EHM 6

COVER EHM6 4:nov08 19/11/2008 16:11 Page 1

WHEN SCIENCE BECOMES MEDICINE Victor Dzau sheds light on the discoveries arising from translational research Page 34 www.executivehm.com • Q4 2008

TALKING ABOUT A REVOLUTION Why retirement won’t stop Cass Wheeler fighting for quality care Page 84

Joseph Heyman on the AMA’s work to eliminate health disparities Page 38

Using preventative care to cut healthcare costs Page 76

FRONT AND

CENTER

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

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

FROM THE EDITOR

7

High noon It's time we ditched our Wild West attitude toward healthcare

O

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

“Academic health institutions like ours have an obligation to address health disparities in the community”

ur country was founded on the notion of individual rights and freedoms. Back in the days when the first European settlers were overwhelmed 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 receive: 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 public 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 doctors, they can choose their hospitals. Our system also fosters innovation, and convenient 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 employer 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 energy 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 civilized nation. It’s time our health system reflected this.

Victor Dzau, CEO of Duke University Health System (page 34)

“All residents of the United States should have meaningful, affordable healthcare coverage” Cass Wheeler, CEO of the American Heart Association (page 84)

Marie Shields Editor

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CONTENTS EHMUS6:oct08

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CONTENTS

9

FEATURES Q4 2008 www.executivehm.com

On the frontline Soaring costs, millions of people uninsured, an uncertain future: why Massachusetts General Hospital’s David Blumenthal believes our healthcare system is still worth fighting for

28 34 Found in translation The translation of basic science into clinical medicine often results in stunning developments in patient care, says Victor Dzau of Duke University Health System

38 On the side of the uninsured The American Medical Association has been advocating for high quality healthcare for all since 1847. More than 160 years later, Joseph Heyman finds the challenge has never been greater

84 Taking it to heart Cass Wheeler may be stepping down as CEO of the American Heart Association, but that doesn’t mean he intends to give up his life’s work

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CONTENTS

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PATIENT CARE, TECHNOLOGY, PHARMACEUTICALS

“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”

56 Helping the nation stay physically active John Barnes on the changes affecting the physical therapy profession

108 Getting in on the ground floor How three big pharma companies got together to bring new technologies to life

58 Creating a sustainable future

114 The future of payer-sponsored electronic health records

42 Close to the bone

PwC’s latest survey looks at global efforts to create a sustainable health system

Lynne Dunbrack examines the current state of EHR technologies

The Mayo Clinic’s Daniel Berry and Michael Yaszemski outline the latest developments in orthopedic surgery

62 The next generation of breast cancer treatment

49 Breathe easy

We’ve come a long way since the days of the radical mastectomy

Jo Rae Wright sheds some light on the latest thoracic research

66 Under cover

52 The science of sleep

Larry Gage on the challenges of improving our healthcare system

Rochelle Goldberg raises awareness about sleep apnea

72 The heart of the matter

Joseph Heyman, American Medical Association P38

ASK THE EXPERT 61 Peter Gailey, OR-Live 71 Darius Francescatti, Rush University Medical Center 106 Jennifer Gilburg, VeriSign Inc.

EXECUTIVE INSIGHT 118 Steven Pap, SecuReach Systems, Inc.

William Baumgartner takes a close look at lifesaving heart transplants

76 Repair works Lars Svensson uses new techniques to improve treatment for cardiac patients

88 Stalking a silent killer John Suh of Cleveland Clinic on the work being done to understand brain tumors

92 Brainwaves The latest in Alzheimer’s treatments with David Yousem of Johns Hopkins Hospital

96 New developments in clinical imaging GSK’s Paul Matthews on the critical advances in this fast-moving field

100 Follow the leader Eliot Siegel reveals how film became a thing of the past

102 All systems go

61

Eric Yablonka on why electronic patient records are making a difference to patient care

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CONTENTS EHMUS6:oct08

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IN THE BACK

96 132

134 132 Travel 134 Benefit focus 138 In review 140 Face-off 144 Final word

38

116 Building IT infrastructure EHM speaks to Brad Blake, Director of IT at Boston Medical Center

120 Top 10 patient safety myths 122 Going global Diane Jorkasky on how geographically diverse clinical research units are transforming phase I trials

124 Hitting the target PwC’s Todd Evans examines changes in pharmaceutical marketing

130 Lessons learned Larry Blankstein looks at the challenges for a global project team

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

CREDITS EHM6:nov08 19/11/2008 13:20 Page 12

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 Online Editor JANA GRUNE

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, JULIA FENTON Director of Business Development RICHARD OWEN Operations Director JASON GREEN Operations Manager CHRISTIAN MORATO

Subscription Enquiries 212 904 0888. www.executivehm.com General Enquiries info@gdsinternational.com (Please put the magazine name in the subject line)

Letters to the Editor letters@gdspublishing.com

Executive Health Management (Q4 2008) is published four times a year by GDS Publishing. All Rights Reserved.

GDS Publishing, 33 Whitehall Street, 14th floor, New York, NY 10004. newyork@gdsinternational.com 212.920.8181

Legal Information The advertising and articles appearing within this publication reflect the opinions and attitudes of their respective authors and not necessarily those of the publisher or editors. We are not to be held accountable for unsolicited manuscripts, transparencies or photographs. All material within this magazine is ©2008 EHM.

GDS International Queens Square House, 18-21 Queen Square, Bristol, BS1 4NH, UK. +44.117.921.4000 info@gdsinternational.com

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UPFRONT

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P16 Top 10 – health-related resolutions P18 The five-minute executive P20 The burning issue P22 From the vault

PALE AND INTERESTING

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new 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 changing 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 educational-based intervention meant to reduce indoor tanning, which is related to an increased risk of melanoma in young women.

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-

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NUMBER CRUNCHING There are

3 types of skin cancer: basal cell and squamous cell carcinomas, and malignant melanoma By the year

2001 1 in every 90 people in the US will have malignant melanoma Over the past

NEW DIGITAL SOLUTION

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raftTracker, a web-based software program by Champion Medical Technologies, offers hospitals a secure, centralized system for tracking all tissue from point of receipt by the hospital to implantation into a patient. Developed in response to stricter FDA and Joint Commission regulations on tissue management, GraftTracker is guaranteed to meet documentation standards.

“GraftTracker was 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.

With GraftTracker, hospital personnel securely enter information about each tissue 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 facilities 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, providing the same level of security as online banks. All of this information is stored securely and available instantly.

GraftTracker is in use at hospitals across the country. The program assures patient safety and regulatory compliance with a complete and secure system.

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

60 years EAT YOUR GREENS damage to the planet’s ozone layer has increased the amount of harmful radiation that reaches your skin If detected early, skin cancer has a

99% cure rate ning, provided information on the history of tanning and tanning norms in society. The booklet also offered guidelines emphasizing tanning abstinence and recommended healthier alternatives to improve appearance including exercise, choosing fashion that does not require a complementary tan and sunless tanning products.

The investigators found that indoor tanning was reduced by approximately 35 percent in women who received the booklets, compared with women who received no intervention.

I

t appears that older men who eat fruit “The fruit and vegetables provide moleandvegetablescandelaytheonsetofthe cules that help reduce acidity in the blood, brittle bone disease known as osteowhich helps reduce bone resorption,” porosis. For years, doctors focused on Tucker says. Resorption means the breaking studying osteoporosis in women only. But down of bone cells to release calcium into men are living longer than in the past, and as the blood. they age, their bones also can get brittle and In this follow-up study, Tucker and her colbreak easily. Tufts University researcher leagues recruited men whose average age was KatherineTuckerexplains about 75 years. Over a period We were able to see that there are parts of the of four years, the researchers bodywherebonelossisa used a bone scanner to make particular problem. regular measurements of the “We want to prevent men’s hips, spines and forewas protective against hip fractures,” she says. arms. Tucker also had the bone loss “And the spine is another men keep detailed informaarea that is really at risk of spinal compression tion about what they ate. In particular, she asked andloss...thatreducesheightovertime.” aboutvitaminC,becausevitaminCseemstoslow Many doctors recommend people eat down bone resorption. foods that include calcium to keep their “We were able to see that vitamin C was bones strong. But in an earlier study, Tucker quite protective against bone loss over four found that people who ate lots of fruit and years,” Tucker says. “It was most significant in vegetables had stronger bones over time men who also had either low calcium or low vitathan people who didn’t eat fruit and vegetamin E intake.”

Source: www.voanews.com bles regularly.

vitamin c

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TOP 10

16 1

Health-related resolutions With the festive period fast approaching, 2009 will soon be upon us and we’ll all be vowing to do something different in an effort to make our lives a little bit easier.

Spend more time with family and friends

2 3 4 5 6 7 8 9 10

Devote time to fitness Tame the bulge

Quit smoking

Enjoy life more

Quit drinking

S

econd-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 status and adverse effects on a regular basis, starting within one to two weeks of the patient beginning treatment.”

The ACP guideline, ‘Using SecondGeneration Antidepressants to Treat Depressive Disorders,’ contains four recommendations:

Learn something new

When clinicians choose pharmacologic therapy to treat patients with acute major depression, they should select second-generation antidepressants on the basis of adverse effect profiles, cost, and patient preferences.

Help others

2

1

Get out of debt

Clinicians should assess patient status, therapeutic response, and adverse effects of antidepressant therapy on a regular basis beginning within one to two weeks of initiation of therapy.

Get organized

T

ocoincidewiththeapproachofthefestive season, a new online survey by Carnegie MellonUniversityrevealsthathealthylivingisstilltopoftheagendawhenitcomes to NewYear’s resolutions.The biggest issue for respondents is the desire to gain a better work/life balance, with the majority then wanting to invest theirfreetimewithfriendsandfamilyorincommit-

16

BEATING THE BLUES

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Clinicians should modify treatment if the patient does not have an adequate response to drug therapy within six to eight weeks of the initiation of therapy for major depressive disorder.

3 tingtoregularexercise.Withover66percentofadult Americans now considered overweight or obese, it is not surprising to find weight loss as one of the mostpopularNewYear’sresolutions.Otherhealthrelated issues, such as giving-up smoking or drinking, remain popular resolutions as studies suggest it takes the average smoker four attempts at quitting before they are successful.

Clinicians should continue treatment for four to nine months after a satisfactory response in patients with a first episode of major depressive disorder.

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NCI PROMOTES PATIENTREPORTED OUTCOMES

C

ancer patients need a prescription for information almost as much as the one they get for treatment. The amount of technical information is growing, but information on the psychosocial aspects of cancer treatment is less prevalent and more necessary on a day-to-day basis. For both patients and caregivers, real-time, personalized responses to symptom changes could turn the daily battle into a productive quest for better health and peace of mind.

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 and manual data processing. Yet, for all the advances in collaborative digital technology in recent years, there is still no single communication tool that addresses the needs of researchers, oncologists, general practitioners, private caregivers, and patients all at once. NCI has decided to push for a solution, with the goal of using medical informatics to modernize cancer care. One of their latest projects is called ‘Integrating PatientReported Outcomes in Hospice and Palliative Care Practices’, and Dynamic Clinical Systems (DCS) is leading the charge to make this happen.

DCS is working with its collaborators at Dartmouth and University of California San Francisco to create a digital habitat for cancer research and comprehensive information sharing, with the goal of ultimately reducing the impact of cancer on human life. DCS’s Integrated Survey System (ISS) is an innovative web-based solution featuring customized patient surveys, clinical observation tools and outcomes reports. Adapted for hospices and other palliative care sources, ISS will be able to streamline the information gathering process, facilitate symptom measurement, and analyze statistics to recommend outcomes-based action on behalf of cancer patients who need it.

ASTHMA LINK

I

n a study investigating how allergic respiratory inflammation leads to the recruitment of cells to the lung, researchers at the Mayo Clinic in Arizona have discovered a link between asthma and the metastasis of breast cancer to the lung.

Beginningwithresearchinmice,MayoClinicresearchershaveidentified thelocalizedtissueinflammationassociatedwithasthmaasapotentiallysignificant contributor to lung metastasis of cancer. More importantly, this researchledtoaretrospectivereviewofabreastcancersurgicalpatientdatabase which appears to confirm that a similar relationship may exist in humans.

“If you are a breast cancer patient with asthma, taking your anti-inflammatory inhaled steroids may be more important to you than simply stopping your wheezing,” says James Lee, a Mayo Clinic researcher and the senior author of the study. “The prognosis of any breast cancer patient with metastatic disease in the lung is very poor, and thus strategies preventing this event may have a significant impact on patient survival.”

ISSUE IN NUM8ERS There are more than

45 million Americans uninsured (p28)

Discovery magazine recognized this work as one of the top 10 discoveries of 2007 (p34) This year the projected drop in payments to physicians was almost

The goal is to reduce coronary heart disease, stroke and risk by

11% 25% (p38)

in 2010 (p84)

Local control rates for patients with early stage lung cancer treated with 3-5 fractions of radiation have been upwards of

$35 trillion (p88)

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THE FIVE-MINUTE EXECUTIVE

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Healing hands Debra Plousha Moore, SVP for Human Resources at OhioHealth, explains how the healthcare provider continues to lead by example.

Working for a high-performing organization like OhioHealth has allowed us to create a solid structure that our associates can compare to other healthcare organizations across the nation. Our associates have a sense of pride, belongingness and security in their work environment, where their contributions are valued. In turn, that allows them to provide better service to our patients and our families in this community.

What we’ve tried to create is an experience where our associates can go from one facility to another, but still have that overarching OhioHealth experience. We have created a place where there is a promise that our associates will be valued and respected, be developed and nurtured and that we will provide them and their families with good benefits. Ultimately we want them to be responsible for their own health and the health of their families, and we’ve created a place where our associates can work for an organization that not only to lives up to, but maintains, a national reputation within the healthcare industry.

We do the work because we live our mission. The external affirmation of being recognized as a great place to work allows our associates to compare and contrast with other organizations and affirm their decision that OhioHealth is both a good place for them to have decided to, and continue to, work.

I’m particularly proud of OhioHealthy, our associate wellness and prevention plan, where we have focused on the health of our associates.

We understand that the quality of life of our associates is as important as their productivity and that the investment in associate health and wellness is a long-term investment for the workforce.

In the last 18 months we’ve lost over 16,000 pounds as an organization.

We have walked around the world over 20 times.We’ve changed the food in our cafeteria and we’ve changed the food we offer for snacks throughout our entire organization because as a healthcare organization our concentration has to be on the health of our associates.

We’ve invested over $1 million in preventative care, highlighting that not only do we understand what the cornerstones of healthcare are, but that for these cornerstones we will make a 100 percent investment for associate health. We’ve also encouraged our associates through a consumerdirected model to be better stewards of healthcare dollars. We need our associates to be good consumer-driven participants in healthcare decisions for themselves and their families.

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

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SUPPORT FOR BREASTFEEDING

FAST FACTS

F

A closer look at schizophrenia and Alzheimer’s

ollowing an extensive evidence review, the US Preventive Services Task Force (USPSTF) concluded that doctors, nurses, hospitals and health systems have a role to play in encouraging and supporting breastfeeding. In an update to its 2003 recommendation on counseling to promote breastfeeding, the USPSTF recommends primary care interventions before, around and after childbirth to encourage and support breastfeeding.

For the study, the task force evaluated more than 25 randomized trials of breastfeeding 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 exclusivity. For example, a cluster-randomized trial of more than 17,000 mother-infant pairs in the Republic of Belarus found that breastfeeding interventions increased the duration and degree (exclusivity) of breastfeeding.

Infants in the intervention group were significantly 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

assistance with initiating and maintaining breastfeeding and lactation and postnatal breastfeeding support.

“Our review produced adequate evidence that multifaceted breastfeeding interventions work,” said task force Chair Ned Calonge, who is also Chief Medical Officer for the Colorado Department of Public Health and Environment, Denver. “We found that interventions that include both prenatal and postnatal components may be the most effective at increasing breastfeeding duration. Many successful programs include peer support, prenatal breastfeeding education, or both.”

S

adults, or about 1.1 percent of the population aged 18 and older in a given year, have schizophrenia Rates of schizophrenia are very similar from country to country – about

1% of the population Schizophrenia ranks among the top

10causes of disability in developed countries worldwide

STEM CELL DISCOVERY cientists around the world are learning more about stem cells and how they function to help the body restore itself throughout the lifespan. Stem cells exist in all sorts of tissues throughout the body – they help the body to continuously repair itself. And with the right stimulus, they can develop into many different kinds of cells.

Researcher Keith March at Indiana University in Indianapolis recently learned more 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 the endothelial cells, and they also have an outer lining which contains stem cells.

2.2 million

“We wondered whether those stem cells that were in the position of the outer wall of the blood vessel were being”, March says. “And we started experiments to test that question.”

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 the endothelial cells were diseased or damaged – for example, from high blood pressure, high cholesterol or high blood sugar – stem cells on the exterior walls of blood vessels transformed themselves into fat cells.

10 million American baby boomers, one in every eight, will develop Alzheimer’s in their lifetime

Source: www.voanews.com

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THE BURNING ISSUE

20

Free for all?

More than 46 million Americans are uninsured and millions more are underinsured for healthcare. EHM asked three health industry insiders for their opinions on solutions for tackling this issue.

Sen. Max Baucus

“The system can work better and cost less for everyone, if leaders are willing to work together for sound policy solutions”

CENTER

for STUDYING

HEALTH SYSTEM CHANGE

“Employer-provided coverage solves this problem by subsidizing coverage sufficiently so that it is attractive to both healthy and sick employees”

American families – and our economy – are in crisis over healthcare. We can’t get coverage to the 61 million who are either uninsured or underinsured without a major overhaul of the system, and there’s no way to really solve America’s economic troubles without fixing healthcare for the long term.

I’m following some basic principles to improve access to care, to improve the quality of care, and to reduce costs. If you are happy with

the coverage you have, you can keep it. But the system can work better and cost less for everyone, if leaders are willing to work together for sound policy solutions.

I am committed to working with my colleagues here on Capitol Hill – Democrats and Republicans – and to working with the incoming Obama Administration to move the ball forward on health reform. In human and economic terms, there is no more time to waste.

Paul B. Ginsburg, President, Center for Studying Health System Change Existing individual insurance markets have an inherent tendency to ‘fail,’ meaning that many people willing to pay a premium that reflects their expected claims costs and competitive margins for administrative costs and profits 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 individual market will have

higher-than-average medical costs, leading to higher premiums. In turn, high premiums further discourage healthier people from purchasing 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.

Jonathan Gruber, Professor of Economics, MIT

“Young and healthy individuals are often able to get insurance at very low rates, while sicker and older individuals find themselves facing very high rates or no access at all”

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Insurance market reform is one of the key pieces to any successful health reform in the US. Right now, health insurance markets function well for those who work for large firms: insurers can fairly price insurance to reflect the underlying mix 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

high rates or no access at all. States which 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 the market and an enormous rise in rates. In the recent report by AHIP, five of the eight most expensive states in the nation to buy non-group insurance are the five that have community rating in some form.

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FROM THE VAULT Q2 2008

22

Elias Zerhouni Director of the NIH

Back in issue four of EHM, Elias Zerhouni talks about his role as Director of the NIH and his ‘road map’ to promote crossinstitutional collaboration. “People are very focused on how we deliver health services in medicine. I’m more focused on what it is we deliver. My point is we need to transform health from a curative type of medicine to a pre-emptive one,” he explains.

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

TOOTH BRUSHING FOUND TO SLASH CASES OF PNEUMONIA

7¢ spent on a toothbrush can be a lifesaver for ICU patients on breathing machines Ventilaro-associated pneumonia (VAP), a life-threatening infection, strikes up to

300,000 patients each year VAP can be reduced by almost half by simply brushing patients’ teeth

twice a day

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seven-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 pneumonia yearly.

A study in the Barnes-Jewish Hospital surgical and trauma intensive care unit found that simply brushing the teeth of patients who needed a ventilator to breathe dramatically reduced cases of ventilator-associated pneumonia (VAP), a lifethreatening 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 conjunction 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 inside 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.

ALWAYS AWAKE

J

ohns Hopkins researchers have found strong evidence supporting the view that the sleeping mind functions the same as the waking mind, a discovery that could significantly alter basic understanding of the normal and abnormal brain.

The evidence comes from a study, to appear in the Journal Human Brain Mapping, of 11 healthy male and female participants whose rapid eye movements (REM) in ‘dream’ sleep were timed using a video camera. The REM tracking was accompanied by special MRI images designed to visualize brain activity. Results revealed activity in areas of the brain that control sight, hearing, smell, touch, balance and body movements.

“This is the first time we have been able to detect brain activity associated with REM in areas that control senses other than sight,” says lead researcher Charles Hong, Assistant Professor in the Department of Psychiatry and Behavioral Sciences at the Johns Hopkins University School of Medicine. “After comparing our data to other studies on awake people, we learned that our findings lend great support to the view that the waking brain functions in a similar way.”

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HOW TO MAKE MORE MONEY

L

ike any other industry, hospitals need to produce bottom line profits. Hospital administrators understand this and claim to do what it takes to maximize their bottom lines. Yet in many hospitals, frontline managers that provide the services, generate the revenues and spend the labor and non-labor dollars have never been provided with the necessary tools to do so.

Healthcare Insights has developed a revolutionary, alert-based management accountability budgeting, monitoring and reporting software solution that helps hospitals to dramatically improve their bottom lines. Healthcare Insights recently released INSIGHTS 5.0, its latest state-of-the art solution. After seven years of client success, INSIGHTS is now more userfriendly and even easier for hospital managers and directors to use. INSIGHTS allows administrators to quickly identify where the managers are out-of-compliance with 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 the alert.

INSIGHTS software allows hospital administration, 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 clear message that the administration is serious about staying within their volume variable goals. At that point, volumes, revenues and expenses 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 improvements.

INSIGHTS has been designed to allow hospital administrators to make better decisions.When used as intended, significantly improved outcomes have been achieved. So, if your organization wants to really make money and . . . not just talk about it, INSIGHTS is the essential tool.

QUICK FACTS ON OSTEOPOROSIS

O

steoporosis is a major public health threat for an estimated 44 million Americans, or 55 percent of people 50 years of age and older.

10 million individuals are estimated to already have the disease in the US

INTERNET USE BOOSTS BRAINPOWER

U

CLA scientists have found that for computer-savvy middle-aged and older adults, searching the internet triggers key centers in the brain that control decision-makingandcomplexreasoning.Thefindings demonstrate that web search activity may help stimulate and possibly improve brain function.

The study, the first of its kind to assess the impact of internet searching on brain performance, 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 investigator Dr. Gary Small, a professor at the Semel Institute for Neuroscience and Human Behavior at UCLA. “Internet searching engages complicated brain activity, which may help exercise and improve brain function.”

As the brain ages, a number of structural and functional changes occur, including atrophy, reductionsincellactivity,andincreasesindepositsofamyloid plaques and tau tangles, which can impact cognitive function.

34 million more are estimated to have low bone mass, placing them at increased risk for osteoporosis

80% of those affected by osteoporosis are women women are

4times more likely to develop osteoporosis than men

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FDA ISSUE WARNING

COLD ALERT

G

oogle has found that certain search terms are good indicators of flu activity.

Google Flu Trends uses aggregated Google search data to estimate flu activity in your state up to two weeks faster than traditional flu surveillance systems. Each week, millions of users around the world search for online health information. As you might expect, there are more flu-related searches during flu season, more allergyrelated searches during allergy season, and more sunburn-related searches during the summer.

You can explore all of these phenomena using Google Trends. But can search query trends provide an accurate, reliable model of real-world phenomena? Google has found a close relationship between how many people search for flu-related 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.

Low is classified as

1 to 7 drinks per week, about one a day

Moderate is

8 to 14

T

here’s been a lot of talk about red wine in the past few years. More doctors are saying drinking red wine in moderation – usually a 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 Framingham study – a large, long-term study that is based in the town of Framingham, Massachusetts.

As part of the study, researchers took 1839 MRIs from normal subjects, which they used to measure brain volumes.

T

he Food and Drug Administration is warning consumers about a fraudulent scheme to extort money from consumers by callers who falsely identify themselves as ‘FDA special agents’ or other FDA officials.

Several instances have been reported to the FDA of calls enticing consumers to purchase discounted prescription drugs by wiring funds to one of several locations in the Dominican Republic. No medications are ever delivered. A subsequent call is received from a fraudulent ‘FDA special agent’ informing the consumer that a fine of several thousand dollars is required to be sent to an address in the Dominican Republic to prevent incarceration or other legal action.

“Impersonating an FDA official is a violation of federal law,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The public should note that no FDA official will ever contact a consumer by phone demanding money or any other form of payment. FDA officials always present identification in person when conducting official business.”

Participants in the Framingham study have filled out detailed questionnaires about their habits, activities and diet.

Paul took data about red wine consumption from these questionnaires and matched it with the results of the brain scans. She found that the more people drank, the more quickly their brains shrank with age.

Normal aging is 0.2 percent per year or 2 percent per decade, she says. The changes between normal and the abstainers, abstainers and all of the different categories was 0.25 percent per group.

Paul says that each extra regular drink per day is equivalent to one to two years of normal aging.

drinks

and high is classified as

>14 drinks

24

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RED, RED WINE

Source: www.voanews.com

DynamicClinical.indd 1

13/11/08 08:46:57

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COMPANY INDEX Q4 2008

26 Accenture 120 Accumetrics 78 American Association of Medical Colleges 66 American Heart Association 84 American Hospital Association 66 American Medical Association 38 American Physical Therapy Association 56 American Sleep Apnea Association 52 Anesthesia 48 BD 126 Bioscan 91 Biospace Med 44 Boston Medical Center 116 Boston University 116 Brigham and Women’s Hospital 62 Champion Medical Technologies 15, OBC Chartlinks 57

Companies in this issue are indexed to the first page of the article in which each is mentioned 76, 88 Cleveland Clinic 69 Client Tell 62 Dana-Farber Cancer Institute 121 Design Clinicals, Inc. 143 Duet DHA 34 Duke University Health System 17, 25 Dynamic Clinical Systems 108, 144 Eli Lilly 137 Emerson 108 Enlight Biosciences 83 Enovate IT 130 Genzyme 96 GlaxoSmithKline 96 Hammersmith Hospital 114 Health Industry Insights 21, 23 Healthcare Insights 98 Imaging on Call 96 Imperial College 110 Ingenious Med 28 Institute for Health Policy

Intact Medical 64 Ion Healthcare 51 Johns Hopkins Hospital 72, 92 Legacy Data Access 105 LifeWatch 80 Massachusetts General Hospital 28 Mayo Clinic 42 Meettheboss.com 138 Merck & Co. 108 National Association of Public Hospitals and Health Systems 66 OR-Live 60, 61 Park Avenue Medical Data Systems 8 PBMI 134 Pfizer 108, 122 PricewaterhouseCoopers 58, 124 Radiologic Society of North America 100 Secureach Systems, Inc. 118, 119, IBC Sheridan Healthcare 4

Sleep Health Management Resources, Inc. 55 Sten-Tel 13 Textware Solutions 103 The American Thoracic Society 49 Topotarget 2 TransPro 12 University of Chicago 102 Medical Center University of Maryland 100 Verisign Inc. 6, 106, 107 Visage Imaging 46 Xoft, Inc. IFC, 70, 71

AROUND THE WORLD IN

80DAYS Our guide to some of the most exciting developments in healthcare over the last quarter.

FDA’S CHINA OFFICE AIDS PATIENT CURED A patient with theAIDS virus in Berlin,Germany, has reportedly been cured of the disease following a bone transplant from a donor who had a genetic resistance to the virus. Since the transplant was carried out two years ago the patient,who also suffered from leukaemia,has shown no sign of either disease.

EHM IMPACT RATING: ####

CHOLERA CONTROL WHO and health partners have launched an intensive operation to prevent and control the increase in the number of cholera cases, which have tripled in some areas to 150 a week, amid the recent escalation of violence in the eastern part of the Democratic Republic of the Congo.

EHM IMPACT RATING: #####

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New FDA offices are to be opened in China with the aim of increase effectiveness in protecting American and Chinese consumers. The offices will be the first outside of the United States and will be situated in Beijing, Guangzhou and Shanghai.

EHM IMPACT RATING: ###

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THE HIGH COST OF DIABETES

T

he annual cost of prescription diabetes drugs nearly doubled to $12.5 billion between 2001 and 2007, according 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 reflect 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 $12.5 billion in 2007 from $6.7 billion in 2001.

FIT AND WELL Heart failure patients who regularly exercise fare better and feel better about their lives than do similar patients who do not work out on a regular basis, say researchers at Duke University Medical Center. The findings go a long way toward addressing concerns about the value of exercise for the nation’s five million patients with heart failure.

FIGHTING HIV

Stanford University

A small antibody fragment that is highly effective in neutralizing the human immunodeficiency virus (HIV) by preventing the virus from entering cells has been identified at the National Cancer Institute.This finding may provide insight into the development of new treatments for HIV and other viruses in the not too distant future.

MIND MATTERS

A dug used to fight leukemia appears to

stop multiplesclerosis in its early stages It is estimated that at least

2.5million people around the world have the neurological disease Campath carries a risk of potentially

serious side effects

DRUG FOR MS

B

ritish 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 potentially serious side effects, it is being called by some the most promising and most significant MS treatment yet discovered.

The three-year study conducted by Cambridge University researchers found for the first time a treatment that showed long-term multiple sclerosis disability improvement. It is estimated that at least 2.5 million people around the world have the neurological disease. Multiple sclerosis causes the body’s immune 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.

Source: www.voanews.com

Massachusetts General Hospital researchers have found that tiny membrane-covered sacs released from glioblastoma cells contain molecules that may help guide treatment of the deadly brain tumor. Researchers describe finding tumor-associated RNA and proteins in membrane microvesicles called exosomes in blood samples from glioblastoma patients.

BE AWARE Awareness of COPD (chronic obstructive pulmonary disease) is growing, but few Americans have a thorough understanding of the disease, according to a new national survey. The new data show that 64 percent of survey respondents had heard of COPD, compared with 49 percent in a 2004 survey.

Among those who reported hearing of COPD, only half recognized the disease as a leading cause of death, and just 44 percent understood it to be treatable.

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COVER STORY

“Americans don’t want to be told they can’t get the care they think they need.”

David Blumenthal leads the fight to keep our healthcare system from the brink of collapse. By Marie Shields e’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 unsustainable 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 believing 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 receive 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 percent of our GDP on healthcare, get mediocre results, and still feel that we’re doing okay.”

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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 affected. 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 taking 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.

Political view It’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 unusual 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 professional organizations and governmental leaders, including several presidential candidates.

This diversity of experience – he worked as a staff member on Senator Edward Kennedy’s Senate Subcommittee on Health and Scientific Research

n 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

I

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.”

DAVID BLUMENTHAL 3:nov08 19/11/2008 13:21 Page 31

David Blumenthal is Samuel O. Thier Professor of Medicine at Harvard Medical School 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 mission and the requirements that are associated with that in terms of producing products that are viewed as useful to a client who is not a researcher,”

“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 affected” he says. “I also continue to be involved politically, and that gives me a different 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 questions: 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 examine one major instance of healthcare policy development and look at how the president participated in that, what factors influenced his decisionmaking 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 making healthcare policy.

The Institute for Health Policy is based at Massachusetts General Hospital

Rising costs For 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 observation under the term technology: the more technology there is, and the better 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 general matter often change their views when they or one of their family members 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 externally funded research – federal research, foundation research and a small

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number of private sector contracts. “The overwhelming amount of work we do is extramurally funded, and we write grants and compete for that funding 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 interesting, academically sound, and that provides support and information that helps policy-makers make better decisions.”

using the Baldridge methodology. The Baldridge methodology was named for Malcolm Baldridge, a promoter of quality improvement across all industries, 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.”

High quality The Malcolm Baldridge National Quality Award is presented annually The institute is divided into three ‘centers of excellence’: the Center for to businesses, and education, healthcare and nonprofit organizations that Performance Excellence, the Center for Genomics and Vulnerable are judged to be outstanding in seven areas: leadership; strategic planning; Populations, and the Disparities Solution Center. customer and market focus; measurement, analysis and knowledge manThe mission of the Center for Performance Excellence is to support the agement; human resource focus; process management; and results. efforts of organizations around the country to improve their performance “Over time, the award has evolved to include healthcare organizations,” 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 healthcare hot topic. The IHP’s Disparity Solution Center carries out training and education related to disparities, 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 display is currently being tested on the website of a David Blumenthal is Director of the Institute for Health Policy at Massachusetts General Hospital large insurance company. Blumenthal says they are and Samuel O. Thier Professor of Medicine at Harvard Medical School. Blumenthal is an internist anxious to see whether people understand the inand an internationally recognized expert in health policy and healthcare delivery systems. He has formation displayed, and whether it affects their held leadership positions in academic health centers; has served as health policy advisor to views of their own doctors. private, civic and professional organizations and governmental leaders, including several “This is part of the trend toward transparency in presidential candidates; and has published widely in prestigious journals across a range of health healthcare. There’s an assumption that transparency policy issues. He became the founding Director of the IHP in 1998. is good, but not very much examination of whether

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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 Technology and genetics cost-effective and how long it will take to get a measurable return on investThe IHP also works with the federal government to develop and then ment. There are some things that will produce very short-term returns, includfield instruments that provide valid and reliable estimates of the level of ing what we call primary prevention activities like immunization, which adoption of health information technology among physicians and in hosprevent acute infectious illness. Making sure that all elderly people are vacpitals. The institute is surveying doctors and hospitals on what electronic cinated against influenza, for example, will produce a very quick return. records they use or don’t use and what the characteristics are, what they’re “It’s also increasingly clear that able to do with those records, what the barriers are to vaccinating children against influenza acquiring records, and what helps them acquire INSTITUTE FOR HEALTH POLICY may be even better than vaccinating records. In the process, Blumenthal says they’ve had to Founded by Partners HealthCare System and elderly people, because children seem do some work defining exactly what an electronic record Massachusetts General Hospital in 1998. to be the reservoir that spreads inis, both in a physician’s office and in a hospital setting. fluenza to the elderly. Ensuring that all “We do a report every year with funding from the Informs and influences health policy on a eligible children have the hepatitis vacRobert Wood Johnson Foundation, on the state of health national level. cination, and vaccinations for information technology in the United States. The last haemophilus B, and for measles, one, which came out in July, had a chapter on internaConducts research to support quality and efficiency mumps, and chickenpox, diphtheria, tional comparisons in health information technology. improvement within Partners HealthCare. typhoid, tetanus, pertussis and polio – We found that it was very difficult to make cross-nationall those things that children get – is al comparisons on the uses of information technology Works to improve health and healthcare across also a critical preventive and moneyin healthcare because there was no uniform consistent America and in other nations. saving investment. I would class some definition of what an electronic record is. This makes it of the screening tests as primary prehard to say the prevalence of the electronic record is X An interdisciplinary faculty of experts in clinical care, vention as well. Colonoscopy, for expercent in Britain and Y percent in Denmark and Z perhealth policy and research methods investigates ample, and mammograms, for many cent in Finland and G percent in the United States, becomplex challenges facing healthcare systems. population groups are likely to have cause the available information simply doesn’t use the long-term payoffs.” same definitions.”

Provides a supportive, collaborative environment Then there is secondary prevenThe third center covers genetics and vulnerable in which researchers can pursue their interests tion: preventing an existing illness from populations, whose mission is to understand how the while also contributing to the IHP’s mission to getting worse, which can also be exgenetic information that is being developed by scieninform health policy and influence practitioners. tremely valuable. According to tists and medical researchers in the United States and Blumenthal, this category includes conelsewhere might affect the equity of our healthcare sysCan translate research results quickly from trolling diabetes, preventing the complitem in all its dimensions, and how it may or may not be academic settings to clinical practice, and identify cations of diabetes and controlling brought to bear to improve the health of disadvantaged cutting-edge issues affecting healthcare efficiency cholesterol levels in people with heart patients and population groups. and quality. disease. He says a number of these This work has involved understanding, for example, strategies are extremely cost-effective, what factors affect the adoption of genetic screening Committed to providing value on an operational because you then avoid having to technologies, and how understanding genetic predisas well as policy level and to disseminating spend money on transplants or acute positions to environmental hazards may be used to reresearch results broadly. care of complications that occur when duce the exposures and the harms that are done to secondary prevention isn’t done. individuals who live in inner city neighborhoods or in imHowever, Blumenthal adds that it’s naïve to think that all prevention is poverished communities where they’re more exposed to toxins. going to save money. “Some types will, and other types will make care more An ounce of prevention cost-effective: you’ll get more quality of life and more extension of life out One potential weapon in the fight to keep healthcare quality up and of a given dollar invested. And some will cost money but prolong life and costs low is to move away from treatment by stepping up prevention. are very much worth it for that reason. Prevention is not a magic bullet, but Blumenthal agrees – as most people would – that this is a good move. it is part of a reform agenda.”

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

We are facing a crisis in our healthcare system and chances are we’ll It also has the potential to improve the value of the care we receive. If you all need to make significant adjustments to our expectations and even to distinguish between short-term cost savings and long-term improvements the way we live our lives. It’s lucky, then, that we have David Blumenthal in the value of services provided, essentially getting better return on the and the IHP to keep us informed on where we stand, and to help lead the money you invest, then there’s no question that many preventive services way forward in the challenging years that lie ahead. n 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.”

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FEATURE

Found in

translation

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

T

he cure for a debilitating muscle disease started with an enzyme isolated in the ovarian cells of a Chinese hamster. Hard work and perseverance marked its slow and steady progress from early clinical trials to its eventual licensure by Genzyme, and worldwide approval for treatment of potentially lethal Pompe disease.

Today, that enzyme’s journey from the bench of a Duke researcher to the bedside of children “is an example of translational medicine, from discovery to human application,” explains Victor J. Dzau, MD, Chancellor for Health Affairs at Duke University, and President and CEO of Duke University Health System since 2004. “It is dramatic how these young lives are now being 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 arrived at Duke in 2005. In October 2006, it was further energized by a $52.7 million grant from the National Institutes of Health to expedite the translation of scientific discoveries into clinical practice.

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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 into working community endeavors.

Promoting measurable improvements in community health and making personalized medicine a reality are two important goals of these programs.

Pioneering work Significant 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 information 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 $350 million NIH

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grant. “Under the leadership of Dr. Bart Haynes, CHAVI Global health is bringing together some of the best scientific minds in Dzau’s views on global health were shaped by his past. “I was born in the world, including Harold Varmus and Peter China and my family and I were forced to leave the country as refugees Dougherty, to conduct the necessary basic science that when the communists took over,” he recounts. “In post-war China, I witwill lead to the development of enabling technologies nessed extreme poverty and the associated health and hygiene problems, that will, hopefully, result in viable HIV vaccine candias well as disparities in care, which has made me passionate about these dates,” Dzau says. issues. In an institution like ours, or any health institution for that matter, Dzau is no newcomer to translahealth disparities need to be met – it’s an obligation.” tional medicine. As a pioneer in gene Today, Dzau is committed to eliminating health distherapy for vascular disease, his laboparities among underrepresented and socio-economiratory studied the molecular and gecally disadvantaged populations both in this country netic mechanisms of cardiovascular and abroad. Initiatives such as Duke’s Community Affairs disease and was among the first to Office, Duke Community Research, and Duke Family and Annual operating revenues, apply gene transfer technologies to deCommunity Medicine, offer preventive care and home Duke University Health System velop novel therapeutic approaches. care to all segments of the population including the elDzau was the first to introduce derly and uninsured. “Academic health institutions like DNA decoy molecules to block tranours have an obligation to address health disparities in scriptions as gene therapy in vivo. the community,” he says. Duke’s Global Health Institute, Speaking about the progress of E2F decoy and nitric oxide synthase gene Duke University employees therapy and their evaluation in clinical trials, Dzau said: “What I do in gene therapy is try to take my initial discovery – the concept of using E2F decoy to shut off gene transcription using small DNA synthetic molecules 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 develop my discovery into a therapeutic product,” recalls Dzau, who is the James B. Duke Professor of Medicine and Director of Molecular and Genomic Vascular Biology. “That helped me understand that although commercialization is not necessarily the endpoint for the work of academic institutions, it is the pathway by which important discoveries ultimately reach human application. In my mind, a healthy relationship with the industry sector is necessary.”

$1.9 BILLION

8113

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.

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INNOVATION-CARE CONTINUUM MODEL 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. Publicprivate 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.

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 total employees at all will be an information system that makes it easier three locations and faster for patients to access their own medical which was founded on the pillars of service, policy and data from computers in their homes or through research, addresses the problem worldwide. kiosks at Duke Clinics. “They can look at lab test reDzau’s interest in health disparity reaches all corsults, make appointments or simply view their ners of the hospital and university, and includes the records,” he explains.

Schools of Medicine, Engineering, Business and To encourage further innovation, Dzau set up the of Duke University Medical Law. “We are sending our students to Tanzania and Science Advisory Council in 2006. It encourages leadCenter employees have an MD or PhD degree (or both) Uganda and our faculty are working in China and ing and young scientists to work together to identify Singapore. Our hope is to bring faculty and stuand discuss the current needs at Duke, and consider dents together with others to find solutions. When what future directions should be taken. For example, you look at healthcare, you realize it encompasses everything, from inone idea that resulted was obtaining funding for international graduate stufrastructure to the economy. We want to address health disparities in a dents, an emerging talent pool that, for the most part, has been unable to holistic fashion.” obtain training funds in the US.

29,826

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GLOBAL HEALTH INSTITUTE The Global Health Institute (GHI) at Duke University contributes to the understanding, diagnosis, prevention and treatment of infectious diseases, which still claim 18 million lives each year and account for half of the deaths in the developing world.

The GHI is currently comprised of five groups whose activities already reflect the Institute's future ambitions. Basic mechanisms of host-pathogen interactions and innate immunity toward pathogens

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are being studied using multidisciplinary approaches.

Crucial world health issues like tuberculosis and HIV/AIDS are being tackled. These include understanding, and hopefully counteracting, the persistence of Mycobacterium tuberculosis, the causative agent of tuberculosis, and designing drugs to treat this disease. Mechanisms of HIV infection and use of this virus in gene therapy approaches are also the subjects of intense research.

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THE DUKE MEDICINE VISION Duke 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

DUKE INSTITUTE FOR GENOME SCIENCES & POLICY

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he 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

The road ahead

implications for science, health and society.

While transforming medicine is the message, the specifics of what needs to be transformed, and how those objectives will be met, have not been finalized. In Washington, DC, and elsewhere, much emphasis has been placed on reforming financing of the healthcare system. While Dzau acknowledges that as a priority, he says it’s not the only one. “We, as providers, have to change the way we deliver care and the way that we make discoveries in new therapies. Therefore, when we talk about the transformation of care, there’s tremendous opportunity for academic health centers to be leaders by creating new models of care.”

But the road ahead will have many challenges, including reimbursement 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 become more constrained, it becomes more difficult for academic health centers to move forward. But hope is in the air.

Already, the Innovation-Care Continuum model is helping leaders at Duke to “realign and restructure ourselves to look at how we deliver care to our patients, and how to bring innovation more quickly 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 only model, but it’s one that appears to be working.

The creation of the IGSP represented Duke’s recognition of

“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”

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.

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FEATURE

On the side of the uninsured Since 1847, the American Medical Association has been fighting for high quality healthcare for all Americans. Joseph Heyman brings us up to date on the association’s latest campaigns.

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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.

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he 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 often means having no health insurance.

Joseph Heyman, Chairman of the Board of Trustees of the American Medical Association, is well aware of these concerns. “When there is a loss of jobs, since most people who are insured in the United States receive their insurance from their employers, 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 concerned about that, so we’re pushing for a plan that would cover everybody. There will be a tremendous window of opportunity immediately after the inauguration of the new President to accomplish this. The amount of money we’re spending on trying to fix the economy dwarfs what it would probably cost to provide additional 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 economy happens to be.”

To this end, the association has instituted the Voice for the Uninsured 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 stage was to make certain that everyone knew there’s at least one plan out there that could accomplish everything we need to do to get people insured.

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“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 immediately after the election, although we were speaking with members of Congress and with both campaigns before that to try to come to some advance agreement about the plan.”

“We’re asking Congress to have the political will to sit down and find a compromise that will work for everybody” The association maintains a website called voicefortheuninsured.org, which receives about 600 messages per month from uninsured 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 everybody, and we think that’s possible.”

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.

Public interest This advocacy on the part of the American public is not a new direction for the AMA – the association was founded in 1847 on a code of ethics that puts patients’ interests before those of physicians. The healthcare reforms the AMA is proposing include the expansion of health insurance coverage to every citizen, a campaign it started back in 1991.

“We’re in the middle of a big campaign 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 system,” Heyman says. “This included millions of dollars worth of advertising and behind-the-scenes discussions with both presidential campaigns, and we’re excited about the opportunity for making some progress in this regard.”

Among the other campaigns the association is currently working on is its opposition to tobacco companies. The AMA has

2008 MACARTHUR FELLOWSHIP 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.

asked the companies to refrain from engaging in advertising practices that target children; it has tried to get the FDA to regulate cigarettes as a drug; and has also expressed 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 negotiate 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 covered by their insurance, prevented them from explaining that there were things not

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As a result of 9/11, the association developed a disaster preparedness and medical 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 payments Every year since 2001, the AMA has been involved in fighting the drop in payments to physicians. “We have a problem with a formula for payment 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 ■ AMA scores crucial projected drop in payments for the folvictories in Congress for physicians and patients with legislation on antitrust relief and health insurance reform

TWO DECADES OF THE AMA

■ AMA launches grassroots campaign for professional liability reform AMA drafts the Patient Protection Act II bill to protect patients through a proposed ban on gag clauses and other practices of insurance plans that infringe on the patientphysician relationship

Highlights of the association’s activities since 1990 1990 - 1991 ■ AMA moves into new building at 515 N. State Street, Chicago AMA adopts guidelines governing gifts to physicians from the pharmaceutical industry ■ AMA launches campaign against family violence

1992 ■ AMA calls on tobacco companies to refrain from engaging in advertising practices which target children

1993 - 1994 ■ AMA passes resolution declaring physician-assisted suicide is fundamentally inconsistent with the physician’s professional role

AMA adopts a recommendation from the Council on Medical Education that continued federal funding should be available for graduate medical education

covered by insurance companies that were very important, and prevented them from complaining about the insurance companies. These gag clauses were eventually rescinded.

In conjunction with the National Medical Association – the association of African-American physicians – and the National Hispanic Medical Association, the AMA has created a commission to end healthcare disparities in the US. This is comprised of leaders from the nation’s largest physician organizations and more than 30 health-related groups, with a mission to educate physicians and healthcare professionals about disparities.

Other notable initiatives have included a campaign against ‘drivethrough deliveries’: when a woman was admitted to have a baby and then discharged on the same day without adequate time in the hospital; and responding to September 11, 2001, when the AMA provided the government with a list of 3500 volunteer physicians who were ready and willing to assist in the recovery efforts.

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1995

AMA national campaign efforts lead to the Food and Drug Administration regulating the marketing of tobacco to minors AMA launches a crusade against health plan ‘gag clauses’ resulting in these restrictive provisions being dropped by five leading managed care providers

1996

lowing year, and every year at the end of the Congressional session we spend a lot of money and expend a lot of energy trying to prevent the drop, and every year we’ve either had a freeze or we’ve had a tiny increase in payments, and it hasn’t kept up with inflation.

“This year the projected drop was almost 11 percent, which was a terrible problem for us because if this happened, patients with Medicare would not be able to see physicians because physicians can’t afford to provide care at such a low price. Everybody in Congress was committed to fixing this, but at the end of the year, when the vote came right before the July 4 weekend, we were 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 states where people were up for re-election who voted against us, we put up campaign ads over the weekend, asking their constituents to call on them to change their vote, and by the time the weekend was over, we not only had enough votes to pass it, but in addition to that we overrode the Presidential veto.

“The outgoing President has a pet project that he calls Medicare advantage 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 the payment. That was the reason behind his planned veto of the bill.”

1997-1999

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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.”

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 constantly higher quality and safety across the healthcare system.We’ve tried all kinds of different ways in which to improve quality and safety. Most citizens 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.”

National reform

Challenging future

Much of he AMA’s current advocacy efforts focus on its push for nationwide 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 create 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

Heyman has faced a range of challenges in his time with the AMA, both personal and from the point of

2000 ■ Through media outreach and member physician grassroots efforts, the AMA determinedly forges ahead with its advocacy for comprehensive Patients Bill of Rights legislation in Congress

2001 ■ Immediately following the September 11th terrorist attacks, the AMA quickly responds to the needs of the nation, providing the government with a list of 3500 volunteer physicians who were ready and willing to assist in recovery efforts

■ After two years of intensive lobbying efforts by the AMA and specialty and state societies, Congress averts a 4.4 percent cut in Medicare physician payments. On December 8th, President George Bush signs the historic Medicare Prescription Drug Bill, and taken a moment out of his speech to thank the AMA for its efforts in support of the bill

2002

2003

■ More than 180 physicians, medical students, public health workers, nutritionists and other health care professionals gather for the first AMA National Summit on Obesity in Chicago. The participants identify ways that healthcare professionals can tackle the obesity epidemic in schools ■ AMA spearheads effort with 129 other healthcare and patient groups that results in the passage and signing of the Patient Safety and Quality Improvement Act

2004 - 2005

■ The AMA, along with 11 other organizations which comprise the ‘Covering the Uninsured’ initiative, launches a national awareness campaign aimed at publicizing the extent of the uninsured population in the United States

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 innovative models, perhaps considering models like the patient-centered medical home model or other innovations in which we can increase payment 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

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 confronts is very challenging.

“That said, this year has been a real highlight of my life. Being able to involve myself in something that affects 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 information 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 everyday solutions for our member physicians that will make us indispensable to physicians in the future.”

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

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

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unning a busy surgical department has its challenges, as Daniel Berry knows well. As Chair of the Orthopedic Surgery department at the Mayo Clinic, he is responsible for the daily operational elements of supporting the department.

“We need to make sure we provide the very best clinical care we can to everybody,” Berry says.

“We are proud of our department, we’ve got outstanding expertise in all the subspecialties of orthopedics, and our focus is to continue to function in a way that’s both efficient for patients and provides outstanding cutting-edge care.”

The department also plays a major role in musculoskeletal research, and works to educate residents and fellows, as well as physicians 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 musculoskeletal 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 capabilities in either research or education or both.

“As Chair of one of the bigger departments in the country, there’s an element of ambassadorship to the rest of both the medical community and the public, in terms of making sure we are doing our best to represent orthopedics and to respond to what the public needs in musculoskeletal care.”

Innovations The Mayo Clinic has long been a hotbed of innovation. Cortico-steroids were discovered at the clinic, for which Dr. Hench and professors Kendall and Reichstein were awarded the Nobel Prize for Medicine in 1950. “The first injection, for example, of cortisone into a lesion of the musculoskeletal system was an injection into a shoulder that was carried out at the Mayo Clinic in the 1960s by Mark Coventry, who was then Chair of the Orthopedics department,” 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 technological innovation has increased in recent

Daniel Berry is Chair of the Orthopedic Surgery department at the Mayo Clinic and the Chair of the Maurice Muller Foundation of North America.

Berry completed his residency at Harvard Medical School. His research interests are in primary hip and knee replacements, revision hip and knee replacements, osteotomies about hip and knee.

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

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he Mayo Clinic’s Orthopedic Surgery department has a long history of caring for patients with musculoskeletal tumors of the spine and pelvis. This work can require the skills of specialists 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, urology, vascular surgery, critical care anesthesia, medical oncology and radiation oncology.”

Over the years, the team has 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 providing critical care to the patient, to reconstruction with the movement of tissues to cover the very large holes that are created.

Coupled with the research side, the department is engaging in regeneration of bone defects, regeneration of cartilage defects, regeneration of nervous system defects (spinal cord and peripheral nerves) and controlled drug delivery to musculoskeletal cancers.

One specific area of concentration is scoliosis, where several novel treatments are currently in the preclinical 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 magnet 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 determined by a wireless connection, much like a cardiology physician would program a pacemaker.”

Hip replacement Yaszemski and his team are working on total joint replacement for hip and knee patients needing reconstruction or prosthetics for amputations.

“We are working on a technique called intraosseous transcutaneous amputation prosthesis, which is a technique of having a metal 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-

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years, and there’s also been a lot of enthusiasm and excitement about new technology shown by the public. “Sometimes that’s spurred by publications and sometimes it’s spurred by marketing campaigns, by different companies that make products. It’s important that the public

hip and the knee. A number of our department members have published on 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 all musculoskeletal procedures

“It’s important that the public have an opportunity to understand whether those technological innovations are going to stand the test of time” have an opportunity to understand whether those technological innovations are going to stand the test of time, and whether they’re even innovations or there’s something new that’s not actually a valuable innovation.

“We’ve had a rigorous program of prospective, carefully evaluated results and trials to determine whether new ideas are in fact better ideas. A good example of that would be a critical assessment of minimally invasive surgery for the

and we’ve got a very innovative group that works on optimizing pain management and making the operative experience one that is both more comfortable, less risky and one with 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 the management of arthritis in younger patients. For example, we

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 infectious diseases, we are trying to engineer the junction between the metal and the skin so that it will be resistant to infection. We know that this happens in other parts of the body. For example, our oral maxillofacial colleagues and our dental colleagues put metal posts in regularly for people. They integrate into the bone of the mandible or the maxilla – the jawbones – and stick out

Michael Yaszemski is a professor of orthopedic surgery and surgeon in the Orthopedic Surgery department at the Mayo Clinic. He is a past Chair of the American Orthopedic Association and Chair of the Scoliosis Research Society. His research interests are in adult scoliosis and spine surgery, primary and revision hip and knee arthoplasty and bone tissue engineeringpolymer synthesis.

have several people who are innovators in the area of management of patients with hip arthritis at a younger age with things such as osteotomies or salvage procedures.”

Joint registry The first FDA-approved total hip replacement, a technology that was invented in the UK, was applied in a government-approved program at the Mayo 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.

through the oral mucosa and then they get a prosthetic tooth put on top of them. It can be done. The challenge is to figure out how to do this for a person 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 Regenerative Medicine, which involves 23 academic institutions around the country. The consortium encompasses five project areas, with the Mayo 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 the bone regeneration project, I’m the co-principal investigator, together with Cleveland Clinic, and in like fashion we 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 the Mayo Clinic are also working on the central nervous system – the spinal cord – with work funded by the National Institutes of Health. We feel that the work that’s being done for AFIRM on the peripheral nervous system will be equally applicable to the central nervous system.”

Nerve work “Our aim is to treat nerve injuries that have gaps in them that currently don’t have an option for treatment. Typically, for microsurgeons who do

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Since then, there have been registries developed to try to do the same thing on a national 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 information. They give the type of implant that somebody has and whether it ever gets taken out, and if so, why. Ours is a detailed database – it has a far more rich detail of information about the operative procedure and about complications of the procedure.

“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 longterm 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 published from data that’s been available through that registry. It has also had a national and international impact on the practice of joint replacement, because so much data has been available that’s not been available from any other source.”

Future focus The delivery of cost-effective, high-quality, high-value healthcare will be an area of increasing importance over the coming several decades, as economic resources that can be devoted 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 musculoskeletal 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 replacing or fixing the musculoskeletal system with metal or plastic or artificial devices, to one where we try to help the musculoskeletal system repair itself biologically,” Berry says.

“To that end, we are focusing on areas where we believe there will be the opportuni-

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 from people who have died, and synthetic polymer scaffolds augmented with stem cells. We’re focusing on adult bone marrow stem cells, and the work is progressing well.”

The Mayo Clinic’s involvement in the consortium will allow for more individuals to be included 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 musculoskeletal cancers, based upon what we take care of clinically, and we

ties for major leaps forward in musculoskeletal care from the biologic side of things, such as cartilage regeneration, bone regeneration and biologic engineering methods. With these, tissue engineering principles are applied 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 resources to them. We have excellent labs working in several of those areas right now and we believe they will soon start bearing fruit. These are areas where there’s been a lot of basic research 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.”

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-

“Inducible electromagnets implanted in spines that have scoliosis to be able to modulate their growth”

tration of this treatment where the tumor is, and minimize the concentration 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 giving additional treatment at the local site of the connective tissue tumor, which is called a sarcoma.”

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THORACIC MEDICINE

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

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

Jo Rae Wright. Many things influenced 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 inflammatory 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 pathogens that are inhaled. Once it binds to them it helps clear them from the lung so that it reduces the incidence 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 becomes 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?

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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 surfactant 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.

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 fellows. 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 outstanding 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. 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 EHM. How would you like the ATS to grow people of all ages. Can you tell us how the and develop in the future? Are there any society is achieving this? areas in which you would like to particuJRW. Everything that we do is directed larly focus your efforts? towards meeting this end. This ranges all JRW. One of our focus areas is to work more the way from providing continuing mediclosely with our patients. A few years ago cal education for our physicians and allied we formed a group called the Public Advihealthcare professionals to publishing pasory Roundtable (PAR). We’d like to grow tient education materials. this partnership and this is something I’m What really distinguishes the ATS is actively involved in. It is made up of 13 that we disseminate the best science and patient-interest groups that encompass research in the fields of pulmonary critical lung, critical care and sleep. It has been Jo Rae Wright, Ph.D., is the 2008-2009 care and sleep medicine. Many of our statean exciting relationship because all of us President of the American Thoracic ments and guidelines, which are generated involved really want to make patient lives Society. She is also vice provost, dean by the ATS, are the gold standard. better. This relationship helps inform my of the Graduate School and professor The three journals that we publish are leadership and future growth at ATS. of cell biology, medicine and pediatrics very influential in the field – our American Having patients as part of our society at Duke University. She earned our Journal of Respiratory and Critical Care has helped influence our yearly internadoctorate in physiology from West Medicine is the highest impact factor in tional conference as they actively parVirginia University and trained at the respiratory medicine. Our annual internaticipate in the meeting. They are hugely Cardiovascular Research Institute at the tional conference has over 5500 abstracts influential in our advocacy efforts. When University of California, San Francisco, and is the biggest forum for research in we go to Congress to talk about the needs where she held worked until joining the these areas. for research and healthcare, the patients faculty at Duke in 1993.

In 2003 we started funding our own are the ones that light up the eyes of the research projects targeted at junior recongresspeople. searchers starting their careers. Our goal We will be working really hard to bring is to support them until they can get their ideas and the information more recognition to the importance of lung disease. A lot of people they need to get funded by major organizations like the NIH and the don’t know about chronic obstructive pulmonary disease, which hapVA. We surveyed ten of the people who got grants in 2004/ 2005 who pens to be the fourth largest killer of Americans. have gone on to get 27 grants that total more than $22 million and The ATS is an amazing society for people to get involved with. It have published 53 scientific papers. brings together a very diverse group of people including basic scienWe have a very strong advocacy program for lobbying our fedtists, clinicians, nurses and therapists. It promotes diversity and has eral government. This has helped with big victories this year for us. a great mission. It’s a privilege for me to serve as president. It’s been The first was to make pulmonary rehabilitation a uniform benefit for a very enriching life experience for me. n

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SLEEP APNEA

The

science of

sleep

Sleep apnea is a serious condition that can cause increased risk of high blood pressure, diabetes, heart attacks, stroke, heart failure and atrial fibrillation, yet it is often not taken seriously by the medical establishment and the public. Rochelle Goldberg sets the record straight.

S

leep 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 condition in which the airway collapses during the night while we’re asleep and causes major stress on the body,” explains Rochelle 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 difficulty 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 fibrillation. There are also many in-

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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 confirm breathing pauses and disturbances 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

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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 technology Technology improvements have also seen a variation in pressure, how pressure is delivered and the machine itself. “We’ve seen more flexibility for travel as the units have become smaller and made it more realistic for people to take equipment 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-specific. 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 financial 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.

Rochelle Goldberg, is a sleep clinician, educator and researcher. She has a full office 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.

“The lack of recognition of sleep apnea shows society’s lack of respect for sleep as a necessary human function” For Goldberg, it is not treatment that needs to be improved but the acceptance of sleep apnea as a medical condition and recognition 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, providing 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 information 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 existence 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 officially given that descriptor but have symptoms. Or to try to help those families or partners who are observing this.”

Dispelling ignorance The 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 field 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 official protector. It has the potential to be diag-

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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 necessary 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.”

THE TRUTH ABOUT SLEEP APNEA

Raising awareness The 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 find 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 continues 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 professionals, clinicians and researchers, and are also present at the American 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 organization’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 someone 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 influence 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.” 

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• 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 specific; 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.

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PHYSICAL THERAPY

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

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 establishment of a strategic planning and thinking process; completion of reviews for all of the departments 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 development of a comprehensive communications plan.

that have seen advances include fall prevention, bone health, cancer rehabilitation, physical activity/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 evaluate 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. Last year the association was selected for the third successive time as one of the Top 60 Great Places to Work by Washingtonian magaEHM. Please tell us about the K12 awards.

“Another challenge in physical zine. What makes the APTA stand out in this way?

JB. One of the most exciting occurrences in physical therapy practice is addressing JB. This was the third time the APTA was chosen therapy research is the awarding by the National the needs of diverse for this recognition and I can tell you why in one Institutes of Health of two K12 awards to consortia patients/clients in response to word: staff. I am truly proud to be part of an awardcomprised primarily of physical therapists. The K known health disparities within awards are a mechanism used by the NIH to advance winning team of hard-working people who are our healthcare system” dedicated to helping each other succeed at what the careers of junior researchers by providing fundwe do best – providing quality service to our meming to institutions to mentor new investigators. bers. The APTA strives to provide the best possible benefits and work enThe current corps of K12 scholars represents a broad range of research vironment for staff, which includes unique offerings like weekly yoga interests. Topics such as stroke, pediatric conditions and low back pain are sessions, subsidized gym memberships and onsite health screenings. 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 EHM. What have been some of the biggest developments in physical thermuscle cells. Through the awarding of the K12, we can be assured that the apy practice over the last few years? upcoming cadre of physical therapist rehabilitation researchers will be very JB. The practice of physical therapy has grown and changed as technology productive. and healthcare needs change. With advances in medicine and improved technology used to save lives, physical therapist practice now assists in EHM. CareerBuilder.com recently included physical therapist and physiimproving/restoring function and movement and reducing pain. For examcal therapist assistant professions in its 30 Top Jobs in 2008. Why would ple, with new technology that enhances the survival of premature infants, you recommend these areas as a career? physical therapists are involved early in the infants’ life to minimize develJB. These rankings simply reflect what we have always known. Physical opmental delays and provide education and training to the family. therapists and physical therapist assistants are highly motivated and fulAs healthcare needs change, physical therapist practice adjusts to filled healthcare providers. Their satisfaction stems from improving qualimeet patient/client needs. For example, physical therapists play an imty of life for patients. It's gratifying to see the profession receive the portant role in safe and active aging through prevention, mitigation of recognition it deserves, and I am confident that we will continue to recruit health conditions and rehabilitation after disease or injury in the growing the brightest and the best. population of older adults who are actively aging and those who are living In an effort to show students what it is like to have a career in physwith chronic conditions. Other growing areas of physical therapist practice ical therapy, the APTA recently developed an 11-minute video titled, ‘You

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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 represent 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 physical therapist services will continue to increase. As with all healthcare professionals, 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 therapy 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 disparities 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 diversity 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 decreasing, this raises significant concerns regarding the level of debt that students take on in completing their physical therapist and physical therapist assistant 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 continue 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 provide high quality physical therapy care for their patients. n

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SPECIAL REPORT

Creating a sustainable future The latest health industry survey from PricewaterhouseCoopers’ Health Research Institute, finds that dramatic change is needed world wide if we are to create sustainable health systems.

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ccording to the latest report on the healthcare sector from phobic. The days when healthcare sectors operate in silos must end. New soPricewaterhouseCoopers, HealthCast 2020, there is lutions are emerging from beyond traditional boundaries and innovative busigrowing evidence that the current health systems of naness models are being formed as healthcare becomes globalized. These tions around the world will be unsustainable if unsolutions are changing the way the Chinese think about financing hospitals, changed over the next 15 Americans recruit physicians, Australians reyears. Globally, healthcare imburse providers for care, Europeans emis threatened by a confluence of powerful brace competition, and Middle Eastern In HealthCast 2020, PwC looked at the trends – increasing demand, rising costs, governments build for future generations. responses around the world to the uneven quality and misaligned incentives.

In a world in which economies are globalglobalization of healthcare and efforts to If ignored, they will overwhelm health sysly interdependent and the productivity of nacreate a sustainable health system, tems, creating massive financial burdens tions relies on the health of its citizens, the highlighting best practices in innovation for individual countries and devastating sustainability of the world’s health systems is and shares insight and lessons learned health problems for the individuals who a national competitive issue and a global ecofrom around the world. live in them. nomic imperative. Moreover, there is a moral The research included a survey of It is time to look outward. The attitude obligation to create a global sustainable health more than 580 executives of hospitals that all healthcare should be local is dangersystem. The stakes could not be higher. and hospital systems, physician groups, ously provincial and, in extreme cases, xenopayers, governments, medical supply Sustainability companies and employers from around The idea of sustainability is subject to the world in 27 countries many interpretations. It is often used in the context of environmental protection and renewal of natural resources. One

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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 organizations of today will be unable to meet demand in the future. Our health systems will be unsustainable.

Beginning in 1997, health spending has been accelerating as a percent of gross domestic product (GDP) among Organisation for Economic Co-operation and Development (OECD) countries. In 2002, the cumulative health spending of 24 OECD countries was $2.7 trillion. PricewaterhouseCoopers estimates that health spending for OECD countries will more than triple to $10 trillion by 2020.

Healthcare organizations and governments around the world are urgently seeking solutions to temper costs while balancing the need to provide access to safe, quality care. Yet, conventional approaches are failing, even in the most advanced nations of the world – throughout Europe, in Asia, and the Middle East and in Australia, Canada and the United States.

“By 2020, healthcare spending is projected to triple in real dollars, consuming 21 percent of GDP in the US” Because they are often viewed as a local industry, healthcare organizations haven’t exchanged ideas globally as much as other industries such as manufacturing and services. While each country faces unique hurdles – regulatory, economic, cultural – the challenges they face are remarkably similar. In their responses, common themes are emerging.

Despite the complexity of the challenges that the healthcare industry faces, successful initiatives – often involving technological innovation, preventive care and consumer-focused business models – are occurring in many places.

Findings Future health spending is expected to increase at a much 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 percent of GDP in other OECD countries. Nearly half of healthcare executives from 26 countries believe healthcare costs will increase at a higher rate of growth than in the past. Executives in areas with high population 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 and physicians are seen as having the greatest opportunity to eliminate wasteful spending in healthcare.

There is wide support for a health system with shared financial risks and responsibility among private and public payers versus the historic costshifting approach. Only a minority of industry leaders in the US, Canada and

GLOBAL SOLUTIONS FOR A SUSTAINABLE HEALTH SYSTEM 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.

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 systems where healthcare is primarily tax-funded, 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 by more than 80 percent of respondents as a contributor to sustainability. 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 and Canada, physicians ranked highest.

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In the Middle East, Australia and Asia, government was viewed as making the most 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. The most effective means of demand management, according to the survey, are wellness, immunization and disease management programs.The vast majority (75 percent) of respondents viewed waiting lists as an ineffective way to manage demand. Yet only 26 percent of respondents thought government and private initiatives promoting better health had been effective and only 33 percent thought educational and awareness campaigns had been effective.

Interest in pay-for-performance and increased cost sharing is soaring.

Industry leaders expect tremendous growth in consumer-oriented programs. Only 35 percent 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-forperformance initiatives, above the 70 percent who had started such programs in 2002. Forty-three percent of respondents said that direct cost sharing by patients is an effective or very effective method to manage demand for healthcare services.

Information technology is an important enabler in resolving healthcare issues when there is systemwide and organizational commitment and investment. The vast majority of respondents viewed IT as important 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).

Convergence Global and industry-wide convergence is occurring as best practices are shared and the lines become blurred among pharmaceuticals, life sciences, 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-related 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-reaching changes in national policy. Policy solutions can be influenced – but are not made – by the managers of healthcare organizations. Other areas over which management has some ability to effect change are plentiful and are driving solutions.

According to the report, at the broadest level, these are the issues facing health systems across the globe, and transferable lessons are emerging. The variety is astounding yet so are the commonalities. Around the world and across all sectors of the industry, healthcare leaders are exploring many of the same solutions.

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ASK THE EXPERT

Moving your marketing online

BY PETER GAILEY

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he technology of healthcare is adapting and advancing at a remarkable rate, and the need for effective communication and engagement with patients, doctors, and allied health professionals has never been greater. Consumers today are bombarded with messages about the latest advancements in pharmaceutical and clinical technology, while their financial responsibilities are increasing as insurance plans are redesigned to stimulate a consumer driven environment. Doctors and allied health professionals are feeling the same information overload, as their ever-increasing time commitments are strained by 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-existent healthcare retailers, specialty hospitals and clinics. Device manufacturers and pharmaceutical companies have to adapt their entire go-to-market strategies due to changes in regulation surrounding how they communicate their product’s value proposition to consumers, and more importantly, physicians and hospitals. The risk in this environment is having 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 challenge here is that while baseline costs continue to increase, it is unlikely that there are more resources available to pour into marketing. Even if you were able to increase your marketing budgets, 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 must move from a focus on impressions to engagement. It means

Peter Gailey is President and CoFounder 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.

getting targeted. Rather than blanketing a market with a general message, send multiple messages, each one tailored to a specific audience you wish to engage. It means making your marketing accountable; being able to tie patient volume or increased product sales directly to specific marketing events. It means building relationships, not awareness.

Traditional marketing won’t provide the medium you need to develop relationships. Look to the web to provide you with the access 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 backing it up with content that solves their need to find relevant information.

The web also offers an economical alternative to less effective traditional forms of marketing. 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 marketing. Well-designed campaigns can provide you with feedback immediately on what’s working 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, engagementdriven strategy. Once you begin, you’ll quickly realize the benefits of not just communicating to your customers, but interacting with them.

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WOMEN’S HEALTH

The next generation of breast cancer treatment New techniques in breast cancer treatment mean women can undergo surgery with much less trauma. Mehra Golshan, Director of Breast Surgery at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital, brings EHM up to speed.

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Mehra Golshan is a surgical oncologist and Director of Breast Surgery at the Dana Farber Cancer Institute and the Brigham and Women’s Hospital. He leads a group of a dozen breast cancer surgeons and helps oversee and effort in delivering multidisciplinary breast cancer to several thousand women each year.

reast cancer treatment has come a long way since the days of the radical mastectomy. Today, women are offered more treatment options than ever before. Much of this improvement is down to more targeted techniques, as Mehra Golshan, Director of Breast Surgical Services explains.

“Surgeries are becoming less and less invasive. This means smaller resections, more work on cosmetic results and outcomes. In the past, around 60-80 years ago, they used to do a radical mastectomy. This was a very morbid 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 this came modified radical mastectomies and then breast conserving therapy, 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 sparing mastectomies. The surgeon leaves all the skin, sometimes even the nipple and areola behind, and uses the remaining tissue as a shell. The reconstructive 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 and medicating it, thereby avoiding toxicity to the other parts of the body.

“Within imaging, with improvements in technology, we’re moving away from just the standard mammogram 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 aided diagnostics, which operates most comparatively like a second eye looking at the mammogram, after the radiologist.”

Diagnosis None of this improved treatment does any good, however, if women aren’t diagnosed properly in the first place. Golshan explains that in the United States and much of the Western world, the standard of care is still mammography or a breast mammogram, which is mostly done in this country as a baseline between the age of 35 and 40, and then yearly once a woman turns 40, as long as they’re otherwise healthy. He points out that more recently there have been attempts at other ways of looking at the breast. The most notible is called breast MRI, whereby a dye called gadolinium is injected through an IV, and multiple pictures are taken of the breasts.

This displays a much different view from that of a mammogram and provides another way of looking for abnormalities, and more 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 from bad. A woman should be alerted to the fact that when an abnormality is found on MRI, that doesn’t necessarily mean she has breast cancer, and the likelihood is that there will be more pictures and workup 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 women who have gene mutations, 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 recommend 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.

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Golshan explains that there are others ways of looking at the breast, including scinto-mammography and molecular imaging. These techniques are being investigated, but researchers don’t yet know how well they will end up working, 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 ultrasound this way.”

Preoperative therapy

So, how will preoperative therapy change the surgical procedure itself?

“Previously, a woman would enter surgery with a large mass in her breast and be treated with a mastectomy. With preoperative therapy, we are able to shrink the tumor, and for a significant number of women, we can then change the treatment from a mastectomy to a lumpectomy, which is a much less morbid procedure,” explains Golshan.

“With a lumpectomy, the woman keeps her breasts intact. The incisions are usually very small, and the cosmetic results are generally very favorable. There’s also work being done on an ablation technique, Treatment whereby the tumor is destroyed by a choice of laser ablation, radio freOnce a woman is diagnosed with breast quency ablation, cryo-ablation or focused ulcancer, there are a number of paths through trasound oblation where you either kill the treatment. If a woman needs a mastectomy, tumor or shrink the tumor with a small incision she will not only see a surgeon and a medical or no incision. This allows the woman to avoid oncologist but also a reconstructive surgeon. having surgery altogether.”

She will also have her slides reviewed by our Early detection in breast cancer remains at One in eight American women dedicated breast pathologist. The dedicated the forefront of Golshan’s idea of patient care. who live to be 85 years of breast imagers or radiologists will look at her “The main question we continuously ask ourage will develop breast pictures, and then the doctors will come up selves as surgeons is how can we treat the cancancer, a risk that was one in with a plan for treatment. cer better, can we operate better, or if you’re 14 in 1960.

“Some people come and get an opinion from going develop a breast cancer, can we catch it us and go home,” says Golshan, “but the majoriearlier?” He notes that some of the work is done 2.4 million women living in the ty will come in for second or third opinions from in the gene mutation group of those who have inUS have been diagnosed with around New England, other parts of the United herited a predisposition to breast/ovarian cancer. and treated for breast cancer.

States and overseas. So we’re always thinking “If we can identify those patients before the beabout how we can more effectively deliver breast ginning of the cancer’s development, surgeons cancer care to a woman who’s diagnosed. can either start screening much earlier than the It has been estimated that five “One exciting area at the moment is preopaverage woman or consider prophylactic surgery to 10 percent of breast cancer erative therapy. This involves giving medication as treatment. This is called genetic counseling cases result from inherited before surgery, whether by IV or by mouth, to and genetic testing for women who are at high mutations or alterations in shrink the cancer and facilitate the surgery that risk of breast cancer.”

BRCA1 and BRCA2. would be necessary afterwards. Most women Advancing technology is also high on who have breast cancer will see a surgeon beGolshan’s agenda, as further improvements of fore undergoing an operation, and then see an mammogram imaging can allow for breast MRI oncologist who will look at the results of the surgery. The oncologist will in the younger population or those with very dense breasts, and result then say whether they need chemotherapy or not, or a medication like tain finding the cancer at a smaller size or at an earlier stage. He adds, moxifen or an aromatase inhibitor. You give them this medication and hope “Prevention remains important. We know there are certain medications that the cancer doesn’t come back.” that can reduce the chances of women developing breast cancer signifGolshan notes that the alternative of targeting the breast cancer beforeicantly, one of them being tamoxifen, and the other raloxifene. hand may one day lead to targeted therapies tailored to the patient’s cancer, “Preventative medicines become much more targeted. Breast cancer a type of personalized medicine. “If you can tell that the cancer is sensitive to is not just one disease process; it can present itself in different ways, and a specific type of therapy, it results in faster, more accurate treatment. A surdoes not need to result in removal of breasts for all women who are at high geon may give a patient one type of therapy and she may not respond, and so risk. That seems unnecessarily aggressive to me. Preventative medicines if we can identify who those non-responders are early, we can change the medallow surgeons to examine family history, so if the patient says, “My mom ication and provide them with new or different treatment. had breast cancer when she was 40; my grandmother had ovarian cancer “We biopsy the tumor while they’re on therapy. There are people curwhen she was 35,” then you know you need to target this patient differently rently undertaking genomic studies to see what genes are turned on and from one with no family history.” off by the type of therapy that they’re given. Hopefully within a decade, While Golshan says it is difficult to predict where the field of breast cantreatment will progress so a woman can come in and have her tumor biopcer treatment will be five years from now, he sees the field moving forward sied, then we will do genetic studies on it and be able to say this is the type on multiple fronts towards a significant improvement, particularly in preof formula you need for your treatment. The future is tailored therapy for ventative measures. And that has to be good news for the 12 percent of breast cancer,” Golshan adds.

American women affected by this serious disease.

BREAST CANCER STATISTICS

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ADVOCACY

With the number of uninsured Americans on the rise, Larry Gage of the National Association of Public Hospitals and Health Systems talks to EHM’s Natalie Brandweiner about the challenges of working with government to improve our healthcare system.

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espite 2007 seeing a decrease for the first time in a decade separate association for public hospitals. “At the end of the Carter adminin uninsured Americans, Larry Gage, President of the National istration, it was obvious that with Ronald Reagan elected as President and Association of Public Hospitals and Health Systems, doesn’t the Senate becoming Republican as well in the Reagan landslide, I would necessarily feel this is a long-term trend. Gage’s primary conhave to do something outside of Congress to continue my work,” says cern since founding the NAPH in 1981 has been to champion Gage. the cause of the uninsured public and to call for the creation of a universal healthcare system.

Government focus Gage began working in healthcare in the 1970s, helping to develop proGage founded NAPH in 1981, and has been its President ever since. posals for national health reform under the Carter administration, which “The association was quite clearly and narrowly focused right from that outunfortunately never came to pass. set on government-owned hospitals that provided substantially Gage’s contacts and background withhigher volumes of care to the uninsured, Medicaid patients and NAPH is a private, in the health industry, such as his work to the low-income elderly,” explains Gage. He notes the memnonprofit organization on the US Senate Health, Employment, bers of the association, even today, receive on average around established in 1981 to Labor and Pensions (HELP) committee, three-quarters of their patients from those three categories. “So address the major issues did have an influence on US health first and foremost, and by far the most important thing NAPH has facing public hospitals, policy. done over the years, is to focus on adequate funding for hospisafety net organizations, underserved However, the Republican takeover tals and other providers that serve those populations,” he says. communities and related health policy of the White House and the Senate in The association originally had only five members. Because issues of national priority.

1981 clearly displayed the need for a it was such a small association initially, Gage also developed a NAPH membership includes more than 100 of America’s most important safety net hospitals and health systems.

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law practice representing public and teaching hospitals, which he continues 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 relatively small in comparison to many other health associations. Gage’s work on Senate healthcare committees and in the Executive Branch has provided him with the background and the contacts to allow this tiny organization 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 reluctant to enforce this, but the influence of both Gage and the association eventually led to its implementation. “It grew from approximately $500 million dollars distributed all over the country to public hospitals in the mid-

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 program or care for the uninsured as the organization to address federal government,” 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 patient.” Gage also notes the role that NAPH plays in linking such associa-

“The US has been stagnant in healthcare for the last eight years. 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.”

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 prohibition against the government implementing these various regulations,” explains 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 mortgage insurance and has pushed for the passing of laws that provide governmental 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 impact Although NAPH remains a relatively small association, in comparison with, for example, the American Hospital Association, which encompass-

Larry Gage 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 organization 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 primary goal of this program.”

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The purpose of the award is to bring NAPH’s members together for “One of the things we’ve done on the quality front is to work with our conferences or educational sessions to transfer information and knowlmembers, to create mechanisms for making sure that patients who come edge in one part of the country to another. “Whether it’s developing a to the emergency room or the trauma center really need those services. It’s novel primary care system that’s fully integrated with hospital and spehigher quality care, for both the patients who need the emergency room cialty services, or developing a novel approach to reaching out to young and for the patient who isn’t an emergency patient who could get cared for males between the ages of 18 and 25, who are at the highest rate of in a primary care setting,” says Gage. uninsurance of any patient population, or With regard to providing additional resources organizing a community around addressing for public hospitals, Gage is already in talks with Larry Gage is President of the National a certain kind of healthcare problem, we Congress to bring in health-related provisions folAssociation of Public Hospitals and Health want to see things that can be replicated,” lowing the US election or the return of Congress in Systems (NAPH), an organization which he says Gage.

January. “We don’t know whether we’re going to get helped found in 1981. He is also a partner in traction on that, but we’re certainly laying the the law firm of Ropes and Gray LLP, where Rising unemployment groundwork now for even temporary increased payhe directs a national healthcare law practice One of the primary concerns of NAPH ments under Medicaid or directly to safety net focused on issues related primarily to public has been to highlight the problems facing providers.” hospitals, Medicaid and the uninsured. the uninsured. With the numbers of It is not just financial resources that create chalLarry’s government experience includes Americans without health insurance steadilenges for US public hospitals; there is also a shortserving as Deputy Assistant Secretary for ly rising apart form the small drop in 2007, age of physicians and non-physician clinical Health Legislation in the Federal Department Gage calls for the enforcement of a new sysspecialists, creating a multifaceted problem. of Health and Human Services and as staff tem. The current economic crisis is likely to counsel to the US Senate Labor and Human Electoral effects further increase the number of people uninResources Committee.

Under President George W. Bush, US healthcare sured, as many US workers have a health In 2007, Larry was among the ‘100 services saw little change and many problems faced policy with their employers. The unemployMost Powerful People in Healthcare’ by public hospitals remained unsolved. “The US has ment figure for the US has hit 6.1 percent, according to Modern Healthcare Magazine. been stagnant in healthcare for the last eight years,” with a prediction from economist and Nobel says Gage. “In 2007, there were only five states where Prize winner Paul Krugman that the figure the number of uninsured actually decreased, and Massachusetts counted could rise as high as eight percent. for most of that with their new program.

Gage explains the effect this will have on the association’s public “We’ve seen a complete lack of any policies to improve the situation hospital members, noting the increasing challenges in serving those withby expanding existing programs. I don’t think any of us expected to see out health insurance. Since these hospitals don’t always have the capamovement under the Bush administration toward universal coverage or nability to generate their own resources to fund such patients, especially tional health reform, but what’s actually happened in the last two or three in the emergency room, resources must be generated from elsewhere. 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 program (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 dominated by the economic crisis, and the related 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 uninsured under the new administration, with its goal of expanding coverage remaining at the forefront of the association’s activities. n

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ASK THE EXPERT

Electronic brachytherapy

By Darius Francescatti, MD, FACS

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adiation Therapy (RT) is a critical component 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 radiation that is driving access to cancer care, is available for the treatment of breast and endometrial cancers, and is being investigated for intraoperative applications.

Radiation therapy is a critical component of cancer treatment, proven to reduce local recurrences and improve long-term survival. It is used annually to treat more than 1 million cancer patients. Unfortunately, RT can also affect normal cells and cause side effects. This makes balancing 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 radiation and accelerated partial breast brachytherapy. The advantage of traditional brachytherapy as well as electronic brachytherapy is that radiation is applied directly to the tumor site, potentially reducing the dose to healthy heart and lung tissue that can result when radiation is delivered externally.

“Thousands of women annually still choose to have a mastectomy instead of pursuing breast conserving therapies” Increase access Despite these advances, we know that thousands of women annually still choose to have a mastectomy instead of pursuing breast conserving therapies and thousands more patients do not comply with their radiation treatment. Much of this is based on fear, time,

the need to deliver treatment in heavily shielded vaults, eBx is designed to help radiation oncologists improve access to critical cancer care and make it available to patients across geographic and socioeconomic levels.

Improve treatment

Darius Francescatti, MD, JD, FACS is an Assistant Professor of Surgery at Rush University Medical Center in Chicago.

distance, or difficulty accessing radiation therapy centers.

Electronic brachytherapy (eBx) brings together the best of external beam and 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 intraoperative applications. FDA-cleared for use where radiation therapy is indicated, the Axxent Electronic Brachytherapy Platform uses a miniaturized electronic X-ray source to deliver localized non-isotopic radiation directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. eBx can offer patients and clinicians a number of distinct benefits. The delivery of therapy without the use of a radioactive isotope is a significant benefit, because Electronic brachytherapy can be used in virtually any clinical setting under the supervision of a radiation oncologist. By eliminating

Delivering therapy more easily and conveniently, Electronic brachytherapy gives physicians and patients a safer and more accessible radiotherapeutic platform. For example, in the study, “A dosimetric comparison of MammoSite high-dose-rate brachytherapy and Xoft Axxent electronic brachytherapy,” researchers found comparable treatment dose volume; however, there is a significantly decreased dose to adjacent 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 to five days. Building on excellent APBI clinical results, electronic brachytherapy offers patients 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 capabilities Unlike traditional brachytherapy sources, the electronic brachytherapy X-ray source can be turned on and off at will. Its unique properties enable it to be delivered in many clinical settings rather than in traditional heavily-shielded environments. For hospitals that already have shielded vaults, this provides the ability to maximize 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, including the ability to free up valuable vault space to enable sites to run multiple procedures in parallel.

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mat ter 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.

ohns Hopkins medical center’s heart transplant program 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 Cardiac 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

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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 relatively static, a trend which is also apparent at Johns Hopkins. Baumgartner 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 ventricular 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 efficiently.

In common with many institutions which have heart failure programs, 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 artificial 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 specific question that you have.

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for a transplant, we put this in to tide them over. We also have approval 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 correspond with – they send me cards, or I see them from time to time. The field 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 quality of life.”

Neurological protection

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 find 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 office. Dr. Michael Johnston is a pediatric neurologist 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

Baumgartner has conducted studies into neurological protection in cardiac 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 field of transplantation, defining 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 identified 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.”

NIH approval for fi ve more years.”

“We are trying to figure 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 supplied by the artery dies.”

In addition to stroke, there are also other subtle changes that occur William Baumgartner in the brain when there’s decreased blood supply. The center now has a drug that researchers think might be beneficial for patients undergoing certain operations and they are about to start a pilot study clinically, 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 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 flow 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 afflicted children around the world, but also opened the door to now-familiar procedures like coronary bypass surgery.

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In the 1950s doctors and scientists at Hopkins developed the first cardiac defibrillator and discovered cardiopulmonary resuscitation or CPR. While defibrillators 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.

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m

“We’re also now looking at the genomics of this problem to see if we can more accurately define 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.”

Challenges

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 director of this clinical program if the basic research shows promise.

One 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 support the young faculty that he has on his On the horizon staff. “They have bright ideas, but it is The hopes Baumgartner has for the William Baumgartner is the Vincent hard these days to obtain an NIH grant. department are based upon the missions of L. Gott Professor in Cardiac Surgery at The budget of the NIH has been flat for Johns Hopkins to provide excellent and qualThe Johns Hopkins University School of several years. Unless you have prelimiity patient care, and to do this through supMedicine and the Cardiac Surgeon-innary data, obtaining a grant is virtually plying them with cutting edge and innovative Charge at The Johns Hopkins Hospital. He impossible. There has to be some kind of therapies.

He is proud that the department is is also Vice Dean for Clinical Affairs and funding mechanism to provide support for exploring new ways to treat patients through President of the Johns Hopkins Clinical these young investigators who have really minimally invasive approaches and through Practice Association, the organizational bright ideas.” different operative techniques like SVR, and body representing more than 1700 full-time Baumgartner recalls that when he first he would like to apply cellular therapy for papracticing physicians at Johns Hopkins. started in the field, the reimbursement for tients with heart failure in the near future.

“If After joining Hopkins in 1982, clinical services was such that at the end of you operate on a patient who has heart failBaumgartner reinitiated the medical center’s paying all the expenses and salaries, there ure, maybe it will be possible to harvest their heart transplant program, now recognized would still be enough money left over to go own cardiac stem cells ahead of time, grow as one of the country’s leading centers in towards funding new research. He laments them and inject them into the heart directly the surgical treatment of heart failure. the fact that the reimbursement rate has when you’re operating on the patient for anbeen decreased by over 50 percent over the other problem such as a bypass operation, a last 10 to 15 years, so by the time bills and salaries have been paid, mitral valve repair or a ventricular assist device implant.” they are almost at a break even point.

Due to the rapid evolution of technology, Baumgartner is opti“We try to help our young faculty through philanthropy,” says mistic that operations through smaller incisions will become more Baumgartner. “We have grateful patients who are interested in helpviable in the future. Dr. David Yuh, Director of this Program at Johns ing us make a difference. We use this money to help our young faculty Hopkins, has performed several of these procedures with and withdevelop the preliminary data they need so they then can apply to the out robotic assistance. Most importantly, he would like to ensure American Heart Association or NIH.” that junior faculty members have every opportunity for advancement, so that they can go from assistant to associate 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 final mission of the department is to train the future leaders in cardiothoracic surgery, an area in In the 1980s cardiac specialists That tradition of pioneering work which they have already had a great deal of success. at Hopkins working with children continues at Johns Hopkins “Two-thirds of our graduates, and we graduate two developed balloon angioplasty – with physicians and researchers a year, go into an academic cardiothoracic surgical inserting a balloon-tipped probe into working in almost every field practice,” explains Baumgartner. “Long term, a little the arteries feeding the heart and then related to cardiovascular over 50 percent continue in an academic practice, inflating it to clear blockages. Like the disorders, from transplant surgery and about 28 percent of our graduates have become first open heart surgery pioneered at to prevention. The hospital chiefs of divisions or departments. We hope to be Hopkins during the Second World War, receives more federal research able to continue to produce the next leaders; it’s a this new technique quickly became a funding than other medical terrific feeling to see how these young kids go on to common procedure for the treatment of institution in the country and its do really great things and I’m proud we have had an adult heart problems as well. cardiology department has been input into their education.”  specially recognized for its work.

Johns Hopkins

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HEART SURGERY

Repair works Cleveland Clinic’s Lars Svensson tells EHM about the new techniques being developed to fix aortic valves.

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he 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 ongoing comprehensive care, genetic screening for families of those with genetic 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

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increasingly rely on very sophisticated computerized tomography scanning. 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 carefully 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.”

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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 endovascular grafts, we can now have specialized endografts built that fit exactly 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 aortic 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 operating 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 medicine 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 example, we might do a robotic left anterior mammary artery bypass to the left anterior descending and then do the percutaneous valve. The operating rooms are built so that we can do both open and fluoroscopic-based percutaneous procedures at the same time.”

Innovative therapies Patients 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 incisions. We also have a big practice of patients who have connective tissue 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 aortic 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-

“One of the biggest improvements in genetic screening in families of those with Marfan Syndrome has been the production of rapid methods of looking at a patient’s genes”

Lars Svensson

cally looking at connective tissue disorders. We’re overseeing 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 improvements 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 devices 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

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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 repair

our stroke rate is very low, but what we don’t know is what the neurocognitive 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 percutaneous aortic valve. I’m on the Edwards Executive Committee running 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 patients. Patients have to have an estimated risk of death of more than 15 percent to be in the study.

Aortic 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 operative technique was fairly complicated with a lot of scientific formulas, and it therefore wasn’t very applicable.

CLEVELAND CLINIC HEART & VASCULAR INSTITUTE “What I did was modify that and reduce the aortic roots, aortic valve annulus and sino-tubular junction to what one would expect The Heart & Vascular Institute at Cleveland Clinic is composed in a normal patient based on postmortem studies. We use a nomoof more than 130 physicians within cardiovascular medicine, gram based on a patient’s body surface area to repair the valve, recardiothoracic surgery and vascular surgery. In October 2008, the pair the valve leaflets, reduce aortic root size, and create a institute moved to the newly constructed Sydell and Arnold Miller neosino-tubular junction that is normal for a patient of that body surFamily Pavilion. This facility will house more than 2000 employees face area. in nearly one million square feet dedicated to treating “We’ve done just over 210 of these, and our success rate after cardiovascular disease. 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 OVERVIEW 2007 operation within nine years, and at least two of those patients had endocarditis. Infection is still a potential problem, but when you conTotal patient visits 294,022 sider that these are young patients – I operated on one patient this Total new patients 8322 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 repair 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 projects The 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 retrograde 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

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

“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 either through the femoral vein or potentially through a small chest incision 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 patients who are inoperable by any other conventional means.”

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General outlook Svensson 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 disease 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 mortality 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 patients’ coronary arteries are opened up.

“The big picture is that there has been a reduction in the incidence of cardiovascular disease. There are many reasons for that; clearly the biggest group of patients are the coronary artery disease patients, and we have new options for those patients in both prevention and treatment after acute events, which has resulted 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 problem. That’s why politicians must address the issue of how to reduce the cost of healthcare in this country.”

No easy answer

WHAT ARE THE CHARACTERISTICS OF MARFAN SYNDROME? Marfan Syndrome affects people in different ways. Some people have only mild symptoms, while others are more severely affected.

Skeleton The 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.

Eyes More 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 system Most 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 system The 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.

Skin Stretch 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.

Lungs Restrictive 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.

“There isn’t one easy, quick answer to how to do this, Svensson explains. “The likelihood is we’re going to see

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some saving in costs from IT. There clearly is benefit to having patients on electronic records and not having to duplicate testing.

Martin Harris, who is head of our IT department, is part of a national 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 insurance 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 information. 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 disease has been very effective, and I suspect with time, we will see people having different types of healthcare plans based on their underlying disease. 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 transplantation. Obviously there’s always the problem of adverse selection, but

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.

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I think we’re going to have to see more cost containment within the healthcare 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 doctor, or an independent functioning cardiac surgery group at the other extreme – those days are numbered. The healthcare situation is becoming so complicated, and no single person can manage all of that, and increasingly 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 vascular 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 problems and physicians working more closely and communicating about patients and offering patients the best possible care.” n

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FEATURE

EHM’s Natalie Brandweiner catches up with Cass Wheeler, current CEO of the American Heart Association, as he prepares for his much-deserved retirement and shares his views on the state of our healthcare system.

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he need to reform our healthcare system is a hot topic among both physicians and patients. Given the current economic climate and the ambitious healthcare policies of a new president, the country is waiting with bated breath to see what, if anything, will change.

Cass Wheeler is closer to this subject than most. His 35-year membership 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 healthcare 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 together,” he says.

In times where the rise of the number 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 the AHA took place in 1997, during his first year of leadership, when the organization was centralized to become a single corporate structure. “This was a move that streamlined many processes for the organization. It resulted in a significant shift in resources 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 duplication and redundancy allowed Wheeler and his executive team greater

“We’re spending $2.1 trillion a year on healthcare and we’re not getting the best care in the world” time in which to make decisions more effectively, capitalizing on opportunities. “In applying business principles, we are looking at what’s sustainable, 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 influenced his adoption of a business mentality within a non-profit organization. During his tenure, the AHA experienced its greatest period of financial growth, with focused revenue streams providing a strong return on investment. “Using business principles, we developed the best practices and drove them throughout the organization,” he says.

Bureaucratic challenges

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.

The consolidation of the association’s structure did not come without its challenges. “Making the decision to consolidate 50-plus separately incorporated state level non-profit organizations under a single corporate 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 consolidation process occurred with speed and efficiency.

The reform of the AHA’s organizational structure paid off, with a successful transition from approximately 50 state organizations to 15 regional organizations, and continuing through the decade to now function as eight. “As with many 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 your mission.”

With his impending retirement, Wheeler is set to release a book entitled 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 nonprofit organizations and highlights the necessity of a clear decisionmaking framework, successful advertising efforts and a greater use of savvy technology.

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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 has been able to focus his attention on expanding his reforms externally into the US healthcare system.

The AHA has always placed the American public as its primary concern, providing accountability for all the dollars its supporters have donated. In return, the association provides a framework in which education on cardiovascular diseases can be provided to both patients and healthcare providers, while furthering scientific advances for treatments.

combination of CPR training and automated external defibrillators, present now in many public places, have made it possible for even bystanders to save lives.

Educational insight

For Wheeler, it is not the remote functioning of scientific advancements that defines the AHA’s activities but the provision of education for the public, which has remained at the forefront of the association’s strategic aims. “The cost savings and streamlined structure have enabled us to do new things and implement programs that we had never imagined earlier, such as our ‘Get With the Guidelines’ and ‘Mission: Lifeline’ programs.

Technological aids Consistency in our statements and healthcare In looking back over the last 35 years and guidelines has actualized into becoming the evaluating the most significant scientific standard for treatment of heart disease in this progress, Wheeler notes the progress in drug country,” he explains. discovery and the technologies developed to The ‘I am a Stroke’ campaign, launched in make the best medical care possible. “We’ve 2003, was one of the AHA’s most effective public made tremendous advances in ultrasound and service announcement campaigns, released in nuclear imaging, along with innovative techpartnership with the Ad Council to raise awarenologies in the field of CT scanning and magness of stroke in the US. It starred actors such as netic resonance imaging,” he explains. The Patrick Dempsey, Don Rickles, Michael-Clarke rapid growth of arteriographic technology in Duncan and actresses Sharon Stone and Penny the 1960s, and the continued advancement of Marshall, and generated more than $50 million ultrasound and echocardiography, brought in advertising value during its first year. the ability to view coronary arteries, heart “If you look at the period 2003 through to valves and muscles, and diagnose disease.

2008, we have launched several other stroke camNancy Brown has been named the These were important developments, based paigns with the Ad Council, and these campaigns next CEO of the American Heart on a better understanding of the structure of have generated more than $200 million in adverAssociation, effective 1 January 2009. the blood vessels and the heart. tising value over the last six years,” adds Wheeler.

Brown has served as the association’s “Thirty-five years ago, angioplasty didn’t According to independent research conducted to Chief Operating Officer for the last even exist, but with the evolution of that techmeasure the effectiveness of the campaign on seven years. Read the next edition of nology, including stents, both bare metal awareness of stroke, the percentage of survey reEHM for an exclusive interview with and drug-eluting, we are able to better open spondents who feel confident in recognizing the Nancy Brown as she begins her arteries and to minimize the chance of the warning signs of stroke, both in themselves and leadership at the association. recurrence of a blocked artery. Our ability to others, increased by ten percent from March 2005 control cholesterol and blood pressure levto May 2007. els with effective medications has also been Most recently, the AHA adopted an Impact enormously significant,” Wheeler explains. He also notes the many adGoal to reduce coronary heart disease, stroke and risk by 25 percent by vancements due to the establishment of coronary care units (CCUs) in 2010. “This goal became a unifying vision for the organization, and resultthe 1960s. ed in a better alignment of financial and human resources,” explains “These units combine two simple strategies: one, the clustering of Wheeler. The end result of employing strategies to reach the 25 percent patients with heart attack on a single hospital unit, where necessary equipgoal meant evaluating the AHA’s various initiatives and streamlining its ment and drugs are readily available and where trained personnel could be strategies to incorporate those that contribute the most to this reduction, in continuous attendance; and secondly, the training of specialized nurses bringing with it further improvement of the AHA’s healthcare strategies. to recognize and treat arrhythmias rapidly in the absence of a physician,” Wheeler has also led the association’s charge to reduce death and Wheeler says. Research from the AHA’s work within the technological dedisability from smoking-related illnesses. Tobacco use kills more than velopment of CCU’s has reported that patients treated within this environ400,000 Americans each year and one-third of these deaths are relatment have an increase of rate of survival. He also notes the significance of ed to cardiovascular diseases. Wheeler has been a strong proponent of work done in the 1970s and 1980s on defibrillators and the creation of imthe association’s campaign to pass federal legislation to give the Food plantable cardiac defibrillators, which have become the treatment of choice and Drug Administration the authority to regulate tobacco products. On for patients with life-threatening ventricular arrhythmias. And of course, a the state and local level, Wheeler has supported AHA advocates in mea-

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sures to increase cigarette excise taxes, sustain and increase funding Influencing policy for tobacco control and cessation programs, and pass smoke-free workMerging the AHA’s guiding principles of healthcare with US policy is place laws. paramount to Wheeler’s personal aims. As presiding CEO for over a Discovery, transfer and processing of knowledge play an important decade, Wheeler has championed a radical change from the current role in the Impact Goal strategies, along with the entrepreneurial tachealthcare system, which is based around acute events, to that which tics of revenue generation through appropriate customer relationships. is demanded by today’s increasingly obese society: chronic care.

The success of Wheeler’s work within the association has been most im“What we’ve got to do is shift from a non-evidence-based delivery of portantly demonstrated by the AHA reaching its 2010 goals for reducour healthcare, to one that is evidence-based. We need a system in ing heart disease and stroke deaths by 25 percent ahead of schedule which we’re not over-treating and we’re not under-treating, but instead in 2008. everybody gets the right care at the right AHA’s Impact Goal success can be attime,” Wheeler says. tributed to its longstanding commitment to According to research by the American THE AHA’S SIX PRINCIPLES approaching healthcare reform from the perObesity Society, approximately 60 million FOR AN OPTIMUM spective of the patient. Most prominent in adults are obese, with another 60 million HEALTHCARE SYSTEM: Wheeler’s evaluation of significant events being severely obese. “What we have is a sysduring his 35-year employment is the healthtem that was designed around acute care, and All residents of the United States care reform debate in the 1990s, in which the now it’s being overwhelmed by chronic disshould have meaningful, association’s Board of Directors approved six eases,” says Wheeler. “About 75 percent of all affordable healthcare coverage. principles for access to healthcare. “The deour healthcare expenditures are now due to bate focused on patient access to preventive chronic diseases as opposed to acute disPreventive benefits should be an services and quality healthcare, as well as eases, yet our system is still based on that essential component of the pursuit of ongoing biomedical research which was set up 40 years ago.” meaningful healthcare coverage. to further improve the prevention and treatWheeler also points to the incompatibilment of cardiovascular disease.” ity of the payment system with recent times All residents of the United States and the need to move away from the payshould receive affordable, highSix degrees of prevention ment of providers via a piece rate, as used in quality healthcare.

In September 2008, the AHA released and the previous acute system. He believes that updated a set of guiding principles which it providers should be paid for on a perforRace, gender and geographic called upon the US presidential candidates mance rate, with inbuilt incentives to disparities in healthcare must be and lawmakers to incorporate in healthcare reachieve successful outcomes. eliminated. form plans.Wheeler explains the six healthcare Wheeler remains optimistic although he principles set by the association in alignment believes reformation of the healthcare sysSupport of biomedical and with this, again highlighting the AHA’s work on tem will be a slow and painful process. health services research should behalf of the public.

“Reform will never take the shape of wholebe a national priority.

“All residents of the United States sale change,” he says. “I am encouraged, should have meaningful, affordable healthhowever, in that President-elect Barack The healthcare workforce care coverage with preventive benefits being Obama has suggested that healthcare reshould continue to grow and an essential component of meaningful form and prevention of disease will be a pridiversify through a sustained healthcare coverage. Incentives should be ority in his administration, and hopefully this and substantial national commitment built into the healthcare system to promote will transfer into a significant change in to education. appropriate preventive health strategies,” he 2009.” says. He notes that race, gender and geoWith our healthcare policy intrinsically graphic disparities in healthcare must be linked to economic policy, the unrolling of reeliminated, and that the United States form that requires increased spending is unhealthcare workforce should continue to grow and diversify through a suslikely to occur within the sphere of the current financial crisis. “Certainly tained and substantial national commitment to medical education and clinhealthcare reform is an economic issue, when we’re spending $2.1 trillion ical training. a year in the United States and we’re not getting the best care in the world Wheeler’s final points stress his individual commitment and passion for that expenditure,” explains Wheeler. for reform of the current US healthcare system, as he underlines the imHe attributes a lack of reform to a system that is based on corporate portance of healthcare within legislative policy: “There should be support competitiveness, rather than healthcare. “People are unable to afford the of biomedical and health services research, which should become a nacoverage that they need. Forty-five million people in the US are uninsured, tional priority, with inflation-adjusted funding for the National Institutes of and we’ve got millions of others who are underinsured,” he underlines.

Health to be maintained and expanded,” says Wheeler.

“We’ve got to change that.”

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Stalking a silent

killer

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Finding a treatment for an illness such as a brain tumor where the causes are often hard to pinpoint is a challenge. John Suh of Cleveland Clinic reveals the work the clinic is doing to better understand this mysterious and often deadly condition.

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he cause of most brain tumors remains a relative enigma, with sufferers being in the frustrating situation of not knowing what is causing their illness in the first place. Spurred on by the poor recovery 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 recovery and improving their quality of life but by aiming to unearth the questions surrounding the condition. Recent advancements in imaging and radiation technologies, and a better understanding of biology have contributed greatly to the huge strides already been made in the area, although there is still much to be done.

Suh’s work has focused extensively on patients with malignant brain tumors who have historically not fared well. “We now know through various clinical 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 delivery, and sophisticated computer programs have allowed us to better target radiation to brain tumors thereby minimizing dose to critical structures and allowing for higher doses of radiation.”

rates that we have seen for patients with early stage lung cancer treated with three to five fractions of radiation have been upwards of 90 percent.”

Group trials

Suh is proud that research has been one of the primary focuses in the department of radiation oncology. He has been fortunate to be involved with a number 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 malignant brain tumors. Other studies have investigated the use of a combination of radiation and chemotherapy or radiation sensitizers for patients. “In terms of pharmaceutical studies, I’ve been mostly involved with radiation sensitizer trials,” recalls Suh. “These are agents that are given before or during radiation treatment to enhance the effect of radiation therapy. I’ve been most involved with two compounds: motexafin gadolinium and efaproxiral.

“Theseareagentsthatwerethought toenhance theeffectofradiationtherapy and have been tested for patients with brain metastases. Unfortunately, the efaproxiral drug does not appear to have activity against patients with brain tumors from breast cancer. The motexafin gadolinium agent appears to improve neurologic progression free survival for patients with non-small cell lung cancer Research areas that has spread to the brain.

Gamma knife radiosurgery is another of Suh’s research areas and has Suh hopes that they will be able to perform another confirmatory study been performed at Cleveland Clinic since January 1997. The clinic’s facility has testing the use of motexafin gadolinium with whole brain radiation patients been upgraded on four separate occasions, the most recent taking place 18 for those with newly diagnosed non-small cell lung cancer. months ago to the Perfexion model. Unlike the previous versions of the TheRadiationTherapyOncologyGroup(RTOG)hasbeenanimportantcomGamma knife used at the facility, the new version uses a robotic table, allows ponent of the research that Cleveland Clinic has performed for cancer patients. treatment of lesions throughout the brain, and autoThe RTOG is a multi-institutional, multidisciplinary cooperIt is estimated that over matically changes the size of the radiation beam. This ative group of over 300 academic and community medical has facilitated treatment efficiency and also accuracy for facilities, funded primarily by the National Cancer Institute. the patients, as Suh reveals: “As a result, we’ve been “It has long been considered a recognized leader to inable to treat a greater number of patients in the same crease survival and improve quality of life for cancer paamount of time. It also allows for the possibility of treatAmericans are diagnosed with tients,” says Suh. “Since my research focus has been ing lesions lower than we could traditionally treat with primarily for patients with brain tumors, we have enrolled brain metastasis every year the gamma knife.” a number of patients with low-grade gliomas, brain metasOver the past few years a number of innovative radiation modalities have tases, malignant gliomas, and other brain tumors onto these studies. In addicome to the forefront. One radiation technique that the clinic has been using is tion, the RTOG has studies devoted to other disease sites including head and transponders and positioning technology to track tumors during treatment neck, lung, gastrointestinal, genitourinary, gynecological, and breast cancers. without adding ionizing radiation. The clinic uses the Calypso system for Our goal is to have active enrollment and leadership in these areas as well.” prostate cancer patients. “We know that the prostate gland moves during raRadiation therapy for brain metastases diation treatment,” explains Suh. “By implanting these wireless transponders It is estimated that over 170,000 Americans are diagnosed with brain to track the motion of the tumor continuously we can minimize the margins that metastasis every year. It is a relatively unknown disease, since it is a combiwe need to properly and precisely treat these patients. This should ultimately nation of many diseases. Breast cancer represents the second most common allow for a decrease in radiation dose to the normal surrounding tissue.” cause of brain metastases.

Another development that has occurred in radiation oncology is shorter Recently, Suh has chaired an international phase III study of whole brain treatment schedules. Stereotactic body radiation therapy with the Novalis unit, radiation therapy efaproxiral and supplemental oxygen for women with brain for example, occurs in one to five treatments, hence the clinic has been able metastases from breast cancer. As he explains: “I’ve been involved with the to treat some of its lung cancer patients and spinal metastasis patients in a use of the drug efaproxiral with the hope of improving outcomes for patients much shorter period of time. “This facilitates patient convenience without with brain metastasis. compromising treatment outcomes,” highlights Suh. “In fact, the local control

170,000

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“Based on some encouraging phase II results, we participated in a large Challenges multi-institutional international study testing efaproxiral, which is a reported One of the challenges Suh and his team have faced in radiation oncoloradiation sensitizer, plus supplemental oxygen and whole brain radiation thergy is how to improve patient care, research and educational opportunities apy versus whole brain radiation therapy alone plus supplemental oxygen. within the department. Suh explains that due to the size of the department The results showed that the subset of patients with breast cancer appeared – which consists of five different centers as well as a main campus facility – to live longer.” communication, accountability and expectaAs a result, the team embarked on a contions are sometimes hard to permeate firmatory phase III study of over 360 women throughout a large enterprise.

John H Suh is the Chairman of the Department of from three different continents with the hope “One of the challenges I’ve had is sendRadiation Oncology at the Taussig Cancer Institute and of demonstrating that the addition of efaproxing a clear consistent message regarding the Associate Director of the Gamma Knife Center at the Brain iral to whole brain radiation therapy would goals about what we’re trying to achieve Tumor and Neuro-oncology Center at the Cleveland Clinic. improve survival for women with brain here in radiation oncology. These goals inHe received his bachelor’s and medical degree from the metastases from breast cancer. clude providing coordinated comprehensive, University of Miami School of Medicine in Miami, Florida.

Unfortunately, the results of the study compassionate, multi-disciplinary care to He completed his internship, residency, and fellowship at demonstrated no survival benefit for women our cancer patients. Through better commuthe Cleveland Clinic, where he was residency program diwho received efaproxiral in combination with nication and expectations we’ve been able to rector from 1996-2002. Suh’s primary clinical, educational whole brain radiation therapy. refine how we go about treating our patients and research interests are brain tumors, Gamma Knife raThe use of this radiation sensitizer, which who have cancer. We have also been focused diosurgery and innovative radiation modalities. He has parwas thought to increase tumor oxygenation, on how to improve the research and educaticipated in various in-house, pharmaceutical, and did not appear to improve outcomes for tional aspects of the program to ultimately cooperative group trials and chaired an international, these women. Therefore, the treatment for improve outcomes and patient experience.” phase III trial of whole brain radiation therapy with efaproxwomen who develop brain metastases from Following these principles has resulted iral, a radiation sensitizer, for women with brain metasbreast cancer remains an unmet need. Suh in improvements in academic productivity, tases from breast cancer. He was recipient of the National believes it is important that they continue to an improved residency program ranking and Brain Tumor Foundation Clinical award in 2003. support clinical trials to improve outcomes higher patient satisfaction scores. In addifor women who develop this devastating contion, the department has employed business dition. “Sadly, the survival for women who develop brain metastasis is under tools such as Fastracs, performance management reviews, and q-boards to a year,” he says. “It’s important we continue to investigate how to best treat better define our expectations, close gaps and create goals as a department. these patients.”

Although Suh admits that aspects of the role as chair has been challenging, The clinic is participating in several multi-institutional trials trying to either it has at the same time been very rewarding to see the many positive changes improve outcomes or quality of life for patients who develop brain metastasis. that have occurred by bringing everyone together and emphasizing quality, The first is a RTOG study testing the use of the drug Namenda in addition to innovation, service, and teamwork, which are the four cornerstones of whole brain radiation therapy with the hope of minimizing the potential neuCleveland Clinic. rocognitive side effects associated with whole brain radiation therapy.

In the future, he hopes to see the department become one of the top-tier “We are also participating in a multi-institutional study investigating the radiation oncology centers. “We will need to continue to enhance our patient use of stereotactic radiosurgery with or without whole brain radiation therapy care, educational, and research portfolio to become one of the top centers.This for patients with 1-4 brain metastases”, says Suh. “Since we’re eager to improve will ultimately enhance patient care, the quality and safety of our care, and also outcomes for patients with malignant brain tumors, our practice has been reprovide a platform for the many dedicated co-workers see their hard work transally focused on enrolling patients onto clinical trials.” late into better survival and quality of life for our cancer patients.”

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BRAINWAVES

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.

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ver since David Yousem arrived at Johns Hopkins his disease in 2006, according to a study conducted by Johns Hopkins work has mostly involved mentoring and developing Bloomberg School of Public Health. Worryingly, the global prevalence people in his division. As Director of Neuroradiology of Alzheimer’s will grow to more than 106 million by 2050. Having been and Professor of Radiology at the hospital his division fascinated by everything centered around the brain and the central nerconsists of 10 physicians and four PhDs specializing in vous system ever since his time as a medical student, Alzheimer’s is an neuroradiology. However, the Russell H. Morgan Deimportant aspect of his focus and of those that he mentors. partment of Radiology and Radiological Science also “One of my goals as a neuroradiologist is to find a test that would includes a number of groups including a CT group, an interventional identify relatively early those people at highest risk for Alzheimer’s before group treating tumors and fibroids of the uterus, and members working they develop symptoms and before cognitive decline,” he explains. “Even in pediatric imaging, ultrasound, nuclear medicine and tumor imaging. before patients with Alzheimer’s disease have memory deficits, they “We are surrounded by brilliant people on a often have deficits with their sense of smell. It daily basis, and the quality of the people in turns out that sense of smell and memory are the clinical realm of neurosurgery, neurology, very closely collocated in the brain. I was inneuroscience and psychiatry is just fantasterested in trying to determine whether there tic,” he says. “Johns Hopkins is a wonderful was a way of exploring patients’ sense of environment to work in.” smell through imaging at a point where there He is particularly proud of his division was no clinical evidence to suggest they had a members’ achievements and recalls how loss of cognition. I then wanted to determine several of his faculty members have been whether this would predict whether or not a promoted and have gone on to become full patient would go on to develop Alzheimer’s professors. “In the 10 years I’ve been here, disease from a young age.” several people have become recognized as There are a number of factors that international experts in carotid plaque imagmake people more susceptible to getting ing (Bruce Wasserman), semantic processthe disease. Genetics is the first of these, ing (Mike Kraut), molecular imaging (Marty with some people just having a genetic Pomper), and teaching (Nafi Aygun, susceptibility for it and much Doris Lin) largely through their own work has been done on the APOE work and my minimal mentorship.

Type 4 allele, which is one of the David Yousem is currently the Director of It’s been most gratifying to see my genetic factors that may influence Neuroradiology and a Professor of Radiology at people come into their own and be the onset of Alzheimer’s. the Johns Hopkins Hospital. His expertise spans promoted and get recognition.”

Head trauma has also been the full gamut of neuroradiology techniques Yousem highlights how clinical linked to Alzheimer’s. “When you including CT, MRI, myelography, sialography, work has virtually doubled in the look at a lot of the patients who plain films, CT guided aspirations and biopsies, past 10 years. The hospital has to have Alzheimer’s, they have had functional MRI, diffusion and perfusion imaging, deal with more cases and more paan event that was related to head MR/CT angiography and 3D reconstructions. tients are getting scanned than ever trauma”, identifies Yousem. “We He is a noted authority on disorders of the before. This is partly due to an aging know this, for example, in patients brain, spine, head and neck, olfaction, cranial population with a lot more patients who were once boxers and have neuropathies and neurodegeneration. being evaluated for conditions such become ‘punch drunk’.” as dementia or degenerative spine Lastly, the vascular risk factors disease. “We’ve seen a lot more for stroke are also increased in papatients being evaluated for low back pain or neck pain as they grow tients with Alzheimer’s disease. If you’re injuring the brain because of older. In neuroradiology, MRI’s and CAT scans of the spine are part of tiny little micro-strokes then this also seems to be a predisposing factor the work that we do. for development of Alzheimer’s disease.

As the incidences of Alzheimer’s disease grow, getting to the As the baby boomer generation gets older, incidences of diseases bottom of why some are susceptible to the disease in comparison to like Alzheimer’s are likely to put a lot of pressure on the healthcare others is a discovery Yousem would like to unearth. More than 26 milsystem. Already a huge amount of money is being spent on assisted lion people worldwide were estimated to be living with Alzheimer’s living for patients who can no longer take care of themselves. As people

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emotions, instincts or reactions are processed in the brain. “We can aclive longer their end-of-life expenses in the last two years of their life tually see what part of the brain is activated given a particular challenge just get higher. “We don’t have a handle on prevention of Alzheimer’s, or task,” highlights Yousem. “The functional MRI team at Hopkins, led good treatment for the disease or a lot of the other neurodegeneraby Jay Pillai, can now tell you what part of the gray matter of the brain tive disorders. There has been so much research into heart attacks is being activated, but the areas of the brain are and atherosclerosis, and we’ve done pretty connected via the white matter. Over the last well with stroke but on the neurodegenerative five years, neuroscientists have developed the disorders, both in the brain and the spine, we “We are surrounded by techniques to look at the white matter tracts.” really haven’t made all that much progress. This brilliant people on a daily Most of this work has been carried out at is therefore an area of potential growth.” basis, and the quality of the Johns Hopkins by the researcher Susumu Mori MRI who was one of the first people to develop diffupeople in the clinical realm Some of the most interesting developsion tensor imaging (DTI). This allows researchof neurosurgery, neurology, ments that have been taking place in neuroraers to see the white matter tracts that connect neuroscience and psychiatry diology techniques include imaging the brain gray matter areas in the brain. “Due to this is just fantastic” and mind, with functional MRI being the main process we are now able to understand much technique used. By using this technology it is better how the brain is wired,” explains Yousem. much easier to understand where different “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 Possible causes of ADHD memory. However, they would have trepidation about cutting across the white matter tracts that connect those areas to other parts of the Significantly low birth weight (very small brain. Now they can avoid not only the gray matter areas that are critical when born) 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 Difficulty during pregnancy have much fewer deficits when they come out of surgery.”

Molecular imaging is something that is still in its infancy. This is Prenatal exposure to alcohol, tobacco and/ the ability to image chemicals that the brain is making or cell surface or drugs markers on the surface of the cells in the brain. Yousem highlights how this is allowing researchers like Marty Pomper and Dima HamExcessively high lead levels (high levels of lead moud to investigate the chemical environment of the brain and to in your blood stream) identify where there is a higher concentration of one particular protein or chemical in the brain compared to others and how this can be Prenatal injury to prefrontal area of the brain manipulated with medications to treat disease.

!

(injured before birth in the front portion of the brain)

Genetic difficulties (this is considered to be the most common cause)

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A way with words Yousem 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 ultimate 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 underlying 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 different 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.

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Not content with keeping his mind active through mentoring, clinical 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 emotional and spiritual world. Learn is your intellectual 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 involved me getting more into religion, meditation and Eastern philosophy. 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 focus An 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

Facts about Alzheimer’s 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

like vaccinations? We need to get to the bottom of why it is occurring 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 identify the areas of abnormality and intervene.” n

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Clinical imaging can now be used to personalize diagnoses and to shed new light on the relationship between disease pathology and what the patient feels. Paul Matthews of GlaxoSmithKline talks to EHM about the benefits of these advances to developing new medicines.

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evelopments in clinical imaging have been moving apace. The nature 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 important 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

New developments in clinical imaging

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to address is: does the molecule even get to the brain? Movement of molecules 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 the molecule, label it with a positron-emitting isotope and administer that subject in micro-doses. We can trace where that molecule moves in the body and literally watch it move into the brain and define how much gets there.

“A second question for PET that follows from this is, does the molecule actually interact with its target and, if so, with what affinity? Knowing this allows a rational prediction of active doses.”

Realizing benefits

of the building is an MRC facility. The three partners work together in managing a common facility resource.

But it’s the non-physical element of the collaboration that Matthews finds exciting. “The development of new techniques that can be markers of disease or markers 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 funded by GSK and half by Imperial College. We have mentorship from GSK and 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 wellequipped, having the largest research income of any UK medical school.

“We also are developing joint scientific programs, for example in the areas of appetite regulation and neuroscience, which are run by Imperial College faculty and our staff and have common resources.”

Matthews points out that in the ‘bad old days’ – before many companies started using these techniques – 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 we don’t know what dose to give to a subject, we need to use many Making advances more subjects in the early phases of drug developAccording to Matthews, imaging is a fantastic ment. This takes more time and costs more money. area to be in and offers a wealth of opportunities, Molecular imaging allows the speeding up of deboth for the research community and for the pharvelopment. By limiting the subjects exposed, it is maceutical industry, because there are so many exsafer for patients who are involved in the trials and citing developments on the horizon. it delivers higher value in the end.”

“In MRI imaging right now, what we’re beginPET is not the only imaging method that can ning to be able to do is characterize the virtual hishelp drive drug development. The CIC also has an Paul Matthews is Head of tology of a tumor in the living body without having active, smaller group that uses advanced MRI scanGlaxoSmithKline’s Clinical Imaging to do a biopsy. That’s important because it would ning. Matthews emphasizes that to gain confidence Centre (CIC). He is also Vice President in potentially allow big decisions to be made about in potential clinical benefits, precise information is drug discovery within the company. CIC what kind of therapy to use with the tumor, how agneeded about pharmacological effects. “Consider is a collaborative venture undertaken by what happens with weight loss. We know there’s an gressive to be with it and what the prognosis might GSK, Imperial College London and the association between weight and poor clinical outbe. This is possible because MRI can probe many Medical Research Council to create the come with diabetes, heart disease and a variety of characteristic issues within minutes of an investilargest new clinical imaging center in the other medical problems. But when we use a drug to gation. This is an emerging area. The range of molworld dedicated to the development and help people lose excess body fat, how do we know ecules that are beginning to be studied is truly application of imaging techniques for we are targeting the right sort of fat? incredible. drug development.

“Fat accumulates in different places in the body “One of the emerging areas that our Head of and it has different clinical consequences dependBiology has been developing, initially with academing on where it is. If you have much fat deep in the ic colleagues, is siRNA. siRNA is one of the most exbody, around organs like the liver, it is a possible cause for clinical concern. citing new ways of delivering an entirely different kind of treatment to On the other hand, if the fat is just under the skin, it may be perfectly compatients, one that would be targeted genetically very selectively to a bad patible with a long, healthy life. With MRI imaging, you can differentiate fat protein, for example, in a cancer cell. loss deep in the body from that under the skin, and define what a weight“SiRNA potentially allows therapeutic modification of a single proloss drug is actually helping to change.” tein, while not touching other parts of cell function. However, the problem has been to know how much of any siRNA administered actually Collaborative science gets into cells, where it goes and whether it is having any effects on the The CIC was built through a collaboration between GSK, Imperial biology. There are new ways of using PET that promise an approach to College and the Medical Research Council. The building sits on a plot of quantitative measurement of how much siRNA is sticking in cells and ground in the middle of the Hammersmith Hospital and is controlled and where it’s going amongst the cells in the body. This should allow cliniowned by Imperial College. The lower three floors are the CIC, the upper cal scientists to move rapidly from the point of dosing to prediction of two floors house Imperial College clinical neurosciences, and the other half possible efficacy.”

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Seeing the brain The latest advances in clinical imaging that help illuminate the relationship between disease pathology and patient feelings are particularly relevant to Alzheimer’s disease 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 feeling. Changes in the way the brain functions determine everything about us, but in the past, the brain has been a black box, so no one could tell what anyone else was thinking 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.We can only see the consequences. However, we can 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 specific diagnoses. There are many diseases in which the same symptom can be caused by many different 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 responses verbally reported by the subject. “This translates again to that critical 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 therapy According 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 that even now, often the only way we have of assessing whether or not 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.

“This means subjecting patients to weeks or months of very difficult treatment, without being certain whether it’s giving them any benefit. It is potentially missing an opportunity to provide benefit using an alternative treatment.

Imaging with molecular markers allows us to look at the way the cells are responding 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.

GKS’s Clinical Imaging Centre at Hammersmith Hospital, London, UK

“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 cycles, how to administer the different drugs within the cycles, what order to give 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 rational 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.”

Matthews points out that this is also important for drug development because it means that assessment of new molecules can be done more quickly.

“It is important for patients because we can end trials with a molecule 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 the CIC is unique in the industry.The company has a big vision: “We are committed to sharing openly with the scientific community, including other pharmaceutical companies. The methodology can transform drug development, and it’s important for the scientific community to share in its development and ownership. This is what will bring the highest value to us as a company.”

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RADIOLOGY

Follow the leader Eliot Siegel reveals to EHM how he and his team revolutionized radiology and made film a thing of the past.

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n 1993 Eliot Siegel, Professor and Vice Chairman of Information Systems, and his partners at the University of Maryland School of Radiology, were the first radiologists to introduce film-less technology. 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 field of study concerned with the broad issues, management and use of biomedical information, including the study of medical information,” explains Siegel. He notes that imaging informatics is defined 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 imaging 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 diagnostic imaging and other disciplines, including engineering, information, technology and physics.”

Challenges Being 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 definition of image quality and how can we actually measure it and improve it? Is image quality just defined as what is aesthetically pleasing to the radiologist, or is there a more general quantifiable definition of it?”

Quantification does not come without its difficulties. Its function in diagnostic radiology is to provide tangible results through enumerate 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 measure lesions and in our criteria for determining size, volume or what is the error of measurement,” Siegel says. Determining these results on a quantifiable 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 fit together we can tailor a specific treat-

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ment or screening regime for a particular patient.”

Quantifying results also produces the benefit of greater communication 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.”

Innovation It is not only diagnosing an accurate interpretation of informatics imaging that poses a problem; communication with physicians brings with it technological challenges as well. Siegel and his team faced those difficulties 15 years ago when they unveiled their creative innovation and introduced film-less technology.

“We were the only department that was film-less in the United States for quite a few months and in order to interface with our incoming 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 film,” Siegel recalls.

As other facilities have made their transition towards digital imaging, 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 different 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.

“We’ve moved to a digital environment and patients are now being handed CDs or DVDs after they have their CT or MRI studies” “I would see the transition in CDs developing in the future towards 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-

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compatibility of formats can be corrected.

Within Siegel’s own department, the changing nature of imaging informatics is exemplified 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 institutions that have made the transition from film-based radiology to film-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

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.

The department has also introduced speech recognition technology, which, with the elimination of the transcription process, allows for the ability to decrease report turnaround times. Advanced 3D workstations are a major development from the film-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 fits 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 subspecialized studies, routine studies can now be reconstructed so that we can get very detailed views of the spine or the patient’s vasculature, pulmonary vasculature or abdominal vasculature. During one visit, we’re able to acquire information volumetrically, and the benefit 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 applied to each of the 30 to 40 projects he may be working on at any one time. In response to progressing quantifiable measurable results, Siegel explains the work he is doing on algorithms: “We’re investigating 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 measurements.” Siegel and colleagues are investigating the use of grid computing which can facilitate the ability for multiple 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 diagnostic 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 radiologists,” says Siegel. “We physicians tend to take better care of our patients than we do ourselves.”

Technological innovation is what propels 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 radiology. “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 significant 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 findings out, so rather than just using a text method for reporting, we’ve done some research looking at gesture based reporting. “We’re also looking at the impact of reducing radiation dosage on computer programs that do automated computer-aided detection as well as novel CAD applications 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 innovation did not end at the creation of film-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. 

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All systems go

Electronic patient records are launching healthcare into the 21st century.

Eric Yablonka looks at how IT is improving functions at the University of Chicago Medical Center.

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 implement Oracle’s ERP system in order to manage our two biggest cost inputs; 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.

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We’ve recently implemented Oracle’s HR system and use this for everything from managing our compensation planning to our performance evaluations. We don’t know exactly what kind of hard dollar quantifiable benefits this has brought about but we have pushed more self-service functionality to management and to end-users. Along with this, data has become 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

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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 radiology implementations were replacements of legacy systems that were no longer being supported by vendors. The pharmacy system implementation was necessary for our planned computerized provider order entry deployment, 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 implementation, 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 opportunities, pathways and resources?

EY. IT tools can certainly make things happen. However, there are many barriers to using such tools, including standards that don’t allow interoperabil-

“IT tools including standards that don’t allow interoperability between various medical providers” 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 interoperability 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 augment the personal health record. From an industry and vendor perspective we’re seeing a lot of activity in the marketplace, with Google and Microsoft getting involved. However, the most universal houser of medical information continues to be the insurance companies and the federal government. I’m sure we’ll continue to find new ways to leverage data regarding patient care.

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EHM. Currently, there’s limited online support to help healthcare profesI’m in a position where I have responsibility from an IT perspective for sionals deliver their best standards of care. What do you think could be the medical, academic and the research side. I find it to be a very exciting done to help remedy this situation? opportunity, and the industry really needs to pay a lot of attention to it.

EY. Having standards would be really helpful because those millions of day-to-day encounters in medical practice EHM. What challenges or opEric Yablonka has over 20 years of don’t necessarily match up. If this is the case then they portunities do you see coming experience in information systems cannot be leveraged or aggregated in a constructive way. up? management. He has served as Vice We need to consider if there is a business need for this in EY. The biggest challenges inPresident and Chief Information Office of the first place. clude the continual decline of the University of Chicago Medical Center reimbursement and funding for (UCMC) since 2001. His responsibilities at EHM. The President’s budget for 2008 includes $15 milmedical care. There is an expecUCMC include all information technology lion in startup funding to create a new electronic network tation that healthcare organizafunctions, biomedical engineering and the that would draw together data from major health data tions and physicians will call center. He has leadership repositories. How will this further the goal of personalized continue to provide the care responsibility for the T-2 program whose healthcare and impact the average consumer? whether they get paid or not. focus is to transform how UCMC EY. To start up an electronic network, which would draw toThe ratcheting down of quality functions in supply chain and gether data for major health data repositories, $15 million standards is both a great chaladministrative management, patient care is nothing. I don’t know how it will further the goal of perlenge and an opportunity. The delivery and patient and physician access. sonalized healthcare or impact the average consumer. payers will no longer pay you if Prior to UCMC, Yablonka was the Vice Even a small startup company in the healthcare space can you have a medical error and President and Chief Information Officer for use up $15 million in 12-18 months just in research, develthis will force healthcare organithe Saint Raphael Healthcare System in opment and trying to get a product to market. Therefore, I zations to treat quality even New Haven, CT. have no idea how that funding will help. If anything, it’s a more seriously. statement of a lack of commitment by the federal government in this area.

We also have challenges in terms of talent in the healthcare IT sector. We need unique people with healthcare knowledge and experience. In many parts of the country there is a competitive marketplace to recruit and retain top talent. n

EHM. What role can IT play in the burgeoning field of personalized medicine and translational medicine?

EY. The University of Chicago and other academic medical centers are doing some groundbreaking work in translational research. There is a lot of benchto-bedside research, and this is very important going forward. When we think of personalized medicine this is a very exciting time in academic medical centers. These centers, which take their research and genetic data and couple that with healthcare information generated from patient care, will be able to develop clinical trials and other treatment protocols that could achieve huge breakthroughs 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 potential to change the way healthcare orgaThe days of searching the shelves for patient records are behind us nizations treat patients.

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ASK THE EXPERT

E-Wellness: Trust is what the doctor ordered The 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.

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lectronic medical records (EMRs), online claims, personalized disease management, email advice programs, and other innovative online services are not only streamlining healthcare, but enabling patients to exercise greater control over their care and expenses. By reducing medical errors and providing faster access to accurate, complete patient information, electronic 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 benefits through the adoption of these online services and transactions. Storage and paper costs, which can run tens of thousands of dollars 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 medical records may make it easier for health plans to identify a fraudulent claim. Claims could potentially be validated by the patient electronically before the health plans issues payment.

From improved quality of care and responsiveness to new levels of efficiency and cost savings, e-healthcare is poised to have a positive 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 retailers 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-

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third of commercially-insured consumers are not sure if their health insurer is fully protecting 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 unauthorized access to personal medical information 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.

“Electronic healthcare can make it easier and faster for consumers and health plans to detect fraud” Setting a higher standard Piecemeal 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.

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.

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 building 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 century healthcare. n

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DRUG DISCOVERY

Getting in on the ground floor Can’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.

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ou’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 Biosciences, 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 support 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 institutions 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 platforms 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-

nologies. We then worked together directly rather than relying on external venture communities to fund these technologies.”

The notion of precompetitive technology 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 proprietary work conducted by each individual user. He compares it to the development of information technologies, in which computer 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 information technology, which is used across many industries, we’re particularly interested in enabling the development of technologies that would be of use to the biopharmaceutical industry, hence our decision to go in as partners in Enlight.”

Sharing the pie Steinberg points out that the model of needing 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

and the financial pie.

“PureTech, as entrepreneurs, are obviously 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 everyone 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 practical benefits of the partnership. “We would define success as the creation of a platform technology, preferably a commercial instrument or perhaps a service company, that could provide a particular technological solution 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 specific types of technologies; for example, technologies for the discovery and validation of biomarkers. The biopharma industry is investing significantly in the use of biomarkers to help us understand whether candidate treatments in development are actually working 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.”

“We’re particularly interested in enabling the development of technologies that would be of use to the biopharmaceutical industry” Reid Leonard get around that by working directly with its pharmaceutical industry partners, so that it doesn’t have to rely on purely financial investors 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 strategic 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

Leonard points out that currently there are many approaches to discovering and validating biomarkers, but these are still a collection 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

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of biomarkers for a particular indication.

“The analogy that I like to use is the measurement 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 transformational technologies that will be useful to everyone, but the proprietary interest in these technologies will come from the way in which we apply them to our internal programs.”

Making the choice The responsibility for identifying potential projects rests with the Enlight board and their scientific advisory board. Leonard explains 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 universities. 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 comment, and then the individual investors in Enlight have a vote in what we do.”

From Steinberg’s perspective, the criteria for choosing a project are: number one, providing impact for the pharma partners; and number two, the ability to be transformational 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 percentage of drugs that fail once they get to the

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 transformational 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

“The pharma industry has proven to be uniquely good at certain things . . . but innovation hasn’t necessarily been one of them” David Steinberg clinic by, for example, developing a dramatically improved prediction mechanism. Or it could mean enabling whole new classes of drugs through delivery strategies that aren’t

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.”

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Leonard stresses that the type of projects Enlight is looking to develop fall outside of Merck’s core business. “Although we’re a big technology user, we’re not in the business 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 areas There are three main areas on which Enlight is expected to focus in the near term. The first is novel biomedical imaging technologies, 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 program; 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 technologies 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 participating 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 membership 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 feasibility 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-

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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.

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 differs 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 technology. 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 financially or not. “If they do support it financially, 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 challenges This joint venture suggests that the industry 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 currently facing?

“One thing that struck me after this was initially announced in mid-July,” says Steinberg, “was the magnitude and the positive tenor of the response from the popular press, the life science press and other pharmaceutical 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 productivity. 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 incredibly 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 approaches have to be tried, and the pharma

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industry has tried everything from their own internal incubators to option funds to different 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 understands 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 biotech 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 concept to earlier-stage partnerships, many of which Merck has formed in the past few years, in which we enter into a researchbased 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 collaborating with others.”

Steinberg points out that with external technology programs, pharmaceutical companies 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 internally because that’s not what they’re best

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.

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 pharmaceutical 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, Enlight is one way of at least starting to think about how to do that.”

Future plans What does the future hold for the pharmaceutical 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 something 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 exceptions, 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 commercial entities and aren’t innovating at all.

“Some companies will probably figure it out through mechanisms like Enlight and other creative internal mechanisms and external approaches and those will be considered 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 interactions 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 partner. 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

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ELECTRONIC RECORDS

THE FUTURE OF PAYER-SPONSORED ELECTRONIC HEALTH RECORDS Health Industry Insights’ Lynne Dunbrack examines the current state of electronic health record technologies used by US payers and presents key findings of two surveys regarding payer deployment of and data contribution to various forms of EHRs.

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ndeniably, 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 records consist of data sourced predominantly by provider healthcare information systems. These two terms, while often used interchangeably by the industry, are viewed as separate but related technologies

by Health Industry Insights. Consumer-controlled personal health records (PHRs) can consist of data from payers and/or providers, as well as data from the consumer.

Acquiring vendors To 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 private-label basis, there have been several notable examples of payers making considerable investments in EHR technology, including investing in or acquiring vendors that offer this capability.

For example, Aetna acquired ActiveHealth Management for approximately $400 million in May 2005 and operates it as a branded,

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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 Profile, 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 clinically 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 initiatives In two separate surveys about payer IT investment priorities, Health Industry Insights asked US payers about the current status of deploying

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PBHRs and PHRs, investing in EMRs, and contributing payer data to provider-owned EHRs. When asked which collaborative initiatives do you expect your organization to invest in, in 2008, both provider EMRs and EHRs were mentioned by 38.7 percent of the respondents. 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 investment 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 hospital 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, lackluster 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 communitybased 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).

“The slow progress in payer-sponsored EHR initiatives is reflective of the highly fragmented US healthcare industry�

Lynne Dunbrack

Future outlook Much 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 national 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 likelihood 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 initiatives, 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 fragmented 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. Providers contract with multiple payers, and any one payer, especially the national payers, might not represent a significant percentage of a provider’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 relationship 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

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 info@healthindustry-insights.com.

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CASE STUDY

Building IT infrastructure EHM speaks to Brad Blake, Director of IT at Boston Medical Center, about data management, security and IT operations at the hospital.

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oston Medical Center is a private, not-for-profi t, academic medical center with a focus on communitybased 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 reliable 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 operational 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 operating costs.”

As Director of IT, Blake has responsibility for Boston Medical Center’s entire IT and telephony infrastructure and as such is

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responsible for overall operations, security, new projects and driving 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 hospital 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 environment has been the key to our success.”

Blake goes on to explain that as a best of breed shop he purchases the best products to meet the needs of the end users. It is

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because of this practice that Boston Medical Center uses several systems from a variety of vendors. “This allows for the sharing of information 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.”

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. “Personally, 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 investigating secure, encrypted and fingerprint USB drives to ensure we have some level of protection if someone were to lose their USB drive.”

Data management Blake and his team are currently managing 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’ technologies 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 allowed us to stay on top of regulations while driving down the cost of storing data.”

Future focus The 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 currently looking at several initiatives to implement in the coming years, which may bring together some of the more disparate systems onto common platforms: “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

Going wireless There 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 information 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 wireless 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 “extraordinary”. “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.”

Security When 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.

WHAT THE ANALYSTS SAY 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.

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EXECUTIVE INTERVIEW

Lost tests result in patient injuries or deaths Why does this still happen in doctor’s offices despite the availability of automated test tracking and communication aids?

STEVEN PAP

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 treatment or diagnosis, fully 55% of these errors are set in motion by informational or personal miscommunication. And these numbers are the tip of the iceberg – they do not reflect the morbidity that also attends to these medical errors. It is a national scandal that offices do not utilize available 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 operating room, steadfastly resists automated aids in the office that could improve patient safety and reduce malpractice risk.

EHM. What can be done to reduce these errors?

SP. An office test tracking and communication system must process – perfectly – the average

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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 retrieval.

• Notify patients that test results are available and provide a vehicle for patient retrieval.

• Send reminders when tests are not completed.

• Track all tests, referrals and follow ups and leave a daily alert for all staff members and physicians for tests not completed and messages not received.

• Record and save all correspondence including voice message files in case of legal issues.

These tasks seem impossible to accomplish until you consider that one can automate every part of the process except the bullet points in bold type above. This allows the office 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 SecuReach 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 office 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 office, the physician or designated staff member dictates the actual results into the web application via a USB port microphone.

The recording applet uploads the file 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 notifies the staff when tests are not completed or messages are not retrieved through a system of daily alerts, which are updated in real time.

Compliance is improved by a series of automated reminders to the patients by both email and phone. Office phone traffic is decreased by up to 50 percent. The efficiencies introduced by automating the process allow clinical staff to concentrate on patient duties instead of clerical ones. All this can be accomplished for less than four dollars per physician per day. 

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.

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TECHNOLOGY SAFETY

Top 10: Patient safety myths 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.

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.

2

My vendor understands patient safety.

Patient safety is still a relatively new discipline. Unfortunately 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.

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 financial benefit 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.

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 decisionmaking, nor will these systems reach that level of functionality in the span of their product lifetimes.

5

If we build it, they will come.

Trying to bring physicians 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 participation up front.

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6

Everyone else has a patient safety problem – except us.

When surveyed, most healthcare leaders 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 reflecting on how your organization delivers care, it can, probably will or even has already happened.

7

Benchmarking will define where we should start improving safety.

We are still early in our development of advanced reporting systems for capturing medical errors. Until we have mature reporting systems and fully institute 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 existing and incomplete benchmarking data, it may hurt – not help – your efforts.

8

Patient safety requires a new corporate 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 positions that focuses solely on safety, let patient safety become an integral part of all processes – part of the organizational fabric in everything you do.

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 between 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.

Most medication errors occur at the order writing stage of the process.

Not all healthcare organizations do the same processes 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 administration? Before implementing a CPOE system, you must undergo a careful study of your existing system. 

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GOING GLOBAL Pfizer’s Diane Jorkasky champions the use of geographically diverse clinical research units to transform the conduct of phase I trials. EHM finds out why.

I

n her role as Vice President for Worldwide Clinical Research panies have to worry about because we bake all of this into the infraOperations at Pfizer, Diane Jorkasky ensures that all exploratory destructure systems that we have.” velopment, clinical pharmacology, translational medicine and clinical In her current position, Jorkasky oversees all phase I studies for Pfizer, technology studies are conducted in accordance with good clinical with the exception of oncology, and all clinical pharmacology studies indepractices standards and are delivered on time and on pendent of their stage of development, including small early budget. Quite a task, but Jorkasky is proud of her team’s proof of concept studies. Most of these studies are conWOMEN MAKE UP achievements in this area. ducted in three clinical research units located in Singapore; LESS THAN “We do achieve this far more than one would expect, New Haven, Connecticut; and Brussels, which act as one given the complexity of working with 10 different therapeuunit with three locations under standard procedures, politic areas, with all of them organized separately. We have cies and principles. many, many customers, and yet we’ve been able to achieve “The greatest challenge I face in this position is ensuring OF THE TOP this through constant interaction with the customers. We that the inhouse resource is utilized to its maximum,” she says.

ECHELONS OF PHARMA have terrific people within my department who bend over “This means some flexibility in the way one schedules. The COMPANIES backwards to ensure that the work gets done, that we get other challenge is trying to overcome people’s resistance to the things done on time. concept of working at global sites with which they may not “It takes a lot of planning on the part of the staff and the research units. have had firsthand knowledge. The resistance is overcome with demonstratWe are very careful about the budget and making sure that we are as efficient ing performance, with a strong emphasis on frequent communication. 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 Innovation human component that’s often required in research settings. We don’t Jorkasky has championed the highly efficient management of global have to worry about quality assurance anywhere near what most comclinical research units – CRUs – all of which deploy state-of-the-art tech-

30%

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nology to drive progress forward. How have these radically transformed the conduct of phase I trials?

“We are able to do very complex studies across all three units simultaneously, 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 company is able to do. As a result of that, the big innovation that we’ve been able to accomplish is that on a moment’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 latest 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 exposed to, whether they were on placebo and whether they were on a biologic. Pfizer has found this to be so valuable that the company working with the NIH now to have all this data analyzed and published, since this information is lacking in the literature.

Equality Behind every exciting new discovery are the men and women who made it happen. While many women work as researchers and in other roles in the pharmaceutical industry, as you move higher up the ladder, the representation of women and people from diverse backgrounds tends to dry up. For this reason, Jorkasky, as an advocate for the Women’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 ensuring opportunities for women and diverse candidates. Across the pharmaceutical industry, probably the majority of employees are women, and yet as you go to higher levels of the organization, you will see far fewer women than you will men. In most companies, women make up less than 30 percent – sometimes less than 20 percent – of the top echelons of the company.

“There is a huge amount of work still to be done in this regard, and the unfortunate thing is that the industry loses out by not having that female perspective at the table.Women are the major care providers across the world and the ones who will often remind folks to use our drugs and to make sure medical care is achieved. We don’t even think about the impact that not having women at the table within our industry has on our products in the marketplace.”

Where next?

The pharmaceutical industry is at a crossroads, with extraordinarily high attrition rates, and there are many attempts to get that next big breakthrough that leads to increased productivity. The cost of doing studies is rising, along with the expectations of those studies in terms of the quantity of data and the safety of the drug in the minds of regulators and the public.

“The challenge we all face is continuing to support R&D research at a time of enormous pressure on the healthcare system, including the pharmaceutical industry,” Jorkasky says. “We are looking at how we do business 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 to work more in a virtual way with a variety of suppliers and vendors and support organizations, including CROs. We’re going to see stronger decision-making on what drugs should not be taken forward, which is really important to an organization’s survival. The sooner you can stop a drug that’s not working, the better off you will be. And we will see smaller, leaner companies, more virtual in their operation than what we’re seeing today.”

Diane Jorkasky is Vice President for Worldwide Clinical Research Operations at Pfizer. She is responsible for ensuring that all exploratory development, clinical pharmacology, translational medicine and clinical technology studies are conducted in accordance with good clinical practices standards. She has been instrumental in providing the leadership and vision for Pfizer’s Clinical Research Units (CRUs), which have radically transformed the conduct of phase I trials.

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Certain tactics in pharmaceutical marketing have tarnished the industry’s reputation in recent times. Todd Evans of PwC looks at the new thinking that can help restore the public’s trust.

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harmaceutical marketing methods have been under much scrutiny in recent times, particularly when it comes to such controversial methods as direct-to-consumer marketing. What once was a rather stable environment in the 70s, 80s and 90s has turned into one in flux. There have been a number of shifting patterns with a diversification of the stakeholder pool, and the recognition that consumers are now empowered to select their preferred medicine. At one time the marketing world was rather one-dimensional with decisions placed exclusively in the hands of physicians. However, times have changed. Influence now comes from large Government payers such as the Centers for Medicare and Medicaid Services (CMS), the private insurance carrier community, employers, advocacy groups, and patient communities, although physicians still carry significant weight in product selection.

A dramatic change in the portfolio composition has affected the status quo. “Historically, we would expect to see fairly simple chemical compound products that employed a fairly standardized go-to-market model which earned tremendous volumes of revenue even as a product enjoyed patent protection,” acknowledges Todd Evans, Director of PricewaterhouseCoopers’ Health Industries Advisory, Pharmaceutical & Life Sciences practice. “In this decade, we’re experiencing a new product conversion from primary care products over to a specialty drug portfolio. 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 change being driven just by the portfolio transition alone, and it’s being exacerbated by a need to supplement organic R&D with biologic acquisitions that are supplementing fairly weak pipelines.”

Evans highlights how such factors as rapid in-licensing deals, and acquisitions of biologic companies implies that the mission of the sales and marketing organization has to become 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, homogenized business model that was designed to address primary care products and is some-

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times slow to adapt. “Organizations need to differentiate quickly and differentiate well – in terms of who is addressed as influencers, what the message 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.

DTC Direct-to-consumer marketing has been the Achilles’ heel for all those involved in the public face of pharma, acting as a partial contributor to a crisis in the industry’s reputation. “In many 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 tremendous publicity 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 successful drugs, some of which are lifestyle focused in nature. The whole DTC revolution has been a big challenge in terms of reputation advancement and industry messaging, despite in a majority of cases delivering informative and educational disease related to the marketplace.”

An additional shift in the industry that Evans identifies is that there has been the beginnings of a transition from a bias towards care delivered in institutional environments to that of the home environment and an emphasis on self-care over going to the physician for every minor ill. He notes how this is being reflected through out-ofTodd Evans pocket payment (OOP) structures, physician reimbursement levels and the decoupling of product pricing from care delivery costs. Retail store based clinics are a particularly 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 direct basis, one can expect that the patient is a critical stakeholder in product selection and cost related decision making where options exist. “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 for many in the industry is that many patents expire over the next few years. Many of these patented primary care products have been the cash engines for the industry over the last 20 years. The imminence of the deadlines is creating a certain sense of crisis as Evans highlights: “Companies are worried about which future products will sustain a company’s growth and position it for growth in the marketplace. Secondly, there is the matter of downsizing sales forces for products moving to generic status while defining what capacity is needed to create specialty treatment brands, maintain a high-quality patient experience, and go to market 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 to be managed carefully and very differently across therapeutic areas.

The market facing organization challenges certainly can’t be ignored as we see a tremendous volume of primary care revenues fall into generic status.

This seismic, industry-wide revenue event demands a well managed industry response that deftly maximizes the new product assets while downsizing 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 seeing a response driven by revenues falling off and generic conversions taking place. Up to now, it appears as a calibrated adjustment in what we spend in going to market the traditional way, versus an end-to-end redesign that is purpose-built for the specialty portfolio profiles that pharma is developing, in-licensing and/or acquiring.”

Image is everything Often when people think of 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 public awareness of healthcare conditions.

However, he argues that this does not serve the needs of political demagogues, which tend to use the industry as the bad boys to get a philosophical or political message across. “Pharma

“Direct-to-consumer marketing has been the Achilles’ heel for all those involved in the public face of pharma” companies tend to be the richest link in the healthcare value chain, so it’s easy to beat the guy with the most 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 two general images that a pharmaceutical company can convey. The first is of pharmaceutical companies as self-interested, growth focused, greedy corporate titans pushing products for the sake of selling

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products above all else. The other is of an industry that delivers previously unmet medical benefits with improved healthcare to the life of an individual. “Those are very different images,” pinpoints Evans. “Unfortunately, during the 90s and up to now, a number of factors have unwittingly created an image of greed, self-interest and cynicism. This image has been easily exploited by politicians and others that find these growth practices inimical to the public interest – that’s a big problem.”

According to Evans, in order to make an impact upon reputation a pharma company must first recognize what its reputation is, accept it, and design a program to correct it. “I believe the industry does recognize that there is a problem and that they need to do something about it,” he affirms.

As far as managing these things, Evans identifies some conflicting behavior. For instance, direct-to-consumer spending continues to be strong; however, the impact and results of it could, he continues, certainly be characterized as dubious. In his opinion, there are tradeoffs between perceived 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 products and for these products to be accepted by the marketplace and the payers that must pay for them, pharmaceutical companies need to work on improving their healthcare reputation, drive trust in their message and reduce the barriers for acceptance for the outcomes they present.”

Brand practice A strong brand can influence the choices that customers, employees and investors make. However, pharma companies only seem to have dabbled with short-term corporate ad campaigns, which are rarely sustained long-term. What are some of 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 an awful lot to do with the fact that we have a far more safety conscious FDA regulator,” outlines Evans. “There is a higher hurdle to meet in terms

of trust. We have less tolerance for safety risks with 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 community and payers is critical towards establishing your motives, objectives and the kind of events that take place on the path to a clinical trial or marketplace result.”

“Branding is often fleeting in pharma and is focused on the product rather than building the public trust” Branding is often fleeting in pharma and is focused on the product rather than building the public trust through corporate branding. Evans highlights how the most important aspect to remember when 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; they may be involved in preventions, cures and/or chronic 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 both within and across a brand. This enables messages 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 tailoring 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.”

BEST PRACTICES FOR A STRONG AND CONSISTENT PRODUCT BRAND ecoming 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.

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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

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Building experience With this in mind, how does a pharma company manage and build 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, integrity and credibility are things that certain segments of society have chosen 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 and only greed, then we have a societal problem in the making. A cynical public shaped by hyperbolic political demagoguery is not one that is going to promote participative involvement in clinical trials, may actively 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.

“You need to recognize that you can take advantage of such messages 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 necessarily always make you money, but because you have money you’re in a position to do it and shape the conditions for a future where new treatments can be developed to deliver societal benefits. These are wise 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 characterized 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. One of the reasons for such a change could be due to a Phase IV study that results in unexpected results whereby the law of unintended consequence forces a change.

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

As Evans highlights, it could be that “a grant that was made and a study was conducted beyond the control of the pharma company, resulting in some bad press for a particular product. There have been several high profile cases of this over the last few years resulting in better controls over studies that could affect a product's image, as well as a dramatic retooling of how we go to market 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 essential. “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 therapy’s value benefits.”

As treatments become increasingly more personalized, with individual 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 acknowledges. “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 experiences and data points that connect patient benefit to treatment practices, 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 mistake that leaves money on the table through an inaccurate patient service model and a misplaced branding experience is intolerable. In the end, getting it right by accurately communicating healthcare expectations and benefits to patients, physicians and payers alike will go a long way to regaining the public trust.”

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.

“Each theraputic area has different needs”

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PHARMA FOCUS

Lessons

learned Genzyme’s Larry Blankstein looks at the challenges of completing global clinical trials on time and effectively.

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enzyme’s clinical research programs are focused on inherited lysosomal storage diseases, renal disease, orthopedics, cancer, transplant and immune diseases, diagnostic 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 studies, 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 entering phase III, we have to make sure our resources are utilized efficiently across studies,” he stresses. “The challenge is to make sure that we’re maximizing both our internal resources 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 receive IV infusions every other week. These were very successful and worked well. However, new small molecule technologies are beginning to make an impact, which means that subjects can take a pill and may not have to come into a clinic, infusion unit or a hospital 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-

Larry Blankstein is Senior Director of Clinical Research at Genzyme.

Blankstein has more than 20 years of experience in pharmaceutical and biotechnology drug development. Prior to joining Genzyme, he was Executive Director of Program Management at Quintiles.

ple, we have a drug used in bone marrow transplants and for multiple myeloma. We’re also looking at using this in other indications for chemosensitization assays and chemosensitization treatments. We’re using drugs that we once used to treat cancer to treat multiple sclerosis. At Genzyme we are focused on expanding our science and technology platforms to treat orphan indications or larger patient population with unmet medical needs.”

An important lesson Blankstein describes how applying a ‘lessons learned’ process early on and throughout 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, everything has happened.

“It’s important to identify issues that are affecting 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 increase the likelihood of approval. Having a project 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 goals Completing its clinical trials on time and efficiently 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 completing 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-

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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 patients 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

GENZYME’S RESEARCH AREAS free, metal-free non-absorbed phosphate binder on the market.

tation treatment for relieving knee pain associated with osteoarthritis.

Adhesion prevention Oncology Genzyme’s oncology program is building a foundation in cancer treatment with a strong focus on antibody and small molecule therapies.

Genzyme currently has two marketed leukemia products, Campath (alemtuzumab for injection) and Clolar (clofarabine) for intravenous infusion. The company is also focused on new treatments for cancer patients through both internal research and external collaboration.

Genetic disease Genzyme is recognized as a global leader in research, product development, and outreach to the medical and patient communities for rare genetic diseases known as lysosomal storage disorders (LSDs). In 1991, the company introduced the first product ever approved to treat a lysosomal storage disorder, Ceredase (alglucerase injection).

Since then, Genzyme has developed a second-generation Gaucher disease product, Cerezyme (imiglucerase for injection), and introduced Fabrazyme (agalsidase beta) for Fabry disease, Aldurazyme (laronidase) for Mucopolysaccharidosis I (MPS I) and Myozyme (alglucosidase alfa) for Pompe disease.

Renal disease Genzyme 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-

Transplant/immune disease The field of transplantation medicine has evolved rapidly, particularly where management of acute organ rejection is concerned. While in the past, organ loss often occurred one to two years after transplantation, the introduction of drugs such as Thymoglobulin (anti-thymocyte globulin, rabbit) has significantly improved the success rate of these surgeries.

Orthopaedics Genzyme 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-

The company has developed a suite of biomaterials used to help improve the outcome of certain types of surgeries. Its Sepra line of hyaluronic acid-based products has been clinically shown to reduce the incidence of adhesions following general abdominal and gynecologic surgical procedures.

Cardiovascular disease Genzyme is a pioneer in exploring both gene therapies and cellular therapies as potential treatment modalities for serious cardiovascular diseases. With clinical programs employing both therapeutic methods, Genzyme is focused on treating ischemic diseases characterized by inadequate blood flow and poor cardiac function.

Diagnostic products and services Genzyme Diagnostics, through its partners and distributors, offers a novel line of products for the diagnostics industry and the clinical laboratory. The company continues to develop new tests for diagnosing a variety of indications including heart disease, diabetes, pancreatitis, infectious disease, emergency medicine and women’s health.

Genzyme Genetics provides reproductive and oncology diagnostic testing services. In the area of reproductive testing, the company focuses on technology that will allow information to be provided on a range of diseases from a single patient sample.

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TRAVEL FOCUS

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A passage to India We take a look at the treks medical tourists will take for cheaper treatments in India.

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 The ‘Gateway of India’ monument, Mumbai

M

edical tourism to countries such as India is becoming a viable option for many sick people disaffected with the care they receive in their native country. The spiraling costs of medical fees mean that patients are expanding their options and looking to hospitals 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 quarter 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

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750,000 Americans travelled abroad for medical care in 2007 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 countries 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 operations in India.

India’s healthcare sector in general has been growing considerably over the past few

Capital:

New Delhi Head of state:

President Pratibha Patil (Since July 2007) Head of government:

Prime Minister Manmohan Singh (Since 2004) years. This growth has been gradually escalating since the 1990s, when healthcare grew at a compound annual rate of 16 percent. 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.

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SCENIC ATTRACTIONS Taj Mahal

Taj Mahal

The 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 Mahal Constructed by Maharaja Pratap Singh in 1799, this outstanding monument created out of pink and red sandstone 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 Temple The 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.

Hawa Mahal

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 technically 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.

Mahabalipuram

Mahabalipuram

Kerala Backwaters

Classified 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 monuments 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 Railway

CITY FOCUS

Nicknamed 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.

Mumbai (pop. 13 million)

New Delhi (pop. 11 million)

Calcutta (pop. 8 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.

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.

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.

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BENEFIT FOCUS

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Just what the doctor ordered?

Innovation, obesity and the future of pharmacy benefit management

I

n a complicated and fragmented healthcare system, good information 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 management 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 experience of the critical role that drug therapy plays, Felthouse had plenty to say when we caught up with her at PBMI’s Arizona headquarters.

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 healthcare organizations in terms of deploying 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 really seeing PBMs leverage 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 therapies. PBMs are using voice response unit technology, other outbound telecommunication and emails to help manage patients with chronic diseases. The current innovation is now on the patient side of things, because the IT infrastructure 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.

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“PBMs are starting to understand that they play a critical role in the overall wellness of their patients”

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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.

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.

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 accessible to more plan members, whether they are employees or retirees.

EHM. Is the social networking aspect something that is actually being utilized by PBMs or is that something that people are finding themselves and using to supplement what they're getting through official channels?

DF. PBMs may be using social computing in different disease management and wellness programs. It's not yet part of the core offering 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. You mentioned 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 patients. If patients can make the type of lifestyle changes necessary so EHM. Are there any particular areas where you they’re not getting so ill then maybe see this transparency having a major effect? a prescription medication is not DF. We know that more information about necessary. You see this with weightof the US population is obese the cost of prescription drugs helps conrelated conditions. Anytime somesumers make better drug purchasing decione can become more physically sions. It's helping educate them about the active or improve their nutrition, it value of generic drugs, so that if the physihelps their cardiovascular system cian has indicated that it's medically approand lowers cholesterol. It’s a huge priate to use a generic therapy, they feel issue not just in the United States, more comfortable with it. Consumers also but in all nations. The obesity epiare using the social networking aspects of demic is far reaching and everythe Internet for all kinds of chronic disease body's going to have to get on management. The health care industry is seeing good results with board. In the United States the data are collected but not reported people monitoring their blood glucose levels if they have diabetes yet to document that the incidence of obesity-related illness and and staying on top of proactive health strategies if they're wrestling disease is getting ready to overtake smoking-related illness and dis-

30-40%

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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 distribution channel that provides the needed level of clinical oversight. If you're taking blood pressure medicine that is an oral medication, you can get it from the mail-order pharmacy and see your physician regularly 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 physician oversight and patient case management.

RANGE IN NUMBER OF PRESCRIPTIONS PER MONTH PER MEMBER

0.47

Active employee

Lowest

2.03 Retiree

0.35 1.61 Average

Combined 2.52

1.29 9.00 Highest

3.00 5.00

0

2

4

6

8

10

RANGE IN GROSS COSTS OF PRESCRIPTIONS PER MEMBER PER 0 2 4 MONTH 6 8 10

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 prescription, or they don't refill a prescription. It's a particular issue for asymptomatic diseases like high blood pressure, high choles-

$1.54 $102.72

Lowest $11.21

$67.77 138.36

Average

EHM. With the presidential election and the ongoing financial crisis, the US is going through some major 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 becoming or staying adherent to their drug therapies. We're seeing a huge amount of advertisement and support for some of the retail pharmacy 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.

$100.67 $204.25 $174.00

Highest

$350.00

0

50

100

150

200

250

300

350

Source: PBMI

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 wellness focus is that the side effects of eating less and being more active are always zero.

EHM. Do you think there are any other key trends currently emerging in the design and management of PBM offerings?

DF. Managing specialty pharmacy therapies is a huge trend and challenge. The PBMs have three dispensing channels – retail pharmacies, mail-order pharmacies and now specialty pharmacies.

Sometimes drugs are covered and reimbursed through the medical

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“There isn’t a magic pill for tackling the obesity-related issues. Sometimes the patient just has to get off the couch.

It may not be the best sound bite, but it’s true” 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-compliance with maintenance medications that increases medical utilization. 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.

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IN REVIEW

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On the shelf EHM takes a look at what this quarter’s business books can offer healthcare executives.

Chasing the Rabbit How 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.

The China Study The 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. 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.

Who Killed Healthcare?

America’s $2 trillion medical problem – and the consumer-driven cure,

by Regina Herzlinger 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 difficulties. The look at new streamlined choices that would give Americans both quality and cost control are both insightful and interesting.

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Book Review Ed P139.indd 138

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FACE OFF Healthcare disparities

Peter Slavin, President of Massachusetts General Hospital

SLAVIN

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 Spanishspeaking 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.

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Drew Altman, President and CEO of The Henry J. Kaiser Family Foundation

ALTMAN

140

The gaps in quality and access to healthcare across ethnic, racial and socio-economic groups is a major concern. We asked two experts about how this issue is being addressed through their organizations.

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.

CATALOGUE PAGE EHM:nov08 19/11/2008 16:19 Page 141

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FINAL WORD

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It’s all in the genes

By Jack Bloom

A

s we better understand the human genome and how genes influence individual patients’ response 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 ‘tailored 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 present unacceptable safety issues.

Pharmacogenomics and sophisticated, novel biomarkers are among the tools that are used to characterize these individual differences. They are increasingly important both in the design of clinical trials and for the delivery of more personalized care in the marketplace.

How a clinical trial subject or patient responds to a medicine will vary in accordance with a variety of genetic influences, ranging from predisposition to a particular disease to how the medicine is metabolized. These genetic associations are used increasingly to predict efficacy, guide dose selection and identify patients susceptible to a particular toxicity. They are of even greater value if they can be used to identify practical biomarkers (a protein,

early in the development of our candidate drugs. We use these tools to predict efficacy and safety (and therefore the probability that the medicine will be successful) and to differentiate our products in the marketplace. Our goal is to optimize individual patient outcomes, and pharmacogenomics and biomarkers are critical tools for achieving this.

An important element in implementing a tailored therapeutics strategy through, in part, the development and application of biomarkers and related enabling technologies, is strategic partnership development. Transitioning to a fully integrated pharmaceutical network (FIPNet) is another key part of that strat-

“Medicines today are effective as little as 50 percent of the time and too often present unacceptable safety issues” receptor, etc.) that can be used to predict these outcomes, and thus enable stratification of clinical trial subjects or the development of companion diagnostics for use in the marketplace.

At Lilly, we put a lot of emphasis on developing thoughtful biomarker strategies

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.

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egy. Having the constellation of specialized 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 enabled us to build virtual biomarker research 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

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