ehm 6

www.executivehm.com • Q4 2008

WHEN SCIENCEBECOMES MEDICINE

Victor Dzau sheds light on the discoveriesarising from translational research

Page 34

FRONTCENTER

Policy, patients and presidents: how the Institute for Health Policy’s David Blumenthal helps to shape our healthcare system Page 28

TALKING ABOUTA REVOLUTIONWhy retirement won’t stopCass Wheeler fighting forquality carePage 84

Joseph Heyman on the AMA’s workto eliminate health disparitiesPage 38

Using preventative care to cuthealthcare costsPage 76

AND

COVER EHM6 4:nov08 19/11/2008 16:11

Xoft.indd 2 13/11/08 08:54:53

Xoft.indd 3 13/11/08 08:55:12

Topotarget.indd 2 14/11/08 14:05:10

Topotarget.indd 3 14/11/08 14:05:12

Sheridan.indd 2 14/11/08 14:19:44

Sheridan.indd 3 14/11/08 14:19:47

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FROM THE EDITORHigh noonIt's time we ditched our Wild West attitude toward healthcare7

“Our healthcare system does havehuge problems. It’s in a crisis, but it’sa slow one” David Blumenthal, Director of the Institute forHealth Policy (page 28)

“Academic health institutions like ourshave an obligation to address healthdisparities in the community” Victor Dzau, CEO of Duke University HealthSystem (page 34)

“All residents of the United Statesshould have meaningful, affordablehealthcare coverage” Cass Wheeler, CEO of the American HeartAssociation (page 84)

Our country was founded on the notion of individual rights and free-

doms. Back in the days when the first European settlers were over-

whelmed by a dangerous and unpredictable landscape, this made

sense. Looking out for yourself was a matter of survival.

When we’re talking about a health system, however, ‘every man for himself’

no longer works. Yes, the majority of us may be happy with the healthcare we re-

ceive: we’re insured and we get good medical care relatively quickly. But what

about those of us with no insurance?

According to the US Census Bureau, 15.3 percent of Americans had no pub-

lic or private health insurance in 2007, down slightly from 15.8 percent in 2006.

A total of 45.7 million of us are uninsured.

That’s a lot of people without access to good quality medical care. And

thanks to the crisis in the financial markets, more people are likely to lose their

jobs and the health insurance that goes with them.

Our healthcare system does have its good points. The main one is choice –

people can choose the kind of insurance they want, they can choose their doc-

tors, they can choose their hospitals. Our system also fosters innovation, and con-

venient access to care means we don’t wait long for treatment.

As a country, we spend 16 percent of our GDP on healthcare. For that amount

of money, we should have a system that provides high quality care to everyone,

regardless of their income or employment status. But because most of us don’t

feel the brunt of this directly, there isn’t the political will needed to turn our health

system upside down.

If the current financial crisis is prolonged, the welfare of the middle class

could be threatened. The 85 percent of those currently covered, many under em-

ployer backed health plans, may end up joining the uninsured minority if the US

continues to shed jobs at its present rate. Perhaps this will finally create the en-

ergy needed to transform healthcare in this country.

We should not have to wait for that to happen. A society is about more than

individuals looking after their own interests. We need to realize that we are no

longer a group of far-flung settlers struggling in harsh surroundings. We are a civ-

ilized nation. It’s time our health system reflected this.

Marie Shields

Editor

EDITORS NOTE EHM6:nov08 19/11/2008 16:21 Page 7

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PArkAvenue.indd 1 13/11/08 08:51:28

CONTENTSFEATURESQ4 2008 www.executivehm.com9

34

2834 Found in translationThe translation of basic science into clinical

medicine often results in stunning develop-

ments in patient care, saysVictor Dzau of

Duke University Health System

38 On the side of the uninsuredTheAmericanMedicalAssociationhasbeenad-

vocating forhighqualityhealthcare for all since

1847.More than 160years later, Joseph Heyman

finds thechallengehasneverbeengreater

84 Taking it to heartCass WheelermaybesteppingdownasCEOof

theAmericanHeartAssociation,but thatdoesn’t

meanhe intends togiveuphis life’swork

On the frontlineSoaring costs,millions

of people uninsured, an

uncertain future:why

MassachusettsGeneral

Hospital’sDavid

Blumenthalbelieves

our healthcare system is

still worthfighting for

CONTENTS EHMUS6:oct08 19/11/08 15:20 Page 9

107

42 Close to the boneThe Mayo Clinic’sDaniel Berry andMichael

Yaszemski outline the latest developments in

orthopedic surgery

49 Breathe easyJo RaeWright sheds some light on the latest

thoracic research

52 The science of sleepRochelle Goldberg raises awareness about

sleep apnea

CONTENTSPATIENT CARE, TECHNOLOGY,PHARMACEUTICALS10

56 Helping the nation stay physicallyactiveJohn Barnes on the changes affecting the phys-

ical therapy profession

58 Creating a sustainable futurePwC’s latest survey looks at global efforts to

create a sustainable health system

62 The next generation of breastcancer treatmentWe’ve come a long way since the days of the

radical mastectomy

66 Under coverLarry Gage on the challenges of improving our

healthcare system

72 The heart of the matterWilliamBaumgartner takes a close look at life-

saving heart transplants

76 Repair worksLars Svensson uses new techniques to

improve treatment for cardiac patients

88 Stalking a silent killerJohn Suh of Cleveland Clinic on the work being

done to understand brain tumors

92 BrainwavesThe latest in Alzheimer’s treatments with

David Yousem of Johns Hopkins Hospital

96 New developments in clinicalimagingGSK’s PaulMatthews on the critical advances

in this fast-moving field

100 Follow the leaderEliot Siegel reveals how film became a thing of

the past

102 All systems goEric Yablonka on why electronic patient

records are making a difference to patient care

ASK THE EXPERT

61 Peter Gailey, OR-Live

71 Darius Francescatti,Rush University Medical Center

106 Jennifer Gilburg,VeriSign Inc.

108 Getting in on the ground floorHow three big pharma companies got

together to bring new technologies to life

114 The future of payer-sponsoredelectronic health recordsLynne Dunbrack examines the current state

of EHR technologies

61

EXECUTIVE INSIGHT

118 Steven Pap, SecuReachSystems, Inc.

“We have a lot of problems with ourhealthcare system, most of which involvethe fact that people are uninsured, but oursystem does have desirable features”

Joseph Heyman, American Medical Association P38


S I LV E R S P O N S O R

116 Building IT infrastructureEHM speaks toBrad Blake, Director of IT at

BostonMedical Center

120 Top 10 patient safety myths

122 Going globalDiane Jorkasky on how geographically diverse

clinical research units are transforming

phase I trials

124 Hitting the targetPwC’s Todd Evans examines changes in phar-

maceutical marketing

130 Lessons learnedLarry Blankstein looks at the challenges for a

global project team

96

38

132 Travel 134 Benefit focus138 In review 140 Face-off144 Final word

134

132

IN THE BACK


Chairman/Publisher SPENCER GREEN

CEO/Publisher JAMES CRAVEN

Director of Projects ADAM BURNS

Editorial Director HARLAN DAVIS

Editor MARIE SHIELDS

Managing Editor BEN THOMPSON

Associate Editor FRANCES DAVIES

Deputy Editors NATALIE BRANDWEINER, MATTHEW BUTTELL,

REBECCA GOOZEE, DIANA MILNE, JULIAN ROGERS, HUW THOMAS

Creative Director ANDREW HOBSON

Design Directors ZÖE BRAZIL, SARAH WILMOTT

Associate Design Directors MICHAEL HALL, CRYSTAL MATHER,

CLIFF NEWMAN

Assistant Designer ÉLISE GILBERT

Online Director JAMES WEST

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Project Director CHRISTIE BUYNISKI

Sales Executives CAITLIN KENNEY, BROOKE THORPE, CHRIS DELOZIER,

JOHN WARD

Finance Director JAMIE CANTILLON

Production Manager ROBERT SIMMS

Production Coordinators HANNAH DRIVER, HANNAH DUFFIE,

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Legal InformationThe advertising and articles appearing within this publication reflect the opinions andattitudes of their respective authors and not necessarily those of the publisher or

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14 www.executivehm.com

14UPFRONTP16 Top 10 – health-related resolutionsP18 The five-minute executiveP20 The burning issueP22 From the vault

Anew study indicates that educational

literature can influence young

women’s use of indoor tanning, not by

raising their fear of skin cancer but by

changing their attitudes about indoor tanning

and promoting healthier alternatives for chang-

ing appearance.

Each year there are more than 1.3 million

skin cancer diagnoses in the US, resulting in

more than 10,000 deaths. A variety of efforts

have attempted to get young people to alter

their sun exposure behaviors, with limited suc-

cess. For the new study, researchers led by Joel

Hillhouse of the School of Public Health at East

Tennessee State University designed a large,

randomized, controlled study on an education-

al-based intervention meant to reduce indoor

tanning, which is related to an increased risk of

melanoma in youngwomen.

The researchers included approximately

430 female university students aged 17 to 21,

200 of who received a booklet on the effects

of indoor tanning. The booklet, which focused

on the appearance-damaging effects of tan-

PALE ANDINTERESTING

UPFRONT EHM US6:12june 19/11/08 15:42 Page 14

ning, provided information on the history of

tanning and tanning norms in society. The

booklet also offered guidelines emphasizing

tanning abstinence and recommended health-

ier alternatives to improve appearance includ-

ing exercise, choosing fashion that does not

require a complementary tan and sunless tan-

ning products.

The investigators found that indoor tanning

was reduced by approximately 35 percent in

women who received the booklets, compared

with womenwho received no intervention.

NEW DIGITAL SOLUTIONWith GraftTracker, hospital personnel

securely enter information about each tis-

sue graft they have in their facility. Data

entry can be made at stations throughout

the hospital, and transfers within hospital

departments or to other healthcare facili-

ties can be reviewed and updated as

they occur.

A permanent record of each tissue graft

is maintained to provide hospital regulatory

compliance and to improve patient safety.

Patient confidentiality is ensured using

state-of-the-art software encryption, provid-

ing the same level of security as online

banks. All of this information is stored se-

curely and available instantly.

GraftTracker is in use at hospitals across

the country. The program assures patient

safety and regulatory compliancewith a com-

plete and secure system.

Visit www.GraftTracker.com or call 866-803-3720 to learn more.

GraftTracker, a web-based soft-

ware program by Champion

Medical Technologies, offers

hospitals a secure, centralized

system for tracking all tissue frompoint of

receipt by the hospital to implantation into

a patient. Developed in response to

stricter FDA and Joint Commission regula-

tions on tissuemanagement, GraftTracker

is guaranteed to meet documentation

standards.

“GraftTrackerwas developed in order

to aid hospitals in meeting the new Joint

Commission guidelines, but its primary

benefit is for patients. We believe

GraftTracker plays an important role in

solving a hospital’s greatest challenge in

efficiently handling recalls with quick

identification of patients who need to be

notified,” says Peter Casady of Champion

Medical Technologies.

NUMBERCRUNCHING

By the year

1 in every 90 peoplein the US will have

malignant melanoma

2001

Over the past

damage to the planet’s ozonelayer has increased the

amount of harmful radiationthat reaches your skin

60 years

There are

of skin cancer: basal celland squamous cell

carcinomas, andmalignantmelanoma

3 types

It appears that older men who eat fruit

andvegetablescandelaytheonsetofthe

brittle bone disease known as osteo-

porosis. For years, doctors focused on

studying osteoporosis in women only. But

menare living longer than in thepast,andas

theyage, their bonesalso cangetbrittle and

break easily. Tufts University researcher

KatherineTuckerexplains

there are parts of the

bodywherebonelossisa

particularproblem.

“Wewant toprevent

hip fractures,” she says.

“And thespine is another

areathat isreallyat riskofspinalcompression

andloss...thatreducesheightovertime.”

Many doctors recommend people eat

foods that include calcium to keep their

bones strong. But in an earlier study, Tucker

found that people who ate lots of fruit and

vegetables had stronger bones over time

thanpeoplewhodidn’t eat fruit and vegeta-

bles regularly.

“The fruit and vegetables providemole-

cules that help reduce acidity in the blood,

which helps reduce bone resorption,”

Tucker says. Resorptionmeans the breaking

down of bone cells to release calcium into

the blood.

In this follow-up study, Tucker and her col-

leagues recruitedmenwhose average agewas

about75years.Overaperiod

of four years, the researchers

usedabonescanner tomake

regularmeasurementsof the

men’s hips, spines and fore-

arms. Tucker also had the

men keep detailed informa-

tionaboutwhat theyate. Inparticular, sheasked

aboutvitaminC,becausevitaminCseemstoslow

downboneresorption.

“We were able to see that vitamin C was

quite protective against bone loss over four

years,” Tucker says. “It was most significant in

menwhoalsohadeither lowcalciumor lowvita-

minE intake.”

Source:www.voanews.com

EAT YOUR GREENS

15www.executivehm.com

We were able to see that

was protective againstbone loss

vitamin c

If detected early, skincancer has a

cure rate99%



BEATING THEBLUES

Second-generation treatments

for depression are all equally

effective, according to a new

clinical practice guideline from

the American College of Physicians (ACP).

“The studies we analyzed show that

second-generation drugs have different

adverse effects but are equally effective

for treating depression,” said Amir

Qaseem, Senior Medical Associate in

ACP’s Clinical Programs and Quality of

Care Department and the lead author of

the guideline. “ACP recommends that

physicians make treatment decisions

based on side effects, cost, and patient

preferences, and make necessary

changes in therapy if the response is not

sufficient after six to eight weeks.

Doctors should also assess patient sta-

tus and adverse effects on a regular

basis, starting within one to two weeks

of the patient beginning treatment.”

The ACP guideline, ‘Using Second-

Generation Antidepressants to Treat

Depressive Disorders,’ contains four rec-

ommendations:

When clinicians choose pharmaco-

logic therapy to treat patients with

acute major depression, they

should select second-generation antide-

pressants on the basis of adverse effect

profiles, cost, and patient preferences.

Clinicians should assess patient sta-

tus, therapeutic response, and ad-

verse effects of antidepressant

therapy on a regular basis beginning with-

in one to two weeks of initiation of therapy.

Clinicians should modify treatment if

the patient does not have an ade-

quate response to drug therapy

within six to eight weeks of the initiation

of therapy for major depressive disorder.

Clinicians should continue treat-

ment for four to nine months after

a satisfactory response in pa-

tients with a first episode of major de-

pressive disorder.

tingtoregularexercise.Withover66percentofadult

Americans now consideredoverweight orobese, it

is not surprising to find weight loss as one of the

mostpopularNewYear’sresolutions.Otherhealth-

related issues,suchasgiving-upsmokingordrink-

ing, remainpopular resolutionsasstudiessuggest

it takes the average smoker four attempts at quit-

tingbeforetheyaresuccessful.

TOP 10Health-related resolutionsWith the festive period fast approaching,2009 will soon be upon us and we’ll all bevowing to do something different in an effortto make our lives a little bit easier.

1

43

65

87

109

2Spend more time withfamily and friends

Devote time to fitness

Tame the bulge

Quit smoking

Enjoy life more

Quit drinking

Get out of debt

Learn something new

Help others

Get organized

16

Tocoincidewiththeapproachofthefestive

season,anewonlinesurveybyCarnegie

MellonUniversityrevealsthathealthyliv-

ingisstilltopoftheagendawhenitcomes

toNewYear’sresolutions.Thebiggest issueforre-

spondents is the desire to gain a better work/life

balance, with the majority then wanting to invest

theirfreetimewithfriendsandfamilyorincommit-

1

2

3

4



This year the project-ed drop in paymentsto physicians was

almost

(p38)11%

The goal is toreduce coronary

heart disease, strokeand risk by

in 2010 (p84)25%

There aremore than

Americans uninsured (p28)

Local control rates for patients with earlystage lung cancer treatedwith 3-5 fractions

of radiation have been upwards of

(p88)$35 trillion

45millionDiscoverymagazine recognizedthis work as one of the top 10discoveriesof2007(p34)

ISSUEIN NUM8ERS

In a study investigating howallergic respiratory inflammation leads to

the recruitment of cells to the lung, researchers at theMayo Clinic in

Arizonahavediscovered a link betweenasthmaand themetastasis of

breast cancer to the lung.

Beginningwithresearchinmice,MayoClinicresearchershaveidentified

thelocalizedtissueinflammationassociatedwithasthmaasapotentiallysig-

nificant contributor to lungmetastasis of cancer.More importantly, this re-

searchledtoaretrospectivereviewofabreastcancersurgicalpatientdatabase

whichappearstoconfirmthatasimilar relationshipmayexist inhumans.

“If you are a breast cancer patient with asthma, taking your anti-in-

flammatory inhaled steroids may be more important to you than simply

stoppingyourwheezing,”says JamesLee,aMayoClinic researcherandthe

seniorauthorof thestudy.“Theprognosisofanybreastcancerpatientwith

metastatic disease in the lung is very poor, and thus strategies preventing

thiseventmayhaveasignificant impactonpatient survival.”

Cancer patients need a prescription for information almost as

much as the one they get for treatment. The amount of tech-

nical information is growing, but information on the psy-

chosocial aspects of cancer treatment is less prevalent and

morenecessaryonaday-to-daybasis. For bothpatients andcaregivers,

real-time, personalized responses to symptom changes could turn the

daily battle into aproductivequest for better health andpeaceofmind.

As the President’s Cancer Panel is giving us a national prescription for

more research and collaboration, the National Cancer Institute (NCI) is

moving forward to fill that prescription with valuable information from

patient-reported outcomes.

Medical informatics has come a long way from the days of paper

charts andmanual data processing. Yet, for all the advances in collabora-

tive digital technology in recent years, there is still no single communica-

tion tool that addresses the needs of researchers, oncologists, general

practitioners,private caregivers, andpatientsall at once.NCIhasdecided

to push for a solution, with the goal of usingmedical informatics tomod-

ernizecancercare.Oneof their latestprojects iscalled ‘IntegratingPatient-

ReportedOutcomes inHospiceandPalliativeCarePractices’,andDynamic

ClinicalSystems (DCS) is leading thecharge tomake thishappen.

DCS isworkingwith its collaboratorsatDartmouthandUniversityof

CaliforniaSanFrancisco tocreateadigitalhabitat for cancer researchand

comprehensive information sharing,with the goal of ultimately reducing

the impactof canceronhuman life.DCS’s IntegratedSurveySystem(ISS)

isan innovativeweb-basedsolution featuringcustomizedpatientsurveys,

clinicalobservationtoolsandoutcomesreports.Adaptedforhospicesand

other palliative care sources, ISSwill be able to streamline the informa-

tiongatheringprocess, facilitatesymptommeasurement,andanalyzesta-

tistics to recommendoutcomes-basedactiononbehalfof cancerpatients

whoneed it.

NCI PROMOTES PATIENT-REPORTED OUTCOMES

ASTHMA LINK



Working for a high-performing organization like OhioHealth has al-

lowedus to createasolid structure that our associates can compare to

other healthcare organizations across the nation.Our associates have

a senseof pride, belongingness and security in theirwork environment,

where their contributionsarevalued. In turn, thatallows themtoprovide

better service toour patients andour families in this community.

Whatwe’vetriedtocreate isanexperiencewhereourassociatescango

fromone facility to another, but still have that overarchingOhioHealth

experience.We have created a place where there is a promise that our

associateswillbevaluedandrespected,bedevelopedandnurturedand

thatwewillprovidethemandtheir familieswithgoodbenefits.Ultimately

we want them to be responsible for their own health and the health of

their families, andwe’ve created aplacewhere our associates canwork

for an organization that not only to lives up to, butmaintains, a national

reputationwithin thehealthcare industry.

Wedotheworkbecauseweliveourmission.Theexternalaffirmationof

being recognizedas agreat place towork allowsour associates to com-

pareandcontrastwithotherorganizationsandaffirmtheirdecision that

OhioHealth is both a good place for them to have decided to, and con-

tinue to,work.

I’mparticularly proudofOhioHealthy, our associatewellness andpre-

vention plan, wherewe have focused on the health of our associates.

Weunderstandthat thequalityof lifeofourassociates isas importantas

their productivity and that the investment in associate health and well-

ness is a long-term investment for theworkforce.

In the last18monthswe’ve lostover16,000poundsasanorganization.

Wehavewalkedaroundtheworldover20times.We’vechangedthe food

inourcafeteriaandwe’vechangedthe foodweoffer for snacks through-

outourentireorganizationbecauseasahealthcareorganizationourcon-

centrationhas tobeon thehealth of our associates.

We’ve investedover$1million inpreventativecare,highlighting thatnot

onlydoweunderstandwhat thecornerstonesofhealthcareare,but that

for these cornerstones we will make a 100 percent investment for asso-

ciatehealth.We’vealsoencouragedourassociates throughaconsumer-

directedmodel tobebetter stewardsofhealthcaredollars.Weneedour

associates to be good consumer-driven participants in healthcare deci-

sions for themselves and their families.

THE FIVE-MINUTE EXECUTIVE

18 Healing handsDebra Plousha Moore, SVP for Human Resources at OhioHealth, explains howthe healthcare provider continues to lead by example.

To read a full interview with Debra Plousha Moore, please subscribe to EHM’s sister publication Human Resources Management at www.hrmreport.com



Scientists around theworld are learn-

ing more about stem cells and how

theyfunctiontohelpthebodyrestore

itself throughout the lifespan. Stem

cells exist in all sorts of tissues throughout the

body – they help the body to continuously re-

pair itself.Andwith the rightstimulus, theycan

develop intomanydifferent kindsof cells.

Researcher Keith March at Indiana

University in Indianapolis recently learnedmore

about one kind of stem cell that exists on the

outer lining of blood vessels. He explains that

blood vessels have an inner lining which are

called theendothelial cells, and theyalsohave

anouter liningwhichcontains stemcells.

STEM CELL DISCOVERY“We wondered whether those stem cells

thatwere in thepositionof theouterwallof the

bloodvesselwerebeing”,Marchsays.“Andwe

startedexperiments to test thatquestion.”

March and his colleagues found that the

two kinds of cells were indeed interacting. It

turns out that the stem cells had the ability to

keep the epithelial cells strong – as long as the

endothelial cells sent the right signals.

But if theendothelialcellswerediseasedor

damaged – for example, fromhigh blood pres-

sure, high cholesterol or high blood sugar –

stemcellsontheexteriorwallsofbloodvessels

transformed themselves into fat cells.

FAST FACTS

Schizophrenia ranksamong the top

of disability in developedcountries worldwide

10causes

Rates of schizophrenia arevery similar from country

to country – about

of the population1%

American baby boomers,one in every eight, willdevelop Alzheimer’s in

their lifetime

10 million

A closer look at schizophreniaand Alzheimer’s

adults, or about 1.1 percentof the population aged 18and older in a given year,

have schizophrenia

2.2 million

Source: www.voanews.com

Following an extensive evidence re-

view, the US Preventive Services

Task Force (USPSTF) concluded that

doctors, nurses, hospitals and

health systemshave a role to play in encour-

aging and supporting breastfeeding. In an

update to its 2003 recommendation on

counseling to promote breastfeeding, the

USPSTF recommends primary care interven-

tions before, around and after childbirth to

encourage and support breastfeeding.

For the study, the task force evaluated

more than 25 randomized trials of breast-

feeding interventions conducted in the

United States and in developed countries

around the world. The task force concluded

that coordinated interventions throughout

pregnancy, birth and infancy can increase

breastfeeding initiation, duration and exclu-

sivity. For example, a cluster-randomized trial

of more than 17,000 mother-infant pairs in

the Republic of Belarus found that breast-

feeding interventions increased the duration

and degree (exclusivity) of breastfeeding.

Infants in the intervention groupwere signifi-

cantly more likely than those in the control

group to be exclusively breastfed (exclusive

breastfeeding is when an infant receives no

other food or drink besides breast milk). The

intervention emphasized healthcare worker

SUPPORT FOR BREASTFEEDINGassistance with initiating and maintaining

breastfeeding and lactation and postnatal

breastfeeding support.

“Our reviewproducedadequateevidence

thatmultifacetedbreastfeeding interventions

work,” said task forceChairNedCalonge,who

is also Chief Medical Officer for the Colorado

Department of Public Health and

Environment, Denver. “We found that inter-

ventions that include both prenatal and post-

natal components may be the most effective

at increasing breastfeeding duration. Many

successful programs include peer support,

prenatal breastfeeding education, or both.”



American families – and our economy – are

in crisis over healthcare.We can’t get coverage to

the 61millionwhoare either uninsuredor under-

insured without a major overhaul of the system,

and there’s no way to really solve America’s eco-

nomic troubles without fixing healthcare for the

long term.

I’m following some basic principles to im-

prove access to care, to improve the quality of

care, and to reduce costs. If you are happy with

THE BURNING ISSUEFree for all?More than 46 million Americans are uninsured and millions more areunderinsured for healthcare. EHM asked three health industry insiders for theiropinions on solutions for tackling this issue.20

HEALTHS Y S T E MCHANGE

forCENTER STUDYING

Existing individual insurance markets have

an inherent tendency to ‘fail,’meaning thatmany

peoplewilling to pay apremium that reflects their

expected claims costs and competitive margins

for administrative costs andprofits are not able to

obtain such an offer of coverage.

The dynamic behind this failure is adverse

selection. People who expect to use a lot of

health services are more likely to purchase

health insurance. The result is that the pool of

people covered in the individualmarketwill have

Insurance market reform is one of the key

pieces to any successful health reform in theUS.

Right now, health insurance markets function

well for those who work for large firms: insurers

can fairly price insurance to reflect the underly-

ingmix of health in the firm. But for smaller firms

and particularly for individuals in the non-group

market, insurance markets are dysfunctional.

Young and healthy individuals are often able to

get insurance at very low rates, while sicker and

older individuals find themselves facing very

higher-than-average medical costs, leading to

higher premiums. In turn, high premiums fur-

ther discourage healthier people frompurchas-

ing insurance. Employer-provided coverage

solves this problem by subsidizing coverage

sufficiently so that it is attractive to both

healthy and sick employees. In other words,

employer coverage establishes a pool of people

whose expected use of healthcare is not very

different from the average of those who work

for the company.

the coverage you have, you can keep it. But the

system can work better and cost less for every-

one, if leaders are willing to work together for

sound policy solutions.

I am committed to working with my col-

leagues here on Capitol Hill – Democrats and

Republicans – and to working with the incoming

Obama Administration to move the ball forward

onhealth reform. In humanandeconomic terms,

there is nomore time to waste.

high rates or no access at all. Stateswhich have

tried to resolve this problem in the non-group

market by removing underwriting based on

health (or even on age in some cases) have seen

exactly what economists would have predicted:

the exit of young and healthy individuals from

themarket and an enormous rise in rates. In the

recent report by AHIP, five of the eight most ex-

pensive states in the nation to buy non-group in-

surance are the five that have community rating

in some form.

Sen. Max Baucus

Paul B. Ginsburg, President, Center for Studying Health System Change

Jonathan Gruber, Professor of Economics, MIT

“Young and healthyindividuals are oftenable to get insurance

at very low rates,while sicker and older

individuals findthemselves facing

very high rates or noaccess at all”

“The system canwork better and

cost less foreveryone, if leadersare willing to worktogether for soundpolicy solutions”

“Employer-providedcoverage solves this

problem by subsidizingcoverage sufficientlyso that it is attractiveto both healthy and

sick employees”


Need a positive and proven impact on your bottom line?

The INSIGHTS business intelligence solutionwill help your HOSPITAL…

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HealthcareInsight.indd 1 13/11/08 08:47:38


FROM THE VAULTQ2 2008

Director of the NIH

Back in issue four of EHM, Elias Zerhouni talks about his roleas Director of the NIH and his ‘road map’ to promote cross-institutional collaboration. “People are very focused on howwe deliver health services in medicine. I’m more focused onwhat it iswe deliver.My point iswe need to transformhealth froma curative type of medicine to a pre-emptive one,” he explains.

To see more, go towww.executivehm.com, click on ‘past issues’, and select‘A Bold Vision’ within lead stories.

Elias Zerhouni

ALWAYS AWAKE

JohnsHopkins researchershave found

strong evidence supporting the view

that the sleeping mind functions the

sameas thewakingmind, adiscovery

that could significantly alter basic under-

standing of the normal and abnormal brain.

The evidence comes from a study, to ap-

pear in the Journal Human Brain Mapping, of

11 healthy male and female participants

whose rapid eyemovements (REM) in ‘dream’

sleep were timed using a video camera. The

REM tracking was accompanied by special

MRI images designed to visualize brain activ-

ity. Results revealed activity in areas of the

brain that control sight, hearing, smell, touch,

balance and bodymovements.

“This is the first time we have been able

todetect brainactivity associatedwithREM in

areas that control senses other than sight,”

says lead researcher Charles Hong, Assistant

Professor in theDepartmentof Psychiatry and

Behavioral Sciences at the Johns Hopkins

University School ofMedicine. “After compar-

ingourdata toother studiesonawakepeople,

we learned that our findings lend great sup-

port to the view that the waking brain func-

tions in a similar way.”

Aseven-cent toothbrush can be a lifesaver

for ICU patients on breathing machines

by heading off bacteria that can cause

up to 300,000 cases of deadly pneumo-

nia yearly.

A study in the Barnes-Jewish Hospital surgi-

cal and trauma intensive care unit found that sim-

ply brushing the teeth of patients who needed a

ventilator to breathe dramatically reduced cases

of ventilator-associated pneumonia (VAP), a life-

threatening hospital-acquired infection that

strikes up to 300,000 patients each year.

The year-long study was led by clinical nurse

specialists in the intensive care unit, in conjunc-

tion with Washington University physicians and

infection control specialists.

In the study, nurses in the 24-bed unit

found that they could cut the incidence of VAP

almost in half by simply brushing patients’ teeth

twice a day and applying mouthwash to the in-

side of the mouth.

VAP is the most common hospital-acquired

infection in critically ill patients. It is a leading

cause of complications and death, and can add

days or weeks to a hospital stay and up to

$40,000 to the cost of a patient’s care.

Ventilaro-associatedpneumonia (VAP), alife-threatening

infection, strikes up to

patients each year300,000

spent on a toothbrushcan be a lifesaver forICU patients on

breathing machines

7¢

VAP can be reduced byalmost half by simplybrushing patients’ teeth

a daytwice

TOOTHBRUSHINGFOUNDTOSLASHCASESOFPNEUMONIA

22



INTERNET USE BOOSTSBRAINPOWER

HOW TO MAKE MORE MONEY

Likeanyother industry,hospitalsneedto

produce bottom line profits. Hospital

administrators understand this and

claim to do what it takes to maximize

their bottom lines. Yet inmany hospitals, front-

linemanagers that provide the services, gener-

ate the revenues and spend the labor and

non-labordollarshaveneverbeenprovidedwith

thenecessary tools todoso.

Healthcare Insights has developed a revo-

lutionary, alert-based management account-

ability budgeting, monitoring and reporting

software solution that helps hospitals to dra-

matically improvetheirbottomlines.Healthcare

Insights recently released INSIGHTS5.0, its lat-

eststate-of-theartsolution.Aftersevenyearsof

client success, INSIGHTS is now more user-

friendly and even easier for hospitalmanagers

anddirectors touse. INSIGHTSallowsadminis-

trators to quickly identify where themanagers

are out-of-compliancewith their goals through

the use of online reports and automated email

alerts. Armed with this information, the man-

agers are able analyze the information by drilling

down to the detailed level to determine what

caused thealert.

INSIGHTS software allows hospital adminis-

tration, for the first time, to instill accountability

into their management system.When hospitals

combine the INSIGHTS solution into their annual

management evaluation system, managers get

the clearmessage that the administration is seri-

ous about staying within their volume variable

goals. At that point, volumes, revenues and ex-

penses become more than just numbers on a

piece of paper. Instead they become limits to be

respected and achieved. Some Healthcare

Insights clients that have adopted the INSIGHTS

formula have shown remarkable bottom line im-

provements.

INSIGHTShasbeendesignedtoallowhospi-

taladministratorstomakebetterdecisions.When

used as intended, significantly improved out-

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tionwants to reallymakemoney and . . . not just

talkabout it, INSIGHTS is theessential tool.

QUICK FACTS ONOSTEOPOROSIS

more are estimated tohave low bone mass,

placing them at increasedrisk for osteoporosis

34 million

individuals are estimatedto already have thedisease in the US

10 million

of those affected byosteoporosis are women

80%

women are

more likely to developosteoporosis than men

4times

Osteoporosis is a major public

health threat for an estimated 44

million Americans, or 55 percent of

people 50 years of age and older.

UCLAscientistshave foundthat for com-

puter-savvy middle-aged and older

adults, searching the internet triggers

keycenters in thebrain thatcontrolde-

cision-makingandcomplexreasoning.Thefindings

demonstrate that web search activity may help

stimulateandpossibly improvebrainfunction.

The study, the first of its kind to assess the

impact of internet searching on brain perfor-

mance, is currently in press at the American

JournalofGeriatricPsychiatryandwillappearinan

upcoming issue.

“The study results are encouraging, that

emerging computerized technologies may have

physiological effects and potential benefits for

middle-aged and older adults,” said principal in-

vestigatorDr.GarySmall,aprofessorat theSemel

Institute forNeuroscienceandHumanBehaviorat

UCLA. “Internet searching engages complicated

brain activity, which may help exercise and im-

provebrain function.”

As thebrainages, anumberof structural and

functional changesoccur, includingatrophy, reduc-

tionsincellactivity,andincreasesindepositsofamy-

loid plaques and tau tangles, which can impact

cognitivefunction.



There’s been a lot of talk about red wine in

thepast fewyears.Moredoctorsaresaying

drinking redwine inmoderation–usuallya

glass a day – is good for your heart. But

what about your brain?

Neurologist Carol Ann Paul was curious to

know the answer to that question.While she was

doing research at the Boston University School of

Public Health, she looked at data from the

Framinghamstudy–a large, long-termstudy that is

based in the town of Framingham,Massachusetts.

As part of the study, researchers took 1839MRIs

from normal subjects, which they used to mea-

sure brain volumes.

Participants in the Framingham study have filled

out detailed questionnaires about their habits, activi-

ties and diet.

Paul took data about red wine consumption from

these questionnaires andmatched it with the results of

the brain scans. She found that themore people drank,

themorequickly their brains shrankwith age.

Normalaging is0.2percentperyearor2percentper

decade, she says. The changes between normal and the

abstainers, abstainers and all of the different categories

was0.25percent per group.

Paul says that each extra regular drink per day is

equivalent to one to twoyears of normal aging.

Moderate is

drinks8 to 14

Low is classified as

drinks per week,about one a day

1 to 7

and high isclassified as

drinks

>14 RED, RED WINE

Google has found that certain search

terms are good indicators of flu activity.

Google Flu Trends uses aggregated Google

searchdata toestimatefluactivity inyourstate

uptotwoweeksfaster thantraditionalflusurveillancesys-

tems.Eachweek,millionsofusersaroundtheworldsearch

foronlinehealth information.Asyoumightexpect, thereare

more flu-related searches during flu season,more allergy-

related searches during allergy season, and more

sunburn-relatedsearchesduringthesummer.

You can explore all of these phe-

nomenausingGoogleTrends. But can

searchquery trendsprovideanaccu-

rate, reliable model of real-world

phenomena? Google has found a

close relationship between how

many people search for flu-relat-

ed topics and how many people

actually have flu symptoms. Of

course, not every person who

searches for ‘flu’ is actually sick,

but a pattern emerges when all

the flu-related search queries

from each state and region are

added together.

FDA ISSUEWARNING

The Food and Drug Administration is

warning consumers about a fraudu-

lent scheme toextortmoney fromcon-

sumers by callers who falsely identify

themselves as ‘FDA special agents’ or other

FDA officials.

Several instanceshavebeenreportedto the

FDAof callsenticingconsumers topurchasedis-

counted prescription drugs by wiring funds to

one of several locations in the Dominican

Republic. Nomedications are ever delivered. A

subsequent call is received from a fraudulent

‘FDAspecial agent’ informing the consumer that

a fine of several thousand dollars is required to

besent toanaddress in theDominicanRepublic

to prevent incarcerationor other legal action.

“ImpersonatinganFDAofficial isaviolation

of federal law,” saidMichael Chappell, the FDA’s

actingassociatecommissioner for regulatoryaf-

fairs. “Thepublicshouldnote thatnoFDAofficial

will ever contact a consumerbyphonedemand-

ingmoneyoranyother formofpayment. FDAof-

ficials always present identification in person

when conductingofficial business.”

COLD ALERT



DynamicClinical.indd 1 13/11/08 08:46:57


COMPANY INDEXQ4 2008

26 Companies in this issue are indexed to the first page of thearticle in which each is mentioned

AccentureAccumetricsAmerican Association of MedicalCollegesAmerican Heart AssociationAmerican Hospital AssociationAmerican Medical AssociationAmerican Physical TherapyAssociationAmerican Sleep Apnea AssociationAnesthesiaBDBioscanBiospace MedBoston Medical CenterBoston UniversityBrigham and Women’s HospitalChampion MedicalTechnologiesChartlinks

12078

66846638

565248126914411611662

15, OBC57

Cleveland ClinicClient TellDana-Farber Cancer InstituteDesign Clinicals, Inc.Duet DHADuke University Health SystemDynamic Clinical SystemsEli LillyEmersonEnlight BiosciencesEnovate ITGenzymeGlaxoSmithKlineHammersmith HospitalHealth Industry InsightsHealthcare InsightsImaging on CallImperial CollegeIngenious MedInstitute for Health Policy

76, 88696212114334

17, 25108, 144

137108831309696114

21, 23989611028

Intact MedicalIon HealthcareJohns Hopkins HospitalLegacy Data AccessLifeWatchMassachusetts General HospitalMayo ClinicMeettheboss.comMerck & Co.National Association of Public Hospitalsand Health SystemsOR-LivePark Avenue Medical Data SystemsPBMIPfizerPricewaterhouseCoopersRadiologic Society ofNorth AmericaSecureach Systems, Inc.Sheridan Healthcare

6451

72, 92105802842138108

6660, 61

8134

108, 12258, 124

100118, 119, IBC

4

Sleep Health ManagementResources, Inc.Sten-TelTextware SolutionsThe American Thoracic SocietyTopotargetTransProUniversity of ChicagoMedical Center University ofMarylandVerisign Inc.Visage ImagingXoft, Inc.

551310349212102

1006, 106, 107

46IFC, 70, 71

FDA’S CHINA OFFICENew FDA offices are to be opened inChina with the aim of increase effec-tiveness in protecting American andChinese consumers. The offices will bethe first outside of the United States andwill be situated in Beijing, Guangzhouand Shanghai.

EHM IMPACT RATING: ��

CHOLERA CONTROLWHO and health partners have launched anintensive operation to prevent and control theincrease in the number of cholera cases,which have tripled in some areas to 150 aweek, amid the recent escalation of violencein the eastern part of the Democratic Republicof the Congo.


AROUND THEWORLD IN

Our guide to some of the most exciting developmentsin healthcare over the last quarter.

80DAYS

AIDS PATIENT CUREDA patient with theAIDS virus in Berlin,Germany,has reportedly been cured of the disease fol-lowing a bone transplant from a donor who hada genetic resistance to the virus. Since thetransplant was carried out two years ago thepatient,who also suffered from leukaemia,hasshown no sign of either disease.




THE HIGH COST OF DIABETES

British scientists have found that a drug used

to fight leukemia appears to stop multiple

sclerosis in its early stages and restore lost

function to patients. Campath is still in the

clinical trial phase. Although it carries a risk of poten-

tially serious side effects, it is being called by some

the most promising and most significant MS treat-

ment yet discovered.

The three-year study conducted by Cambridge

University researchers found for the first time a treat-

ment that showed long-term multiple sclerosis dis-

ability improvement. It is estimated that at least 2.5

million people around the world have the neurologi-

cal disease. Multiple sclerosis causes the body’s im-

mune system to mistakenly attack and damage the

insulation that protects nerve fibers. In this study,

more than 300 patients received an annual dose of

the drug alemtuzumab, which was created at

Cambridge 30 years ago to kill off cancerous immune

system cells in leukemia patients.


It is estimatedthat at least

people around theworld have the

neurological disease

2.5million

A dug used to fightleukemia appears to

multiplesclerosis inits early stages

stop

Campath carries arisk of potentially

side effectsserious

DRUG FOR MS

FIT AND WELLHeart failure patients who regularly ex-ercise fare better and feel better abouttheir lives than do similar patients whodo not work out on a regular basis, sayresearchers at Duke University MedicalCenter. The findings go a long way to-ward addressing concerns about thevalue of exercise for the nation’s fivemillion patients with heart failure.

FIGHTING HIVA small antibody fragment that is highlyeffective in neutralizing the human im-munodeficiency virus (HIV) by prevent-ing the virus from entering cells hasbeen identified at the National CancerInstitute.This findingmayprovide insightinto the development of new treatmentsfor HIV and other viruses in the not toodistant future.

MIND MATTERSMassachusetts General Hospital re-searchers have found that tiny mem-brane-covered sacs released fromglioblastoma cells contain moleculesthat may help guide treatment of thedeadly brain tumor. Researchers de-scribe finding tumor-associated RNAand proteins in membrane microvesi-cles called exosomes in blood samplesfrom glioblastoma patients.

BE AWAREAwareness of COPD (chronic obstructivepulmonary disease) is growing,but fewAmericans have a thorough under-standing of the disease, according to anew national survey. The new datashow that 64 percent of survey respon-dents had heard of COPD, comparedwith 49 percent in a 2004 survey.Among those who reported hearing ofCOPD, only half recognized the diseaseas a leading cause of death, and just 44percent understood it to be treatable.

The annual cost of prescription dia-

betes drugs nearly doubled to $12.5

billion between 2001 and 2007, ac-

cording to a study by researchers at

the Stanford University School of Medicine

and the University of Chicago. The researchers

say the findings raise questions about

whether the higher cost actually translates

into improved care and better outcomes.

“It’s important to recognize how expensive

treatment for diabetes has become,” said

Randall Stafford, Associate Professor of

Medicine at the Stanford Prevention Research

Center and senior author of the study. “This

near-doubling of diabetes costs may partly re-

flect better care, but we need to step back and

examine the value of newer and more costly

medications that may be overused.”

The study, which used data from an ongoing

national survey of randomly selected physicians’

prescriptions,foundthecostofdiabetesdrugsrose

to$12.5billion in2007from$6.7billion in2001.

Stanford University


We’re constantly being told that our healthcare system is in crisis. Healthcare

has become a hotly debated national issue, with medical costs soaring and

more than 45 million Americans uninsured. And we’re not the only ones under

pressure. According to a recent report by analysts PricewaterhouseCoopers,

HealthCast 2020: Creating a Sustainable Future, “There is growing evidence

that the current health systems of nations around the world will be unsustain-

able if unchanged over the next 15 years.

“Globally, healthcare is threatened by a confluence of powerful trends – increasing demand, rising

costs, uneven quality, misaligned incentives. If ignored, they will overwhelm health systems, creating

massive financial burdens for individual countries and devastating health problems for the individuals

who live in them.”

Yet oddly enough, most of us here in the US still have faith in our healthcare system, even believ-

ing it to be the best in the world. This gap between perception and reality is puzzling, but David

Blumenthal has an explanation. Right now, on a daily, individual basis, the majority of Americans re-

ceive the care they need when they need it, which can obscure the deterioration driving the bigger

picture. And the bigger picture is something that, as Director of the Institute for Health Policy (IHP) at

Massachusetts General Hospital, Blumenthal is certainly familiar with.

“Our healthcare system does have huge problems,” he says. “It’s in a crisis, but it’s a slow one.

Most of us are still able to afford good healthcare because we’re a rich country. We can expend 16 per-

cent of our GDP on healthcare, get mediocre results, and still feel that we’re doing okay.”

COVER STORY

“Americans don’t wantto be told they can’t

get the care they thinkthey need.”

David Blumenthal leads the fight to keepour healthcare system from the brink of

collapse. By Marie Shields

DAVID BLUMENTHAL 3:nov08 19/11/2008 13:21 Page 28

Political viewIt’s obvious, even from only a brief time spent in his presence, that

Blumenthal is the sort of person who makes others feel instantly at ease,

a quality that must help him get the best from the various roles he’s called

upon to play. This view is confirmed by Celeste Robb-Nicholson, Associate

Chief of the General Medical Unit at MGH, and a practicing internist with a

group of physicians that includes Blumenthal.

“In addition to being a bright, thoughtful health policy expert, David is

a committed physician, and has continued direct patient care throughout

all of the time he’s been involved in health policy, which is somewhat un-

usual for someone so distinguished in that area.

“He’s a marvellous physician: he wears a beeper all the time, he takes

calls with the rest of us, he participates in our weekly staff meetings, and

he’s very highly regarded by all staff and beloved by his patients. That sort

of willingness to continue to stay close to the trade as a physician while he’s

working on large policy issues is really wonderful and unique.”

Blumenthal also has the ability to see both sides of most healthcare

issues, having served as health policy advisor to private, civic and profes-

sional organizations and governmental leaders, including several presiden-

tial candidates.

This diversity of experience – he worked as a staff member on Senator

Edward Kennedy’s Senate Subcommittee on Health and Scientific Research

Blumenthal, however, doesn’t see this situation remaining feasible for

much longer. “Within policy-making circles, and even in some sectors of the

business community, there is a sense of urgency about where the system

is evolving to. Among the general population, I don’t think a sense of crisis

has occurred yet, though it could, if we have a deep, long recession as part

of the current economic crisis. What is a slowly evolving collapse could be

accelerated dramatically, because businesses will back out of insurance

provision and cut back on insurance, and many middle class families will

start to feel vulnerable.

“Right now the 84 percent of Americans who have health insurance can

still get the care they need; it’s only that minority of 16 percent who are af-

fected. That’s not enough to communicate to the electorate as a whole the

sense of urgency that is needed to turn the system upside down. Because

of the atomistic, self-interested nature of the US political culture, there

needs to be much more of a sense of threat to the welfare of the middle

class to create a political movement that will sustain radical change.”

One logical question that springs from the current crisis in the financial

markets is: Will the huge amounts of money that the government is putting

toward saving our banks and relubricating the capital markets preclude tak-

ing meaningful action on healthcare? Blumenthal points out, however, that

if the crisis is severe enough, it may make action on healthcare inescapable

because of the threats that will be created to people’s welfare.

In January of 2007, David

Blumenthal became senior

health advisor to President-elect

Barack Obama’s presidential

campaign. In the early part of the

campaign, this involvement meant

helping the campaign to develop a

healthcare plan that Obama could

run on during the primaries and

during the election. This was

followed by a prolonged period of

explaining the plan within the

context of the primaries, which

Blumenthal says often meant

responding to descriptions of the

plan that appeared in the

newspapers or on television, and

occasionally debating people

representing other candidates.

“Over time, this increasingly

became a matter of talking with and

about Hillary Clinton’s proposals and

her advocates. After the convention,

it meant mostly either critiquing the

McCain plan or defending the

Obama campaign against charges

from the McCain plan.

Now that the election is over, it

will be up to the new President to

put his policies in place once he

takes office. “The broad outlines of

the plan are clear, but Congress will

ultimately determine what happens

with respect to healthcare,”

Blumenthal says. “The President

can create political opportunities

and he can set directions, but this

is a collaborative work. Compared

to some other countries, we have a

very complicated government, with

powers that are decentralized and

dispersed. We can do things

extremely fast. We can act almost

like a parliament when there is a

huge national crisis, such as a war

or threatened oppression.

“But when things are less

clear, the negotiations are very,

very complicated and slow. It

takes a lot of organizing and

political skill to get anything

accomplished. It takes a President

deciding on a priority and pushing

it. But it also takes a Congress

that’s organized enough and

values the project enough to push

it through the Byzantine processes

on both sides of Capitol Hill.”


and served on the White House Health Professional Advisory Group during

the Clinton Administration – has enabled him to understand the perspective

of a diverse set of clients for potential research topics, and to think ahead

about the types of questions policy-makers and healthcare managers are

going to want answers to.

“My previous positions have helped with the adoption of a service mis-

sion and the requirements that are associated with that in terms of produc-

ing products that are viewed as useful to a client who is not a researcher,”

he says. “I also continue to be involved politically, and that gives me a dif-

ferent perspective on the topics and a different set of contacts perhaps than

is true of many other people who play the kind of role I do.”

Blumenthal has used his political background to write a book about

presidents and health policy with James Morone, Professor of Political

Science at Brown University. The book, due out next spring, asks the ques-

tions: How do presidents make health policy? What factors make them

more or less successful? What factors influence their decisions? And: How

have those things changed over time?

Blumenthal and Morone go back to Franklin Delano Roosevelt and

move forward right through to George W. Bush. In each presidency, they ex-

amine one major instance of healthcare policy development and look at

how the president participated in that, what factors influenced his decision-

making in those circumstances, what factors influenced his success in

achieving his objectives, and, comparing successes and failures, what

things stand out as important to making a president more effective in mak-

ing healthcare policy.

Rising costsFor the President-elect Obama, the crisis in the healthcare system, and

the rising costs that are part of it, are sure to be high on the agenda, though

the causes of this upward trend may not be what we think. “Our rising

healthcare costs are mostly the result of us using more care and doing more

care per capita, and not as much from the aging of the population, or from

inflation,” Blumenthal says. “Given the same kind of patient with the same

kind of problem, we are doing much more for that patient and that problem

now compared to what was done 10 or 20 years ago.

“In health policy and health services research, we lump that observa-

tion under the term technology: the more technology there is, and the bet-

ter it gets, the more we use it. This is encouraged by our fee-for-service

reimbursement system and the absence of any central controls on the

amount that’s spent on healthcare. The result is unconstrained incentives

to do more, because the more you do, the more income the providers gain.

“We also have a population that, by and large, feels that more is better,

and that is very trusting in technology and untrusting of government. The

reason our managed care revolution fell apart in the 1990s was that people

resented being denied access to specialists with sophisticated care at their

fingertips. Americans don’t want to be told that they can’t get the care they

think they need. And you can’t blame them. People who decry this as a gen-

eral matter often change their views when they or one of their family mem-

bers is ill.”

In such a rapidly changing, volatile environment, information is key –

and information is what the IHP specializes in, one of its missions being to

inform and influence health policy on a national level, and to improve health

and healthcare across the US and in other nations worldwide.

As Blumenthal explains, about 85 percent of the IHP’s work is exter-

nally funded research – federal research, foundation research and a small


“The 84 percent of Americanswho have health insurance canstill get the care they need; it’sonly that minority of 16 percent

who are affected”

David Blumenthal is Samuel O. Thier Professorof Medicine at Harvard Medical School

The Institute for Health Policy is based atMassachusetts General Hospital


using the Baldridge methodology. The Baldridge methodology was named

for Malcolm Baldridge, a promoter of quality improvement across all indus-

tries, who was Secretary of Commerce under Ronald Reagan.

“This was at a time in our history when US industry was considered to

be falling behind international competitors because of a deficiency in the

quality of our products,” Blumenthal says. “Japan was resurgent and we

were losing market share in many areas; among them the auto industry.

Baldridge was very attuned to that.”

The Malcolm Baldridge National Quality Award is presented annually

to businesses, and education, healthcare and nonprofit organizations that

are judged to be outstanding in seven areas: leadership; strategic planning;

customer and market focus; measurement, analysis and knowledge man-

agement; human resource focus; process management; and results.

“Over time, the award has evolved to include healthcare organiza-

tions,” Blumenthal explains. “For the first 20 years

or so, no organizations from healthcare competed,

but now it’s pretty common for one of the prizes to

be in healthcare. The Director of the Center for

Performance Excellence is very experienced with

the Baldridge process and helps organizations that

want to compete for it or want to use it, to learn

about its methods and its criteria of assessment to

improve management.”

The issue of disparity is another current health-

care hot topic. The IHP’s Disparity Solution Center

carries out training and education related to dispar-

ities, and helps develop tools that organizations can

use in a practical way to reduce disparities.

According to Blumenthal, the center runs the gamut

of research and service. A typical project might be

carrying out studies of hospital quality and how

they vary with hospital characteristics and also with

patient characteristics, including ethnic and racial

identity.

“We’ve done studies of the safety of care in

American emergency departments and what factors

are associated with that. We’re developing new

measures of safety that are clinically relevant and

meaningful for clinicians, which has not been the

case so much in the past.”

The IHP is also developing and testing ways to

display information on physician performance for

healthcare consumers, so that people can figure

out how their doctor compares in quality and cost

to other doctors. The effectiveness of this data dis-

play is currently being tested on the website of a

large insurance company. Blumenthal says they are

anxious to see whether people understand the in-

formation displayed, and whether it affects their

views of their own doctors.

“This is part of the trend toward transparency in

healthcare. There’s an assumption that transparency

is good, but not very much examination of whether

number of private sector contracts. “The overwhelming amount of work we

do is extramurally funded, and we write grants and compete for that fund-

ing in the peer review process at the federal level or in the foundation world.

The remaining 15 percent of our work is service work, both for and outside

of Partners HealthCare. Our goal is to do work that is intellectually interest-

ing, academically sound, and that provides support and information that

helps policy-makers make better decisions.”

High qualityThe institute is divided into three ‘centers of excellence’: the Center for

Performance Excellence, the Center for Genomics and Vulnerable

Populations, and the Disparities Solution Center.

The mission of the Center for Performance Excellence is to support the

efforts of organizations around the country to improve their performance


David Blumenthal is Director of the Institute for Health Policy at Massachusetts General Hospital

and Samuel O. Thier Professor of Medicine at Harvard Medical School. Blumenthal is an internist

and an internationally recognized expert in health policy and healthcare delivery systems. He has

held leadership positions in academic health centers; has served as health policy advisor to

private, civic and professional organizations and governmental leaders, including several

presidential candidates; and has published widely in prestigious journals across a range of health

policy issues. He became the founding Director of the IHP in 1998.


the people who consume healthcare information can make heads or tails of

it, or what ways of presenting it would make it easier for them to understand.”

Technology and geneticsThe IHP also works with the federal government to develop and then

field instruments that provide valid and reliable estimates of the level of

adoption of health information technology among physicians and in hos-

pitals. The institute is surveying doctors and hospitals on what electronic

records they use or don’t use and what the characteristics are, what they’re

able to do with those records, what the barriers are to

acquiring records, and what helps them acquire

records. In the process, Blumenthal says they’ve had to

do some work defining exactly what an electronic record

is, both in a physician’s office and in a hospital setting.

“We do a report every year with funding from the

Robert Wood Johnson Foundation, on the state of health

information technology in the United States. The last

one, which came out in July, had a chapter on interna-

tional comparisons in health information technology.

We found that it was very difficult to make cross-nation-

al comparisons on the uses of information technology

in healthcare because there was no uniform consistent

definition of what an electronic record is. This makes it

hard to say the prevalence of the electronic record is X

percent in Britain and Y percent in Denmark and Z per-

cent in Finland and G percent in the United States, be-

cause the available information simply doesn’t use the

same definitions.”

The third center covers genetics and vulnerable

populations, whose mission is to understand how the

genetic information that is being developed by scien-

tists and medical researchers in the United States and

elsewhere might affect the equity of our healthcare sys-

tem in all its dimensions, and how it may or may not be

brought to bear to improve the health of disadvantaged

patients and population groups.

This work has involved understanding, for example,

what factors affect the adoption of genetic screening

technologies, and how understanding genetic predis-

positions to environmental hazards may be used to re-

duce the exposures and the harms that are done to

individuals who live in inner city neighborhoods or in im-

poverished communities where they’re more exposed to toxins.

An ounce of preventionOne potential weapon in the fight to keep healthcare quality up and

costs low is to move away from treatment by stepping up prevention.

Blumenthal agrees – as most people would – that this is a good move.

“It’s a wise direction to take; I don’t think anyone would dispute that.

It also has the potential to improve the value of the care we receive. If you

distinguish between short-term cost savings and long-term improvements

in the value of services provided, essentially getting better return on the

money you invest, then there’s no question that many preventive services

are extremely valuable. Over the long term, this will produce a healthier

population and healthcare costs should be lower than they otherwise

would have been.

“What people can argue about is which preventive services are most

cost-effective and how long it will take to get a measurable return on invest-

ment. There are some things that will produce very short-term returns, includ-

ing what we call primary prevention activities like immunization, which

prevent acute infectious illness. Making sure that all elderly people are vac-

cinated against influenza, for example, will produce a very quick return.

“It’s also increasingly clear that

vaccinating children against influenza

may be even better than vaccinating

elderly people, because children seem

to be the reservoir that spreads in-

fluenza to the elderly. Ensuring that all

eligible children have the hepatitis vac-

cination, and vaccinations for

haemophilus B, and for measles,

mumps, and chickenpox, diphtheria,

typhoid, tetanus, pertussis and polio –

all those things that children get – is

also a critical preventive and money-

saving investment. I would class some

of the screening tests as primary pre-

vention as well. Colonoscopy, for ex-

ample, and mammograms, for many

population groups are likely to have

long-term payoffs.”

Then there is secondary preven-

tion: preventing an existing illness from

getting worse, which can also be ex-

tremely valuable. According to

Blumenthal, this category includes con-

trolling diabetes, preventing the compli-

cations of diabetes and controlling

cholesterol levels in people with heart

disease. He says a number of these

strategies are extremely cost-effective,

because you then avoid having to

spend money on transplants or acute

care of complications that occur when

secondary prevention isn’t done.

However, Blumenthal adds that it’s naïve to think that all prevention is

going to save money. “Some types will, and other types will make care more

cost-effective: you’ll get more quality of life and more extension of life out

of a given dollar invested. And some will cost money but prolong life and

are very much worth it for that reason. Prevention is not a magic bullet, but

it is part of a reform agenda.”

We are facing a crisis in our healthcare system and chances are we’ll

all need to make significant adjustments to our expectations and even to

the way we live our lives. It’s lucky, then, that we have David Blumenthal

and the IHP to keep us informed on where we stand, and to help lead the

way forward in the challenging years that lie ahead. n


Founded by Partners HealthCare System and

Massachusetts General Hospital in 1998.

Informs and influences health policy on a

national level.

Conducts research to support quality and efficiency

improvement within Partners HealthCare.

Works to improve health and healthcare across

America and in other nations.

An interdisciplinary faculty of experts in clinical care,

health policy and research methods investigates

complex challenges facing healthcare systems.

Provides a supportive, collaborative environment

in which researchers can pursue their interests

while also contributing to the IHP’s mission to

inform health policy and influence practitioners.

Can translate research results quickly from

academic settings to clinical practice, and identify

cutting-edge issues affecting healthcare efficiency

and quality.

Committed to providing value on an operational

as well as policy level and to disseminating

research results broadly.

INSTITUTE FOR HEALTH POLICY



translationFound in

When basic science is transformed into clinical practice and ultimately optimizespatient care, the results are incredibly satisfying and worthwhile, as Victor Dzau ofDuke University Health System reveals to Frances Davies.

Translation is also a central theme for the Duke Clinical Research

Institute and the Duke Center for Clinical Community Research, both of

which aim to turn innovative research intoworking community endeavors.

Promoting measurable improvements in community health and making

personalizedmedicine a reality are two important goals of theseprograms.

Pioneering workSignificant advances have been made in other areas of the medical

center as well. For example, researchers at Duke’s Institute for Genomic

Science and Policy Discovery have unearthed the molecular signature

for a certain form of lung cancer that appears to indicate a patient’s risk

for developing a recurrence of disease following surgery. This crucial in-

formation can help physicians determine whether their patients need

chemotherapy. Discovery magazine recognized this work as one of the

top ten discoveries of 2007.

Notable achievements are expected in the future from Duke’s Centre

for HIV and AIDS Vaccine Institute (CHAVI), funded by a $350million NIH

The cure for a debilitatingmuscle disease startedwith an enzyme

isolated in the ovarian cells of a Chinese hamster. Hardwork and

perseverancemarked itsslowandsteadyprogress fromearlyclin-

ical trials to itseventual licensurebyGenzyme,andworldwideap-

proval for treatment of potentially lethal Pompedisease.

Today, that enzyme’s journey from the bench of aDuke researcher to the

bedsideofchildren“isanexampleof translationalmedicine, fromdiscovery to

human application,” explainsVictor J. Dzau,MD, Chancellor for Health Affairs

at DukeUniversity, and President and CEOof DukeUniversity Health System

since2004. “It is dramatichowthese young lives are nowbeing saved.”

Academic health centers look set to play an increasingly larger role in

similar translations of basic science discoveries to clinical medicine, and

Dzau is confident that Duke is at the forefront of this trend. The Duke

Translational Medical Institute was established shortly after Dr. Dzau ar-

rived at Duke in 2005. InOctober 2006, it was further energizedby a $52.7

million grant from theNational Institutes of Health to expedite the transla-

tion of scientific discoveries into clinical practice.

FEATURE

Dzau ED:31MAY 19/11/08 15:22 Page 34

grant. “Under the leadership of Dr. Bart Haynes, CHAVI

is bringing together some of the best scientific minds in

the world, including Harold Varmus and Peter

Dougherty, to conduct the necessary basic science that

will lead to the development of enabling technologies

that will, hopefully, result in viable HIV vaccine candi-

dates,” Dzau says.

Dzau is no newcomer to transla-

tional medicine. As a pioneer in gene

therapy for vascular disease, his labo-

ratory studied the molecular and ge-

netic mechanisms of cardiovascular

disease and was among the first to

apply gene transfer technologies to de-

velop novel therapeutic approaches.

Dzau was the first to introduce

DNA decoy molecules to block tran-

scriptions as gene therapy in vivo.

Speaking about the progress of E2F

decoy and nitric oxide synthase gene

therapy and their evaluation in clinical

trials, Dzau said: “What I do in gene

therapy is try to take my initial discov-

ery – the concept of using E2F decoy to

shut off gene transcription using small DNA synthetic mol-

ecules to directly using genes as a transfer into vascular

tissues to treat vascular disease – from the bench all the

way to clinical application.

“During this process I learned about the need to de-

velop my discovery into a therapeutic product,” recalls

Dzau, who is the James B. Duke Professor of Medicine and

Director of Molecular and GenomicVascular Biology. “That

helped me understand that although commercialization is

not necessarily the endpoint for the work of academic in-

stitutions, it is the pathway by which important discover-

ies ultimately reach human application. In my mind, a

healthy relationship with the industry sector is necessary.”

Global healthDzau’s views on global health were shaped by his past. “I was born in

China and my family and I were forced to leave the country as refugees

when the communists took over,” he recounts. “In post-war China, I wit-

nessed extreme poverty and the associated health and hygiene problems,

as well as disparities in care, which has made me passionate about these

issues. In an institution like ours, or any health institution for that matter,

health disparities need to be met – it’s an obligation.”

Today, Dzau is committed to eliminating health dis-

parities among underrepresented and socio-economi-

cally disadvantaged populations both in this country

and abroad. Initiatives such as Duke’s Community Affairs

Office, Duke Community Research, and Duke Family and

Community Medicine, offer preventive care and home

care to all segments of the population including the el-

derly and uninsured. “Academic health institutions like

ours have an obligation to address health disparities in

the community,” he says. Duke’s Global Health Institute,


Victor Dzau was appointed chancellor for health affairs at Duke

University and President and CEO of Duke University Health

System effective July 1, 2004. He is also the James B. Duke

Professor of Medicine and Director of Molecular and Genomic

Vascular Biology at Duke.

Before coming to Duke, Dzau was the Hersey Professor of the

Theory and Practice of Physic (Medicine) at Harvard Medical

School, Chairman of the Department of Medicine at Brigham and

Women's Hospital, and Physician-in-Chief and Director of

Research at Brigham and Women's Hospital, Boston. Dzau's

academic interests are in cardiovascular translational research

and mission-based education.

8113Duke University employees

$1.9BILLION

Annual operating revenues,Duke University Health System

Dzau ED:31MAY 19/11/08 15:23 Page 35

Meeting patients’ needs has always been the driving force behind

everything Dzau does, and creating a culture within Duke Medicine that

centered on this main goal has been an underlying

theme. That’s an ever-changing dynamic, Dzau says.

“We’ve been developing new ways of delivering

care that places the patient rather than the physician

at the center. And we’re adapting modern technology

to do so.” For example, the new Duke Health Portal

will be an information system that makes it easier

and faster for patients to access their own medical

data from computers in their homes or through

kiosks at Duke Clinics. “They can look at lab test re-

sults, make appointments or simply view their

records,” he explains.

To encourage further innovation, Dzau set up the

Science Advisory Council in 2006. It encourages lead-

ing and young scientists to work together to identify

and discuss the current needs at Duke, and consider

what future directions should be taken. For example,

one idea that resulted was obtaining funding for international graduate stu-

dents, an emerging talent pool that, for the most part, has been unable to

obtain training funds in the US.

which was founded on the pillars of service, policy and

research, addresses the problem worldwide.

Dzau’s interest in health disparity reaches all cor-

ners of the hospital and university, and includes the

Schools of Medicine, Engineering, Business and

Law. “We are sending our students to Tanzania and

Uganda and our faculty are working in China and

Singapore. Our hope is to bring faculty and stu-

dents together with others to find solutions. When

you look at healthcare, you realize it encompasses everything, from in-

frastructure to the economy. We want to address health disparities in a

holistic fashion.”


Victor Dzau has developed a new model for academic

medicine in which organizational infrastructure supports

seamless translation from basic science discoveries to

clinical application as well as from clinical trials to advances

in healthcare in communities around the globe. Public-

private partnerships enable delivery of clinical advances and

allow bi-directional service-learning and globalization.

This Innovation-Care Continuum model will enable

academic health centers to fulfill what Dzau believes is

their responsibility to transform medicine and to address

health disparities through innovation and globalization.

INNOVATION-CARECONTINUUM MODEL

The Global Health Institute (GHI) at Duke Universitycontributes to the understanding, diagnosis,prevention and treatment of infectious diseases, whichstill claim 18 million lives each year and account forhalf of the deaths in the developing world.

The GHI is currently comprised of five groupswhose activities already reflect the Institute's futureambitions. Basic mechanisms of host-pathogeninteractions and innate immunity toward pathogens

are being studied using multidisciplinary approaches.Crucial world health issues like tuberculosis and

HIV/AIDS are being tackled. These includeunderstanding, and hopefully counteracting, thepersistence of Mycobacterium tuberculosis, thecausative agent of tuberculosis, and designing drugsto treat this disease. Mechanisms of HIV infectionand use of this virus in gene therapy approaches arealso the subjects of intense research.

GLOBAL HEALTH INSTITUTE

29,826total employees at all

three locations

of Duke University MedicalCenter employees have anMD or PhD degree (or both)

13%

Dzau ED:31MAY 19/11/08 15:23 Page 36

The road aheadWhile transformingmedicine is themes-

sage, the specificsofwhat needs tobe trans-

formed, andhowthoseobjectiveswill bemet,

have not been finalized. In Washington, DC,

and elsewhere, much emphasis has been

placedonreformingfinancingofthehealthcare

system. While Dzau acknowledges that as a

priority, he says it’s not the only one. “We, as

providers, have to change thewaywe deliver

care and theway that wemake discoveries in

new therapies. Therefore,whenwe talk about

thetransformationofcare, there’s tremendous

opportunity for academic health centers to be

leadersby creatingnewmodelsof care.”

But the road ahead will have many challenges, including reimburse-

ment issues and the continuing complexity of healthcare. Barriers that

exist today, such as too little incentive for patients and providers to

focus on prevention and wellness rather than playing treatment

catch-up for late-stage diseases, need to be addressed.

Technology, such as electronic health records, needs to

be further developed. As resources becomemore con-

strained, it becomes more difficult for academic

health centers tomove forward. But hope is in the air.

Already, the Innovation-Care Continuummodel

is helping leaders at Duke to “realign and restruc-

ture ourselves to lookat howwedeliver care toour

patients, andhowtobring innovationmorequick-

ly to areas of patient care. It’s helping us break

down the silos that exist today to create a

seamless continuum.” Dzau says it’s not

the onlymodel, but it’s one that appears

to be working. �


The Duke Institute for Genome Sciences &

Policy (IGSP) was established with the

explicit conviction that scientific

advancement in genetics and genomics requires

exploration and scholarship carried out at the

intersection of traditional disciplines in the life

and health sciences, social sciences and

engineering.

Launched as a direct result of Duke

University’s previous strategic planning process,

the IGSP has become an integrated

interdisciplinary network of centers, research

programs, and educational activities that together

constitute a campus-wide approach to advancing

the Genome Revolution and to addressing its

implications for science, health and society.

The creation of the

IGSP represented

Duke’s recognition of

the need to build

bridges among

researchers,

clinicians, policy

experts, and scholars

based in all of Duke’s

schools and to ensure

that the next

generation of

scholars is trained across the range of

experimental, quantitative and social sciences

and humanities disciplines needed to address

the challenges and opportunities represented

by the genome revolution.

DUKE INSTITUTE FOR GENOMESCIENCES & POLICY

“We’ve been developing new waysof delivering care that places thepatient rather than the physician atthe center. And we’re adaptingmodern technology to do so”

THE DUKE MEDICINE VISIONDuke Medicine seeks to transform healthcare, teaching, and

research to benefit society. It aims to accomplish this vision by:

� Making important advances in biomedical science and

fundamental research

� Fostering a multidisciplinary environment in the lab and clinic

� Translating discoveries into clinical practice

� Designing clinical interventions and measuring their

effectiveness

� Creating innovative approaches to health and wellness

� Addressing health disparities in its community and around

the world

� Sharing its vision and advances globally

� Training the people who will lead this work in the future

Dzau ED:31MAY 19/11/08 15:23 Page 37

Since 1847, the AmericanMedical Association hasbeen fighting for high

quality healthcare for allAmericans. Joseph Heyman

brings us up to date on theassociation’s latest campaigns.

The current crisis in the financial

markets is raising concerns

across many sectors, and

healthcare is not exempt. With

more people losing their jobs,

the number of unemployed is sure to rise,

and in our country being unemployed

oftenmeans having no health insurance.

Joseph Heyman, Chairman of the

BoardofTrustees of the American Medical

Association, is well aware of these con-

cerns. “When there is a loss of jobs, since

most people who are insured in the United

States receive their insurance from their em-

ployers, there will be an increasing number of

people who have no health insurance, and we know that

those people live sicker and die younger because of this.

“As an association,we’re very concernedabout that, sowe’re push-

ing for a plan thatwould cover everybody. Therewill be a tremendouswin-

dow of opportunity immediately after the inauguration of the new

President to accomplish this. The amount ofmoneywe’re spending on try-

ing to fix the economy dwarfs what it would probably cost to provide ad-

ditional insurance to those people who are not insured now. This is an

issue that has to be addressed, no matter what the situation in the econ-

omy happens to be.”

To this end, the association has instituted theVoice for theUninsured

campaign. As Heyman explains, the campaign was rolled out in three

stages. “The first stage was to raise the issue so that people would think

about it. The second stagewas tomake certain that everyone knew there’s

at least oneplan out there that could accomplish everythingweneed todo

to get people insured.


FEATURE

On the sideof the uninsured

THE AMERICAN MEDICAL ASSOCIATION

Mission: To promote the art and science of medicine

and the betterment of public health.

Core values: leadership, excellence, and integrity and

ethical behavior.

Vision: To be an essential part of the professional life of

every physician.

The American Medical Association helps doctors help

patients by uniting physicians nationwide to work on

important professional and public health issues.

Heyman ED:31MAY 19/11/08 15:25 Page 38

“The third stage was to be able to influence what’s going on in

Congress. We’re at the third part of the campaign now, which started im-

mediately after the election, although we were speaking with members of

Congress and with both campaigns before that to try to come to some ad-

vance agreement about the plan.”

The association maintains a website called voicefortheunin-

sured.org, which receives about 600 messages per month from unin-

sured patients willing to share their stories about the problems caused

by not having health insurance.

“I live in Massachusetts, which is a state that recently did pass

some health insurance reform that aims to insure almost all of its citizens,”

Heyman says. “We’ve insured about 600,000 more than had insurance two

years ago. We realized in Massachusetts that what we need is the political

will to accomplish this; even if the numbers don’t add up, if you have the

political will to accomplish it, you can get it done.

“What the association is doing is asking Congress to have the political

will to sit down together and find a compromise that will work for every-

body, and we think that’s possible.”

Public interestThis advocacy on the part of the

American public is not a new direction

for the AMA – the association was found-

ed in 1847 on a code of ethics that puts

patients’ interests before those of physi-

cians. The healthcare reforms the AMA is

proposing include the expansion of

health insurance coverage to every citi-

zen, a campaign it started back in 1991.

“We’re in the middle of a big cam-

paign that has been using a tremendous

amount of resources to promote our plan

and to promote some change, even if it

isn’t our plan, in the US healthcare sys-

tem,” Heyman says. “This included mil-

lions of dollars worth of advertising and

behind-the-scenes discussions with both

presidential campaigns, and we’re excit-

ed about the opportunity for making

some progress in this regard.”

Among the other campaigns the asso-

ciation is currently working on is its oppo-

sition to tobacco companies. The AMA has

asked the companies to refrain from en-

gaging in advertising practices that target

children; it has tried to get the FDA to reg-

ulate cigarettes as a drug; and has also ex-

pressed its concern about the use of

tobacco not only within the United States,

where it has dropped dramatically, but also

throughout the world.

“Another thing we’ve been working on

is getting antitrust relief for physicians and

patients, which we’ve been working on

since 1996,” Heyman explains. “We aim to

make it possible for physicians to negoti-

ate as a group rather than as individuals,

where the balance of power is so extreme

in favour of insurance companies.

The AMA has also led a crusade

against health plan gag clauses, which

prevented physicians from describing all

of the possible ways in which a patient

could be treated if they were not cov-

ered by their insurance, prevented them

from explaining that there were things not


Regina Benjamin, the AMA’s Chairman of

Council on Ethical and Judicial Affairs, has

been named as a 2008 recipient of a

prestigious MacArthur Fellowhip. The

fellowships are given to individuals who show

exceptional creativity in their work and the

prospect for still more in the future, and

comprise an award of $500,000, paid in

quarterly installments over five years.

Benjamin is a rural family physician

working in one of the most underserved

regions of the United States. In 1990, she

founded the Bayou La Batre Rural Health

Clinic to serve the Gulf Coast fishing

community of Bayou La Batre, Alabama. She

has established a family practice that allows

her to treat all incoming patients, many of

whom are uninsured, and frequently travels

by pickup truck to care for the most isolated

and immobile in her region.

2008 MACARTHUR FELLOWSHIP

“We’re asking Congress to have thepolitical will to sit down and find acompromise that will work foreverybody”

Joseph Heyman, MD, an obstetrician-gynecologist with a private

practice in Amesbury, Mass., has been a member of the American

Medical Association Board of Trustees since 2002. He served as its

secretary (2005-2006) and was chair of the finance committee. In June

2008 he began serving as Chair for 2008-2009. Heyman has been

involved in organized medicine since joining the Massachusetts Medical

Society in 1973. He joined the AMA in 1980 and has been a member of

the Massachusetts delegation to the AMA since 1987.


lowing year, and every year at the end of the

Congressional session we spend a lot of money and ex-

pend a lot of energy trying to prevent the drop, and every

yearwe’ve either hada freezeorwe’vehada tiny increase

in payments, and it hasn’t kept up with inflation.

“This year the projected drop was almost 11 per-

cent, which was a terrible problem for us because if this

happened, patients with Medicare would not be able to

seephysiciansbecausephysicians can’t afford toprovide care at sucha low

price. Everybody in Congresswas committed to fixing this, but at the endof

the year,when the vote came right before the July 4weekend,wewere short

a couple of votes, and the then President had threatened to veto it, so we

were very, very worried.

“Over the July 4 weekend, we put together an incredible campaign. In

stateswhere peoplewere up for re-electionwho voted against us, we put up

campaign ads over theweekend, asking their constituents to call on them to

change their vote, and by the time the weekend was over, we not only had

enoughvotestopassit,but inadditiontothatweoverrodethePresidentialveto.

“The outgoing President has a pet project that he calls Medicare ad-

vantage plans – private plans that provide Medicare, with Medicare giving

them a subsidy to pay for the care – and we wanted to use that subsidy to

pay for the increase in thepayment. Thatwas the reasonbehindhis planned

veto of the bill.”

As a result of 9/11, the association developed a disaster preparedness

andmedical response online resourse guide which patients and physicians

can use in the event of another disaster, which was called in to use during

Hurricane Katrina.

Dropping paymentsEvery year since 2001, the AMA has been involved in fighting the drop

in payments to physicians. “We have a problem with a formula for pay-

ment to physicians under Medicare, where our payment amounts are

based on the volume of care from the

previous year. Every year there’s been a

projected drop in payments for the fol-


1990 - 1991 1992 1993 - 1994 1995 1996

� AMA moves into newbuilding at 515 N. StateStreet, ChicagoAMA adopts guidelinesgoverning gifts to physiciansfrom the pharmaceuticalindustry

� AMA launches campaignagainst family violence

� AMA calls on tobaccocompanies to refrain fromengaging in advertisingpractices which target children

AMA adopts a recommendationfrom the Council on MedicalEducation that continuedfederal funding should beavailable for graduate medicaleducation

� AMA launchesgrassroots campaign forprofessional liability reform

AMA drafts the PatientProtection Act II bill to protectpatients through a proposedban on gag clauses and otherpractices of insurance plansthat infringe on the patient-physician relationship

TWODECADESOF THE AMA

1997-1999

� AMA scores crucialvictories in Congress forphysicians and patients withlegislation on antitrust reliefand health insurance reform

AMA national campaignefforts lead to the Food andDrug Administrationregulating the marketing oftobacco to minors

AMA launches a crusadeagainst health plan ‘gagclauses’ resulting in theserestrictive provisions beingdropped by five leadingmanaged care providers

� AMA passes resolutiondeclaring physician-assistedsuicide is fundamentallyinconsistent with thephysician’s professional role

Highlights of the association’sactivities since 1990

covered by insurance companies that were very important, and prevented

them from complaining about the insurance companies. These gag clauses

were eventually rescinded.

In conjunctionwith theNationalMedical Association – the association

of African-American physicians – and the National Hispanic Medical

Association, the AMA has created a commission to end healthcare dispar-

ities in theUS. This is comprised of leaders from the nation’s largest physi-

cian organizations andmore than30health-related groups,with amission

to educate physicians and healthcare professionals about disparities.

Other notable initiatives have included a campaign against ‘drive-

through deliveries’: when awomanwas admitted to have a baby and then

dischargedon the samedaywithout adequate time in the hospital; and re-

sponding to September 11, 2001, when the AMA provided the government

with a list of 3500 volunteer physicians who were ready and willing to as-

sist in the recovery efforts.


view of the association. “Personally, trying to keep up with

my own practice at the same time as fulfilling my role as

Chairman at the AMA has been a little difficult. I’m in solo

practice, and it has been hard to divide my time up. Also,

trying to stay on top of all of the issues that the AMA con-

fronts is very challenging.

“That said, this year has been a real highlight of my

life. Being able to involve myself in something that af-

fects so many people and having the opportunity to

make things better has been amazing. I’ve been learning every day, I’ve

been meeting incredibly talented people, and it’s been a delight.

“From a broader viewpoint, I’m an eternal optimist, and I’m very

optimistic that there is a bright future for American medicine. We will

have greater emphasis on prevention and much wider use of health in-

formation technology. As a solo practitioner, I’ve been paperless since

2001, and I believe that health information technology will eventually

make a dramatic difference to our healthcare system.

“We’re looking for a more efficient healthcare system, and the

American Medical Association is going to continue to be at the forefront

when our law-makers are searching for practical solutions to the nation’s

healthcare priorities, and we’re going to do our very best to pave the way

for establishing realistic, practical solutions. We’re striving to provide every-

day solutions for our member physicians that will make us indispensable

to physicians in the future.” �

The end result of this campaign was that the subsidy no longer exists

and that physicians are being paid more than they would have been paid.

An 18-month reprieve was also introduced, giving the association more time

to work on a new formula for payment.

“It was such an important issue that Senator Kennedy came to the

House to vote in the second vote, the only time he has done so since being

diagnosed with a malignant brain tumor,” Heyman recalls. “He was given

a standing ovation in the Senate, so it was a pretty exciting moment.”

National reformMuch of he AMA’s current advocacy efforts focus on its push for na-

tionwide healthcare reform, and addressing the predicted shortfall of

85,000 physicians in many medical specialties by 2020. Heyman outlines

the association’s recommendations.

“We need to increase medical school class size, allow for additional

residency slots to train physicians, and somehow improve the distribution

of physicians to underserved and undersupplied specialties. We must cre-

ate incentives for those who choose to practice in an area where they’re

needed rather than in an area that’s particularly attractive.

“Re-entry programs that address the educational needs of physicians

who re-enter the workforce after there’s some inactivity will ensure that

they’re current and proficient in their practice areas. And we must improve

a tremendous ability to innovate, and we have very convenient access

to care where people don’t have to wait very long. Those are places in

which we really shine.

“As far as quality and safety is concerned, we’re working hard to achieve

constantlyhigherqualityandsafetyacross thehealthcaresystem.We’ve tried

all kindsofdifferentways inwhich to improvequalityandsafety.Mostcitizens

in the United States feel that they have a very high quality healthcare system.

As an association, we’re not satisfied, but I think most people are.”

Challenging futureHeyman has faced a range of

challenges in his time with the AMA,

both personal and from the point of


99 2000 2001 2002 2003 2004 - 2005

� Through media outreachand member physiciangrassroots efforts, the AMAdeterminedly forges aheadwith its advocacy forcomprehensive Patients Bill ofRights legislation in Congress

� Immediately following theSeptember 11th terroristattacks, the AMA quicklyresponds to the needs of thenation, providing thegovernment with a list of3500 volunteer physicianswho were ready and willingto assist in recovery efforts

� The AMA, along with 11other organizations whichcomprise the ‘Covering theUninsured’ initiative,launches a nationalawareness campaign aimedat publicizing the extent ofthe uninsured population inthe United States

� After two years ofintensive lobbying effortsby the AMA and specialty andstate societies, Congressaverts a 4.4 percent cut inMedicare physicianpayments. On December8th, President George Bushsigns the historic MedicarePrescription Drug Bill, andtaken a moment out of hisspeech to thank the AMAfor its efforts in support ofthe bill

� More than 180 physicians,medical students, publichealth workers, nutritionistsand other health careprofessionals gather for thefirst AMA National Summit onObesity in Chicago. Theparticipants identify waysthat healthcare professionalscan tackle the obesityepidemic in schools

� AMA spearheads effortwith 129 other healthcareand patient groups thatresults in the passage andsigning of the Patient Safetyand Quality Improvement Act

the attractiveness of careers in primary care. We need to do something

about the educational system to make certain that people who do choose

primary care realize that they’re doing something special that’s very, very

important to our country.

“Physician reimbursement changes need to be encouraged for those

who are practicing, especially in primary care, and we need to look at in-

novative models, perhaps considering models like the patient-centered

medical home model or other innovations in which we can increase pay-

ment to primary care physicians.”

That’s not to say that our healthcare system doesn’t have its good side,

as Heyman points out. “We have a lot of problems with our healthcare

system, most of which involve the fact that people are uninsured, but

our system does have desirable features. The main one of these is

choice – patients can choose the kind of insurance they want, they have

a choice of physicians, they have a choice of hospitals. We also provide



EHM talks to the Mayo Clinic’s Daniel Berry, Chair of theOrthopedic Surgery department, and Michael Yaszemski,orthopedic surgeon, who outline the cutting-edge developmentsin the treatment of musculoskeletal conditions.

Berry/Yaszemski:31MAY 19/11/08 15:30 Page 42

The Mayo Clinic’s Orthopedic Surgery department has a long

history of caring for patients withmusculoskeletal tumors of

the spine and pelvis. This work can require the skills of spe-

cialists in many different areas, as orthopedic surgeon

Michael Yaszemski explains. “We have a team here at the

clinic that has a special interest in treating these patients.

That team includes orthopedic oncology surgeons, orthopedic spinal

surgeons, and colleagues from colon-rectal surgery, plastic surgery, urol-

ogy, vascular surgery, critical care anesthesia, medical oncology and ra-

diation oncology.”

Over the years, the teamhas refined techniques to remove these very

large tumors and to perform reconstruction of the spine back to the pelvis.

These techniques involve everything from removing the tumor and provid-

ing critical care to the patient, to reconstruction with the movement of tis-

sues to cover the very large holes that are created.

Coupled with the research side, the department is engaging in regen-

eration of bone defects, regeneration of cartilage defects, regeneration of

nervous systemdefects (spinal cord andperipheral nerves) and controlled

drug delivery tomusculoskeletal cancers.

One specific area of concentration is scoliosis, where several novel

treatments are currently in thepreclinical stage. “We are working on using

inducible electromagnets implanted in spines that have scoliosis to be

able to modulate their growth from a minimally invasive perspective,”

says Yaszemski. “We position electromagnets to one side of the spine

or the other. These magnets can either distract across the growing part

of the vertebral body, or compress, depending upon whether the mag-

net is attractive or repulsive. The strength of this attraction or repulsion

to encourage the spine to grow in the direction we want it to grow is de-

termined by a wireless connection, much like a cardiology physician

would program a pacemaker.”

Hip replacementYaszemski and his teamareworking on total joint replacement for hip

and knee patients needing reconstruction or prosthetics for amputations.

“We are working on a technique called intraosseous transcutaneous am-

putation prosthesis, which is a technique of having ametal prosthesis put

into the residual limb. Typically this is for an above-knee amputation, and

then the metal prosthesis will stick out through the skin and have an ex-


Running a busy surgical depart-

ment has its challenges, as

DanielBerryknowswell. AsChair

of the Orthopedic Surgery de-

partment at the Mayo Clinic, he

is responsible for the daily oper-

ational elements of supporting the department.

“Weneed tomake sureweprovide the very best

clinical care we can to everybody,” Berry says.

“Weareproudof ourdepartment,we’vegot out-

standingexpertise in all the subspecialties of or-

thopedics, and our focus is to continue to

function in away that’s bothefficient for patients

and provides outstanding cutting-edge care.”

The department also plays a major role in

musculoskeletal research, and works to edu-

cate residents and fellows, as well as physi-

cians from around the world through the

educational programs that it runs nationally

and internationally.

“In the longer term,we are setting a vision

and a direction for the department which will

continue to support all these things,” Berry

explains. “We also aim to work in a way that is

forward-thinking and that can advance mus-

culoskeletal care, both at our clinic as well as

around the country and around the world.”

Hiring the right people is also a big part of

Berry’s job. “Our philosophy is if you get the

right people on board and clear the track to let

them run, they’ll run fast and run well. We

look for people who have outstanding clinical

capabilities, as well as outstanding capabili-

ties in either research or education or both.

“AsChairofoneof thebiggerdepartments in

thecountry, there’sanelementofambassadorship

to the restofboth themedical communityandthe

public, in terms ofmaking sure we are doing our

best to represent orthopedics and to respond to

what thepublic needs inmusculoskeletal care.”

InnovationsThe Mayo Clinic has long been a hotbed of

innovation. Cortico-steroids were discovered

at the clinic, for which Dr. Hench and profes-

sors Kendall and Reichstein were awarded the

Nobel Prize for Medicine in 1950. “The first in-

jection, for example, of cortisone into a lesion

of the musculoskeletal system was an injec-

tion into a shoulder that was carried out at the

Mayo Clinic in the 1960s by Mark Coventry,

who was then Chair of the Orthopedics de-

partment,” Berry says. “That’s a good example

of an innovative process that has since been

used millions of times around the world.”

Berry acknowledges that the pace of tech-

nological innovation has increased in recent

As Chair of one of the country’s bigger orthopedic surgery departments, Daniel Berry hasa lot on his plate.

Orthopedic surgeon Michael Yaszemski and his team are working on new techniques forthe treatment of bone tumors.

Daniel Berry is Chair of the Orthopedic Surgery department at the MayoClinic and the Chair of the Maurice Muller Foundation of North America.Berry completed his residency at Harvard Medical School. His researchinterests are in primary hip and knee replacements, revision hip and kneereplacements, osteotomies about hip and knee.


BIOSPACE ADVERT:31MAY 19/11/08 15:35 Page 44

ternal component attached to it that would contain both a knee and an

ankle. The difficult part of this is the junction between the metal and the

skin, and that’s the focus of our investigation at this time.”

“Together with our colleagues in engineering, and most importantly

infectiousdiseases,weare trying to engineer the junctionbetweenthemetal

andtheskinso that itwill be resistant to infection.Weknowthat thishappens

in other parts of the body. For example, our oralmaxillofacial colleagues and

our dental colleagues putmetal posts in regularly for people. They integrate

into the bone of themandible or themaxilla – the jawbones – and stick out

through the oral mucosa and then they get a prosthetic tooth put on top of

them. It can bedone. The challenge is to figure out how to do this for a per-

son with an amputation, whether it’s in the leg or the arm.”

Mayo Clinic research is part of the national consortium AFIRM, the

Armed Forces Institute of RegenerativeMedicine, which involves 23 acade-

mic institutionsaroundthecountry.Theconsortiumencompassesfiveproject

areas, with theMayo Clinic having responsibility for two of those five. “With

respect to nerve regeneration,we’re the lead institution,” explains Yaszemki.

“Our collaborators on the nerve project are at Cleveland Clinic, Rutgers and

MIT.With respect to thebone regenerationproject, I’m the co-principal inves-

tigator, together with Cleveland Clinic, and in like fashionwe have about five

institutions that are contributing to the bone project.

“The goals of the nerve project are to work on the peripheral nervous

system, meaning the nerves of the arms, legs and brachial plexus. We at

theMayoClinic are alsoworking on the central nervous system– the spinal

cord – with work funded by the National Institutes of Health. We feel that

thework that’s being done for AFIRMon theperipheral nervous systemwill

be equally applicable to the central nervous system.”

Nerve work“Our aim is to treat nerve injuries that have gaps in them that current-

ly don’t have an option for treatment. Typically, for microsurgeons who do


years, and there’s also been a lot of enthusiasm

andexcitement about new technology shownby

the public. “Sometimes that’s spurred by publi-

cations and sometimes it’s spurred by market-

ing campaigns, by different companies that

make products. It’s important that the public

have an opportunity to understand whether

those technological innovations are going to

stand the test of time, andwhether they’re even

innovations or there’s something new that’s not

actually a valuable innovation.

“We’ve had a rigorous program of prospec-

tive, carefully evaluated results and trials to de-

termine whether new ideas are in fact better

ideas. A goodexample of thatwould be a critical

assessment ofminimally invasive surgery for the

hip and the knee. A number of our department

members havepublishedon topics such as that.

We’re also working on a critical evaluation of

resurfacing arthroplasty of the hip.

“We’ve made big strides in the area of pain

management for allmusculoskeletal procedures

andwe’ve got a very innovative group thatworks

onoptimizingpainmanagement andmaking the

operative experienceone that is bothmore com-

fortable, less risky and onewith less time spent

in the hospital, because that’s quite important

from the standpoint of cost-effectiveness in

medicine.

“One other area that we have a particular

interest in our department is themanagement of

arthritis in younger patients. For example, we

have several people who are innovators in the

area of management of patients with hip arthri-

tis at a younger age with things such as os-

teotomies or salvage procedures.”

Joint registryThe first FDA-approved total hip replace-

ment, a technology that was invented in the

UK, was applied in a government-approved

program at theMayo Clinic. “We’ve had a total

joint registry here for a long time,” Berry

points out, “as well as registries in other fields.

Those have provided the basis for not only

good clinical care, but also critical evaluation

of the results of what we do.”

The clinic established a joint registry in the

early 1970s, right after joint replacements were

first carried out in the United States. Berry

says that the idea was that every patient who

had a joint replacement at the clinic would be

followed for their whole life, and the life of

their implant, to determine how well it did,

what problems developed with it, and what

the results of it were. Berry explains that at

the time this was something that wasn’t being

done by anybody else.

Michael Yaszemski is a professor of orthopedicsurgery and surgeon in the Orthopedic Surgerydepartment at the Mayo Clinic. He is a past Chairof the American Orthopedic Association andChair of the Scoliosis Research Society. Hisresearch interests are in adult scoliosis andspine surgery, primary and revision hip andknee arthoplasty and bone tissue engineering-polymer synthesis.

“It’s important that the public have anopportunity to understand whether thosetechnological innovations are going tostand the test of time”


VisageImaging.indd 73 19/11/08 08:32:42

Since then, there have been registries de-

veloped to try to do the same thing on a nation-

al level, although in Berry’s opinion this has not

achieved success in the United States. “National

registries, though complementary to the type of

registry we have, don’t provide the same informa-

tion.They give the type of implant that somebody

has and whether it ever gets taken out, and if so,

why.Ours isadetaileddatabase– ithasa farmore

rich detail of information about the operative pro-

cedure andaboutcomplications of theprocedure.

“The reason this has been so important is

that it has allowed us to very carefully learn what

works and what doesn’t, why it works, why it

doesn’t, and then to systematically reduce long-

term failure and short-term complications. That’s

been a huge resource to us, in terms of moving

the practice of joint replacement forward, and

it’s been a huge academic opportunity for our

department – over 700 papers have been pub-

lished from data that’s been available through

that registry. It has also had a national and in-

ternational impact on the practice of joint re-

placement, because so much data has been

available that’s not been available from any

other source.”

Future focusThe delivery of cost-effective, high-quality,

high-value healthcare will be an area of increas-

ing importance over the coming several

decades, as economic resources that can be de-

voted to all medical care come under both

greater scrutiny and there is greater difficulty in

obtaining them. When people reach their 60s,

70s and 80s, a very large proportion of their

medical problems are musculoskeletal in nature.

As the population ages in Western countries,

there will be a greater need for cost-effective

musculoskeletal care, which is why the Mayo

Clinic is in the process of boosting its research

programs in the area of cost-effectiveness of

medical interventions, particularly in the mus-

culoskeletal area.

“We believe that as time goes on there will

be a greater focus on moving orthopedics from

a specialty which has more or less relied on re-

placing or fixing the musculoskeletal system

with metal or plastic or artificial devices, to one

where we try to help the musculoskeletal sys-

tem repair itself biologically,” Berry says.

“To that end, we are focusing on areas

where we believe there will be the opportuni-

ties for major leaps forward in musculoskele-

tal care from the biologic side of things, such

as cartilage regeneration, bone regeneration

and biologic engineering methods. With

these, tissue engineering principles are ap-

plied to the musculoskeletal system, to try to

grow back cartilage where cartilage wasn’t

present, to try to grow back bone where bone

wasn’t present.

“These are areas that will be the future of

orthopedics, and we’re devoting quite a few re-

sources to them. We have excellent labs working

in several of those areas right now and we be-

lieve they will soon start bearing fruit. These

are areas where there’s been a lot of basic re-

search done over the last several decades, in

stem cell research, for example, and cartilage

regeneration research and bone regeneration

research. But these research efforts have not

yet reached their full potential in terms of

translation to humans, and we hope that all

that background and foundation that’s been

built over the last couple of decades is getting

pretty close to paying off in terms of really

changing how we can manage some of these

conditions.” �


peripheral nerve work, gaps of up to about an inch can be handled with

local tissues, mobilization of the nerves and grafts from nerves borrowed

during surgery from other parts of the body. These are typically sensory

nerves that give the patient a bit of a numb spot, but then function to

bridge a gap.

“There is no treatment for gaps about one

inch or larger, which is why this work will focus on

larger gaps of more than two inches. It involves

both allograft nerve tissue, meaning donations

frompeoplewhohavedied,andsynthetic polymer

scaffolds augmented with stem cells.We’re focus-

ing onadult bone marrow stemcells,andthe work

is progressing well.”

The Mayo Clinic’s involvement in the con-

sortium will allow for more individuals to be in-

cluded in this project. Over the next 12 to 18

months, Dr. Yaszemski’s efforts will focus on segmental defects in bone

using polymeric materials fabricated into specific shapes and sizes that are

loaded with cells and bioactive molecules.

“We’re also looking at controlled delivery of novel biomolecules for

cancer treatment,” says Yaszemski. “The cancer project focuses on mus-

culoskeletal cancers, based upon what we take care of clinically, and we

have a number of small molecules that seem to induce the natural death of

these cells, while not affecting normal connective tissue cells.

“We’re trying to understand the molecular signaling that goes on to

make this effect happen, and then to harness this effect by controlled

local delivery to the site of the tumor, so we can get a higher concen-

tration of this treatment where the tumor is, and minimize the concen-

tration to other parts of the body that are cared for, quite appropriately,

by systemic chemotherapy that people are getting now. We view this as

an adjunct to the existing surgery and systemic chemotherapy by giv-

ing additional treatment at the local site of the connective tissue tumor,

which is called a sarcoma.” �

“Inducible electromagnets implanted inspines that have scoliosis to be able tomodulate their growth”


Anestresia.indd 1 13/11/08 08:46:06

EHM. What fi rst attracted you to a career in medicine and research?

Jo Rae Wright. Many things infl uenced my choice. I’ve always liked science and I was

attracted to the idea that some research areas could potentially help cure disease.

I got interested in lung disease by coincidence. Through a job as a research

technician I worked on black lung, a disease that affects coalminers. I fell in love

with this area of lung biology since the lung is an organ that has a great interface

with the environment.

EHM. Your research focuses on infl ammatory and infectious lung disease

at the cellular and molecular level with a particular focus on the role

of surfactant in innate and adaptive immunity. Can you tell us

about some of the developments that have been made in

these areas?

JRW. One major discovery in the immunity area is that

surfactant binds to bacteria, viruses and other patho-

gens that are inhaled. Once it binds to them it helps

clear them from the lung so that it reduces the inci-

dence of infection.

We know from studying mice if there isn’t any

surfactant and a person gets an infection then they are sicker and the lung be-

comes more damaged. Some of our future work will involve looking at whether

humans have mutations in their surfactant genes that may make them susceptible

to infection.

EHM. Can you tell us about your current study involving lung function immunity and

defense, which is being funded by the National Heart, Lung and Blood Institute?

EHM talks to Jo Rae Wright, President of the American Thoracic Society, about the society’s work and the latest advances in thoracic research.

easy


THORACIC MEDICINE

easysys

jo wright.indd 49 19/11/08 15:11:10


JRW. We’re looking at a new area for surfactant functions and whether

it plays a role in chronic lung diseases such as asthma and idiopathic

pulmonary fibrosis. It has been known for over 10 years idea surfac-

tant is important in defending the lungs against pathogens such as

bacteria and viruses. However, the idea that surfactant might also

be important in chronic lung diseases is a relatively new focus area

for our lab. We are trying to understand how surfactant regulates

inflammation and how dysfunctions or low levels of surfactant might

contribute to chronic lung disease.

We have a project that runs as part of

a big grant at Duke University, along with

other collaborators, which looks at the role

of surfactant and chronic lung disease.

This is a new area for us and we’ve been

lucky to be supported by the NHLBI.

EHM. The long-range goal of the ATS is

to decrease morbidity and mortality from

respiratory, critical care, sleep disorders

and life-threatening acute illnesses in

people of all ages. Can you tell us how the

society is achieving this?

JRW. Everything that we do is directed

towards meeting this end. This ranges all

the way from providing continuing medi-

cal education for our physicians and allied

healthcare professionals to publishing pa-

tient education materials.

What really distinguishes the ATS is

that we disseminate the best science and

research in the fields of pulmonary critical

care and sleep medicine. Many of our state-

ments and guidelines, which are generated

by the ATS, are the gold standard.

The three journals that we publish are

very influential in the field – our American

Journal of Respiratory and Critical Care

Medicine is the highest impact factor in

respiratory medicine. Our annual interna-

tional conference has over 5500 abstracts

and is the biggest forum for research in

these areas.

In 2003 we started funding our own

research projects targeted at junior re-

searchers starting their careers. Our goal

is to support them until they can get their ideas and the information

they need to get funded by major organizations like the NIH and the

VA. We surveyed ten of the people who got grants in 2004/ 2005 who

have gone on to get 27 grants that total more than $22 million and

have published 53 scientific papers.

We have a very strong advocacy program for lobbying our fed-

eral government. This has helped with big victories this year for us.

The first was to make pulmonary rehabilitation a uniform benefit for

Medicare patients. The second was a domestic and international bill

on tuberculosis that was drafted by the ATS and provides funding for

tuberculosis surveillance and research.

EHM. When talking about your career you said that the thing you

were most proud of is the accomplishments of your students and fel-

lows. Why is this aspect so important to you?

JRW. It’s because I believe that one person can only make a relatively

small difference in research. You can discover things, but the way you

can spread these findings is by training

other people who can then carry out out-

standing research and help cure disease.

It’s a bit like the concept of ‘pay it

forward’, when a person does good things

for other people, then those people go on

to do other doing good things for other

people and so forth. This is how I see

things working.

EHM. How would you like the ATS to grow

and develop in the future? Are there any

areas in which you would like to particu-

larly focus your efforts?

JRW. One of our focus areas is to work more

closely with our patients. A few years ago

we formed a group called the Public Advi-

sory Roundtable (PAR). We’d like to grow

this partnership and this is something I’m

actively involved in. It is made up of 13

patient-interest groups that encompass

lung, critical care and sleep. It has been

an exciting relationship because all of us

involved really want to make patient lives

better. This relationship helps inform my

leadership and future growth at ATS.

Having patients as part of our society

has helped influence our yearly interna-

tional conference as they actively par-

ticipate in the meeting. They are hugely

influential in our advocacy efforts. When

we go to Congress to talk about the needs

for research and healthcare, the patients

are the ones that light up the eyes of the

congresspeople.

We will be working really hard to bring

more recognition to the importance of lung disease. A lot of people

don’t know about chronic obstructive pulmonary disease, which hap-

pens to be the fourth largest killer of Americans.

The ATS is an amazing society for people to get involved with. It

brings together a very diverse group of people including basic scien-

tists, clinicians, nurses and therapists. It promotes diversity and has

a great mission. It’s a privilege for me to serve as president. It’s been

a very enriching life experience for me. n

Jo Rae Wright, Ph.D., is the 2008-2009

President of the American Thoracic

Society. She is also vice provost, dean

of the Graduate School and professor

of cell biology, medicine and pediatrics

at Duke University. She earned our

doctorate in physiology from West

Virginia University and trained at the

Cardiovascular Research Institute at the

University of California, San Francisco,

where she held worked until joining the

faculty at Duke in 1993.

jo wright.indd 50 19/11/08 15:11:11

IonHealthcare.indd 1 20/11/08 09:20:51

Sleep apnea’s failure to fi t within an internal organ system

or a certain health category has resulted in the sidelining

of the disorder, both in terms of its effects on the body

and its nationwide prominence. “Sleep apnea is a condi-

tion in which the airway collapses during the night while

we’re asleep and causes major stress on the body,” explains Ro-

chelle Goldberg, President of the American Sleep Apnea Association

(ASAA). “Since sleep is supposed to be a time of recovery for our

bodies, it’s a particularly vulnerable time when the body is pushed

to do extra work to try to breathe, because of the airway collapse.”

As Goldberg notes, the effects of this stress on the body produce

daytime consequences of fatigue, low energy, poor concentration

and even diffi culty with focus, creating a huge impact on a person’s

productivity. There can also be health risks involved if the condition

is undiagnosed. “Untreated sleep apnea does cause an increased

risk of problems like high blood pressure, diabetes, heart attacks,

stroke, heart failure and atrial fi brillation. There are also many in-

Sleep apnea is a serious condition that can cause increased risk of high blood pressure, diabetes, heart attacks, stroke, heart failure and atrial fi brillation, yet it is often not taken seriously

by the medical establishment and the public. Rochelle Goldberg sets the record straight.

The science of sleep


direct impacts, such as patients being at risk for other things like

motor vehicle injury,” she explains.

The symptoms are often more apparent to a bed partner than

to the patients themselves. “Their partner may notice breathing

pauses or gasping or choking in the night. The person often is the

least aware of their snoring and breathing changes, but they may be

aware of disturbed sleep,” says Goldberg. Diagnosis of sleep apnea

is made through testing to confi rm breathing pauses and disturbanc-

es in sleep. They may have also have low oxygen levels because of

the breathing pauses.

The treatment of sleep apnea is also changing, as awareness

of the disorder grows. The early 1980s saw sleep apnea enter a

more clinical venue with the introduction of continuous positive

airway pressure therapy (CPAP). The equipment has become more

technologically advanced over the decades but the basic concept of

pressure delivery stays the same. “Comfort is very much affected by

mask styles, the materials that the mask is made of, how it contours

SLEEP APNEA

goldberg-sleep.indd 52 20/11/08 09:19:13


to the face and the various ways

that you can get air pressure into

the airway – that has been a major

area of competition in the different

manufacturers of CPAP,” explains

Goldberg.

Advancing technologyTechnology improvements have

also seen a variation in pressure,

how pressure is delivered and the

machine itself. “We’ve seen more

fl exibility for travel as the units have

become smaller and made it more realistic for people to take equip-

ment with them,” says Goldberg. “Many of the units have adaptors

or adjusters that go from 110 to 220 volts, and adjust for altitude.

So there are a number of ways that people can use their equipment

more effectively.”

Most notable in terms of technological advancements is the

introduction of oral appliance therapy to those patients suffering

with mild to moderate obstructive sleep apnea. “Most dentists have

access to facilities that can make up an appliance that will work

to advance the jaw, to move the mandible forward to increase the

space at the back of the throat. It helps the tongue move forward so

that it doesn’t get in its own way.”

However, this type of technology must be carefully implemented

only in those patients with a mild form of the condition and needs to

be handled through someone who is well versed in the airway from

a dental perspective to determine its effectiveness. “CPAP is very

non-specifi c. It blows air pressure through the airway. Wherever

there’s narrowing it can help prop the airway open. It works in 99

percent of people. We know it works by testing before the person

gets it and costs are incurred. With dental appliances it’s more of a

challenge because patients have to get the appliance fi tted to them,

to see if they tolerate it.”

Another challenge in implementing this new technology is the

availability of fi nancial capabilities to implement oral appliance

therapy. With recognition for sleep apnea remaining low, funding

for treatment is often hard to come by. “Our centres for medical

service, CMS, are now contemplating payment for oral appliances,

but for many people this is a sizeable out-of-pocket expense,” says

Goldberg.

The science of sleep

For Goldberg, it is not treatment that needs to be improved but

the acceptance of sleep apnea as a medical condition and recogni-

tion of it by the American public. The association’s primary function

is to support the patient, with half of the executive board comprised

of patient representatives. “We have served a major role since 1990

in trying to help people who have sleep apnea on a number of levels.

Firstly, we’ve done so for those who are already diagnosed, provid-

ing them with a resource for more information about sleep apnea.

The organization has launched a user-friendly website that’s grown

substantially in the last several years, providing them with informa-

tion on how to pursue more effective treatment.”

Another major role for the organization has been helping those

who are undiagnosed through educating the public about the exis-

tence of sleep apnea. “We believe that sleep apnea affects at least 18

million people in the US, most of whom are currently undiagnosed.

Our aim in light of this is to be a resource for those people who

haven’t been offi cially given that descriptor but have symptoms. Or

to try to help those families or partners who are observing this.”

Dispelling ignoranceThe high number of untreated patients and the ignorance of

sleep apnea as a nationwide disorder can be attributed to the

uneducated stereotype of those affected. During the early stages

of recognition in the mid 1980s, sleep apnea was thought to be a

diagnosis given only to middle-aged, obese men. “While certainly

older, heavier men have an increased likelihood of sleep apnea, the

disservice that this created was to work against effective diagnosis

for people who don’t fi t that image,” explains Goldberg.

Greater recognition over the last few decades has shown that

women are also subject to sleep apnea, along with it occurring in

a multitude of ages. “That’s the other function that the American

Sleep Apnea Association has been trying to play in disseminating

the idea that sleep apnea is an equal opportunity condition, that it is

not just gender and obesity.”

More challenging than instilling recognition into the public is the

acceptance of apnea as a condition by healthcare professionals. As

Goldberg notes, the sleep fi eld in general has not had a champion to

propel such issues to the forefront of medical discussion. Disorders

are thought of in relation to organs or categories, but sleep apnea

has never had an offi cial protector. It has the potential to be diag-

“The lack of recognition of sleep apnea shows

society’s lack of respect for sleep as a necessary

human function”

Rochelle Goldberg, is a sleep clinician, educator

and researcher. She has a full offi ce practice

dedicated to the care of sleep patients and continues

to work through all avenues that help to educate

patients and the healthcare community on the

importance of sleep disorders, their diagnosis and

treatment.



nosed through internal medicine, neurology or psychiatry, but there is

not a uniform department of medicine that has made this their cause

and concern.

Goldberg describes this lack of recognition to be a sign of the times.

“To some degree, it shows society’s lack of respect for sleep as a neces-

sary human function. I think we spend more time in our world trying to

work around sleep as a necessary evil, trying to see how little can we get

away with. So of course any condition that disturbs sleep is also looked

at as something that’s in the way.”

Raising awarenessThe Alert Well And Keep Energetic (A.W.A.K.E) network, which comes

under the auspices of the association, has performed a useful function

in taking information about sleep apnea out to communities. “If you get

people involved in their diagnosis, and they fi nd other people involved

in their diagnosis, the grassroots effect has always been quite strong.

Then they, as a body, can have more say with other healthcare providers

and with politicians when they get involved in healthcare and especially

healthcare dollars,” says Goldberg. “The patient role is critical.”

In order to raise awareness within healthcare, the association con-

tinues to maintain its presence at the major medical meetings where this

condition is addressed. “We have presence at the American Academy of

Sleep Medicine, which is the greater venue of sleep diagnoses for pro-

fessionals, clinicians and researchers, and are also present at the Ameri-

can College of Chest Physicians, which has an international audience.”

This has allowed for education about sleep apnea for those who are

involved in the care of diagnosed patients and the patients themselves.

“The majority of materials that we have are patient-directed, but they’re

patient-directed in a way that helps them interface with the healthcare

provider audience,” says Goldberg.

When Goldberg is asked what she predicts for the future of the

American Sleep Apnea Association, she points out that knowledge and

recognition of the condition still remain at the forefront of the organiza-

tion’s functions. “It’s through these measures that treatment options

should expand, that prevention or the chronic disease model should be

adopted,” she says. “It’s very much a condition of continuity of care,

health issues that impact sleep apnea, device upkeep, weight factors

– all of these things need to be looked at in an ongoing fashion by some-

one who is familiar with this,” she adds.

The association is adopting a much more prominent approach. “We

aim to help encourage governments and the healthcare industry develop

the model that we need to move forward. The more we educate patients

about this condition and the need for ongoing treatment, the more we

help compliance. Of course, that’s a challenge in any healthcare issue,

but this is one where patients can very much take the helm.”

Goldberg notes that this is a very exciting time for the recognition of

sleep apnea and for the association, because awareness has increased

and there is the potential to infl uence the primary care audience. “These

are all people that need to be thinking about sleep apnea, and as they

continue to do so we’ll see sleep apnea become more of a hub for many

of these other conditions, including metabolic syndrome. The sooner

we can identify these conditions and treat them, the more favorable the

impact will be on our society.”

• Estimates are that between 12 and 20 million

Americans suffer from sleep apnea to some

degree.

• Sleep apnea is a condition that affects a person’s

breathing during sleep. Apnea comes from a

Greek word meaning ‘want of breath’. Sleep apnea

a chronic health problem, and is progressive,

often getting worse over time.

• The stoppage of breathing can last anywhere from

10 to 30 seconds per incident; up to 400 seconds

over the course of a single night with multiple

occurrences. Although research is ongoing, Sleep

apnea is still largely misunderstood.

• There are three types of sleep apnea: obstructive,

central and mixed. Of the three, obstructive sleep

apnea (OSA) is by far the most widespread. OSA

can be mild, moderate or severe.

• Sleep apnea is not age specifi c; it can affect

anyone from childhood through to old age. Men

and women can both develop it, but it is more

common to men, particularly those who are also

overweight.

THE TRUTH ABOUT SLEEP APNEA


SleepHealthManage.indd 1 13/11/08 08:52:26

EHM. What have been some of the highlights of

your career so far at the association?

JB. I became the APTA’s CEO in the summer of

2007. In the past year we have had a number of

successes at the APTA that have involved the

board, other APTA leaders, APTA members and

staff, including the successful development of a

strategic plan for the association as well as the es-

tablishment of a strategic planning and thinking

process; completion of reviews for all of the de-

partments at the APTA, including reviews of our

initiatives, our processes and our staff structure;

the development of a comprehensive membership

recruitment and retention plan; and the develop-

ment of a comprehensive communications plan.

EHM. Last year the association was selected for

the third successive time as one of the Top 60

Great Places to Work by Washingtonian maga-

zine. What makes the APTA stand out in this way?

JB. This was the third time the APTA was chosen

for this recognition and I can tell you why in one

word: staff. I am truly proud to be part of an award-

winning team of hard-working people who are

dedicated to helping each other succeed at what

we do best – providing quality service to our mem-

bers. The APTA strives to provide the best possible benefits and work en-

vironment for staff, which includes unique offerings like weekly yoga

sessions, subsidized gym memberships and onsite health screenings.

EHM. What have been some of the biggest developments in physical ther-

apy practice over the last few years?

JB. The practice of physical therapy has grown and changed as technology

and healthcare needs change. With advances in medicine and improved

technology used to save lives, physical therapist practice now assists in

improving/restoring function and movement and reducing pain. For exam-

ple, with new technology that enhances the survival of premature infants,

physical therapists are involved early in the infants’ life to minimize devel-

opmental delays and provide education and training to the family.

As healthcare needs change, physical therapist practice adjusts to

meet patient/client needs. For example, physical therapists play an im-

portant role in safe and active aging through prevention, mitigation of

health conditions and rehabilitation after disease or injury in the growing

population of older adults who are actively aging and those who are living

with chronic conditions. Other growing areas of physical therapist practice

that have seen advances include fall prevention,

bone health, cancer rehabilitation, physical activi-

ty/exercise, women’s health and wound care.

Finally, enhancements have been made in

bridging education, practice and research to make

research evidence readily available for students

and clinicians. This continues to advance practice,

providing safe and quality of care to our patients

and clients.

As a result of their education and clinical

preparation, physical therapists have emerged as

independent and autonomous practitioners.

Patients are able to have physical therapists eval-

uate their conditions without a referral in all but

two states, and Medicare has significantly reduced

requirements for certification and recertification of

plans of care.

EHM. Please tell us about the K12 awards.

JB. One of the most exciting occurrences in physical

therapy research is the awarding by the National

Institutes of Health of two K12 awards to consortia

comprised primarily of physical therapists. The K

awards are a mechanism used by the NIH to advance

the careers of junior researchers by providing fund-

ing to institutions to mentor new investigators.

The current corps of K12 scholars represents a broad range of research

interests. Topics such as stroke, pediatric conditions and low back pain are

being studied under the guidance of a mentor. In addition, basic science

questions are being studied, such as the use of stem cells to regenerate

muscle cells. Through the awarding of the K12, we can be assured that the

upcoming cadre of physical therapist rehabilitation researchers will be very

productive.

EHM. CareerBuilder.com recently included physical therapist and physi-

cal therapist assistant professions in its 30 Top Jobs in 2008. Why would

you recommend these areas as a career?

JB. These rankings simply reflect what we have always known. Physical

therapists and physical therapist assistants are highly motivated and ful-

filled healthcare providers. Their satisfaction stems from improving quali-

ty of life for patients. It's gratifying to see the profession receive the

recognition it deserves, and I am confident that we will continue to recruit

the brightest and the best.

In an effort to show students what it is like to have a career in phys-

ical therapy, the APTA recently developed an 11-minute video titled, ‘You


Helping the nation stay physically activeEHM talks to John Barnes, CEO of the American Physical Therapy Association,about the effects of advances in technology and changes in healthcare needs onthe physical therapy profession.

“Another challenge in physicaltherapy practice is addressing

the needs of diversepatients/clients in response to

known health disparities withinour healthcare system”

PHYSICAL THERAPY

BARNES 2:31MAY 19/11/2008 16:15 Page 56

Can Be Me,’ which can be viewed on the American Physical Therapy

Association’s website at www.beapt.org. The video features physical

therapist and physical therapist assistant members of the APTA who rep-

resent various physical therapy practice settings, as well as individual

interviews with PTs and PTAs.

EHM. What effect will the aging population have on the need for physical

therapy?

JB. As the population ages and people remain active, the demand for phys-

ical therapist services will continue to increase. As with all healthcare pro-

fessionals, payment issues are a continual challenge. But we are committed

to meeting these challenges by striving to provide effective care to improve

the quality of life for many people.

The provision of quality physical therapist services is an issue that the

profession is confronting. As the population ages, there will likely be a

much larger demand for our services. This demand is not restricted to an

elderly population; advances in healthcare have increased the number of

potential pediatric patients as well. The APTA is working on a number of

initiatives to deal with this workforce issue.

We are in the process of creating a model that will project physical ther-

apy workforce requirements into the future. We also continue to work with

other healthcare policy-makers to ensure that there is adequate support

for expanding the physical therapy workforce to meet the demands of the

US population.

EHM. What other challenges exist for those entering the profession?

JB. Another challenge in physical therapy practice is addressing the

needs of diverse patients/clients in response to known health dispari-

ties within our healthcare system. The profession needs to continue to

work to increase the number and diversity of qualified applicants to

physical therapy programs as well as further expand the number and di-

versity of qualified academic faculty and clinical educators who serve

as role models and mentors for future physical therapists and physical

therapist assistants.

As the cost of higher education continues to increase at the same time

as the level and availability of scholarships, grants and loans are decreas-

ing, this raises significant concerns regarding the level of debt that students

take on in completing their physical therapist and physical therapist assis-

tant degrees. This may be a potential deterrent for some to enter physical

therapy or any health profession.

EHM. What are your hopes for the association in the future?

JB. It is my hope that the American Physical Therapy Association will con-

tinue to do all it can to live up to our recently adopted Association Purpose.

The APTA exists to improve the health and quality of life of individuals in

society by advancing physical therapist practice.

We will do this by continuing to get better at the work we do on behalf

of the members of the APTA and supporting them as they continue to pro-

vide high quality physical therapy care for their patients. n

BARNES 2:31MAY 19/11/2008 13:18 Page 57

According to the latest report on the healthcare sector from

PricewaterhouseCoopers, HealthCast 2020, there is

growing evidence that the current health systems of na-

tions around the world will be unsustainable if un-

changed over the next 15

years. Globally, healthcare

is threatened by a confluence of powerful

trends – increasing demand, rising costs,

uneven quality and misaligned incentives.

If ignored, they will overwhelm health sys-

tems, creating massive financial burdens

for individual countries and devastating

health problems for the individuals who

live in them.

It is time to look outward. The attitude

that all healthcare should be local is danger-

ously provincial and, in extreme cases, xeno-

phobic.Thedayswhenhealthcaresectorsoperate in silosmustend.Newso-

lutionsareemerging frombeyondtraditionalboundariesand innovativebusi-

ness models are being formed as healthcare becomes globalized. These

solutions are changing theway the Chinese think about financing hospitals,

Americans recruit physicians, Australians re-

imburse providers for care, Europeans em-

brace competition, and Middle Eastern

governments build for future generations.

In aworld inwhicheconomiesareglobal-

ly interdependent and the productivity of na-

tions relies on the health of its citizens, the

sustainability of theworld’s health systems is

a national competitive issue and a global eco-

nomic imperative. Moreover, there is amoral

obligationtocreateaglobalsustainablehealth

system.The stakes couldnot behigher.

SustainabilityThe idea of sustainability is subject to

many interpretations. It is oftenused

in the context of environmental

protection and renewal of

natural resources. One

Creating a


The latest health industry survey from PricewaterhouseCoopers’ HealthResearch Institute, finds that dramatic change is needed world wide if we areto create sustainable health systems.

SPECIAL REPORT

In HealthCast 2020, PwC looked at the

responses around the world to the

globalization of healthcare and efforts to

create a sustainable health system,

highlighting best practices in innovation

and shares insight and lessons learned

from around the world.

The research included a survey of

more than 580 executives of hospitals

and hospital systems, physician groups,

payers, governments, medical supply

companies and employers from around

the world in 27 countries

sustainable future

PWC ED NEW:31MAY 19/11/08 15:39 Page 58

comprehensive definition can be found in Paul Hawkin’s book, The

Ecology of Commerce: “Sustainability is an economic state where the

demands placed upon the environment by people and commerce can be

met without reducing the capacity to provide for future generations.”

This definition applies in profound ways to healthcare. At the current

rate of consumption and at the current level of thinking, the healthcare or-

ganizations of today will be unable to meet demand in the future. Our

health systemswill be unsustainable.

Beginning in 1997, health spending has been acceleratingasapercent

of gross domestic product (GDP) amongOrganisation for Economic Co-oper-

ation and Development (OECD) countries. In 2002, the cumulative health

spendingof24OECDcountrieswas$2.7 trillion.PricewaterhouseCooperses-

timates that health spending forOECDcountries will more than triple to $10

trillion by 2020.

Healthcare organizations and governments around the world are ur-

gently seeking solutions to temper costs while balancing the need to pro-

vide access to safe, quality care. Yet, conventional approaches are failing,

even in the most advanced nations of the world – throughout Europe, in

Asia, and theMiddle East and in Australia, Canada and the United States.

Because they are often viewed as a local industry, healthcare organiza-

tions haven’t exchanged ideas globally asmuch as other industries such as

manufacturingandservices.Whileeachcountry facesuniquehurdles– regu-

latory, economic, cultural – thechallenges they faceare remarkablysimilar. In

their responses, common themesare emerging.

Despite the complexity of the challenges that the healthcare industry

faces, successful initiatives – often involving technological innovation, pre-

ventive care and consumer-focused business models – are occurring in

many places.

FindingsFuture health spending is expected to increase at amuch higher level

of growth than in the past. By 2020, healthcare spending is projected to

triple in real dollars, consuming 21 percent of GDP in the US and 16 per-

cent of GDP in other OECD countries. Nearly half of healthcare execu-

tives from 26 countries believe healthcare costs will increase at a

higher rate of growth than in the past. Executives in areas with high popu-

lation growth (for example, the Middle East and Asia) were more likely to

say that healthcare costs would accelerate, but more than half of US and

Australian executives also said that costs would exceed previous growth

rates. Governments, hospitals andphysicians are seen as having the great-

est opportunity to eliminate wasteful spending in healthcare.

There is wide support for a health system with shared financial risks

and responsibility amongprivate andpublic payers versus thehistoric cost-

shifting approach.Only aminority of industry leaders in theUS, Canadaand


Collaboration. Payers, hospitals, physicians, and

community service organizations are working together

to foster standardization and adoption of technology

and process changes.

Consumerism. Providers are reorganizing themselves

in a patient-centric continuum through care

management approaches. Payers are developing

consumer-oriented benefits plans.

Technology assessment and dissemination. Payers,

providers and community organizations are coming

together on a regional and/or national basis to establish

infrastructure and communications standards.

Transparency. New payment and reporting methods

are emphasizing safety, performance and accountability

for health organizations across all industry sectors.

Portfolio management. Hospitals, pharmaceutical

companies, life science organizations, and payers are

increasingly called upon to manage their service

portfolios in a balanced, fiscally responsible manner.

Manpower management. New models of developing,

recruiting and retaining manpower are developing to

address the root causes of gaps in service and

impending future needs.

GLOBAL SOLUTIONS FOR ASUSTAINABLE HEALTH SYSTEM

Europe think that a sustainable system is one that is mostly tax-funded.

More than 75 percent of respondents believe that financial responsibility

should be shared. Even in systemswhere healthcare is primarily tax-fund-

ed, such as in Europe and Canada, only 20 percent of respondents favored

that approach.

Universally, health systems face challenges to sustainability around

cost, quality and consumer trust. Transparency in quality and pricing was

identified bymore than 80 percent of respondents as a contributor to sus-

tainability. Respondents’ opinions regarding who is making the most

progress in improving quality vary by locale. In the US, patient advocacy

groups rated first, while in Europe andCanada, physicians rankedhighest.

“By 2020, healthcare spending isprojected to triple in real dollars,consuming 21 percent of GDP in the US”


In the Middle East, Australia and Asia, government was viewed as making

themost progress.

Preventive care and disease management programs have untapped

potential to enhance health status and reduce costs, but require support

and integration across the industry for their benefits to be realized. Themost

effectivemeans of demandmanagement, according to the survey, are well-

ness, immunizationanddiseasemanagementprograms.Thevastmajority (75

percent) of respondents viewedwaiting lists as an ineffectiveway tomanage

demand.Yetonly26percentof respondents thoughtgovernmentandprivate

initiatives promoting better health had been effective and only 33 percent

thought educational andawareness campaignshadbeeneffective.

Interest in pay-for-performance and increased cost sharing is soaring.

Industry leaders expect tremendous growth in consumer-oriented pro-

grams.Only 35percent of respondents in the survey said hospital systems

are prepared to meet the demands of empowered consumers. But a large

majority (85 percent) of organizations surveyed has initiated pay-for-

performance initiatives, above the 70 percent who had started such pro-

grams in 2002. Forty-three percent of respondents said that direct cost

sharing by patients is an effective or very effective method to manage de-

mand for healthcare services.

Information technology is an important enabler in resolving health-

care issues when there is systemwide and organizational commitment

and investment. The vast majority of respondents viewed IT as impor-

tant or very important to integrate care (73 percent) and improve infor-

mation sharing (78 percent). But IT is not a solution in and of itself. A

smaller percentage saw IT as important or very important for improving

patient safety (54 percent) or restoring patient trust (35 percent).

ConvergenceGlobal and industry-wide convergence is occurring as best practices

are shared and the lines becomeblurred amongpharmaceuticals, life sci-

ences, providers, clinicians and payers in the provision of care, access

and safety. It is time that health systems – hospitals and physicians,

public sector agencies, governments and other commercial health-re-

lated entities – view the benefits of working together and connect by

formal partnership or informal business affiliations to deliver health

services to consumers.

How, specifically, are various health systems addressing the need for

sustainability? The study found that some solutions will require far-reach-

ing changes in national policy. Policy solutions can be influenced – but are

notmade – by themanagers of healthcare organizations. Other areas over

whichmanagement has some ability to effect change are plentiful and are

driving solutions.

According to the report, at the broadest level, these are the issues fac-

ing health systems across the globe, and transferable lessons are emerg-

ing. The variety is astounding yet so are the commonalities. Around the

world and across all sectors of the industry, healthcare leaders are explor-

ingmany of the same solutions. �



The technology of healthcare is adapt-

ing and advancing at a remarkable

rate, and the need for effective com-

munication and engagement with pa-

tients, doctors, and allied health

professionals has never been greater. Consumers

today are bombarded with messages about the

latest advancements in pharmaceutical and clini-

cal technology, while their financial responsibili-

ties are increasing as insurance plans are

redesigned to stimulate a consumer driven envi-

ronment. Doctors and allied health professionals

are feeling thesameinformationoverload,as their

ever-increasing timecommitments arestrainedby

the need to keep pace with rapid advancements

and the urgency to respond effectively to patients

seeking informed care.

While consumers and doctors wrestle with

information overload, hospitals continue to

wrestle with increasing costs and the challenge

of adapting to the changing market where they

now face competition from previously non-ex-

istent healthcare retailers, specialty hospitals

and clinics. Device manufacturers and phar-

maceutical companies have to adapt their en-

tire go-to-market strategies due to changes in

regulation surrounding how they communi-

cate their product’s value proposition to con-

sumers, and more importantly, physicians and

hospitals. The risk in this environment is hav-

ing the best products or services to offer and

being unable to be heard above the noise.

The traditional response to this would be

more – more investment in TV advertising, more

print advertising, more direct mailing. The chal-

lenge here is that while baseline costs continue to

increase, it is unlikely that there are more re-

sources available to pour into marketing. Even if

youwereable to increaseyourmarketingbudgets,

it’s unlikely that you would see any improvement

– if you could measure the effectiveness of your

campaigns at all.

Remember the information overload; there

are simply too many options available, and to be

successful, healthcare marketing mustmove from

a focus on impressions to engagement. It means

getting targeted. Rather than blanketing a market

with a generalmessage,sendmultiplemessages,

each one tailored to a specific audience you wish

to engage. It means making your marketing ac-

countable; being able to tie patient volume or in-

creased product sales directly to specific

marketing events. It means building relation-

ships, not awareness.

Traditional marketing won’t pro-

vide the medium you need to de-

velop relationships. Look to the

web to provide you with the ac-

cess and the platform you need to

communicate more targeted mes-

sages to your audience. This doesn’t solve the

information overload, but the solution to cutting

through the noise is to have information that the

consumer or physician trusts and is relevant to

their immediate needs. Get their attention with

targeted messaging, and then keep it by back-

ing it up with content that solves their need to

find relevant information.

The web also offers an economical alter-

native to less effective traditional forms of mar-

keting. For roughly the same price as producing

and airing a regional television ad campaign that

delivers only your tag line in 30-second bursts to

a random and largely irrelevant audience, you can

develop an on-demand, interactive environment

where a more highly targeted audience can learn

about your product and service offerings, assess

their needs, discover their treatment options, and

even make an appointment.When they want and

where they want.

Web-based solutions allow you to extend

your offering to fit the needs of your audience,

and is an incredibly accountable form of mar-

keting. Well-designed campaigns can provide

you with feedback immediately on what’s work-

ing and what needs to be adjusted, and the data

collected can be used to determine the ROI of

your efforts. As you evaluate your marketing

strategy and budgets for the coming year, do not

overlook the web, and as you make trade-offs,

consider shifting investment from traditional

marketing to an interactive, online, engagement-

driven strategy. Once you begin, you’ll quickly re-

alize the benefits of not just communicating to

your customers, but interacting with them. �

Moving your marketing online

ASK THE EXPERT

Peter Gailey is President and Co-

Founder of OR-Live. He has over 25

years of experience developing

interactive video communications

solutions, and for the past eight

years has been working to establish

OR-Live as the trusted source for

relevant, high quality surgical video

and clinical content on the internet.

BY PETER GAILEY

OR-Live:31MAY 19/11/08 15:27 Page 61

The nextgeneration of breastcancer treatment


New techniques in breast cancer treatment mean women can undergosurgery with much less trauma. Mehra Golshan, Director of Breast Surgeryat the Dana-Farber Cancer Institute and Brigham and Women’s Hospital,brings EHM up to speed.

WOMEN’S HEALTH

Golshan ED:31MAY 19/11/08 15:34 Page 62

Breast cancer treatment has comea long way since the days of the rad-

ical mastectomy. Today, women are offered more treatment options

than ever before. Much of this improvement is down to more tar-

geted techniques, as Mehra Golshan, Director of Breast Surgical

Services explains.

“Surgeries are becoming less and less invasive. Thismeans smaller resections,

morework on cosmetic results and outcomes. In the past, around 60-80 years ago,

they used to do a radicalmastectomy. Thiswas a verymorbid procedure; it removed

the nipple, areola, all the breast tissue, it took muscle off the chest wall, a lot of

lymph nodes, and it left the woman very debilitated.

“After thiscamemodified radicalmastectomies and thenbreast conserving ther-

apy, such as a lumpectomy or quadrantectomy, and now we’re looking at ablation

techniques, or if a woman still has to have a mastectomy, we do what’s called skin

sparing or nipple sparingmastectomies. The surgeon leaves all the skin, sometimes

even the nipple and areola behind, and uses the remaining tissue as a shell. The re-

constructive surgeon then fills that in with options, such as an implant, muscle and

skin fat, so from the outside, you really can’t even tell that the woman even ended

up having surgery.

“Drug therapy is becoming more targeted, meaning that it’s not just trying to

globally kill cancer cells and sometimes normal tissue in kind of an uncontrolled

fashion; instead it’s finding a specific target andmedicating it, thereby avoiding tox-

icity to the other parts of the body.

“Within imaging,with improvements in technology,we’removing away from just

the standardmammogram to the digital mammogram, which gives a better picture

of the breast, especially in younger women and those with dense breast tissue.

There are programs such as computer aideddiagnostics, which operatesmost com-

paratively like a second eye looking at themammogram, after the radiologist.”

DiagnosisNone of this improved treatment does any good, however, if women aren’t di-

agnosed properly in the first place. Golshan explains that in the United States and

much of theWestern world, the standard of care is still mammography or a breast

mammogram,which ismostly done in this country as a baseline between the ageof

35 and 40, and then yearly once a woman turns 40, as long as they’re otherwise

healthy. He points out thatmore recently there have been attempts at otherways of

looking at the breast. The most notible is called breast MRI, whereby a dye called

gadolinium is injected through an IV, andmultiple pictures are taken of the breasts.

This displays amuchdifferent view from that of amammogramandprovides another

way of looking for abnormalities, andmore specifically, breast cancer.

“An MRI is more sensitive than mammography, but it’s moderately specific,”

Golshan says. “Sometimes it can find abnormalities, but it can’t always accurately

distinguish good frombad. Awoman should be alerted to the fact that when an ab-

normality is foundonMRI, that doesn’t necessarilymean shehas breast cancer, and

the likelihood is that therewill bemore pictures andworkup done.Most of the time

it doesn’t end up being breast cancer, so the groups that the MRI is used for are

those who are at very high risk of developing breast cancer.

“There is a population of womenwhohave genemutations, specifically BRCA1

and 2; that’s about seven percent of breast cancers in the United States. These

women, through a genetic mutation, have anywhere from a 60-80 percent chance

of developing breast cancer over the course of their lives, which is why we recom-

mend breast MRI for them, because it might help us to find a cancer earlier. There

are some other high-risk groups that we discuss this with also.


Mehra Golshan is asurgical oncologist andDirector of Breast Surgeryat the Dana FarberCancer Institute and theBrigham and Women’sHospital. He leads agroup of a dozen breastcancer surgeons andhelps oversee and effortin delivering multi-disciplinary breast cancerto several thousandwomen each year.


IntactMed.indd 1 13/11/08 08:48:29

Golshan explains that there are others ways of looking at the breast,

including scinto-mammography andmolecular imaging. These techniques

are being investigated, but researchers don’t yet know how well they will

end upworking, although there have been some interesting studies done.

“Ultrasound has also been around for a while as a screening test. It’s

not very good because it’s operator-dependent and hasn’t had a lot of

success here, although in Asia, specifically Korea, Japan and parts of

China, there’s actually a fair amount of work that has been done using ul-

trasound this way.”

TreatmentOnce a woman is diagnosed with breast

cancer, there are a number of paths through

treatment. If a woman needs a mastectomy,

she will not only see a surgeon and a medical

oncologist but also a reconstructive surgeon.

She will also have her slides reviewed by our

dedicated breast pathologist. The dedicated

breast imagers or radiologists will look at her

pictures, and then the doctors will come up

with a plan for treatment.

“Somepeoplecomeandgetanopinion from

us andgohome,” saysGolshan, “but themajori-

ty will come in for second or third opinions from

around New England, other parts of the United

States and overseas. So we’re always thinking

abouthowwecanmoreeffectively deliver breast

cancer care to awomanwho’s diagnosed.

“One exciting area at themoment is preop-

erative therapy. This involves giving medication

before surgery, whether by IV or by mouth, to

shrink the cancer and facilitate the surgery that

would be necessary afterwards. Most women

who have breast cancer will see a surgeon be-

fore undergoing an operation, and then see an

oncologist who will look at the results of the surgery. The oncologist will

then say whether they need chemotherapy or not, or a medication like ta-

moxifenor an aromatase inhibitor. Yougive them thismedication andhope

that the cancer doesn’t come back.”

Golshan notes that thealternativeof targeting thebreast cancerbefore-

handmay one day lead to targeted therapies tailored to the patient’s cancer,

a typeof personalizedmedicine. “If you can tell that the cancer is sensitive to

a specific type of therapy, it results in faster, more accurate treatment. A sur-

geonmaygiveapatientone typeof therapyandshemaynot respond,andso

ifwecan identifywhothosenon-respondersareearly,wecanchangethemed-

ication andprovide themwith newordifferent treatment.

“We biopsy the tumor while they’re on therapy. There are people cur-

rently undertaking genomic studies to see what genes are turned on and

off by the type of therapy that they’re given. Hopefully within a decade,

treatmentwill progress so awoman can come in and have her tumor biop-

sied, thenwewill do genetic studies on it andbe able to say this is the type

of formula you need for your treatment. The future is tailored therapy for

breast cancer,” Golshan adds.

Preoperative therapySo, howwill preoperative therapy change the surgical procedure itself?

“Previously, a woman would enter surgery with a large mass in her breast

and be treated with amastectomy.With preoperative therapy, we are able

to shrink the tumor, and for a significant number of women, we can then

change the treatment fromamastectomy to a lumpectomy,which is amuch

lessmorbid procedure,” explains Golshan.

“With a lumpectomy, the woman keeps her breasts intact. The inci-

sions are usually very small, and the cosmetic results are generally very

favorable. There’s also work being done on an ablation technique,

whereby the tumor is destroyed by a choice of laser ablation, radio fre-

quency ablation, cryo-ablation or focused ul-

trasound oblation where you either kill the

tumor or shrink the tumor with a small incision

or no incision. This allows the woman to avoid

having surgery altogether.”

Early detection in breast cancer remains at

the forefront of Golshan’s idea of patient care.

“The main question we continuously ask our-

selves as surgeons is how can we treat the can-

cer better, can we operate better, or if you’re

going develop a breast cancer, can we catch it

earlier?” He notes that some of the work is done

in the genemutation group of thosewhohave in-

herited apredisposition to breast/ovarian cancer.

“If we can identify those patients before the be-

ginning of the cancer’s development, surgeons

can either start screening much earlier than the

average woman or consider prophylactic surgery

as treatment. This is called genetic counseling

and genetic testing for women who are at high

risk of breast cancer.”

Advancing technology is also high on

Golshan’s agenda, as further improvements of

mammogram imaging can allow for breast MRI

in the younger population or those with very dense breasts, and result

in finding the cancer at a smaller size or at an earlier stage. He adds,

“Prevention remains important. We know there are certain medications

that can reduce the chances of women developing breast cancer signif-

icantly, one of them being tamoxifen, and the other raloxifene.

“Preventative medicines become much more targeted. Breast cancer

is not just one disease process; it can present itself in different ways, and

does not need to result in removal of breasts for all womenwhoare at high

risk. That seems unnecessarily aggressive to me. Preventative medicines

allow surgeons to examine family history, so if the patient says, “Mymom

had breast cancer when she was 40; my grandmother had ovarian cancer

when shewas35,” then youknowyouneed to target this patient differently

from onewith no family history.”

WhileGolshan says it is difficult to predictwhere thefieldof breast can-

cer treatmentwill be five years fromnow, he sees the fieldmoving forward

on multiple fronts towards a significant improvement, particularly in pre-

ventative measures. And that has to be good news for the 12 percent of

American women affected by this serious disease. �


BREAST CANCERSTATISTICSOne in eight American womenwho live to be 85 years ofage will develop breastcancer, a risk that was one in14 in 1960.

2.4 million women living in theUS have been diagnosed withand treated for breast cancer.

It has been estimated that fiveto 10 percent of breast cancercases result from inheritedmutations or alterations inBRCA1 and BRCA2.


Despite 2007 seeing a decrease for the first time in a decade

in uninsured Americans, Larry Gage, President of the National

Association of Public Hospitals and Health Systems, doesn’t

necessarily feel this is a long-term trend. Gage’s primary con-

cern since founding the NAPH in 1981 has been to champion

the cause of the uninsured public and to call for the creation of a universal

healthcare system.

Gage began working in healthcare in the 1970s, helping to develop pro-

posals for national health reform under the Carter administration, which

unfortunately never came to pass.

Gage’s contacts and background with-

in the health industry, such as his work

on the US Senate Health, Employment,

Labor and Pensions (HELP) committee,

did have an influence on US health

policy.

However, the Republican takeover

of the White House and the Senate in

1981 clearly displayed the need for a

separate association for public hospitals. “At the end of the Carter admin-

istration, it was obvious that with Ronald Reagan elected as President and

the Senate becoming Republican as well in the Reagan landslide, I would

have to do something outside of Congress to continue my work,” says

Gage.

Government focusGage founded NAPH in 1981, and has been its President ever since.

“The association was quite clearly and narrowly focused right from that out-

set on government-owned hospitals that provided substantially

higher volumes of care to the uninsured, Medicaid patients and

to the low-income elderly,” explains Gage. He notes the mem-

bers of the association, even today, receive on average around

three-quarters of their patients from those three categories. “So

first and foremost, and by far the most important thing NAPH has

done over the years, is to focus on adequate funding for hospi-

tals and other providers that serve those populations,” he says.

The association originally had only five members. Because

it was such a small association initially, Gage also developed a


With the number of uninsured Americans on the rise, Larry Gage of the NationalAssociation of Public Hospitals and Health Systems talks to EHM’s NatalieBrandweiner about the challenges of working with government to improve ourhealthcare system.

Undercover

NAPH is a private,

nonprofit organization

established in 1981 to

address the major issues

facing public hospitals,

safety net organizations, underserved

communities and related health policy

issues of national priority.

NAPH membership includes more

than 100 of America’s most important

safety net hospitals and health systems.

ADVOCACY

LARRY GAGE:31MAY 19/11/2008 16:01 Page 66

law practice representing public and teaching hospitals, which he contin-

ues today as a partner in the law firm, Ropes and Gray LLP. Since then,

NAPH has grown to include over 140 hospitals, but even now is still rela-

tively small in comparison to many other health associations. Gage’s work

on Senate healthcare committees and in the Executive Branch has provid-

ed him with the background and the contacts to allow this tiny organiza-

tion to impact US legislation.

“We were able to write into those laws in 1981 a requirement that the

federal government and states would provide supplemental payment under

Medicaid programs to hospitals that serve a disproportionate number of

low-income patients,” says Gage.

This supplemental payment has come to be known as the

Disproportionate Share Hospital Payment under both the Medicare and

Medicaid programs. Gage notes that the Reagan administration was reluc-

tant to enforce this, but the influence of both Gage and the association

eventually led to its implementation. “It grew from approximately $500 mil-

lion dollars distributed all over the country to public hospitals in the mid-

1980s, to $17 billion today on the Medicaid side and another $4 billion

dollars through Medicare, as supplemental payments,” he points out.

It has not been easy for NAPH to implement policies for the uninsured.

For Gage. The Disproportionate Share Hospital Payment scheme is the only

federal program of such a size and carries great importance, resulting in

substantial controversy. Gage explains the huge amount of legislative work

the association has faced, and points to its recent disagreement with the

federal government.

Earlier this year, the association decided to take the government to court

following regulations that would have dramatically reduced the payments that

were to be made to public hospitals under the current programs. “We were

successful both in court and in convincing Congress this year to extend a pro-

hibition against the government implementing these various regulations,” ex-

plains Gage. The relationship between NAPH and the Bush administration in

implementing these programs has been one of constant battling.

NAPH has also been successful in influencing government to better

provide for public hospitals. It has helped them get access to hospital mort-

gage insurance and has pushed for the passing of laws that provide gov-

ernmental discounts on drugs for the uninsured. The association has also

done a lot of work over the years on HIV/AIDS since the beginning of the

epidemic, making outpatient-related therapies available.

Partnership impactAlthough NAPH remains a relatively small association, in comparison

with, for example, the American Hospital Association, which encompass-

es approximately 5000 hospitals, Gage says it is influential in its goals and

retains the support of the rest of the industry.

“Those associations look to us when issues relate to the Medicaid pro-

gram or care for the uninsured as the organization to address federal gov-

ernment,” he says. “Just like we look to the American Association of

Medical Colleges to represent teaching hospitals and to take the lead on

graduate medical education and payment methodologies, and others have

looked to us within the hospital industry to represent the low-income pa-

tient.” Gage also notes the role that NAPH plays in linking such associa-

tions with the uninsured, wanting to bridge those gaps within healthcare.

“We’re their principal tie to the hospital industry, or we’re certainly the or-

ganization in the hospital industry that is most likely to be able to work with

them closely on issues related to expanding coverage, because this has

always been our goal, right from the very beginning.”

This year, NAPH celebrates the 20th anniversary of the Safety Net

Award, highlighting nationwide support for those who have contributed

to extraordinary efforts of public hospitals and health systems. “We give

out awards to programs that have demonstrated unparalleled, system-wide

excellence in addressing the needs of underserved patient populations and

that serve as important models of excellence that should be replicated by

other hospital systems across the country," explains Gage. “It’s important

that when you’re in, for example, Harborview Medical Centre in Seattle,

Washington, and a study is being done at Jackson Memorial Hospital in

Miami that you could benefit from, that you know about it. That’s a prima-

ry goal of this program.”


“The US has been stagnant in healthcarefor the last eight years. In 2007, therewere only five states where the numberof uninsured actually decreased, andMassachusetts counted for most of thatwith their new program.”

Larry Gage


“One of the things we’ve done on the quality front is to work with our

members, to create mechanisms for making sure that patients who come

to the emergency room or the trauma center really need those services. It’s

higher quality care, for both the patients who need the emergency room

and for the patient who isn’t an emergency patient who could get cared for

in a primary care setting,” says Gage.

With regard to providing additional resources

for public hospitals, Gage is already in talks with

Congress to bring in health-related provisions fol-

lowing the US election or the return of Congress in

January. “We don’t know whether we’re going to get

traction on that, but we’re certainly laying the

groundwork now for even temporary increased pay-

ments under Medicaid or directly to safety net

providers.”

It is not just financial resources that create chal-

lenges for US public hospitals; there is also a short-

age of physicians and non-physician clinical

specialists, creating a multifaceted problem.

Electoral effectsUnder President George W. Bush, US healthcare

services saw little change and many problems faced

by public hospitals remained unsolved. “The US has

been stagnant in healthcare for the last eight years,”

says Gage. “In 2007, there were only five states where

the number of uninsured actually decreased, and Massachusetts counted

for most of that with their new program.

“We’ve seen a complete lack of any policies to improve the situation

by expanding existing programs. I don’t think any of us expected to see

movement under the Bush administration toward universal coverage or na-

tional health reform, but what’s actually happened in the last two or three

years is a shift from what might have been called benign neglect in the early

years to a more intentional neglect and even reduction.”

Gage says the most prominent example of this is the vetoing of the

effort to extend and expand the State Children’s Health Insurance pro-

gram (SCHIP). “For the first time in the last 10 years we’ve actually

seen the numbers and proportion of uninsured children go up.

And that is a real tragedy because that’s an opportunity

that we clearly are wasting until we can expand that

program,” he explains.

The election campaign was greatly dom-

inated by the economic crisis, and the re-

lated healthcare issues that need to

be addressed. “Insurance coverage

for children needs to be a high and

very early priority, and extending and expanding that program clearly

needs to be an early agenda item for the new President,” says Gage. “We

have to fight further erosion of these programs, especially during the

economic crisis.”

NAPH will continue to play its established role as the voice for the unin-

sured under the new administration, with its goal of expanding coverage

remaining at the forefront of the association’s activities. n

The purpose of the award is to bring NAPH’s members together for

conferences or educational sessions to transfer information and knowl-

edge in one part of the country to another. “Whether it’s developing a

novel primary care system that’s fully integrated with hospital and spe-

cialty services, or developing a novel approach to reaching out to young

males between the ages of 18 and 25, who are at the highest rate of

uninsurance of any patient population, or

organizing a community around addressing

a certain kind of healthcare problem, we

want to see things that can be replicated,”

says Gage.

Rising unemploymentOne of the primary concerns of NAPH

has been to highlight the problems facing

the uninsured. With the numbers of

Americans without health insurance steadi-

ly rising apart form the small drop in 2007,

Gage calls for the enforcement of a new sys-

tem. The current economic crisis is likely to

further increase the number of people unin-

sured, as many US workers have a health

policy with their employers. The unemploy-

ment figure for the US has hit 6.1 percent,

with a prediction from economist and Nobel

Prize winner Paul Krugman that the figure

could rise as high as eight percent.

Gage explains the effect this will have on the association’s public

hospital members, noting the increasing challenges in serving those with-

out health insurance. Since these hospitals don’t always have the capa-

bility to generate their own resources to fund such patients, especially

in the emergency room, resources must be generated from elsewhere.

Larry Gage is President of the National

Association of Public Hospitals and Health

Systems (NAPH), an organization which he

helped found in 1981. He is also a partner in

the law firm of Ropes and Gray LLP, where

he directs a national healthcare law practice

focused on issues related primarily to public

hospitals, Medicaid and the uninsured.

Larry’s government experience includes

serving as Deputy Assistant Secretary for

Health Legislation in the Federal Department

of Health and Human Services and as staff

counsel to the US Senate Labor and Human

Resources Committee.

In 2007, Larry was among the ‘100

Most Powerful People in Healthcare’

according to Modern Healthcare Magazine.


ClientTell.indd 1 14/11/08 14:31:21

Xoft_SP.indd 1 13/11/08 08:54:13


RadiationTherapy (RT) is a critical compo-

nent of cancer treatment; however, tens

of thousands of breast cancer patients

avoid or do not comply with their RT regimen.

Electronic brachytherapy, a new approach to ra-

diation that is driving access to cancer care, is

available for the treatment of breast and en-

dometrial cancers, and is being investigated for

intraoperative applications.

Radiation therapy is a critical componentof

cancer treatment, proven to reduce local recur-

rences and improve long-term survival. It is used

annually to treat more than 1 million cancer pa-

tients. Unfortunately, RT can also affect normal

cellsandcausesideeffects.Thismakesbalancing

the destruction of cancer cells and preserving

healthy tissue critical to effective treatment.

As we’ve seen improvements in the early

detection of cancer, radiation therapy options

have also improved for both external beam radi-

ation and accelerated partial breast brachyther-

apy. The advantage of traditional brachytherapy

as well as electronic brachytherapy is that radi-

ation is applied directly to the tumor site, po-

tentially reducing the dose to healthy heart and

lung tissue that can result when radiation is de-

livered externally.

Increase accessDespite these advances, we know that

thousands of women annually still choose to

have amastectomy instead of pursuing breast

conserving therapies and thousands more pa-

tients do not comply with their radiation treat-

ment. Much of this is based on fear, time,

distance, or difficulty accessing radiation ther-

apy centers.

Electronic brachytherapy (eBx) brings to-

gether the best of external beamand traditional

brachytherapy. This award-winning oncologic

treatment platform is available for the treatment

of early stage breast cancer and endometrial

cancer and is being investigated for intraopera-

tive applications. FDA-cleared for use where ra-

diation therapy is indicated, the Axxent

Electronic BrachytherapyPlatformuses aminia-

turized electronic X-ray source to deliver local-

ized non-isotopic radiation directly to cancer

sites with minimal radiation exposure to sur-

rounding healthy tissue.

eBxcanofferpatientsandcliniciansanumber

of distinct benefits. The delivery of therapywith-

out theuseofa radioactive isotope isasignificant

benefit, becauseElectronic brachytherapy canbe

used in virtually any clinical setting under the su-

pervisionofa radiationoncologist.Byeliminating

the need to deliver treatment in heavily shield-

ed vaults, eBx is designed to help radiation on-

cologists improve access to critical cancer care

and make it available to patients across geo-

graphic and socioeconomic levels.

Improve treatmentDelivering therapy more easily and conve-

niently, Electronic brachytherapy gives physi-

cians and patients a safer and more accessible

radiotherapeutic platform. For example, in the

study, “A dosimetric comparison ofMammoSite

high-dose-rate brachytherapy and Xoft Axxent

electronic brachytherapy,” researchers found

comparable treatment dose volume; however,

there is a significantly decreased dose to adja-

cent healthy tissues with eBx.

Designed to deliver a treatment equivalent

to isotope-based brachytherapy, eBx supports

the growing utilization of accelerated partial

breast irradiation (APBI), reducing treatment

time tofivedays. Buildingonexcellent APBI clin-

ical results, electronic brachytherapy offers pa-

tients a better treatment experience, i.e.

isolation during treatment; reducing anxiety by

enabling clinicians and staff to remain in the

room during treatment – which is not possible

with other forms of radiation treatment.

Expand capabilitiesUnlike traditional brachytherapy sources,

the electronic brachytherapyX-ray source canbe

turned on and off at will. Its unique properties

enable it to be delivered in many clinical set-

tings rather than in traditional heavily-shield-

ed environments. For hospitals that already

have shielded vaults, this provides the ability

tomaximize utilization of vaults for procedures

that can only be performed in shielded rooms.

By enabling radiation oncology centers to shift

whole breast RT procedures and isotopic APBI

cases, this provides a number of benefits, in-

cluding the ability to free up valuable vault

space to enable sites to run multiple proce-

dures in parallel. �

Electronic brachytherapyBy Darius Francescatti, MD, FACS

Darius Francescatti, MD, JD, FACS is an

Assistant Professor of Surgery at Rush

University Medical Center in Chicago.

ASK THE EXPERT

“Thousands of womenannually still choose tohave a mastectomy insteadof pursuing breastconserving therapies”

Xoft1:31MAY 20/11/08 08:05 Page 71


Johns Hopkins medical center’s heart transplant pro-

gram is recognized as one of the country’s leading

centers in the surgical treatment of heart failure. It

has a long history with transplant patients and has

been undertaking these complex operations since

1983. In fact, it was the first hospital in the US to

complete a domino donor transplant in 1987. The

completion of this complex procedure helped put

Hopkins on the map as a center for transplantation.

“The patient in question needed a heart-lung transplant,” says

William Baumgartner, Vincent L. Gott Professor in Cardiac Surgery

at the Johns Hopkins University School of Medicine and the Car-

diac Surgeon-in-Charge at the Johns Hopkins Hospital, recalling the

groundbreaking operation.

“Back in the early days it was believed that the best operation for

a person who needed lung transplantation was to use the heart and

both lungs, even though the heart, in this particular case, belonged to

the recipient with cystic fibrosis. The patient actually had a pretty good

heart. The process involved taking the heart and lungs from a donor;

then the heart and both lungs were transferred into the patient who

had cystic fibrosis. The heart was then taken from the cystic fibrosis

patient and given to the patient who only needed a heart transplant.

The name coined for the procedure was ‘domino donor transplant’.

Baumgartner arrived at Johns Hopkins in 1982, a year after the

first successful heart-lung transplant operation was carried out by

Transplants have been responsible for

saving the lives of those on the brink of

death. William Baumgartner of Johns

Hopkins explains the role his department

has played in mending some broken hearts.

t h e

h e a r to f t h e

m a t t e r

Baumgartner Ed P72-75.indd 72 19/11/08 15:23:33


his friend and colleague, Bruce Reitz, at Stanford University Medical

Center. Following his arrival, Baumgartner set up the Johns Hopkins

heart transplant program, which took a year to develop. “In those

days,” he recalls, “there weren’t any well established transplant

organ procurement centers. We had to develop most of it within

the institution. However, it gave me a great opportunity to immerse

myself in transplantation.” Currently the lung transplant program, led

by Dr. Ash Shah, implants single and double lungs for patients with

end-stage lung disease, with few recipients actually needing heart

and lung transplantation.

Across the country, the number of heart transplants is now rela-

tively static, a trend which is also apparent at Johns Hopkins. Baum-

gartner points out, however, that the center does have a number of

patients who are treated with various new medications, some with

biventricular pacing, and others undergoing fairly standard operations

like mitral valve repair. Still others are treated with surgical ventricu-

lar restoration, a procedure developed by Dr. Vincent Dor in Monaco,

during which patients who have suffered a myocardial infarction have

the scars removed from their hearts, thereby allowing them to pump

blood more effi ciently.

In common with many institutions which have heart failure pro-

grams, under the leadership of Dr. John Conte, Johns Hopkins has

a very active ventricular assist device program for certain patients

who deteriorate while they’re on the heart transplant list. “We use

one of these artifi cial devices to bridge a patient to transplantation,”

says Baumgartner. “If patients decompensate while they’re waiting

Steady hands is certainly a must in cardiac surgery, but what other characteristics make a good surgeon? We asked William Baumgartner, cardiac surgeon in charge at the Johns Hopkins Hospital, for his views.

First, you must establish yourself as someone

who can operate properly and have complete

competency in your operative procedures. A humble

approach to what you do is also very necessary.

Most successful cardiothoracic surgeons are very

hard workers. They’re dedicated to what they do –

taking care of patients. You have to have a certain set

of interpersonal skills – not just with your patients but

with your colleagues.

To get into a leadership position, your focus must

shift from yourself to your colleagues and you need

to be cognizant of the promotion and advancement

of your young faculty. You need to have a certain

inquisitive curiosity about science and what you think

might be the next best operation or the next research

project that might help better the care of patients or

provide an answer to a specifi c question that you have.



for a transplant, we put this in to tide them over. We also have ap-

proval from CMS to use a permanent device for certain patients who

are not transplant candidates.”

Baumgartner keeps in contact with many of his past transplant

patients. He explains how rewarding it is to hear from them about

their progress: “There are a number of transplant recipients who are

still alive between 15 and 22 years

after their operation, whom I still cor-

respond with – they send me cards, or

I see them from time to time. The fi eld

of cardiothoracic surgery is a very

gratifying one where you can really

help patients and, over a period of

time, make a difference in their qual-

ity of life.”

Neurological protectionBaumgartner has conducted stud-

ies into neurological protection in car-

diac surgery, an area of research that

has had continuous funding support

from the National Institute of Health

over the past 15 years. Although he

did all his early basic science work in

the fi eld of transplantation, defi ning

the mechanisms of neurologic injury

fascinates him. “Sixteen years ago,”

he says, “A cardiac fellow by the

name of Mark Redmond arrived at the

department with a keen interest in

neurologic research. We had achieved a certain amount of success

in preserving hearts for transplantation. However, Mark identifi ed

that not much inroad had been made to protect the brain. I agreed

with him that he had a very compelling argument and was something

we needed to look into.”

There is a certain receptor in the brain known as NMDA that

if over-stimulated can cause brain cells to die. Decreased oxygen

causes over-stimulation by one of the neurotransmitters (glutamate).

This pattern of neuronal cell injury is called excitotoxity.

When they began to look up information about NMDA receptors,

Baumgartner was thrilled to fi nd that an expert in this area worked

at Hopkins. “It is one of the amazing

things about this place,” he enthuses.

“There are experts almost around

every door or within every offi ce. Dr.

Michael Johnston is a pediatric neu-

rologist and neuroscientist and was

happy to work with us. That was the

start of it. We now have about a dozen

different collaborators involved in

this research that has been ongoing

for 16 years, and we recently received

NIH approval for fi ve more years.”

“We are trying to fi gure out what

exactly is the mechanism of neuronal

injury. One of them is stroke. This

often happens when a fragment is

dislodged from the heart or aorta that

then causes an occlusion of an artery.

As a result, the part of the brain sup-

plied by the artery dies.”

In addition to stroke, there are

also other subtle changes that occur

in the brain when there’s decreased

blood supply. The center now has a

drug that researchers think might be benefi cial for patients undergo-

ing certain operations and they are about to start a pilot study clini-

cally, based upon this lab work. It will be particularly used in aortic

operations, performed by faculty within Cardiac Surgery led by Dr.

Duke Cameron, Director of the Broccoli Center for Aortic Diseases.

IN A HEARTBEAT Some cardiac surgery innovations from Johns Hopkins

In 1944 doctors at Johns Hopkins performed the surgery that

opened the door to today’s heart surgery. Working together, the

Johns Hopkins Hospital’s chief surgeon, Dr. Alfred Blalock, and

pediatric cardiologist Dr. Helen Taussig devised a means for

improving the fl ow of oxygen into the blood by connecting one of

the heart’s major arteries with another feeding into the lungs.

Known as the Blue Baby Operation, it brought relief to a

young girl plagued with a combination of heart defects that kept

her blood so starved for oxygen that her skin was literally blue. In

time the procedure not only helped save the lives of thousands of

similarly affl icted children around the world, but also opened the

door to now-familiar procedures like coronary bypass surgery.

In the 1950s doctors and

scientists at Hopkins developed

the fi rst cardiac defi brillator and

discovered cardiopulmonary

resuscitation or CPR. While

defi brillators today with their metal

paddles are a familiar feature of

hospital emergency rooms and

ambulances almost everywhere,

CPR has been credited with saving

hundreds of thousands of lives.

William Baumgartner



Another area of involvement for Baumgartner is researching

whether stem cells may be an effective treatment for patients who

have neurological injury with cardiac surgery. Although the first

experiments have not been done yet, the team is already gearing

up to apply for another set of funding. This might be particularly

applicable in pediatric heart surgery where stem cells from cord

blood could be grown and infused at time of operation. Dr. Luca

Vricella, Chief of Pediatric Heart Transplantation will be the direc-

tor of this clinical program if the basic research shows promise.

On the horizonThe hopes Baumgartner has for the

department are based upon the missions of

Johns Hopkins to provide excellent and qual-

ity patient care, and to do this through sup-

plying them with cutting edge and innovative

therapies. He is proud that the department is

exploring new ways to treat patients through

minimally invasive approaches and through

different operative techniques like SVR, and

he would like to apply cellular therapy for pa-

tients with heart failure in the near future. “If

you operate on a patient who has heart fail-

ure, maybe it will be possible to harvest their

own cardiac stem cells ahead of time, grow

them and inject them into the heart directly

when you’re operating on the patient for an-

other problem such as a bypass operation, a

mitral valve repair or a ventricular assist device implant.”

Due to the rapid evolution of technology, Baumgartner is opti-

mistic that operations through smaller incisions will become more

viable in the future. Dr. David Yuh, Director of this Program at Johns

Hopkins, has performed several of these procedures with and with-

out robotic assistance. Most importantly, he would like to ensure

that junior faculty members have every opportunity for advance-

ment, so that they can go from assistant to associ-

ate and then to full professor. These opportunities

were readily available to him 20 years ago and he

would like to insure these opportunities continue

for the next generation.

The fi nal mission of the department is to train the

future leaders in cardiothoracic surgery, an area in

which they have already had a great deal of success.

“Two-thirds of our graduates, and we graduate two

a year, go into an academic cardiothoracic surgical

practice,” explains Baumgartner. “Long term, a little

over 50 percent continue in an academic practice,

and about 28 percent of our graduates have become

chiefs of divisions or departments. We hope to be

able to continue to produce the next leaders; it’s a

terrifi c feeling to see how these young kids go on to

do really great things and I’m proud we have had an

input into their education.”

“We’re also now looking at the genomics of this problem to see if

we can more accurately defi ne the mechanism. One day it may be

possible to identify which patients might be more susceptible. This

is an area that is going to take several more years of research, but

it’s where we’re going.”

ChallengesOne of the most frustrating aspects of Baumgartner’s work is

when a breakthrough in the lab does not translate to the patient.

Another challenge for him is how to sup-

port the young faculty that he has on his

staff. “They have bright ideas, but it is

hard these days to obtain an NIH grant.

The budget of the NIH has been flat for

several years. Unless you have prelimi-

nary data, obtaining a grant is virtually

impossible. There has to be some kind of

funding mechanism to provide support for

these young investigators who have really

bright ideas.”

Baumgartner recalls that when he fi rst

started in the fi eld, the reimbursement for

clinical services was such that at the end of

paying all the expenses and salaries, there

would still be enough money left over to go

towards funding new research. He laments

the fact that the reimbursement rate has

been decreased by over 50 percent over the

last 10 to 15 years, so by the time bills and salaries have been paid,

they are almost at a break even point.

“We try to help our young faculty through philanthropy,” says

Baumgartner. “We have grateful patients who are interested in help-

ing us make a difference. We use this money to help our young faculty

develop the preliminary data they need so they then can apply to the

American Heart Association or NIH.”

William Baumgartner is the Vincent

L. Gott Professor in Cardiac Surgery at

The Johns Hopkins University School of

Medicine and the Cardiac Surgeon-in-

Charge at The Johns Hopkins Hospital. He

is also Vice Dean for Clinical Affairs and

President of the Johns Hopkins Clinical

Practice Association, the organizational

body representing more than 1700 full-time

practicing physicians at Johns Hopkins.

After joining Hopkins in 1982,

Baumgartner reinitiated the medical center’s

heart transplant program, now recognized

as one of the country’s leading centers in

the surgical treatment of heart failure.

IN A HEARTBEAT Some cardiac surgery innovations from Johns Hopkins

In the 1980s cardiac specialists

at Hopkins working with children

developed balloon angioplasty –

inserting a balloon-tipped probe into

the arteries feeding the heart and then

infl ating it to clear blockages. Like the

fi rst open heart surgery pioneered at

Hopkins during the Second World War,

this new technique quickly became a

common procedure for the treatment of

adult heart problems as well.

That tradition of pioneering work

continues at Johns Hopkins

with physicians and researchers

working in almost every fi eld

related to cardiovascular

disorders, from transplant surgery

to prevention. The hospital

receives more federal research

funding than other medical

institution in the country and its

cardiology department has been

specially recognized for its work.


The mission of the Aorta Center, Marfan Syndrome Clinic and

Connective Tissue Disorder Clinic at Cleveland Clinic is to

bring together a multidisciplinary team of cardiology, cardiac

surgery, radiology and vascular doctors and other cardiology

experts to carry out a thorough evaluation of patients using

state-of-the-art diagnostic testing. The clinic also provides on-

going comprehensive care, genetic screening for families of those with ge-

netic disorders such as Marfan Syndrome, and ongoing research and

education to provide patients with high quality and innovative therapies.

Lars Svensson, Director of the center, outlines the role that evolving

technology has played in bringing this high quality care to patients: “We

increasingly rely on very sophisticated computerized tomography scan-

ning. There has been a huge boom in coronary arteries CTA, and we’ve

also been doing a lot of research looking at the aortic valve with CT. We

do this for all our patients for whom we’re planning aortic valve repairs

or bicuspid valve repairs, and it gives us a lot of information about the

function of leaflets.

“For the patients in whom we’re inserting percutaneous valves, which

is a completely new technology, we are also looking at the valve very care-

fully prior to inserting those devices. In some patients, based on the CT

studies of the aortic root, this enables us to say whether this is a suitable

patient for a percutaneous valve or not.”

Repair works


Cleveland Clinic’s Lars Svensson tells EHM about the newtechniques being developed to fix aortic valves.

HEART SURGERY

SVENSSON:nov08 19/11/2008 16:03 Page 76

According to Svensson, the field of endovascular aortic procedures has

grown tremendously, and the center now uses these procedures for every

patient. “We also, as part of that, are able to create computer models of

the branch arteries leading from the aorta; for example, the great arch or

the abdominal visceral arteries. That’s important because with the new en-

dovascular grafts, we can now have specialized endografts built that fit ex-

actly into those arteries, based on the center line of flow models. We can

have these new specialized grafts built with side grafts so it’s much easier

to put them into patients.”

Once these studies have been done, both for the percutaneous valves

and for the thoraco-abdominal grafts, the center’s surgeons can see exactly

which angles are going to be best for fluoroscopic examination of the aor-

tic valve or the visceral vessels. This saves the patients a lot of dye load and

cuts down on radiation exposure, because the settings and angles can be

determined beforehand.

“The challenge has been to keep up with the technologies,” Svensson

says. “Over the last year, we’ve been building what we call our hybrid op-

erating rooms – choosing the best possible equipment and setup for that.

We’re currently putting together the final parts of two hybrid ORs, and we

have space for another four, for a total of six. We see cardiovascular medi-

cine being done increasingly percutaneously in the future, which is why

we’re preparing this now.

“There will be cases where we’ll want to combine procedures. For ex-

ample, we might do a robotic left anterior mammary artery bypass to the

left anterior descending and then do the percutaneous valve. The operat-

ing rooms are built so that we can do both open and fluoroscopic-based

percutaneous procedures at the same time.”

Innovative therapiesPatients with diseases of the aorta, connective tissue disorder and

Marfan Syndrome are an important subgroup served by the center. “We’re

doing most of the mitral valve repairs now with a robot,” Svensson says.

“We do a lot of aortic valve repairs, for which we use minimally invasive in-

cisions. We also have a big practice of patients who have connective tis-

sue disorders like Marfan Syndrome, Loeys-Dietz Syndrome and

Ehlers-Danlos.

“In terms of new developments in this sphere, we have now more

blood tests we can use to screen patients for connective tissue disorders.

We have specific mutations we can detect in patients, for

example, with Loeys-Dietz Syndrome, which helps us in

their management. There’s also a big push to do more aor-

tic research and connective tissue disorders research. I sit

on National Heart and Lung Committees, subcommittees

of the NIH, looking at aortic disease research and specifi-

cally looking at connective tissue disorders. We’re over-

seeing a prospective randomized trial that’s investigating

a drug called Losartan as a method to prevent growth of

the aorta in patients with Marfan Syndrome. We should

have the results from that in a couple of years’ time.”

Svensson explains that one of the biggest improve-

ments in genetic screening in families of those with Marfan

Syndrome has been the production of rapid methods of

looking at a patient’s genes. “We now have automated de-

vices that work very rapidly to search for mutations, and

templates to compare them with, and as part of that, we

now have blood tests we can use in patients who have

these kinds of tissue disorders.

“We still use some of the older methods, for example,

with Ehlers-Danlos patients. We still rely on tissue cultures


Lars Svensson

“One of the biggestimprovements in geneticscreening in families ofthose with Marfan Syndromehas been the production ofrapid methods of looking ata patient’s genes”


Accumetrics.indd 1 13/11/08 08:45:44


our stroke rate is very low, but what we don’t know is what the neu-

rocognitive function is like after these operations, so the results of that

study will be very interesting.

“Another area of prospective study that I’m working with is the per-

cutaneous aortic valve. I’m on the Edwards Executive Committee run-

ning the PARTNER trial, which is a randomized trial between open

surgery versus percutaneous aortic valves either put in through the

femoral artery or through a mini-thoracotomy in high-risk surgical pa-

tients. Patients have to have an estimated risk of death of more than 15

percent to be in the study.

“Another part of the prospective study I’m working on is looking at

Group B patients – patients who are inoperable by conventional means.

Those patients are randomized either to the best medical treatment or

to a transfemoral percutaneous aortic valve. We’ve now randomized 400

patients. The aim is to present the results to the FDA for approval of the

device in the United States. In Europe, the device has a CE mark, so it’s

already available.

“My other area of interest is percutaneous mitral valve procedures.

We have a new device that we’ve used in 60 animal studies, and we’re

now trying it out in patients. It’s what we call a spacer that is put in ei-

ther through the femoral vein or potentially through a small chest inci-

sion into the mitral valve. We’re still doing the research, but it looks

promising as far as treating patients who have mitral valve regurgitation

and are not otherwise candidates for surgery, and we will aim to help pa-

tients who are inoperable by any other conventional means.”

from the skin, but increasingly we’re going to see the genetic information

coming from the blood rather than a biopsy, whether it’s from the aorta or

from the skin.”

Aortic repairAortic valve repair has been tried since the 1960’s, particularly for the

tricuspid valves and the bicuspid aortic valves, but Svensson points out that

success rates in the early periods weren’t very good, and so it was largely

abandoned. “Then Tirone David from Toronto came up with a technique for

managing a tricuspid aortic valve in a patient with a dilated root. The oper-

ative technique was fairly complicated with a lot of scientific formu-

las, and it therefore wasn’t very applicable.

“What I did was modify that and reduce the aortic roots, aortic

valve annulus and sino-tubular junction to what one would expect

in a normal patient based on postmortem studies. We use a nomo-

gram based on a patient’s body surface area to repair the valve, re-

pair the valve leaflets, reduce aortic root size, and create a

neosino-tubular junction that is normal for a patient of that body sur-

face area.

“We’ve done just over 210 of these, and our success rate after

nine years is 96 percent freedom from re-operation. What that means

is that four percent of our patients, one in 25, has needed a repeat

operation within nine years, and at least two of those patients had

endocarditis. Infection is still a potential problem, but when you con-

sider that these are young patients – I operated on one patient this

week who was 22 years old, and another one who was 15 – you don’t

want them to be on warfarin with a mechanical valve if you can avoid

it. We do these repairs and the patients have a lower risk of stroke

and a long-term lower risk of infection, and they don’t have to deal

with issues of being on an anticoagulation.”

Svensson’s team can repair about 90 percent of tricuspid aortic

valves and 80 percent of leaky bicuspids valves; those they can’t re-

pair often have leaflets that have been distorted by calcium. For

those patients with bicuspid valves, the results aren’t quite as good

as the tricuspid valves. In the most recent analysis, the center had a

90 percent freedom from re-operation in 10 years. Svensson points

out that this is also a young patient population, and if this procedure

keeps them from needing a mechanical valve or being on warfarin,

the procedure is very worthwhile.

Research projectsThe recent retrospective studies Svensson has been involved in

have focused on showing the benefits of min-invasive mitral valve repair

versus a standard sternotomy. Patients with minimal invasive surgery

require fewer blood transfusions and recover quicker. In his prospective

studies, he’s looking at brain protection, and in particular at patients

who have complex arch aneurysms and the entire aortic arch has to be

replaced.

“We’ve been randomizing the patients to either antegrade or retro-

grade brain diffusion; antegrade being via the carotids and retrograde

being via the jugular vein. We then do preoperative and post-operative

neurocognitive function – essentially memory tests and IQ tests. We’re

hoping to complete that study toward the end of the year. We know that

The Heart & Vascular Institute at Cleveland Clinic is composed

of more than 130 physicians within cardiovascular medicine,

cardiothoracic surgery and vascular surgery. In October 2008, the

institute moved to the newly constructed Sydell and Arnold Miller

Family Pavilion. This facility will house more than 2000 employees

in nearly one million square feet dedicated to treating

cardiovascular disease.

CLEVELAND CLINIC HEART & VASCULAR INSTITUTE

OVERVIEW 2007

Total patient visits 294,022

Total new patients 8322

Admissions (acute and post-acute patients) 16,351

Total beds 369

Coronary intensive care beds 16

Heart failure intensive care beds 8

Thoracic and cardiovascular surgery intensive care beds 67

Cardiology/vascular step-down beds 278


LifeWatch.indd 1 13/11/08 08:50:39


General outlookSvensson says there has recently been a drop in the

incidence of heart disease, which is most likely related to

better use of antihypertensives, better control of heart

failure and the introduction of the cholesterol statin.

However, recent data suggests this decline in heart dis-

ease in the US may be slowing, particularly in women.

“The other undeniable fact is that the deaths have

been reduced by greater and more rapid intervention in

patients with acute myocardial infarction and stroke,”

Svensson says. “We’re working to reduce what we call

‘door to balloon’ time – the time from a patient showing

up in the emergency department to getting them to the

cath lab to open up the coronary arteries as

quickly as possible; and in the case of strokes,

re-perfusing them. We’re putting a lot of effort

into doing that, but in addition, we also have a

big campaign to get emergency departments to

be quicker at calling us and having us send out

our helicopters to pick up patients.

“When I was doing cardiology many years

ago, we talked about a 20 to 30 percent mortali-

ty rate for acute myocardial infarction, and now

in some areas – for example, the Northwestern

states – they have been able to reduce their mortality rate

for acute myocardial infarction to about 10 percent. There

is some variation across the country in mortality rates,

which is why there’s a big push to rank hospitals, and one

of the ways this is done is through their mortality

for acute MIs and also the speed at which pa-

tients’ coronary arteries are opened up.

“The big picture is that there has been a re-

duction in the incidence of cardiovascular dis-

ease. There are many reasons for that; clearly

the biggest group of patients are the coronary

artery disease patients, and we have new op-

tions for those patients in both prevention and

treatment after acute events, which has result-

ed in better outcomes. There is a debate around

the cost in making this available to everybody, but that’s

for the politicians to deal with.”

Svensson believes that the cost of healthcare will be

one of the major issues facing Congress and the new

President, especially the unfunded costs of Medicare.

“It’s been calculated that in the next 75 years, Medicare

will cost the US taxpayer $35 trillion. That’s obviously a

rough calculation, but it shows the magnitude of the prob-

lem. That’s why politicians must address the issue of how

to reduce the cost of healthcare in this country.”

No easy answer“There isn’t one easy, quick answer to how to do this,

Svensson explains. “The likelihood is we’re going to see

SkeletonThe syndrome affects the long bones of

the skeleton. The arms, legs, fingers and

toes may be disproportionately long in

relation to the rest of the body.

EyesMore than half

of all people

with the

syndrome experience dislocation of one or

both lenses of the eye. Many people with the

Marfan Syndrome are also nearsighted, and

some can develop early glaucoma or

cataracts.

Cardiovascular systemMost people with Marfan Syndrome have problems associated with the

heart and blood vessels. The valve between the left chambers of the

heart is defective and may be large and floppy, resulting in an

abnormal valve motion when the heart beats.

Nervous systemThe brain and spinal cord are surrounded by

fluid contained by a membrane called the

dura, which often weakens and stretches,

then begins to weigh on the vertebrae in the

lower spine and wear away the bone

surrounding the spinal cord.

SkinStretch marks develop on the skin, even without any significant weight

change or pregnancy. In addition, there is an increased risk for

developing an abdominal or inguinal (groin) hernia, where a bulge

develops that contains part of the

intestines.

LungsRestrictive lung disease, primarily due to

pectus abnormalities and/or scoliosis,

occurs in 70 percent of people with MFS.

Sleep-related breathing disorders are

also associated with it.

WHAT ARE THE CHARACTERISTICS OF MARFANSYNDROME?

Marfan Syndrome affects people in differentways. Some people have only mild symptoms,while others are more severely affected.



some saving in costs

from IT. There clearly is

benefit to having pa-

tients on electronic

records and not having

to duplicate testing.

Martin Harris, who is

head of our IT depart-

ment, is part of a na-

tional committee that

is setting the standard

for communication of

healthcare data and

medical records between institutions.

“This will be a privately run organization with the big in-

surance companies such as, for example, Kaiser, the big healthcare groups

or plans like Partners in Boston and Cleveland Clinic healthcare systems,

and input from the big IT companies, including Google and Microsoft. Those

companies will all be part of setting a standard for healthcare transfer in-

formation. This should cut the cost of testing and having a common record,

and the flow of information will cut down on unnecessary testing and waste

in the system.”

Svensson points out that an increase in preventative medicine should

also help to bring costs down. “Preventative care for cardiovascular dis-

ease has been very effective, and I suspect with time, we will see people

having different types of healthcare plans based on their underlying dis-

ease. For example, if you’ve got diabetes, you’ll probably lean towards a

healthcare plan that caters more to wellness for diabetics. Or if you have

liver disease, you might choose a plan that has an option for liver trans-

plantation. Obviously there’s always the problem of adverse selection, but

I think we’re going to have to see more cost containment within the health-

care system.

“In terms of what’s going to happen with healthcare practice in the

United States and how it’s delivered, the days of the private practitioner –

whether it be an individual practicing as general practitioner or family doc-

tor, or an independent functioning cardiac surgery group at the other ex-

treme – those days are numbered. The healthcare situation is becoming

so complicated, and no single person can manage all of that, and increas-

ingly we’re going to see physicians working for big healthcare systems and

in all likelihood being on salaries with various types of incentives. That will

make it easier to organize the healthcare system and regulate it.

“Here at Cleveland Clinic, we are structuring our system into silos of

institutes dealing with diseases. For example, we have our heart and vas-

cular institute, where everybody deals basically with the same problem,

and we talk a lot to each other, and which makes communication easier and

improves patient care. We will see an increase in that type of grouping of

diseases into what is called institutes or centers to deal with those prob-

lems and physicians working more closely and communicating about pa-

tients and offering patients the best possible care.” n

Lars Svensson is an attending surgeon and Director of

the Center for Aortic Surgery and Director of the Marfan

Syndrome and Connective Tissue Disorder Clinic in the

Department of Thoracic and Cardiovascular Surgery at

Cleveland Clinic.

Svensson is board-certified in general, vascular,

thoracic and cardiac surgery. He specializes in adult

cardiac surgery; cardio-aortic and aortic surgery;

minimally invasive mitral and aortic valve surgery; mitral

and aortic valve repair operations; Marfan Syndrome;

peripheral vascular surgery; percutaneous valve surgery;

and the Maze procedure.

He was born in Barberton, South Africa. He received

his training in cardiology and in general surgery at the

Johannesburg Hospital and his training in cardiothoracic

surgery at Baylor College of Medicine and the Cleveland

Clinic Foundation, for which he received a fellowship.

In 2005, Dr. Svensson was named King James IV

Professor of Surgery of the Royal College of Surgeons of

Edinburgh.


Humanscale.indd 1 14/11/08 14:07:33

EHM’s Natalie Brandweiner catches up with Cass Wheeler, current CEO of theAmerican Heart Association, as he prepares for his much-deserved retirement andshares his views on the state of our healthcare system.

FEATURE

Wheeler ED:31MAY 19/11/08 15:49 Page 84

The need to reform our healthcare system is a hot topic among

both physicians and patients. Given the current economic cli-

mate and the ambitious healthcare policies of a newpresident,

the country iswaitingwith batedbreath to seewhat, if anything,

will change.

CassWheeler is closer to this subject thanmost. His 35-yearmember-

ship and 11 years as CEO of the American Heart Association have been

largely driven by his passion to repair a healthcare infrastructure that

he can only describe as hopeless. “When we talk in terms of a health-

care system, that is an oxymoron because it’s not about health, it’s

about sickness; it’s not about care, it’s about money; and it certainly

is not about a system, because a system implies that all parts work to-

gether,” he says.

In timeswhere the riseof thenumber of uninsured people correlates

with increasing unemployment figures, it is healthcare associations that

have the American public as their primary focus. Wheeler’s attempts to

challenge the current system began with an internal reorganization,

calling for a change in the structure of associations in order to combat

the exploits of bureaucracy.


The reorganization of theAHA tookplace in 1997, during his first year

of leadership, when the organization was centralized to become a sin-

gle corporate structure. “This was a move that streamlined many

processes for the organization. It resulted in a significant shift in re-

sources from back office operations to more mission-related activities,

including our educational programs and research funding,” Wheeler

points out.

The streamlining of the AHA through the elimination of back office du-

plication and redundancy allowedWheeler and his executive teamgreater

time in which to make decisions more effectively, capitalizing on opportu-

nities. “In applying business principles, we are looking at what’s sustain-

able, what is keeping our costs down, yet accelerating our growth through

focusing specifically on a few areas, rather than endorsing a scattered and

fragmented system.”

Before joining the AHA,Wheeler was as a stockbroker, a background

that influencedhis adoption of a businessmentalitywithin a non-profit or-

ganization. During his tenure, theAHAexperienced its greatest periodof fi-

nancial growth,with focused revenue streamsproviding a strong return on

investment. “Using business principles, we developed the best practices

and drove them throughout the organization,” he says.

Bureaucratic challengesThe consolidationof theassociation’sstructuredidnotcome without its

challenges. “Making the decision to consolidate 50-plus separately in-

corporated state level non-profit organizations under a single corpo-

rate structure meant setting the bar to make sure this happened with

rock solid execution,” explains Wheeler. With the affiliates all voting in

agreement, the pressure was on for the association to ensure the con-

solidation process occurred with speed and efficiency.

The reform of the AHA’s organizational structure paid off, with a suc-

cessful transition from approximately 50 state organizations to 15 region-

al organizations, and continuing through the decade to now function as

eight. “Aswithmany non-profit and profit organizations, there is a need to

streamline, simplify and reduce internal bureaucracy in order to focus and

be successful externally in achieving yourmission.”

With his impending retirement, Wheeler is set to release a book en-

titled You’ve Got to Have Heart: Achieving Purpose Beyond Profit in the

Social Sector, outlining his strategy for improving the performance of

the non-profit sector through intelligent business strategies. In the

book, he discusses the effectiveness of profit strategies within non-

profit organizations and highlights the necessity of a clear decision-

making framework, successful advertising efforts and a greater use of

savvy technology.

“We’re spending $2.1 trillion ayear on healthcare and we’re notgetting the best care in the world”

Cass Wheeler has been CEO of the American Heart Association since October

1997. He began his career with the association in 1973, at the Texas Affiliate

in Austin, where he became Vice President for Field Operations and later

Executive Vice President. Prior to joining the AHA, he was a stockbroker in

Dallas with two New York Stock Exchange firms and has served on a number

of committees, including the National Health Council and the President’s

Commission on Improving Economic Opportunity in Communities Dependent

on Tobacco Production While Protecting Public Health.


combination of CPR training andautomated external defibrillators, present

now in many public places, have made it possible for even bystanders to

save lives.

Educational insightForWheeler, it is not the remote functioningof scientific advancements

that defines theAHA’s activities but the provision of education for the pub-

lic,which has remainedat the forefront of the as-

sociation’s strategic aims. “The cost savings and

streamlined structure have enabledus todonew

things and implement programs that we had

never imagined earlier, such as our ‘GetWith the

Guidelines’ and ‘Mission: Lifeline’ programs.

Consistency in our statements and healthcare

guidelines has actualized into becoming the

standard for treatment of heart disease in this

country,” he explains.

The ‘I am a Stroke’ campaign, launched in

2003,was one of the AHA’smost effective public

service announcement campaigns, released in

partnership with the Ad Council to raise aware-

ness of stroke in theUS. It starred actors such as

Patrick Dempsey, Don Rickles, Michael-Clarke

Duncan and actresses Sharon Stone and Penny

Marshall, and generated more than $50 million

in advertising value during its first year.

“If you look at the period 2003 through to

2008,wehave launchedseveralotherstrokecam-

paignswith the Ad Council, and these campaigns

have generatedmore than $200million in adver-

tising valueover the last six years,” addsWheeler.

According to independent research conducted to

measure the effectiveness of the campaign on

awareness of stroke, the percentage of survey re-

spondents who feel confident in recognizing the

warning signs of stroke, both in themselves and

others, increasedby tenpercent fromMarch2005

toMay2007.

Most recently, the AHA adopted an Impact

Goal to reduce coronary heart disease, stroke and risk by 25 percent by

2010. “This goal became a unifying vision for the organization, and result-

ed in a better alignment of financial and human resources,” explains

Wheeler. The end result of employing strategies to reach the 25 percent

goal meant evaluating the AHA’s various initiatives and streamlining its

strategies to incorporate those that contribute the most to this reduction,

bringing with it further improvement of the AHA’s healthcare strategies.

Wheeler has also led the association’s charge to reduce death and

disability from smoking-related illnesses. Tobacco use kills more than

400,000 Americans each year and one-third of these deaths are relat-

ed to cardiovascular diseases.Wheeler has been a strong proponent of

the association’s campaign to pass federal legislation to give the Food

and Drug Administration the authority to regulate tobacco products. On

the state and local level, Wheeler has supported AHA advocates in mea-

Wheeler has implemented and redefined the AHA’s strategies to such

principles. The internal structure has been refocused, and the association’s

infrastructure has been realigned. With internal success already behind

him,Wheeler hasbeenable to focushis attentiononexpandinghis reforms

externally into the US healthcare system.

TheAHAhas alwaysplaced theAmericanpublic as its primary concern,

providing accountability for all the dollars its supporters have donated. In

return, the association provides a framework

inwhich education on cardiovascular diseases

can be provided to both patients and health-

care providers, while furthering scientific ad-

vances for treatments.

Technological aidsIn looking back over the last 35 years and

evaluating the most significant scientific

progress, Wheeler notes the progress in drug

discovery and the technologies developed to

make the best medical care possible. “We’ve

made tremendousadvances inultrasoundand

nuclear imaging, along with innovative tech-

nologies in the field of CT scanning and mag-

netic resonance imaging,” he explains. The

rapid growth of arteriographic technology in

the 1960s, and the continued advancement of

ultrasound and echocardiography, brought

the ability to view coronary arteries, heart

valves and muscles, and diagnose disease.

These were important developments, based

on a better understanding of the structure of

the blood vessels and the heart.

“Thirty-five years ago, angioplasty didn’t

evenexist, butwith the evolution of that tech-

nology, including stents, both bare metal

and drug-eluting, we are able to better open

arteries and to minimize the chance of the

recurrence of a blocked artery. Our ability to

control cholesterol and blood pressure lev-

els with effective medications has also been

enormously significant,” Wheeler explains. He also notes the many ad-

vancements due to the establishment of coronary care units (CCUs) in

the 1960s.

“These units combine two simple strategies: one, the clustering of

patientswith heart attackona single hospital unit, where necessary equip-

ment anddrugs are readily available andwhere trainedpersonnel could be

in continuous attendance; and secondly, the training of specialized nurses

to recognize and treat arrhythmias rapidly in the absence of a physician,”

Wheeler says. Research from the AHA’s work within the technological de-

velopment of CCU’s has reported that patients treatedwithin this environ-

ment have an increase of rate of survival. He also notes the significance of

work done in the 1970s and 1980s on defibrillators and the creation of im-

plantable cardiac defibrillators,whichhavebecome the treatment of choice

for patientswith life-threatening ventricular arrhythmias. And of course, a


Nancy Brown has been named the

next CEO of the American Heart

Association, effective 1 January 2009.

Brown has served as the association’s

Chief Operating Officer for the last

seven years. Read the next edition of

EHM for an exclusive interview with

Nancy Brown as she begins her

leadership at the association.


sures to increase cigarette excise taxes, sustain and increase funding

for tobacco control and cessation programs, and pass smoke-free work-

place laws.

Discovery, transfer and processing of knowledge play an important

role in the Impact Goal strategies, along with the entrepreneurial tac-

tics of revenue generation through appropriate customer relationships.

The success ofWheeler’s work within the association has beenmost im-

portantly demonstrated by the AHA reaching its 2010 goals for reduc-

ing heart disease and stroke deaths by 25 percent ahead of schedule

in 2008.

AHA’s Impact Goal success can be at-

tributed to its longstanding commitment to

approaching healthcare reform from theper-

spective of the patient. Most prominent in

Wheeler’s evaluation of significant events

during his 35-year employment is the health-

care reformdebate in the 1990s, inwhich the

association’s Board ofDirectors approved six

principles for access to healthcare. “The de-

bate focusedonpatient access to preventive

services and quality healthcare, as well as

the pursuit of ongoing biomedical research

to further improve the prevention and treat-

ment of cardiovascular disease.”

Six degrees of preventionInSeptember2008, theAHAreleasedand

updated a set of guiding principles which it

called upon the US presidential candidates

and lawmakers to incorporate inhealthcare re-

formplans.Wheelerexplains thesixhealthcare

principles set by the association in alignment

with this,againhighlighting theAHA’sworkon

behalf of thepublic.

“All residents of the United States

should have meaningful, affordable health-

care coveragewith preventive benefits being

an essential component of meaningful

healthcare coverage. Incentives should be

built into the healthcare system to promote

appropriate preventive health strategies,” he

says. He notes that race, gender and geo-

graphic disparities in healthcare must be

eliminated, and that the United States

healthcareworkforce should continue to growanddiversify through a sus-

tained and substantial national commitment tomedical education and clin-

ical training.

Wheeler’s final points stress his individual commitment and passion

for reform of the current US healthcare system, as he underlines the im-

portance of healthcare within legislative policy: “There should be support

of biomedical and health services research, which should become a na-

tional priority, with inflation-adjusted funding for theNational Institutes of

Health to bemaintained and expanded,” saysWheeler.

Influencing policyMerging the AHA’s guiding principles of healthcare with US policy is

paramount to Wheeler’s personal aims. As presiding CEO for over a

decade, Wheeler has championed a radical change from the current

healthcare system, which is based around acute events, to that which

is demanded by today’s increasingly obese society: chronic care.

“What we’ve got to do is shift from a non-evidence-based delivery of

our healthcare, to one that is evidence-based. We need a system in

which we’re not over-treating and we’re not under-treating, but instead

everybody gets the right care at the right

time,” Wheeler says.

According to research by the American

Obesity Society, approximately 60 million

adults are obese, with another 60 million

beingseverelyobese. “Whatwehave isasys-

temthatwasdesignedaroundacutecare,and

now it’s being overwhelmed by chronic dis-

eases,”saysWheeler. “About75percentofall

our healthcare expenditures are now due to

chronic diseases as opposed to acute dis-

eases, yet our system is still based on that

whichwas set up40 years ago.”

Wheeler also points to the incompatibil-

ity of the payment systemwith recent times

and the need to move away from the pay-

ment of providers via a piece rate, as used in

the previous acute system. He believes that

providers should be paid for on a perfor-

mance rate, with inbuilt incentives to

achieve successful outcomes.

Wheeler remains optimistic althoughhe

believes reformation of the healthcare sys-

tem will be a slow and painful process.

“Reformwill never take the shape of whole-

sale change,” he says. “I am encouraged,

however, in that President-elect Barack

Obama has suggested that healthcare re-

form and prevention of diseasewill be a pri-

ority in his administration, andhopefully this

will transfer into a significant change in

2009.”

With our healthcare policy intrinsically

linked to economic policy, theunrolling of re-

form that requires increased spending is un-

likely to occur within the sphere of the current financial crisis. “Certainly

healthcare reform is an economic issue, when we’re spending $2.1 trillion

a year in the United States andwe’re not getting the best care in the world

for that expenditure,” explainsWheeler.

He attributes a lack of reform to a system that is based on corporate

competitiveness, rather than healthcare. “People are unable to afford the

coverage that they need. Forty-fivemillion people in theUS are uninsured,

and we’ve got millions of others who are underinsured,” he underlines.

“We’ve got to change that.” �


1All residents of the United States

should have meaningful,

affordable healthcare coverage.

2Preventive benefits should be an

essential component of

meaningful healthcare coverage.

3All residents of the United States

should receive affordable, high-

quality healthcare.

4Race, gender and geographic

disparities in healthcare must be

eliminated.

5Support of biomedical and

health services research should

be a national priority.

6The healthcare workforce

should continue to grow and

diversify through a sustained

and substantial national commitment

to education.

THE AHA’S SIX PRINCIPLESFOR AN OPTIMUMHEALTHCARE SYSTEM:



killerStalkinga silent

SUH ED:31MAY 19/11/08 15:36 Page 88

The cause of most brain tumors remains a relative enigma, with

sufferers being in the frustrating situationof not knowingwhat is

causing their illness in the first place. Spurred on by the poor re-

covery rates of patients, John Suh, Chairman of the Department

of Radiation Oncology at Cleveland Clinic has spent the past 15

years working with brain tumor patients – not only by helping with their re-

covery and improving their quality of life but by aiming to unearth the ques-

tions surrounding the condition. Recent advancements in imaging and

radiation technologies, and a better understanding of biology have con-

tributed greatly to thehuge strides alreadybeenmade in the area, although

there is still much to be done.

Suh’swork has focused extensively on patientswithmalignant brain tu-

morswhohavehistoricallynot faredwell. “Wenowknowthroughvariousclin-

ical trials and studies that some patients can do better than others through

the incorporation of imaging, biology and radiation technology to help tailor

treatment,” explains Suh. “The use of imaging, advances in radiation deliv-

ery,andsophisticatedcomputerprogramshaveallowedustobetter target ra-

diation to brain tumors thereby minimizing dose to critical structures and

allowing for higher dosesof radiation.”

Research areasGamma knife radiosurgery is another of Suh’s research areas and has

beenperformedatClevelandClinic since January 1997.Theclinic’s facilityhas

been upgraded on four separate occasions, themost recent taking place 18

months ago to the Perfexion model. Unlike the previous versions of the

Gammaknifeusedat the facility, thenewversionusesa robotic table, allows

treatment of lesions throughout the brain, and auto-

matically changes the size of the radiation beam. This

has facilitated treatmentefficiencyandalsoaccuracy for

the patients, as Suh reveals: “As a result, we’ve been

able to treat a greater number of patients in the same

amountof time. It alsoallows for thepossibilityof treat-

ing lesions lower than we could traditionally treat with

the gammaknife.”

Over thepast fewyearsanumberof innovative radiationmodalitieshave

cometothe forefront.Oneradiationtechniquethat theclinichasbeenusing is

transponders and positioning technology to track tumors during treatment

without adding ionizing radiation. The clinic uses the Calypso system for

prostate cancer patients. “We know that the prostate glandmoves during ra-

diation treatment,” explainsSuh. “By implanting thesewireless transponders

totrackthemotionof thetumorcontinuouslywecanminimizethemarginsthat

we need to properly andprecisely treat these patients. This should ultimately

allow foradecrease in radiationdose to thenormal surrounding tissue.”

Another development that has occurred in radiation oncology is shorter

treatmentschedules.Stereotacticbodyradiationtherapywith theNovalisunit,

for example, occurs in one to five treatments, hence the clinic has been able

to treat some of its lung cancer patients and spinal metastasis patients in a

much shorter period of time. “This facilitates patient convenience without

compromising treatmentoutcomes,”highlightsSuh.“In fact, the local control

rates thatwehaveseen forpatientswithearly stage lungcancer treatedwith

three tofive fractionsof radiationhavebeenupwardsof 90percent.”

Group trialsSuh is proud that research has been one of the primary focuses in the

departmentof radiationoncology.Hehasbeen fortunate tobe involvedwith

anumber of in-house, pharmaceutical and cooperative group trials over the

past 15 years. Driven by his interest to provide better outcomes for patients

with brain tumors these trials have focused primarily on patients with ma-

lignantbrain tumors. Other studieshave investigated theuseof a combina-

tion of radiation and chemotherapy or radiation sensitizers for patients. “In

terms of pharmaceutical studies, I’ve beenmostly involved with radiation

sensitizer trials,” recallsSuh. “Theseareagents thataregivenbeforeordur-

ing radiation treatment to enhance the effect of radiation therapy. I’ve been

most involvedwith two compounds:motexafin gadoliniumand efaproxiral.

“Theseareagentsthatwerethoughttoenhancetheeffectofradiationther-

apyandhavebeentestedforpatientswithbrainmetastases.Unfortunately, the

efaproxiraldrugdoesnotappear tohaveactivityagainstpatientswithbrain tu-

mors frombreast cancer. Themotexafingadoliniumagent appears to improve

neurologicprogressionfreesurvival forpatientswithnon-smallcell lungcancer

thathasspread to thebrain.

Suh hopes that theywill be able to perform another confirmatory study

testing the use ofmotexafin gadoliniumwithwhole brain radiation patients

for thosewith newlydiagnosednon-small cell lung cancer.

TheRadiationTherapyOncologyGroup(RTOG)hasbeenanimportantcom-

ponentof the research thatClevelandClinichasperformed forcancerpatients.

TheRTOGisamulti-institutional,multidisciplinarycooper-

ativegroupofover300academicandcommunitymedical

facilities, fundedprimarilybytheNationalCancer Institute.

“It has long been considered a recognized leader to in-

crease survival and improve quality of life for cancer pa-

tients,” says Suh. “Since my research focus has been

primarily for patientswith brain tumors,wehaveenrolled

anumberofpatientswithlow-gradegliomas,brainmetas-

tases,malignant gliomas, andother brain tumorsonto these studies. In addi-

tion, the RTOGhas studies devoted to other disease sites including head and

neck, lung, gastrointestinal, genitourinary, gynecological, andbreast cancers.

Ourgoal is tohaveactiveenrollmentand leadership in theseareasaswell.”

Radiation therapy for brain metastasesIt is estimated that over 170,000 Americans are diagnosed with brain

metastasis every year. It is a relatively unknown disease, since it is a combi-

nationofmanydiseases.Breast cancer represents thesecondmostcommon

causeof brainmetastases.

Recently, Suhhaschairedan internationalphase III studyofwholebrain

radiation therapyefaproxiralandsupplementaloxygen forwomenwithbrain

metastases frombreast cancer. As he explains: “I’ve been involvedwith the

useof thedrugefaproxiralwith thehopeof improvingoutcomes for patients

with brainmetastasis.


Finding a treatment for an illness such as a brain tumor where the causes are often hard topinpoint is a challenge. John Suh of Cleveland Clinic reveals the work the clinic is doing tobetter understand this mysterious and often deadly condition.

It is estimated that over

Americans are diagnosed withbrain metastasis every year

170,000

SUH ED:31MAY 19/11/08 15:37 Page 89


“Basedon someencouraging phase II results, weparticipated in a large

multi-institutional international study testing efaproxiral, which is a reported

radiationsensitizer,plussupplementaloxygenandwholebrain radiation ther-

apy versus whole brain radiation therapy alone plus supplemental oxygen.

The results showed that the subset of patients with breast cancer appeared

to live longer.”

Asaresult, the teamembarkedonacon-

firmatory phase III study of over 360women

fromthreedifferentcontinentswith thehope

ofdemonstrating that theadditionofefaprox-

iral to whole brain radiation therapy would

improve survival for women with brain

metastases from breast cancer.

Unfortunately, the results of the study

demonstratednosurvivalbenefit forwomen

whoreceivedefaproxiral incombinationwith

wholebrain radiation therapy.

Theuseof this radiationsensitizer,which

was thought to increase tumor oxygenation,

did not appear to improve outcomes for

these women. Therefore, the treatment for

womenwho develop brainmetastases from

breast cancer remains an unmet need. Suh

believes it is important that they continue to

support clinical trials to improve outcomes

forwomenwhodevelopthisdevastatingcon-

dition. “Sadly, the survival forwomenwhodevelopbrainmetastasis is under

a year,” he says. “It’s important we continue to investigate how to best treat

thesepatients.”

Theclinic isparticipating inseveralmulti-institutional trials tryingtoeither

improveoutcomesorqualityof life forpatientswhodevelopbrainmetastasis.

The first is a RTOG study testing the use of the drug Namenda in addition to

whole brain radiation therapywith the hope ofminimizing the potential neu-

rocognitive sideeffectsassociatedwithwholebrain radiation therapy.

“We are also participating in amulti-institutional study investigating the

useof stereotactic radiosurgerywithorwithoutwholebrain radiation therapy

forpatientswith1-4brainmetastases”,saysSuh.“Sincewe’reeagerto improve

outcomes for patientswithmalignant brain tumors, our practice has been re-

ally focusedonenrollingpatientsontoclinical trials.”

ChallengesOneof the challenges Suh andhis teamhave faced in radiation oncolo-

gy is how to improve patient care, research and educational opportunities

within the department. Suh explains that due to the size of the department

– which consists of five different centers as well as amain campus facility –

communication, accountability andexpecta-

tions are sometimes hard to permeate

throughout a large enterprise.

“Oneof the challenges I’vehad is send-

ingaclear consistentmessage regarding the

goals about what we’re trying to achieve

here in radiation oncology. These goals in-

cludeprovidingcoordinatedcomprehensive,

compassionate, multi-disciplinary care to

our cancerpatients.Throughbetter commu-

nicationandexpectationswe’vebeenable to

refinehowwegoabout treatingourpatients

whohavecancer.Wehavealsobeen focused

on how to improve the research and educa-

tional aspects of the program to ultimately

improveoutcomesandpatient experience.”

Following these principles has resulted

in improvements in academic productivity,

an improved residencyprogramrankingand

higher patient satisfaction scores. In addi-

tion, thedepartmenthasemployedbusiness

tools such as Fastracs, performancemanagement reviews, and q-boards to

betterdefineourexpectations, closegapsandcreategoalsasadepartment.

Although Suh admits that aspects of the role as chair has been challenging,

it hasat thesametimebeenvery rewarding tosee themanypositive changes

that have occurred by bringing everyone together and emphasizing quality,

innovation, service, and teamwork, which are the four cornerstones of

Cleveland Clinic.

In the future, hehopes to see thedepartmentbecomeoneof the top-tier

radiation oncology centers. “Wewill need to continue to enhance our patient

care,educational,andresearchportfolio tobecomeoneof thetopcenters.This

willultimatelyenhancepatientcare, thequalityandsafetyofourcare,andalso

provideaplatformforthemanydedicatedco-workersseetheirhardworktrans-

late intobetter survival andqualityof life forour cancerpatients.”�

John H Suh is the Chairman of the Department of

Radiation Oncology at the Taussig Cancer Institute and

Associate Director of the Gamma Knife Center at the Brain

Tumor and Neuro-oncology Center at the Cleveland Clinic.

He received his bachelor’s and medical degree from the

University of Miami School of Medicine in Miami, Florida.

He completed his internship, residency, and fellowship at

the Cleveland Clinic, where he was residency program di-

rector from 1996-2002. Suh’s primary clinical, educational

and research interests are brain tumors, Gamma Knife ra-

diosurgery and innovative radiation modalities. He has par-

ticipated in various in-house, pharmaceutical, and

cooperative group trials and chaired an international,

phase III trial of whole brain radiation therapy with efaprox-

iral, a radiation sensitizer, for women with brain metas-

tases from breast cancer. He was recipient of the National

Brain Tumor Foundation Clinical award in 2003.

SUH ED:31MAY 19/11/08 15:37 Page 90

Bioscan.indd 1 14/11/08 14:21:43


B R A I N - W A V E S

A better understanding mental disorders and degenerative diseases such as Alzheimer’s is the basis for research at the neuroradiology department of Johns Hopkins Hospital as David Yousem explains.

Yousem Ed P92-95.indd 92 19/11/08 15:59:41


disease in 2006, according to a study conducted by Johns Hopkins

Bloomberg School of Public Health. Worryingly, the global prevalence

of Alzheimer’s will grow to more than 106 million by 2050. Having been

fascinated by everything centered around the brain and the central ner-

vous system ever since his time as a medical student, Alzheimer’s is an

important aspect of his focus and of those that he mentors.

“One of my goals as a neuroradiologist is to find a test that would

identify relatively early those people at highest risk for Alzheimer’s before

they develop symptoms and before cognitive decline,” he explains. “Even

before patients with Alzheimer’s disease have memory deficits, they

often have deficits with their sense of smell. It

turns out that sense of smell and memory are

very closely collocated in the brain. I was in-

terested in trying to determine whether there

was a way of exploring patients’ sense of

smell through imaging at a point where there

was no clinical evidence to suggest they had a

loss of cognition. I then wanted to determine

whether this would predict whether or not a

patient would go on to develop Alzheimer’s

disease from a young age.”

There are a number of factors that

make people more susceptible to getting

the disease. Genetics is the first of these,

with some people just having a genetic

susceptibility for it and much

work has been done on the APOE

Type 4 allele, which is one of the

genetic factors that may influence

the onset of Alzheimer’s.

Head trauma has also been

linked to Alzheimer’s. “When you

look at a lot of the patients who

have Alzheimer’s, they have had

an event that was related to head

trauma”, identifies Yousem. “We

know this, for example, in patients

who were once boxers and have

become ‘punch drunk’.”

Lastly, the vascular risk factors

for stroke are also increased in pa-

tients with Alzheimer’s disease. If you’re injuring the brain because of

tiny little micro-strokes then this also seems to be a predisposing factor

for development of Alzheimer’s disease.

As the baby boomer generation gets older, incidences of diseases

like Alzheimer’s are likely to put a lot of pressure on the healthcare

system. Already a huge amount of money is being spent on assisted

living for patients who can no longer take care of themselves. As people

Ever since David Yousem arrived at Johns Hopkins his

work has mostly involved mentoring and developing

people in his division. As Director of Neuroradiology

and Professor of Radiology at the hospital his division

consists of 10 physicians and four PhDs specializing in

neuroradiology. However, the Russell H. Morgan De-

partment of Radiology and Radiological Science also

includes a number of groups including a CT group, an interventional

group treating tumors and fibroids of the uterus, and members working

in pediatric imaging, ultrasound, nuclear medicine and tumor imaging.

“We are surrounded by brilliant people on a

daily basis, and the quality of the people in

the clinical realm of neurosurgery, neurology,

neuroscience and psychiatry is just fantas-

tic,” he says. “Johns Hopkins is a wonderful

environment to work in.”

He is particularly proud of his division

members’ achievements and recalls how

several of his faculty members have been

promoted and have gone on to become full

professors. “In the 10 years I’ve been here,

several people have become recognized as

international experts in carotid plaque imag-

ing (Bruce Wasserman), semantic process-

ing (Mike Kraut), molecular imaging (Marty

Pomper), and teaching (Nafi Aygun,

Doris Lin) largely through their own

work and my minimal mentorship.

It’s been most gratifying to see my

people come into their own and be

promoted and get recognition.”

Yousem highlights how clinical

work has virtually doubled in the

past 10 years. The hospital has to

deal with more cases and more pa-

tients are getting scanned than ever

before. This is partly due to an aging

population with a lot more patients

being evaluated for conditions such

as dementia or degenerative spine

disease. “We’ve seen a lot more

patients being evaluated for low back pain or neck pain as they grow

older. In neuroradiology, MRI’s and CAT scans of the spine are part of

the work that we do.

As the incidences of Alzheimer’s disease grow, getting to the

bottom of why some are susceptible to the disease in comparison to

others is a discovery Yousem would like to unearth. More than 26 mil-

lion people worldwide were estimated to be living with Alzheimer’s

David Yousem is currently the Director of

Neuroradiology and a Professor of Radiology at

the Johns Hopkins Hospital. His expertise spans

the full gamut of neuroradiology techniques

including CT, MRI, myelography, sialography,

plain films, CT guided aspirations and biopsies,

functional MRI, diffusion and perfusion imaging,

MR/CT angiography and 3D reconstructions.

He is a noted authority on disorders of the

brain, spine, head and neck, olfaction, cranial

neuropathies and neurodegeneration.

Yousem Ed P92-95.indd 93 19/11/08 15:59:42


emotions, instincts or reactions are processed in the brain. “We can ac-

tually see what part of the brain is activated given a particular challenge

or task,” highlights Yousem. “The functional MRI team at Hopkins, led

by Jay Pillai, can now tell you what part of the gray matter of the brain

is being activated, but the areas of the brain are

connected via the white matter. Over the last

five years, neuroscientists have developed the

techniques to look at the white matter tracts.”

Most of this work has been carried out at

Johns Hopkins by the researcher Susumu Mori

who was one of the first people to develop diffu-

sion tensor imaging (DTI). This allows research-

ers to see the white matter tracts that connect

gray matter areas in the brain. “Due to this

process we are now able to understand much

better how the brain is wired,” explains Yousem.

“This has been really useful because up until

now when neurosurgeons did surgery they’ve been able to avoid the

gray matter areas that are important for speech, motor activity or for

memory. However, they would have trepidation about cutting across

the white matter tracts that connect those areas to other parts of the

brain. Now they can avoid not only the gray matter areas that are critical

to good life function, but also identify the white matter tracts they also

have to avoid. The result is that patients who are having neurosurgery

have much fewer deficits when they come out of surgery.”

Molecular imaging is something that is still in its infancy. This is

the ability to image chemicals that the brain is making or cell surface

markers on the surface of the cells in the brain. Yousem highlights

how this is allowing researchers like Marty Pomper and Dima Ham-

moud to investigate the chemical environment of the brain and to

identify where there is a higher concentration of one particular pro-

tein or chemical in the brain compared to others and how this can be

manipulated with medications to treat disease.

A way with wordsYousem has been credited with injecting humor and fun into the

subject of neuroradiology, which is perfectly exemplified in the book

Neuroradiology: The Requisites, which he co-authored with Bob

Grossman of New York University Medical School. As Yousem admits,

a science like neuroradiology can be a dry subject to cover; therefore

writing a book on the subject that was different and catchy was the ul-

timate aim. As he discusses: “Our goal was to write a book that could

be read cover to cover in sequential order so it was important that it

contained an underlying plot. We achieved this by injecting an under-

lying theme of politics or art history or humor in each of the chapters

so that people enjoyed the ‘story of neuroradiology.’ We also sought

to use the humor, limericks, poems, alliteration as a mnemonic device

for learning differential diagnoses.”

An example that illustrates this technique can be found in his

chapter on brain tumors. Yousem likens each brain tumor to a differ-

ent impressionist artist. For instance, for diseases that spread on the

surface of the brain Yousem compares this to the dripping objects that

are characteristic of the work of Salvador Dali.

live longer their end-of-life expenses in the last two years of their life

just get higher. “We don’t have a handle on prevention of Alzheimer’s,

good treatment for the disease or a lot of the other neurodegenera-

tive disorders. There has been so much research into heart attacks

and atherosclerosis, and we’ve done pretty

well with stroke but on the neurodegenerative

disorders, both in the brain and the spine, we

really haven’t made all that much progress. This

is therefore an area of potential growth.”

MRISome of the most interesting develop-

ments that have been taking place in neurora-

diology techniques include imaging the brain

and mind, with functional MRI being the main

technique used. By using this technology it is

much easier to understand where different

“We are surrounded by brilliant people on a daily basis, and the quality of the people in the clinical realm of neurosurgery, neurology, neuroscience and psychiatry is just fantastic”

PossIble cAuses of ADHD

Significantly low birth weight (very small when born)

Difficulty during pregnancy

Prenatal exposure to alcohol, tobacco and/or drugs

Excessively high lead levels (high levels of lead in your blood stream)

Prenatal injury to prefrontal area of the brain (injured before birth in the front portion of the brain)

Genetic difficulties (this is considered to be the most common cause)

!

Yousem Ed P92-95.indd 94 19/11/08 15:59:43


like vaccinations? We need to get to the bottom of why it is occur-

ring more frequently, and to use either imaging by our pediatric

Neuroradiology team of Thierry Huisman, Aylin Tekes, Doris Lin

and Izlem Izbudak or therapeutic interventions that we can instill

in the brain to reverse these deficits in order to allow our children

to reach their full potential.”

“It’s just shocking to me how many children are

developmentally disabled in America. We should

be able to do something more for these kids.

I hope that through things like molecular

imaging we will be able to iden-

tify the areas of abnormality

and intervene.” n

Not content with keeping his mind active through mentoring, clini-

cal care and research, Yousem is also a keen participant in sporting

pursuits and has completed two marathons, several triathlons, a half

Ironman and a full Ironman competition. He is a keen advocate of the

principles discussed in the book The Seven Habits of Highly Effective

People by Stephen Covey which includes the motto ‘Live, love, learn

and leave a legacy’. Yousem aims to incorporate these ideas into his

own life as he explains:

“When the author speaks about live, he is

referring to the physical world and the things

you do for your body. Love is your emo-

tional and spiritual world. Learn is your in-

tellectual side, and leave a legacy is what

you do for your community and your social

society service.

“I try to follow these by setting goals for

myself with respect to the physical world as far

as competition, exercise and health. I kept pushing

the bar higher from initially completing 10K runs to a half marathon,

then a triathlon, a mini-Ironman and then doing the Ironman. This was

part of my ‘live realm’. As far as the ‘love realm’ is concerned this in-

volved me getting more into religion, meditation and Eastern philoso-

phy. Learning is the process of research and continuing to maintain

my knowledge in my field. Finally, leaving a legacy would include the

volunteer work I’ve done, for example, in Mexico with Mayan tribes,

but also I feel the books that I write are part of my leaving a legacy to

the neuroradiology community.”

future focusAn area that Yousem is keen for his team to focus on in future is

neurodegenerative disorders or learning disorders. He notes that

the incidence of conditions such as Attention Deficit Hyperactivity

Disorder (ADHD) and autism seem to have dramatically increased.

Yousem recalls how when he was growing up the instances of these

disorders were minimal: “It is a weird phenomenon. We don’t know

what is causing this increase – could it be due to the

environment or things

Scientists think that as many as 4.5 million Americans suffer from AD

Alzheimer’s is the sixth leading cause of death

The disease usually begins after age 60, and risk goes up with age

About five percent of men and women ages 65 to 74 are affected

Nearly half of those age 85 and older may have the disease

The direct and indirect costs of Alzheimer’s and other dementias to Medicare, Medicaid and businesses amount to more than $148 billion each year

fActs About AlzHeIMeR’s

Yousem Ed P92-95.indd 95 19/11/08 15:59:53

Developments in clinical imaging have been moving apace. The na-

ture and course of diseases can now be followed at a molecular

level in the human body, and new methods have emerged to make

the development of medicines faster, better and safer.

Paul Matthews, Head of GlaxoSmithKline’s Clinical Imaging Centre (CIC)

at the Hammersmith Hospital campus of Imperial College in London, UK, is

on the frontline of this fast-moving field, as he explains: “We identify the

major compound development targets and then develop imaging strate-

gies to speed the early stages of moving a drug into the clinic, to make it

faster, safer and more likely to succeed.

For example, neuroscience is an area where there are particularly im-

portant applications for positron emission tomography (PET). PET allows

us to image where in the body a tagged molecule goes. With some special

approaches, it helps to image interactions with the drug targets on cells.

“Why is that important? When we try to develop a new drug to treat a

major brain disease, such as schizophrenia or depression, the first big issue


Clinical imaging can now be used to personalize diagnoses and to shed new light onthe relationship between disease pathology and what the patient feels. Paul Matthewsof GlaxoSmithKline talks to EHM about the benefits of these advances to developingnew medicines.

in clinical imagingNew developments

MATTHEW:31MAY 19/11/08 15:33 Page 96

to address is: does the molecule even get to the brain? Movement of mol-

ecules from the blood to the brain can be blocked by the so-called blood

brain barrier.

“Pre-clinical models are not good predictors. To resolve this, we can

simply take themolecule, label it with a positron-emitting isotope and ad-

minister that subject in micro-doses. We can trace where that molecule

moves in the body and literallywatch itmove into the brain anddefinehow

much gets there.

“A secondquestion for PET that follows from this is, does themolecule

actually interact with its target and, if so, with what affinity? Knowing this

allows a rational prediction of active doses.”

Realizing benefitsMatthews points out that in the ‘bad old days’

– beforemany companies started using these tech-

niques – a relatively common cause for the failure

of a drug to move through early development was

that it wasn’t getting to the targeted organ.

“Another practical issue is that if wedon’t know

what dose to give to a subject,weneed tousemany

more subjects in the early phases of drug develop-

ment. This takesmore time and costsmoremoney.

Molecular imaging allows the speeding up of de-

velopment. By limiting the subjects exposed, it is

safer for patients who are involved in the trials and

it delivers higher value in the end.”

PET is not the only imaging method that can

help drive drug development. The CIC also has an

active, smaller group that uses advancedMRI scan-

ning.Matthews emphasizes that to gain confidence

in potential clinical benefits, precise information is

needed about pharmacological effects. “Consider

what happenswithweight loss.Weknow there’s an

association between weight and poor clinical out-

come with diabetes, heart disease and a variety of

othermedical problems. Butwhenweuse adrug to

help people lose excess body fat, how do we know

we are targeting the right sort of fat?

“Fat accumulates in different places in thebody

and it has different clinical consequences depend-

ing on where it is. If you have much fat deep in the

body, aroundorgans like the liver, it is a possible cause for clinical concern.

On the other hand, if the fat is just under the skin, it may be perfectly com-

patiblewith a long, healthy life.WithMRI imaging, you candifferentiate fat

loss deep in the body from that under the skin, and define what a weight-

loss drug is actually helping to change.”

Collaborative scienceThe CIC was built through a collaboration between GSK, Imperial

College and the Medical Research Council. The building sits on a plot of

ground in the middle of the Hammersmith Hospital and is controlled and

owned by Imperial College. The lower three floors are the CIC, the upper

twofloors house Imperial College clinical neurosciences, and theother half

of the building is anMRC facility. The three partnerswork together inman-

aging a common facility resource.

But it’s the non-physical element of the collaboration that Matthews

finds exciting. “Thedevelopment of new techniques that canbemarkers of

diseaseormarkers of response to treatment, is everyone’s concern, not just

a GSK interest. We are developing programs that are actively engaging

these partners in ongoing work.

“We set up a series of clinical research training fellowships, half fund-

ed byGSKandhalf by Imperial College.Wehavementorship fromGSKand

mentorship from Imperial College. The Fellows have the opportunity of

working with our cutting-edge equipment, as well

as in laboratories in Imperial, which is well-

equipped, having the largest research income of

any UKmedical school.

“We also are developing joint scientific pro-

grams, for example in the areas of appetite regula-

tion and neuroscience, which are run by Imperial

College faculty and our staff and have common

resources.”

Making advancesAccording to Matthews, imaging is a fantastic

area to be in and offers a wealth of opportunities,

both for the research community and for the phar-

maceutical industry, because there are somany ex-

citing developments on the horizon.

“In MRI imaging right now, what we’re begin-

ning to be able to do is characterize the virtual his-

tology of a tumor in the living body without having

to do a biopsy. That’s important because it would

potentially allow big decisions to be made about

what kind of therapy to usewith the tumor, howag-

gressive to bewith it andwhat the prognosismight

be. This is possible because MRI can probe many

characteristic issues within minutes of an investi-

gation. This is an emerging area. The range of mol-

ecules that are beginning to be studied is truly

incredible.

“One of the emerging areas that our Head of

Biologyhas beendeveloping, initiallywith academ-

ic colleagues, is siRNA. siRNA is one of themost ex-

citing new ways of delivering an entirely different kind of treatment to

patients, one that would be targeted genetically very selectively to a bad

protein, for example, in a cancer cell.

“SiRNA potentially allows therapeutic modification of a single pro-

tein, while not touching other parts of cell function. However, the prob-

lem has been to know how much of any siRNA administered actually

gets into cells, where it goes and whether it is having any effects on the

biology. There are new ways of using PET that promise an approach to

quantitative measurement of how much siRNA is sticking in cells and

where it’s going amongst the cells in the body. This should allow clini-

cal scientists to move rapidly from the point of dosing to prediction of

possible efficacy.”


Paul Matthews is Head of

GlaxoSmithKline’s Clinical Imaging

Centre (CIC). He is also Vice President in

drug discovery within the company. CIC

is a collaborative venture undertaken by

GSK, Imperial College London and the

Medical Research Council to create the

largest new clinical imaging center in the

world dedicated to the development and

application of imaging techniques for

drug development.

MATTHEW:31MAY 19/11/08 15:33 Page 97

ImagingOnCall.indd 1 14/11/08 13:57:23

Seeing the brainThe latest advances in clinical imaging that help illu-

minate the relationship between disease pathology and

patient feelingsareparticularly relevant toAlzheimer’sdis-

ease and schizophrenia, as Matthews explains: “When we

feel something or we have a thought, certain cells in the

brain start working together. This cell network functions

something like a computer to produce the thought or feel-

ing. Changes in the way the brain functions determine

everything about us, but in the past, the brain has been a

blackbox,sonoonecould tellwhatanyoneelsewasthink-

ing or feeling unless they described it.

“In someone with Alzheimer’s, because the patient is

impaired, they can’t tell us what is going wrong in their

brain.Wecanonlysee theconsequences.However,wecan

use functional imaging to look at the activity of the brain to

define relatively precisely what systems are working when

the subject performs a task. Perhaps more importantly,we

can see what systems aren’t working. So when we ask

someone with Alzheimer’s disease to try to remember

something, we can define those parts of the brain that we

need to modulate to make their thinking better.

“These techniques also allow us to make more spe-

cificdiagnoses.Therearemanydiseases inwhichthesame

symptomcanbecausedbymanydifferent things.Memory

problems, for example, are not only caused by Alzheimer’s

disease; they can also be caused by stroke, forms of

Parkinson’s disease and depression. ”

Functional MRI can also be used to provide a useful

marker of the effectiveness of any treatment that might be

tried on the patient. Signals from MRI can be more sensitive than the re-

sponses verbally reported by the subject. “This translates again to that criti-

cal issue in drug development: a faster, safer and potentially more effective

route from a possible treatment toward something that will get out there and

help patients.”

Cancer therapyAccording to Matthews, imaging will play an important role in the future

of cancer research. “Cancer treatment is a very challenging area for doctors

and patients, because the drugs that are used are highly toxic. A remarkable

thing is thatevennow,oftentheonlywaywehaveofassessingwhetherornot

a particular treatment regimen is effective in a particular patient is to give the

regime over weeks, sometimes even months, and see if it has had any impact

on the tumor size or growth.

“Thismeanssubjectingpatients toweeksormonthsofverydifficult treat-

ment, without being certain whether it’s giving them any benefit. It is poten-

tiallymissinganopportunity toprovidebenefitusinganalternative treatment.

Imaging with molecular markers allows us to look at the way the cells are re-

sponding on a molecular scale.We can begin to get measures of whether the

tumor is responding to the treatment within days.”

Matthews explains that by characterizing the types of tumor cells more

specifically and looking at the kinds of molecules they express, we can target

the chemotherapy better.

“In chemotherapy, you can’t administer the drugs every day, particularly

if you’re giving a cocktail; they are administered in a schedule. For example,

you give some drugs on Monday, you then repeat it on Friday, come back on

the next Monday, next Friday, and so on.

“At this point, decisions about how long to wait between each of the cy-

cles,howtoadminister thedifferentdrugswithin thecycles,whatorder togive

them and what delays to put between them are often just educated guesses.

But what we can now do with some imaging tools is begin to use more ratio-

nal ways of dose scheduling, bringing the science right to the bedside.

“This brings immediate benefits to patients. It provides them with more

effectively directed therapy and reduces the amount of time that is spent on

ineffective therapy.”

Matthewspointsout that this is also important fordrugdevelopmentbe-

cause it means that assessment of new molecules can be done more quickly.

“It is important forpatientsbecausewecanendtrialswithamolecule that isn’t

having any effect and get patients back on something that will be effective.

Matthews and his team are passionate about the opportunity to bring

clinical imaging to the heart of drug development. He says GSK’s investment

in theCIC isunique in the industry.Thecompanyhasabigvision:“Wearecom-

mitted to sharing openly with the scientific community, including other phar-

maceutical companies. The methodology can transform drug development,

and it’s important for thescientificcommunity toshare in itsdevelopmentand

ownership. This is what will bring the highest value to us as a company.”�


GKS’s Clinical Imaging Centre at Hammersmith Hospital, London, UK

MATTHEW:31MAY 19/11/08 15:34 Page 99

Follow the leader

In 1993 Eliot Siegel, Professor and Vice Chairman of Information

Systems, and his partners at the University of Maryland School of

Radiology, were the fi rst radiologists to introduce fi lm-less tech-

nology. Fifteen years later, they are continuing in their innovative

quest to transform imaging informatics, producing technologies

ahead of the digital age.

“Imaging informatics can be thought of in diagnostic imaging as

a subset of medical informatics, the fi eld of study concerned with the

broad issues, management and use of biomedical information, includ-

ing the study of medical information,” explains Siegel. He notes that

imaging informatics is defi ned as the subset of medical informatics,

which touches on every aspect of the imaging chain.

“That includes not only the creation and acquisition, distribution

and management of images, their storage and retrieval, but also imag-

ing processing, image analysis and image and navigation, and image

interpretation and reporting and communication and many other

areas,” he adds. “Imaging informatics is the nexus between diagnos-

tic imaging and other disciplines, including engineering, information,

technology and physics.”

ChallengesBeing at the forefront and creating such innovative technology brings

with it many challenges. “One of the particularly interesting areas

creating media attention recently has been the optimal trade-off

with regard to dose and image quality central to diagnostic imaging,”

Siegel says. “What is the defi nition of image quality and how can we

actually measure it and improve it? Is image quality just defi ned as

what is aesthetically pleasing to the radiologist, or is there a more

general quantifi able defi nition of it?”

Quantifi cation does not come without its diffi culties. Its function

in diagnostic radiology is to provide tangible results through enumer-

ate means. “When using CT, MRI or other modalities as a metric for

patient change, we need to have more rigor in the way that we mea-

sure lesions and in our criteria for determining size, volume or what is

the error of measurement,” Siegel says. Determining these results on

a quantifi able basis allows for diagnostic radiology to move into an

era of personalized medicine.

“Quantitative diagnostic radiology provides the ability to use the

patients individual DNA and the tumour’s DNA and correlate that with

laboratory and quantitative diagnostic radiology information, and

through making all of those fi t together we can tailor a specifi c treat-

ment or screening regime for a particular patient.”

Quantifying results also produces the benefi t of greater com-

munication between patient and physician. “An important role for

imaging informatics is ensuring that this information is communicated

properly to the physicians taking care of the patient, and also that

there is acknowledgement back from those physicians that they’ve

received the message,” Siegel points out, adding, “From this, we’re

able to track whether or not recommendations that we’ve made are

actually followed up.”

InnovationIt is not only diagnosing an accurate interpretation of informatics im-

aging that poses a problem; communication with physicians brings

with it technological challenges as well. Siegel and his team faced

those diffi culties 15 years ago when they unveiled their creative in-

novation and introduced fi lm-less technology.

“We were the only department that was fi lm-less in the United

States for quite a few months and in order to interface with our incom-

ing patients, along with being able to share our images for patients

who were seen at other hospitals or clinics in addition to ours, we had

to resort to interfacing using fi lm,” Siegel recalls.

As other facilities have made their transition towards digital im-

aging, things have not necessarily become easier. “Although we’ve

moved to a digital environment and patients are now being handed

CDs or DVDs after they have their CT or MRI studies, the problem we

have now is a ‘Tower of Babel’ situation of confusion due to the dif-

ferent formats which those CDs are written,” says Siegel. In an era of

vast technological advancements, the communication of images from

one facility to another is made harder due to a lack of standards that

exist for the interchanging of information even using standard media

such as CD’s.

“I would see the transition in CDs developing in the future to-

wards a direct electronic mechanism that allows me to access my

information, regardless of the hospital I’m in, in a manner analogous

to when I go to an ATM machine to access my US account when I

visit London. We’re investigating the standards for the capability

to be able to electronically exchange that medical information in a

safe and secure way. Siegel believes technological development is

progressing toward a direct electronic mechanism in which this in-

Eliot Siegel reveals to EHM how he and his team revolutionized radiology and made fi lm a thing of the past.

“We’ve moved to a digital environment and patients are now being handed CDs or DVDs

after they have their CT or MRI studies”

RADIOLOGY

EHMUS6_Siegel 100 19/11/08 15:06:49


compatibility of formats can be corrected.

Within Siegel’s own department, the

changing nature of imaging informatics is ex-

emplifi ed by the innovations currently being

created. “We’ve radically redesigned our

radiology reading room, and created what we

call the radiology reading room of the future,

which embraces all of these technological

challenges,” he explains. “Many of the insti-

tutions that have made the transition from

fi lm-based radiology to fi lm-less have merely

substituted computer workstations for the

viewing boxes without thinking of changes

required in lighting, ergonomics and seating.

We’ve done a lot of work with architects and

experts to completely redesign our radiology

reading room.”

Technologies The department has also introduced speech

recognition technology, which, with the elimi-

nation of the transcription process, allows

for the ability to decrease report turnaround

times. Advanced 3D workstations are a major

development from the fi lm-less technology

that was previously used, creating a much

shorter timeframe in which images can be

received.

“Fifteen years ago, we were looking at images electronically in

a much more passive way, whereas now we’re navigating through

3D space with advanced visualization systems. We’re interacting as

radiologists and determining the way we want to look at the images,

rather than the way the patient fi ts into the CT scanner,” Siegel says.

He compares the technology being used within the department as

similar to that of Google Earth. The Google mechanism of looking at

maps is translated within informatics to communicate information

via a server that is able to provide advanced imaging processing

and visualization.

“The ultimate effect of this on the patients is that they can now

come to our department, and without having to have additional sub-

specialized studies, routine studies can now be reconstructed so that

we can get very detailed views of the spine or the patient’s vascu-

lature, pulmonary vasculature or abdominal vasculature. During one

visit, we’re able to acquire information volumetrically, and the ben-

efi t of this for the patient is that we’re able to make more rapid and

more accurate diagnoses using less intravenous contrast than we

were previously.”

The innovative technologies used by Siegel and his team are ap-

plied to each of the 30 to 40 projects he may be working on at any

one time. In response to progressing quantifi able measurable results,

Siegel explains the work he is doing on algorithms: “We’re investigat-

ing different types of algorithms and ways in which to make better

volumetric quantitative measurements on patient lung lesions, rather

than just making axial or coronal mea-

surements.” Siegel and colleagues are

investigating the use of grid computing

which can facilitate the ability for mul-

tiple computers to work on an imaging

challenge such as the detection of lung

nodules in a patient to either decrease

the time required for computer assisted

diagnosis or create a consensus among

multiple different algorithms working in

parallel.

“We’re also conducting an ergonomic

study, evaluating the impact on diagnos-

tic accuracy and the physiologic impact on

radiologists walking slowly, somewhere

around one mile per hour, on a treadmill

while doing image interpretation. This

will help us measure the physiologic

impact and other impacts on radiolo-

gists,” says Siegel. “We physicians tend

to take better care of our patients than we

do ourselves.”

Technological innovation is what pro-

pels Siegel and his team to the forefront

of discovery. One project he is currently

working on focuses on the development of

multi-touch technologies, and the impact

such mechanisms can provide within ra-

diology. “The ability for a radiologist to be able to navigate, not with

a mouse or a trackball, but via a multi-touch interactive screen when

looking at a complex CT or MRI dataset will dramatically change the

way information is visualized.”

Discovery One of the major projects Siegel has just received funding for is the

building of a new CT scanner within the department. “We’ll be creating

our own scanner technology, using different types of dose detectors

in which there will be a signifi cant reduction in the dose of radiation

in comparison to what is conventionally used in CT,” he says. “We’re

also looking at different ways that radiologists can report fi ndings

out, so rather than just using a text method for reporting, we’ve done

some research looking at gesture based reporting. “We’re also look-

ing at the impact of reducing radiation dosage on computer programs

that do automated computer-aided detection as well as novel CAD ap-

plications such as the creation of computer aided detection programs

for some new novel applications, for example evaluating for meniscal

or tendon tears within the knee.”

For Siegel and his radiology team at the University of Maryland

School of Medicine, becoming pioneers of imaging informatics in-

novation did not end at the creation of fi lm-less technology. Their

research and technological developments have produced intriguing

results and this has furthered their desire to remain at the forefront of

technological advancements.

Eliot Siegel is Professor and Vice Chairman of

the University of Maryland School of Medicine

Department of Diagnostic Radiology and is

Chief of Radiology and Nuclear Medicine for

the VA Maryland Healthcare System. He has

responsibility for the imaging workspace for the

National Cancer Institute’s cancer biomedical

informatics grid. His areas of research and

publications include all aspects of computer

applications in radiology and medicine in

general with a focus on imaging informatics.

EHMUS6_Siegel 101 19/11/08 15:06:52


EHM. What are some of the most recent IT investments you’ve made at the

University of Chicago Medical Center?

EY. We have been working on a couple of things. The first of these is to im-

plement Oracle’s ERP system in order to manage our two biggest cost in-

puts; our supply chain and human capital. We hope the system will help cut

over $30 million of supply costs for the organization. We are already more

than halfway there in terms of meeting that goal and the Oracle system has

been critical from an analytics perspective in providing the data for us to

achieve this.

We’ve recently implemented Oracle’s HR system and use this for every-

thing from managing our compensation planning to our performance eval-

uations. We don’t know exactly what kind of hard dollar quantifiable

benefits this has brought about but we have pushed more self-service func-

tionality to management and to end-users. Along with this, data has be-

come more accessible and we are achieving our goal to improve processes

and services.

Another system we have implemented is an Epic system on the clinical

side for pharmacy, radiology and the electronic medication administration

All

systems

go

Electronic patient records are launching healthcare into the 21st century.Eric Yablonka looks at how IT is improving functions at the Universityof Chicago Medical Center.

YABLONKA 2:nov08 19/11/2008 13:42 Page 102

record (EMAR). For the first time the EMAR is online and available to our

clinicians. They have found this to be an incredible benefit and now have

easy access rather than having to hunt down charts. The pharmacy and ra-

diology implementations were replacements of legacy systems that were

no longer being supported by vendors. The pharmacy system implementa-

tion was necessary for our planned computerized provider order entry de-

ployment, which will take place in March.

This fall we have been deploying a nursing documentation system as

well as an emergency department system by Epic. In the spring we are

going to put in a computerized provider order entry system and also begin

our ambulatory clinic rollout with Epic’s products.

We also have two other large projects around January 1. The first large

project is a conversion from a legacy system to Oracle’s payroll system.

We’re also having a major conversion of our hospital billing system. As you

can tell, our roadmap over the next 12 months is very aggressive. We expect

improvements in revenue cycle, effectiveness, cash collections, safety and

quality of care, CPOE implementation and our clinical document implemen-

tation, and we hope to save some costs by retiring legacy systems.

EHM. Could you explain the importance of health IT in achieving the goal

of greater individualization of care, and how will we maximize opportuni-

ties, pathways and resources?

EY. IT tools can certainly make things happen. However, there are many bar-

riers to using such tools, including standards that don’t allow interoperabil-

ity between various medical providers. These are large hurdles that have

to be overcome. This is less of a technical issue and more an industry one.

There needs to be some agreement on what those standards are. Assuming

that someday these will exist, then I think the opportunity for not only in-

teroperability between healthcare providers, but also personal health

records, will increase.

We’re very much in the infancy of this. Many doctors’ offices and a

lot of hospitals still don’t have electronic data at a level that would aug-

ment the personal health record. From an industry and vendor perspec-

tive we’re seeing a lot of activity in the marketplace, with Google and

Microsoft getting involved. However, the most universal houser of med-

ical information continues to be the insurance companies and the federal

government. I’m sure we’ll continue to find new ways to leverage data re-

garding patient care.

“IT tools including standardsthat don’t allow interoperabilitybetween various medicalproviders”


I’m in a position where I have responsibility from an IT perspective for

the medical, academic and the research side. I find it to be a very exciting

opportunity, and the industry really needs to pay a lot of attention to it.

EHM. What challenges or op-

portunities do you see coming

up?

EY. The biggest challenges in-

clude the continual decline of

reimbursement and funding for

medical care. There is an expec-

tation that healthcare organiza-

tions and physicians will

continue to provide the care

whether they get paid or not.

The ratcheting down of quality

standards is both a great chal-

lenge and an opportunity. The

payers will no longer pay you if

you have a medical error and

this will force healthcare organi-

zations to treat quality even

more seriously.

We also have challenges in

terms of talent in the healthcare

IT sector. We need unique people with healthcare knowledge and experi-

ence. In many parts of the country there is a competitive marketplace to re-

cruit and retain top talent. n

EHM. Currently, there’s limited online support to help healthcare profes-

sionals deliver their best standards of care. What do you think could be

done to help remedy this situation?

EY. Having standards would be really helpful because

those millions of day-to-day encounters in medical practice

don’t necessarily match up. If this is the case then they

cannot be leveraged or aggregated in a constructive way.

We need to consider if there is a business need for this in

the first place.

EHM. The President’s budget for 2008 includes $15 mil-

lion in startup funding to create a new electronic network

that would draw together data from major health data

repositories. How will this further the goal of personalized

healthcare and impact the average consumer?

EY. To start up an electronic network, which would draw to-

gether data for major health data repositories, $15 million

is nothing. I don’t know how it will further the goal of per-

sonalized healthcare or impact the average consumer.

Even a small startup company in the healthcare space can

use up $15 million in 12-18 months just in research, devel-

opment and trying to get a product to market. Therefore, I

have no idea how that funding will help. If anything, it’s a

statement of a lack of commitment by the federal govern-

ment in this area.

EHM. What role can IT play in the burgeoning field of personalized medi-

cine and translational medicine?

EY. The University of Chicago and other

academic medical centers are doing

some groundbreaking work in transla-

tional research. There is a lot of bench-

to-bedside research, and this is very

important going forward. When we think

of personalized medicine this is a very

exciting time in academic medical cen-

ters. These centers, which take their re-

search and genetic data and couple that

with healthcare information generated

from patient care, will be able to develop

clinical trials and other treatment proto-

cols that could achieve huge break-

throughs in medicine.

We’re coming into a golden age in

medical research and there are many

unbelievably great academic medical

centers around the country including

Johns Hopkins, Harvard, Yale and

Chicago. This is something we really

should watch as an industry because

personalized medicine has the poten-

tial to change the way healthcare orga-

nizations treat patients.


Eric Yablonka has over 20 years of

experience in information systems

management. He has served as Vice

President and Chief Information Office of

the University of Chicago Medical Center

(UCMC) since 2001. His responsibilities at

UCMC include all information technology

functions, biomedical engineering and the

call center. He has leadership

responsibility for the T-2 program whose

focus is to transform how UCMC

functions in supply chain and

administrative management, patient care

delivery and patient and physician access.

Prior to UCMC, Yablonka was the Vice

President and Chief Information Officer for

the Saint Raphael Healthcare System in

New Haven, CT.

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Electronic medical records (EMRs),

online claims, personalized disease

management, email advice pro-

grams, and other innovative online

services are not only streamlining healthcare,

but enabling patients to exercise greater con-

trol over their care and expenses. By reducing

medical errors and providing faster access to

accurate, complete patient information, elec-

tronic healthcare and online medical records

can save lives and improve patient outcomes.

Insurance companies, medical practices,

hospitals, self-insured employers, and other

service providers stand to gain sizeable ben-

efits through the adoption of these online

services and transactions. Storage and paper

costs, which can run tens of thousands of dol-

lars each month for a medium to large practice,

can be drastically reduced or eliminated.

And electronic healthcare can make it

easier and faster for consumers and health

plans to detect fraud. Access to complete medi-

cal records may make it easier for health plans

to identify a fraudulent claim. Claims could po-

tentially be validated by the patient electroni-

cally before the health plans issues payment.

From improved quality of care and respon-

siveness to new levels of efficiency and cost

savings, e-healthcare is poised to have a posi-

tive effect on the future of healthcare.

Addressing confidentiality concerns

This unparalleled opportunity hinges

on whether patients believe that their online

confidential information is safe from prying

eyes and criminals. Recent data shows that

the healthcare industry has a long way to go to

create the level of patient trust and confidence

needed to enable e-healthcare to succeed.

While other industries have made inroads

in establishing consumer trust – online retail-

ers for example – today’s consumers don’t feel

the same way when it comes to their medical

data being online. A survey conducted in 2007

by Forrester Research, Inc., showed that one-

third of commercially-insured consumers are

not sure if their health insurer is fully protect-

ing the privacy of their personal information.

The survey also showed that consumers with

privacy concerns are nearly twice as likely to

switch plans.

Consumers are worried about unauthor-

ized access to personal medical informa-

tion as well as identity theft. According to

Columbia University Professor Emeritus

Alan F. Westin, a leading authority in privacy

research, approximately 73 percent to 80

percent of the public will want to be assured

of robust privacy and security practices by

online personal health record services, if they

are to join those offerings.

Setting a higher standardPiecemeal security measures are no

longer enough to deliver the high standard of

protection consumers demand. Healthcare

organizations need a multilayer solution

that delivers a systematic approach to

security across the entire online transaction

to mitigate threats at multiple levels. A

multilayer solution establishes a continuum

of protection for patients that addresses the

essential components of the transaction:

patient identity protection, confidential data

protection, Website authentication, and

fraud detection.

Using this approach, complementary

security layers such as Secure Sockets Layer

(SSL) certificates, two-factor authentication,

and fraud detection, fortify each other to

create a solution that is stronger than the sum

of its parts.

E-Wellness: Trust is what the doctor orderedThe shift to electronic healthcare promises far-reaching benefits for all involved – from saving lives to saving dollars. The key to success however, lies in convincing patients their online data is safe, as Jennifer Gilburg of VeriSign explains.

SSL authenticates the organization to the

patient or consumer – consumers can validate

visually that they are visiting a trusted and

authentic site before they enter their personal

information. Two-factor authentication and

fraud detection authenticate the patient to the

company with strong authentication and fraud

prevention. Deploying these complementary

technologies in tandem ensures the highest

level of security and confidence – key to build-

ing patient trust in online services.

With layered security, hospitals, practices,

health plans, self-insured employers, and the

other participants in the healthcare lifecycle

can build consumer trust in online medical

transactions to set the standard for 21st cen-

tury healthcare. n

Jennifer Gilburg is Director of

Business Development, VeriSign Inc.

Jennifer joined VeriSign in June, 2007

to lead business development for the

Authentication Services business unit.

Her primary responsibilities include

growing the VeriSign Identity Protection

(VIP) community of financial service,

eCommerce, healthcare and gaming

organizations. Additionally she is focused

on international channels and creating

a partner ecosystem to create solutions

around online security.

ASK THE EXPERT

“Electronic healthcare can make it easier and faster for consumers and health

plans to detect fraud”

verisign.indd 106 19/11/08 15:13:01

Verisign.indd 1 13/11/08 08:53:49


Getting in on the ground floorCan’t find the drug discovery technologies you’re looking for? Then make your own. Or at least, form a company that does. Reid Leonard of Merck & Co. and David Steinberg of Enlight Biosciences tell Marie Shields how they went about it.

DRUG DISCOVERY

EHMUS6_Enlight.indd 108 19/11/08 15:14:25


nologies. We then worked together directly

rather than relying on external venture com-

munities to fund these technologies.”

The notion of precompetitive technol-

ogy is an interesting one, because it enables

companies to work together at a point before

any conflicting commercial interests arise. As

Leonard explains, the aim with Enlight is to

identify broad areas in need of better tools

to support what would ultimately be pro-

prietary work conducted by each individual

user. He compares it to the development of

information technologies, in which com-

puter processing power and the growth of

distributed computing and the internet has

facilitated the individual business objectives

of users.

“We’re trying to support the same sort

of foundational technologies,” he says.

“But unlike something broad like informa-

tion technology, which is used across many

industries, we’re particularly interested in

enabling the development of technologies

that would be of use to the biopharmaceuti-

cal industry, hence our decision to go in as

partners in Enlight.”

Sharing the pieSteinberg points out that the model of need-

ing to put a lot in to get a lot out isn’t as

appealing as it used to be, even though the

ROI could be the same. Enlight’s aim is to

get around that by working directly with its

pharmaceutical industry partners, so that it

doesn’t have to rely on purely financial inves-

tors to fund the technologies.

“The reason this works is that you’ve

created an additional source of value beyond

just the financial upside, which is the strate-

gic value to pharma companies. Now it’s no

longer a zero sum game. Instead of having

one financial pie and fighting over every

dollar, you have two pies: the strategic pie

and the financial pie.

“PureTech, as entrepreneurs, are obvi-

ously more motivated by the financial pie on

a near term level, and the pharma companies

are much more motivated by the strategic

impact that these new technologies will

make in their organizations. The two sides

can carve up the two pies in a way that ev-

eryone wins, and we’re not facing the same

limitations that we would be if it was purely a

financial endeavor.”

Leonard, in turn, points out the practi-

cal benefits of the partnership. “We would

define success as the creation of a platform

technology, preferably a commercial instru-

ment or perhaps a service company, that

could provide a particular technological so-

lution that would allow us to gain access to a

tool that would otherwise not be available or

would be available only much later.

“It’s easier to describe in terms of spe-

cific types of technologies; for example,

technologies for the discovery and validation

of biomarkers. The biopharma industry is

investing significantly in the use of biomark-

ers to help us understand whether candidate

treatments in development are actually work-

ing through the desired mechanisms; and

whether they are having the intended effects

on the targets prior to our ability to assess

whether those interventions are ultimately

altering the course of a disease.”

Leonard points out that currently there

are many approaches to discovering and vali-

dating biomarkers, but these are still a collec-

tion of available technologies, from nucleic

acid technologies and proteomics, which are

essentially being repurposed and applied to

the task of specific biomarker development.

He says there is a sense that somewhere in

the entrepreneurial imagination of academic

scientists exists an efficient platform that

could be useful for the development of a set

You’re a big pharma company,

and you’re feeling frustrated

about the lack of enabling

platform technologies to

support the initial stages of

drug discovery. What do you

do? Get together with two of

your competitors and form a company aimed

at bringing these technologies to life? That’s

exactly what Merck, Pfizer and Eli Lilly did:

they formed a new company, Enlight Biosci-

ences, with the help of PureTech Ventures.

According to Reid Leonard, Executive

Director of Licensing for Merck & Co., the

purpose of the venture is to encourage the

development of enabling technologies that

pharmaceutical companies can use to sup-

port their internal efforts for drug discovery

development and clinical decision-making.

“There is a lack of venture capital being

devoted to the development of ‘tools’

companies needed in order to create these

technologies. Some technologies are dying

on the vine for lack of capital. The concept

for Enlight was to bring together the institu-

tions that will be the ultimate customers, and

therefore have a stake in the future of this

space, to determine which precompetitive

foundational technologies we would like

to see, that we could then apply to internal

programs.”

David Steinberg, CEO of Enlight and a

partner at PureTech Ventures, points out that

the formation of Enlight followed a slightly

different path than normal. “Usually we

start by identifying areas of unmet need in

life sciences medicine, then bring in top-tier

academic luminaries and key opinion leaders

to form a founding scientific advisory board

of a company with us, and with that group

we identify opportunities for innovation and

existing technological approaches.

“With Enlight, we decided to work directly

with the pharmaceutical industry so that the

groups that were most in need of those plat-

forms and enabling technologies could work

with us from the beginning in developing

them. The idea was to bring the two parties,

PureTech and the pharma industry, together.

On PureTech’s side, we had the deal flow and

the ability to get these companies started,

and on the pharma industry side there was

the unmet need around novel enabling tech-

“We’re particularly interested in enabling the development of technologies that would be of use

to the biopharmaceutical industry”Reid Leonard


IngeniousMed.indd 1 13/11/08 08:47:57


of biomarkers for a particular indication.

“The analogy that I like to use is the mea-

surement of gene expression. In the old days,

all we could do was a single-gene PCR. Now,

we use high-density array technologies.

We’re looking for those sorts of transforma-

tional technologies that will be useful to ev-

eryone, but the proprietary interest in these

technologies will come from the way in which

we apply them to our internal programs.”

Making the choiceThe responsibility for identifying potential

projects rests with the Enlight board and

their scientific advisory board. Leonard ex-

plains that part of the attraction for Merck in

the arrangement is that the Enlight team will

focus on networking with academic centers.

“Enlight is matching our aspirations

against what they see coming out of the uni-

versities. They develop a detailed proposal

around a particular company or a project that

they would like to initiate: identifying the

investigators, working out the intellectual

property situation, and determining who else

they would need to involve. They may need to

identify assets from several universities and

bring them all together.

“We’re seeing a fairly well-developed

proposal by the time it comes to us for com-

ment, and then the individual investors in

Enlight have a vote in what we do.”

From Steinberg’s perspective, the crite-

ria for choosing a project are: number one,

providing impact for the pharma partners;

and number two, the ability to be transfor-

mational in the long haul. “We don’t want to

just make an existing screening technology

a little bit faster or make an existing safety

testing protocol a little bit cheaper,” he says.

“That means having a big impact on the per-

centage of drugs that fail once they get to the

clinic by, for example, developing a dramati-

cally improved prediction mechanism. Or it

could mean enabling whole new classes of

drugs through delivery strategies that aren’t

available now, to open up pipelines, rescue

failed compounds and open up whole new

R&D strategies, because you now know you

can deliver something that you never would

have been able to deliver before.

“Number three is that we want to make

sure that while the technologies are transfor-

mational in the long run, there’s a near term

impact with our pharma partners as well.

For example, Endra, our imaging company,

will have small animal tabletop instruments

available in 2009, so that’s the near term

impact; but the long term transformational

element is the clinical applications from the

devices that we’ll be bringing online in the

following years. It’s the idea of quick hits

and big ideas and making sure both of those

things are there.”

“The pharma industry has proven to be uniquely good at certain things . . . but innovation hasn’t

necessarily been one of them”David Steinberg



Leonard stresses that the type of proj-

ects Enlight is looking to develop fall outside

of Merck’s core business. “Although we’re a

big technology user, we’re not in the busi-

ness of developing technology per se, with a

few specific exceptions. We’re not scanning

the academic community for these types of

enabling technologies with the same degree

of focus we put into searching the academic

landscape for potential new therapeutic

opportunities.”

Focus areasThere are three main areas on which Enlight

is expected to focus in the near term. The

first is novel biomedical imaging technolo-

gies, which would ideally supplement the

existing imaging technologies to provide for

additional noninvasive methods of tracking

drug action and identifying patients who are

candidates for particular therapy.

The second area is biomarkers. Enlight

will not necessarily aim to develop specific

biomarkers for a particular development pro-

gram; the pharma partners instead hope

to identify technologies that can be turned

into a product or a company that would then

enable them to use that technology.

The third area is identifying technolo-

gies that will allow the industry to work with

biologic therapies in the same way that it can

work with small molecule therapies today.

These would include delivery technologies

for biologics, such as protein engineering

and alternative expression systems.

According to Leonard, one of the key

benefits of being a partner in Enlight is that

partners get access to the technologies as

they’re being developed. “For example, if a

project takes off at Enlight with the goal of

producing a new instrument, then the par-

ticipating partners will have access to that

technology during its development phase

and will have input into the final design. We

will in some capacity serve as beta testers.”

“Ideally there is some benefit of mem-

bership conferred to us. It’s not as though we

have to wait until everything is done. We do

hope to get a jumpstart on testing the feasi-

bility of some of these technologies through

our participation in Enlight.”

But Leonard points out as well that

it is an explicit goal of Enlight to commercial-

ize these technologies. The company may

choose to develop an instrument to the point

where an existing medical device or medical

instrumentation company may take it up.

In other instances, it may decide to form a

company to provide a specific service to the

industry. This is where the Enlight model dif-

fers from a traditional consortium approach.

“There have certainly been examples of

industry consortia in which companies have

pooled assets, or at least intellectual input,

to help facilitate the development of a tech-

nology. In contrast, Enlight has the specific

purpose of running a business. Enlight does

aspire to be a profit-making enterprise, and

what we’re hoping is this business model

approach will increase the probability of

success of some of these projects, because

they will have to stand on their own merit as

a business proposition.”

Steinberg explains that as each new

spinout company is formed, at the time of

formation the pharma partners each have

the opportunity to either support it finan-

cially or not. “If they do support it finan-

cially, they get all kinds of rights including,

most importantly, early influence on how

specifically the technology is developed. Take

the example of our imaging company Endra;

there are a million different ways we could

go with respect to everything from design

elements like animal handling to application

development – what are the first applications

for which it’s optimized – and everything

in between.

“For the pharmas to be involved with

that from the very beginning is important,

because then we can develop it so that it’s

incredibly useful to them right away. Those

that choose to invest also get ongoing access

during the time we’re developing it, i.e.,

alpha and beta testing, regular input and

updates to develop the process. Then

they have the possibility of special access

rights for a period of time after launch and

guaranteed ongoing access rights once it’s

launched commercially.”

Industry challengesThis joint venture suggests that the in-

dustry is looking at novel ways to develop

innovative technologies and bringing new

medicines to patients. What does this tell us

about the challenges that the industry is cur-

rently facing?

“One thing that struck me after this was

initially announced in mid-July,” says Stein-

berg, “was the magnitude and the positive

tenor of the response from the popular press,

the life science press and other pharmaceuti-

cal companies. It has struck a chord with a lot

of people because there is a big gap in pharma

R&D in terms of its efficiency and productiv-

ity. Everyone quotes the statistic that the

number of new drug approvals is going down

and the amount spent on R&D from pharma

is going up dramatically. Shouldn’t those be

moving in the same direction? What’s wrong?

What’s broken?

“Everyone recognizes there’s a problem.

We’re spending more and more money for

fewer and fewer successful drug launches.

The amount of risk that you undertake with

each new development program is incred-

ibly high. You’ve literally got billions on the

line, and it could easily fail, and it will very

likely fail for any given compound. The whole

industry recognizes that some novel ap-

proaches have to be tried, and the pharma

Reid Leonard is Executive

Director, External Research and

Licensing for the Merck Research

Laboratories. His role is to identify

partnering opportunities that fit

with Merck’s strategic research

and development goals across all

therapeutic and technology areas.



industry has tried everything from their own

internal incubators to option funds to dif-

ferent ways of doing venture. The problem

with many of the internal programs is that

pharma companies aren’t necessarily set up

to manage innovation in the same way that

entrepreneurs are, so that’s where those

programs can fall down.”

“The biopharmaceutical industry un-

derstands there is a limit on what any one

organization is capable of pursuing on its

own,” Leonard adds. “We all have varying

strengths and areas of focus, and the days

where a major pharmaceutical company,

like Merck, would choose to rely entirely on

its internal innovation engine have long

passed. The general model in industry now

is moving much more aggressively toward

partnerships.”

Enlight serves as an example of a

broadening of the concept of partnership.

Traditionally partnerships were centered

on a specific product. A pharma and a bio-

tech company partnered to complete the

development and commercialization of a

molecule that was developed by the biotech

company.

“We’ve seen a broadening of that con-

cept to earlier-stage partnerships, many

of which Merck has formed in the past few

years, in which we enter into a research-

based collaboration with a biotech company

with the specific goal of jointly discovering

molecules to take into development. I see

Merck’s participation in Enlight as moving

one step earlier in the value-creation chain

of attempting to fertilize the landscape for

the development of tools that will enable

all of our business, whether it be projects

of our own, or projects in which we’re col-

laborating with others.”

Steinberg points out that with external

technology programs, pharmaceutical com-

panies can be too far removed, so they can’t

control or get access to the technologies

at the right times, and there are flaws with

the different kinds of systems that currently

exist. “Pharma companies are still looking

for ways to improve R&D productivity so they

can both have enough influence to make

sure it’s right, while still not being required

to do the work and the development inter-

nally because that’s not what they’re best

at. They’re best at developing drugs. Enlight

is designed to fill that void and that’s why it

struck a chord.

“When we look back in 10 years are we

going to say Enlight transformed pharma-

ceutical R&D? I don’t know. I hope so, or I

hope we can say it played an important role

in helping various other things get started. I

don’t know what it’s going to look like, but I

do think there’s broad recognition that this

is a big problem and the industry needs to

be creative about how to approach it, En-

light is one way of at least starting to think

about how to do that.”

Future plansWhat does the future hold for the pharma-

ceutical industry? Does the formation of

Enlight point to the way forward? Steinberg

certainly thinks so. “It would not surprise

me if a lot of the industry ended up like that

in the future, because if a small startup

biotech gets something into phase II for $25

million and a pharma takes $200 million to

get that same compound, eventually some-

thing has to break.

“On the other hand, there are things

that pharmas can do uniquely well. Only

certain companies have the scale to run

huge clinical trials, or have a 2000 or 3000

person sales force. With almost no excep-

tions, very few biotechs are ever going to

be able to do that themselves, so there may

be a natural kind of bifurcation where some

pharmaceutical companies become com-

mercial entities and aren’t innovating at all.

“Some companies will probably figure

it out through mechanisms like Enlight and

other creative internal mechanisms and ex-

ternal approaches and those will be consid-

ered the real innovators. You could easily

see it going that way because the pharma

industry has proven to be uniquely good at

certain things, but over the last five to ten

years, innovation hasn’t necessarily been

one of them.”

Leonard has seen increased attention

being paid by the pharma industry and the

biotech community to actively engage with

academic inventors and entrepreneurs in a

way that is more directed and more focused

than in the past. “For the past decade,

the traditional model for many interac-

tions between pharma and academia has

centered around essentially unrestricted

grants or sponsored research agreements

that primarily support ongoing work from

the academic investigator in areas that

were chosen essentially by the academic

investigator.”

“There’s a shift occurring on both

sides toward a greater effort to identify

opportunities for industry and academia to

work together on areas in which the project

focus is determined by the industrial part-

ner. There’s a greater level of engagement

between the companies and academia

around the specific work plan and much

more thought going into what constitutes a

successful outcome. That’s an area in which

the academic mission and the industrial

mission have to find common ground.

“There’s still a lot of inefficiency in the

way information and scientific discoveries

progress through that interface, and that’s

an area where industry and academia can

work together more productively.” n

David Steinberg has worked in

the biopharmaceuticals industry

for more than 13 years. As a

member of PureTech, Steinberg

has been on the teams of Enlight

Biosciences and Endra Inc. as

founding CEO. Previously, he

served as Chief Business Officer

of portfolio company Follica, Inc.



THE FUTURE OF PAYER-SPONSORED ELECTRONIC HEALTH RECORDS

Undeniably, payers have more electronic health data than any

other healthcare stakeholder, and so are uniquely poised to play

an important role in contributing data to their own and other

stakeholder electronic health records (EHRs).

It should be noted that in this context, the term EHR is being used

in its broadest sense to encompass various forms of health records.

Payer-based health records (PBHRs) consist of data sourced by payer

core administrative systems, including medical and pharmacy claims

systems. Electronic medical records (EMRs) and electronic health re-

cords consist of data sourced predominantly by provider healthcare

information systems. These two terms, while often used interchange-

ably by the industry, are viewed as separate but related technologies

by Health Industry Insights. Consumer-controlled personal health re-

cords (PHRs) can consist of data from payers and/or providers, as well

as data from the consumer.

Acquiring vendorsTo date, the predominant form of payer contribution to EHRs has been

to offer members a PHR. In addition to simply offering a PHR on a pri-

vate-label basis, there have been several notable examples of payers

making considerable investments in EHR technology, including invest-

ing in or acquiring vendors that offer this capability.

For example, Aetna acquired ActiveHealth Management for ap-

proximately $400 million in May 2005 and operates it as a branded,

standalone business. ActiveHealth Management offers ActivePHR

along with other health management and data analytic solutions.

Blue Cross Blue Shield of Tennessee (BCBSTN) formed Shared

Health as a wholly owned subsidiary in July 2005. The Shared Health

Clinical Health Record (CHR) is a PBHR with data sourced from BCBSTN

and TennCare, Tennessee’s Medicaid program. MySharedHealth is the

consumer view into CHR.

Availity LLC is a unique joint partnership between Blue Cross and

Blue Shield of Florida Inc. (BCBSF), Humana Inc., and Health Care

Service Corporation (HCSC). In May 2007, leveraging the connections

established for administrative transactions, Availity launched Care

Profi le, a multipayer PBHR, accessible through its portal.

HCSC acquired MEDecision earlier this year; the transaction was

valued at approximately $121 million. MEDecision’s Nexalign suite

includes Care Summaries, a PBHR that aggregates and presents clini-

cally validated payer-sourced data. Much of this activity happened two

or three years ago, after the Bush administration pronounced in 2004

that every American would have an electronic health record by 2014.

So where are payers today in their investment plans for PBHRs, PHRs,

and other forms of EHRs?

Collaborative initiativesIn two separate surveys about payer IT investment priorities, Health In-

dustry Insights asked US payers about the current status of deploying

Health Industry Insights’ Lynne Dunbrack examines the current state of electronic health record technologies used by US payers and presents key fi ndings of two surveys regarding payer deployment of and data contribution to various forms of EHRs.

ELECTRONIC RECORDS

EHMUS6_Dunbrack.indd 114 19/11/08 15:12:11


PBHRs and PHRs, investing in EMRs, and con-

tributing payer data to provider-owned EHRs.

When asked which collaborative initia-

tives do you expect your organization to invest

in, in 2008, both provider EMRs and EHRs

were mentioned by 38.7 percent of the re-

spondents. Increasingly, payers are investing

in applications to be used by their members

and providers. This same survey revealed that

the top three factors driving investment were

response to consumerism, and provider and

employer demands. Investments in external

applications is thus creating a new tension

between internal and external application in-

vestment allocation as well as new integration

and data requirements.

PBHRs are not widely deployed by payers,

nor will they be any time soon according to a

2008 Health Industry Insights survey. About

10 percent of the surveyed payers have a

PBHR in production, while 14.3 percent and

9.5 percent of respondents indicated that they

are evaluating solutions or piloting solutions,

respectively. Less than five percent reported planning for a PBHR in

2009, not one organization reported planning for a PBHR in 2010, and

57.1 percent reported no plans at all.

Certainly, PBHRs have their merits; they aggregate member

health information such as recent diagnoses, procedures, and hospi-

tal admissions; medication history; and lab tests (ideally along with

results), thereby creating a consolidated view for providers without

access to a provider-owned EHR that is fed with data from clinical

information systems.

However, workflow and data availability issues have inhibited

widespread provider adoption of PBHRs, especially if the payer is not

one of the dominant players in the geographic market. In turn, lack-

luster adoption of these PBHRs have discouraged other payers from

offering their own solutions.

In the 2008 Health Industry Insights survey, payers were asked

the status of contributing data to various EHR initiatives. Payers

were more likely to be actively contributing data to a community-

based health record hosted by a third party than any other types of

EHR; 26.6 percent of respondents indicated that their organization

is contributing data (e.g., in production) and another 19 percent are

evaluating solutions. Other frequently mentioned initiatives included

provider-owned EHRs (19 percent in production and 26.6 percent

evaluating solutions).

Future outlookMuch of the investment activity in PBHRs happened two to three years

ago, after the Bush administration pronounced that every American

would have an electronic health record. Today, while the major na-

tional payers offer a PHR to their members, just a few offer a PBHR to

their providers and only in certain geographic markets. For example,

Availity Care Profile is only available in Florida

and Texas, and HCSC operates the Blue Cross

Blue Shield plans of Illinois, New Mexico,

Oklahoma, and Texas. Achieving a critical

mass of members and providers in any given

geographic market remains a major inhibitor

to widespread use of PBHRs.

Providers, which typically contract with

multiple payers, want multipayer solutions to

ease workflow issues and increase the likeli-

hood of finding health information for a given

patient. With few exceptions, most payers

have been unwilling to collaborate with their

competitors on such payer data sharing ini-

tiatives, preferring to go it alone to preserve

branding and competitive advantage in the

marketplace. The lack of widespread Medicaid

and Medicare data also creates a data void.

The slow progress in payer-sponsored

EHR initiatives is reflective of the highly frag-

mented US healthcare industry. Members

change health plans every few years, creating

a financial disincentive for payers to invest in

strategies that have long term rather than immediate benefits. Provid-

ers contract with multiple payers, and any one payer, especially the

national payers, might not represent a significant percentage of a pro-

vider’s revenue stream to justify the provider changing administrative

or clinical workflows or adopting new technology for the sake of a few

members of that health plan.

The year 2014 is six years away. Unless there are fundamental

changes in the US healthcare system that create a more stable rela-

tionship between payer and member, as well as between member/

patient and provider, then payer-sponsored EHRs will continue to be

experimental only with a few health plans rolling them out in select

geographic markets where critical mass can be achieved. Without

critical mass measured in terms of the number of patients with data

readily available in the EHR, providers will continue to be reticent to

adopt EHRs sponsored by individual payers. n

“The slow progress in payer-sponsored EHR

initiatives is reflective of the highly fragmented US

healthcare industry”Lynne Dunbrack

Lynne Dunbrack is a nationally recognized thought leader in the

application of information technology to the business problems of the

health industry. Her understanding of industry needs is grounded in

experience over the last 25 years working as a consultant and in the

healthcare field.

As Program Director for Health Industry Insights, Dunbrack

provides research-based advisory and consulting services that enable

health provider and payer executives to maximize the business value

of their technology investments and minimize technology risk through

accurate planning.

Visit Health Industry Insights at www.healthindustry-insights.com

or contact the company at [email protected].

EHMUS6_Dunbrack.indd 115 19/11/08 15:12:13


Building ITinfrastructure

Boston Medical Center is a private, not-for-profi t,

academic medical center with a focus on community-

based care and prides itself on never turning away a

patient. In order to provide a consistently accessible

health service the hospital’s employees need a reli-

able and wide range of IT applications to give patients

the best possible care. “We’ve been working diligently for the past

few years to computerize the majority of both our clinical and op-

erational processes,” explains Brad Blake, Director of IT. “The push

to automation has allowed us to improve on existing processes and

provide better patient care, as well as allowed us to decrease oper-

ating costs.”

As Director of IT, Blake has responsibility for Boston Medi-

cal Center’s entire IT and telephony infrastructure and as such is

responsible for overall operations, security, new projects and driv-

ing technical strategy. With this comes a huge challenge: to ensure

that the entire infrastructure meets the clinicians demand. “We have

an extremely bright and talented pool of clinicians here at the hos-

pital and they are constantly coming up with new ideas.” Meeting

with the clinicians and vetting these new ideas is an important role,

and Blake ensures that everyone in the IT department is included in

this. “Since we are the main teaching hospital for Boston University

School of Medicine we have to be on the cutting edge because we

train the doctors of tomorrow,” he says. “Balancing the drive for new

solutions and technologies, while ensuring a stable and robust envi-

ronment has been the key to our success.”

Blake goes on to explain that as a best of breed shop he pur-

chases the best products to meet the needs of the end users. It is

EHM speaks to Brad Blake, Director of IT at Boston Medical Center, about data management, security and IT operations at the hospital.

CASE STUDY

EHMUS6_Blake-BuildingIT.indd 116 19/11/08 15:10:16


because of this practice that Boston Medical

Center uses several systems from a variety

of vendors. “This allows for the sharing of in-

formation across most of our systems so that

the data is where it needs to be in order for

clinicians to efficiently and effectively access

it without having to log out and log in to other

applications.”

Data managementBlake and his team are currently manag-

ing over 300TB across the enterprise, utilizing

a variety of EMC storage platforms. “We have

built a robust storage infrastructure based

around information lifecycle management,

which is built on the simple fact that the older

the data gets the less relevant it is,” says

Blake. This infrastructure allows Blake to take

advantage of four levels of storage. These

levels range from the high-end and fastest

Symmetrix SAN, all the way through to the

EMC Centerra platform that allows him to take

advantage of ‘write once read many’ technol-

ogies to manage ever-growing data retention

costs. “Being in a hospital we have several

regulatory requirements to keep hospital data

for specified time ranges. This solution has al-

lowed us to stay on top of regulations while

driving down the cost of storing data.”

Going wirelessThere is a continued trend across the

healthcare industry to push towards a more mobile workforce and

ensure end users are well informed on the topics they need informa-

tion on. It’s all about getting the right information to the right person

at the right time. “We have been fielding a lot more calls for people

looking to connect their personal devices to our wireless network,”

explains Blake. “One solution we provide is free public internet

access – this allows our end users or patients and visitors to access

the internet, but keeps this traffic separate from our internal wire-

less network.”

Blake goes on to say that technologies such as the iPhone and

Blackberry are penetrating the market more and more and that the

use cases that both clinicians and vendors come up with are “ex-

traordinary”. “I still believe that the vendors have a long way to go to

penetrate this market, which will require the re-development of their

applications geared towards tablets or handhelds.”

SecurityWhen USB drives first started penetrating the consumer market,

Blake was concerned about data loss and took measures to block

USB drives from being used. He quickly learned that the use of this

technology was prevalent, not only in his hospital, but in most others.

In Forrester’s Global Information Management

Services Forecast: 2007 to 2012 report, Tim

Sheedy, states that business intelligence services

dominate a $7.3 billion market. The report says that

information management solutions are moving to

the center of IT strategies as a way of driving IT

and business alignment and delivering real and

visible value to the business. The global information

services market will grow from $7.9 billion to $10.9

billion in 2012 with BI and business performance

solutions dominating the spend, although the

information strategy segment will see the fastest

growth throughout the forecast period.

WHAT THE ANALYSTS SAY

Clinicians would find that patients would walk in to

their appointment with a USB drive or CDROM that

contained their health information, and whether it

was a CatScan, MRI or X-ray, it was imperative that

end users had access to this information. “Person-

ally, I had an MRI this past year and when I walked

out of my doctor’s office he handed me a CDROM

that had my entire MRI on it so that I could bring

that back to my primary physician,” says Blake.

“It is this type of workflow that now has us inves-

tigating secure, encrypted and fingerprint USB

drives to ensure we have some level of protection

if someone were to lose their USB drive.”

Future focusThe IT department at Boston Medical Center is

continually focused on finding solutions that will

add value, reduce costs and reduce complexity

in the environment. Blake explains that he is cur-

rently looking at several initiatives to implement in

the coming years, which may bring together some

of the more disparate systems onto common plat-

forms: “The clinicians need for access to critical

patient data is always at the forefront of anything

the IT department produces.”

By continuing to refine business continuity

plans, increasing uptime of systems by introducing

high availability solutions to existing systems and

working with vendors to minimize the downtime

required for upgrades and enhancements to the

systems, Blake hopes to continually improve IT

infrastructure at Boston Medical Center. “We will

persist in implementing wireless solutions to meet the ever growing

demands of our mobile workforce and will always have a sharp focus

on security across everything we do,” concludes Blake. n

“We will persist in implementing

wireless solutions to meet the ever

growing demands of our mobile workforce”

Brad Blake

EHMUS6_Blake-BuildingIT.indd 117 19/11/08 15:10:19


EHM. Why is this an issue?

Steven Pap. The Institute of Medicine in their

report of November 1999, found that medical

errors are responsible for up to 98,000 deaths

a year. Researchers have found that although

the ultimate error is generally a mistake in treat-

ment or diagnosis, fully 55% of these errors are

set in motion by informational or personal mis-

communication. And these numbers are the tip

of the iceberg – they do not refl ect the morbidity

that also attends to these medical errors. It is a

national scandal that offi ces do not utilize avail-

able automated aids to track and communicate

lab tests to patients and avoid these results

entirely. It is ironic that the same physician who

embraces the latest in technology in the operat-

ing room, steadfastly resists automated aids in

the offi ce that could improve patient safety and

reduce malpractice risk.

EHM. What can be done to reduce these errors?

SP. An offi ce test tracking and communication

system must process – perfectly – the average

of 2500 tests that the typical physician orders

in a year. The ideal system should:

• Enter all tests, referrals, and follow ups into

the tracking system.

• Send email and voice messages to remind

patients of tests that need to be done.

• Record test result messages for patient re-

trieval.

• Notify patients that test results are available

and provide a vehicle for patient retrieval.

• Send reminders when tests are not com-

pleted.

• Track all tests, referrals and follow ups and

leave a daily alert for all staff members and

physicians for tests not completed and mes-

sages not received.

• Record and save all correspondence including

voice message fi les in case of legal issues.

These tasks seem impossible to accom-

plish until you consider that one can automate

every part of the process except the bullet

points in bold type above. This allows the offi ce

to institute a sophisticated test tracking and

communication system while not creating any

additional work for its beleaguered staff!

EHM. How does an automated system like Se-

cuReach work?

SP. A system must track tests from the date

the test is ordered until the patient receives the

results in order to close the loop. SecuReach

delivers this solution as an ASP (Application

Service Provider). The only requirement is a

broadband internet connection. There is no

expensive software or hardware to buy. The

medical offi ce is provided a user name and

password to access the system.

The basic system works as follows: Each

patient is provided with a custom patient

card (credit card quality) with a unique box

number and pin number. When a test returns

to the offi ce, the physician or designated staff

member dictates the actual results into the

web application via a USB port microphone.

The recording applet uploads the fi le into the

SecuReach database.

At this time, the system calls the patient

with a generic message that states a result

has been dictated into the patient’s private

voicemail box. When the patient receives this

message, he or she simply calls the toll free

number, inputs the box and pin number and

listens to the message. All correspondence

is recorded and available to the practice as

necessary. The application keeps track of all

tests and referrals and notifi es the staff when

tests are not completed or messages are not re-

trieved through a system of daily alerts, which

are updated in real time.

Compliance is improved by a series of auto-

mated reminders to the patients by both email

and phone. Offi ce phone traffi c is decreased by

up to 50 percent. The effi ciencies introduced by

automating the process allow clinical staff to

concentrate on patient duties instead of cleri-

cal ones. All this can be accomplished for less

than four dollars per physician per day.

Why does this still happen in doctor’s offi ces despite the availability of automated test tracking and communication aids?

Dr. Steven M. Pap is the President

of SecuReach Systems, Inc. (www.

secureachsystems.com). He graduated

from the Ohio State University College

of Medicine in 1977 and was in private

practice as an OB/GYN for 24 years.

In 2005, he founded the company and

designed its automated test tracking and

communication system. Over 400,000

patients are currently using SecuReach in

20 states.

STEVEN PAP

EXECUTIVE INTERVIEW

Lost tests result in patient injuries or deaths

secuReach.indd 118 19/11/08 15:12:22

Secureach_AD.indd 113 13/11/08 08:52:04


Many provider CIOs are re-evaluating their institutions’ processes for insuring patient safety. With this in mind, analysts Accenture have compiled the following list of the most dominant patient safety myths.

Top 10: Patient safety myths

1 Computerized physician order entry (CPOE) alone can improve patient safety.

While CPOE has been helpful minimizing errors associated with medication orders, it

is only one piece of the overall patient safety solution. Healthcare executives should

consider how their technology supports safety across the entire enterprise and realize

that any time you add new technology or change a process you can enhance safety and

reduce certain errors, introduce new errors into the system and make some errors harder

to detect.

5 If we build it, they

will come.

Trying to bring phy-

sicians on board after a

clinical system has been

selected and implemented

is a common and, quite

often, costly mistake. Do

not expect anyone to ‘heal

your pain’ if you take a step

that affects your medical

and nursing staffs without

their involvement and par-

ticipation up front.

6 Everyone else has a pa-

tient safety problem

– except us.

When sur-

veyed, most

healthcare lead-

ers believe that

patient safety is a major issue

in the United States – but not at

their facility. If you can imagine

an error occurring when refl ect-

ing on how your organization de-

livers care, it can, probably will

or even has already happened.

7 Benchmarking will defi ne where

we should start improving safety.

We are still early in our develop-

ment of advanced reporting systems for

capturing medical errors. Until we have

mature reporting systems and fully insti-

tute a culture where reporting errors is

less threatening, we can’t really get the

full picture of where medical errors may

and have occurred. If you rely on exist-

ing and incomplete benchmarking data,

it may hurt – not help – your efforts.

Most medication errors occur at the order writing

stage of the process.

Not all healthcare organizations do the same pro-

cesses the same way, and often there are many variations of the

same processes within an organization. Published reports from

other healthcare organizations about where errors occur may

not apply to yours. Are you positive that none of your errors are

occurring when medication is dispensed? Or during its adminis-

tration? Before implementing a CPOE system, you must undergo

a careful study of your existing system.

9 It’s okay to store almost all of

our patient data on an outpatient

system because that is how most

receive care.

Since there are no standards to carry

hard-coded critical system messages be-

tween vendor systems, the usefulness of

best-of-breed systems is limited. Though

a patient experiences the majority of care

as an outpatient, storing rich patient data

on an outpatient system that cannot be

extended into an inpatient or long-term

care system creates a major gap through

which safety issues can likely arise.

8 Patient safety requires a new cor-

porate department.

If you want to make lasting change

in your organization, patient safety

should be part of the organizational

‘genome.’ Instead of creating another

large siloed department with new posi-

tions that focuses solely on safety, let

patient safety become an integral part of

all processes – part of the organizational

fabric in everything you do.

4 Implementing an advanced clinical system will mean layoffs.

Beware the vendor story that “our system will provide you enough rules and

alerts that you can reduce or remove certain people from your processes.”

No clinical system contains enough current information to replace human decision-

making, nor will these systems reach that level of functionality in the span of their

product lifetimes.

3 Return on investment (ROI) is the

reason to address patient safety.

Don’t build your ROI based on

safety alone. Common folklore aside, it is

impossible to directly measure any fi nan-

cial benefi t from patient safety initiatives.

Instead, consider investing in technology

as a way to achieve high performance by

improving patient safety while it enhances

your bottom line in other ways.

2My vendor understands

patient safety.

Patient safety is still a

relatively new discipline. Un-

fortunately there are very few

individuals who understand the

key issues of and approaches for

patient safety, and can match that

with experience to make it relevant

for you and your health system.

TECHNOLOGY SAFETY

Accenture-top 10.indd 120 20/11/08 08:13:49

DesignClinical.indd 1 19/11/08 08:48:03

In her role as Vice President for Worldwide Clinical Research

Operations at Pfizer, Diane Jorkasky ensures that all exploratory de-

velopment, clinical pharmacology, translationalmedicine and clinical

technology studies are conducted in accordance with good clinical

practices standards and are delivered on time and on

budget. Quite a task, but Jorkasky is proud of her team’s

achievements in this area.

“We do achieve this far more than one would expect,

given the complexity of working with 10 different therapeu-

tic areas, with all of them organized separately. We have

many, many customers, and yet we’ve been able to achieve

this through constant interaction with the customers. We

have terrific people within my department who bend over

backwards to ensure that the work gets done, that we get

things done on time.

“It takes a lot of planning on the part of the staff and the research units.

Weareverycarefulabout thebudgetandmakingsure thatweareasefficient

as we possibly can be in keeping costs to a minimum, and we have

brought in a high degree of technology that takes away much of the

human component that’s often required in research settings. We don’t

have to worry about quality assurance anywhere near what most com-

panies have to worry about because we bake all of this into the infra-

structure systems that we have.”

In her current position, Jorkasky oversees all phase I studies for Pfizer,

with the exception of oncology, and all clinical pharmacology studies inde-

pendent of their stageof development, including small early

proof of concept studies. Most of these studies are con-

ducted in three clinical research units located in Singapore;

New Haven, Connecticut; and Brussels, which act as one

unit with three locations under standard procedures, poli-

cies and principles.

“The greatest challenge I face in thisposition isensuring

that the inhouseresource isutilizedto itsmaximum,”shesays.

“This means some flexibility in the way one schedules. The

otherchallenge is tryingtoovercomepeople’s resistancetothe

concept of working at global sites with which they may not

havehadfirsthandknowledge. The resistance isovercomewithdemonstrat-

ingperformance,with a strongemphasis on frequent communication.

InnovationJorkasky has championed the highly efficient management of global

clinical research units – CRUs – all of which deploy state-of-the-art tech-

GOING GLOBAL


Pfizer’s Diane Jorkasky champions the use of geographically diverse clinical researchunits to transform the conduct of phase I trials. EHM finds out why.

30%WOMEN MAKE UP

LESS THAN

OF THE TOPECHELONS OF PHARMA

COMPANIES

Jorkasky ed:31MAY 19/11/08 15:26 Page 122

nology todrive progress forward. Howhave these radically transformed the

conduct of phase I trials?

“We are able to do very complex studies across all three units simul-

taneously, and to the same level of medical integrity, the same level of

standardization of the quality of the methodology involved, the assays,

the evaluations by the medical staff and the nursing staff, and we have

a standardized database that’s a technology coupled with a disciplined

behavior by our staff, such that everything is done according to the

highest standards.

“This gives us a phenomenal opportunity to be innovative, because if

you collect your data in a way that is standardized, no matter what those

data are, you can still have great degree of flexibility in evaluating them.

If you can collect those data in a way that allows you to do anything with

them, you have a great capability that goes beyond what any other com-

pany is able to do. As a result of that, the big innovation that we’ve been

able to accomplish is that on amoment’s notice, for example, you can tell

exactly what the adverse event rate is among phase I volunteers across

every study conducted.”

Jorkasky says this allows researchers to tell, day-to-day, what the lat-

est subject count is, and this can be parsed out according to where that

subject is in the world, what kind of pharmacological agent they were ex-

posed to, whether they were on placebo and whether they were on a bio-

logic. Pfizer has found this to be so valuable that the companyworkingwith

the NIH now to have all this data analyzed and published, since this infor-

mation is lacking in the literature.

123

EqualityBehind every exciting new discovery are the men and women who

made it happen.Whilemanywomenwork as researchers and in other roles

in the pharmaceutical industry, as youmove higher up the ladder, the rep-

resentation of women and people from diverse backgrounds tends to dry

up. For this reason, Jorkasky, as an advocate for theWomen’s Leadership

Network, has been an enthusiastic supporter for greater roles for women

both within Pfizer and elsewhere.

“The pharmaceutical industry is trying to improve its track record in en-

suring opportunities for women and diverse candidates. Across the pharma-

ceutical industry, probably themajority of employees arewomen, and yet as

yougo tohigher levelsof theorganization, youwill see far fewerwomen than

you will men. In most companies, women make up less than 30 percent –

sometimes less than20percent – of the topechelonsof the company.

“There isahugeamountofworkstill tobedone inthis regard,andtheun-

fortunate thing is that the industry loses out by not having that female per-

spectiveat thetable.Womenarethemajorcareprovidersacrosstheworldand

the oneswhowill often remind folks to use our drugs and tomake suremed-

ical care is achieved. We don’t even think about the impact that not having

womenatthetablewithinour industryhasonourproducts inthemarketplace.”

Where next?Thepharmaceutical industry is at a crossroads,with extraordinarily high

attrition rates,and therearemanyattempts toget thatnextbigbreakthrough

that leads to increasedproductivity. The cost of doing studies is rising, along

with theexpectationsof thosestudies in termsof thequantityofdataandthe

safety of thedrug in themindsof regulators and thepublic.

“The challenge we all face is continuing to support R&D research at a

time of enormous pressure on the healthcare system, including the phar-

maceutical industry,” Jorkasky says. “We are looking at how we do busi-

ness and what we need to dramatically change to continue to bring

medicines to patients.

“We’re going to see tremendous flux in all companies, where they start

toworkmore inavirtualwaywithavarietyof suppliersandvendorsandsup-

portorganizations, includingCROs.We’regoing toseestrongerdecision-mak-

ingonwhatdrugsshouldnotbe taken forward,which is really important toan

organization’ssurvival.Thesooneryoucanstopadrug that’snotworking, the

better off youwill be. Andwewill see smaller, leaner companies,more virtual

in their operation thanwhatwe’re seeing today.”�

www.executivehm.com

Diane Jorkasky is Vice President for Worldwide ClinicalResearch Operations at Pfizer. She is responsible forensuring that all exploratory development, clinicalpharmacology, translational medicine and clinicaltechnology studies are conducted in accordance withgood clinical practices standards. She has beeninstrumental in providing the leadership and vision forPfizer’s Clinical Research Units (CRUs), which haveradically transformed the conduct of phase I trials.

Jorkasky ed:31MAY 19/11/08 15:26 Page 123

Todd Evans ed:31MAY 19/11/08 15:28 Page 124

Pharmaceuticalmarketingmethods havebeenundermuch scrutiny in re-

cent times, particularlywhen it comes to such controversialmethods as

direct-to-consumer marketing. What once was a rather stable environ-

ment in the70s, 80s and90shas turned intoone influx.There havebeen

a number of shifting patterns with a diversification of the stakeholder

pool, and the recognition that consumers are nowempowered to select

their preferred medicine. At one time the marketing world was rather

one-dimensionalwith decisionsplacedexclusively in thehandsof physi-

cians. However, times have changed. Influence now comes from large Government payers

such as the Centers for Medicare andMedicaid Services (CMS), the private insurance carri-

er community, employers, advocacy groups, and patient communities, although physicians

still carry significant weight in product selection.

Adramatic change in theportfolio composition has affected the status quo. “Historically,

wewould expect to see fairly simple chemical compoundproducts that employeda fairly stan-

dardizedgo-to-marketmodelwhichearned tremendousvolumesof revenueevenasaproduct

enjoyed patent protection,” acknowledges Todd Evans, Director of PricewaterhouseCoopers’

Health Industries Advisory, Pharmaceutical & Life Sciences practice. “In this decade, we’re ex-

periencing anewproduct conversion fromprimary care products over to a specialty drug port-

folio. With this, we’re seeing a lot more discovery upon the biologic molecule, which is

significant due to its step-point increase in complexity and cost. This development offers a

great deal of challenge not just to the patient, but to the physician and payer community as

well. There’s a great deal of go-to-market changebeing driven just by the portfolio transition

alone, and it’s being exacerbated by a need to supplement organic R&D with biologic ac-

quisitions that are supplementing fairly weak pipelines.”

Evans highlights how such factors as rapid in-licensing deals, and acquisitions of bio-

logic companies implies that themission of the sales andmarketing organization has to be-

come terrifically diversified in an awfully big hurry. Despite this, more often than not, and

particularly within the traditional ‘big pharma’ companies, there is highly efficient, homog-

enized business model that was designed to address primary care products and is some-


Certain tactics in pharmaceutical marketinghave tarnished the industry’s reputation inrecent times. Todd Evans of PwC looks atthe new thinking that can help restore thepublic’s trust.


BD.indd 1 14/11/08 14:25:17

times slow to adapt. “Organizations need to differentiate quickly and dif-

ferentiatewell – in termsofwho is addressed as influencers,what themes-

sage is, the types of people that are the face to the market and how

products are branded so as to create a well defined and differentiated

brand experience around the product,” he advises.

DTCDirect-to-consumermarketing has been the Achilles’heel for all those

involved in thepublic face of pharma, acting as apartial contributor to a cri-

sis in the industry’s reputation. “Inmany instances it [DTC] has earned the

wrath of the public as the adverts that come into the home even as Mom,

Dad and the kids are watching TV are often unwelcome,” laments Evans.

“The industry may have unwittingly taken

a black eye from that situation. There has

been tremendouspublicity linked to it and,

to some degree, demagoguery into how

the industry trades – with many stories of

greed and tremendous wealth that has

been created by a handful of very success-

ful drugs, some of which are lifestyle fo-

cused in nature. Thewhole DTC revolution

has been a big challenge in terms of repu-

tation advancement and industrymessag-

ing, despite in a majority of cases

delivering informative andeducational dis-

ease related to themarketplace.”

An additional shift in the industry that

Evans identifies is that there has been the

beginnings of a transition from a bias to-

wards care delivered in institutional envi-

ronments to that of the homeenvironment

andanemphasis on self-care over going to

the physician for every minor ill. He notes

how this is being reflected through out-of-

pocket payment (OOP) structures, physi-

cian reimbursement levels and the decoupling of product pricing fromcare

delivery costs. Retail store based clinics are aparticularly important service

delivery innovation, as well as the formation of home nursing and infusion

networks.With the consumer bearing an increasing degree of cost on a di-

rect basis, one can expect that the patient is a critical stakeholder in prod-

uct selectionand cost relateddecisionmakingwhereoptionsexist. “There’s

a big transition in terms of the incentives that are being put in place for the

consumer to respond to by the payers,” he identifies.

A serious concern formany in the industry is thatmany patents expire

over thenext fewyears.Manyof thesepatentedprimary careproducts have

been the cash engines for the industry over the last 20 years. The immi-

nence of the deadlines is creating a certain sense of crisis as Evans high-

lights: “Companies are worried about which future products will sustain a

company’s growth and position it for growth in themarketplace. Secondly,

there is thematter of downsizing sales forces for productsmoving to gener-

ic status while defining what capacity is needed to create specialty treat-

ment brands,maintain a high-quality patient experience, and go tomarket

in a way that is rational and appropriate for the stakeholder communities

and on an affordable basis that the enterprise can sustain. Those costs

need tobemanaged carefully and very differently across therapeutic areas.

Themarket facing organization challenges certainly can’t be ignored aswe

see a tremendous volumeof primary care revenues fall into generic status.

This seismic, industry-wide revenue event demands a well managed in-

dustry response that deftlymaximizes the newproduct assetswhile down-

sizing forces that are facing obsolescence.

“You can see this in the tentative steps that are currently being taken

to downsize pharma’s sales force populations. There’s some lip service

being given to the fact that the model’s changing, when in fact we’re see-

ing a response driven by revenues falling off and generic conversions tak-

ing place. Up to now, it appears as a calibrated adjustment in what we

spend in going to market the tradition-

al way, versus an end-to-end redesign

that is purpose-built for the specialty

portfolio profiles that pharma is devel-

oping, in-licensing and/or acquiring.”

Image is everythingOftenwhenpeople thinkof pharma

companies the image conjured up by

many is not overly flattering. In fact, the

image of the industry has been harmed

by a number of different factors.

According to Evans,most of the effort to

deal with reputation has been made in

the context of delivering therapeutic

health value and creating greater pub-

lic awareness of healthcare conditions.

However, he argues that this does not

serve the needs of political dema-

gogues, which tend to use the industry

as the bad boys to get a philosophical

or political message across. “Pharma

companies tend to be the richest link in the healthcare value chain, so it’s

easy to beat the guy with themost money up.What is lost is the full value

of healthcare value that many pharmacological treatments deliver versus

the hospital and acute care charges that a lack of pharma treatment may

ultimately drive.”

There are twogeneral images that a pharmaceutical company can con-

vey. The first is of pharmaceutical companies as self-interested, growth fo-

cused, greedy corporate titans pushing products for the sake of selling


“Direct-to-consumer marketinghas been the Achilles’ heel forall those involved in the publicface of pharma”

Todd Evans


products above all else. The other is of an industry that delivers previous-

ly unmet medical benefits with improved healthcare to the life of an indi-

vidual. “Those are very different images,” pinpoints Evans. “Unfortunately,

during the 90s and up to now, a number of factors have unwittingly creat-

ed an image of greed, self-interest and cynicism. This image has been eas-

ily exploited by politicians and others that find these growth practices

inimical to the public interest – that’s a big problem.”

AccordingtoEvans, inorder tomakeanimpactuponreputationapharma

companymustfirst recognizewhat its reputationis,accept it,anddesignapro-

gramtocorrect it. “Ibelievethe industrydoesrecognizethat there isaproblem

and that theyneed todosomethingabout it,”heaffirms.

As far asmanaging these things, Evans identifies some conflicting be-

havior. For instance, direct-to-consumer spending continues to be strong;

however, the impact and results of it could, he continues, certainly be char-

acterized as dubious. In his opinion, there are tradeoffs betweenperceived

influence on product sales versus the certain influence on reputation and

how that affects product sales and reputation. “There’s a conflict there,” he

states. “The industry continues to focus on high cost specialty drug prod-

ucts and for theseproducts to be acceptedby themarketplace and thepay-

ers that must pay for them, pharmaceutical companies need to work on

improving their healthcare reputation, drive trust in their message and re-

duce the barriers for acceptance for the outcomes they present.”

Brand practiceA strong brand can influence the choices that customers, employees

and investors make. However, pharma companies only seem to have dab-

bled with short-term corporate ad campaigns, which are rarely sustained

long-term.What are someof the reasons behind this? Evans highlights how

a number of companies have taken significant ‘black eyes’ as a result of a

combination of mistakes and believes the demagoguery of their motives

and intentions have done real damage. This has forced pharma to begin to

defend themselves. “I believe that what you’re seeing in the marketplace

around corporate branding and campaigns to resuscitate corporate image

has anawful lot to dowith the fact thatwehave a farmore safety conscious

FDA regulator,” outlines Evans. “There is a higher hurdle to meet in terms

of trust.Wehave less tolerance for safety riskswith products,whether they

are already in market or are new products that are just trying to come to

market. There’s anecdotal evidence that things are getting tougher.

Therefore, your ability to communicate to the public, the physician com-

munity andpayers is critical towards establishing yourmotives, objectives

and the kind of events that take place on the path to a clinical trial or mar-

ketplace result.”

Branding is often fleeting in pharma and is focused on the product

rather than building the public trust through corporate branding. Evans

highlights how themost important aspect to rememberwhen talking about

branding is that brand is an experience, not a name. He highlights how a

corporate brand experience is something we associate with a company

such as Coca-Cola or Kodak. However, with pharma companies things are

different, “A pharma company plays in lots of different disease states and

therapeutic areas; theymaybe involved inpreventions, cures and/or chron-

ic treatments. Branding all of those things homogenously under a single

brand name tends to be not as effective. If you accept the premise that

brand is an experience and that you have a diversified stakeholder pool

across the value chain, it forces you to differentiate bothwithin and across

a brand. This enablesmessages to be tailored to discreet targets in such a

way that they drive value and that value resonates in a response, a feeling,

a perception and hopefully, a premium on the price.”

Evans believes that the pharmaceutical industry is learning quickly to

take on the challenge of recognizing the need for differentiation and tailor-

ing an effective brand response to it. He states, “The landscape has

changed with specialty products and we are now seeing the envelopment

of a patient through a service experience that’s being branded.”


Becoming externally oriented with stakeholder

communities far sooner in the development process is

absolutely key. Firstly, this can lead to reprioritizing

product pipelines and even de-funding a product that no one

might pay for. Secondly, the clinical trial process offers insight

into how patients experience the therapy itself. It helps the

team understand what branding messages need to be

emphasized and what kind of business/service model the

franchise should wrap around the product. These are

important decisions that must be synchronous with the

branding experience as it’s rolled out in sales and marketing

launch campaigns.

The best practices are really coming from organizations that

are more externally focused earlier in the process than others.

They are able to get a good bead on stakeholder preferences

prior to the mad dash when a product is released into the value

chain upon the regulator’s approval. Getting the patient and

physician experience defined accurately out of the gate while

preparing the healthcare community for that experience and its

value in health benefit during the run up to product approval can

make a big difference in compressing the time to peak sales.

The final best practice to add is found in differentiation –

recognizing key points of difference across the primary care and

specialty drug landscape, as well as patient needs. Each

BEST PRACTICES FOR A STRONG AND CONSISTENT PRODUCT BRAND

“Branding is often fleeting in pharmaand is focused on the product ratherthan building the public trust”


Building experienceWith this inmind, howdoes apharma companymanage andbuild this

kind of corporate experience? Firstly, when referring to corporate branding

it is often about the intangibles such as messages of trust, integrity, and

credibility that need to be conveyed. “These are big messages,” explains

Evans. “They’re about humanity. They’re about a value system and about

the morality of how we conduct our business. The destruction of trust, in-

tegrity and credibility are things that certain segments of society have cho-

sen to destroy by broadly demonizing the pharma industry for when an

occasional bad actor in the pharma community commits a wrong. I’m not

sure it oftentimes results in a net benefit to society to do that. If everyone

runs around believing that the pharma industry is an evil community bent

on greed andonly greed, thenwehave a societal problem in themaking. A

cynical public shaped by hyperbolic political demagoguery is not one that

is going to promote participative involvement in clinical trials, may active-

ly suppress deserved pricing premiums and ultimately inhibit an increase

in the healthcare outcomes that we all seek in new products.”

Evans’s advice is for pharma to ensure they communicate to society

that the company is ethical and delivering societal healthcare benefits –

sometimes even if this means taking a bullet in terms of the bottom line.

“Youneed to recognize that you can take advantageof suchmessages from

a branding point of view by communicating that your head and your heart

are in the right place and that you’re doing the right thing. It may not nec-

essarily alwaysmake youmoney, but because you havemoney you’re in a

position to do it and shape the conditions for a future where new treat-

ments can be developed to deliver societal benefits. These arewise things

for pharma companies to consider, and there are some characters in the

community that are actually acting upon this story.”

A further challenge for the pharmaceutical industry is the seemingly

inconsistent way that they brand and promote their products, often char-

acterized by frequent changes. As a result, consistency is lost, which can

send out confusing messages. There are both good and bad reasons for

brand strategy changes.Oneof the reasons for such a change could bedue

to a Phase IV study that results in unexpected results whereby the law of

unintended consequence forces a change.

As Evanshighlights, it couldbe that “a grant thatwasmadeanda study

was conducted beyond the control of the pharma company, resulting in

somebadpress for a particular product. There have been several high pro-

file cases of this over the last few years resulting in better controls over

studies that could affect a product's image, aswell as a dramatic retooling

of howwe go tomarket as a brand.”

Trial and error is generally not a good way to go to market warns

Evans, which is why getting things right from the start is absolutely es-

sential. “Brand is experience,” he reinforces. “…the challenge for the

industry is in embracing that message as opposed to brand being

name recognition and pretty much leaving it there. It’s really about

what the patient, care giver and physician experiences and what the

payer organizations and employers experience relative to that thera-

py’s value benefits.”

As treatments become increasingly more personalized, with indi-

vidual genetic assessment and recommendations for biomarket driven

treatments commonplace, success will depend on how well a pharma

company is able to connect brands to the people using their treatments.

“One could argue that the evolution of a brand is synchronous with the

increasing benefits that such a product may deliver to society,” he ac-

knowledges. “We need to look back to the whole development process,

and to introduce the aspect of external stakeholder communities to the

product. The experience a product starts to reveal and deliver back in

Phase II and throughout Phase III clinical trials is critical for getting the

branding right as you are coming to market. If you wait until too late in

the development process to identify critical services, patient experi-

ences and data points that connect patient benefit to treatment prac-

tices, then the identification of a branding program may be rushed,

insularly defined, and likely to miss the bulls-eye. In an era of billion

dollar new product development costs, the possibility of making a mis-

take that leaves money on the table through an inaccurate patient ser-

vice model and a misplaced branding experience is intolerable. In the

end, getting it right by accurately communicating healthcare expecta-

tions and benefits to patients, physicians and payers alike will go a long

way to regaining the public trust.” �


therapeutic area has patients and physicians with remarkably

different needs and perceived expectations.

Aligning a model that meets such differences on

a tailored basis is a requisite for specialty drug

success. Physician education needs from

pharma are extraordinarily different for specialty

drugs and place a premium on deploying the

right message and personnel to deliver it. For

many new products there is a very discrete

experience that patients will either sail through

with ease or have to confront with a range of

pharma supplemented support services, thereby giving patients

the tools to overcome the obstacles that can defeat a full course

of therapy and its intended outcome and benefit.

Companies that go to market in a homogenized,

vanilla manner, as if all products and patients are

the same, tend to leave a lot of money on the

table by not differentiating where necessary. The

price of inappropriate alignment with patients is

early discontinuation of therapy, wasted payer

funds and lost pharma sales, whereas good

alignment maximizes the new product asset and

drives superior outcomes in satisfied

stakeholder communities.

“Eachtheraputic area

has differentneeds”


ple, we have a drug used in bone marrow trans-

plants and for multiple myeloma. We’re also look-

ing at using this in other indications for

chemosensitization assays and chemosensitiza-

tion treatments. We’re using drugs that we once

used to treat cancer to treat multiple sclerosis. At

Genzyme we are focused on expanding our sci-

ence and technology platforms to treat orphan in-

dications or larger patient population with unmet

medical needs.”

An important lessonBlankstein describes how applying a

‘lessons learned’ process early on and through-

out a development program will help the study

team perform at a much higher level and be

much more effective and successful

at completing a trial. The key is

trying to understand by

using lessons learned what the challenges are

for a project team as they work through a large

global study. “It is important to use a lessons

learned process throughout the study so the

team is regularly understanding and managing

team issues,” he advises. “In many situations,

lesson learned are performed at the end of a

project, which is often too late. By then, every-

thing has happened.

“It’s important to identify issues that are af-

fecting team performance early in the project so

they can be dealt with immediately, so as the

team progresses through a global trial they

have a greater likelihood of meeting the study’s

challenges and achieving success. With global

trials, the goal is to complete them on time and

on budget with a high level of quality to in-

crease the likelihood of approval. Having a pro-

ject team not proactively manage issues as they

develop on an ongoing basis through the study

can lead to significant delays and poor quality.

A timely, effective lessons learned process can

help avoid many of these issues.”

Future goalsCompleting its clinical trials on time and ef-

ficiently is another focus for the company.

Genzyme has four key clinical programs, and

Blankstein believes the company has done well

to organize itself around these programs and

adjusting resource allocation to focus on com-

pleting them on time.

“If the company is successful in doing this,

then it will continue to contribute to the growth

of Genzyme,” he explains. “Over the next 12-18

months, we will emphasize these key programs,

keep our focus on them, but not forget other pro-

Genzyme’s clinical research programs are

focused on inherited lysosomal storage

diseases, renal disease, orthopedics,

cancer, transplant and immune diseases, diag-

nostic and genetic testing. As Senior Director of

Clinical Research, Larry Blankstein has clinical

operations responsibility for the endocrinology

business unit. He has been actively engaged in

a number of drug-drug interaction phase I stud-

ies, as well as thorough QTc studies in

Genzyme’s other business areas.

For Blankstein, ensuring the company’s

resources are being optimized across studies

is an important focus. “As certain studies slow

and begin to wind down, while others are en-

tering phase III, we have to make sure our re-

sources are utilized efficiently across studies,”

he stresses. “The challenge is to make sure

that we’re maximizing both our internal re-

sources as well as our external ones in terms

of their utilization and effectiveness.”

One of the most interesting developments

happening has been in ultra-orphan diseases.

The initial technologies deployed were enzyme

replacement therapies where patients would re-

ceive IV infusions every other week. These were

very successful and worked well. However, new

small molecule technologies

are beginning to make an im-

pact, which means that subjects

can take a pill and may not have to

come into a clinic, infusion unit or a hospi-

tal every two weeks or so.

“This is one of the advances we’re seeing

in this area,” highlights Blankstein. “We

are expanding our

platforms into

other areas.

For exam-

Lessons

Genzyme’s Larry Blankstein looks at thechallenges of completing global clinical trialson time and effectively.

Larry Blankstein is Senior Director of

Clinical Research at Genzyme.

Blankstein has more than 20 years of ex-

perience in pharmaceutical and biotech-

nology drug development. Prior to joining

Genzyme, he was Executive Director of

Program Management at Quintiles.

learned PHARMA FOCUS

BLANKSTEIN:nov08 19/11/2008 16:05 Page 130


Genetic diseaseGenzyme is recognized

as a global leader in research, product devel-

opment, and outreach to the medical and pa-

tient communities for rare genetic diseases

known as lysosomal storage disorders

(LSDs). In 1991, the company intro-

duced the first product ever approved

to treat a lysosomal storage disorder,

Ceredase (alglucerase injection).

Since then, Genzyme has devel-

oped a second-generation

Gaucher disease product,

Cerezyme (imiglucerase for in-

jection), and introduced

Fabrazyme (agalsidase beta) for Fabry disease,

Aldurazyme (laronidase) for

Mucopolysaccharidosis I (MPS I) and Myozyme

(alglucosidase alfa) for Pompe disease.

Renal diseaseGenzyme is enhancing the treatment of

chronic kidney disease with its phosphate

binder, Renagel (sevelamer hydrochloride).

Nearly all patients on hemodialysis take a

phosphate binder which, before Renagel

was introduced, was typically aluminum or

calcium-based. Renagel is the only calcium-

free, metal-free non-ab-

sorbed phosphate binder

on the market.

OncologyGenzyme’s oncology pro-

gram is building a founda-

tion in cancer treatment with

a strong focus on antibody

and small molecule therapies.

Genzyme currently has two

marketed leukemia products,

Campath (alemtuzumab for in-

jection) and Clolar (clofarabine)

for intravenous infusion. The

company is also focused on

new treatments for cancer pa-

tients through both internal

research and external col-

laboration.

Transplant/immunediseaseThe field of transplantation

medicine has evolved rapidly,

particularly where management of acute organ re-

jection is concerned. While in the past, organ loss

often occurred one to two years after transplanta-

tion, the introduction of drugs such as

Thymoglobulin (anti-thymocyte globulin, rabbit)

has significantly improved the success rate of

these surgeries.

OrthopaedicsGenzyme is a leader in the field of orthopaedics,

with a promising group of products on the market

and in the development. The leading product in this

area is Synvisc (hylan G-F 20), a viscosupplemen-

tation treatment for relieving knee pain associ-

ated with osteoarthritis.

Adhesion preventionThe company has developed a suite of bioma-

terials used to help improve the outcome of

certain types of surgeries. Its Sepra line of

hyaluronic acid-based products has been clini-

cally shown to reduce the incidence of adhe-

sions following general abdominal and

gynecologic surgical procedures.

Cardiovascular diseaseGenzyme is a pioneer in exploring both gene

therapies and cellular therapies as potential

treatment modalities for serious cardiovascu-

lar diseases. With clinical programs employing

both therapeutic methods, Genzyme is fo-

cused on treating ischemic diseases charac-

terized by inadequate blood flow and poor

cardiac function.

Diagnostic products and servicesGenzyme Diagnostics, through its partners and

distributors, offers a novel line of products for

the diagnostics industry and the clinical labora-

tory. The company continues to develop new

tests for diagnosing a variety of indications in-

cluding heart disease, diabetes, pancreatitis, in-

fectious disease, emergency medicine and

women’s health.

Genzyme Genetics provides reproductive and

oncology diagnostic testing services. In the

area of reproductive testing, the company fo-

cuses on technology that will allow information

to be provided on a range of diseases from a

single patient sample.

GENZYME’S RESEARCH AREAS

jects that are in pre-clinical, phase I or phase II

that are also important for our long term growth.

We have a level of resource and funding for these

programs as well, so when we complete the key

projects others will move up in priority. We also

have a very active business development focus

that looks for acquisitions, partnerships and

mergers, to add to our pipeline so Genzyme can

continue to provide important treatments for pa-

tients with unmet medical needs.”

In the clinical research area, Blankstein sees

a number of developments ahead. He believes

there will be a move towards more outsourcing

models. “The traditional concept of companies

like Genzyme having a large clinical staff that

can manage and monitor all of their trials is

changing. Companies are moving more towards

outsourcing certain operations so they can focus

on their core competencies with a staff that is

much more experienced in how to outsource

and manage service providers successfully. By

doing so the relationship between the sponsor

and the provider can be maximized to bring the

greatest potential.” n

BLANKSTEIN:nov08 19/11/2008 13:19 Page 131

60,000 patients between 2001 and spring 2004.

The excellent resources these facilities offer and

the competitive prices have proven a particular

draw for patients not only from developing coun-

tries but even from a number of developed ones

who come to India for specialized treatment.

Patients can get packaged deals that tend

to include flights, transfers, hotels, treatment

and often a post-operative vacation. US and UK

patients are responsible for the biggest growth

in this sector although visitors from 55 countries

come to India for treatment. Taj Medical Group

is just one example of an agency that receives

200 inquiries a day from around the world and

arranges packages for patients to have opera-

tions in India.

India’s healthcare sector in general has

been growing considerably over the past few


TRAVEL FOCUS

132A passage to IndiaWe take a look at the treks medical tourists will take forcheaper treatments in India.

Medical tourism to countries such

as India is becoming a viable

option for many sick people dis-

affected with the care they re-

ceive in their native country. The spiraling

costs of medical fees mean that patients are

expanding their options and looking to hos-

pitals abroad to provide them with cheaper

treatments while maintaining a high level of

experience and skill. For example, patients

from the US are seeking treatment at a quar-

ter or sometimes even a 10th of the cost at

home. Reports indicate that medical tourism

to India is growing by 30 percent a year and

could bring between $1 billion and $2 billion

US into the country by 2012.

The private sector accounts for more

than 80 percent of total healthcare spending

in India. State-of-the-art private hospitals

have been opened in cities like Mumbai,

New Delhi, Chennai and Hyderabad Major

funded by major corporations such as Tatas

and the Apollo Group. In fact, Apollo

Hospital Enterprises treated an estimated

years. This growth has been gradually esca-

lating since the 1990s, when healthcare

grew at a compound annual rate of 16 per-

cent. Today the total value of the sector is

more than $34 billion. By 2012, India’s

healthcare sector is projected to grow to

nearly $40 billion.

The ‘Gateway of India’ monument, Mumbai

INDIA STATS

Area: 3,166,414 sq km(1,222,582 sq miles)

Population: 1.1 billion(Estimated 2007)

Population density: 347 per sq km

Capital: New Delhi

Head of state: President Pratibha Patil (Since July 2007)

Head ofgovernment: Prime Minister Manmohan Singh (Since 2004)

750,000Americans travelledabroad for medical

care in 2007

TRAVEL INDIA EHM:nov08 19/11/2008 13:40 Page 132


SCENIC ATTRACTIONS

Taj MahalThe Taj Mahal was built by the Mughal emperor Shah Jahan for his beloved queen Mumtaz.

Situated on the banks of the river Yamuna, in the historic city of Agra, it was created out of

marble and took a workforce of 20,000 22 years to build. It is now a UNESCO World Heritage

Site. Visitors will be awed by this marble mausoleum with its spectacular ornate features.

Hawa MahalConstructed by Maharaja Pratap Singh in 1799, this out-

standing monument created out of pink and red sand-

stone is a part of the City Palace of Jaipur and boasts an

impressive Rajput architecture. Conceived and designed by Lal Chand Ustad, Hawa Mahal was constructed for

the women of the royal household so that they could enjoy observing the activities and colors of everyday life of

the streets covertly.

Golden TempleThe four-centuries-old Harmandir Sahib or The Golden Temple of Amritsar, Punjab is the paramount pilgrimage

canter of the Sikhs. Situated in the middle of a lake, its stunning dome is decorated with 100 kg of gold leaf and

it combines a blend of Hindu and Muslim architecture.

Kerala Backwaters This network of water channels lies parallel to the Arabian

Sea coast and is a major tourist attraction. The inter-connected network of water-channels,

lakes, lagoons and estuaries of about 44 rivers, which empty in the Arabian Sea, are techni-

cally termed as backwaters. Elaborately decorated houseboats can be seen floating along the

waters, providing a peaceful view

of daily life on and off the shore.

MahabalipuramClassified as a UNESCO World Heritage Site, Mahabalipuram is a town in the

Kancheepuram district in the Indian state of Tamil Nadu consisting of many historic mon-

uments built between the seventh and the ninth centuries. These have been classified

as examples of early stages Dravidian architecture and Buddhist elements of design

are prominently visible.

Darjeeling Himalayan RailwayNicknamed the ‘toy train’ this 2 ft gauge railway follows serpentine route from Siliguri to Darjeeling and offers passengers stunning views of lush

and tranquil tea plantations along the journey. Built between 1879 and 1881, the train became a World Heritage site in 1999.

CITY

FOC

US

Taj Mahal

Hawa Mahal

Kerala Backwaters

Mahabalipuram

Mumbai (pop. 13 million)Formerly know as Bombay,

Mumbai as it is now is known as

the financial capital of India and

the second most populous city in

the world. Prizing itself for being

the most eclectic and

cosmopolitan city in India it is

also home to its film industry,

Bollywood.

New Delhi (pop. 11 million)The city is situated within the

metropolis of Delhi and serves as

the seat of the Government of

India. In terms of its layout, Delhi

encapsulates two very different

worlds: the ‘old’ and the ‘new’.

New Delhi was built as the imperial

capital of India by the British; Old

Delhi served as the capital of

Islamic India.

Calcutta (pop. 8 million)Located in eastern India on the

east bank. Although the city is

infamous for its poverty it is also

recognized as the cultural center

of India. The city is littered with

museums, bookshops and is home

to many poets and artists. The city

is full of English street names,

architecture, and the English

language itself.

TRAVEL INDIA EHM:nov08 19/11/2008 13:41 Page 133


BENEFIT FOCUS

Just what the doctor ordered?Innovation, obesity and the future of pharmacy benefit management134

In a complicated and fragmented healthcare system, good in-

formation is invaluable. Set up in 1995, the Pharmacy Benefit

Management Institute seeks to make sense of the marketplace,

providing research and education on the design and manage-

ment of drug benefit programs. Representing payers, pharmacy

benefit managers and vendors, the PBMI aims to be a one stop shop

for just about everyone involved in the pharmacy benefit manager

(PBM) space. The task of leading this organization falls to president

Dana Felthouse. With a long career in healthcare and extensive ex-

perience of the critical role that drug therapy plays, Felthouse had

plenty to say when we caught up with her at PBMI’s Arizona head-

quarters.

EHM. IT innovation is having a big impact on the business of

healthcare. How is new technology affecting the PBM space?

Dana Felthouse. PBMs are on the cutting edge of American health-

care organizations in terms of de-

ploying technology. PBMs were

the first sector of healthcare to

adjudicate a claim on line in

real time at the point-of-care in

the pharmacy. Now we're re-

ally seeing PBMs lever-

age the power of the

Internet to help drug

plan members learn

more about their drug

therapy and use some of

those technologies to try and

increase adherence with drug ther-

apies. PBMs are using voice response

unit technology, other outbound telecommuni-

cation and emails to help manage patients with

chronic diseases. The current innovation is now

on the patient side of things, because the IT in-

frastructure for the prescription drug benefit is state

of the art and has been for 20-plus years.

To give you a specific example, probably the greatest thing PBMs have

been able to do is give patients access to drug pricing databases. If a

patient wants to check what a prescription might cost at a pharmacy

near work, you can log on and do that. Then if you decide before you

leave work you're going fill it at the pharmacy by your house, you can

check to see what the price would be at that pharmacy.

“PBMs are starting tounderstand that they play a

critical role in the overallwellness of their patients”

Dana Felthouse Ed P134-136:31MAY 19/11/08 15:39 Page 134


with heart disease or high cholesterol. There also are programs for

weight management, with a lot of people logging onto a chat room

or a blog to communicate with other people that are experiencing

the same thing. Patients and health plan sponsors are finding all of

those things to be helpful in the mix of communications about how

to take better care of themselves.

EHM. Is the social networking aspect something that is actually

being utilized by PBMs or is that something that people are find-

ing themselves and using to supplement what they're getting

through official channels?

DF. PBMs may be using social computing in different disease man-

agement and wellness programs. It's not yet part of the core offer-

ing because the tools are being tried and tested in populations who

have certain disease states. PBMs will continue to find ways to

leverage social computing to help patients and to provide the type

of oversight for drug therapies that helps improve patients’ health.

EHM. Youmentioned wellness initiatives. Is that an area that PBMs

are looking into as well, giving information to people to perhaps

even reduce the necessity for medication?

DF. PBMs are starting to understand that they play a critical role in

the overall wellness of their pa-

tients. If patients can make the type

of lifestyle changes necessary so

they’re not getting so ill then maybe

a prescription medication is not

necessary. You see this with weight-

related conditions. Anytime some-

one can become more physically

active or improve their nutrition, it

helps their cardiovascular system

and lowers cholesterol. It’s a huge

issue not just in the United States,

but in all nations. The obesity epi-

demic is far reaching and every-

body's going to have to get on

board. In the United States the data are collected but not reported

yet to document that the incidence of obesity-related illness and

disease is getting ready to overtake smoking-related illness and dis-

People want information in whatever medium they need when they

want it. So a plan member may like to have something come from

their employer in paper such as a brochure that tells them how to

use their drug benefit. If they're sitting at their desk, they want to

be able to access the information on the computer, and then when

they get to the pharmacy, they want the pharmacist to help them.

Deploying Internet technology makes the information more acces-

sible to more plan members, whether they

are employees or retirees.

EHM.Are there anyparticular areaswhere you

see this transparency having amajor effect?

DF. We know that more information about

the cost of prescription drugs helps con-

sumers make better drug purchasing deci-

sions. It's helping educate them about the

value of generic drugs, so that if the physi-

cian has indicated that it's medically appro-

priate to use a generic therapy, they feel

more comfortable with it. Consumers also

are using the social networking aspects of

the Internet for all kinds of chronic disease

management. The health care industry is seeing good results with

people monitoring their blood glucose levels if they have diabetes

and staying on top of proactive health strategies if they're wrestling

30-40%of the US population is obese

Dana Felthouse is President of the Pharmacy Benefit

Management Institute (PBMI). PBMI provides research,

education, and publication services to help health care

benefit executives work with pharmacy benefit

managers (PBMs) to design and manage prescription

drug benefit programs. PBMI provides a forum for

health care purchasers to exchange ideas, advance

best practices, and drive marketplace changes that

improve pharmacy benefits and control costs.

For more information go to www.pbmi.com.


ease. PBMs will be looking at obesity more closely because all of

their customers are impacted by it. Obesity is a market externality

that PBMs and other health care organizations are going to have to

address. There isn't a magic pill for prescription therapy for tackling

the obesity-related issues. As my one pharmacist friend told me,

"Sometimes the patient just has to get off the couch." It may not be

the best sound bite, but it’s true. A major benefit of a genuine well-

ness focus is that the side effects of eating less and being more ac-

tive are always zero.

EHM. Do you think there are any other key trends currently emerg-

ing in the design and management of PBM offerings?

DF.Managing specialty pharmacy therapies is a huge trend and chal-

lenge. The PBMs have three dispensing channels – retail pharma-

cies, mail-order pharmacies and now specialty pharmacies.

Sometimes drugs are covered and reimbursed through the medical


benefit, and sometimes through the drug benefit. The PBM industry

will be working to manage across all of these variables so that the

patient gets the right drug at the right time from the right distribu-

tion channel that provides the needed level of clinical oversight. If

you're taking blood pressuremedicine that is an oral medication, you

can get it from the mail-order pharmacy and see your physician reg-

ularly to ensure the therapy is managed correctly. But if you have

multiple sclerosis and you're taking Betaseron, this biologic therapy

that needs to be dispensed through a specialty pharmacy with physi-

cian oversight and patient case management.

EHM.With the presidential election and the ongoing financial crisis,

the US is going through somemajor changes at the moment. Do you

think external factors could have an impact on the PBM space?

DF. I think the economic downturn has reminded everybody that the

affordability of prescription drugs is a key issue in patients becom-

ing or staying adherent to their drug therapies. We're seeing a huge

amount of advertisement and support for some of the retail phar-

macy generic drug programs. These programs encourage people to

take as many generics as are medically appropriate so that there's

money left over when there may not be a generic alternative.

EHM. Do you think that the economic situation could directly affect

patients’ health?

DF. There won't be any problems with the supply of prescription

drugs, but people may not go to the pharmacy to pick up a pre-

scription, or they don't refill a prescription. It's a particular issue

for asymptomatic diseases like high blood pressure, high choles-

terol and diabetes, where patients feel fine so they don't think they

need to take medication. If they stop taking the medication, they

may be putting themselves at greater risk for heart attack or

stroke. The healthcare costs will be higher because then they'll be

an acute case.

We may see over the next couple of years after a lot of non-compli-

ance with maintenance medications that increases medical utiliza-

tion. But this is a hypothesis. We’re going to have to wait to see

what happens because the economic downturn is unprecedented.

In the Great Depression, you didn't have all of these prescription

drugs. People rarely even went to the doctor. Healthcare is a more

complex picture now. �

0 2 4 6 8 10

0.47

2.03

0.35

1.61

2.52

1.29

9.00

3.00

5.00

Lowest

Average

Highest

RANGE IN NUMBER OF PRESCRIPTIONSPER MONTH PER MEMBER

0 2 4 6 8 10

0 50 100 150 200 250 300 350

Active employee

Retiree

Combined

$1.54

$102.72

$11.21

$67.77

138.36

$100.67

$204.25

$174.00

$350.00

Source: PBMI

Lowest

Average

Highest

RANGE IN GROSS COSTS OF PRESCRIPTIONSPER MEMBER PER MONTH

“There isn’t a magic pill fortackling the obesity-related

issues. Sometimes the patientjust has to get off the couch.It may not be the best sound

bite, but it’s true”


Emerson.indd 1 19/11/08 08:56:08


138IN REVIEWOn the shelfEHM takes a look at what this quarter’s business books can offer healthcare executives.

In the battle for US healthcare, patients and doctors are losing. With Who Killed Healthcare? one of

America’s most respected healthcare analysts exposes the motives of those who have crippled America’s

healthcare system and proves how the current system, organized around payers and providers rather than

the needs of its users, is dangerously eroding patient welfare and pushing costs out of the reach of millions.

EHM says: Who Killed Healthcare? offers a vision of the way things can and should be, and provides

knowledge of the system’s existing diffi culties. The look at new streamlined choices that would give

Americans both quality and cost control are both insightful and interesting.

Chasing the RabbitHow market leaders outdistance the competition and how great companies catch up and win, by Steven J. Spear

In this insightful book, Spear examines the internal operations of dominant organizations, including Toyota,

Alcoa and top-tier teaching hospitals – organizations operating in vastly differing industries, but with one

thing in common: the skillful management of complex internal systems that generate constant, almost

automatic self-improvement at rates faster, durations longer, and breadths wider than anyone else.

EHM says: Chasing the Rabbit contains ideas that form the basis for continuous learning and improvement

in every aspect of our lives. It is an important book that will challenge and inspire executives in all

industries and help leaders generate better results using less capital and leave competition in the dust.

Examining more than 350 variables of health and nutrition with surveys from over 6000 adults across

China and Taiwan, this book conclusively demonstrates the link between nutrition and heart disease,

diabetes and cancer. The text calls into question the practices of many of the current dietary programs

widely popular in the West and explores the politics of nutrition and the creation and dissemination of

public healthcare information.

EHM says: Every doctor, parent and teacher needs to read this book. Part biography, part nutrition guide,

part exposé, The China Study reports on a cover-up of nutritional truth so widespread that we should all be

enraged and offers answers to move forward.

The China StudyThe most comprehensive study of nutrition ever conducted and the startling implications for diet, weight loss and long-term health, by T. Colin Campbell, PhD and Thomas M. Campbell II.

www.executivehm.com

Who Killed Healthcare?America’s $2 trillion medical problem – and the consumer-driven cure, by Regina Herzlinger

Book Review Ed P139.indd 138 19/11/08 15:24:48

20,000 Challenges. One Industry.20,000 Executives. One Community.

But there’s more. Weekly interviews with industry leaders are webcast on the site’sdedicated channel. These are combined with live, moderated discussion groups,video conferencing, IM and secure e-mail in one easy-to-use app that’s dedicatedto financial services.

Join now: www.meettheboss.com

New York 8:50 a.m.John is upgrading some corebanking functions. He wants toknow how to ensure a smoothtransition, so he calls…

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Tokyo 9:50 p.m.

MeettheBoss.com membership reads like a financial services industry who’s who. CEOs, CIOs and other senior executives fromthe leading institutions are just two clicks away.

If your network isn’t focused on your business, change it.

Paul, who has seen the benefitsof an upgrade and is now sharing project management tipswith…

Ringo has the local knowledge.But he’s also planning for tomorrow, and that’s all aboutcore banking…

Dedicated To Finance

MeettheBoss.com is simple, intuitive, unintrusive and secure. It’s also free to use. Membership restrictions apply.

MTB MAG AD:Layout 1 19/11/2008 09:44 Page 139


SLA

VIN

FACE OFF

140Healthcare disparitiesThe gaps in quality and access to healthcare across ethnic, racial andsocio-economic groups is a major concern. We asked two expertsabout how this issue is being addressed through their organizations.

ALT

MA

N

Peter Slavin, President of MassachusettsGeneral Hospital

Addressing important health-related issues is part of our

focus on patient care. To this end, MGH has created a

Disparities Solution Center, which looks at healthcare

disparities within the hospital. I’m convinced, based on

national and local data, that healthcare disparities are an

important public health issue. In the world of academic

medicine, there has been a lot of good work done to

document those disparities through good clinical research,

but a couple of years ago we became convinced that there

was too little effort going into actually addressing and

trying to remedy those disparities.

We established a Disparities Committee at the hospital,

and also set up the Disparities Solution Center and are

busy looking within our own walls at where healthcare

disparities exist. When we find them, we put in place

programs aimed at eliminating them.

For example, one of the areas in which we did find a

disparity had to do with the diabetes care of our Spanish-

speaking patients, who were getting tested for diabetes

less frequently, and whose diabetic control was poorer than

their English-speaking counterparts. We’ve instituted a

program to improve the care of these patients, and some

results I’ve seen recently showed that we’ve made

significant progress.

Drew Altman, President and CEO ofThe Henry J. Kaiser Family Foundation

The organization focuses on bringing awareness to issues

impacting vulnerable and disadvantaged populations and

the public programs that serve them.

Kaiser views it as a special obligation to serve the less

privileged and prides itself on being an expert on programs

such as Medicaid, S Chip and Medicare, to focus on the

problem of healthcare disparities. To focus on those in

greatest need is inherent in the values of our organization.

It is a challenge for us because our main role is to be there

with analysis and information on whatever the big issues

are that may be before the country, the Congress, the

White House and the national media, and the issues that

most affect the vulnerable and the poor aren’t always on

the national agenda.

Part of the world knows the work that we do on health

policy issues, which is embodied in our policy research

work and our communications efforts, where we try to be a

broker or clearinghouse of information on health policy.

Then there is a part of the world that knows us for the

work that we do that focuses on young people, public

health issues and HIV.

Face Off Ed P140:31MAY 19/11/08 16:04 Page 140

Executive Healthcare ManagementThe healthcare industry is changing. Understanding how toimprove clinical processes, meet industry standards andmerge the maze of disparate systems is vital.

EHM combines unbiased industry news withthought leadership from the most respectedexecutives in healthcare, providing a platformfor strategy and learning.

Your World. Covered

gdsinternational www.gdsinternational.com

From the people you hire to the products you sell, if you’re in business, we’ve got it covered...

Business ManagementWhat business processes work? What are the proven,successful strategies for taking advantage of domestic andinternational markets?

Business Management is about real, daily managementchallenges. It is a targeted blend of leadership and learningfor key decision makers in government and privateenterprise.

Available for: US, Middle East, Russia

Find out more: www.busmanagement.com

NextGen Power & EnergyA poll of 4000 utility executives posed the simple question:what keeps you up at night? The answers were costs, newtechnologies, ageing infrastructure, congested transmissionand distribution, viable renewables and inadequategeneration capacity.

NextGen P&E covers them all.

Available for: US

Find out more: www.nextgenpe.com

Available for:

US

CXOTechnology leadership is merging with strategic andfinancial leadership, and senior management is beingcalled into a partnership for the future.

CXO brings together a range of voices with one sharedvision: to develop a strategy that considers business needsand technology’s role in moving your company forward.

Available for: Europe

Find out more: www.cxo.eu.com

Next Generation PharmaceuticalApproximately 50% of new drug development fails in thelate stages of phase 3 – while the cost of getting a drug tomarket continues to rise.

NGP is written by pharmaceutical experts from thediscovery, technology, business, outsourcing, andmanufacturing sectors. It is committed to providinginformation for every step of the pharmaceuticaldevelopment path.

Available for: US, Europe

Find out more: www.ngpharma.com

Find out more: www.executivehm.com

HRManagementHR needs three eyes: one on the past – don’t lose sight ofthe systems that generate value; one on the present –determine if current processes are efficient; and one onthe future – be proactive in meeting new challenges.

HRManagement concentrates on the development of HRstrategies, directions and architectures.


Find out more: www.hrmreport.com

Financial Services TechnologyProviding for its customer’s needs and demands is thegoal of financial institutions now more than ever. But it isa tricky remit to fulfill. Your customers want it all –security, cost-efficiency, speed, added functionality and,most of all, convenience.

Can it be done? Read FST to find out…


Find out more: www.usfst.com

CATALOGUE PAGE EHM:nov08 19/11/2008 16:19 Page 141

4Th-6Th April 2009The Fairmont Mission Inn

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144 www.ngpharma.com

early in the development of our candidate

drugs. We use these tools to predict effi-

cacy and safety (and therefore the proba-

bility that the medicine will be successful)

and to differentiate our products in the

marketplace. Our goal is to optimize indi-

vidual patient outcomes, and pharma-

cogenomics and biomarkers are critical

tools for achieving this.

An important element in implement-

ing a tailored therapeutics strategy

through, in part, the development and

application of biomarkers and related

enabling technologies, is strategic part-

nership development. Transitioning to a

fully integrated pharmaceutical network

(FIPNet) is another key part of that strat-

egy. Having the constellation of special-

ized biomarker and pharmacogenomics

partnerships and collaborations that

complement those we have with larger

CROs (such as vendors providing central

lab, ECG and imaging support) has en-

abled us to build virtual biomarker re-

search capacity and capability.

The groups we support now have

dozens of such partners, whose services

range from DNA sequencing to validation

of novel ELISA assays. They work closely

with their internal Laboratory for

Experimental Medicine and Clinical

Diagnostic Services department, which

coordinates these services and provide

technical oversight. n

144A

s we better understand the

human genome and how genes

influence individual patients’ re-

sponse to medicines, we are

able to use this blossoming knowledge to

both discover more sophisticated, targeted

agents and ensure that they are used to

treat the right patients. This notion of ‘tai-

lored therapeutics’, or developing the right

drug for the right patient, has become an

important part of Lilly’s corporate strategy.

This is driven by the stark reality that

medicines today are effective as little as

50 percent of the time and too often pre-

sent unacceptable safety issues.

Pharmacogenomics and sophisticated,

novel biomarkers are among the tools

that are used to characterize these indi-

vidual differences. They are increasingly

important both in the design of clinical tri-

als and for the delivery of more personal-

ized care in the marketplace.

How a clinical trial subject or patient

responds to a medicine will vary in accor-

dance with a variety of genetic influences,

ranging from predisposition to a particu-

lar disease to how the medicine is metab-

olized. These genetic associations are

used increasingly to predict efficacy, guide

dose selection and identify patients sus-

ceptible to a particular toxicity. They are of

even greater value if they can be used to

identify practical biomarkers (a protein,

receptor, etc.) that can be used to predict

these outcomes, and thus enable stratifica-

tion of clinical trial subjects or the develop-

ment of companion diagnostics for use in

the marketplace.

At Lilly, we put a lot of emphasis on de-

veloping thoughtful biomarker strategies

FINAL WORD

It’s all in the genesBy Jack Bloom

Jack Bloom is Distinguished Medical Fellow at Lilly and leader of its Diagnostic and

Experimental Medicine division. He joined Lilly Research Laboratories in 1989 as Head,

Clinical Pathology in the Toxicology Division, and in 1991 moved to the Medical Division,

where he established the department of Clinical Laboratory Medicine, and later the

departments of Experimental Medicine and Clinical Diagnostic Services. Bloom has authored

several manuscripts, chapters and reviews, and has edited texts on toxicology and clinical

biomarkers in drug development.

“Medicines today are effective as littleas 50 percent of the time and too often

present unacceptable safety issues”

FINAL WORD:nov08 19/11/2008 13:23 Page 144

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ehm 6

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