historically been rewarded at levels comparable to treatment.
technologies and tools for the application of personalized medicine But economics is changing that equation.
exist today.”
“There is going to be lots of economic incentive to do personalized
Shifting business model medicine. When half of the drugs that people take don’t work, there’s a
stake that the payer community has in getting it right the first time and
If viewed in its entirety, the field of personalized medicine reaches
Gerald McDougall, not doing it by trial and error.” The barrier remains, Hamermesh says, in
beyond a core of targeted therapeutics and diagnostics to encompass
U.S. Principal and “how much it costs to get that information.”
Health Sciences Leader, personal health record management, disease management, wellness
PricewaterhouseCoopers and nutrition. PricewaterhouseCoopers estimates that the core market Initial investments will have to be made—in expanding molecular
Having trouble listening?
Click here. alone accounts for $24 billion in sales now, and will grow 10% annually medicine capacity or in acceleration of the electronic medical record
to $42 billion by 2015. decision support.

THE BIG PICTURE 5
{ }
“If you’re able to subclassify patient popula-
tions to a better accuracy of therapeutics, the “There is going to be lots of economic incen-
cost savings associated with that is enormous,” tive to do personalized medicine. When half
McDougall says. “If you’re able to get better of the drugs that people take don’t work,
information at the individual level to reduce there’s a stake that the payer community has
adverse events, the cost savings is enormous. in getting it right the first time and not doing
Can a Blue Cross Blue Shield or an Aetna say it by trial and error.”
that some of these strategies related to genetic –RICHARD HAMERMESH, PROFESSOR OF MANAGEMENT PRACTICE, HARVARD BUSINESS SCHOOL
risk susceptibility are going to save them cost in
the short term? to have had his genome sequenced, and shares his genome, medical
No. But we have to be very careful on how we generalize personal- records, and other personal information with the research community
ized medicine and the personalized medicine strategies because some and indeed, the general public, with the idea of taking away some of the
of it has massive cost reduction to the system.” fear patients have about genetics.
Personalized medicine would not be the first shift that asks health-
Commitment
care leaders to make an educated jump based on current projections of
John Halamka, MD, chief information officer at Beth Israel Deaconess
future reality. Healthcare systems that are going to lead in personalized
Medical Center in Boston, says the key to using genomic information
medicine can start now, particularly in information technology, says
has much to do with automating the routine tasks in medicine, which is
Dan Roden, MD, assistant vice chancellor for personalized medicine at
ironically where a lot of medical mistakes now occur.
Vanderbilt University Medical Center.
PatientSite, Beth Israel’s electronic medical record system, went
“It is an absolute given that if we’re going to execute on the current
live in 2000. It enables, “at the touch of a button, appointment making,
vision of personalized medicine, you have to have information technol-
medication refills, referrals to specialists, and secure e-mail, so that
ogy,” Roden says. Others, he says, are a commitment to translational
doctors and patients can collaborate together online,” Halamka says.
and genome science, as well as a strong commitment to excellence
Now, every month, 50,000 patients use it.
in clinical care. “Institutions that embrace that, and especially at the
Halamka is also personally committed to the success of genomics leadership level, are the institutions that are going to lead the way in
in the everyday practice of medicine. He was the fourth person ever personalized medicine.”

THE BIG PICTURE 6
KEY FINDINGS
Identify health and wellness products and services to Hospitals that are linked to universities will have an advantage, genetic tests and translate them into effective prevention and
potentially offer to patients as they are poised to take the lead in personalized medicine treatment strategies. As there are a limited number of genetic
As healthcare moves toward a more patient-centered system, research. specialists available, this remains a significant challenge
providers have an important role to play in educating patients to the progress of personalized medicine. Providers must
to be co-managers of their health and wellness. But as the Encourage patients to become educated in personalized communicate the need for greater education in the field of
emphasis on wellness grows and consumers seek alternative, medicine and take steps to advance it genomic and proteomic science to medical universities.
less expensive forms of care, hospital admissions may shrink, In the new era of individualized care, educational efforts
and thus provider systems will have to deliver new clinical targeted to patients will help to raise awareness of and Adopt electronic health records, capture genomic
service offerings in order to maintain their revenue flows. demand for new personalized therapeutics, and thus may data to populate them, and support industry efforts
Through better health education with patients, providers can result in new business opportunities for health systems. The to create a system of interoperable EHRs across the
help raise awareness of and demand for new personalized doctor-patient role should evolve from doctors being the sole country
therapeutics and diagnostic tests, and thus create new source of knowledge to greater emphasis on patient education There is a vast amount of information being collected in
sources of revenue. A hospital’s cancer center, for instance, to support shared decision-making and choice. Providers healthcare databases around the nation, including patient
could eventually have much of its revenues and margins in should, for instance, counsel patients on the benefits of history, diagnostic reports, clinical research findings, and now
therapeutics. contributing genetic information for research, participating in a growing body of genomic data that will explode to billions
clinical trials, using health-oriented social networking sites and of data points on every individual as powerful analytical tools
Collaborate in research efforts to accelerate translation donating biospecimens for bio banks. are developed. The increasing adoption of electronic health
of discoveries from the bench to the bedside records (EHRs) by hospitals and health systems will increase
Now is the time for medical research and medical practice Partner with experts in personalized medicine, and the collection of health data exponentially over the next
to collaborate to plan together for the practice and recruit physicians and administrators with expertise in several years, and bring with it an important opportunity. The
implications of personalized medicine. Such collaboration is the field value of the genomic, proteomic, and other health data being
already occurring between oncologists and clinical research Personalized medicine is creating a booming market, but collected becomes greater as it is shared among research
professionals, who are experimenting with clinical trial rapid growth of this field is outpacing clinicians’ ability to organizations and mined to become more predictive.
pilot projects to accelerate the process of applying research understand it, apply it, or to interpret diagnostic test results.
But, the full value of EHR systems won’t be realized until cross
findings to patients more quickly. These pilots are guiding Providers will have to build an expertise in personalized
sector interoperability is achieved. Provider systems, payers
doctors to make personalized treatment regimens for cancer medicine if they want to succeed in the new era of healthcare
and the pharmaceutical industry should work together to
patients. Provider systems should partner with scientists delivery. Ambitious physicians will educate themselves in
create a new data architecture that will enable interoperability
in personalized medicine who can facilitate collaboration genomics and proteomics, but others will gain knowledge
among IT systems to facilitate the linking and analysis of
with research institutes and physicians to translate scientific from experts in the field and recruit physicians and genetic
health data across the country.
discoveries into more effective treatments for patients. counselors who can interpret the results of sophisticated
Source: PricewaterhouseCoopers

LETTER 7
Personalized The Time to Act and

Gerald
McDougall
Medicine: Collaborate Is Now
DANA THOMAS
Many within the healthcare industry are wondering whether personalized medicine has reached the tipping point of
mainstream medicine and at what point it deserves serious attention from clinicians. From our recent conversations with Principal,
providers in the U.S. and internationally, we are seeing an excitement and urgency about how to integrate personalized PricewaterhouseCoopers
medicine into a new era of customized care and treatments.
Now is the time for medical research and medical practice to of the new science of genetics, our understanding of the human
collaborate and to plan together for the promise, practice, and genome and heritable variation has been a long time coming. Yet,
implications of personalized medicine. scientific advancement and the pace of innovation have accelerated
exponentially in the past decade. Medical scientists now have
The urgent day-to-day pressures of running a hospital, clinic, or
unprecedented insight into how DNA variations can lead to new ways
any other health organization leave little time to contemplate what-ifs
of diagnosing, treating, and soon preventing thousands of diseases in
and hypotheticals that may occur sometime in the distant future. It
all of their sub-classifications.
is under this category that many healthcare providers, outside of the
largest academic medical centers, have placed personalized medicine. The practice of medicine will be revolutionized when not only
From their perspective, exuberance over the science of personalized scientists, but also clinicians and consumers, are armed with
medicine exists largely in research laboratories, but it is still a faraway knowledge about the influence of genetic factors on health status and
fantasy as a clinical reality. outcomes. Even more exciting is when that knowledge is used to guide
individual behavior and treatment decisions before, during, and after
In the 145 years since Gregor Mendel’s work, whose discovery
an illness occurs.
of inheritance traits in certain plants earned him fame as the father

LETTER
? 8
Framework for Customized Care that to embody all of the products and services that provide a
targeted approach to prevention and care. For example, personalized
medicine may be a biologic that targets specific cells or an interactive
technology that allows a diabetic patient and his or her physician to
Funding
tives develop a customized food plan and exercise regime.
en
nc For providers, the case for personalized medicine is becoming
Genetic
I
more and more compelling in light of the intense pressure they are
under to demonstrate value. Further, major market forces and trends
are driving the need for transformational change in the health system.
munication
Regulatory cha
Among these trends are the rise of chronic disease, the empowerment
l sys t e m
of health consumers, the push for comparative effectiveness, an
INDIVIDUAL
Beha urgent need for coordinated care yet decentralized care delivery, and
Gerald McDougall, regulatory and payment reforms that tie reimbursement to patient
co m
U.S. Principal and
ic a
vi o
outcomes, quality, and efficiency—all of which are working together
Health Sciences Leader,
l
ed
ra
to pave the way for a more patient-focused system.
nt
PricewaterhouseCoopers M
ng
tie
e

While progress has been made, several key issues need to be
Pa
Click here.
In addressed to accelerate the adoption of personalized medicine:

for
m ation technol ogy New value creation formulas. Personalized medicine
proponents need to be able to communicate the science’s
Source: PricewaterhouseCoopers long-term value to physicians. And, payers must then develop
incentives to accelerate adoption. Because of the individualized
Personalized medicine is at the core of a larger trend toward approach to care, reimbursement decisions may require
healthcare that is more individualized, predictive, and preventive. The subjectivity on a case-by-case basis and far greater collaboration
meaning of personalized medicine to most people implies targeted among payers, providers, and the makers of drugs, diagnostics,
therapies and molecular diagnostics, but our definition goes beyond devices, and therapeutics.

LETTER
? 9
{ “Personalized medicine is a holistic model of care that examines each indi-

vidual’s unique makeup and designs appropriate strategies for maintaining
wellness and treating illness over a lifetime. Our definition of this model
goes beyond diagnostics and therapeutics to embody all of the products and
services that provide a targeted approach to prevention and care.”
Dissemination of knowledge. The rapid growth of this

–GERALD MCDOUGALL, PRINCIPAL, PRICEWATERHOUSECOOPERS
IT infrastructure. Personalized medicine will spawn an

}
field is outpacing the ability of patients and even clinicians to exponential increase in genetic, biologic, and metabolic data. Far
understand it, apply it, or to interpret diagnostic test results; more important than the collection of the data for providers is
and, there are a limited number of genetic specialists or their informatics competency and data interoperability to enable
counselors available. coordinated care and broad-based clinical decision support for
individualized patient management.
Lack of regulatory pathways for new products. The current
linear, population-based approval process for drug development Personalized medicine will touch the lives of everyone. It
and commercialization will be outdated in an era of personalized represents a major shift that will ripple across multiple industries and
medicine. As one of the technologies underpinning personalized economic sectors, including ones not traditionally associated with
medicine, diagnostics will play a crucial role in its advancement healthcare. Providers should begin now to peer inside the cradle of
for their ability to target specific therapies to specific patients personalized medicine and realize that it holds enormous possibilities
for whom these therapies are known to work. But the current for them and their patients.
structure of the FDA is poorly equipped to handle all of the
various individual variations associated with personalized
medicine. The regulatory pathway for the commercialization
of new diagnostics, for example, is unclear due to diversity in
approval pathways and an ongoing expectation of regulatory
reform Gerald McDougall, Principal, PricewaterhouseCoopers

{
The Impact of
CASE STUDIES Personalized
Medicine Today
11 Beth Israel Deaconess Medical Center
Not Just the Genome
18 The Ohio State University Medical Center

Driving Value
24 Partners HealthCare
Creating the First Waves
28 Vanderbilt University Medical Center

Building the Information Platform
CASE STUDIES BY PHILIP BETBEZE 11
Beth Israel Deaconess Medical Center

Not Just the Genome
Computer-Assisted Communication, Decision-Making, Ties Personalized
Healthcare Together
J
John Halamka, MD, knows a lot about the human genome. In fact, clinical systems so that you can turn data into information, knowledge,
he’s the fourth person ever to have his genome sequenced. But the chief and wisdom. What we have to do is filter all this data and try to present
information officer at Beth Israel Deaconess Medical Center in Boston it to the doctor or the nurse just in time, when it’s actionable, when it’s
still knows that all the genome mapping in the world won’t improve important.”
healthcare outcomes, cost, and quality without effective ways to
The promise of personalized healthcare goes beyond the technical
deliver the huge volume of information contained in the genome to the
knowledge of what each piece of the genome tells clinicians about a
physicians who are actually providing patient care. Besides that, there’s
person’s susceptibility to diseases of different types. While the genome
a lot more to personalized healthcare than genetic mapping, which is
is the glitz and glamour of personalized medicine, it’s the information
still in its rapidly developing infancy as far as practical applications to
HEALTH SYSTEM SNAPSHOT
systems and, of course, the clinicians, that are the glue.

healthcare outcomes.
His genome, and everyone else’s, contains 750 megabytes of clinical

Developing an elastic PHR
data. Beth Israel Deaconess has the capacity to store a petabyte— Beth Israel Deaconess, as a health system at the forefront of using
that’s 1,000 trillion bytes—a lot of information. But much of that the personal health record (PHR) in patient care, developed its PHR,
information is irrelevant to disease treatment. “Clinicians are utterly PatientSite, in 2000. Some 50,000 patients access their medical
overwhelmed by data,” Halamka says. “So my challenge is to build records through it each month, and everything, including clinicians’

Beth Israel Deaconess Medical Center 12
CASE STUDIES
notes as of this year, is there for patients to inspect. The idea behind have some lab results at Quest and LabCorp or you have data with CVS
sharing this information with patients is to encourage patients and and Walgreens? The challenge is you have a very fractured record,” he
their caregivers to work together as a team to deliver the best care for says.
that patient.
Through Google Health, for example, patients can pull their data
“It’s total shared decision-making and total collaboration, taking in from all those various sources and then “it’s almost Facebook-like,”
into account patient care preferences, because the doctor and the Halamka says. The patient can invite his or her clinician into the record.
patients are on the same team,” Halamka says. That kind of interoperability is what the push for EMRs has always been
about, but the promise has until now not matched the hype.
PatientSite incorporates a variety of alerts and reminders for
doctors and patients for routine elements of care that are nonethe- Then what?
less extremely important to garnering good outcomes. At Beth Israel
At Beth Israel Deaconess, the PHR came last, after seemingly end-
Deaconess, those alerts—medication reminders, dosage checks, vac-
less discussions about how physicians and other clinicians wanted the
cination reminders—are tailored to the patient’s unique demographic
data sliced and presented to them, Halamka says. “So you come into
circumstances. The architecture of the system, says Halamka, can
the office, and I don’t need you to fill out the stupid clipboard for the
incorporate genomic information as well, should the patient desire it,
umpteenth time, to tell me your medications 27 times, or your allergies
and, very importantly, if it’s relevant.
again.”
“We do these things based on your age, your susceptibility to the flu
That’s the behavioral aspect of what he sees as two parts of person-
or to pneumonia, for example,” Halamka says. “So a number of things
alized healthcare. Then there’s the genetic aspect. “I know what diseas-
are personalized, based on sex, age, and what conditions you have.”
es I am likely to develop,” Halamka says of the information he gained
Further, PatientSite works with vendors such as Microsoft and from having his genome mapped. “I know my probabilities for disease.
Google, which make available free patient health tools directly to I am twice as likely as the normal human male to get prostate cancer. I
the consumer, to record private data from multiple access points in have a mutation in my genome that gives me that risk.”
the healthcare continuum. If a patient gets all his or her care at Beth
That means Halamka needs prostate exams and PSA tests even
Israel Deaconess, that’s great, says Halamka, because everything is on
though he is only 48 years old. “Now, if my PSA, which is 0.4, came
PatientSite.
back as 4.0, that would be something I’d better pay attention to. So
“But what if you went to the Cleveland Clinic or MinuteClinic or you personalized medicine, at the genome level, helps you to decide with
EDITOR’S NOTE

13
CASE STUDIES
BIDMC Patient Web site Traffic
50,000 Active Patient Users (logged in within two years)
Roll over each colored box to

reveal number of active users
45,000
40,000
35,000
30,000 *
07 07 07 07 07 08 08 r - 08 r - 08 y - 08 - 08 - 08 08 08 08 - 08 - 08 - 09 - 09 r - 09 r - 09 y - 09 - 09 l - 09 - 09 - 09 - 09 - 09 - 09 - 10
g- -
Oct
- v- c - an - eb - Jul g - ep - Oct -
Au Sep No De J F Ma Ap Ma Jun Au S No
v
De
c Jan Feb Ma Ap Ma Jun Ju Au
g
Sep Oct No
v
De
c Jan
* No data for July 2009.

Source: Beth Israel Deaconess Medical Center

14
CASE STUDIES
the healthcare system, based on probabilities, what tests you need and already know from the diseases that run in your family. In fact, with
what care or what lifestyle choices you may make.” today’s knowledge and technology, a personal genotype is much less
powerful than a good family medical history, Boguski says.
Connecting the data dots
“Once the genome becomes part of the medical record, it’s really
The United States does not have a healthcare system, per se. What
going to dwarf everything else that’s there in terms of sheer volume,”
it really has is disconnected hospitals, labs, pharmacies, and doctors’
he says. “But that doesn’t mean it’s that much more important than
offices. Getting that information to doctors, nurses, and other clinicians
anything else. And, in fact, our view is that DNA is not destiny.”
at the point of care is the major challenge of the EMR, and it’s what
is meant by an interoperable patient record. That’s a huge element of Still, Boguski doesn’t underestimate the potential for further
personalized healthcare so that a clinician can determine, with prompts personalizing and making more efficient the delivery of medicine
from the EMR, the right path of care for a patient based on countless based on the genome. Pathology is uniquely situated to his field, he
variables. says, despite the reservations of medical geneticists, to name one

group that disagrees.
“So my goal, in not only my Beth Israel Deaconess role but also as
the chairman of the state’s health information exchange, is to make “A genotype is no different than a urinalysis or a blood count,” he
sure that every place the patient goes, it’s like Cheers,” Halamka jokes. says. “It’s another piece of laboratory data about a patient that has to
“Everybody knows your name. And with your consent, they understand be analyzed and integrated with everything else we know about in the
Mark Boguski, MD
Professor, Department of Pathology, your medication list, your problem list, and they can deliver personal- medical record in order to make clinically actionable recommendations
Beth Israel Deaconess Medical to patients’ providers.”
ized medicine to you.”
Center, Center for Biomedical
Informatics at Harvard Medical At this point, molecular medicine is all about signaling pathways.
Even though Mark Boguski, MD, has worked for years on genomics
School
in various capacities in leadership positions with major drugmakers, The roadblock over the past half dozen years in pathways is that
Click here.
biotechs, and even the Allen Institute for Brain Science (named after researchers identify what they think is a key node in the pathway, which
the Microsoft cofounder), he says the genome’s promise is still largely becomes a drug target. They then develop a very specific therapy to
untapped as far as practical uses in medicine. Boguski, associate pro- inhibit or kill that node in the pathway.
fessor of pathology at Beth Israel Deaconess Medical Center and the “But from what we know today about network biology, there isn’t
Center for Biomedical Informatics at Harvard Medical School, says a one node. There are many ways to get to the end state,” Boguski says.
personal genotype is probably not going to tell you anything you didn’t “And just because we drugged one of the pathways doesn’t mean

15
CASE STUDIES
BIDMC Patient Web Site Communications
30 Clinical Messages from Patients to Providers per 100 Patients
Roll over each colored box

to reveal number of
messages per month
25
20
15
*
06 06 07 - 07 r - 07 - 07 - 07 - 07 - 07 - 07 - 07 - 07 - 07 - 07 - 08 - 08 r - 08 - 08 - 08 - 08 - 08 - 08 - 08 - 08 - 08 - 08 - 09 - 09 r - 09 - 09 - 09 - 09 - 09 - 09 - 09 - 09 - 09 - 09 - 10 - 10
v- c- n- r y n l g p t v c r y l g t v c r y l g t v c n b
No De Ja Feb Ma Ap Ma Ju Ju Au Se Oc No De Jan Feb Ma Ap Ma Jun Ju Au Sep Oc No De Jan Feb Ma Ap Ma Jun Ju Au Sep Oc No De Ja Fe
* No data for July 2009.

Source: Beth Israel Deaconess Medical Center

16
CASE STUDIES
there’s not going to be an alternative pathway where that disease con- “So today, you don’t order a chemotherapy drug,” Halamka says.
tinues to progress or express itself.” “You order a pathway. If the patient has prostate cancer, for example,
there are five pathways for that disease, which are customized based
In the future, researchers are not only going to have to look at what
on information in that patient’s PHR. The computer customizes that
they think are key genes that are drug targets but will also have to look
pathway based on renal and liver function, among other issues. That
at the whole pathway.
way, we ensure there’s best evidence used.”
“So if we block one step, another cork is not going to just pop up
With the personalized pathway, physicians are allowed variation
on the other side,” Boguski says. He predicts that by 2020, most
within reason but don’t allow such heterogeneity that each patient
everyone will be genotyped shortly after birth in the same way they’re
has disparate quality of care. With the addition of the genome, those
typed for blood, and that genotype will become a permanent part of
five pathways will probably break from five clinical pathways to
that person’s EMR.
perhaps a million.
“By that time, we’ll know enough about the disease gene associa-
“In breast cancer, for example, it’s already being done,” Halamka
tions to predict the kind of diseases you might develop 30 or 40 years
says. “You’re doing sequencing of the tumor and then determining
in the future,” he says. “It’s a very exciting time to be able to think
what agent is most effective. And in the future, it’ll be important in
about being able to do that because of the rapid price drop in genomic
medications.”
sequencing.”
Often, medications have a therapeutic index. The difference
The research possibilities of such widespread genotyping are nearly
between therapy and side effect may be pretty small. But if you
endless. If, for example, a patient presents at age 35 with a lymphoma,
have enough genetic markers, a clinician could say for one patient
John Halamka, MD pathologists will take the cancer genotype, sequence it again, and
Chief Information Officer, the right dose of a certain chemotherapy drug might be 1.2
compare it against the genotype that person had at birth to tell exactly
Beth Israel Deaconess milligrams—the perfect balance between therapeutic effect and
Medical Center which mutations have occurred that have led to that particular tumor.
minimal side effects.
Having trouble listening? “That’s a precision diagnostic, which will lead to precision, cost-effec-
Click here.
tive therapy,” Boguski says. Right now, Halamka notes, every manufacturer says, “‘for the aver-
age human, it’s 2 milligrams. Just start with that.’ Some people get
Decision support extremely ill from that and some people tolerate it well or get no effect.
Beth Israel Deaconess’ PHR system has 2,000 decision support rules, That’s where genomics, especially on medication and therapeutics
which include all hematological and oncological clinical pathways. delivery, will substantially change the way we deliver care.”

17
CASE STUDIES
{ }
Personalized also means personal “So if we block one step, another cork is
Healthcare that is optimal means not only not going to just pop up on the other side.”
personalized, but also personal, says Mark Boguski predicts that by 2020, most everyone
Zeidel, MD, chair of the Department of will be genotyped shortly after birth in the
Medicine at Beth Israel Deaconess Medical same way they’re typed for blood, and that
Center. That means the clinician is still in genotype will become a permanent part of
charge and can ignore or further refine the that person’s EMR.
pathway of care that the computer helps
–MARK BOGUSKI, MD, DEPARTMENT OF PATHOLOGY, BETH ISRAEL DEACONESS MEDICAL CENTER
develop for specific patients.
“That kind of care requires you, as a physi-

cian, to have a clear grasp of the patient’s goals
and needs,” Zeidel says. “We’re developing new pathways and targets “The outcome will be better if they have these custom therapies,
all the time. The key is moving that to the general practice of medicine.” but you have to do something,” he says. “So the big barriers relate to
cost and rapidity, which will get better over the next several years.
Zeidel sees barriers to using the genome effectively in the practice
They are not qualitative challenges, they’re quantitative.”
of care, not only at large academic medical centers that are at the fore-
front of research and technology, but also at smaller community-based Zeidel predicts that because the cost of sequencing infrastructure
hospitals and healthcare facilities. is expensive, it will be outsourced—from community hospitals, for
example—and will be done at outside labs. Analyzing the information
“You currently can measure for a lot of markers that we think are
will be difficult, but commercial vendors will provide ways for local
important, but you may miss mutations that are important because you
clinicians to analyze the information.
don’t have the whole sequence,” he says.
“Our job is to make our care obsolete every year,” Zeidel says.
That’s why genetic sequencing needs to become inexpensive, “but
“We’re in the business of developing competition for ourselves.
we need real efforts to be able to process the data. The IT platforms
need to look at this information, process it promptly,” Zeidel says. As the technology becomes available to community hospitals,
Currently, the process takes a few weeks. The physician, meanwhile, they will treat common diseases and academic centers will develop
has a patient for whom treatment is urgent. approaches to treat patients with rare and difficult diseases.”

CASE STUDIES BY PHILIP BETBEZE 18
The Ohio State University Medical Center

Driving Value
Can Personalization Drive Better Value in Healthcare?
C
Clay Marsh, MD, isn’t alone when he calls healthcare delivery in But what is personalized healthcare? Some hear the term and think
this country, “fundamentally broken.” But where he differs from all the immediately of genome mapping—figuring out a person’s proclivity to
naysayers is that he thinks he and his institution can be a part of doing come down with any number of diseases based on heredity. Turns out
something about that. “Certainly the lack of centralization and precision that’s only a small part of what Marsh means by personalized health-
in what we do in medicine would generally equate to failure of most care, and a part that, with few exceptions, is not ready for a large-scale
other business sectors,” he says. rollout.
So what does that have to do with so-called personalized First there’s the challenge of figuring out what the genome says
medicine? A lot, it turns out. Marsh, in addition to his role as vice about a person’s susceptibility, but second, and most importantly, what
dean of research with the Ohio State College of Medicine, is executive modern medicine can actually do about it. Marsh and OSUMC have a
director of the Center for Personalized Health Care at the Ohio State more expansive definition of personalized medicine, and its challenges
University Medical Center (OSUMC). While he doesn’t necessarily see are less those of pure science and more those of money, patient partici-
personalized medicine as the latest silver bullet that will eliminate pation, and clinical pathways that are evidence-based.
waste and harm in healthcare, he thinks it can go a long way toward
“One of the challenges in personalized medicine has been defining
achieving that goal.
what you mean by it,” he says. The Center for Personalized Health Care

19
CASE
CASE STUDIES
STUDIES
P4 Medicine™
NON-RESPONDERS AND TOXIC RESPONDERS
PRESCRIPTION BLANK Treat with
alternative
ALL PATIENTS
drug or dose
WITH SAME DIAGNOSIS
Roll over each arrow to reveal

PREDICTIVE DEA # AJ0000000
BATCH #000001
the elements of each “P”
PATIENT_____________________________________________ D.O.B. ___________
GENETIC
ADDRESS __________________________________________ DATE ____________
CHIP
PERSONALIZED
RESPONDERS AND PATIENTS NOT
PREDISPOSED TO TOXICITY
Treat with
conventional
drug or dose
PREVENTIVE
REFILL__________ SIGNATURE OF PRESCRIBER
TIMES
PARTICIPATORY
Wellness and Risk Management

Source: The Ohio State University Medical Center
at Ohio State, says Marsh, models itself on the philosophies of Leroy refers to predictive, preventive, personalized, and participatory care,
Hood, MD, one of the world’s leading scientists in molecular biotech- says Marsh. “We believe, fundamentally, the goal is to take care today,
nology and genomics, and his Institute for Systems Biology. Hood calls which is disease-based, and create care in the future, which is health- and
for a healthcare system that relies on so-called “P4 Medicine™,” which wellness-based.”

20
CASE STUDIES
Moving from disease treatment to health treatment “Our focus is to standardize what we do to reduce the variability in
Developing a personalized medicine model that works in the real practice and make sure that if we know something’s good to do, that we
world means integrating genomics with the delivery of healthcare, execute it seamlessly, and we execute it all the time, no matter where we
Marsh says. “It’s actually taking evidence-based medicine to a different are, no matter who the doctor is in the environment. The environment
level,” he says, “because it’s not just evidence-based medicine, it’s trying itself is actually part of the protection.”
to automate the delivery of that medicine on an individual basis.”
That’s a step that most hospitals and healthcare providers have not
The first level of personalized medicine, which Marsh says is achiev- made because it’s technically sophisticated on the IT front. Marsh says
able today with discipline and culture change even outside of academic it’s also a culturally sophisticated step, because “it requires us to say
medical centers, is to standardize the way medicine is practiced, and to
that in this cockpit management kind of scheme that we’re not trying
create a more automated system that would be active irrespective of who
to serve the pilot, we’re trying to serve the passengers.”
is supervising the care of the patient. The Center for Personalized Health
Care at Ohio State depends heavily on automated, closed-loop, opt-out It’s already here, in dribs and drabs
practice pathways using information technology and other computational
Steven Gabbe, MD, the CEO of The Ohio State University Medical
tools to push best practices to the physician in charge of a patient’s care.
Center, says personalized healthcare is already here, but far from per-
“We shouldn’t ask physicians to choose to activate them. Instead we fected. He uses the example of diabetes, from which he suffers.
should make them an automated response in our safer, more standard-
“I’ve had diabetes for over 40 years, so I really had a chance to
ized system, and allow physicians or other professionals to opt out if experience the changes for people with diabetes from a limited num-
they don’t think they are correct for a particular patient,” he says. ber of options and a limited amount of flexibility, to a point now where
Measurement of adherence to the pathways ingrained in the way thanks to scientific and technological advances, we have remarkable
ability to personalize the care of people with diabetes.”
the electronic medical record “talks” to the preloaded systems of care
for a patient is key to reducing variability and mistakes, Marsh says. Gabbe, offers the example of blood glucose meters, which are taken
In many ways, the doctor is still the hierarchical leader of the medi- for granted now, but weren’t available until about 1980. He personally
cal team and practices whatever way he or she feels is important, as uses a more advanced continuous glucose sensor, which monitors one’s
opposed to having a commitment to creating and executing this auto- glucose levels throughout the day, during exercise, work, and sleep.
Further, “we have a variety of new insulins that can be used to tailor
mation like autopilot in a plane, he says.
EDITOR’S NOTE

21
CASE STUDIES
treatment to one’s diet, and activity. So these advances allow each indi- healthcare theoretically stands, says Marsh, is what most people
vidual’s lifestyle, diet, exercise pattern, and work schedule to be accom- associate with the term “genetic markers” and how those markers can
modated,” Gabbe explains. Personalized medicine of a sort is also key to be used to tailor therapies. But the genome doesn’t always provide
taking care of OSUMC’s employees. Personalized health assessments clear answers—at least not yet.
are done for each of its employees, and then lifestyle modification—
“Most diseases are what we call complex diseases, meaning, there
diet, and healthcare, and coaching—are prescribed so they can improve
are multiple different elements that actually come together to either
their health. “This, of course, helps us in our goal to be a workplace
have you experience something you’re at risk for or not,” he says. “So
of choice, which is one of our strategic objectives, and helps us get a
you may have a genetic element that says that you’re predisposed to
return on that investment very quickly.”
cancer, but that doesn’t necessarily mean that you will get it.”
Currently, through some basic genetic testing, Ohio State is able to
For example, there are genetic markers that help doctors obtain a
assess therapy for people who may be on warfarin, an anticoagulant, by
picture of risk for breast cancer. But to consider doing something as
using their genetic information to prescribe the best dosage for them.
traumatic and highly interventional as preventive bilateral mastecto-
Further, simple tests can determine whether certain individuals can be
mies, for example, much more information is needed, because perhaps
treated with certain chemotherapeutic drugs for certain types of colon
Clay Marsh, MD 80% of people with that marker will get the disease at some point, but
Executive Director, Center for cancer, Gabbe says.
20% don’t.
Personalized Health Care,
“I think it relates to about 5% of colon cancers, but when you think
The Ohio State University “So why does that 20% not get it?” he asks. “Or if you look at smok-
Medical Center about that across the country, that’s a lot of people. ”He sees further
ers, 15% of people might get lung cancer or chronic lung disease, but
Having trouble listening? promise as health risk assessments mature, as well. “By developing a
Click here. 85% of people don’t. So understanding why, even though you might
genetic database and a patient database and linking those, we’ll begin
have the same genetic risk, some people progress to a disease and
to discover new opportunities to use genetics for therapy and risk
other people don’t, is really important.”
assessment. More expansion of our genetic knowledge will allow us to
rapidly and inexpensively screen individuals as part of their assessment, Developing that snapshot of an individual’s health risk at a three-
and use that information for risk assessment, lifestyle interventions, dimensional level based on genetic information, environment, and a
and therapy. That’s going to grow over the years.” number of other variables is really the cutting edge of research, which
is still in the experimental and data-gathering stage, says Marsh. That’s
Potential not to say that many personalized medicine constructs aren’t ready for
The second leg of a three-legged stool upon which personalized prime time now.

22
CASE STUDIES
“Personalized medicine at its most fundamental level is both high-touch and high-tech,” Marsh says.
What he means is that the center at OSU aims to facilitate programs that look at cancer, heart disease, criti-
cal care, and neurological disease, and apply tools to understand more specifically and precisely how to help
OSUMC Personalized people differently and better with their overall health and wellness. “So we are clearly actively connecting
Health Portal with people, the leaders of these strategically driven programs in our hospital system, to understand how we
can use the information that exists today in more meaningful ways, and create additional information that
Family Health might add precision to our ability to treat people correctly.”
History
For example, today, around 75% of healthcare dollars are spent on patients with chronic disease. OSU’s
health plan, like any large group of insured people, has a relatively small percentage of its total patient pool
Personal Health and that requires an extraordinary amount of expense. “I look at that as identifying a group of people that really
Medication History
aren’t getting what they need to stay healthy,” Marsh says. To address that problem, the center is creating a
medical home team that can be immediately available and could interface proactively with these patients in
Roll over each pillar to
Genetic Tests & their homes and communities to try to solve the types of challenges that cause them to have further health
reveal explanations
Molecular Markers problems. “It’s really good for them, but also is good from the standpoint of expenditure of healthcare dollars,”
he says.
Personal Health
Assessment
IT runs through it
Strong data systems are, of course, paramount in tailoring medical care. From the “opt-out” systems of care
protocols to data richness in the EMR to integrating that information and sharing it among siloed medical
Source: The Ohio State University
Medical Center
practitioners depends on critical IT systems, says interim CIO Phyllis Teater. Teater says effective personal-
ized healthcare depends first on developing a set of services for the patients themselves, so that they feel
more connected to their healthcare providers.
“I’m talking about systems where we don’t have to ask them the same questions 10 and 20 times
because we have an electronic record. That way, when they present at a new place within the system, they
feel that we know them,” she says. “We also have a suite of tools that impact the direct patient experience.
Some are about convenience, certainly, like wayfinding tools, but if they’re looking at a 40-building medical
center complex trying to find out where they’re supposed to be, that doesn’t feel personalized.” The ultimate

23
CASE STUDIES
goal is one where not only does the healthcare system care for patients The building of each of those individual rules is a labor-intensive
better when they have the onset of any sort of complications through process, because there is no opportunity to make mistakes. “It has to
opt-out clinical pathways, but to offer patients predictive data to help be supported by widely accepted evidence that there is a link between
them modify their behavior or environment before they have the onset these two pieces of information,” she says. “In the end, it is still a physi-
of something for which they have a proclivity. cian making care decisions for their patients, but that is extra informa-
tion for them.”
“Being able to look at that data and look for trends is a very com-
putational and data-intensive process that is a throughput challenge Standardization of care
from an IT perspective,” Teater says. “To sift through that information
Standardization of our care models and execution of evidence-based
manually is clearly impossible. There’s way too much of it. So you have
practices, in a more low-variability way is one way to achieve the prom-
to have electronic processes to start to understand some of these rela-
ise of personalized medicine, says Marsh. Certainly providing access and
tionships between data.”
help to people with chronic disease who are spending a lot of the health-
She uses herself as an example. “I had surgery a few years ago, care dollar and preventing chronic disease is a low-hanging fruit that
and had a complication with a blood clot. At the time, through trial and could be harvested. “But to fundamentally benefit people and transform
error, they discovered that I am resistant to blood-clotting drugs. It the way we do things, we have to think of a much greater and deeper
takes an inordinately high dose for clotting drugs to work on me. If I ecosystem change that needs to made in medicine,” he says. “Just like
Steven Gabbe, MD
Senior VP for Health Sciences, Chief were able to provide that information through the EMR to the physi- our car maintenance, we wouldn’t drive our cars until the red lights
Executive Officer, The Ohio State cians that were taking care of me up front, they would have known that come on, and drive them even more until they break down on the side of
University Medical Center
out of the gate, and it may have helped them make decisions in a differ- the road, and then call somebody to get it fixed. We would spend money
Click here. ent way that would have made my clinical progress move along a little to try to prevent them from having problems.” Clearly that’s not the way
faster. Certainly it’s in my medical record now.” that healthcare is delivered, nor is it the way it’s currently reimbursed.
The key to providing that information for patients who haven’t “We need fundamental change that integrates the whole system,
experienced surgery before, for example, would require taking some and provides tools and capabilities to really empower people in a differ-
of the information gleaned from patients who are enrolled in OSU’s ent way,” he says. “We’re working with a lot of outstanding partners to
research studies, “and load those markers into our EMR so that we can tr y to come up with some of those solution sets, and to figure out how
provide that additional information to our clinicians as they make deci- to apply them in ways that are meaningful, compelling, less expensive,
sions,” says Teater. and higher quality using the principles of P4 Medicine™.”

CASE STUDIES BY JIM MOLPUS 24
Partners HealthCare
Creating the
First Waves
R
Research into personalized medicine rotates around a classic endocrinologist, says that warfarin “has a relative narrow therapeutic
conundrum: To find the science and evidence behind a particular, indi- index,” meaning that not giving enough anticoagulant and giving too
vidualized therapy that can be called “personalized” requires a large much is a small window. And the consequences of a misdiagnosis
pool to be narrowed to a very small one, and then to one person. are dire, including stroke. There are two gene products, two proteins,
that “have a major impact on how you metabolize warfarin.” Within
To find the relatively few people who may deviate from the
those gene products, there are six genetic variants in the protein
norm may mean testing a larger group. So researchers at Partners
that metabolize the drug and three genetic variants in the targeting
HealthCare, the combination of Brigham and Women’s and
of the drug, meaning there are 18 possible variants that affect the
Massachusetts General Hospital and the major teaching affiliates of
metabolism and target response, Freeman says.

Harvard Medical School, are exploring a multi-structured approach to
make personalized medicine turn from science to practice. “So what the study did was to try to understand that, if you knew
the genetic variants, could you come up with an algorithm for treat-
Mason W. Freeman, MD, director of the Translational Medicine
ment that would alter the dose of warfarin that would provide them
Group at Massachusetts General Hospital, is leading a clinical trial
better anticoagulation control,” Freeman says. Initial results of the
in partnership with the FDA to understand how certain people with
study, which is not yet published, found which variants needed more
a defined list of genetic variations respond differently to commonly
medication and which ones less.
used blood thinners such as warfarin. Mason, an internist and

25
Partners HealthCare
CASE STUDIES
“There are a couple of things that are absolutely spot-on central to infrastructures to create the framework for personalized medicine.
the whole issue of personalized medicine,” says Freeman. “For probably
The first is as chief information officer at Partners, where he and
two-thirds of the potential genotype variants, you don’t need to change
his team are building the IT vision to fit the goals of the Partners
the dose. But in the third, where they have a more atypical variant that
HealthCare Center for Personalized Genetic Medicine, which include a
has a bigger impact on the warfarin dose, then you do change the dose
robust electronic medical record, personalized genomic data available
quite a bit.”
for clinical use, and physician access to electronic decision support
So early results are clearly showing that for those patients tools. The second is as senior advisor to David Blumenthal, MD, the
with the atypical variant, physicians get much better control of their federal coordinator for healthcare information technology, in the devel-
anticoagulation therapy when they use the genetic information, opment of meaningful use definitions under the HITECH provisions
Freeman says. To understand who has the variant requires a single of the American Recovery and Reinvestment Act. In a national sense,
$400 genetic test, Freeman says. But for the two-thirds of people in the the hope is to lay the foundation for the decision support that will be
study who were not in the atypical variant, the test did not alter treat- needed for personalized medicine, but to get there will mean taking
ment. “Now you have the classic conundrum of personalized medicine some first steps.
for a lot of conditions,” Freeman says. “Are you willing to pay to have
“When I look at the standards that have come through the interim
everybody have it done to benefit a third?” The issue may not last long,
final rule and the definition of meaningful use that is currently in the
as the so-called $1,000 genome—i.e., the entire sequence at once—
notice of proposed rulemaking, it is very fundamental,” Glaser says. “It’s
may only be a few years away.
things like a code for a lab test and e-prescribing. And there’s nothing in
“Everything changes in this equation on the day that whole the current definition that includes personalized medicine. But there’s
genome sequencing is now part of your medical record because you’ve also nothing being done there that will make personalized medicine
got all of the gene variants already in the computer, done with one harder over time.”
test,” says Freeman. “So it’s not a per-condition gene test. Once you
It won’t necessarily be too far along before those rules may come
pay $1,000 or less to have it in your computer system, you have every
into future definitions of meaningful use, Glaser says. “Maybe we’ll see
variant that they have for every disorder that you would ever have a
in 2013 and 2015 definitions of meaningful use and in standards in the
genetic relationship to. It’s incredibly cost-effective.”
years to come that are more dead center to personalized medicine,”
Next meaningful use he says. “But we’re laying a foundation that the personalized medicine
revolution will be able to leverage and frankly will be necessary,
John Glaser is helping to build two information technology
EDITOR’S NOTE

26
Partners HealthCare
CASE STUDIES
because in the years ahead,
the sheer amount of decision
Functioning of the Information Technology Infrastructure
support will require an EHR Physician
foundation.”Before that decision
support can be actualized, some
connections in research have Molecular Electronic
to be made. Partners is leading Diagnostic Medical Record
Laboratory Manages storage and security
on multiple research fronts, of structured genetic/genomic
test results
particularly on the software Clinical Security
Context
that is necessary to merge EHR
and genetic data in biomedical
computing, which is why National Genetic/
Genomic Geneticist/
Institutes of Health Center’s Testing Genetic
Informatics for Integrating Counselor
Biology and the Bedside resides Genomic Variant
Interpretation Engine
at Partners. Gateway for Integrated (GVIE) and GeneInsight
Genomics-Proteomics Manage interpretation of
In the clinical areas, Partners Applications and Data test results
Mason W. Freeman, MD,
Manage physical aspects of the
Director of the Translational has already begun to deploy testing process
Medicine Group, genetic-related decision sup- Bioinformatics
Massachusetts General Hospital
Having trouble listening? port. One of the challenges that Testing Platform
Click here. Source: Partners HealthCare
Partners found isn’t necessarily in
getting the data to physicians, but
They know how to read a pathology report. But they actually don’t
rather getting the results in ways physicians can process. A cryptic set
know how to look at this data and to make decisions based on it.”
of raw results is not useful
Partners has developed software called Patient Genome Explorer,
to today’s physicians.
which pops up in the genetic results a physician sees for treatment
“A lot of clinicians don’t know how to interpret genetic results,” decisions and explains what the data mean in treatment terms.
Glaser says. “They know how to look at a graph of chemistry results. Another program, GeneInsight creates a report for the patient and

27
Partners HealthCare
CASE STUDIES
{ “A lot of clinicians don’t know how to interpret genetic results,” Glaser

says. “They know how to look at a graph of chemistry results. They know
how to read a pathology report. But they actually don’t know how to look
at this data and to make decisions based on it.”
referring physicians that describes the genetic variance and possible

–JOHN GLASER, CHIEF INFORMATION OFFICER, PARTNERS HEALTHCARE
Raju Kucherlapati, PhD, Paul C. Cabot Professor of Genetics at Harvard

}
ramifications for treatment. Like any decision support tool, the ones Medical School. Estimates are that only 15% of cancer patients nation-
at Partners are only as good as their data, and even in the relatively ally receive their treatment at premier academic medical centers, with
new field of personalized medicine must be kept in line with current the rest receiving care at a community hospital or oncology center.
evidence.
“Even at the academic medical centers, different levels of personal-
“One of the other challenges, and you see this in cancer, is that our ized medicine are being applied,” Kucherlapati says. “In the community
understanding of what a gene mutation meant five years ago has been setting, it is widely variable. There are probably a few practices that
replaced by more knowledge that has come through,” Glaser says. “So a practice some level of personalized medicine, but many of them do not.
prior result might have led you to do X. Now the research may want you It is still a big challenge and an opportunity to get all of these communi-
to do something different than X. So if you have a patient under your ty oncology practices to embrace these ideas of personalized medicine,
care and all of a sudden we have new understanding, we need to tell because for the first time, if they do embrace it, they have the oppor-
you that because the course of treatment needs to change.” tunity to provide the kind of care that major academic medical centers
would be able to provide.”
John Glaser, Community next
Glaser advises that even a medium-sized community hospital
Chief Information Officer,
Although the wave of personalized medicine is rolling from academic
Partners HealthCare should start to look at whether its clinicians are studying or engaged in
Having trouble listening? medical centers to community hospitals at a fast pace, Glaser says the
Click here. personalized medicine, especially in cancer. “It’s also worth asking your
wave “won’t wash up on all shores at the same time,” with particular
EHR vendor what their plans are for personalized medicine,” Glaser
areas such as cancer already being a service line in which community
says. “Meaningful use may be more of an immediate agenda item. But I
hospitals may enter the translational science. Rather than being a
wouldn’t lose track of those things and would expect that I may need to
threat, embracing personalized medicine may be an opportunity, says
respond to personalized medicine in the near-term.”

CASE STUDIES BY JIM MOLPUS 28
Vanderbilt University Medical Center

Targeting Decision Support
Vanderbilt University Medical Center is building off of its history of innovation
in informatics to bring personalized medicine to physicians when they need it.
T
The hope of the American Recovery and Reinvestment Act (ARRA) “The first recognition is that genetic variation, the minute differenc-
was to build the infrastructure for future innovation and commerce. For es between you and me constituting less than 1% of our DNA blueprint,
retail and construction, the future is built on highways. For personalized can strongly predict in some cases whether we will get a good result
medicine, the paths are the data points in an electronic health record from a medication or a bad result,” Masys says. He explains that VESPA
that store those few genetic differences that separate a personalized will work like “1.9 million experiments of nature” by combing de-iden-
care plan. tified data of treatments and reactions stored from those treated at
Vanderbilt, plus the data from BioVU, a de-identified DNA bio bank that
In 2009, Vanderbilt University Medical Center in Nashville
stores leftover blood from 80,000 individuals treated at Vanderbilt.
launched VESPA (Vanderbilt Electronic Systems for Pharmacogenomic
(Patients sign a consent form for the use of leftover blood.)
Assessment), a $6.4 million research grant sponsored by the National

Institutes of Health under its Grand Opportunities program using “The idea is to use the electronic medical record to find a group of
ARRA funds. The program tries to blend new science with some of individuals who got a medicine and got a good effect, and then another
the vision and potential use of personalized medicine, says Dan Masys, group who got the same medicine and got a bad effect, and then go to
MD, coprincipal investigator of the VESPA program and chair of the the DNA and do a genomewide scan to see whether we could have pre-
department of biomedical informatics at Vanderbilt University Medical dicted, based on minute variations in the DNA, whether one group had
School. a different pattern than the other,” Masys says.

29
CASE STUDIES
But the idea behind VESPA is not to stop at bench science, but The way personalized medicine works in clinical practice today
to make a quick leap into the clinical realm. “Once we’ve found those is typically too slow to be effective, says Dan Roden, MD, coprincipal
patterns, the normal way is you just publish a scientific paper in the lit- investigator with Masys on VESPA and assistant vice chancellor for
erature. That’s the way that science generally runs, but that’s not what personalized medicine at Vanderbilt.
VESPA is proposing to do,” says Masys. “VESPA is proposing to take
“There’s no question that personalized medicine is not in wide-
that information back into the clinic through patient-specific computer-
spread clinical practice, not at all,” Roden says, because the typical
ized clinical decision support so that we could have, in essence, a small
patient-physician encounter is built around a diagnosis based on clinical
panel of genotypes—that is, small points of variation in your DNA—
factors, a treatment decision made by the doctor, and communication
that we would just go ahead and capture ahead of time on everyone
of both to the patient.
who walks through the door. So that information would already be
there at the point where some fraction of people will have a doctor pre- “If at the end of that discussion I have to turn around and say,
scribe a medicine that they’ve never been exposed to before, for which Oh, and by the way, your response to that drug is influenced by genetic
we know DNA variation predicts a different response.” factors, and that test will be available maybe tomorrow, but it’s more
likely a couple of weeks.’ And I’ll call you up when we have the result.
Masys and his team hope to get the results of VESPA into
And I might tell you you’re on the right dose of the right medicine. I
Vanderbilt’s EHR within a year to 18 months, at which point the infor-
might also tell you you’re on the wrong dose of the right medicine.
mation will be available to physicians at the point of care. That, says
I might tell you you’re on the wrong medicine.
Masys, is a true acceleration of the promise of personalized medicine.
“It’s hard enough to explain to people that they need to go on this
“There is a little bit of this occurring out there already, and it’s been
new medicine and why. But then to turn around and say, ‘Oh, and by
called personalized medicine, but it’s all after-the-fact personalized
the way, we’re going to have this whole discussion again in a couple of
medicine. It’s after the doctor has already prescribed the medicine,”
weeks—I don’t exactly know when’? It’s just way too cumbersome.”
Masys says. “So in a sense, the moment has passed where the infor-
mation is important. And so we’re proposing to move this ahead and Cost behind the science
formally evaluate how much additional improvement in care results Although the VESPA study is built on a research grant, Vanderbilt is
from the DNA information compared to the way we normally make our concurrently tracking the data for cost analysis with its Institute for
clinical decision.” Medicine and Public Health. It is that type of data which will build the
EDITOR’S NOTE

30
CASE STUDIES
basis for future discussions with
payers on reimbursement and
Molecular Medicine Drives the Need for Patient-
effectiveness of the genetic data.
“A very small number of tests

Specific Decision Support Assistance
are already paid for,” Masys says.
“So if you get put on Plavix, one of
these blood thinners that people 1000
with coronary stents have and Proteomics and other
Facts per Decision

such, that’s actually reimbursable. effectormolecules
But what we expect is there

are going to be a whole lot of 100
genetic associations where there’s Functional Genetics:
Gene expression profiles
strong scientific evidence but the
reimbursement machinery has
not yet caught up. What gets 10
Structural Genetics:
paid for and what doesn’t get e.g., SNPs, haplotypes
paid for in healthcare isn’t always Decisions by
clinical phenotype: Human Cognitive
based on science.”
Dan Masys, MD, i.e., traditional Capacity
Chair of Biomedical Informatics, healthcare
Masys anticipates soon
Vanderbilt University
1990 2000 2010 2020
Medical School “working with insurers to perhaps
Having trouble listening? set up a mechanism where these Source: Vanderbilt University Medical Center
Click here.
things can be recognized, vali-
dated, accepted, and paid for.”
The future tense envisioned by Masys and others in the field would already done—a much more cost-effective way of maximizing the
be that a person’s genome would be a common part of his or her elec- value of personalized medicine. VESPA will initially be built to look at a
tronic health record, and so genetic tests would be run against typing relatively limited number of a few thousand genotypes, Masys says, but

31
CASE STUDIES
Proposed Medical Oncology Provider ‘White Board’

Demographics Diagnosis/ Relevant Disease Current Tx CBC Chem Imaging Trial
Stage Biomarkers Status Status
Roll over the “White Board”
to gain insight on the future GW 55AF NSCLC EGFR+ Metastatic Erlotinib 11:33 11:33 Last CT Consider
of standard care from VUMC’s Adenocarcinoma since 6/7/08 CAP 8/7/09 2nd -gen
William Pao, MD Stage IV EGFR
TKI if
POD
JD 68WF NSCLC KRAS+ Recurrent Carboplatin/ - - Last CT Consider

Adenocarcinoma Metastatic Paclitaxel s/p CAP KRAS
Stage II 2 cycles; 7/12/09 trial;
started unlikely
7/15/09 to
respond
to EGFR
TKI
DS 45WM NSCLC ALK+ Metastatic Untreated - - Today - Consider
Adenocarcinoma pending ALK trial
Stage IV
WP 55M Malignant BRAF+ Recurrent PLX-0432 - - Last CT -

Melanoma Metastatic since CAP
Stage II 08/12/08 9/22/09
TM 42W Malignant KIT+ Metastatic Interferon- - - Last CT Consider

Melanoma alfa2b CAP 7/7/09 imatinib
Stage IV
Source: Vanderbilt University Medical Center

32
CASE STUDIES
with the computer rules and algorithms will be able to “actually reason Targeting resistance
with your entire genome once that becomes available,” he says.
Nowhere is the science of personalized medicine more in practice than
The data crunching and storage issues associated with the genetic in cancer care, where Vanderbilt researchers are tracking genetic vari-
variants are not as daunting as they would appear, Masys says. “We’re ance in cancer tumors to more precisely target therapies. Certain lung
saved by the fact that you and I are actually 99% the same. And this is cancers have a sensitivity and resistance to targeted therapies such as
just talking about genes. There’s another order of magnitude complex- Iressa and Tarceva, which both work by blocking the activity of epider-
ity when you go out and measure proteins, because there are a lot more mal growth factor receptors.
of them than there are genes.
A single mutation, however, may cause the tumors to become
But the same principle applies: that if we have a data reference that resistant to the drug and allow tumors to return within a year, says
is our standard definition, then you and I just become a set of differ- William Pao, MD, Ingram associate professor of cancer research at the
ences to the norm, and so it reduces the data storage problem by 99%. Vanderbilt-Ingram Cancer Center. Researchers found that by compar-
Because at the front end what we can compute is, where there are no ing the genes of the tumors versus normal lung tissue, they identified a
differences, we’ll just use the standard genome, and where there are strategy that a new combination of two drugs—erbitux and the com-
differences, we’ll store what’s exactly and only you, and only me.” pound BIBW-2992—can overcome tumors with the second mutation.
Storage is not the issue, but what systems will require is a robust, Pao’s research now is concentrating on getting standard genetic
Dan Roden, MD, actively used EMR with decision support. Vanderbilt has been develop- mutation analysis done on cancer patients that will be built into the
Assistant vice chancellor
for personalized medicine, ing its EMR for more than two decades and clinical decision support university’s plans for decision support.
Vanderbilt University tools since 1994, Masys says, yet fewer than 10% of hospitals nation-
Medical Center “First we just wanted to get what we would consider standard
wide have reached that level. So although many in the industry may
Having trouble listening? mutation analysis done in a prospective manner, meaning that the data
Click here. view the EMR as a process tool for preventing today’s medical errors
is done automatically on patients’ tumors,” Pao says. “And there we’re
and recordkeeping, its real use is as the basis for a higher level of deci-
testing for three main mutations in lung cancer and then one main
sion support in personalized medicine.
mutation in melanoma. That’s our one-year goal, and we’re already
“What we do know is that the only way to deal with the complex- there, basically. Our second goal is to develop an assay for detection of
ity of the patterns is with computerized decision support rules,” says more mutations. So we have one in lung, where we can detect about 40
Masys. “There’s no way for a human being to look at these patterns and mutations, and then one in melanoma, again about 40 mutations, all of
be able to recognize them.” which are relevant to targeted therapy in cancer.”

ROUNDTABLE
The Promise of
Personalized Medicine
Featuring highlights of a Roundtable of peer experts:
Mark Raju Clay Gerald Dan

Boguski, MD Kucherlapati, PhD Marsh, MD McDougall Roden, MD
Department of Pathology, Paul C. Cabot Professor Executive Director, Center Principal and U.S. Assistant Vice Chancellor
DANA THOMAS
Beth Israel Deaconess Medical of Genetics, Harvard for Personalized Health Health Sciences Leader, for Personalized Medicine,
Center, Center for Informatics Medical School Care, The Ohio State PricewaterhouseCoopers Vanderbilt University
at Harvard Medical School Having trouble viewing? Click here.
University Medical Center Having trouble viewing? Click here.
Medical Center
Having trouble viewing? Click here. Having trouble viewing? Click here. Having trouble viewing? Click here.
To see and hear the panelists’ introductions, click on their pictures above.
ROUNDTABLE 34
The Promise of
Personalized Jim Molpus
Strategic Partnerships
Philip Betbeze
Senior Editor
P
Director Leadership
HealthLeaders Media HealthLeaders Media
Medicine
DANA THOMAS
Personalized medicine is a phrase that encompasses all HEALTHLEADERS MEDIA It seems that the definition of personal-
ized medicine varies. Could each of you define what it means to your
that healthcare should be—that is, care carefully tailored
organizations?
to the specific needs of the patient. Advances in the science
CLAY MARSH, MD | The Ohio State University Medical Center | My
of genetics, along with the development of necessary
definition is system-based. I look at personalized healthcare as the abil-
infrastructure like the electronic medical record, may ity to understand individual health and stratify outcomes based on their
finally be near to pushing personalized medicine from an genetics, and environment, including sleep, biological rhythm, exercise,
nutrition, and stress. The definition also includes the healthcare deliv-
aspiration to the standard practice of care. HealthLeaders
ery system, data analysis, data integration and complexity, so that we
Media recently convened a panel of experts from four of can automate executing evidence-based practices we know today and
the world’s leading medical centers to discuss how the practices we learn tomorrow on a more personal, individual basis.
personalized medicine is at work today, and what Standardizing care and reducing variability is an important opportunity.
healthcare leaders everywhere should expect in the MARK BOGUSKI, MD | Beth Israel Deaconess Medical Center | I’ll
expand on it in a little different direction. I feel that direct consumer
next few years to come.
genetic testing is just really a subset of the larger challenge of educat-
ing patients enough to be comanagers of their health and wellness with
their physicians. In the personal genomics space, we have seen that the

35
ROUNDTABLE
business community and direct consumers got lot of what we’re talking about, but each has its to be able to do common prognosis, and to be
way ahead of the medical profession in provid- own domains. able to make the right treatment decisions—is
ing these tools and technologies, and I don’t what I would call personalized medicine.
RAJU KUCHERLAPATI, PHD | Harvard
think that failure is an option to help the con-
Medical School | To put it in the framework,
sumers understand this information, wherever Gerald McDougall
genetics as it relates to medicine has undergone Principal and U.S. Health
it comes from. Patients have an important role, Sciences Leader
an evolution towards the end of last century, PricewaterhouseCoopers
too, because personalized medicine is preven-
and that evolution is the recognition that genet-
tive medicine as well, and if people are informed
ics plays a very important role in virtually every
by health awareness and increased medical
aspect of health and disease in the human popu-
knowledge, amplified by their personal genomic
lations, and we’re beginning to understand very
information, I think they can be equipped to play
significantly what these genetic components
DANA THOMAS
a much more active role.
are that make us susceptible to disease, how we
GERALD MCDOUGALL | Pricewaterhouse- respond to particular types of drugs, and how
Coopers | At PricewaterhouseCoopers, we’ve we could enhance the wellness of human popula-
defined it as a holistic, individual model of care tions. So one of the evolutions that is happening DAN RODEN, MD | Vanderbilt University Medical
that examines each individual’s unique makeup in the early stages of the century is our ability Center | The ultimate in personalized medicine
and designs appropriate strategies for main- to use this genetic and genomic information to will be when we understand what it is that
Having trouble
viewing? Click here. taining wellness and treat- be able to make risk assessments for individuals makes you an individual and tailor your health-
ing illness. Others have and say who is going to be susceptible to get care to those factors. The things we’re working
coined it P4 Medicine™, particular types of diseases, and to be able to on right now are obviously genes and genetic
where it’s personalized, clinically diagnose, accurately diagnose a dis- variants. But the downstream effects of genes
preventive, predictive, and ease, and determine which drug is going to be and genetic variants are proteins and protein
participatory. I always most effective for those individuals. So the abili- variants, and so proteomics plays a role in that.
think those four P’s are ty to do all of these things—the ability to be able And proteomic profiling can be particularly use-
broad enough to capture a to do risk assessment, to be able to do diagnosis, ful in some cancers. That’s not a future tense

36
ROUNDTABLE
vision. That’s upon us as we speak. There’s a lot virus and changed HIV from a death sentence to RODEN I trained as an internist, and then I
more than just genes and proteins that make us a chronic disease. In the pharmacogenomic field, came to Vanderbilt in the late 1970s to study
who we are. There’s the way we were brought we now have more targeted therapies for people something called clinical pharmacology. And
up, the sociology in which we live, the society in with cancers based on the genetics of the tumor it took 10 years of my life to figure out how to
which we live, the family relations and the per- to give treatment that is more precise, safer, and explain clinical pharmacology to those people
sonal, professional relations that we have, all of more effective. who are not in the discipline, like my mother.
which color the way you approach healthcare, Clinical pharmacology is the science of trying
BOGUSKI Participatory medicine is a very
whether you’re a compliant person, a not-com- to understand the mechanisms underlying vari-
interesting phenomenon that’s been going on for
pliant person, whether you’re an obsessive per- ability in response to drugs in human beings and
several years with groups like e-Patients.net, and
son or a not-obsessive person. Those things all using that information to use the drugs we have
these people are very assertive folks who not
have to get taken into account when you start now better or to develop new drugs. And there’s
only want to be participants in their healthcare
to think about personalizing healthcare. been a story in clinical pharmacology for the last
but actually the managers of it, because they
30-plus years that there are genetic variants
have a vested interest in getting the best treat-
Current state that profoundly affect response to certain drugs.
ments. That’s not a model for the whole popula-
HEALTHLEADERS MEDIA Give us a status And so the frustration has been, in the clinical
tion, because you have to have a lot of motiva-
report on personalized medicine as it relates to
tion and assertiveness to insist on that level of
getting into working clinical practice.
participation. My message is that doctors have Clay Marsh, MD
Executive Director, Center
MARSH If you look at the Institute of to prepare themselves to anticipate this and not for Personalized Care
The Ohio State University
Medicine’s report, it takes about 17 years to reflexively react that, you know, “I’m the doctor Medical Center
get a discovery from the bench to the bedside. and you shut up,” which is something I’ve heard
There have been some really nice examples of in my training. I think the medical profession has
where that time has been shortcutted, where not yet fully realized that not only do they need
we’ve really benefited people. The HIV epidemic to update their training in terms of content, but
is certainly one of those, where we aggressively
DANA THOMAS
sort of rethink the way that they’re going to deal
put drugs in clinic with activity against that with patients and consumers.

37
ROUNDTABLE
pharmacology community, that we know that those individuals. The second area that I think Mark Boguski, MD
Department of Pathology, Beth
there is variability in response to drugs, and we has a significant impact is in cancer. The classic Israel Deaconess Medical Center
Center for Biomedical Informatics
know the mechanisms in some cases, and yet we examples of the use of genetic information at Harvard Medical School
don’t act on those mechanisms. We don’t incor- for determining risk are in early–onset breast
porate those mechanisms into the way we prac- cancer, where it’s possible to do a test and be
tice medicine. One of the reasons is that genetic able to determine whether the individuals have
testing has been difficult to accomplish and has mutations in BRCA1 or BRCA2 and to make
been sort of esoteric and foreign to most doc- a risk assessment. Similar sorts of tests are
DANA THOMAS
tors. So most doctors will say, “Well, I accept the available for other types of cancers, such as
idea that there’s variability. I’ll give the drugs, colon cancer. And then, following the prognosis
and if my patient happens to be one of those out- issues, there are actually treatment issues. ment to the right patient at the right time. That
liers, then we’ll figure that out and move on.” We Maybe lung cancer is one of the best examples, is not new for anyone looking across at a patient,
can do better. where genetic testing of the tumor samples is but I think the standardization of variability is
going to inform us as to what is the nature of the something that needs to be dealt with as well.
KUCHERLAPATI The one practice where
drug that should be given to those individuals. HEALTHLEADERS MEDIA Much of the
personalized medicine is used extensively is in
pediatrics. There are many, many childhood MCDOUGALL When we’re looking at the potential in personalized medicine is in the value
diseases for which the diagnosis, prognosis, opportunity to personalize medicine, we still proposition it provides—of avoiding unneces-
and treatment decisions will not be made in have to overlay it into a current healthcare sys- sary tests. That value may remain elusive for
the absence of genetic information. In cystic tem that has a lot of variability. That variability, now, but is the proposition changing?
fibrosis, for example, we are able to make a in terms of the delivery of healthcare and then MARSH If you think about the cancer field or
determination that the child would have cystic clinical adoption, is a huge issue that needs to be the pediatrics field, there now are pressures
fibrosis, confirm it with a test, and then the dealt with by the entire healthcare ecosystem. from the cost reimbursement side to test for
results that you obtain from the test would Personalized medicine has been around for a specific targets, so we use expensive therapies
determine how that child is going to be treated very long time. I don’t know a physician who specifically from a provider standpoint. So I
and how you would be able to extend the lives of wouldn’t want the tools to get the right treat- think that aligning the systems together to

38
ROUNDTABLE
create an automated framework to consistently genetic variants that will tell a doctor whether on wellness and prevention. We now have a bet-
practice the same high-quality care is critical. In that person is likely to be a responder or not a ter understanding of the influence that individual
this way, we will deliver the best care to everyone responder, or whether that person is likely to genetic factors, behavior and lifestyle have on
irrespective of the physician. If we can stan- get severe adverse effects from that drug. Those health, and individuals are more informed and
dardize our delivery system to do simple things things are reality now. The only issue is how knowledgeable. They want a more complete pic-
consistently with low variability, we will benefit to incorporate them into healthcare so we can ture of their overall health at both the individual
consumers greatly. As new discoveries in per- use that information more efficiently. There are and family level, much like they have of their
sonalized medicine are gained, we will put these other kinds of reactions that are not as impor- financial health. Ultimately, this information will
decisions into this automated delivery, which ulti- tant in terms of mortality, but very important in help to forge a stronger, more participatory rela-
mately will place medicine in the patient’s hands. terms of the way we practice. If you’re a poor tionship between physicians and their patients
metabolizer and you’re prescribed Prozac®, the as they discuss and agree on wellness strategies,
RODEN I’ll give
Raju Kucherlapati, PhD likelihood is that you’ll get a severe headache treatment decisions and behavior before, during
Paul C. Cabot Professor of
you a couple of
Genetics and you will not be able to tolerate the medicine. and after they become ill. The current health sys-
Harvard Medical School
examples that are
Now, you’re not going to die of that. But it takes tem is focused on illness, not wellness, but this
either upon us or
a long time to figure that out. It’s an inefficiency is changing, and the shift will have significant
will be upon us
in the healthcare system. And it’s one of the implications for the patient-physician relation-
within the next
reasons that people become noncompliant with ship. Physicians will need to adapt to the needs
dozen or two
drugs. It’s one of the reasons drugs don’t work, of a more informed patient and have a stronger
dozen months. I’d
DANA THOMAS
because people get frustrated. partnership with that patient to help him or her
prefer to think of
manage health. Furthermore, physicians will
the time horizon HEALTHLEADERS MEDIA Does the pressure
need new skills to not only interpret diagnostic
in months rather than years because we’re mov- in this business model that you describe in per-
tests but also to incorporate that knowledge into
ing extremely fast. For somebody who is starting sonalized medicine exist now to be disruptive, to
clinical practice.
tamoxifen for breast cancer or who is starting change the way medicine is practiced now?
6-mercaptopurine for acute lymphocytic leuke- KUCHERLAPATI There’s a tremendous
MCDOUGALL As health insurance premiums
mia, a childhood disease, there are well-described amount of pressure for diagnostic costs to go
continue to go up, there is a much greater focus

39
ROUNDTABLE
down, and they have gone down. I ran a diag- bodies against epiderman growth factor recep- catastrophic drug effect that occurs one time
nostics lab for eight years. We started offering tor, should be tested for a gene called KRAS. in a hundred, and you manage to reduce that to
a test for EGF receptor mutations in non–small And they said that if such a test is done for all of one time in a thousand, it becomes quite difficult
cell lung cancer, and when we began to offer the patients who are being considered for such a to measure. But after a number of years, you’ll
that one test, it was about $1,500. Today, the treatment, after paying for the test, the society finally recognize that you have done something.
same lab offers that test, plus six other tests would be saving approximately $620 million for And when you’ve done something, then you can
for that cancer, for $1,200. We used to offer one of those two drugs every year. go back and figure out what a human life costs.
comprehensive tests for cardiovascular diseases But those are the kinds of outcome measure-
HEALTHLEADERS MEDIA With any new
like hypertrophic cardiomyopathy for $10,000. ments that we’re going to have to work on.
technology, there is an adoption curve before the
Now, five years later, you can do it for $3,000.
initial investment pays off. Where do we stand
Clearly, our ability to sequence the complete Dan Roden, MD
with personalized medicine on that curve? Assistant Vice Chancellor
human genome for $1,000 is truly near. The for Personalized Medicine
ability to get that test done is not the critical RODEN There are these ups and downs, and I’m Medical Center
component. Number one, there should be strong not sure whether we’re in a valley or a peak, you
scientific evidence that the tests are useful, and know? But I think we’re just starting. And there’s
the second is that you need to have a very clear going to be a lot more work that’s going to be
pharmacoeconomic analysis. One of the best needed to try to understand which genetic vari-
Having trouble ants become important to incorporate into the
DANA THOMAS
viewing? Click here.
examples of that:
The American Society care of your average 45-year-old man—because
of Clinical Oncology that person is likely to need drugs in the future—
made a recommenda- and how that will affect outcomes, how expen-
HEALTHLEADERS MEDIA Isn’t the basic
tion at the beginning sive that will be to do initially, and how much
infrastructure of personalized medicine the deci-
of last year that every money you’ll save by avoiding adverse drug reac-
sion support tool in the electronic medical record
metastatic colon cancer tions and by improving outcomes in therapy. And
that allows that clinician to know who can’t
patient who is going to then some of that is going to be pretty difficult
tolerate a certain drug based on their genetic
be treated with anti- to measure, by the way. If you have a rare but

40
ROUNDTABLE
Raju Kucherlapati, PhD

Paul C. Cabot Professor of
profile? How far away patient might be able to benefit if you get this typical community hospital or health system lay
Genetics
Harvard Medical School
are we? test done. Would you be willing to do so?” If the groundwork for the next steps in personal-
they’re willing to do so, it gets to Mayo. Mayo ized care?
MARSH I don’t think
would do the test and get the results back to the
we’re talking about the MCDOUGALL On the provider side, there will
docs. For those patients whose tests get done,
future. We’re talking be massive changes to the revenue cycle. When
their travels to the emergency room and all
about things that are you start looking at some of the more novel
DANA THOMAS
other adverse events are significantly reduced.

available and being done technologies or diagnostics, target therapies,
And now they’re trying to apply that to all of
in pockets today and and you look at it from a provider’s perspective,
their patients. And this spring, CVS Caremark
then what is needed to a cancer center, for example, could eventually
and Generation Health are going to launch a
accelerate the implementation. I think it’s only have 40% of its revenues, and much of its mar-
series of 20 genetic tests that are all based upon
going to get better as the science and technol- gins, in therapeutics. That has real bottom line
prescriptions, so every time that one of the CVS
ogy advances. I would not want the readers to business implications. Some of these things are
Caremark patients would get a drug prescribed,
be left with the notion that this is a futuristic wonderful for the patient and the employer, but
when it gets to be filled at the pharmacy, it will
strategy. they could displace or eliminate other clinical
come up and say that maybe this patient would
service lines that, today, are significant rev-
KUCHERLAPATI It’s being done today. Mayo benefit from a particular genetic test, and then
enue drivers. As anyone who has run a hospital
Clinic and Medco started an experiment with they would recommend it. No coercion; they just
knows, there are always certain cash cows but
the use of the anticoagulant drug warfarin. Any say this might benefit, and if so, then the tests
they inevitably change over time. The ability to
time that any of those physicians that Medco would get done and then the results would come
proactively anticipate shifting revenue sources
supports, they would prescribe or offer this back, and then for those 20 or 25 tests, that they
is a first step in preparing for a future of more
anticoagulant drug, and before the prescrip- would have a decision support system and be
personalized care. Community hospitals should
tion is filled, it will come out on the computer able to say to the docs, “This is what you might
be thinking now about how their current revenue
when you go to a retail pharmacy. So Medco consider doing.”
cycle will be affected by outcomes-based reim-
will be able to identify individuals who are being
bursement, value-based purchasing, increasing
prescribed warfarin, and it would send a mes- In the community
demand for diagnostic testing and therapeutics
sage to the physician and say, “You know, your HEALTHLEADERS MEDIA How should your

41
ROUNDTABLE
as well as new regulations directed at avoidable using all the data and evaluating it three-dimen- really have to go to the communities. I’ll give an
readmissions and never events, and how the sionally. So as we look for adoption, what we’ve example: cancer. There are 1.5 million cancer
adoption of personalized care can help them not touched upon to date are exciting examples and patients that are diagnosed every year. Eighty
only protect margins but potentially increase opportunities for patients. As we get to a more percent of them get treated in the community
revenue in the future. They also need to be think- consumer-based healthcare approach, one of the setting. Less than 20% of them actually go to
ing about how their IT infrastructure and adop- real opportunities is to understand how we can major academic medical centers. All of this
tion of interoperable, electronic medical records transition from disease-based care to truly facili- outpatient cancer care is run by outpatient
will be used to support the increase in data and tate health. We believe that is an active process oncology centers that are run by 15, 20 physi-
analytics. A more personalized approach to care and a tremendous opportunity to understand cians. How are they making money today? The
is the practice of medicine and the way that health and wellness. We also need to engage way that they are able to make the money is they
healthcare will be delivered and financed in the individuals with meaningful data and feedback would buy the drug, market it after a markup of
future. Agile organizations that begin planning that is exciting and useful. If we can actually 30%–50%. That whole equation has changed.
now for the changes ahead will have a competi- help individuals understand how to stay healthy, CMS now says, “We will provide you average
tive advantage. and we understand how the environment and sales price for this drug, plus 6%; that’s it.” No
the genome interface to make each of us unique, more 30%, 40% margins. The community oncol-
MARSH We are working closely with the
we can give people longitudinal opportunities ogy practices need to have a different model.
Institute for Systems Biology in Seattle to join
to individually alter their environment—diet, What’s the different model? One model is that
together to form the P4 Medicine™ Institute,
Having trouble
viewing? Click here.
exercise, sleep, biological rhythms, stress—and they would be able to provide as good care for
which is predictive, pre-
help them define health at a molecular and bio- their patients as a major active medical center
ventive, personalized,
social level. These factors with an individual’s would be able to do. One of the opportunities
and participatory, and a
genome control health and disease, and that’s a where they can do that is personalized medicine.
systems-based healthcare
tremendous opportunity for us to really change Right? That’s how you would be able to move
focus. I think that part of
the paradigm and create the tipping point for the needle, if they are willing to do that. U.S.
the challenge, when you
healthcare transformation. Oncology is a collection of a whole bunch of
look at how systems biol-
these outpatient oncology practices, and they
ogy uses data, is that it’s KUCHERLAPATI To move the needle, you
recently made an announcement that together

42
ROUNDTABLE
Mark Boguski, MD
with a commer- when confronted with your own data, you really implement personalized medicine? One is that
Department of Pathology,
Beth Israel Deaconess Medical
cial entity, they are incentivized to learn what it means. In our the American Medical Association now consid-
Center
Center for Biomedical Informatics
are going to do residency training program in pathology, we ers that personalized medicine is an important
at Harvard Medical School
an experiment require a personalized genomic medicine track component. They just had a meeting this year in
of sequencing that presents a series of lectures to remind them which personalized medicine plays a prominent
the DNA of about genetics because they forgot it since their role, and that they are going to educate the
breast can- first year of medical school. It gives them an membership in what they do. The second thing is
cers from the overview of modern genomics, and then they’re that all of the specialties in medicine need to be
patients that informed about the technologies, their uses and recertified every ten years. So every time you get
come in and limitations. We also offer them the voluntary recertified, in that board exam there are going to
see if it is possible to treat them based upon the opportunity to have themselves genotyped by be genetics questions because that’s the state of
data that they will get from this information. one of the commercial companies as part of science today. So how do you do that? I have ini-
Obviously, that’s what they’re thinking of. That’s their educational experience. And, of course, it’s tiated an effort at Harvard where we’re creating
a classic, terrific example that it is truly driven genetic information, so that part of the program an online continuing medical education module
financially. We had an example of a hospital is not compulsory, but it turns out that we were that we put on the Web site, and anybody can
called El Camino Hospital in California, in north- able to demystify this enough for them that two- take those modules and they get CME credit.
ern California, and they have an agreement with thirds of our residents and two of the faculty
HEALTHLEADERS MEDIA Any advice for
DNA Direct to offer over 25 different tests, in members opted to get themselves genotyped
providers who are looking to the future of per-
many different fields, for all of their patients. So after going through these initial lectures.
sonalized medicine and wondering what to do?
that is the way to drive it.
KUCHERLAPATI There are 600,000 physi-
MARSH What we would really love to do would
HEALTHLEADERS MEDIA Are we training cians in this country, so let’s leave the young
be to try to understand how we can start to link
new doctors to practice personalized medicine? people aside. It takes them ten years to be able
groups together in a kind of consortium arrange-
to get there. But how do you get all of these
BOGUSKI I’ll summarize it by stating we’re ment and rigorously generate the data that will
physicians around the country to implement
not genotyping the patients—we’re genotyp- be meaningful, to be able to incorporate care in
personalized medicine, to get knowledge and
ing our doctors, literally, under the theory that a closed academic system, say, versus care in a

43
ROUNDTABLE
more open community-based system. As we go will be able to have. That’s number one. Second Implementation of personalized medicine is
forward, everybody’s got to play, and it’s got to is for provider organizations, it’s not only a ques- going to result in better outcomes for patients,
work for partners in industry, academics, pay- tion of providing better care, but there have to and I truly believe there is going to be reduced
ers, providers, government and other healthcare be financial models that are sustainable. For pro- cost and that those issues are going to be so
systems. We don’t really have that yet, and I vider organizations, they’re all dependent upon critical in terms of implementation. It’s happen-
think that’s really the opportunity here. We have insurance companies, so what you need to do is ing today, it’s not some time in the future. This
a lot of people doing a lot of work, but we don’t have the payers be cognizant of this stuff and be is going to be the normal practice as we move
have the connected groups of people doing the able to say that this is going to help improve the forward.
work, in my opinion, that could make the differ- quality and at least keep the costs level.
RODEN It’s easy to say that in 10 or 15 years,
ence and really start to test rigorously different
BOGUSKI Let me make a few specific recom- the way we’ll do healthcare will be a lot more
solutions across different systems. We need the
mendations to practitioners. Number one, seek interactive. People will be responsible for their
finite data on how this approach will reduce
out relevant opportunities such as CME courses own healthcare to a greater extent than now,
costs and increase quality to create the tipping
in personalized medicine and genomics. Number and that mandates a huge educational mission.
point we need.
two, work with your specialty’s professional We’ll be doing a lot more intensive monitoring.
KUCHERLAPATI For providers, the most organization to make them aware of how fast I mean, people do glucose monitoring every
important piece of information is evidence. this technology is coming and what impact it day and blood pressure monitoring every day,
That’s what they want to be able to do, evi- may have on their members, their scope of prac- and certain kinds of monitoring in patients with
Having trouble
viewing? Click here. dence-based medicine. We tice and their business models. Lastly, anticipate congestive heart failure, for example, every day.
talked about examples of that some patients are going to demand a more If you were to write a science fiction novel, it’d
them, but how do you dis- active role in decision-making affecting their say, you know, that Joe Smith got up in the year
seminate that knowledge health. For further insight into this phenomenon, 2050 and put his finger into a socket in the wall,
to the providers? I think see http://e-patients.net/. and a sensor read whether he was coming down
the more they would get to with the flu or not. Sounds crazy, but so did the
KUCHERLAPATI Personalized medicine is
hear about, I think there’s Internet 25 years ago. That’s all very science-fic-
going to revolutionize the practice of medi-
more influence that they tion-y. The real question is not what happens in
cine, there is absolutely no doubt about it.

44
ROUNDTABLE
2050, but what happens in 2012 and 2015 and of a disease. The United States needs to continue diagnostics are here now and more are coming.
2020. It’s going to be incremental. And so the to lead the world in that aspect and seek inter- The advance of science and its adoption into
first step will be to start to identify some genetic national collaborations on the science. I’m not clinical practice will have to require regulatory
markers to put in the records of some patients in trying to make a political statement, but I think and policy reform. I would also say that we need
a prospective or preemptive kind of way. You will it’s very important that we continue to invest in to continue to explore ethics and develop strate-
need this information at some point in the future, and advance clinical research and innovation. gies to demonstrate value and balance the cost
but we have The regulatory approval process and clinical of quality.
to stick it in trials haven’t changed in a generation. The cur-
Gerald McDougall MARSH Complexity is an area that’s going to
Principal and U.S. Health
your chart now rent approach is quickly becoming outdated and
Sciences Leader be a more important part of how we solve prob-
PricewaterhouseCoopers
because other- there is a need for fundamental changes to keep
lems in the future. We have a lot of data, and
wise it becomes pace with scientific advancement in an era of
we’re talking about generating a lot more infor-
unbearably personalized medicine. We need a new regula-
mation, but we need to translate this data into
cumbersome to tory pathway and new tools, technologies and
knowledge and provide decision support tools to
try to do. And approaches to conducting clinical trials in a way
use this knowledge in improving healthcare. To
DANA THOMAS
by the way, if that accelerates innovation and provides appro-

predict health and disease, we would follow this
you have lots of priate incentives for physicians to participate.
information longitudinally and track the blood
genetic material Health information infrastructure also must be
profile of the individual. Having that level of feed-
in the charts of lots of people whose outcomes addressed and overlaid with a new approach to
back will also be quite disruptive and will allow
you can follow, then you can actually use that clinical trials. HIT is crucial for our ability to col-
people to individually manage their health in new
as a tool to find new markers. Well, we have the lect, store, analyze and share the vast amount of
ways to prevent disease. The world is changing
tools. If you have the genetics and their charts, personal and genetic information that is being
and will change even more, in a very positive
and you have the outcomes, you can ask that generated now. But HIT will have to be phased
way, and as we go forward that will empower
question and get an answer pretty quickly. in to be realistic. I couldn’t agree more with Raju.
people to participate in their personalized life
Science and technology are marching forward,
MCDOUGALL There still is a dire need for con- health plan and change the game in very positive
and a more personalized approach to care is
tinuing investment into the underlining biology ways for all of us.
inevitable. Targeted therapeutics and novel

EX EC U T I V E S U M M A RY 45
So Much More than a Patient’s

Genetic Code
CONCLUSIONS
These systems are attacking the challenge of
Hospitals are scary enough for patients as it
is, without the added burden of patients know-
ing that their genetic predispositions to certain
All four of the institutions in this report have
different approaches to personalized medicine,
starting with the definition of what it is. But
personalized medicine from different angles, maladies will be laid open to view not only by all can be emulated in some form or fashion by
their caregivers but by the people who pay their hospitals and health systems that see the person-
but they share a desire to pioneer the use of
bills—often, the insurance companies. But personalization of healthcare as the only way to make a
technology, treatment pathways, and genetic
alized medicine encompasses so much more than a sustainable business case for their futures.
data to provide better, more cost-effective
patient’s genetic code, and the four leading health-
healthcare to their patients. They are develop- The Ohio State University Medical Center in
care systems profiled in this HealthLeaders Media
ing models and behaviors for other hospitals Columbus sees personalized medicine as key to
Breakthroughs report recognize that fact and are
its future. To that end, it’s created a Center for
and health systems to emulate, including: acting on it.
Personalized Health Care that seeks to fundamen-
J_Xiè^n`k_gXk`\ekjk_\ì]lcc<DI# Though the latest revolution in patient care is tally change the way healthcare is delivered from
so that patients and caregivers can limited almost exclusively to large academic medi- disease-based to health-based. That means that
work together to deliver the best care cal centers, changes are coming quickly. One part caregivers will be tasked not only with treating
Ljè^^\e\k`Z[XkXkfdXb\Zcè`ZXci\Z- of personalized medicine is genetics, but equally and releasing patients, but following their compli-
ommendations to patients’ providers important, and more ready for action now, is the ance, encouraging healthy behaviors and ensur-
potential of the electronic medical record (EMR) ing that to the extent possible, those patients
KXbè^ZXi\kf[Xp#n_`Z_`j[`j\Xj\$
to help doctors and other caregivers better coor- won’t have to see the inside of a hospital again.
based, and creating care in the future dinate the care they give to patients with multiple That approach is contrary to the way healthcare
that is health-based disease states. Some of those steps can be taken is reimbursed, of course, but many healthcare
:i\Xkè^Xdfi\XlkfdXk\[jpjk\d# by just about any hospital with an electronic medi- systems are working to change that paradigm as
in order to eliminate unnecessary cal record system. well. Central to this approach is patient safety and
variation in care
EXECUTIVE
? SUMMARY 46
satisfaction, meaning the challenge is through To that end, the plan is to lay the foundation for
treatment protocols, to standardize the way the clinical decision support that will be needed On helping physicians
medicine is practiced, and to create a more auto-
mated system that would be active irrespective
for personalized medicine that incorporates a
patient’s genetic profile.
with data instead of
of who is supervising the care of the patient.
Vanderbilt University Medical Center in inundating them:
Beth Israel Deaconess Medical Center Nashville is looking for ways to differentiate the
“Clinicians are utterly overwhelmed by data. So my
(BIDMC) in Boston, one of Harvard Medical 1% of the human DNA blueprint that will help
challenge is to build clinical systems so that you can turn
School’s teaching hospitals, also has high hopes distinguish patients from each other so that their
data into information, knowledge, and wisdom. What
for the effective coordination of care through treatments might be fully personalized from a
we have to do is filter all this data and try to present
the EMR, but like the others, sees the future genetic standpoint. One of its groundbreaking
it to the doctor or the nurse just in time, when it’s
potential of tying genetic information with the research programs seeks to use the EMR to find
actionable, when it’s important.”
more traditional information, like family medical a group of individuals who got a medicine and a
history, contained in the EMR. BIDMC introduced therapeutic effect and then another group who —John Halamka, MD,
its EMR, PatientSite, in 2000. Some 50,000 got the same medicine and got a poor effect. Chief information officer,
patients a month access their medical records Then, researchers should be able to go to the DNA Beth Israel Deaconess Medical Center,
through it, and everything, including clinicians’ and do a genomewide scan to see whether care- Boston, MA
notes, is there for patients to inspect. The idea givers might have been able to predict, based on
behind sharing this information is to encourage minute variations in the DNA, whether one group “We are clearly actively connecting with people, the
patients and their caregivers to work together as has a different genetic pattern than the other. leaders of these strategically driven programs in our
a team to deliver the best care for that patient. That sort of research will be critical to developing hospital system, to understand how we can use the
standards of care that are missing, despite what information that exists today in more meaningful ways,
Partners HealthCare, a two-hospital teaching
is known about the human genome. and create additional information that might add
affiliate of Harvard Medical School in Boston, is
following the genome in exploring a multi-struc- The promise of personalized medicine is precision to our ability to treat people correctly.”
tured approach to turn the genomic side of per- here now, but it’s also experimental. In this —Clay Marsh, MD,
sonalized medicine from science to practice. It’s Breakthroughs report, HealthLeaders Media pro- Executive director of the Center
working on the future of combining that genetic files the institutions that are at the forefront of for Personalized Health Care,
information into the EMR in a way that doesn’t bringing the now and the experimental together, The Ohio State University Medical Center,
overload clinicians with irrelevant information and speaks with their leaders candidly about this Columbus, OH
toward treating a given patient’s disease state. exciting time in healthcare.

47
Additional Resources Additional Materials

For more information about our case study participants, go to: EMR Adoption: Starting to Evolve or Still Stuck in the Past?
NEXT
Beth Israel Deaconess Partners HealthCare Despite ARRA’s HITECH provision, which offers more than $30 billion in HealthLeaders Media
Medical Center
www.bidmc.org
www.partners.org
incentives, the basic questions about how EMRs will impact practices remain
largely unanswered. Breakthroughs
The Ohio State University
Medical Center
Medical Center
www.mc.vanderbilt.edu
http://www.healthleadersmedia.com/content/TEC-246979/EMR-Adoption-
Starting-to-Evolve-or-Still-Stuck-in-the-Past.html Coming in June:
nnn%medicalcenter.osu.edu
A Captive Audience—and Providers—Benefit from Telemedicine
HIT That Enables
About PricewaterhouseCoopers Where might be the perfect setting to launch a successful telemedicine project?
http://www.healthleadersmedia.com/content/COM-245964/A-Captive-
Quality, Efficiency,
Committed to the transformation of healthcare through innovation,
collaboration and thought leadership, PricewaterhouseCoopers’ Health
Industries Group offers industry and technical expertise across all health-
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and Value
related industries, including providers and payers, health sciences, biotech/ Patient Engagement Occurs One Step at a Time
medical devices, pharmaceutical and employer practices. The firms of the
One of the steps toward achieving quality care is getting patients more engaged
PricewaterhouseCoopers global network (www.pwc.com) provide industry-
in their health by working with their providers to better understand the treatment
focused assurance, tax and advisory services to build public trust and enhance
they are receiving.
value for clients and their stakeholders. PricewaterhouseCoopers has aligned its Publisher
professional service offerings around the future direction of the health system. http://www.healthleadersmedia.com/content/QUA-247839/Patient-Engagement- MATTHEW CANN
mcann@healthleadersmedia.com
Occurs-One-Step-at-a-Time.html
By applying broad understanding of how individual, specialized sectors work
Breakthroughs Editor &
together to drive the performance of the overall health system, the Health Strategic Relationships Director
Industries Group is positioned to help clients, industry and governments address Consider Human Factors Engineering When Designing JIM MOLPUS
jmolpus@healthleadersmedia.com
the changing market forces of globalization, consumerism, consolidation and
expansion, regulation, technology, and margin compression. More than 163,000 Patient Safety Projects Editorial Director
RICK JOHNSON
people in 151 countries across our network share their thinking, experience and Creating a “culture of safety” is a concept that many healthcare facilities rjohnson@healthleadersmedia.com
solutions to develop fresh perspectives and practical advice. have become familiar with in the past five years. One Arizona facility begins
any new patient safety project by examining the principles of human factors Senior Editor
DISCLAIMER: This document is for general information purposes only and should not be used as a substitute for consultation with PHILIP BETBEZE
professional advisors. engineering. pbetbeze@healthleadersmedia.com
http://www.healthleadersmedia.com/content/QUA-247396/Consider-Human- Managing Editor
Sponsorship Factors-Engineering-When-Designing-Patient-Safety-Projects BOB WERTZ
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For information regarding underwriting opportunities for HealthLeaders
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800/639-7477 Media Sales Operations Manager

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HealthCast: The Customization of Diagnosis, Care and Cure amullen@healthleadersmedia.com
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HealthLeaders Media is a leading multi-platform media company dedicated Copyright ©2010 HealthLeaders Media, 5115 Maryland
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April 2010

Medical Center 11 Vanderbilt University

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Personalized Medicine 2009 TOTAL MARKET: 2015 TOTAL MARKET:

Roll over each category

Totals may differ due to rounding.

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Personalized The Time to Act and

Medicine: Collaborate Is Now

medicine into a new era of customized care and treatments.

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to pave the way for a more patient-focused system.

Having trouble listening?

In addressed to accelerate the adoption of personalized medicine:

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{ “Personalized medicine is a holistic model of care that examines each indi-

Dissemination of knowledge. The rapid growth of this

IT infrastructure. Personalized medicine will spawn an

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18 The Ohio State University Medical Center

28 Vanderbilt University Medical Center

Beth Israel Deaconess Medical Center

systems and, of course, the clinicians, that are the glue.

His genome, and everyone else’s, contains 750 megabytes of clinical

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Roll over each colored box to

* No data for July 2009.

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variables. says, despite the reservations of medical geneticists, to name one

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* No data for July 2009.

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“That kind of care requires you, as a physi-

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The Ohio State University Medical Center

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Roll over each arrow to reveal

Wellness and Risk Management

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metabolism and target response, Freeman says.

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{ “A lot of clinicians don’t know how to interpret genetic results,” Glaser

referring physicians that describes the genetic variance and possible

Raju Kucherlapati, PhD, Paul C. Cabot Professor of Genetics at Harvard

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Vanderbilt University Medical Center

Assessment), a $6.4 million research grant sponsored by the National

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“A very small number of tests

Facts per Decision

Dissemination of knowledge. The rapid growth of this

IT infrastructure. Personalized medicine will spawn an