EHM 7

HERO WORSHIP

How BWH’s Gary Gottlieb battles healthcare disparities in his own community and across the nation PAGE 34

www.executivehm.com • Q2 2009

VIEW FROM THE TOP Nancy Brown on what it’s like to be the first woman CEO of the American Heart Association PAGE 76

A DIGITAL REVOLUTION Why your medical information will soon be available in electronic format PAGE 80

BAL ANCING ACT

for healthcare reform.

President Obama is weighing up the options PAGE 28 How will he succeed where others have failed?

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FROM THE EDITOR

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Déjà vu all over again Healthcare reform is back on the agenda, but the whole thing has a familiar ring

A

“Healthcare is driving the employment base, and to disrupt that will have substantial ramifications” Gary Gottlieb, President, Brigham and Women’s/Faulkner Hospitals (Page 34)

“We’ve got to have a new model. We’ve got to focus on prevention and find a way to make our healthcare system economically viable”

t last our healthcare system is getting some help. People are excited, moneyisflowing,everythingisgreat.Orisit?Thisisn’tthefirsttimeapresident has tried to shake up our health system – it’s the third time, in fact.

Bill Clinton and Harry Truman both tried and failed. What does Obama have that they did not?

Popular support? Clinton had that too, as did Truman, at least in the beginning.

Urgent necessity? Our health system does seem to be in its worst shape ever, although that could be an illusion – a function of the fact that we’re living in it. Didn’t we also feel like that back in the Clinton era? And those who were around inTruman’s time probably thought the same.

Obama has done one thing that Clinton andTruman did not – left the details of his proposedreformdeliberatelyvague.Tryaskinganalystsandthoseimmersedinthefield what they think of the proposals. Most will say – even after the passing of the stimulus bill – that the general direction is good, but they’re waiting for more details. Obama’s plan puts the responsibility for the nitty gritty squarely on the shoulders of Congress, who were instrumental in scuppering Clinton’s work.

The new government has also learned some lessons from Clinton’s attempt – even if its main architect, Hillary Clinton, is now Secretary of State. Gone are the closed-door sessions and backroom dealings that led to the previous plan’s downfall, to be replaced by what appears to be a greater attempt at openness, at least at this early stage.

There are aspects of the current proposals that have not been addressed before – one of them being the beefing up of electronic health records.This is variously hailed as a forward-looking method of reining in costs and improving patient care; or as impractical and difficult to implement on a national basis, with a payback that will take years to arrive.

One thing’s for sure – the process of converting hundreds of thousands of small physician offices to electronic records is bound to be challenging. And even if every office and healthcare institution in the country goes electronic, they won’t necessarily be able to talk to each other, because there is no requirement that systems be synchronized between institutions. Based on this, the five-year time period for nationwide conversion begins to look hopelessly optimistic.

Obama and his team are determined to push at least some of their proposals through. It won’t be easy, but nothing worth doing ever is. Anyone care to bet on whether healthcare reform will succeed third time around? I’d say right now, the odds are about even.

Nancy Brown, CEO, American Heart Association (Page 76)

“What’s a bit of a wild card still is understanding the interoperability requirements and how we might communicate” Jim Noga, CIO, Massachusetts General Hospital (Page 80)

Marie Shields Editor

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CONTENTS FEATURES

Third time lucky?

Our health system finally seems to be getting some help – but surely we’ve been here before

34 Local hero How Gary Gottlieb battles healthcare disparities in his own community, while championing the need for reform on a national scale

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76 Leading from the front Nancy Brown enjoys the view from the top of the American Heart Association

The grass is always greener The truth about astroturfing, big pharma and patient groups,

by Natalie Brandweiner

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CONTENTS PATIENT CARE, TECHNOLOGY INDUSTRY INSIGHT 38 Francesco Pompei, Exergen Corporation 52 Ernest A. Elgin, Nephros Inc. 102 Stefanos Damianakis, Netrics 120 Staf C. Van Cauter, Bioscan Inc.

ASK THE EXPERT 56 Steven M. Gottlieb, Anesthetix Management 68 Alexander J. Barr, The Siesta Group 74 Jay Cyr, University of Massachusetts Memorial Center

FIVE-MINUTE EXECUTIVE 20 Steven Liu, Ingenious Med

62 A risky business?

Roy Snell on the increasing risks to regulatory compliance

42 At the edge of innovative care

64

Andrew Warshaw on the importance of minimally invasive techniques in diagnosing pancreatic cancer

64 Death of the single designer Peter Bardwell explains why modern hospital design must be done by consensus

CASE STUDY

47 Waging a war on germs

70 Heart’s ease

Johns Hopkins’ Trish Perl battles hospitalacquired infections

The non-invasive dream is coming true for Jeffrey Moses

96 Jason Adams, MultiCare Health System

50 Infection control

80 On the record

Why we all need to take responsibility for keeping the hospital workplace clean

Jim Noga and John Glaser talk up electronic patient details

54 Feeling the pain

86 Staying on track

David Brown of Cleveland Clinic explains why physicians often fail to understand pain

Nina Schwenk tackles reform in the nation’s healthcare IT infrastructure

58 Clean living

91 Comment

The lifestyle choices that make healthy genes

Electronic health records in the spotlight

EXECUTIVE INTERVIEW 98 Quentin Gallivan, PivotLink 101 Steven Berger, Healthcare Insights 119 Kathleen P. Deardorff, GE Healthcare

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CONTENTS MEDICAL IMAGING, PHARMACEUTICALS

ROUNDTABLE

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114 Contrast imaging With Anthony Lombardo of Bracco Diagnostics Inc., Rick Lytle of Covidien, Kathleen P. Deardorff of GE Healthcare and Melissa Buchanan of Guerbet LLC

IN THE BACK 132 Comment 134 Travel 136 Events 138 In review 140 Face off 144 Final word: Why 2009 will be a good year for creative thinking

92 Staying informed Linda Kloss on the challenges of health information management

100 The reformer’s task Stephanie Reel finds it can be hard to lead the way in EHR

104 Going digital Burton Drayer examines the role of radiology in preventative care

108 Location, location, location Richard Robb on how advances in digital imaging help surgeons find their targets

122 Patient power Isabelle Mercier explores the power of patient influence in pharmaceutical marketing

124 Making the leap Amgen’s Brian Kotzin translates science into medicine

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128 High standards Why CDISC is pushing for international standardization of clinical trials

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CREDITS EHM7:mar09 18/03/2009 14:57 Page 10

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STEM-CELL RESTRICTIONS LIFTED

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On March 9, President Obama signed an order lifting the existing restrictions on embyronic stem-cell research, a move which researchers say could lead to dramatic advances in the understanding and treatment of conditions like diabetes, heart disease and Alzheimer’s.

THE RESTRICTIONS WERE IMthey have been eager to study POSED by George W. Bush in hundreds of other lines, some of 2001. Bush’s policy was which contain specific intended as a comgenetic mutations for The restrictions promise: banning diseases like were imposed by the use of federal Parkinson’s. funds for the creUnder the reation of new emstrictions, scienbryonic stem-cell tists had to use in 2001 lines while allowing different lab equipscientists to study the ment for privately funded lines that had already been creand government-funded reated. Researchers say those search; in some cases even lines aren’t diverse enough and building separate lab space.

George W. Bush

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STEM CELL Q&A

What are stem cells?

Stem cells are cells that have the potential to develop into many different cell types in the body

What are their special properties?

They can theoretically divide without limit to replenish other cells for as long as the person or animal is still alive

What are the classes of stem cells?

Totipotent, multipotent and pluripotent

Where do they come from?

cells derived from a governThere was also a negative efment-approved line against fect on collaboration, with respinal-cord injuries. searchers supported by There is still private money unable Earlier controversy, howto team up with scithis yesr,the FDA ever. Critics from entists funded by the ranks of the government.

Republicans and Earlier this the first clinical trial conservative year, the FDA apof embryonic Christian groups proved the first clinistem cells disapprove of the use cal trial of embryonic of embryos for medical restem cells in the United search, and they’re not shy States. Geron, a biotech comabout communicating their pany, will test embryonic stem

approved

views. They see the new guidelines as sanctioning the use of taxpayer dollars to subsidize the destruction of human life.

In addition to signing an executive order that will lift federal funding restrictions for embryonic stem-cell research, President Obama signed a presidential memorandum aimed at restoring scientific integrity to government decision making.

Pluripotent stem cells are isolated from human embryos that are a few days old

Why do scientists want to use them?

Once a stem cell line is established, it is essentially immortal and can be grown in the laboratory indefinitely

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FRONTLINE

PROFILE Kathleen Sebelius Kathleen Sebelius, Governor of Kansas and Chair of the Democratic Governor’s Association, has been named as the new Secretary of Health and Human Services. Daughter of the former Ohio Governor, Democrat John Gilligan, Sebelius and her father became the first father/daughter governor pair in the US following her election.

Known for becoming state insurance commissioner in 1994, the first time a Democrat had won in more than 10 years, Sebelius’ actions are often the focus of political journalists. She has been highly commended for her successful Democrat leadership within a Republican state.

As insurance commissioner, she helped prevent the sale of the state’s Blue Cross/Blue Shield insurance program to a for-profit healthcare system, and as governor she ensured a capping of rising healthcare costs through a series of negotiations with business leaders, health providers and insurers.

A campaigner for abortion rights, her administration has initiated a number of healthcare reforms in the state, including adoption incentives, extended health services for pregnant women and a variety of welfare support services for families. As a result, during her tenure as governor, abortions have declined 8.5 percent.

In April 2008, Sebelius vetoed House Substitute for Senate Bill 389, titled the Comprehensive Abortion Reform Act by its sponsors. Proponents of the bill claimed the legislation would strengthen late-term abortion laws and prevent ‘coerced abortions’ in minors.

An opponent of capital punishment and concealed carry laws for firearms, Sebelius has received a significant amount of recognition for her bipartisan approach to governing. In February 2006, the White House Project named Sebelius one of its ‘8 in ’08’, a group of eight female politicians who they felt qualified and a likely candidate to run for or be elected president in 2008.

Sebelius had long been considered a contender for a Presidential position, and following Obama’s election, there was much speculation that she would be appointed to his cabinet. Tom Daschle’s withdrawal of his nomination led to Obama officially announcing Sebelius as his nominee on March 2.

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FRONTLINE

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SIMILAR EFFECTS OF SMOKING AND OBESITY FOLLOWING ALMOST 60 LONG-TERM STUDIES, including almost a million people worldwide, researchers have found that moderate obesity is predicted to shorten life expenctancy up to four years, and severe obesity up to 10.

The results from researchers at the Clinical Trial Service Unit (CTSU) show that the effects of severe obesity, a still uncommon disease, to be comparable to the lifelong effects of smoking. The in-depth study followed approximately 895,000 people based mostly in North America, with some from Europe, over a period of 10-15 years.

The researchers used BMI to assess obesity, and the results showed that rates of death were lowest among men and women whose BMI was 23 to 24. They believe the comparison of the disease to lifelong smoking is due to the doubling of body weight that smoking brings.

Obesity is known to increase the rate of death not only for some forms of cancer, but moreover by increasing the risk of heart disease and stroke. In the US, one in three deaths from heart attack or stroke, and one in 12 cancer deaths is due to being overweight or obese.

From the study, they are advising those that are already overweight or gaining weight that stopping short the path to obesity could literally add years to your life.

MEMORY LOSS effectiveness of the treatment and the intensity POSTTRAUMATIC STRESS DISORDER (PTSD), one of the initial trauma. of the most common psychiatric illness of comThe drug works by being initially adminisbat, and a state of psychosis found to be on the tered shortly before or after recalling the memorise, may soon be treated with a new approach. ry of the trauma. The use of the treatment of Those suffering from PTSD often suffer from vivid RU38486 is sufficient for one or two treatments intrusive memories of their traumatic situation, to maximally disrupt the memory, resultbut with current forms of treatment proing in a long-lasting effect for the seviding almost little or no controlling Those lection of recalled memory. of symptoms, calls for research suffering from Until the recent findings, the into an alternative have been treatment of PTSD was the aturged by physicians. often suffer from tempt to reduce the negative disBased on the study of vivid intrusivememories tortions of traumatic memories, to RU38486, a drug which claims of their traumatic allow people to better cope with to block the effects of the stress situation their traumas. The new study suggests hormone cortisol, scientists at the that blocking the effects of cortisol may be Mount Sinai School of Medicine used an one strategy to promote the ‘normalization’ of animal model of traumatic memory to show that traumatic memories. There is hope that the findRU38486 selectively reduces stress-related memings from RU38486 may have positive effects ories, leaving other non-traumatic memories unfrom the treatment of other anxiety disorders. changed. They found a correlation between the

PTSD

GOUT’S RE-EMERGENCE AFTER 40 YEARS THE FDA HAS ORDERED APPROVAL for the marketing of a new drug that provides treatment to those suffering from gout, claiming the current treatment, introduced almost 40 years ago, has left many patients untreated.

Gout is a painful form of arthritis, causing swollen and stiff joints, that is brought on by a buildup of uric acid in the blood. The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NAMS) advises that there could be as many as six million Americans, some as young as 20, who will have the symptoms of

gout at least once during their lives.

The new drug, Uloric (genereic name febuxostat), is being developed and marketed in the US by Takeda Pharmaceuticals North America. In a statement, Takeda said that febuxostat is a new, highly potent non-purine selective inhibitor of xanthine oxidase, and has a completely different structure from the current treatment.

The drug works by lowering the concentration of uric acid in the blood, and will be available as 40mg or 80mg tablets to be taken once a day.

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FRONTLINE

PREVENTION OF MAJOR BIRTH DEFECTS A STUDY UNDERTAKEN by a group of Washington-based researchers has found that women need enough vitamin B12, in addition to folic acid, to cut the risk of having a baby with a serious birth defect of the brain or spinal cord. One of the researchers, Dr. James Mills of the NIH, said the study showed that vitamin B12 deficiency was a risk factor for neural tube defects independent of folic acid, another B vitamin.

Irish women have been found to have the lowest vitamin B12 levels, and are therefore five times more likely to have a baby with a neural tube defect.

In response to the results found in the study, Mills has advised that women who do not eat meat or dairy products to be particularly vigilant with their vitamin B12 intake during pregnancy.

MUSSELS MAY IMPROVE SURGERY RESEARCHERS AT NORTH CAROLINA STATE UNIVERSITY have worked out a new way of producing medical adhesives using a natural glue produced by marine mussels. The method could replace traditional sutures and result in less scarring, quicker times for recovery and more precision in surgery.

The traditional method is to join two tissues post-surgery

using sutures and synthetic adhesives, which requires a lot of skill and often results in increased operating times. Sutures can also be associated with complications that include inflammation, infection and discomfort. It may be possible to replace synthetic adhesives with the adhesive proteins produced by marine mussels, which are non-toxic and biodegradable, according to study co-author Dr. Roger Narayan.

NEWS IN NUM8ERS

86

100,000+ people each year die in hospitals of maladies that they did not go into the hospital to be treated for (p64)

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HEALTH WEBSITE LAUNCHED AMERICANS EXPRESSED SERIOUS CONCERNS regarding healthcare in a new report released today by the Department of Health and Human Services. The report, Americans Speak on Health Reform: Report on Health Care Community Discussions, summarizes comments from the thousands of Americans who hosted and participated in Health Care Community Discussions across the country and highlights the need for immediate action to reform healthcare.

The report is available on a new website dedicated to health reform: www.healthreform.gov. Unveiled today, the site will allow Americans to share their thoughts about health reform with the Obama

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administration and sign a statement in support of President Obama’s commitment to enacting comprehensive health reform this year.

“This new website will ensure that when we discuss health reform, the American people will have an equal stake in the health reform efforts,” said HHS Spokeswoman Jenny Backus.

“Sky-rocketing healthcare costs are creating enormous pressure on families, on businesses and our fiscal future.

The Obama administration is committed to taking action this year on health reform and is calling on government, business, healthcare stakeholders and everyday Americans to come together to make it happen.”

16.3% of America’s GDP was spent on healthcare in 2008 (p58) We would be hard pressed to bring the four percent of EHR adoption up to

100% in 5 years (p80)

AHA’s impact goal seeks to reduce coronary heart disease and stroke risk by 25% by the year 2010 (p76) The

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INTERNATIONAL NEWS

TOBACCO EPIDEMIC POLICYMAKERS IN ASIA are raising the bar to cut smoking, following a concern that tobacco-related lung diseases are on the rise, which could lead to an epidemic.

Tobacco use has been steadily on the increase in many Asian countries in recent years, particularly in women, and with-

INNOVATIVE BREAST TREATMENT out any attention paid to health risks, there are concerns that this could put an economic burden to countries in terms of healthcare and insurance costs.

Cases of tuberculosis due to smoking are reported to be increasing in Asia from 20 to 60 percent, and as a result health professionals want anti-smoking legislation to be introduced, including bans on tobacco advertising.

MEASLES EXPORTER EUROPE MAY BECOME A SIGNIFICANT SOURCE of ‘exported’ measles in poor countries that have done a better job eliminating the virus.

A study published in The Lancet found that the WHO is unlikely to meet its goal of eliminating measles in the European region by 2010 because vaccination rates in many countries, including Germany, the UK and Italy,

are too low to stop the spread of the virus.

In contrast, Latin America eliminated measles in 2002, but has since suffered outbreaks ‘imported’ from Europe. While measles rarely kills in Europe, in poorer countries malnutrition and limited healthcare make the virus far more lethal, warns Jacques Kremer of Luxembourg’s National Health Institute in an accompanying editorial.

INDIA GOES DIGITAL FOLLOWING THE LEAD of the US and its Western counterparts, India is now seeing the emergence of personal health management technology, allowing physicians to store, access and manage patient data online.

However, just like the US, the biggest challenge the coun-

try now faces is standardizing the data, particularly with numerous technology providers in the region managing data through different programs. Also, there is a degree of uncertainty as to where this will leave the smaller players without the funds to invest in this type of technology.

patients often feel following BRITISH SURGEONS are piotreatment. neering an innovative reconMore than 31,000 British struction technique for women are diagnosed with earlypatients who have undergone stage breast cancer each a lumpectomy and rayear and undergo diotherapy folMore than treatment in which lowing breast just the lump is recancer. The moved, resulting surgeons are British women are in a dip in the using stemdiagnosed with early breast.

Scientists cell-enriched stage breast cancer believe the stemfat from the each year cell fat will reduce the body to restore the need for lumpectomies by patient’s skin to its level suppressing inflammation and enbefore the operation. Early rehancing a healthy blood supply sults also show the surgery and minimizing fat loss. dramatically eases the pain

31,000

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INTERNATIONAL NEWS RECESSION BRINGS CANCER RISK

ILL EFFECTS OF NIGHT SHIFTS

The World Health Organization ANDROULLA VASSILIOU, EU has found evidence of a substantial Health Commissioner, voiced increase in the number of mentally concerns that the economic criill following cuts during the sis is likely to have far last economic downturn, more of an impact on The which gives cause for health than previeconomic crisis concern in the curously thought. is likely to have far rent crisis, which is Although there more of an expected to last are medical another two years. safety nets and on health than previVassiliou is welfare programs oulsy thought planning to hold talks that make health with other European health concerns far less than ministers to discuss the issue and those in the US, fears remain provide a strategy with which to that spending cuts may affect tackle the repercussions of the filife-saving efforts, such as nancial crisis on the health industry. screening tests.

A GROUP OF 40 DANISH WOMEN who developed breast cancer after working night shifts for many years are to receive compensation from the government.

Following a ruling by a research agency of the United Nations that working night shifts probably increases your risk of developing cancer, the Danish government announced it will pay compensation to

impact

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women whose breast cancer may have been caused by these circumstances.

Shiftwork ranks among what the International Agency for Research on Cancer calls category 2A exposures (probably carcinogenic to humans), a long list of chemical agents including lead compounds and anabolic steroids; creosotes and diesel exhaust; and some occupations.

MALARIA CURE

KEEP EXERCISING RESEARCHERS IN SWITZERLAND have found that any type of exercise improves the function of blood vessels in patients who had recently suffered a heart attack, but the benefits stopped within one month of patients ceasing exercise. The findings indicate that exercise helps you recover from a heart attack but only if you keep at it.

The study was carried out by scientists at the Cardiac Rehabilitation Center, Clinique Valmont-Genolier in Glion-surMontreux and the University of Lausanne and was published in the Circulation, a journal of the American Heart Association.

In the study, Dr. Margherita Vona of Clinique Valmont-Genolie and her colleagues evaluated the effect of different types of exercise training on endothelial function (how well the blood flows through blood vessels) in 209 patients who had recently had their first heart attack.

THE RECENT INVENTION of fixed- malaria among children for dose artemisinin combination over a decade, but there are therapy tablets (ACTs) in disworries as to the affects of persible forms is anticitheir continuous use. pated by physicians The WHO arThe to be literally a gues that the WHOreports life-saver for overuse of the that over African children crushed antiunder age five. malaria tablets childrendiefromthe The WHO are likely to effects of malaria reports that over lead to a form of every year 800,000 children resistance in the die from the effects of near future. By using malaria every year on the conti- ACTs in dispersible tablets, nent. ACTs have been in use for much more effective outcomes the treatment of uncomplicated should be produced.

800,000

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FRONTLINE healthcare industry, but conwork to submit the charges for stantly exposed to scenarios work performed. that affect their decision on With an engineer’s mind and which tools to further develop. a physician’s sensibility, the enterRecently, Dr. Liu has been prising Dr. Liu built his own interhonored as a ‘top hospitalist’ by net-based solution that allowed the American College of him to easily track the paPhysicians. In additient care he delivtion to this recogniered. Thus, IM Ingenious Med has quickly tion, Liu was Practice Manager become the recently appointwas born. “It is a ed to serve on revenue-generatthe Practice ing tool for physipractice management solution Analysis cians, built so they Committee for the can spend more time Society of Hospital with their patients,” says

number one

THE FIVE-MINUTE EXECUTIVE STEVEN LIU, INGENIOUS MED ON A ROUTINE SHIFT during his residency in 1999, Dr. Steven Liu was about to start his patient rounds when he noticed an attending physician’s jacket hanging on the door, filled with nearly a hundred index cards. Upon closer in-

spection, each index card represented a patient and an accounting of that doctor’s charges during their entire stay – left behind and forgotten, never to be submitted for payment. The problem was partly that doctors never have time to fill out the necessary paper-

COMMON COLD CURE US RESEARCHERS HAVE DECODED the genome for 99 strains of the common cold, and as a result, may have come one step closer to finally finding the long-awaited cure. Stephen Liggett of the University of Maryland created findings from a process of cataloguing the vulnerabilities of the virus; he says the benefits are a breakthrough for asthma sufferers and those with chronic obstructive pulmonary disease.

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However, the cost for the development of such drugs can be high. Anti-viral drug experts predict the typical cost of developing a new drug to be around $700 million. There is also a long process of regulations to go through.

With the effects of the common cold being very minor, combined with an expensive process in which to manufacture and market the drug, it seems unlikely that the common cold cure will take off.

Dr. Liu. With over 500 clients nationwide, Ingenious Med has quickly become the number one practice management solution for inpatient doctors.

IM Practice Manger makes it easy for physicians to track patients, submit professional charges, and prompt and capture pay-for-performance quality initiatives, without disrupting their daily workflow.

IM Practice Manager is a culmination of expertise from practicing inpatient physicians who are not only in tune with the

Medicine (SHM), a position requiring expertise, leadership and education in the field of hospital medicine. As the current chairman, CMO and a practicing physician, Dr. Liu still has an active hand in building and enhancing the product. Dr. Liu and his team at Ingenious Med live by the motto ‘built by physicians, for physicians,’ to ensure IM Practice Manager is the most user-friendly inpatient practice management solution available.

For more information, please go to www.ingeniousmed.com

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HAND HYGIENE INTERVENTION THE SPRIXX HAND HYGIENE SYSTEM (SHHS) is a comprehensive package of integrated multimodal components combined to initiate and sustain a safety culture paradigm shift and raise hand hygiene to a highly regarded advanced clinical skill. The system is based on the CDC and WHO hand hygiene guidelines, IHI improvement process, and Six Sigma principles. The system includes: PERSONAL DISPENSERS – personal, ergonomic, wearable point-of-care hand sanitizer dispensers that clip to belt or clothes, quickly become a second-nature habit, keep healthcare providers in their workflow, and act as visible symbols of the program.

ELECTRONIC TRACKING – finally, truly meaningful and economical measures; the personal dispensers automatically record timestamp data for every use.

The data are downloaded into a central database to provide individual and group performance indicators that drive change and sustain improvements.

ELECTRONIC TRAINING – an audio reminder and other training aids help providers expand working indications for hand hygiene. e-LEARNING – online e-learning programs focus on achieving fast buy-in and go on to teach advanced clinical skills. In-service and collateral programs are also included.

PROMOTION SUBSCRIPTION PROGRAM – keeps hand hygiene promotional messages rotating, relevant and fresh.

HAND HYGIENE MANAGEMENT SOFTWARE – makes it easy to manage the new system and provide ongoing administrative performance indicators for joint commission and hospital leadership.

SHHS is a fresh approach to a highly complex problem in a highly complex setting. Clinicians like how the system helps them focus on quality patient care. It earns clinician respect by challenging them with meaningful performance indicators, saving them time, and making it possible to protect their patients from all hand transmitted contamination.

Unlike so many hand hygiene interventions, SHHS is designed to achieve actual infection rate reductions and sustain a much higher level of clinical hand hygiene adherence.

For more information, call 866-477-7499 and visit www.sprixx.com

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PROTECTION AGAINST BIRD FLU RESEARCHERS HAVE DISCOVERED human antibodies that can neutralize not only H5N1 bird flu, but also other strains of influenza. The antibodies, comprised of immune system proteins, may be used to protect frontline workers and others that may be at high risk, should a pandemic of flu break out.

The initial tests on mice, done by scientists in Hong Kong and the US, have shown to be highly effective. The speed of antibody response is reported to be far higher than the H5N1 bird fly vaccine produces by sanofi-aventis for humans.

SaaS LIFTS PLANNING ACCORDING TO THE REPORT, ‘Technology Trends: Analyzing Enterprise IT Budgets 2008’, by Datamonitor, the majority of businesses globally are planning to cut back on IT expenditures. So, if you’re a CFO and this scenario describes your business, what do you when you are struggling to provide executive management with updated plans based in this challenging economy? Or when you have pushed the limits of Excel for planning and it can’t keep up?

Or if there is no IT budget for new planning software?

The answer to each question: It’s time to consider a budgeting and planning solution delivered via the Software-as–aService (SaaS) methodology.

SaaS offers companies facing tough economic times the opportunity to rent the resources needed to drive the planning process and manage their businesses more strategically. It also reduces the implementation time and risk compared to typical IT delivered solutions. SaaS customers typically pay a subscription fee to the software vendor on a monthly, quarterly or annual basis, and the cost is treated

as an operating expense. In addition, businesses can activate the user seats they need now, prove the benefit (and be more agile), and add more seats as they need them. And if they don’t see the benefit, they cancel the service. The application is delivered over the web, so there is no hardware to buy or complex protocol stacks to manage. According to software expert Timothy Chou in his book, ‘Seven’, the cost saving is achieved because SaaS vendors have one-tenth the hard cost of typical on-premise solutions.

Budgeting and planning solutions delivered via the SaaS model from industry leaders like Host Analytics provide businesses the strategic innovation they need to mitigate the common pitfalls and costs of traditional software licenses, and become more agile. SaaS-based budgeting and planning solutions are accessible to companies of all sizes and can be delivered using an incremental approach – a key in these quickly changing economic times. Just as importantly, SaaS solutions can be deployed quickly, just in time to make your CFO look responsive and innovative for his or her next executive management meeting.

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IN MY VIEW Moncef Slaoui, Chairman of Research and Development at GSK A few months after I became Chairman of R&D, I had a meeting with the 60 most senior R&D leaders to discuss my vision and the strategy we’d be pursuing. One of the participants said at the end, “This is amazing because it’s such common sense. It’s not sexy and it’s not crazy, but it’s so pragmatic that we believe in it.”

You can publish a paper in one of the great journals – Nature, let’s say, or Science – and even if your paper is 95 percent right and 5 percent wrong, it will still be considered a success. In pharmaceuticals, either you’re 100 percent right and you have a medicine, or you’re one percent wrong, and there’s no medicine.

As an organization, we have to acknowledge that we need intuitive people and we need them in the right places. We don’t need thousands of them, but we need to have people who are going to make the right guesses, coming not from out of the blue but from deep expertise.

We know that we’re making changes that will make us stronger in four or five years. If we don’t make them now, we’re not going to be standing when it’s havoc in the industry. But it’s hard to relate that to an individual who may be losing his or her job today.

It is difficult to tell people who have been working for you for a long time and doing their best to discover medicines that now they are going to lose their jobs, because we can’t continue doing things the same way we used to do them. That in order to stay at the top, we have to redesign our organization.

Scientists are faithful to their projects and to their science.

They do their best for their projects. It’s not because they fail individually that they lose their jobs. Globally there may be an element of failure, or at least of limited success, because we haven’t had enough blockbusters coming through, but on an individual basis and a small team basis, it’s very hard.

There will come a time when a significant number of players in the industry will disappear and only a few will remain around the table. Those who remain will be those with a strong R&D pipeline and a strong R&D organization.

SIERRA AD:mar09 17/03/2009 09:15 Page 23

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FRONTLINE

DRUG ADS NEED MORE FACTS

FROM THE VAULT

PEOPLE COULD MAKE BETThe FDA requires pharTER DECISIONS about which maceutical companies to list drug to choose if all ads carthe risks associated with a ried a facts box clearly statdrug but not its benefits. But ing the medication’s pros and in order to make any sense cons, a new study suggests. of side effects, you have to “People don’t know what the benehave access to fits are, and if it is They say this information worth exposing drug reduces your about how yourself to any risk of stroke by well drugs potential work,” risks. says Dr. Woloshin’s but they won’t tell you 30 percent Steven team conducted of what Woloshin, an two trials to see associate profeswhat choices consor at Dartmouth Medical sumers would make when School and co-author of the shown drug ads that did and study. “The ads don’t tell did not include a facts box. them the most fundamental Participants looked at ads for information they need.” He two prescription heartburn suggests adding a facts box medications and two cardioto provide that information. vascular drugs.

According to Woloshin, The addition of facts current drug advertising can boxes to prescription drug be deceptive. “For example, ads resulted in consumers they say this drug reduces making better choices of your risk of stroke by drugs for their symp30 percent, but they toms and being won’t tell you 30 better informed percent of what,” about the benehe says. fits of drugs

30%

used for prevention.

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In the Q3 2008 of issue of EHM, DREW ALTMAN, President and CEO of The Henry J. Kaiser Family Foundation, emphasizes the special role of the foundation as an independent, trusted source of information, and tells us why policy analysis and research is increasingly needed to address the concerns of 45 million uninsured Americans.

Go to www.executivehm.com to browse ‘Past issues’ and view the cover story of the Q3 2008 issue, and read of Altman’s solutions for curing the healthcare system he can only describe as “mostly dominated by money and politics”.

WALDENSTROM AWARD THIS YEAR’S WALDENSTROM AWARD was presented on February 27 to Dr. Brian Durie, the founder and chairman of the International Myeloma Foundation (IMF).

In receiving the award, he said, “Today our mission is to continue this progress, to expand access to these medical advances to all who need it, and to support and encourage innovation in research and drug development so this momentum continues. I’m deeply

honored that the contributions I’ve made in the field of myeloma have been recognized by my peers.”

Along with his leadership role, Durie is also a practising hematologist/oncologist and chairs three major research groups: the Myeloma Network for Aptium Oncology, the IMF’s International Myeloma Working Group and the Myeloma Committee (CoChair) for the Southwest Oncology Group (SWOG).

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FRONTLINE PROVEN TECHNOLOGY FOR FAST DATA ENTRY COMPUTERS ARE NOT GOOD AT UNDERSTANDING a doctor’s speech. Even though speech recognition technology is making progress, information is most reliably entered through a keyboard.

One way to accelerate text and data entry is to save keystrokes by using abbreviations or word completion. A number of abbreviation systems are currently in use; however, they use old technology.

The founder of Textware Solutions and chief architect for the design of the computer language Ada, Jean Ichbiah, was among the first software engineers to insist on innovative, reliable and easily maintainable software designed to achieve re-

alistic goals. He designed Instant sary will bring up bilateral salpinText to accelerate the text entry go-oophorectomy when the user process with new technology, types bso, whereas a general taking into account the inglossary may bring up Boston creased speed and inSymphony Orchestra expensive memory and a German glosOne way to in modern PCs. sary will show The new besonders. technology ofWhen they text and data entry is to save key fers an easy way assess a patient’s strokes by using to produce words health, doctors like abbreviations and phrases with to be able to use narjust a few keystrokes. rative language rather As soon as the user types a than predefined structured few letters, Instant Text matches language. When Instant Text comthem with the vocabulary that is piles a glossary from existing rein the customized glossary. ports, it examines the frequency A million invisible tasks are of the words and phrases used executed between keystrokes to and discovers the structure of make visible the words and phraseach doctor’s language. es one may need for input in a For more information, please see particular context. A medical gloswww.textware.com

accelerate

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STIs ON THE RISE A REPORT RELEASED IN JANUARY 2009 by the Centers for Disease Control and Prevention (CDC) found that STIs, most notably chlamydia, gonorrhea and syphilis, have increased in the US. The CDC claim the results to highlight a growing public health problem, and the sufferers of the infections to be mostly young women.

The figures only account however, for those cases reported by local health departments, clinics and hospitals, and therefore produce an estimated figure of only half of the actual number of STI cases.

Despite all three of the STIs being successfully treatable with antibiotics, the number of cases continues to rise, due to the spreading of the conditions by those who are unaware and remain untreated.

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FRONTLINE

HEALTHCARE DESIGN IS A PROCESS ONE OF THE ONLY CERTAINTIES healthcare organizations are faced with today is change. Change is pervasive throughout healthcare. It seems every facet is being affected: technology, delivery of care, staffing models, financial resources, codes and standards, best practices.

The way in which these organizations prepare to adapt will determine how they can effectively respond to a changing world.

The first step in any building project is determining the right team. The team will address complexities of the physical environment and of the performing environment.

With such diverse implications, the team should be carefully selected based on diverse talents and knowledge.

1 2

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VISUALIZE: Establishing the organization’s goals early during the initial steps will give the entire team a direction and underlying mission to adhere to throughout the design process.

This will be the project vision.The purpose of the vision is to drive all decisions. The vision statement needs to be simple.The vision is the starting point to which all other efforts are tied.

PLAN:The master plan is the road map to a vision. It is the path to which a hospital or a system reaches its short-term and long-term goals.

The master plan can be a system-wide endeavor or can be site specific. It will define how an immediate project will react to current needs. It will predict how a project will adapt to future needs.

ADAPT:With a vision defined and the master plan developed, the team can begin to concentrate on developing the project.This is the step in the process where the team will begin to adapt the project to the overall vision and master plan of the organization.The definition of adapt is “to make fit often by modification”.

That is the purpose of healthcare project design.

The completed project must fit within the vision of the organization.

Healthcare building projects have the ability to facilitate change or impede it.The right process and the right team are essential parts in making a project a success; now and in the long term.The time spent on the front end of a building project will help to ensure sustainability, viability, and flexibility.

For more information see www.cdhpartners.com

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SUPPLEMENT FAILINGS AN OVER-THE-COUNTER DIETARY SUPPLEMENT taken by arthritis patients has been found to be not as affective as once thought.

Glucosamine, a substance that is naturally produced in the body, has failed to emerge from trials as a suitable supplement for sufferers.

Anomalies in the wide-ranging results of the trials of glucosamine sulphate mean the results of the study are inconclusive, and therefore the compound is too unstable to be used as a supplement.

Another study was conducted as a followup to the glucosamine trial; the second study also tested chondroitin sulphate, a carbohydrate that helps cartilage retain water, which is often taken in combination with glucosamine.

The results of the study deemed the substance to be just as unreliable as straight glucosamine, and therefore no treatment could be suggested.

SIMPLIFICATION/STANDARDIZATION To improve overall performance, a large WITH A FREEZE ON NEW CAPITAL expendimid-western, multi-facility IDN embarked on an tures and a hunt to reduce operating exextensive, across-the-board standardization penses, perhaps this is a great time to project in its information technology. All hospisimplify your fleet of applications by retals would be converted to a standard set of somoving applications that have been relutions for revenue cycle, clinical and ERP placed but are still in production to provide processes. The result has been a highly effiaccess to the data. cient new operation.

With a singular focus on the healthcare However, the ‘debris’from this proindustry, Legacy Data Access, Inc. ject was a hodge-podge of retired stores data from systems that This webapplications – each containing are being retired, replaced or based access is valuable data – but each reoverburdened, and proquiring continued operating vides secure, web-based expense as well as care and access to the information. from any type feeding by the information of database or data This web-based access is source and systems team. available from any type of any platform Following the theme, database or data source and ‘Simplify through Standardization’, any platform. You have online acthe IDN partnered with Legacy Data Access. cess to your data, 24/7. Retrieve informaWith the data from each of the retired systems tion through a secure and encrypted request migrated, as is, under the LegacySuite umbrelsystem. View records online, download them la, the IDN completed their IT simplification to a PC, or print them via an internet browser. loop. The result is a greatly simplified IT land“Our LegacySuite of products also provides scape and an enterprise-wide, consistent techreceivables management functionality to nology and methodology for all retired data. support ongoing revenue processes for ac-

available

counts from the retired system,” adds Shelly Peters of Legacy Data Access, Inc.

Visit www.legacydataaccess.com or call 866-601-2416 to learn more.

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FRONTLINE HIGH RESOLUTION IMAGING SIERRA SCIENTIFIC INSTRUMENTS, Inc. was founded with a goal of bringing high-resolution pressure imaging to the medical community for the diagnosis of motility disorders within the GI tract. Starting in 1999, a group of leading scientists and engineers formed with the goal to develop, produce and sell an innovative technology that would deliver an unprecedented view of the physiology within the GI tract and demonstrate significant improvements in simplicity and diagnostic accuracy. The result was the ManoScan 360 system, the first high-resolution pressure imaging system that provides detailed images of the full esophagus.

Today Sierra produces a complete line of high-resolution solidstate manometry systems for gastrointestinal motility study. Our ManoScan 360 sets the new stan-

dard of practice in clinical motility testing. Using 432 data points in 36 fully circumferential sensors, the system enables accurate and repeatable data collection in less than a 10minute recording period. With a simple probe placement and swallow protocol, motor function is fully characterized from the pharynx to the stomach with results that reveal motility physiology in an intuitive and concise manner. ManoScan incorporates a unique set of useful features such as patented physiological visualization and analysis software, an auto-calibration system, ManoShield disposable sanitary sheaths, and the world’s smallest HRM catheter available (2.75 mm). Diagnostic accuracy is further enhanced by ManoScan’s distinctive capabilities that include advanced computer-assisted HRM disorder classification, a compre-

hensive set of normal values, autoreport generation, modular expansion for adjunctive modalities, and much more. This technology dramatically simplifies clinical procedures and provides intuitive pressure images that reveal diagnostically significant conditions not seen with conventional manometry.

The ManoScan 360 is now upgradeable to high-resolution manometry with Impedance. Also available are the new AccuTrac pH & Impedance monitoring systems, ManoShield disposable catheter sheaths for both esophageal and anorectal catheters, and small diameter adult and pediatric solidstate catheters. This long list of features is only part of the capabilities designed

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to assure you that you have the most simple, accurate and complete diagnostic solution available.

Contact Sierra to find out more about ManoScan 360 and our entire product line, www.sierrainst.com

COMPANY INDEX Q2 2009 Companies in this issue are indexed to the first page of the article in which each is mentioned Accumetrics AHIMA American Heart Association American Institute of Architects Amgen Anesthetix Management APIC Athena Health Bardwell & Associates Bioscan Inc. Bracco Diagnostics Brigham and Women’s Hospital CareMedic Systems CDH Partners CDISC Cleveland Clinic Covidien Dell Children’s Medical Center Enoviate Exergen Corporation

61 92 76 64 124 56, 57, IBC 50 85 64 4, 120 IFC, 114 34 96 26, 67 128 55, 58 114 64 127 6, 38, 39

GE Healthcare 2, 114, 119, OBC Guerbet LLC 114, 116 Healthcare Compliance Association 63 Healthcare Insights 17, 101 Host Analytics 21, 82 Ingenious Med 20, 95 Insight Information 90 Johns Hopkins Hospital 47 Johns Hopkins Medicine 100 Legacy Data Access 26, 88 LifeSync 74, 75 Mayo Clinic 87, 108 Medegen 73 Medtronic 45 Massachusetts General Hospital 42, 80 Millennium 122 Mount Sinai Medical Center 104 MultiCare Health System 96 Nephros, Inc. 52, 53 Netrics 102, 103

New York Presbyterian Medical Center 71 Partners HealthCare 80 Phillips 112 PivotLink 98, 99 Radiologic Society of North America 104 rL Solutions 49 Secureach 143 Sierra Scientific Instruments, Inc. 23, 27 Sprixx 21, 46 Textware Solutions 25 The Siesta Group 11, 68, 69 Transcription South 93 Translate Medical 107 Verisign 33

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COVER STORY

Third time lucky?

President Obama plans to radically reform our health system, and few would disagree that it needs it. But bringing change to such a complicated entity is no easy task. How will the new administration succeed where others have failed? By Marie Shields

A

president is elected partly on the promise of healthcare reform. He makes a rousing speech on the subject, to near universal acclaim. He then sets in motion a process to rebuild our health system from the ground up. Sound familiar? I’m describing President Obama and recent events in Washington, but I could just as well be talking about Bill Clinton’s health proposals back in 1993, or Harry Truman’s before him. And we all know how those turned out. Can Obama do what Clinton and Truman could not?

History repeats On a cold January day, punctuated by applause and shouts of “Obama! Obama!”, the new President gave his inaugural address in customary inspiring fashion. In amongst the talk of challenges and vision, the state of our healthcare system was not neglected. In Obama’s words, “Our healthcare is too costly . . . We will restore science to its rightful place and wield technology’s wonders to raise healthcare’s quality and lower its costs.”

Since then, the new government has overseen the passage of the economic stimulus bill, which sets out, among other things, an increased federal medical assistance package for Medicaid; $1 billion in funding for research comparing the effectiveness of treatments funded by Medicare, Medicaid and SCHIP; $2 billion in extra money for the Office of the National Co-ordinator for Health Information Technology; and $1 billion in funding for community preventative health campaigns, vaccination programs and healthcare-associated infection reduction strategies.

On February 5, Obama also signed into law a bill to expand government-funded health insurance to cover an additional four million children, a $32.8 billion expansion of the State Children’s Health Insurance Program. The money to pay for the expansion will reportedly be generated by raising the federal tobacco tax.

So far so good. But history has shown that it’s one thing to have a vision, and quite another to make that vision reality.

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“We will wield technology’s wonders to raise healthcare’s quality and lower its costs”

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Truman’s plan 1945-1950

In 1993, shortly after being elected to his first term as President, Bill Clinton created the Task Force on National Health Care Reform. Its core element was an enforced mandate for employers to provide health insurance coverage to their employees through regulated health maintenance organizations. The plan initially met with a positive response, but controversy arose when Clinton appointed his wife, Hillary Rodham Clinton, to chair the task force, giving her an unprecedented level of responsibility for a president’s spouse.

The plan drew litigation relating to its processes and Hillary’s role, and became an easy target for criticism from Republicans, who called it unnecessarily bureaucratic and said that it restricted patient choice. Predictably, the health insurance industry was also critical of the plan, and, more surprisingly, a number of Democrats broke ranks and produced competing plans of their own. The whole thing descended into chaos, and in August 1994 a compromise bill aimed at enshrining at least some of the original plan’s ideas into law was declared dead.

Clinton wasn’t the first American president to attempt major healthcare reform. In November 1945, seven months into his presidency, Harry S. Truman gave a speech to Congress proposing a new national healthcare program. Truman’s plan was to address a number of healthcare-related issues, including the lack of doctors, dentists, nurses and other health professionals in lower-income areas of the country and the lack of quality hospitals in rural counties. Truman proposed the establishment of a board of doctors and public officials that would create standards for hospitals and ensure that new hospitals met these standards.

The most controversial aspect of Truman’s plan was its proposed national health insurance plan. The fund was to be open to all Americans, but would remain optional, with participants paying monthly. The plan also

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On November 19, 1945, Harry S. Truman gave a speech to the United States Congress proposing a new national healthcare program.

Truman argued that the federal government should play a role in healthcare. He aimed to address five issues: the lack of doctors, dentists and nurses in lower-income areas; the lack of quality hospitals in rural counties; the need for a board of doctors and public officials to be created; the lack of national standards for hospitals and other health centers and the need for a national health insurance plan.

Truman’s health proposals finally came to Congress in the form of a Social Security expansion bill, co-sponsored

by Democratic Senators Robert Wagner and James Murray along with Representative John Dingell. For this reason, the bill was popularly known as the WMD bill.

Following the outbreak of the Korean War, President Truman was finally forced to abandon the bill. Although Truman was not able to create the health program he desired, he was successful in publicizing the issue of healthcare in America.

aimed to provide a cash fund to replace wages lost due to illness or injury.

When the proposals came before Congress they were vociferously opposed by the American Medical Association, which called the bill an example of ‘socialized medicine’, therefore tying it to the fears of communism that dominated public consciousness at the time. Organized labor, one of the bill’s main supporters, had also lost the goodwill of the American people thanks to a series of disruptive strikes. When the Korean War broke out, Truman was forced to abandon his bill completely.

Different times Will things be different this time around? President Obama is starting from a good place: he has a tremendous groundswell of popular support, and is widely regarded as a man of intelligence and vision. And the timing seems to favor him as well: our healthcare system is in the worst shape it’s ever been, there’s been a cultural shift toward government activism, and the opposition seems to be in disarray.

According to Charlie Whelan, Director of Consulting in the Healthcare Practice at analysts Frost & Sullivan, Obama has learned from Clinton’s mistakes. “Obama’s strategy is very different to Clinton’s. He has prepared the vision and the parameters to frame the argument and put it on the back of Congress to hash out the details.

“He’s essentially said, ‘These are the objectives, this is what we are trying to achieve, and we are allocating X dollars to fund these particular objectives, whether they are EMRs or comparative effectiveness studies or money to improve NIH research grants.’ The strength of Obama’s plan is that it is open-ended, and puts the responsibility of hashing out the details on the shoulders of Congress, who scuttled Clinton’s plan a decade ago.”

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Mike Thompson, Principal in PricewaterhouseCoopers’ Global Human Resource Solutions Group, agrees: “In retrospect the way that the process was handled last time was done in a very closed-door, take it or leave it approach. This time it’s being done in a more open and collaborative way. It’s also important to note that the proposals that are on the table today will not affect 85 percent of Americans, in contrast to the previous plan, which was to re-engineer the entire system. History suggests that health reform is more successful when it is more incremental and less revolutionary.

“Healthcare is one of those areas that everyone holds near and dear to their hearts, and if what they have is threatened, this creates a built-in resistance to change. The great majority of Americans already have coverage and healthcare they are satisfied with, and it’s easy for them to buy in to reform that improves the lot for people who are less fortunate.”

Strong points Obama’s plan does have some acknowledged strengths: specifically, prohibiting insurance companies from determining price or denying coverage based on health status; expanding provision for children from lowincome backgrounds; requiring large and medium-sized employers to enroll employees in health insurance plans and make a contribution toward the cost; and providing subsidies to low-income people so that they can afford coverage under the National Health Insurance Exchange.

“History suggests that health reform is more successful when it is more incremental and less revolutionary” Mike Thompson, PwC But these strengths can also be weaknesses. Take for example, the notion that insurance companies should treat all people in a given community the same, regardless of any pre-existing health conditions they may have. This idea will only work if everyone is required to enroll; otherwise healthy people will wait until they become sick before buying insurance – why buy it when you’re healthy if you know the insurer is bound by law to cover you regardless of circumstances? Unless the entire country signs up to an insurance plan voluntarily, we will need a mandate that requires everyone to join – and the lack of a mandate was one of the key points in Obama’s pre-election platform.

There will also be opposition to the proposed changes from a number of obvious sources, including pharmaceutical companies and manufacturers of medical devices, because some of the funding for the changes will come from trimming their revenues.

The proposed move to expand access to generic medicines, for example, understandably has many pharmaceutical companies up in arms.

Shortly after the details of the stimulus bill were announced, pharmaceutical giant AstraZeneca released the following statement: “As policymakers consider further comparative effectiveness research measures in the context of healthcare reform, we encourage them to keep clinical effectiveness at the forefront, recognizing the differences in the efficacy, safety and tolerability of treatment interventions among individual patients. A narrow focus on cost-effectiveness can compromise

Clinton’s plan 1993-1994

Bill Clinton’s goal was to introduce a comprehensive plan to provide universal healthcare for all Americans, which was to be a cornerstone of the administration's first-term agenda.

The plan’s key element set out a mandate that would force employers to provide health insurance coverage to all employees. This would be achieved through competitive but closely regulated health maintenance organizations.

Conservatives, libertarians and the health insurance industry waged a campaign against the plan, criticizing it as being overly bureaucratic and restrictive of patient choice. Democrats, instead of uniting behind the President's proposal, offered competing plans of their own.

In August 1994, Democratic Senate Majority Leader George Mitchell introduced a compromise proposal that would have delayed the requirements of employers until 2002, and exempted small businesses.

A few weeks later, Mitchell announced that his compromise plan was dead, and that healthcare reform would have to wait at least until the next Congress. The defeat gave Republicans additional ammunition in their fight to weaken Clinton.

patients’ access to needed medicines and stifle innovation. In addition to providing information on the benefits and risks of our medicines, AstraZeneca is committed to helping people who have difficulty affording the medicines they need.”

While at first glance this reads like an endorsement of the proposals, on closer inspection it contains a thinly veiled argument for retaining the

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In November 2008, Barack Obama was elected as the 44th President of the United States on a platform that placed a large emphasis on healthcare reform. His plan proposed a comprehensive, standardized federal health benefits structure; a massive expansion of federal regulatory authority over health insurance; and an enlargement of federal regulatory power over healthcare delivery, including the definition of what constitutes quality care.

The plan also aimed to prop up the existing employerbased health insurance system and government health programs, such as Medicaid and the State Children’s Health Insurance Program (SCHIP), to expand health insurance coverage.

Since taking office, the new government has pushed through the American Recovery and Reinvestment Act, also known as the economic stimulus bill. The bill sets out, among other things, an increased federal medical assistance package for Medicaid; $1 billion in funding for research comparing the effectiveness of treatments funded by Medicare, Medicaid and SCHIP and $2 billion in extra money for the Office of the National Co-ordinator for Health Information Technology.

On February 5, Obama also signed into law a $32.8 billion expansion of the State Children’s Health Insurance Program.

status quo when it comes to patent protection for branded drugs – a battle that could become protracted and nasty, given the power and influence of the big drug companies and what they stand to lose.

Even hospitals and physicians may find themselves on the wrong side of the fence: if money is clawed back from savings made in more effectively managing chronic care, for example, this could cut their revenues. What some see as waste, others see as essential income.

More information Improving health IT has been touted as one method of cost containment, which is why the universal adoption of electronic health records is being promoted so heavily, with funding to the tune of $20 billion. Yet while putting medical records online will undoubtedly improve care for patients in the short term, actual cost savings are more of a long-term goal.

According to the Congressional Budget Office, “Approaches such as the wider adoption of health information technology or greater use of preventive medical care could improve people’s health but would probably generate either modest reductions in the overall costs of healthcare or increases in such spending within a 10-year budgetary window.”

Frost & Sullivan’s Director of Research for Healthcare, Monali Patel, puts it this way: “The intention is that there would be cost savings in the long term, because you would start to have more efficiencies in the system. You would start to reduce some types of waste in terms of time and energy, and perhaps manpower that’s going into maintaining paper records, but also potentially when a patient moves from provider to provider or insurance company to insurance company, it’s a more streamlined transition.

“In terms of when we will start to see cost savings, I don’t know that anyone has been able to outline a concrete year, or what the actual ROI

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Obama’s plan 2009-??

would be. Over the long term there will be a lot of benefits, and some of those benefits will not just be administrative, but will be clinical as well. If you have an electronic medical record, you have better data sources. You have more clarity in terms of what’s happening with the patient, because there will be fewer errors compared to something like handwriting.”

According to PwC’s Thompson, “It’s widely accepted that we can’t get a true handle on the healthcare system if we continue operating under an antiquated infrastructure that is not electronically based. Most of the significant improvements that have been made in other industries have been empowered by leveraging technology. It will require a significant investment upfront and may require a reconfiguration of the provider system.

Much of the system is dominated by individually practicing physicians and we will see a move toward larger groups of physicians who are better able to implement these changes.

“These changes are unlikely to lead to short-term savings – if anything, they will require a short-term investment. Longer term, the only way for us to turn the ship and get better control on what’s happening and reduce variation around practice patterns is to have a system that is more technology enabled, so we can understand where the variations are and gradually work to improve on that.”

Money money Obama has promised that much of the funding for the proposed reforms will come from a 10-year fund of $634 billion in tax revenues. The trouble is, there are already many claims on this tax money, including improving infrastructure and rebuilding the military. It is also possible that it will be politically unworkable to claw back such large amounts of money from upper income earners and businesses.

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Says Frost & Sullivan’s Charlie Whelan: “Other people have criticized tax proposals are being considered, but nothing big enough to offset the where some of the money is coming from, and whether it’s changing the cost of this implementation. amount of tax deductions that rich people and corporations are able to take “If you look at the prognosis on the expenditures of the federal govor cuts to reimbursement to Medicare managed funds. I believe they were ernment, we can’t get control of those unless we get control of healthcare well chosen, but are we going to be able to generate as much money from costs. The problems associated with Medicare and Medicaid are so deep those cuts as anticipated?” and immediate, that we can’t solve the overall funding issue without tackThe stimulus bill legislation would impose financial penalties for those ling healthcare. If we’re able to turn the ship on healthcare, that will pay who have not adopted the appropriate health information technology for itself many times over in the long run as we look at the magnitude of strategies within six or seven years. Many large hospitals and healthcare the deficit we’re going to be facing if we don’t turn the ship around.” institutions have already implemented such systems, so these requireThe consensus seems to be that Obama’s vision is good, if perhaps a ments will not cause them difficulties, but small organizations and offices little overambitious, and challenging to implement. This is not unexpected of four physicians or fewer could find it challenging to comply.

– it has taken years for our healthcare system to become the tangled mass Gary Gottlieb, President of Brigham and Women’s Hospital, acknowlof complexities that it is. Any plan that promises to resolve this quickly or edges both the importance and challenges of moving to computerized paeasily would clearly be either lying or severely misguided. tient records. “We believe strongly that this is critically important. We’ve In historical terms, Obama has a better chance of realizing his vision endorsed it. We’ve invested in it. We’ve had very substantial funding of it than his predecessors did. But he will need to act before the momentum internally. For other institutions it’s going to be challenging, and therefore stalls. Otherwise we will wind up back where we started, with our third the incentives that are in the stimulus package will be critical. You don’t chance at healthcare reform gone completely down the drain. n want to disable small community hospitals that have frail balance sheets or urban centers that are HOUSE BILL vs SENATE BILL doing their best to take care of very sick populations by causing them an additional capital cost.”

On February 10, the Senate passed an amended version of the The other problem, of course, being the curAmerican Recovery and Reinvestment Act of 2009 by a vote of rent state of the economy. As Whelan points out, 61-37. While the healthcare-related provisions are very similar to “When the government plans its budgets, it looks those included in the bill passed by the House on January 28, into the future and says, ‘ We anticipate future there are some important differences: revenues to be at these levels, in 2010, 2011, 2012, 2013, 2014, 2015.’ And then it says, • Both bills provide COBRA subsidies for workers who have been ‘Assuming we get that amount of money back into involuntarily terminated from their jobs for 12 months. The House subsidy the coffers, we can allocate some of that money is 65 percent of premium costs and the Senate subsidy is 50 percent. to EMRs, and some of that money to provide people who don’t have healthcare insurance with • The House bill would also allow COBRA-eligible workers aged 55 and older, and healthcare insurance.’ those who have worked for an employer for 10 years or more, to retain COBRA “There isn’t a big pool of $1.5 billion in cash coverage at their own expense beyond the 18 months provided under current law. sitting there that they’re going to start disbursing.

They’re going to be submitting IOUs to all of these • The increased federal medical assistance percentage (FMAP) for Medicaid parties, saying, ‘We anticipate getting these dolis 4.9 percent in the House bill and 7.6 percent in the Senate bill. lars in the future, and when we do, we will be funding it in such and such a way.’

• The House bill includes $600 million to address shortages in the primary care “That’s important, because if in the future we workforce; the Senate bill does not include this provision. Funds for prevention find that we don’t have that money, if the econoand wellness, pandemic preparedness, and other public health initiatives were my doesn’t improve or there are other types of prialso deleted from the Senate bill. orities that pop up, the amount of money that • The House bill would repeal the three percent withholding tax on might go to funding some of these things might government contractors (including Medicare providers) that is scheduled not be as high as it is now. So there’s an element to take effect on December 31, 2010; the Senate bill would delay of risk there.” implementation of the withholding tax for one year.

Thompson also believes that the proposals may run into funding problems in the long term, but that doesn’t mean they shouldn’t go ahead: “Right now the country has a willingness to spend a lot more money than it’s taking in as part of the economic stimulus, and healthcare reform is being financed as part of that. Longer term, some

• The incentive payment structures for health information technology (HIT) adoption differ. In particular, the imposition of Medicare payment reductions for those providers who are not meaningful users of HIT would begin in 2015 in the Senate bill, one year earlier than in the House bill.

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Local hero

As a community leader in his own Boston neighborhood, Brigham and Women’s Hospital President Gary Gottlieb works to correct healthcare disparities at the grassroots level. But as Marie Shields finds out, he hasn’t lost sight of the need for reform on a grander scale.

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t happened because Gary Gottlieb told the mayor of Boston and particularly post-secondary training, that’s necessary to do the exactly what he thought. Not about the mayor’s method of type of work we have now and what we’ll need in the future. running the city, but about what he saw as an opportunity to “The notion of being able to embrace our community, which is a improve the lives of its large immigrant community. Very soon critical part of the mission of the institution, and at the same time, to afterward Gottlieb, who is President of Brigham and Women’s be able to help deal with some of the long-term employment needs and Hospital, was asked to head up the Workforce Investment improve people’s lives seemed to me to be a terrific opportunity.”

Board, part of the mayor’s Private Industry Council. The board, comChallenging times prised of leaders from business, Since becoming President of education, government, labor and Brigham and Women’s in 2002, Gotthe community, oversees the distritlieb has faced a number of opportubution of public workforce developnities and challenges, as he explains, ment funds, charters Boston’s three “Bringing all of the parties together one-stop career centers and works to share a vision around how to dethrough them to implement workliver on the tripartite mission that force development strategies. we have in the context of a very, very The board plays a key role in dynamic healthcare marketplace encouraging and improving educaand changes in the demands related tion in the city, as Gottlieb explains: to discovery and science and fund“It’s the way in which all federal and ing, as well as the way that providers state workforce dollars are chanare trained; I would say that those nelled into the city, and it has several have been both the challenges and elements. One is a compact with the the opportunities. There’s been real public school district on creating dynamism in all those areas, and at pipelines to improve the complethe same time, they all require subtion of public education, creating stantial attention. linkages to post-secondary higher “It’s been my responsibility to education, increasing graduation convey to people that all three legs Gary Gottlieb is President of Brigham and Women’s/Faulkner rates and reducing dropout rates. It of that stool are critical to our being Hospitals; a position he has held since March 1, 2002. He is also creates training programs that able to deliver on our promise and also a professor of Psychiatry at the Harvard Medical School. start with summer jobs in a variety our mission, and we’ve been sucGottlieb became the first chairman of Partners Psychiatry in of specific programs that create opcessful in honing that focus. Each of 1998 and he served in that capacity through 2005. In 2000, portunity in various industries. It’s a those areas has improved in some he added the role of President, North Shore Medical Center, combination of CEOs, union leaders remarkable way, and we’ve been where he served until early 2002. Prior to Boston, Gottlieb and key public entities. able to justify the investments we’ve spent 15 years in positions of increasing leadership in health “The other element relates to made in the enterprise, whether care in Philadelphia. career centers that support people they’ve been physical capital inwho are unemployed, training comvestments or investments in people ponents that create pipelines for the around making certain that we could under-skilled, and English language learning opportunities for immideliver better on our fiduciary responsibilities.” grant populations to be trained in various industries. I’ve used some of The healthcare sector is also facing challenges on a national level, the assets and things I’ve learned there to help to create access to the with the introduction of President Obama’s healthcare reforms. GotBrigham as a major employer, as well as a set of career paths for people tlieb supports the President’s vision, but points out that any changes even at the entry level or pre-entry level from our communities.” must be made carefully and with great delicacy.

It’s a role he clearly enjoys. His original involvement was “President Obama has expressed a vision for healthcare reform and founded on the notion of enlightened self interest: the realization created placeholders for funding its reform, and that vision is inspiring. that he could do good and do well simultaneously. “If you look at The emphasis on near universal population access to insurance and apthe population base in Boston and nearby southeastern Massachupropriate healthcare, not only in moments of crisis, is wonderful. setts, it’s relatively flat in terms of growth. The only real growth is “Given that the cost of healthcare has inflated so remarkably as a in immigrant populations. Our businesses have been developing proportion of gross domestic product, the concerns about the impact remarkably in terms of doing more sophisticated and technical busithat creating universal access will have on government and business – ness, and there’s a very substantial skills gap between the level of because at the moment we still have employer-based insurances – are training the people in the community have and the level of training, reasonable because we don’t want to create a fiscal drag.

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“At the same time, healthcare is driving the employment base, and to disrupt that will have substantial secondary and unanticipated ramifications unless it’s done thoughtfully. It’s also driving entities like the Brigham, and Mass General, and others where science is embedded in the care that we do. IT is driving the growth of the United States as a powerhouse in biotechnologies, in the life sciences where we remain a discovery leader and in the development of new cures to illnesses.

“There is a narrow ledge that one has to walk along in regard to how these plans are implemented, but the vision is inspiring, and to have somebody truly taking this on and not shirking the responsibility to make certain that people in the United States ultimately have the best healthcare in the world is critical.”

Gottlieb agrees strongly that there need to be greater efficiencies. He points out that the nature of the relationship between payers and hospitals causes substantial inefficiencies. “We’re doing retail transactional business, where we have to hire substantial parts of overhead to make sure that we get paid for what we’re doing, and additionally, the incentives that have been created for the long run in indemnity-based insurances, in Medicare, have had some perversions associated with them. We have to narrowly walk along the line to reduce either those that lead to more care being

produced for no reason – provider-induced demand; or those that create inappropriate barriers to access to care, as we saw during the years of capitation.”

Electronic records One aspect of the reform proposals revolves around the nationwide conversion of patient records to electronic form. Gottlieb says this won’t pose any problems for BWH, “100 percent of our primary care doctors are on computerized records and all of our specialists will be using only e-prescribing and will be on electronic health records by the end of the year. Virtually our entire network in the Partners HealthCare system requires one to have adopted one of two electronic health records several years ago. We’ve already had people leave the network because they were not on electronic records in time. That was a deadline that we had in the past year for the whole system, specialists and primary care doctors.

“The question is what is the cost of local implementation and training beyond just the individual costs, because how those then affect the ability to simultaneously deliver care during implementation will be critical for some of these entities that are under a lot of pressure. Not for us, because we have made very substantial investments in creating system-wide goals and have met very rigid criteria. We are probably among a tiny handful of entities in the country that have adopted computerized physician order entry. We’re fully bar-coded and are in the process across the system of introducing an electronic medication administration record for safety purposes and in having system-wide electronic health records.”

Introducing an electronic system for patient records and providing the best care for patients are not the only focuses of the hospital’s work. BWH is internationally known for the high quality of its clinical translational bench and population-based research studies. Two big clinical trials in the last year alone are sufficient to illustrate this.

Groundbreaking research “One really big one that hit the headlines was the JUPITER trial,” Gottlieb says. “That was Dr. Paul Ridker, who is identified with the focus on C-reactive protein as a proxy for inflammation and identifying the importance of inflammation in risk for heart attack and other components of atherosclerotic cardiovascular disease.

“Until a few months ago, there was no proven method to detect and prevent many heart attacks and strokes in patients who had normal or low cholesterol. JUPITER was a trial of almost 18,000 patients, with scientists from the Brigham running trials across the world. They found that one of the statins reduced by almost 50 percent the risk of heart attacks, stroke and cardiovascular disease among people who otherwise had normal cholesterol. This is whole group of people that we previously were making safe through one type of screening, and now we find that they could benefit from treatment. The C-reactive protein is a proxy that showed they had a high risk for cardiovascular disease.

“This was a huge finding, and will likely save a lot of lives, because doctors will now know they have to treat many people who have abnormal C-reactive proteins, even if their cholesterol is normal.

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Brigham and Women’s Hospital There’s about 250,000 heart attacks, strokes, and re-vacuolization procedures, or cardiac deaths, that could potentially be avoided in the US if the strategies that were recommended in the trial are applied over a five-year period.”

Other current BWH research work that Gottlieb is excited by includes that of Dr. Scott Weiss, a pulmonary specialist who works in genetics and genomics. Weiss has identified that the vitamin D receptor in our bodies is associated with a gene for asthma. “He and his colleagues believe that during pregnancy, vitamin D can affect the way a fetus develops his or her immune system and lungs,” explains Gottlieb.

“They’re testing this hypothesis by observing large numbers of pregnant women and have found that women who had less vitamin D during pregnancy were much more likely to give birth to babies with asthma and allergies.” Weiss recently received funding from the NIH through the National Heart, Lung and Blood Institute for a $10 million randomized control trial of 800 pregnant women to see whether, if they are given vitamin D supplements, they will have a lower risk of their babies having autoimmune and inflammatory disorders, particularly asthma.

This work touches on Gottlieb’s personal interest in healthcare disparities: “You see a big disparity in black kids with asthma. The best way to raise your vitamin D levels is through sunlight, particularly in people who have light skin and not a lot of melanin in their skin. Black women need a lot more sunlight in order to convert more vitamin D, and they have to take many more supplements to get their levels up. When their grandmas used to give them cod liver oil they were doing fine, but when the vitamin D enriched milk was introduced, people stopped taking vitamin D supplements, and black women are at much higher risk for vitamin D deficiency. It happens that black children, at least in urban communities, are at very high risk for asthma. So if we can link these two together we might be able to ease a healthcare disparity.”

Personal care

Brigham and Women’s Hospital is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated healthcare delivery network.

In July of 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery.

The hospital has roots in medicine that date back to 1832.

BWH formed in 1980 with the merger of three of Boston’s oldest and most prestigious Harvard teaching hospitals: the Peter Bent Brigham Hospital, the Robert Breck Brigham Hospital and the Boston Hospital for Women.

BWH combines clinical care with initiatives in quality improvement and patient safety initiatives and dedication to educating and training the next generation of healthcare professionals.

Through the investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, involving more than 860 physician-investigators and renowned biomedical scientists and faculty supported by more than $416 million in funding. obstetrics and gynecology, we have nearly 300 of 777 beds in which family members can sleep overnight. That’s a big deal. We need to train doctors and nurses to manage things differently, and also how to work with family members, but it allows a real family-centeredness at a time when people are at great vulnerability.”

The rooms themselves allow state-of-the-art care. Gottlieb underlines that as more care is done out of hospital or is at a lower level in a community hospital, and inpatient care is increasingly reserved for the sickest people, there is the need for a resource with the technologies to monitor every aspect of potential instability within that environment.

The Shapiro Cardiovascular Center also contains ambulatory clinics that juxtapose providers from different disciplines; cardiologists, cardiac surgeons, vascular medicine specialists, vascular surgeons and cardiac imagers are all in the same clinical space.

“You can go from one to the other, if that’s necessary, or they can consult with one another around the patient and his or her needs in order to be able to provide the best possible care,” Gottlieb says. “They’re also specially outfitted with very flexible diagnostic procedures, as well as ORs that were conceptualized to bring together various disciplines and more minimally invasive approaches.”

With his work in health disparities in the local community, his focus on maintaining the highest quality patient care at BWH, and his strong views on national healthcare reform, it’s no surprise that Gary Gottlieb regularly appears in lists of the most powerful people in healthcare. In these challenging times, the healthcare sector needs as many champions like him as it can get. n

“The emphasis on near universal access to appropriate healthcare is a splendid and wonderful vision”

In July of last year, Brigham and Women’s opened the Carl J. and Ruth Shapiro Cardiovascular Center. As Gottlieb tells us, the new center is at the cutting edge of patient care.

“One of the overall strategies for the Brigham has been to create patient and familycentered care, and in so doing to create care that’s at the convenience and the benefit of patients in the greatest possible way.

“We’ve done that in Partners with the Dana-Farber Cancer Institute. We have 13 different disease centers that bring together surgeons and medical oncologists and radiation oncologists together in the same place to be able to to provide care without somebody having to schlep all the way around, and also so that our doctors don’t end up contradicting one another.

“We built the same principles into the new cardiovascular center, but to an even greater degree. It’s a 136-bed inpatient unit. All the beds are private, and every room, including ICU units, allow family members to sleep in the room with patients, which has made us a leader in the mission of family-centered care. With those 136 beds, and the other 50 med surg beds we have in the tower, and about another 100 beds in

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Exergen Corporation:31MAY

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INDUSTRY INSIGHT

Renewing the oldest vital sign

BY FRANCESCO POMPEI

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ever was known as a vital sign to ancient Egyptians at least 5000 years ago, using the hand as measuring instrument. Galileo invented the first thermometer 500 years ago. Carl Wunderlich, ‘Father of Clinical Thermometry,’ proposed 98.6°F (37°C) as the mean normal temperature 140 years ago.

Until very recently we have been taking patients’ temperatures more or less the same way for more than 100 years, circa 10 billion measurements per year worldwide (approximately half in the US). Can we improve on what we have been doing for thousands of years and countless billions of times? Emphatically yes.

Today’s patient expectations Importantly, today there is a much higher patient expectation of non-invasiveness. After all, the 10 billion temperatures mean a similar number of probe insertions into a body cavity, causing discomfort and unnecessary indignity, as well as some risk of harm. Patients undergoing cancer treatment are grateful for a reprieve from things that hurt, when their temperature is taken with the latest non-invasive methods. It is not uncommon today for a parent to refuse to permit a rectal thermometer to be used on their child.

Non-invasiveness is unachievable if the vital sign lacks the necessary clinical accuracy. The scientific and engineering challenge is to accurately measure the temperature inside, from the outside.

From medical science we have learned that certain external locations have useful properties for ascertaining internal temperature.The ear, for example, has a 50-year history of investigation for thermometry, and in the last 20 years devices developed on this principle have been widely used.

Although perhaps less invasive than older methods, inserting a probe into an ear is not what patients consider non-invasive. Further, there are accuracy problems, particularly with small children.

Back to the future As inventor of much of the ear thermometer technology in use, Exergen was asked by

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Francesco Pompei is founder and CEO of Exergen Corporation, and holds 60 US patents in non-invasive thermometry for medical and industrial applications. Earning BS and MS degrees from MIT, and SM and PhD degrees from Harvard, Pompei also holds an appointment as Research Scholar in the Department of Physics at Harvard in cancer research.

physicians to reconsider non-invasive thermometry, since ear thermometers were not an acceptable solution to the patients’ requirement for non-invasiveness and the clinicians’ requirement for accuracy. Within this context we re-examined the medical science of fever assessment, going back not 50 years, but 5000 years, to the hand on the forehead.

Although never precise enough for clinical accuracy, laying a hand on the forehead provided useful fever indications under certain conditions, and was safe, gentle and a reassuring caress for the patient. Preserving these desir-

able attributes while making the measurement robust and reliably accurate for clinical use for all ages was the challenge. Our mathematical models indicated we needed to find an easily accessible external skin surface with high and consistent perfusion. We found this property at the superficial temporal artery, where it traverses the forehead. A measurement modality was developed based on scanning the temperature of the skin over the temporal artery, and with proprietary algorithms we could then accurately compute the internal core temperature, for all ages, under essentially all clinical conditions.

In the past five years Temporal Artery Thermometry has become widely accepted and is resp0nsible for about 0.5 billion temperatures per year by medical professionals in the US, a very good start in reducing the number of probe insertions into body cavities and improving the clinical experience for both patients and clinicians. About two million consumers have home versions for their personal use.

Future with zero cost and zero waste An unexpected benefit of Temporal Artery Thermometry is that without insertion into a body cavity there is no requirement for disposable probe covers, and simple wiping is adequate. Thus, future operating budgets for thermometry in institutions using only Temporal Artery Thermometers are zero.

Furthermore, with disposable waste eliminated, the institution contributes significantly to ‘green’ operations, while reducing storage space and handling costs. In the past two years, US institutions have saved approximately $40 million in disposable costs, and 3000 tons in disposable waste. With Temporal Artery Thermometry initial cost is about the same as other thermometry devices available and acquisition cost is usually less than one year of disposables cost, thereby not requiring capital budgeting.

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SPECIAL FEATURE

How pharmaceutical companies influence patient groups to create a grassroots demand for their products. By Natalie Brandweiner

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stroturfing is a term first used by former US Senator Lloyd Bentsen that has come to be known as the imitating or faking of popular opinion or behavior. Within the pharmaceutical industry, it is the name given to the behind-the-scenes funding of prominent patient representative groups by some pharmaceutical companies, which has been deemed as unethical by the Public Relations Society of America.

Such close-knit relationships between drug companies and patient groups throws the integrity of both parties into question, and may be accused of creating a false grassroots demand for drugs, hence the term. But should the drug firms bear the brunt of all the negative press, or should patient groups be dealt just as much responsibility for accepting their funding?

There are very few patient groups that are transparent about their funding: how much they get and the how they arrived at that figure.

Non-profit organizations are not required by law to outline the sources of their funding or how much they may be storing in their kitty. It’s only through careful examination of tax returns and annual reports that detailed figures can be arrived at.

As representatives of those affected by certain diseases, the function of patient groups is to offer support to the American public, with the patients as their primary concern, campaigning for treatments and sitting on advisory committees. Some patient groups are large and powerful, but many are small and are subject to the financial and lobbying restrictions placed upon all public charities. For those with little or no lobbying power and only a small membership in tow, there is a perhaps understandable temptation to accept the readily available funds from pharma companies to help fund their activities and prolong their existence.

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THE GRASS IS ALWAYS GREENER And why shouldn’t the drug companies seize upon these opportunities? They are looking to make a profit like any other business, after all their stock price on Wall Street will always be among their primary concerns. By filtering their marketing message into patient groups, drug firms can reach the public in a very effective way.

The criticism of this being that many Americans place their trust in the groups they believe are representing them, and have limited awareness that a group’s agendas and actions may be influenced by its ties to a pharmaceutical company.

The timing of the donations is often carefully planned by the drug companies to coincide with their marketing strategies. For example, Pfizer was a major fund provider to the Restless Leg Syndrome Foundation in 2003 and 2004. However, after the company announced plans to stop manufacturing its candidate RLS drug in July 2004, all donations to the patient group stopped abruptly.

Influence A study undertaken by the New Scientist in 2007 to investigate the extent of influence by drug firms on patient groups attempted to find out exactly how many dollars were being used to buy marketing power. In certain cases, the donation funds were huge; the American Heart Association, for example, was found to have received more than $23 million from drug companies.

The study found that in total, seven groups received more than 20 percent of their funding from drug firms: the Depression and Bipolar Support Alliance, the Restless Leg Syndrome Foundation, Children and Adults with Attention Deficit/Hyperactivity Disorder, Child and Adolescent Bipolar Foundation, C3: Colorectal Cancer Coalition, the Narcolepsy Network and the Hypertrophic Cardiomyopathy Association.

One group that caused much ethical outrage over its relationship to pharmaceutical

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the HRT market. Following NIH’s announcement, welcomed by women’s health and consumer groups across the globe, Wyeth’s share prices dropped dramatically and affected them so much that they called in lawyers to file a classaction lawsuit against the NIH.

Controversy

“Many Americans place their trust in the groups they believe are representing them, and have limited awareness that a group’s agendas and actions may be influenced by its ties to a pharmaceutical company” companies was the Depression and Bipolar Support Alliance in the UK. Allegations of disease mongering were made following the revelation that the patient group had received more than half of its funding from the industry. The group remained vague about the exact figures, but when annual reports and tax return figures were combined, the amount was found to be equal to 77 percent of its revenue.

One example of this that caused most outrage is the Society for Women’s Health Research (SWHR) and its connection with the drug firm, Wyeth. In July 2002, the National

Institutes of Health (NIH) announced its abandonment of the study of the effects of Prempro, the market-leading hormone replacement therapy (HRT) drug, produced by Wyeth. The study was expected to last eight years and to produce glowing reports of HRT, but after only five years of clinical trials, the NIH announced it had secured enough evidence to deem the drug a health risk to women who use the drug over a long period of time.

The HRT drug was one of Wyeth’s most important drugs, earning them $900 million annually in sales and holding a 70 percent share of

However, the controversy surrounding the drug came not because of the filed lawsuit, but because of the support for the drug from the SWHR, who condemned the NIH’s decision and distributed letters to newspapers across the country in support of Wyeth. When Washington Monthly news journalist Alicia Mundy investigated SWHR’s support of Wyeth, she found that although the company is represented on the group’s corporate advisory board, the patient group’s funding details remain obscure.

Doubt about the transparency of SWHR’s support of the drug deepened further with the knowledge that Wyeth is a corporate sponsor of the patient group’s annual fundraising ball at the Washington Ritz Carlton.

The questions that surround such partnerships center on the amount of influence gained by such funding, and whether this affects what the patient groups do. Many patient groups are charged with producing treatment information, which could obviously be influenced by which pharma company is funding them and what drug it is marketing.

However, are the drug companies really all to blame for the controversial astroturfing? Just as the funding provides the pharma firms with influence, it also brings significant benefits for the patient groups. Some groups argue that without the funding, they would be unable to operate, and with the additional funds they are able to serve more patients than if they excluded drug firms altogether.

However, many critics claim that even if the level of transparency of a patient group is extremely high, it still loses its claim to objectivity and cannot properly represent its patient group if it receives funding from a specific group, pharma or not.

If funding of patient groups by pharmaceutical companies is to continue, there should be transparency around how much is given to which groups, and patients should demand full disclosure before placing their trust in any association supposedly advocating on their behalf. n

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DIAGNOSTICS

At the edge of innovative care

EHM talks to Andrew Warshaw of Massachusetts General Hospital about the importance of minimally invasive techniques in diagnosing pancreatic cancer.

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man of multiple layers, Andrew Warshaw is not just a surgeon. He spent nearly four decades in the area of academic surgery, focusing specifically on pancreatic diseases and using his findings in his academic writing and mentoring faculty. As a faculty member at MGH since 1972, his focus has been pancreatic cancer, and he has watched as the field has dramatically changed, owing to new tools to investigate the disease.

“When I started we didn’t have CT, ultrasound, ERCP or any kind of invasive measures of evaluating the pancreas. All of that has come

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in and allowed us to increase our knowledge of pancreatic diseases exponentially. That has then led to the development of new techniques, new understanding about disease processes and increased safety,” Warshaw explains.

He points to the example of a Whipple operation for pancreatic cancer producing statistics of a 25 percent mortality rate in the 1970s and the contrast of that to 2009, where it now has a two percent mortality rate with a higher number of patients treated each year.

One operation that Warshaw developed himself is the middle segment pancreatectomy; there is now much more laparoscopic

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work done around the pancreas and Warshaw and his team have developed a whole new field of understanding of the pancreatic cystic neoplasms and the development of these into cancer. In the 1970s, pancreatic tumors were still not understood as a separate group of pancreatic tumors.

Research “My laboratory concentrated for the first 20 years on understanding the pathogenesis and mechanisms, and so the treatment of pancreatitis has now switched entirely to pancreatic neoplasms, and the research world has become a world of molecular biology and cellular biology. We’re trying to understand the cellular machinery that makes the cancer in the pancreas. We’ve got wonderful young scientists who understand much more than I do now about the basic genetics, genomic, and proteomics of pancreatic cancer and we’re trying to figure out how to deal with it at that level, not just at the surgical level.

The development of the middle segment pancreatectomy was first done in the MGH in 1998, the previous method before that time being either a distal pancreatectomy or a Whipple operation, depending on which side the tumor was located.

“Very often the tumor sits in the middle or close to the middle and it’s very wasteful to throw away a lot of good, normal pancreas to get a small benign tumor out. We asked the question, ‘Why do we have to do that?’ and decided that rather than using the previous method, we would take out a slice, a segment in the middle instead that gets rid of the tumor, and then it becomes a matter of how do you put things back together?

“You can’t reattach the two remaining pieces of the pancreas, so we sewed up the one on the head of the pancreas side, the right, and brought a loop of intestine up to give drainage to the remaining body and tail, and that works. Now we’re doing an increasing number of those, especially as we’re finding more appropriate tumors to do it for, such as cystic tumors and neuroendocrine tumors. We probably do 30 or 40 a year now of those, which didn’t exist 10 years ago,” explains Warshaw.

directions. In the pancreas, the distal left-sided pancreatectomy is commonly done with a laparoscopic technique. There are people in the world who’ve done Whipples laparoscopically. From my point of view that’s overkill and foolish and perhaps even dangerous, and serves no real advantage.

“In other areas, laparoscopic colosesectomy took the world by storm in 1990 and now the laparoscopic techniques are pretty routine for colectomy. They’re being advanced for esophagectomy and a number of other inter-abdominal types of resections and repairs.

“The next generation of minimally invasive approaches is endoluminal. Whether it’s fixing the gastroesophageal reflux by going down the esophagus and using one of a variety of techniques that are being developed or actually going through the wall of either the stomach or the esophagus, or coming up from the other end, the colon, the rectum or even the vagina, people are using natural orifice transluminal endoscopic

“As soon as you have competing approaches, it’s good to have experts from each of those come to a consensus about treatment”

Invasive techniques MGH’s minimally invasive techniques have produced huge benefits to patients over the past 40 years; by saving more pancreatic tissue, there is a far lower risk of patients developing diabetes.

Warshaw also used invasive techniques when he developed laparoscopy for staging pancreatic cancer in the early 1980s, allowing physicians to look for potential metastatic lesions that didn’t show up on CAT scans.

Since then, the department has streamlined this technique further to define which patients it is appropriate for, and in the next phase development, the team expanded approaches to treatment, not just diagnosis or staging. “We’ve developed treatments in a number of

surgery. So nothing through the skin but only through these natural orifices.”

This approach is very much a throwback to early experimental approaches to surgery. MGH is highly involved in this technique, and it is currently in its developmental phase. However, the extent of this development is dependent not only on new techniques and instruments, but also on the knowledge and definition of what are the appropriate operations to be carried out. “We don’t yet know the advantage of doing something such as this and what the added risk of infection will be. That’s a very early, potentially exciting area that we’ve been working on here. One of my division chiefs is highly involved in that with a group of colleagues in the lab.

“There’s a potential danger that one hopes that people don’t do something in a minimally invasive way because they can, rather than because it’s the best way, but there are sometimes even economic drivers. Back in 1990 what drove laparoscopic colosesectory was a marketing explosion. Why would you want to have an open operation when you could do it laparoscopically?

Advantage “It turns out that that was perfectly correct but sometimes you have to be able to show an advantage. If there’s an advantage in terms of safety or an advantage in terms of length of hospitalization, or an advantage in terms of injury to the body or scars, then you can justify it. Some-

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treatment. If it isn’t strictly cookie cutter, it’s good to be able to come to a consensus about treatment for individual patients, and not have patients have to run from my office today to somebody else’s office across town tomorrow or the next day.

“If you get everybody together and you make a consensus decision after hearing the same discussion, there are great benefits to that. A real paradigm to that has been when the multi-disciplinary breast clinics have become the state of the art in managing breast disease, at least in an institution like this.

“However, there is a big drawback. For the individual physician participant, it can be horribly inefficient. The difference between my seeing however many patients an hour I can see in my office versus sitting in the multi-disciplinary clinic doing one patient an hour and hearing a lot of things that I perhaps didn’t need to hear or didn’t contribute, it’s a time sink from that point of view. The balance is what’s better for the patient versus what’s better for the physician and I think that the multi-disciplinary clinics for the right sorts of disease processes are, at least in an institution like this, valued,” explains Warshaw.

Patient care Andrew Warshaw is a graduate of Harvard College and of Harvard Medical School. His residency training was at Massachusetts General Hospital. He also spent two years as a Clinical Associate in the Section on Gastroenterology of the National Institutes of Health. Since 1972, he has been on the staff at the Massachusetts General Hospital and the faculty of Harvard Medical School. In 1987, he became Professor of Surgery at Harvard and in 1997, the W. Gerald Austen Professor of Surgery, Surgeon-in-Chief and Chairman of the Department of Surgery at the Massachusetts General Hospital.

times people do because they can. The mountain is there so you climb it. We’re obligated on all of these to test the cost benefit ratio of any of these putative advances,” he says.

More and more invasive techniques are being used, and used correctly. Warshaw notes that as new technologies are developed, more can be achieved than was ever envisioned. His division is particularly keen on using a multi-disciplinary approach to various treatments, and the benefits have been far reaching.

“Increasingly in a number of disease processes, there may be benefits to more than one modality of treatment; for example, surgery plus radiation or surgery plus chemotherapy or surgery plus chemotherapy and radiation, or alternatively chemotherapy or radiation and not surgery. So the multi-disciplinary approach often benefits cancer in particular – although it’s also true for inflammatory bowel disease, ulcerative colitis and Crohn’s disease.

“As soon as you have competing approaches or competing technologies or complementary approaches, it’s good to have the proponents and experts from each of those to have a consensus about

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Ascertaining the correct balance between the needs of the patient and the efficiency needed by the physician is something that MGH certainly pride itself on. According to its own survey, 99 percent of patients say they would recommend MGH general surgery to a friend or family member, and the hosptial seems to be striking the balance. Warshaw attributes these glowing results to the ‘MGH culture’ of placing great value upon the personal relationship between the patient and physician.

“MGH is not a factory or a clinic model. It’s a personal physician model, and we as surgeons get personal with our patients”

“MGH is not a factory or, in a pejorative sense, a clinic model. It’s a personal physician model and we as surgeons get personal with our patients. We make a relationship, maintain a relationship, and people look at us as their doctors. It’s quite usual for patients to come from long distances, not just the local region, and we treat a lot of people from out of region or even out of state or out of country,” he says.

The clinic’s treatment of the patient does not simply end with the closing stitches of the operation. Its doctors pride themselves on maintaining a long-established relationship with each individual patient, and it is this quality that differentiates it as a healthcare institution. n

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EPIDEMIOLOGY

WAGING

A WAR ON GERMS

The incidence of hospital-acquired infections may not be on the rise, but awareness of it certainly is. Trish Perl outlines the Johns Hopkins Hospital’s strategies to keep healthcare-acquired infections in check.

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ith the increased interest in healthcare-associated infections, HAIs there is improved surveillance, but what is not clear to us is if we’re seeing increased infections or if we have enhanced case ascertainment. With some of the changes that we’re seeing within public reporting, we will soon be in a position to monitor this. It can be easy for people to say, “Our patients are sicker,” and it may be true, but it also may be an excuse.

Prevention What is important in terms of prevention of infections and prevention of acquisition of resistant organisms, or epidemiologically significant organisms, are hand hygiene and the use of isolation precautions: barrier precautions and cohorting. We look for the organizms and we measure them so that we can understand the problem; we have a very active surveillance program.

We focus on cleaning the environment, and cleaning the whole interaction between patient and environment. We are interested in promoting immunization programs that prevent transmission primarily of respiratory diseases, but also other diseases where appropriate.

We put a lot of focus on getting our healthcare workers vaccinated against influenza, measles, mumps, rubella and chicken pox – all of these important vaccines.

How do we actually make those things happen? We do a lot of education. I’ve become very interested in marketing and I’ve realized it’s a very

important part of what we do. We used to have tiny posters, but now they are much bigger. We use posters to present data and get our message out, and communicate at a visceral level. Building these elaborate communications marketing campaigns has been very, very effective.

The final thing that has been key is behavioral change. This has been driven by a number of groups, including the intensive involvement of leadership – getting them engaged so that you have programs in place to support your interventions. It’s great for us to have a hand hygiene campaign and we can have posters all over the place, but if we don’t have enough dispensers so people can make sure their hands are clean, it won’t happen. You need to have all of these pieces together to facilitate the behaviors you want to occur.

Bundling up The concept of central line bundles focuses around fi ve evidencebased procedures. Most of this was known as long as 20 years ago, but it has been packaged in a way that makes it easier to understand.

We told healthcare workers, “We want you to do fi ve things when you put in central lines. We want you to clean the skin with the right disinfection and we want you to use it the right way. We want you to wash your hands or clean your hands. We want you to use sterile drapes and keep the field sterile. We want you to take catheters out when you don’t need them anymore. And we want you to use sites that are less likely to get infected.”

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These are five things that even a three-year-old would understand, and it was getting people to focus as opposed to handing them a cumbersome guideline. We learned a lot from this process. We learned that you had to have a cart with all the equipment because people wouldn’t do it if the equipment wasn’t available. Everyone would promise that the equipment would be available but it never was. These are the kinds of things you need to work out when you’re trying to make things work efficiently.

Our hand hygiene initiative grew out of the interest in multi-drug-resistant organisms. It has been very helpful to have so much focus on that in the lay press, because this creates pressure from the outside. The woman who developed the campaign, Hanan Aboumatar, worked with a communications group in the School of Public Health and helped develop a campaign where there was a lot of buy-in from healthcare workers.

We worked on measurement. We have a standard measuring device and then we went out and started measuring, and feeding the data back, and then we went into the denial phase where everybody said, “We don’t like your measurement. We don’t believe what you’re finding,” and so we had to walk through that and start getting people to buy into it. Since then, we’ve developed it even further, and Hanan has developed a web-based program so you can get instant feedback on the hand hygiene rates in the department. It’s very elegant.

In order to have effective intervention, you need to have the knowledge, attitudes and beliefs when teaching people about hand hygiene. You educate them about it and you work on changing their attitudes and beliefs. You need to facilitate it so that you have enough hand hygiene dispensers, as well as posters and reminders. People

don’t usually fail to wash their hands because they’re sitting there thinking, “I’m not going to wash my hands and I’m going to purposely spread bacteria from one person to another.” It’s usually that they’re doing 800 things and they forget, so you have to have the reminders in place.

Then you have to have reinforcement, and that includes support from leadership. It includes having feedback of data. We now have a campaign in which we celebrate the groups that have done a really good job.

We even sent out letters to a couple of groups that hadn’t improved their rates and said, “All right, you guys really need to ante up at this point. We’re looking at this and you aren’t going anywhere.”

This caused a lot of angry emails and phone calls, but the result is that now they’re doing it.

“There is a lot that we need to take forward that we’ve done very well over the years, but we do need to rethink some of it and make sure we are responding to a changing world”

Incentives

For a lot of the campaigns, more and more of what I’m seeing at this institution is the use of incentives. A couple of departments have said that the first unit that gets its rates up over 75 percent compliance for three months, gets a $2500 prize. Even at the executive level, we’re seeing a trend toward incentivizing pay for safety goals as well as financial goals.

These incentives are an important culture change that I’m seeing in at least our institution. We have always valued safety but now we’re putting our money where our mouths are, which is very important. You can feel it in the pulse of the organization and the healthcare workers. They can see that leadership is doing something about it.

Trying to look at novel ways to solve problems is very important. It has been a real paradigm shift in how we work – we’ve moved from a ‘woe Trish Perl is Director of Hospital Epidemiology and Infection is me’ department where we complain Control, and Hospital Epidemiologist at the Johns Hopkins about not having enough resources to Hospital. She is also a Professor in the Departments of being much more proactive. That’s Medicine (Infectious Diseases) and Pathology at Johns how you become a leader.

Hopkins University School of Medicine in Baltimore, The other thing that’s been very Maryland, and in the Department of Epidemiology at the important, especially in a research Bloomberg School of Hygiene at Johns Hopkins University. organization, like ours, is to do novel Perl has been a principal and co-principal investigator research. It’s a much more complex for studies on healthcare-associated infections and world than it was 20 years ago and to antimicrobial resistance for the Centers for Disease Control think that the techniques used then and Prevention. Her scientific interests encompass avian will be adequate today is like being influenza and pandemic influenza planning, surgical an ostrich and putting your head in site infections, emerging infection prevention and the sand. There is a lot that we need interventions to prevent healthcare-associated infections to take forward that we’ve done very and epidemiologically significant organisms, bioterrorism well over the years, but we do need to preparedness, and patient and healthcare worker safety. rethink some of it and make sure we are responding to a changing world. n

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EPIDEMIOLOGY

Infection control

With over 25 years of experience in the management of healthcare associations, Kathy Warye more than qualifies for the job of Executive Director of the Association for Professionals in Infection Control and Epidemiology.

Rather than emerging into the industry from a clinical profession, Warye entered it via a management perspective to tackle the issue of infection control.

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here is debate about whether hospital-acquired infections are on the rise, or whether we are just more aware of them. There are, however, several things that are not in dispute, as Warye explains, “We have an increasing degree of antibiotic resistance. When you look at the whole group of infections that have become multi-drug resistant – MRSA, C difficile and Acinetobacter baumannii – there are no antibiotics that will treat them, so when you have a declining arsenal of treatments and antibiotics, you’re going to see an increase in those infections.

The resistance is due in great part to our overuse and misuse of antibiotics over a very long period of time,” she explains.

Warye says the lack of resources in infection control poses the greatest challenge in the debate: “There is a misunderstanding on the part of many healthcare executives around the cost of the infection.

So often when our members want to implement even an intervention that is pennies in comparison to what the institution spends otherwise to undertake some sort of infection prevention intervention, the answer is no because they’re viewed as a cost center, and it’s more cost. And what that tells us is that those executives don’t appreciate the huge sums of money they’re spending on treating and controlling those infections after they’ve occurred.”

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Savings

Kathy Warye joined the Association for Professionals in Infection Control and Epidemiology (APIC) in March of 2004 as Executive Director. Prior to joining APIC, Warye served as Senior Vice President, Education and Government Relations with the Association for the Advancement of Medical Instrumentation.

Studies have suggested that the fi ve percent of patients with healthcare-associated infections (HAIs) erode the bottom line by millions of dollars in the average institution, displaying the inconsistency between what the intervention costs and the dollars that will be saved by avoiding those infections. As Warye explains, “Along with the shift to prevention, we’ve got to shift the mindset of healthcare executives from infection control as a cost center to infection prevention being one of their partners in profitability. That is one of our biggest obstacles, and dispelling that “The Department of Health and Human Services (HHS) has remyth has proven to be a very hard thing to do.” cently launched a plan for nationwide reduction of HAIs, and APIC As a non-lobbyist organization, APIC operates via its established has been very instrumental in helping to guide HHS in that effort in relationships with other organizations, and through producing simple identifying which infections are appropriate and what the appropriyet in formative guidelines for its members. “We work very closely ate targets and measures are. So our relationship with government with the Centers for Disease Control and Prevention (CDC), who issue is very strong. They released a plan recently for public comment, and scientific guidelines for the prevention of infection that are highly if they’re able to maintain the resources behind this, that emphasis scientific and technical in nature. They can run into the hundreds of and the intensity of the interest on the part of our federal agencies in pages with hundreds of references. That kind of reference may be fine seeing HAIs decline will help move the needle. for someone in a big academic medical center who can translate it into “However, unless there are the resources to do it, we may find action, but most of our members appreciate APIC’s ability to drill down that that optimistic point of view is not realized. As far as Obama in and extract specific implementation strategies from those guidelines. particular is concerned, he and his administration will be very supFor example, giving them information such as fi ve key things you need portive of this initiative that HHS began last fall. We will probably see to do to reduce MRSA, or saying here are the fi ve things you need to do some sort of federal legislation around the public reporting of HAIs, consistently to reduce C difficile.” that’s inevitable. Obama was a co-signer of the very first piece of HAI “We produce what we call ‘elimination guides’ that translate those reporting legislation that was signed in the US – in Illinois when he CDC guidelines into more bedside practice that is easier implemented,” was a state senator – and there are several bills at the federal level Warye says. “That’s one of the things we bring to the community. You that are pending. have CDC producing these guidelines, and the “He has shown a sincere interest in imSociety for Healthcare Epidemiology of America proving patient safety and perhaps believes NUMBER OF (SHEA), which recently published a document that transparency is one path to that. So we’re PATIENTS WITH HAI that helps to translate the guidelines as well, watching the federal level very closely. On the collecting all of the scientific references around other hand, with our economic situation and HAIs into one place. This is helpful, but it still the challenges we’re facing as a nation in gendidn’t drill down into the more implementationeral, it could be that this moves more slowly based, ICP-based types of strategies – that’s than it would have under other circumstances,” where APIC comes into play. says Warye.

“We also support the work of the Institute As APIC’s Executive Director, Warye confor Healthcare Improvement. They recently tinues her mission of educating the American launched an initiative around urinary tract infecpublic on the importance of infection preventions (UTIs), and APIC’s guide is being promoted tion. She prefers to place responsibility on each very heavily by them as an elimination guide on individual, as opposed to Obama’s governUTIs, as a key resource in helping infection prevention and reducing ment, to help reduce the risk. The information is available out there, those infections. We have a number of collaborative relationships, and Warye believes individual attention to the issue is the key to and I’m very pleased to see the extent to which APIC is able to extend significantly reducing HAIs.  its expertise out into these communities.”

57% Medicare 17% Commercial 14% Medicaid 14% Other

Targets

About APIC

With the new government pledging to reduce the risk of infection, the heat is on for APIC to deliver its services and inform its members of any new changes brought in. When asked if the reduction of such a risk is achievable, Warye says she fully supports Obama’s proposals and believes them to be feasible, although she believes the rate at which such a proposal can become reality is debatable.

APIC’s mission is to improve health and patient safety by reducing risks of infection and other adverse outcomes.

The Association’s more than 12,000 members have primary responsibility for infection prevention, control and hospital epidemiology in healthcare settings around the globe.

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INDUSTRY INSIGHT

CLEANER WATER TO PATIENTS

By Ernest A. Elgin

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ater reaches patients every day. All tap water has the potential to contain harmful micro-organisms. Hospitals with their multitude of sites where water reaches patients, need to implement a comprehensive system to ensure water purity.

Water is a reservoir for micro-organisms that can cause infections amongst patient and visitor populations. The most common are: Legionella pneumophila, Pseudomonas aeruginosa, Stenotrophomonas maltiphilia, Acinetobacter baumannii, and Aspergillus. All are found in potable water.

Hospital-acquired pneumonia is commonly caused by water-borne pathogens. Immuno-compromised patients in hospitals are at the greatest risk of being negatively impacted with increases in morbidity/mortality, prolonged hospital stays, and obviously elevated costs and legal exposure to the hospital for additional care.

Water is clean when it gets to our facility.

True, local municipal water supplies are clean as they leave the source. The issue to manage as a hospital executive is, “What is the quality of the water when it reaches the patient?” There are many variables that have to be considered when evaluating how to maintain the final ‘end-prod-

“Hospital-acquired pneumonia is commonly caused by water-borne pathogens”

uct’ water quality; such as the age, size, renovation, or general construction of the facility.

Current water cleaning systems are comprehensive but do not address all of the scenarios present that enable bio-film formation and therefore enable and proliferate many of the above micro-organisms. Water supplied to hos-

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pitals can be checked and treated at multiple points along the way from onsite water towers to mid-way points along the water lines into specific hospital areas.

The critical consideration is to ensure the quality of the water reaching the patient is at the common end-points, which are within the patient rooms themselves. Common end-points include sinks and showers. Realistically, all water sources with the potential for aerosolization

Only ultra-filtration of water, prior to use, ensures that if any contaminant is present, it is filtered and kept from coming in contact with patients.

Delivering safe water is the primary goal of all of these efforts.This critical filtration step has to come very near the end of the water line itself where it is delivered to the patient to ensure pathogen-free, biologically pure water is reaching the patient.

Often, hospitals have well-structured and supported protocols for ensuring that water

Ernest A. Elgin III is President and CEO of Nephros, Inc. He has spent 20 years of his career within the healthcare industry. Most of his time was spent in product and business development. Products he has guided through R&D and commercialization include surgical, therapeutic and diagnostic devices. His business development work includes licensing, M&A, and providing leadership to large and small organizations.

need to be considered, especially when they are located near susceptible patient populations.

We have a process for ensuring water quality. There are several water system disinfection modalities. Among the more advanced are: thermal shock, chlorination, source filtration, copper-silver ionization and others. All have considerable literature available through manufacturers and clinical studies to prove their efficacy under specific processes. All do a good job treating the water system at a ‘macro’ level.

Even with one of these systems installed, and proper water system cleaning, a hospital cannot guarantee water leaving a tap is 100 percent free of all potential infection-causing bacteria. The complexity of the system virtually ensures that there will always be areas that cannot be cleaned ‘as well’ or treated frequently enough to prevent bacterial formation. It is this formation within the hospital’s water lines that is part of the problem.

reaching immuno-compromised patient areas is given extra scrutiny but without proper ultra-filtration at the sink and shower you cannot be assured you are properly protecting your high-risk patients. Anything less than 100 percent protection means that there is exposure to harmful bacteria that can be passed along to the patient population.

A plan has to ensure the maximum water purity to be effective. Executive management is responsible for patient safety and hospital financial performance. The reduction and ultimate elimination of hospital-acquired infections (HAIs) is an ever-present objective shared by all.

The water supply to any hospital has as its final destination, the patient. When developing a comprehensive HAI program it is critical that the entire system of water supply to the hospital and patient be managed to ensure only safe water reaches the patient from faucets and showers.

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ANESTHESIOLOGY

Feeling the pain Cleveland Clinic’s David Brown talks to EHM about the factors that lead many physicians to misunderstand the true nature of pain.

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ith almost 30 years of experience in the field of anesthesia, David Brown has built up a considerable amount of patient knowledge that allows him to understand pain and the importance of successfully managing pain, in both its acute and chronic forms. As the recently appointed Chair of Cleveland Clinic’s Anesthesiology Institute, Brown’s mission is to change the way in which pain is viewed in order for it to be successfully understood and treated. He believes pain should be regarded as a disease, rather than a symptom.

Brown’s background in pain research has led him to focus on pancreatic cancer, a disease which leads to a relatively short lifespan after diagnosis, yet carries with it a great deal of pain. This has been the basis for Brown’s focus on realigning pain as a disease – a disease that is unquantifiable and that differs in its manifestation in each individual, which makes defining and treating it exceptionally difficult.

“Pain in and of itself is invisible to most imaging tools. If you were doing a laminectomy or something similar, the pain is not visualized, which is why the clinical exam and the clinical setting is so important,” explains Brown.

Diagnosis In order to diagnose pain and determine a patient’s care needs, every aspect of the individual must be diagnosed, from clinical evidence to their lifestyle routine. “The biggest tools we use are cross-sectional imaging, ei-

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ther MRIs or CT scans, as well as some electro diagnostics such as EMGs. Putting together a clinical diagnosis from what the patients have told us in the physical exam, along with the history, is probably the most important,” he says.

Pain that cannot be seen, or that is not the result of any visible wounds, often presents a dilemma to physicians who attempt to understand or diagnose it. Brown notes the relative ease of understanding the pain of patients who have had an abdominal operation where the incision is visible

“There are types of pain that fall into fairly well-defined categories, but every patient must be individualized according to their life setting” and they are in post-operative pain: “There’s a reason for their hurting; it typically is time-limited, and it seems like physicians as well as the general population understand that quite intuitively.

“Let’s change the setting a little bit. Imagine somebody who has had back pain for years, and there are no specific findings on physical examinations or on imaging, yet the pain is very severe. This becomes chronic pain as a disease rather than as a symptom; pain is a biochemical event

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that sometimes cannot be imaged; there are no blood tests that say, ‘this person is in pain,’ and that’s very different than in many other settings in medicine.”

Brown notes that the treatment of pain depends on the setting: “If a person with chronic back pain has had one or two operations, there may be efforts to rehabilitate the patient by physical rehabilitation, getting them active again, and it may take combinations of nerve blocks or it may take a different approach. The patient may need treatment such as neural modulation or the application of some of the advanced tools, often called dorsal column stimulators. With these we apply an electrode in the epidural space and stimulate that to mask some of the pain that they’re currently having, allowing them to become more active.”

Personalized care “A lot of it has to do with getting that patient active again and providing pain care,” Brown continues. Some of it may just be done through getting their sleep back into balance, as well as taking care of the pain with oral meds and getting them active. There are types of pain that fall Cleveland Clinic’s Anesthesiology Institute offers patients care from into fairly well-defined categories, but every patient must be individualan internationally renowned medical staff and dedicated support staff. ized according to their life setting, because the same medications that A wide range of specialties and departments are all dedicated to you might use for a construction worker might not work for someone who improving the quality of care and quality of life for patients. flies an airplane or someone who drives a truck. There’s a lot of individSpecialities and departments include: ual assessment that goes on.”

Such personalized care often takes a lot of time, but this is due to inGeneral anesthesiology – comprehensive services for all nonefficiency rather than anything else. Brown explains that patients are often cardiothoracic subspecies and outpatient surgery subjected to time-consuming experiences of treatment, and are often seen Cardiothoracic anesthesiology – anesthesia and critical care by a number of physicians before they even arrive at the pain management cardiothoracic surgical practice department at Cleveland Clinic. He advises that there are a surprisingly Pediatric anesthesiology – comprehensive anesthesia for children large number of physicians who are unable to understand pain and find Pain management – treatment options for patients with chronic and themselves uncomfortable around patients as a result. “These patients acute pain from disease, surgery or trauma very often have a complicated history, and that initial history and physical Regional practice – anesthesia, pain management and critical care examination need to be detailed enough so that the patient, as well as the medical services for community hospitals physician, have a pretty good idea of which direction they’re heading in Outcomes research – research to provide the evidence for evidenceafter that first meeting.” based anesthesiology Understanding pain is as important for the physician as the patient.

Clinical engineering and information services – anesthesia The clinic has a number of psychologists as well as psychiatrists who spesupport services cialize in pain. The staff consists of both physical medicine rehabilitation physicians, as well as occupational medicine physicians to treat the multidisciplinary specialty that is pain. will help our patients will be able to find physicians that are better trained “We take physicians from a similar background to mine, that can conin a multi-disciplinary approach to pain care,” says Brown. tribute to what we do. We have our palliative care colleagues when patients However, before better diagnosis can be achieved, there is still a subhave cancer pain or other illnesses at the end of life where palliation is the stantial amount of understanding to be developed by patients and physicians, most important thing. Nationally, I chaired and certainly for those physicians attempting to care for patients the Accreditation Council for Graduate on a localized and general level. There is also the challenge facDavid Brown was appointed Medical Education (ACGME), which brings ing patients from insurance companies, who find it difficult to balChair of Cleveland Clinic’s together four specialties: neurology, psychiance the need for the importance of pain management with the Anesthesiology Institute in atry, physical medicine and rehabilitation, so expense that can sometimes come from it.

December 2008, and is due to that we have a unified training program. We Brown predicts that for pain management to become a take up his role in June 2009. worked from 2001 through to 2007 to make much more important issue, and for it to be recognized on a Prior to taking the position at that come to pass, and we’ve improved pain much wider scale, physicians must make sure that there is evCleveland, Brown led the training across the country. We’re not far idence for the treatment that is provided. The most important Department of Anesthesiology from increasing that pain training out from treatment for his patients is to return them to the life they lived and Pain Medicine at The annually to two per year, and we believe that before pain and get them back doing their daily activities. n University of Texas M.D. Anderson Cancer Center. www.executivehm.com

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ASK THE EXPERT

Anesthesiology: Beyond just ‘staffing’ The sophisticated delivery of anesthesiology services has evolved from a simple ‘staffing model’ into a full-fledged ‘service and business partner model’ that can contribute to your facility’s product and bottom line, as Steven M. Gottlieb, President and CEO of Anesthetix Management, explains.

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nesthesiology services in the hospital environment have come a long way since the first drop of ether fell on a towel back in the 1840s. Successful anesthesiology groups have adopted cutting-edge business and service practices, in addition to the latest innovative medical technologies. Why? Because successful hospital executives currently demand it.

Beyond historically provided operating room ‘staffing’, a successful anesthesia group today must apply proven business and clinical ‘best practices’ to ensure consistency of quality outcomes, optimal efficiency and improved hospital revenues with reduced costs. This requires today’s anesthesiologist to serve as a team member (and leader) intimately involved in the coordination of patient care, beginning with the patient pre-assessment process and continuing through patient discharge. Hence, the evolution of the term ‘perioperative physician’. But even more than a ‘perioperative physician’, a successful anesthesiologist today must serve as a hospital’s ‘perioperative partner’.

Perioperative partner As a perioperative partner, today’s anesthesiologist has a responsibility to establish and support proper and timely pre-assessment of the surgical patient. The goal of the preassessment process should be to ‘properly prepare patients for surgery’ in advance of surgery, to avoid surgical case delays and case cancellations – not to obstruct or delay patients from proceeding to surgery.

The pre-assessment process needs to be regularly updated to include the latest peer-reviewed standards, and needs to be consistent among all anesthesia providers within a group.

Timely surgical case starts, rapid surgical case turnover, and optimal OR schedule management can be enhanced and assured by today’s anesthesiologist. Being accountable and working cooperatively to support and/or lead

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With involvement in the satisfaction of your customers, in the time - and cost-efficient management of your staff and resources, and in the development of greater service volumes and new service lines, today’s anesthesiology group has completed its evolution from a mere provider of ‘staffing’ into an invaluable ‘perioperative partner’.

A higher standard

“With the right partner, anesthesiology can go from being a cost center to being a profit center” the team of perioperative providers is essential to achieve this critical goal. These activities not only promote operating suite throughput and surgical case volume, but also often reduce OR nursing overtime costs and improve nursing job satisfaction (as well as patient and surgeon satisfaction). Further, proper anesthetic technique can assure optimal patient postoperative comfort, as well as a shorter recovery period and shorter hospital stay. Not only does this impact a facility’s bottom line directly, but also indirectly via the impact of improved patient and surgeon satisfaction.

Today’s anesthesiologist needs to actively participate in promoting not only the hospital’s surgical services, but also its labor and delivery services. A timely and effective labor epidural program not only grows a labor and delivery service, but enhances a hospital’s reputation and the use of all hospital services – especially since it tends to be the ‘thrilled mom’ who is often making the healthcare decisions for her entire family.

Today, as a hospital executive, you can and should expect more from your anesthesia department. At a minimum, you can anticipate that they will provide the safest anesthesia care possible for your shared patients. You can also expect their attention to your bottom line. This includes: their active interest and participation in the satisfaction of your customers – both surgeons and patients; preoperative assessment plans that work to prevent surgical case delays and cancellations; anesthetic strategies (e.g., postoperative pain management) to improve patient comfort and recovery, decrease complication rates, and reduce hospital lengths of stay; active participation in OR schedule management to promote better OR throughput and the efficient utilization of facility resources; the addition of new service lines (e.g., pain procedures, open heart, bariatrics, diagnostic services), as well as the growth of existing service lines to promote greater patient volumes.

Today, with the right ‘perioperative partner’, you can expect leadership and accountability, service administration, quality management, improved customer satisfaction rates, and, yes, profitability, from your anesthesia department. n Steven M. Gottlieb is President and CEO of Anesthetix Management, LLC. Dr Gottlieb co-founded Anesthetix with the vision of delivering quality anesthesia services in a customer-focused manner that improves the business operations of its hospital and ASC partners nationwide.

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WELLNESS

Clean

living Michael Roizen knew as early as nine years old that he was destined for the world of healthcare.

A home visit from a pediatrician to cure a brief, sudden illness motivated him to take up a career in health, as he tells EHM. 58

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n optimist, Roizen, who is Chief Wellness Officer at Cleveland Clinic, believes in the possibility of great change – in structural reform from the current model of disease care to one of preventative care, a change championed by the new administration in Washington. This is a change so drastic that it has been met in some quarters with great criticism, with opponents claiming that it is an unrealistic policy that cannot be implemented given the funds that would be needed in the current economic climate.

However, Roizen holds firm to the notion

that such a change makes economic, as well as health-related, sense.

“Last year in the United States we spent one out of every six dollars, 16.3 percent of our gross domestic product, on healthcare.

In eight years we’re projected to spend 19.6 percent. That obviously lowers our standard of living and makes us less competitive.

We’re twice as expensive as the 10 developed countries in Europe, not because we’re more expensive per episode of care, but because we have twice the chronic disease.

“If you look at heart disease for people aged 55-65 in Europe it’s 11.4 percent. It’s 21.8 percent in America. If you look at arthri-

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long as we focus on those three areas,” explains Roizen.

Incentives

tis it’s 21.3 percent in Europe, including Great Britain, but it’s something like 53 percent in the United States. If you add all the major chronic diseases up, we’re twice as expensive. There are three things that cause 70 percent of chronic disease in both the United States and Europe: tobacco use, physical inactivity and food choices. Not to criticize sick care – a lot of improvements have been made because of a great sick care system – but it makes more sense and is much less expensive to have great preventative care.

There’s no reason in the United States why we can’t reduce our total healthcare budget by 50 percent, or at least not increase it, as

In order to bring about a system such as this, Roizen proposes that instead of paying physicians solely for treating patients who are ill, incentives – both monetary and otherwise – should be made to favor prevention.

“We need to make people understand that they control the quality and length of their lives, and that they can influence their genes if they want to. It is much less difficult than most people assume,” he says. Cleveland Clinic has begun a program, under the leadership of CEO Toby Cosgrave, to take a tough stance and propel the clinic into the limelight for preventative care, as Roizen explains.

“We have banned smoking on campus, along with offering a free smoking cessation program to the community and our employees, and we will cease hiring smokers. We’ve started with something relatively tough but that was the biggest and most immediate thing.” Cleveland Clinic’s strategy has been successful so far, with nearly 16,000 people in the community quitting smoking, and an additional 4000 employees and 1000 of their dependants quitting.

In order to bring about such a high rate of reduction, Cleveland Clinic initially used two programs. It now has 12, and one of the ways in which it encourages its employees to quit is through the support of family health centers. The practices are run by between three and 20 people, offering internal medicine offices with some sub-specialties distributed in various places in Northeast Ohio, and a few located internationally. There are now smoking cessation programs in 10 of those locations rather than just one at the main site.

The clinic’s main site is a 1300 bed inpatient facility that cares for around two million outpatients a year. Roizen explains, “We did a number of things to encourage smoking cessation at the main site, one of those being reimbursement. “It costs roughly $600 for us to get someone to quit smoking, and most smoking cessations were not covered by health insurance. With our own employees we paid the dollars for it. In most programs the employee has to pay and then gets reimbursed.

“Smoking is a very interesting thing, as are most habits. Most people hold pleasure money in the left pocket and medical money in the right pocket and the two don’t mix. The savings from not buying cigarettes would have easily paid for the program, but the smokers don’t consider those interchangeable pockets. Our method was brilliant because it allowed us to do things that meant all the employees responded very positively.”

This was not the only method Cleveland Clinic used to rid the workplace of toxins.

In the various vending machines located around the clinic, all available snacks were made healthy, with a clear labeling of foods.

Baked chips replaced fried and chocolate bars were made from cocoa and not milk chocolate – with no more than four grams of sugar per bar. Nuts, fruit and fruit drinks were also introduced.

Community care A farmer’s market was started on campus, referred to as ‘community-supported agriculture’, located at the outlying hospitals and sourcing locally grown vegetables for both staff and patients. Roizen notes that for each of the first 5000 visitors

“Last year in the United States we spent one out of every six dollars, 16.3 percent of GDP, on healthcare” to the market, the clinic donated $1 to a community food bank so it could buy fruit and vegetables for people using the communitysupported grocery and food items. “Therefore, although a lot of it was to invest in our employees to help them get healthier, help them walk the walk of health, it was also to invest in patients in our communities and show that we can make this area of the country more competitive, lowering not only our own health costs but the health costs for everybody in our community,” says Roizen.

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The farmer’s market program must certainly make the farmers happy, as the clinic guarantees full sale of all their products: any product not bought by staff is purchased by the hospital’s cafeterias, which use the food over the next few days. The reaction was overwhelmingly positive from patients, employees and the community. Only one negative comment was recorded regarding wheelchair access, which has since been rectified.

Labeling is also a major focus of Cleveland Clinic, in an attempt to meet the peerreviewed criteria they have set, such as decreasing saturated fat and trans fat, and

one side of the line and great tasting food on the other, so that great tasting and healthy could be the same.

“The purpose of the whole program is to allow us to be more competitive for jobs by driving healthcare costs down, and also to enrich the lives of all the people we touch by letting them live longer and healthier lives, with a higher quality of life,” explains Roizen.

There are 21 chronic diseases in which lifestyle changes have a bigger effect than drugs. However, the majority of Americans tend to be quick to take a pill to make themselves well, rather than pursuing a

“We need to make people understand that they control the quality and length of their lives, and that they can influence their genes if they want to” the removal of simple sugars and syrups.

Sales from vending machines fell during the early stages of the healthy criteria implementation, but increased as both patients and staff became used to the changes. The same thing happened with inpatient meals.

“We went through a serious menu makeover and worked with our vendors and within the hospital to break down the line between what most people consider healthy food on

Michael Roizen was named Chief Wellness Officer at Cleveland Clinic in 1997.

Prior to that he was CEO of the Biotechnology Research Corporation of Central New York, before accepting the position of Chair of the Anesthesiology Institute at Cleveland Clinic.

Roizen is also the Cofounder and Chair of RealAge, Inc.

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better lifestyle – eating healthy, exercising and reducing stress levels – and this is why the clinic has responded with a program of lifestyle change. Along with the benefit of a program that is more compelling and fun than a simple dose of medication, there are the added advantages of a less expensive option when avoiding the outcome of treating a chronic disease.

Healthy living Cleveland Clinic’s commitment to providing this healthy program to its staff is displayed by the free access it provides to the Weight Watchers program. “We sent 31,000 full-time employees covered by our health plan, and in six weeks 7200 employees had signed up for Weight Watchers either at work or at an offsite location. In the first four weeks roughly 3000 people lost a little over 12,400 pounds,” says Roizen.

The only criticism of the program came from male participants, who felt overwhelmed by the number of women in attendance compared to men. “As a healthcare

organization my guess is we’re probably 60-70 percent female, so we started some male-only classes in Weight Watchers.”

The impressive results generated by the program have continued with the non-Weight Watcher employees who are encouraged to attend sunrise-sunset yoga classes on campus. There are currently six at the Cleveland Clinic sites, with 47 classes each week and 1000 employees participating.

The clinic has also launched Realage. com, a free website available to everyone with information that can help each individual ingrain themselves with at least one healthy living habit. Roizen explains the purposes of the website, the first being a ‘do-over’: a focus on the good genes that determine a healthy life. He notes that the function of genes is to make proteins, which invariably govern your life, and it is the changing of both the quantity and quality of these genes that can affect your health.

Changing habits “Second, walking 30 minutes a day and calling a buddy after doing so keeps you motivated. Third is to avoid the five aging foods: saturated fat, trans fat, simple sugars, syrups and high fructose corn syrup.

The fourth one is talk to your doctor and see about taking five pills and flossing. The pills are DHA, which is the omega 3 that’s active in the brain. Calcium, magnesium and vitamin D, that’s the second pill; the third pill is a multi-vitamin, the fourth pill is aspirin, and the fifth pill ensures the right amounts of calcium, magnesium and vitamin D are delivered. Flossing is important because the periodontal disease causes inflammation in your arteries and in your immune system, and leads to both heart disease and more serious conditions,” says Roizen.

Cleveland Clinic’s success is found not only in the statistics of pounds lost or the number of people no longer smoking; its employees are demonstrably happier, according to Roizen, and as a result, patients are better served. Employee health costs are also coming down due to healthy employee living. The clinic is consistently rated in the top five best hospitals in the US, so it’s easy to see how employee wellness can make a positive impact. n

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COMPLIANCE

A risky business?

Roy Snell, CEO of the Health Care Compliance Association, talks to EHM about the increasing risks to regulatory compliance.

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ith over 12 years in the compliance and ethics profession, Roy Snell was appointed to CEO of the Health Care Compliance Association (HCCA) following his hand in the founding of the association itself. During the six years of his tenure, Snell has developed the association far beyond expectations, in both its membership and influence.

“We have grown from nothing in 1996 to about 6000 members.

In that time, we have been involved with the enforcement community, particularly the Office of Inspector General, to develop schools people can use to improve their compliance programs. We have set up a certification for compliance professionals that is now required or preferred in 80 percent of organizations in the United States. We also developed a code of conduct for compliance and ethics professionals, and subsequently started an association for compliance professionals from all industries, and we have members from about 20 countries,” says Snell.

Organizational challenges are the biggest problems facing this recent profession in the current climate.

“The biggest challenge is that because compliance and ethics is a new profession, and its programs are new, a lot of people who have very little knowledge and experience are trying to help define the role of compliance and ethics professionals and the function of a compliance and ethics program. These people are putting things into a compliance program that don’t belong. Some are trying to control the evolution of the compliance program to serve their own interests, and if compliance and ethics programs become diluted, they will be less effective. It’s very important that we get these programs defined appropriately and mitigate the influence of those with a lack of knowledge or ulterior motives.

Recession risks In light of the economic recession, many countries are now increasing their regulations, along with the level of enforcement, which could place more pressure on company leaders, with unbeneficial results. “We surveyed our members, and 85 percent believe that the risk of fraud and abuse will increase because of the economic recession. That is because there is greater pressure to perform and some people may make poor decisions and skirt the edges of the law to compensate for the financial pressure they’re under. Our members

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also believe that although few budgets will be cut, many believe that their budgets will not increase to handle the increased pressure that may cause more problems to occur.

“The reason there are more countries with more regulations and more enforcement is because they want to participate in the global economy, and they can’t participate in the global economy as easily if they are found to break the laws of other countries. For instance, the Chinese have been hurt because of the pet food contamination problems and the lead in toys. Even though they may not have regulations against those problems in China, they essentially have to follow the regulations of other countries to whom they sell products, who have regulations with regard to contaminants in food and other products.”

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With so many companies skating close to the regulatory edge in order to cut costs and survive in a difficult economic climate, now is the time for the HCCA to really step up and provide much-supported need to its members.

“We have a code of conduct that helps them tell their management what their roles should be. Our organization certifies compliance and ethics professionals in healthcare through training, and we provide books and videos and tools they can use to improve compliance within their organizations.

“We observe Compliance Week once a year and provide things that compliance and ethics professionals can use to celebrate. We don’t necessarily try to affect the law; our organization doesn’t lobby.

We also don’t get involved in enforcement. Our mission is related to helping those who have the job of ensuring their healthcare organization understands the law and follow the law,” says Snell.

can show this code of ethics to their employers, and it helps the employer understand that what they are saying is their role is the industry standard for the role.

“For instance, it gets into some detail about when a mid-level manager refuses to change something they’re doing to comply with regulations, and it helps them with some suggestions on how to escalate the issue to the proper authorities,” he adds.

The question remains, what does this mean for the future of the HCCA? “We shall continue to grow in membership as more people become certified.

We’ll get more actively involved with providing tools and resources for compliance and ethics professionals to help implement compliance programs in their companies. Because our orRoy Snell is the CEO of the Society of Corporate ganization has now become more inCompliance and Ethics (SCCE) and the Health ternational, we would be interested in Care Compliance Association (HCCA). Snell was working with compliance professionals a co-founder and the organization’s first CEO. He in other countries to help develop speis a former Mayo Clinic administrator, consultant Guidance cific tools and education for them. and compliance officer and has participated in the With predictions about the economy “We hold 50 conferences or workdevelopment of compliance program guidance, being less than optimistic for the next shops each year on compliance. We did professional certification programs and the two years at least, what will this mean one in Switzerland last year, and we’re Compliance Professionals Code of Ethics. for regulatory compliance during this going to do one in Toronto this year. period? Snell advises that a code of We’re interested in providing more ethics has never been so important than training in other countries and in workin the confusion of current times. “The compliance job is extremely ing with the experts in those countries to get the right content,” Snell difficult. Telling people that they have to change the way they’re doing concludes. business to ensure compliance with the law can be a very difficult job, Exciting times lie ahead for the HCCA, as it continues to expand and sometimes you have to tell very powerful people that they can into foreign compliance circles. With the uncertain state of the global or cannot do something. The code of ethics provides them with the industry, the impact of the association could extend far beyond what framework of what the typical compliance professional must do. They it had imagined. n

What is compliance?

Compliance is the process of meeting the expectations of others. More specifically, it is the process of helping healthcare professionals understand and meet the expectations of those who grant money, pay for services and regulate the industry. Healthcare compliance includes numerous issues such as reimbursement, grant accounting, managed care, OSHA and Joint Commission on Accreditation of Healthcare Organizations regulations, licensure and due diligence to prevent and detect violations of the law.

HCCA’s major functions 1. To promote quality compliance programs in healthcare – their introduction, development and maintenance.

2. To provide a forum for interaction and information exchange to enable our members to provide high-quality compliance programs.

3. To create high-quality educational opportunities for those involved with compliance in the healthcare industry.

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HOSPITAL DESIGN

DEATH OF THE SINGLE DESIGNER As one of the most complex of building types, hospital design requires a range of specialists rather than a single architect working alone. Peter Bardwell tells EHM about his experience with the process.

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ospital planning is not simply a process of allotting various high technology clinical spaces. Hospitals also need to include spaces for functions typical of buildings for public assembly, such as lobbies and conference space.

As Peter Bardwell, Past Chair of the AIA Academy of Architecture for Health, explains, in addition to the patient room environment, the hospital must also accommodate commercial establishments, such as food service, gift spaces and other services of that nature. “Office components must also be taken into account, along with space for industrial environments to house sizeable materials. A structured parking facility is needed, particularly in urban hospitals.

“All of these have to be assembled into what I’ll characterize as a cohesive, functional, attractive environment for healthcare delivery. The challenge this presents is taking all of the skill sets associated with

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each of those disparate elements and assembling them into a cohesive environment.”

Regulations “In regard to the design of hospitals, assembling those various subtypes is also a challenge we regularly face. In addition, healthcare here in the US is notable as one of the few building types that is highly regulated. No fewer than 50 different state regulatory bodies are noted for inconsistency in how they require a building to be regulated. It’s subject to changes in federal and state reimbursement policies, and it’s subject to constant change in technology and consumer expectations.

“More importantly, unlike other building types, a hospital is never finished. Many healthcare projects represent the most recent expansion of an established physical plant dating back decades, and even a

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new, free-standing hospital can be expected to expand and change within a very short period of time following its initial occupancy,” explains Bardwell.

The challenge of knowing what requirements must be met from each state is further complicated by the regulations from districts and territories, making a one-size-fits-all approach almost impossible. Each hospital must be specifically designed and tailored to its particular location. In order to implement these ever-changing elements successfully, a large number of people are needed in the design process, although this tends to bring further challenges, with the often impossibility of meeting with the wide range of users and stakeholders during a design effort.

“Nevertheless, we as planners and designers do strive to elicit perspectives from each group during the gestation of the design,” Bardwell says. “We do this through focus groups, community presentations and initial consultations with myriad regulatory bodies along the way. And particularly with what we call user group meetings that typically extend from the programming phase through schematic design and through design development.

Design “Programming, schematic design and design development are typically used designations here in the US. I also use them in other settings around the world. These user group sessions can include literally dozens

“This is the antithesis of the characterization of the designer as a singular genius emerging with a magical moment of the announcement of a solution” upon dozens of hours of contact time between designers and individual department representatives over the course of the planning and design phases. So this is the antithesis of the characterization of the designer as a singular genius emerging with a magical moment of the announcement of a solution. Rather, this is a long period, measured in months or years, of detailed investigation by a multitude of representatives of the design process,

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and a multitude of representatives of room, where you as the caregiver are adthe users along the way,” he says. ministering medications and care to only Understanding individual state reguone patient at a time, and not being dislations and amalgamating different ideas tracted by multiple patients.” between all those involved are not the This has also led to an increase in only difficulties to be considered. Cost efthe single-handed private patient room, fectiveness, flexibility, cleanliness, safety wherein patient rooms are identical and the ability to expand the building rather than mirrored, such that in an must all be taken into account. emergency situation where seconds Bardwell notes that all of the above count, staff know precisely where to are extremely important factors to be find certain switches and medications, considered during the design process, as enhancing safety. This concept is gainis safety. “In the US right now, safety has ing considerable traction in the US, but risen in prominence over the past half it’s criticized for not producing hard evdozen years, in terms of what is spoken idence that has shown to contribute to about and written about. By safety, we the level of safety it is promoting. mean the fact that, depending upon the source you wish to cite, upwards of Cost 100,000 people each year die in hospitals However, security is not the only of maladies that they did not go into the issue of importance within the design Peter Bardwell is the Past Chair of the American hospital to be treated for. This includes a process. It must be compared with cost Institute of Architects Academy of Architecture for variety of hospital-acquired infections or effectiveness, particularly against the inHealth, and was 2008 National President. incorrect medications.” clusion of the cost of single rooms for He explains that the design response every patient. “The proponents argue to this increased need for security is to minimize negative distractions: the that the cost increase is minimal or non-existent, and that any cost inareas where medications are compounded or prepared should be well-lit, crease is minimized through the standardization that is inherent with quiet spaces, “It’s one of the contributors to the rise of the private patient that. From a construction standpoint, you’re actually reducing the unit costs by standardizing. That’s their premise,” explains Bardwell.

“Others state that there is indeed a certain percentage increase in cost, AMERICAN INSTITUTE OF ARCHITECTS but that the long-term reduction in medication errors or other incidents predicts a very quick payback on that initial construction cost. So there are key Based in Washington, DC, the AIA has been a professional outcome measures that include favorable outcomes in staff and physician membership association for licensed architects, emerging recruitment and retention, which are extraordinarily important, and favorprofessionals and allied partners since 1857. able patient satisfaction scores. All of the latter lead to favorable market The AIA aims to serve as the voice of the architecture share numbers, and where consumers have a choice, favorable market profession and a resource for our members in service to share capture is important as well.” society. We carry out our goal through advocacy, One of the ways in which a building can be measured is through the information and community.

Leadership in Energy and Environmental Design (LEED) certification, a Each year the AIA: green building rating system, which was developed by the US Green • Sponsors continuing education experiences to help Building Council. Bardwell points to the Dell Children’s Medical Center in architects maintain their licensure Central Texas as an institution that was built with the LEED process in mind • Sets the industry standard in contract documents from the very beginning.

• Publishes online publications “This was welcomed very much from the design team, and became • Provides web-based resources for emerging architecture a guiding principle for the process. They were looking toward evidenceprofessionals based design and green building technologies, and that’s a concept • Conducts market research and provides analysis of that’s gotten a lot of press over the last half a dozen years. The whole economic factors range of changing reimbursement imperatives has been made more • Hosts the annual AIA National Convention and Design transparent, particularly in those safety outcomes where you want to do Exposition no harm.

• Serves as an advocate of the architecture profession “Evidence-based design, green building technology and changing re• Champions architects’ future through an annual ad imbursement patterns were key guiding principles for Dell Children’s campaign Medical Center. Subsets of those related to the fact that there is now a beginning in this evidence-based design world in which we’re living, that there

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are now initial outcomes being documented to relay that day lighting improves your staff productivity.

“So you have a major initiative now toward the introduction of day lighting into key staff and patient areas, certainly beyond anything that we had previously seen, and that day lighting is favorable to staff recruitment and retention. Dell Children’s Medical Center now has a waiting list for nurses, which is laudable, given the historic shortage of nurses in recent years in the US,” he says.

Carbon Reducing the carbon footprint is a focus of most institutions across society, not just within healthcare, and even if hospitals are not directly seeking LEED certification, they are certainly becoming increasingly environmentally conscious and promoting greener policies.

“Dell Children’s Medical Center achieved the LEED platinum certification, and this provides a great example of how it is possible for a hospital to overcome the fact that the energy and atmosphere requirements for LEED are to some degree contradictory with the 24/7 nature of hospitals,” Bardwell says. He notes the stringent requirements of hospitals in that unlike other built environments, they have to control air changes.

“All of those characteristics run slightly or directly contrary to some of the LEED initiatives. One of the things that Dell benefited from was the existence of a cogeneration plant on the site that allowed them to make millions of dollars in energy savings, and they were able directly to fund some of the additional green initiatives, which was a wonderful serendipity.

“What we will see over the next few years, as this body of evidence from the evidence-based design initiative begins to take hold, is that long-term cost will continue to outweigh short-term construction cost.

This will happen as owners and constructors are sensitized to the fact that short-term gain in reduced construction costs should not pre-empt long-term responsibility to the environment, and long-term measurable dollar or monetary outcomes in savings by making wise decisions that are environmentally responsible,” Bardwell concludes.

The far-reaching regulations, subject to change depending on which state the building is in, puts great strain on architects to not only design within the guidelines, but also to incorporate the ever growing functions of a hospital while leaving room for yet more expansion. With these increasing challenges, it remains to be seen if uniform guidelines, such as LEED, can be incorporated on a federal level. Until that happens, architects will continue to work together to decipher the ambiguous code of hospital design.

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ASK THE EXPERT

A revolution in assisted sleep scoring

By Alexander J. Barr

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omnolyzer 24x7 is the first robust and valid computer-assisted sleep scoring system that really works. It calculates a hypnogram according to Rechtschaffen & Kales and AASM rules from your all-night sleep recordings. It will significantly reduce the time lag between study and scoring completeness, as well as prove to be a significant contributor to the reduction in lab costs and ensuring that your scorings are of consistent quality by eliminating the excessive variability that different experts have among each other. Somnolyzer 24x7 is the new quality standard as a basis for reliable diagnosis worldwide.

As opposed to other automatic scoring programs you might have seen, Somnolyzer 24x7 has a proven performance that makes it indistinguishable from a human expert. It was developed and tested on the largest normative database on healthy and disturbed sleep available worldwide. Given the known variability between and within human scorers, achieving ‘100 percent correct’ scoring is impossible. Instead, Somnolyzer 24x7 has been proven to have the same performance as any human expert when compared to other experts. What counts even more, Somnolyzer 24x7 does not make any systematic errors that would have an influence on subsequent diagnosis. It delivers results you can trust and rely on.

It applies the same rules as any human expert. It first reliably detects all relevant visual features, such as spindles, eye movements, delta waves, etc., and then discriminates between the stages according to what is present in each epoch. This discrimination corresponds to the application of the Rechtschaffen & Kales or AASM rules the way they are applied by expert scorers. Somnolyzer 24x7 works is comprehensively compliant with multiple acquisition systems and software.

We care about quality and thus we ensure that you are getting the best possible result.

Automatic analysis can always fail if the recording is distorted or contains unexpected or unusual events. To prevent meaningless results

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being returned, we filter data for possible error sources and check the results before sending them to you. In some cases, visual correction might be necessary and will be performed by us.

In very rare cases, the recording will have to be returned un-scored.

“Our aim is to guarantee a result within 24 hours after you have sent your data” Our aim is to guarantee a result within 24 hours after you have sent your data. In early stages – when we have not seen many of your recordings – some visual correction might be necessary and thus a response might take longer. However Somnolyzer 24x7 learns and continuously improves! The more recordings you send us, the more we will be able to treat them

fully automatically and thus ensure an even quick response. When the onsite server solution is chosen, results are returned almost instantaneously.

Somnolyzer 24x7 is absolutely safe and treats your data according to international rules of data protection. Data you send always gets anonymized and encrypted. The certificate under which our website is protected ensures that it is only us who get your data, and no one else can read it. Your data are stored only for a few days (allowing you a period during which you can provide us feedback or check on possible problems) and then completely erased.

We will never use your data for anything else other than providing you the results you need, without your explicit approval. The Siesta Group is also prepared and willing to sign off any confidentiality agreements required by your lab organization.

Somnolyzer 24x7 is the most validated computer-assisted solution available today: it aids sleep lab businesses to increase consistency, reduce internal costs and guarantee cycle time reduction from acquisition completion to delivery of final results. n

Alexander J. Barr is Vice President/Director of North American Business for The Siesta Group, which is based in Salisbury, MD. He has 21 years of large corporate management experience, and graduating from Motherwell Technical College, Scotland in 1988 and University of Paisley, Scotland in 1994. He is a certified Six Sigma black belt, and a certified engineer

by ASQ.

SIESTA GROUP AD:mar09 17/03/2009 15:03 Page 69

CARDIOLOGY

HEART’S EASE Jeffrey Moses on how the noninvasive dream is coming true for cardiovascular treatments.

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he Center for Interventional Vascular Therapy (CIVT) grew out of the New York Presbyterian/Columbia University Medical Center’s commitment to establishing a worldclass center for the treatment of cardiovascular disease.

We’re fulfilling this message first of all by attempting to attain excellence in clinical care through recruiting and retaining those we think are the leaders in the field of interventional vascular therapy in all its dimensions, as applied to cardiovascular disease.

We set up care systems that are both patient-friendly and also organized efficiently, trying to incorporate the latest systems in terms of protocol-driven care as well. We work in terms of clinical research, and we’re engaged and have leadership positions in most of the major innovations in this field.

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DEFINITIONS Our group is very creative, and we interact with both researchers and other physicians around the world, testing the most promising therapies in a rigorous way and helping to bring them into the clinic from the earliest stages of development. We work on the educational front by running and being involved with our group in literally dozens of meetings, being course co-directors or having major scientific input in the program content, and speaking on and demonstrating new techniques in live cases.

Those areas are all ingredients to help make us a world-class center. They complement so many of the other services of cardiology here – we have the largest heart transplant program in America, as well as a vigorous and innovative electrophysiology program, and some of the leading cardiac surgeons.

Non-invasive techniques The actual techniques and technology used in the center to treat patients have advanced in many fronts. On the cardiac and coronary side we’ve had major advances in the less-invasive treatment of obstructive coronary disease. Certainly recent studies have justified this in terms of being able to substitute stenting for surgery in a very large segment of the population that previously was considered primarily a surgical province. That’s a good thing, and recent randomized trials have indicated that you can achieve the same result with fewer strokes, shorter length of stay, and a much more pleasant experience for the patient.

We’re working on a big innovation with percutaneous valves, in which we have a major leadership position. We’re installing aortic valves for aortic stenosis in clinical trials that are well-advanced and heading toward completion. That would potentially substitute for open-heart surgery for aortic valves.

“The key for both physicians and patients is knowing that this field involves a lot of cognition and technical skills, and there needs to be a meeting between the two” This is no longer pie in the sky; it’s being widely practiced in Europe, and we are closing in on 100 valves being done here at Columbia alone with this innovative technique, and have a leadership position in a major US trial.

On the structural side, we’re involved in trials looking at closing holes in the heart for prevention of stroke, for eventually substituting for blood thinners in patients who can’t take blood thinners, who have atrial fibrillation, by putting devices in to prevent clotting in the heart.

On the aneurysm forefront we’re expanding the reach of non-surgical treatment of diseases of the aorta and increasing treatment in the cath lab, as catheter-based treatments and in hybrid procedures.

Atrial fibrillation An abnormal heart rhythm involving the two upper chambers of the heart. Can often be identified by taking a pulse and observing that the heartbeats don’t occur at regular intervals. Conclusive indication is the absence of P waves on an electrocardiogram.

Non-invasive A medical procedure in which there is no break in the skin and no contact with mucosa or an internal body cavity beyond a natural body orifice.

Percutaneous Any medical procedure where access to inner organs or other tissue is done via needle-puncture of the skin, rather than by using an approach where inner organs or tissue are exposed.

Stenosis Abnormal narrowing in a blood vessel or other tubular organ.

Stent A tube inserted into a natural passage/conduit in the body to prevent, or counteract, a disease-induced, localized flow constriction. The term may also refer to a tube used to hold such a natural conduit open to allow access for surgery.

On top of that, we’re involved in many new imaging technologies to help advance our understanding of the disease process, applying the imaging so we can more effectively treat the patients as well. There’s an overall move toward more non-surgical techniques; avoiding surgery will always be a good option for the patient.

Research The Cardiovascular Research Foundation has over 100 members and is involved in more than 40 meetings a year. The crown jewel of those meetings is the Transcatheter Cardiovascular Therapeutics conference (TCT), which has well over 11,000 attendees from all corners of the world and involves more than 900 faculty, several thousand lecturers and over 100 live cases during fi ve days of workshops. These workshops include extensive detailed updates on virtually every aspect of minimally invasive and non-surgical treatments of heart disease, with the most current data and innovators.

Alternatively, we also recently ran a meeting focusing on some narrow niches, such as totally occluded arteries, which previously have not been approached in the cath lab, but were sent to surgery. We are involved in developing and exploring and teaching new techniques in opening those, which again expands the venue for these catheter-based treatments as a substitute for surgery.

These are smaller meetings, where just a few physicians will come for a day or two on focused didactic and technical training for

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Jeffrey W. Moses is Professor of Medicine at Columbia University College of Physicians and Surgeons, and Director of the Center for Interventional Vascular Therapy at New York Presbyterian Hospital/Columbia University Medical Center. He is also Director of the Cardiac Catheterization Lab at New York Presbyterian/Columbia. Moses previously held a professorship in Clinical Medicine at New York University School of Medicine, and served in various positions at The New York Hospital, where he became Associate Director of the Adult Cardiac Catheterization Laboratory and Director of Clinical Electrophysiology.

NEW YORK PRESBYTERIAN HOSPITAL The New York Presbyterian, based in New York, is the nation’s largest not-for-profit hospital. It accommodates 2224 beds and provides state-of-the-art inpatient, ambulatory and preventative care in all areas of medicine.

These divisions combined allow New York Presbyterian to provide acute care, long-term care facilities and ambulatory services to its patients; the hospital serves one in four patients in the New York metropolitan area.

CENTER FOR INTERVENTIONAL VASCULAR THERAPY The center was created by the New York Presbyterian/ Columbia University Medical Center, and provides patients with a team of physicians operating in almost every field of cardiovascular medicine.

The center is also affiliated with one of the country’s most esteemed academic institutions, providing patients with access to one of the most notable clinical research programs available in the country. The Cardiovascular Research Foundation (CRF) provides a platform for physicians to learn about the most innovative techniques and technologies in the area of cardiovascular intervention.

The CRF hosts the annual Transcatheter Cardiovascular Therapeutics conference, which attracts more than 11,000 physicians, making it the world’s largest cardiovascular interventional meeting.

COLUMBIA UNIVERSITY MEDICAL CENTER Vital statistics 2008 Academic Schools ................................................................ 4 Budget (FY 2007) ..................................................$1.56 billion Endowment (June 1, 2008) ................................... $1.67 billion Philanthropic gifts ......................................... $200.032 million Endowed chairs ................................................................. 198 Total enrollment, fall 2007 ............................................ 3,4651 Degrees granted, 2007 ....................................................1,422 Full-time faculty .............................................................2,4162 Total faculty ................................................................... 5,4622 Research expenditures, 2007 ........................... $584.8 million Nobel Prizes .............16 in Medicine or Physiology (2 current)

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specific techniques in the cath lab, whether it’s training to study percutaneous valves or learning how to do complex coronary interventions. So we go from 11,000 down to very small meetings for teaching.

In the move toward non-surgical techniques, we’ve had some major triumphs in the field of interventional vascular therapy, but we’ve also been confronted with some setbacks regarding the thrombosis issue in stents. Although not as large as it was thought to be by the headlines, and not an overwhelming problem, it’s still enough of a problem that it limits broader applicability. We’re moving toward the technological responses to that, which will make the current treatments with stenting much safer, and thereby much more effective.

The valve area is potentially transforming: in fi ve years the whole landscape of how patients with heart valve disease are treated is going to be radically changed, if the clinical trials outcomes are what we expect. That’s a big deal. In the endovascular realm, with the noncardiac vessels, we’re going to have a wealth of new evidence in the next few years, which will help us understand and broaden the applications of these non-surgical techniques with evidence; not just with assertion, but with good randomized data.

Advances We will also have some potential advances in stroke prevention with certain devices we’re using, as certain other trials emerge in the next year or two to support their use in certain individuals and help prevent stroke. This is done in several ways, by actually installing devices into the heart.

The key for both physicians and patients is knowing that this field involves a lot of cognition and technical skills, and there needs to be a meeting between the two.

The spread of understanding what the capabilities are, even among the interventional community, is very wide. It’s important if you’re going to get an opinion in this field to make sure you’re dealing with people who have a true understanding of both the capabilities and the limitations of the technique. My adage is that sometimes patients’ needs are dictated by the capabilities of the individual or groups you’re working with, and that shouldn’t be the case. Adopting the broadest potential application of the technology to meet those needs should be the standard. 

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MEDEGEN ADVERTORIAL:31MAY

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ADVERTISING FEATURE

New products help fight infection

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edegen is a leading innovator in infusion therapy, focused on developing product technologies that significantly improve patient safety and outcomes. The rapidly growing company provides clinically superior medical products and components to the medical community through its two operating units: Maximus and KippMed. Maximus develops, manufactures and markets needleless access connectors and other intravenous therapy products for the acute and alternate care markets. KippMed manufactures and markets IV therapy components for the OEM market.

Worldwide leaders in infusion therapy products source IV components from KippMed. With the new federal policy restricting reimbursement for healthcare-associated infections (HAIs), healthcare professionals are seeking technologies to assist in their bloodstream infection prevention efforts. Medegen’s leading product MaxPlus Clear™ and newest product MaxGuard™ are designed to enhance common catheter maintenance practices such as swabbing and flushing, resulting in better outcomes.

MaxPlus Clear™ offers the benefit of a needleless access device designed to assist in

the prevention of common catheter complications such as bloodstream infection and catheter occlusion. These complications typically result from blood reflux in the catheter, poor flushing, and inadequate disinfection of the access port. MaxPlus Clear™ features Medegen’s patented positive displacement technology, which provides a bolus of fluid to clear the catheter tip upon disconnection from the device. It also features Medegen’s patented Tru-Swab® top which features a double sealed barrier to contamination and allows for true disinfection during pre-access swabbing and a clear housing minimizing the occurrence of poor flushing.

With the addition of Agion® antimicrobial technology, MaxGuard™ is an enhancement of the MaxPlus Clear™ connector. MaxGuard™ is the first positive displacement needleless connector featuring impregnation of the antimicrobial additive into each of the components of the device. Laboratory testing demonstrates this new antimicrobial device exhibits a kill rate of greater than 99.99 percent, representing a 4+ log reduction of infection-causing organisms predominantly responsible for catheter-related bloodstream infections. The introduction of MaxGuard™ comes at a time when bloodstream infection rates continue to be a major concern among hospitals.

“Healthcare professionals and facilities are seeking new technologies and practices to assist in their efforts to reduce the occurrence of catheter-related bloodstream infections (CRBSI),” said Jeffrey Goble, President of Medegen. “In addition to the negative impact on the patient, the cost of treating a single CRBSI can reach $56,000 or more according to the CDC and with changes in healthcare reimbursement practices, hospitals are looking for assistance in meeting infection reduction goals. We are very pleased to see the clinicians’fast rate of adoption of MaxPlus Clear™, and more importantly to receive feedback from many hospitals regarding bloodstream infection rate reductions concomitant with use of the MaxPlus Clear device.”

“We are excited to introduce MaxGuard™ and offer hospital clinicians yet another product to help prevent bloodstream infections, improve patient outcomes and reduce costs.”

LifeSync ATE:31MAY

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ASK THE EXPERT

Increasing patient safety Jay Cyr discusses the benefits of using a hospital wireless alarm system.

EHM. How has your facility implemented the LifeSync System?

Jay Cyr. After having some issues dealing with standard reusable ECG lead wires, a combination of alarms issues and other clinical concerns, we identified the LifeSync Wireless ECG System as a potential clinical solution.

We conducted a study of the system that demonstrated we could have improved outcomes, so we rolled the product out to our cardiac medical telemetry unit, cath lab, cardiac ICU and telemetry floors. Being able to use the LifeSync System throughout the continuum of care was a big factor in our decision.

EHM. How has the LifeSync System helped to increase patient safety?

JC. A lot of times with standard leads, the leads dislodge or come off, which can lead to nurses becoming desensitized to some of these audible alarms that are constantly going off.

We had some clinical events that could have resulted in patient harm, but fortunately didn’t, but had we not taken steps to alleviate the problem by implementing the LifeSync System, we felt that it would have resulted in some patient harm in the future. With the LifeSync System, we have seen at least a 50 percent reduction in lead off alarms, improving patient safety.

EHM. How has the LifeSync System helped to improve patient outcomes?

JC. We know that false alarms and lead off alarms have reduced dramatically. The nurses feel confident that the ECG tracing they are receiving is more accurate using the LifeSync System and they have confidence the LeadWear is on the patient where it’s supposed to be. That plays into staff satisfaction but even more importantly into patient satisfaction. Nurses aren’t coming in the middle of night waking patients up to replace leads and electrodes all the time.

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and removed multiple times – just the skin irritation and all the effects that come from that alone were discomforting.

Jay Cyr is Vice President of the Heart & Vascular Center of Excellence at University of Massachusetts Memorial Health Care, and has spent his entire 28 year nursing career in the cardiovascular service area. Jay writes and speaks nationally on issues including Acute Coronary Syndrome and other issues in cardiovascular care.

EHM.How does the LifeSync System help to increase nurse productivity?

JC. Our nurses have become more effective with the LifeSync System. The LifeSync System allows us to put the LeadWear on the patient one time and it remains with the patient for the duration of their stay. So instead of multiple sets of leads and electrodes, it’s just one set of LeadWear and electrodes. We saw improvement in productivity and patient comfort.

Productivity improvements came from not having to run to the room and exchange things often, because with LeadWear the electrodes stay on securely and for a longer period of time.

And for patient comfort, imagine patients having multiple electrodes and lead wires put on

EHM. How has the LifeSync System aided in your early ambulation efforts with cardiac patients?

JC. Cardiac patients, once the procedure is completed, are encouraged to ambulate. From a nursing perspective, we have definitely seen improvements. When the patients get up initially they can be a little unsteady even just moving around the bed. LeadWear and electrodes are more secure than standard leads and electrodes. With standard lead wires, patients had lead wires dangling all over the place, which could present a safety issue.

With LifeSync System, the potential of tripping over dangling wires is gone.

EHM. How has the use of LifeSync’s disposable ECG LeadWear contributed to reductions in your HAI concerns?

JC. Infection control is a factor in patient safety, liability, public reporting and regulatory issues.

The LifeSync Wireless ECG System with its disposable LeadWear has helped us to reduce and maintain a reduction in infection for these most critically ill patients; in particular, the cardiac surgery patients in the ICU. EHM. With improvements in patient safety and nursing productivity, has the LifeSync Wireless ECG System paid for itself in your facility?

JC. From a productivity perspective, with the way nurses are being paid these days, it doesn’t take much to improve their productivity to help offset any minor increase in product cost.

From an infection control perspective, and considering the cost of just one or two infections, as well as the potential for payers not to reimburse for any nosocomial infections – LifeSync is a cost saver. In the long run the return on investment has been several-fold since its introduction.

LIFE SYNC CORP AD:mar09 18/03/2009 14:39 Page 75

In every department, LifeSync wireless = more.

NANCY BROWN v2:mar09 18/03/2009 15:00 Page 76

Leading from the front

Nancy Brown tells EHM’s Natalie Brandweiner about her sense of responsibility and excitement following her recent appointment as CEO of the American Heart Association.

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FEATURE

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s the first female to take office as CEO of the American Heart Association, Nancy Brown has found her recent transition from COO surprisingly smooth, given the current state of the economy and the excitement surrounding the election of the new administration in Washington.

Her role as Chief Executive took effect on January 1, and for Brown, there couldn’t be a more thrilling time to take office: “We’re very excited about the new administration’s focus on health and healthcare, and issues that are important to the AHA.” Brown held the position of COO for seven years, and so is well equipped to lead the association. Being the first female to find herself in such as position has not posed any challenges, she tells me. “One of the things I have treasured in my career is that the association has always given me and other women the opportunity to advance and succeed. I’m certainly very proud to be selected as the first woman to lead the AHA.” As COO, Brown had an established relationship with Cass Wheeler, AHA’s previous CEO, and was influential in bringing about many of the changes he implemented. Wheeler ran the association along the lines of a

“We’ve got to get people to change their lifestyles before they develop risk factors for serious disease” private business, resulting in the streamlining of its operations and an increase in funds. As an integral part of Wheeler’s team, Brown was a part of this strategy and is sure to continue running the organization on such profitable lines. “I’m committed to running the AHA like a business and have a very corporate mentality,” she says.

Maintaining a presence in shaping the direction and the strategic plan for the organization, Brown has had a hand in forming the association’s major decisions from the shadows long before her appointment as CEO. Many of its cause initiatives in the past, such as ‘Go Red for Women’ and the ‘Alliance for a Healthier Generation’, can be attributed to her.

“We are about to announce our new 2020 strategic impact goal, which will guide the work of the organization for the next decade,” Brown says.

“There may be the need to focus resources on newer, higher priority initiatives or activities that come out of that new strategic plan.

“We are committed to being nimble as an organization, allowing our resources to move and support the priorities that we have. In terms of the changes that I’ll make as CEO, one of the things I’ll be doing over the coming weeks and months is connecting with our staff and volunteers from across the AHA to hear their ideas about the future of the organization. I’m very confident about the future of the AHA because we’ve got such terrific volunteer leaders and a great staff team, along with an important mission and strategic goals. It’s extremely important for me to listen to the ideas

others have about the organization as I finalize plans for any near-term changes that I might make.”

Brown’s main focus as CEO is to work very closely alongside the new administration, bringing greater representation to American heart patients, along with highlighting the broader issue of the ever increasing amount numbers of uninsured. Brown aims to do this through the implementation of the 2020 impact goal.

“Our 2020 impact goal seeks to reduce coronary heart disease and stroke risk by 25 percent by the year 2010. We have achieved already the mortality reductions for coronary heart disease and stroke, and we’re making progress on some of the risk factors, but not all of them. This goal will continue to focus on reducing death rates from coronary heart disease and stroke, but a very exciting new component is a focus on improving the cardiovascular health of Americans.

“There does not currently exist a metric for measuring the status of cardiovascular health, and so the volunteer leaders of the AHA, through our science community and our epidemiology council, have created one. We will release a stated goal for the next decade that will hold the organization accountable to having a measurable improvement in the cardiovascular health of Americans by a certain percent.

“This will shift the organization’s thinking very much to prevention. It will also have us focusing on moving people who are at poor health to intermediate health, and people who are at intermediate health to optimal health,” explains Brown.

Preventative care The shift in focus to preventative healthcare has spread across the industry – even finding its way into President Obama’s inaugural speech – and Brown and the AHA are no exception. In September 2008, the AHA released a set of guiding principles for initiating change in the US healthcare system, setting out preventative benefits as an essential component of a healthcare infrastructure.

“For us as an organization, and externally when we think about healthcare and healthcare reform, we’ve got to get people to change their lifestyles before they develop risk factors for serious disease. Just look, for example, at the increase in the numbers of people suffering from obesity and type 2 diabetes. We’re really concerned about that, as are many other organizations and people who care about the status of health.

“If you look at the population as a whole, there are many people who have risk factors for cardiovascular disease – high blood pressure, high cholesterol, they’re obese, they have type 2 diabetes, they’re not exercising – and so the important mix for the AHA will be to continue with our robust disease management offerings to the public to help them manage their risk.

The overall trend for healthcare has to be to focus on the obesity and diabetes rates, but not forgetting about those people who already have significant risk that need to have that risk managed,” says Brown.

In a previous issue of this magazine, Cass Wheeler gave a scathing account of the current system and its hopelessness: “It’s a system not about health, but 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.”

Brown also believes our healthcare system is broken: “The whole system focuses on treating people after they have been diagnosed with a dis-

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search, medical education and clinical training. For example, we hope the covered services will include things that we know are important to preventing cardiovascular disease, like blood pressure, cholesterol and blood sugar monitoring and smoking cessation.

“The fact that this is high on President Obama's radar screen is a really important thing, both for healthcare and for the economy of the US as a whole, because the medical system in this country is currently a drain on the financial wellbeing of the US, and there are ways that that can be turned around,” says Brown.

The correlation between rising unemployment figures and the uninsured is of great concern to Brown. As she explains, “Corporations are having to face tough decisions about how to trim their budgets, so some might find themselves increasing co-pays and deductibles for office visits and prescription drug refills, and some individuals may not feel that that’s something they can afford if they have to make a choice between feeding their

“Our 2020 impact goal seeks to reduce coronary heart disease and stroke risk by 25 percent by the year 2010”

Nancy Brown is CEO of the American Heart Association.

Since 1986, she has worked with the AHA in a variety of roles, including as Metro Detroit Director in the Michigan Affiliate and as the AHA’s Chief Operating Officer. Prior to joining the AHA, Brown served as Director of Development/Deputy Director of the Endowment Campaign for the Michigan Cancer Foundation, and as Special Events Director for Mount Carmel Mercy Hospital in Detroit.

ease, not helping them to prevent it,” she says. Obama’s administration has focused heavily on highlighting prevention as a strategy to underline his new policies, and Brown is fully supportive of Obama as a leader. She notes the rising number of those unable to visit their doctor or fill their prescriptions, due to the economic crisis, and believes this will have a longterm adverse effect on the American healthcare system. “We’ve got to have a new model. We’ve got to focus on prevention and find a way to make our healthcare system economically viable. President Obama and his team will make that a major priority, both because it’s the right thing to do and because it’s an economic issue for the country.”

Providing quality healthcare to uninsured Americans has always been the AHA’s primary aim, Obama or not. However, the new administration’s commitment to preventative services certainly makes it easy for the AHA to work alongside them. “We encourage President Obama and all the decision-makers to support legislation that will help prevent chronic disease, eliminate disparities and expand preventive care, as well as supporting re-

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family or getting their prescriptions refilled. These are things that we have got to get under control for the stability of the healthcare system in the United States.”

Obama has set as his target providing coverage to 46 million uninsured people, and despite much skepticism from within the industry as to the feasibility of reaching this figure, Brown is in full support. “Covering the uninsured has to be a priority, because it fits in with the overall reform of the healthcare system, which ultimately will make the country more financially viable,” she says.

“We’re optimistic that the goal of providing quality, affordable healthcare to the uninsured can be achieved through measures that support a sustained investment in medical research, coverage for existing conditions, health information technologies that will help providers make guidelinebased treatment decisions, as well as the state-based heart disease and stroke prevention programs and other prevention and wellness programs that are in the package.”

Leadership Brown’s debut has come at both a challenging and exciting time. The intrinsic link between the economy and healthcare means she must set the bar high in terms of leadership, and ensure the AHA continues in its success, both as a representative for patients and as a structured organization. “I want to continue the fine tradition of leadership that Cass has displayed in the organization over the past decade. In terms of the mission of the organization, I’ll be making sure that we are well-prepared to focus our resources on achieving the 2020 strategic impact goal, and that will require new expertise in the organization, volunteers and staff.

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“As we look at the external trend that all of us will need to deal with – the economic situation, the global opportunity for the association to have more of a global impact, the changing in the demographics and aging of the population – all of those things will require the AHA to look and act differently moving forward. If you look at just the onset of social media and how we focus on communicating our messages to the public, that will have a dramatic shift in the short and long term. These are all things that we’ll be doing to prepare the organization for the 2020 goal.

“Certainly our work and systems have changed, and healthcare reform will remain a major priority for me, as will the research enterprise of the association, and our advocacy function as well. The other thing that we’ll be very focused on is communication and messaging, and how to get the attention of Americans about the fact that they are creating this lifelong risk for themselves by not caring for themselves when it comes to obesity, type 2 diabetes and managing their weight,” says Brown.

Educating the American public about the dangers of such diseases has always been at the forefront at the AHA, regardless of leadership. The organization has been extremely resourceful in finding different media through which to project its message, recognizing that over time the way in which it reaches the public has changed. Brown explains that during the 1990s, traditional public service announcements were used to edu-

cate the public, which changed to paid advertising in the mid-2000s.

“We are looking at continuing with those more traditional forms of outreach to the public, as well as our ad council campaign, but also adding a lot more social media, trying to engage people that way to care about their risk for heart disease. We have our cause campaigns, ‘Go Red for Women’, ‘Power to End Stroke’, the ‘Alliance for a Healthier Generation’ and our physical activity campaign ‘Start’, which all also engage people in caring about themselves and others, and then of course we have media strategies, celebrity strategies and other forms of media outreach.”

“We’ve also just developed and launched our new global strategic plan. We have a lot of work to do here in the US, but heart disease and stroke are global burdens, and we believe the American Heart Association can play a major role in helping with the global burden of cardiovascular disease. So we’ll be extending the reach of the association even more broadly in the global marketplace than it is today.”

The AHA’s diligent campaign on behalf of the uninsured looks like it’s about to pay off with the arrival of the new administration. The staff in the DC office is engaged with Obama’s team, providing ideas for health IT and funding for medical research. With so much in its favor, now is the time for the AHA to work even harder to reach its goals. n

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ON THE

RECORD

If the new administration has its way, all patient details will be converted to electronic form within five years. Jim Noga of Massachusetts General Hospital and John glaser of Partners HealthCare tell EHM about the programs their institutions have in place to meet this goal.

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ccording to John Glaser, CIO of Partners Healthcare, depending on the statistics you read, the adoption rate of well-developed and robust electronic health records (EHR) among US physicians is about four percent. If you loosen the definition of electronic health record so that it doesn’t include things like decision support, then the adoption rate is about 17 percent. What does this mean for President Obama’s goal to have all patient records available in electronic format within fi ve years?

“We would be hard pressed to bring the four percent up to 100 percent in fi ve years,” says Glaser. “I don’t doubt that we’ll make extraordinary gains, but it’s a guess more than anything else about what percent will have adoption in a fi ve-year period of time. It could be as low as 25 percent or it could be as high as 75 percent; but there are for example 180,000 physician groups in this country with four physicians or fewer, and it will be a challenge for us to bring them all up to full EHR within that period of time.”

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Jim Noga, CIO of Massachusetts General Hospital, one of the founding members of Partners HealthCare along with Brigham and Women’s hospital, agrees with this sentiment, and points out that his institution has worked hard to be ahead of the game. “From an MGH perspective, we’ve been fortunate to start early, and we’re at the 99 percent level among our physicians in terms of use of EHR in the ambulatory environment. Where we still have some work to do is in the acute environment in terms of documentation of progress notes, nursing notes, etc., but we’ve kicked off that initiative.

We will continue to focus and bring that across the line in a timely manner – we’re already targeting the 2011/2012 timeframe to complete that initiative.

“Additionally what’s a bit of a wild card still is understanding the interoperability requirements and how we might communicate with either a regional or national health network or interoperability with personal health records. That is yet to be defined but is expected as part of President Obama’s effort to computerize the nation.”

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Primary focus The computerization of health records has been a big focus in the new government’s healthcare proposals – some say perhaps too much focus. Noga stresses that while EHR is important, there are other aspects that also need to be considered. “The electronic health record forms the core, but in addition to that is a whole effort around process flow initiative; for example, how do you move patients through the system effectively while not compromising quality and safety in terms of admissions and discharges?

“There’s a parallel focus besides the functionality of the EHR that is supporting the practice of medicine of the ambulatory and inpatient environment – plus supporting the research efforts, whether that’s genetics and genomics or personalized medicine – that’s extremely important for the advancement of medicine.”

Glaser agrees: “The outpatient setting and the electronic health record is the right primary focus, because that’s where most of the care occurs, and particularly most of the management of people with chronic disease. But there are also secondary focuses that are important. The hospital setting is important; the ability to do public health biosurveillance is important; the ability to accelerate clinical research of new drugs and new therapies is important.

“Across all of this, the interoperability is important, and then last but not least is the ability to reach out to patients directly through things like personal health records to help them be more actively engaged in their care. But I still think the outpatient is the most important because that’s where the vast majority of care occurs in this country.”

physicians who in the future will be getting all this data from other providers and fundamentally becomes overwhelmed by the amount of data. They might say, ‘There’s too much here; I don’t have time to go through it,’ and so a lot of the value of interoperability will be wasted because there are hundreds of notes.

“They need to be able to pick out the four or five pieces that are the most important to them. We have incentives and workflow to deal with, and privacy to deal with, and the looming challenges to help physicians maximally use this set of data that’s now being exchanged.”

Size does matter Most large hospitals and healthcare institutions have already made strides in the direction of EHR. However, a large percentage of the healthcare community is made up of offices of four physicians or fewer, and it can be more difficult to persuade these smaller entities of the need to take their records online.

“The looming challenge is to help physicians use this set of data that’s now being exchanged” - Jim Noga

Standards Even if all healthcare institutions and physician offices in the country computerize their health records, it doesn’t necessarily mean they’ll be able to exchange information electronically. Individual systems are not always designed to be able to communicate with each other. How can we make this happen?

“What’s important is obviously development and adherence to standards as well as developing the core infrastructure,” Glaser explains. “Two billion of the stimulus package is geared toward some of those efforts, toward developing the office that oversees that infrastructure for developing the interoperability standard.”

“The next set of challenges will be the fact that even though you might be able to interoperate, that doesn’t mean you will interoperate,” says Noga. “There’s a lot of work we have to do with the providers to help them understand why they should do this and what the care gain and the practice will be in sharing data. They do some of that today in the paper world, but obviously the country’s envisioning a lot more.

“There are still privacy issues to wrestle with, which are complicated. For example, there is still a lot of diversity of privacy laws across the states. So if you’re in a small geography like New England with Vermont and New Hampshire and Connecticut and Rhode Island nearby, differences in state law can confuse people about what they can and can’t do.”

Noga also points out that there is another set of looming challenges that some of the research will go to. “An example would be

Jim Noga, CIO at Massachusetts General Hospital

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in the US. If we computerize everyone’s records, how will we tell apart people with the same name?

“I would add that to the list of challenges we have,” says Glaser.

“You don’t have to go too far outside of Massachusetts to have a problem with Mary Smith. If you’re in the Southeast Los Angeles/ Texas area, there are a lot of Hispanic names that are consistent, and if you’re in California many Asian names are quite common. The country has been loathe to assign an identifier for privacy reasons, and there’s some thought that we could use Social Security numbers, but then there is a large immigrant population that doesn’t have a Social Security number.

“I don’t know how we’re going to address this issue. There’s an area of computer science research that is being done to help identify people using matching algorithms. At Partners we have a team of people who look at situations in which the algorithm does a partial match; for example, that this Mary Smith could be the same as that, the ages are two years apart. We have to have people who go look at records and determine whether they really are or are not the same Mary Smith. We’ve no idea how you do that on a national basis.”

Moving around John Glaser, CIO at Partners HealthCare “It is more difficult with the smaller operations,” says Glaser.

“Although clearly the economic stimulus language provides money to them. It says if you’re doing this by 2011 or some of the years after, you can make $40,000 or $50,000, which is a lot of money relative to the expenses. That will clearly help them move in the right direction.

“The other challenge they now face is they say, ‘I’m ready to do this, and I’d like to – who will help me? Who will help me pick the right type of record? Who will help me figure out where to put all the terminals? Who will help me do the workflow stuff?’ All the challenging work that goes on with an implementation.

“If you work at Mass General, Jim’s got a team that can help you do that, but if you’re out in the community, there is no team.

One of the things that is in the legislation is the creation of regional extension centers, which would fund organizations to help those physicians with an effective implementation. Right now, not many of those organizations exist, though there are some. We have some work to do to put these organizations in place so physicians have someone to turn to.

“It’s also a real challenge communicating with that many physician practices to make sure they understand what they have to do to get these funds and what they have to do in order to implement the technology effectively. Many state and national medical societies and state governments are trying to sort through how best to reach everybody.”

Identification required Another challenge facing the introduction of a nationwide EHR system is the fact that currently there is no single patient identifier

Patients are increasingly mobile and often attend different institutions for different aspects of their care. As Noga explains, institutions like MGH are using a number of technologies to support this increasing mobility. “One is the product we call Patient Gateway that is available at all Partners entities. It’s a patient portal into a practice where you can communicate with physicians and where you can request prescription refills, and where visit letters are returned to you.

“I happen to be a patient at a practice that is using Patient Gateway, and I find it very valuable in terms of the asynchronous communications, being able to the day after my visit see my lab results

“It’s a real challenge communicating with that many physician practices to make sure they understand what they have to do to get these funds” - John Glaser

and have my physician push his summary of the visit and follow-up items to me. That’s one way we’re reaching out. We’re not complete with that rollout, we’re in the early stages.

“In the home setting, we have an initiative called Connected Health, which is aimed at helping patients manage either chronic diseases or things like wound management from home. They’re not having to come into a hospital to see the physician; instead they can be monitored and managed remotely. We’re not yet looking at things like the Google Personal Health Record, though we’re watching it carefully.”

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With electronic systems, there can be concerns about data security. MGH and Partners both have initiatives in place to address these concerns. “Our approach to audits has become more and more robust in terms of being able to audit down to the transaction level,” explains Noga.

“On a national level as we look at interoperability, this is something that is going to have to be addressed from a security perspective. We can easily do that within the Partners network; as things become externalized, obviously systems will have to be in place so that people can’t make a request for electronic health information on an individual that would result in a breach. There are still more things that need to go into that as the interoperability standards are developed.”

Partners has begun experimental work looking at algorithms similar to those used by credit card companies to detect suspicious patterns of purchasing. These kinds of algorithms allow you to see whether there are anomalous patterns of access within the systems and to the degree that the algorithms suggest a pattern that’s unusual, to then ask the privacy people to take a look at that and do further diligence if necessary.

MGH offers its patients and staff the ability to review the audit records to see who has looked at their records. Noga says this is important knowledge for people accessing the records, so that they know the capability exists and hopefully it helps them act more responsibly.

Also looking at the decision support to the degree that physicians’ decisions are guided by knowledge of genetic makeup, what types of decision supports are needed, and the other piece – which I hadn’t thought of until it was pointed out to me – is that we are physicians.

“We know how to present our cholesterol results or operative notes, and they can look at them and know what to do based on that. We don’t really know yet how to present 1000 genetic test results so that a physician at a glance can say, ‘Oh, my goodness, this is what we need to do.’

We’ve done some initial work to understand how the EHR is altered by the personalized medicine revolution, and that’s Part A,” continues Glaser.

“Part B is looking at the patient portal and progressively incorporating family history into that. That is obviously a terrific indicator of whether you’re at great risk of cancer or all kinds of other diseases.

Even if we’re not quite sure of your genetic makeup, if there are hot zones in your family then we have a greater risk than not.

“The third part, or Part C, is we have a lot of investigators here at Mass General. We have a large research enterprise and a lot of individuals looking at the genomic basis behind disease or treatment variability. For example, people who are studying bariatric surgery in the weight loss clinic at the Mass General note that if you’re obese and they do the surgery, on average you lose one-third of your weight following the surgery, but sometimes you lose no weight. ‘Sometimes you lose so much weight that you need nutritional supplements for the rest of your life.

Why does the same surgery have such different outcomes? Is there a genetic underpinning there? What we are doing with them is seeing to what degree can we leverage the existing EHR data such that research like that can be done much faster and for a lot less money, and it appears that we can.

“It’s still very exploratory, the genetic and EHR family history research, but nonetheless, we’re getting something we think will be quite common in medical care delivery in about three to five years.

It’s already common in some areas; they’re just some areas of cancer and for kids who are born with genetic anomalies, but it is yet to be broadly part of medicine.”

It’s clear there are many challenges still to be overcome on the route to computerization of patient health records, but with institutions like MGH and Partners HealthCare leading the way, others should soon follow. n

The adoption rate of (EHR) among US physicians is

4%

Getting personal The increasing computerization of health records and the growth of personalized medicine have happened more ore less in tandem. How has the first affected the second?

“We’re spending some time looking at how these issues affect each other,” says Glaser. “One is looking at in the era to come, if we store either all or large portions of your genome along with what they call the proteome, which is the protein expression of the genes, what do we have to do in terms of the data structures that we have underneath the electronic record?

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HEALTHCARE IT When is a national electronic health record system like a railroad? When it faces the same challenges in ensuring all the pieces fit together. Nina Schwenk, VP for Integration and Chair of Mayo Clinic’s IT Committee, explains.

Staying on track

T

he election of an administration with a strong focus on healthcare reform can mean only one thing for Nina Schwenk: a faster, more dynamic system of patient care. President Obama’s proposals to dramatically change the way in which health information is managed require the development of innovative technologies to support them, and as Chair of Mayo Clinic’s IT Committee, Schwenk will be one of hundreds of IT heads in hospitals and associations across the US attempting to implement the administration’s proposed establishment of a National Health Information Exchange.

But at what stage is the technology, and can it realistically cope with an expansion of information flow whilst still keeping patient health records secure? As one of the largest healthcare organizations in the US, Mayo Clinic cares for a high number of patients in several locations, and coordinating an increased flow of information could present challenges for Schwenk and her team.

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Making tracks For President Obama to successfully achieve a transformation of the current electronic medical records (EMR), reform would need to take place across the entire US healthcare infrastructure.

Given the time and funding needed for such a project, is it even possible to implement something of this size, in the current economic climate, even with the delayed passage of the economic stimulus package?

Schwenk advises that how exactly the infrastructure is to be developed is critical, and the creation of a uniform mandate of standards will be the key to successfully achieving a federal EMR system.

Even with the correct implementation of procedures, she notes the challenges that still remain: “We can create more problems and increase the health risks and safety issues because we can’t specifically identify individuals, as we do not have a universal or unique patient identifier in the United States,” she says.

Identification by name only cannot make a successful infrastructure.

Without the creation of determining, specific factors, such as individual patient numbers, there will be a problem of patient differentiation. “If we can’t electronically exchange data, we won’t be able to make sure it’s the right person’s data we’re sending; a unique patient identifier is a key factor that the government will have to introduce. There will also be the need for the creation of a broad incentive to ensure the electronic system or clinical information data exchange follows certain guidelines.

“It’s similar to when we put the railroads in; if there wasn’t a common gauge, we wouldn’t have been able to get the railroad track from one side of the country to the other. We need something similar in healthcare information transfer, because without the standardization, we’re going to be hampered.”

Patient data Mayo Clinic is one of the few organizations that has unified patient medical records in its paper format. “We began this journey in 1907,” Schwenk explains. “If you were a patient seen at any of the sites at Mayo Clinic, for example if you were seen by a cardiologist in one of the hospitals, you were provided with a paper record in a plastic jacket that followed you around everywhere. Such a system doesn’t exist even now in many organizations, but we’ve had that for a long time. So, the tradition for information in a consolidated, integrated manner has been there for a century.”

With patient data at Mayo Clinic already operating at an organized level for a substantial length of time, the blueprint for data handling has been set. The technologies needed to consolidate patient information into digital form have been in the development process for a long time prior to the election of Obama and his subsequent healthcare reforms.

“We began the journey of consolidating and accessing data in an electronic format in the early 1990s, and in 2009 we find ourselves fully digital in the clinic and in the hospital. As a physician, I can see a patient in my office and have access immediately to all their medical data that’s collected in Mayo Clinic’s records via the computer.

All their lab data, their surgical data, their radiology data, their radiology images; their past information all in sequential format.

And this is available for every single patient for me now, both outpatient and inpatient.”

As Schwenk explains, the implementation of an electronic system is beneficial not only in terms of access to medical data, but also in terms of the consolidation of every single patient record. Mayo Clinic’s main site is located in Rochester, Minnesota; its precise situation is in a cornfield, described by Schwenk as “pretty much the middle of nowhere.” However, such a setting does not limit the number of those that are cared for by the Clinic or its influence within healthcare.

Mayo Clinic is the primary employer for the town, and expands its operations outside of Minnesota to care for patients across the US, and even across the globe. “The vast majority of our patients come from our fi ve-state or regional areas, and we do have extra-regional clinics we are affiliated with; it’s called the Mayo Health System, and we now have the ability to electronically share data about those patients with those clinical sites as well,” she explains.

“If a patient is seen in Austin, Minnesota, the Austin physician, their primary care doctor in their community, is able to see all of the data on that patient that may have been provided at Mayo Clinic as a tertiary center. Likewise, I can see that data when I see the patient at Mayo Clinic or any of the health system sites that we are connected with; I can see the data that’s collected there as well. Also, if a patient saw their primary care provider two weeks ago and had tests done, when I see them here two weeks later, I have access to all of that data, so repetition and inefficiency in terms of repetitive testing is unlikely to occur.”

Digital benefits The challenge that the Mayo Health System faces is not necessarily due to limitations within the organization, but rather to incompatibility between systems on a national level. As Schwenk explains, if patients come to the clinic from outside of the Mayo Health System, the lack of a federal uniform system of patient records slows down the processing of data.

“There’s not going to be an automatic sharing of the data because each individual organization is not connected. It’s still very much a manual process. We may fax it, we may give it to them in a paper format, or we can put it on a CD and give it to the patient before they go to their local site. But it doesn’t automatically populate it; somebody has to read it, decipher it and then change the formats to meet those of the electronic medical records of wherever they’re going to be treated.”

The biggest challenge facing Mayo Clinic is the same challenge facing Johns Hopkins Hospital, UCLA Medical Center and all other high-ranking, innovative clinics: without the interoperability or the standards to be automatically exchanging that information, humans have to be intermediaries.

Schwenk explains that the two problems standing in the way of organizing patient data are very different and must be dealt with separately and consecutively: computerizing all health records and then the sharing of this data between institutions. “These are two very different goals. If all health records are computerized, then that’s an advantage to the site that computerized them, but there’s a long gap between computerizing data and then being able to share that data.

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“For example, we have other sites within Mayo Clinic, in Florida and Arizona. Because they have different electronic medical records, we still have to use other means to exchange data. Even within our own system, the standards and the interoperability aren’t there to be automatically shifting data across those lines, and this is often because of the differentiation in products from the different vendors who build the electronic medical records. Even if you give a computerized record to every physician in the United States, it doesn’t mean they’re going to be able to talk to each other, and to me that’s one of the biggest challenges.”

cryptions and that there is enough network security so that somebody can’t hijack the data. The exact storing of the data is also kept in check.

“Having said this, you can put in better security barriers to information theft in the electronic format than in the paper format. But unfortunately, if they break down in the paper format, you’ve lost one person’s record; in the electronic one, once you get in you can steal multiple people’s records. The risk is greater, although the security measures are probably tighter around the electronic data than they ever were in the paper data.

“Monitoring levels of security remains Nina Schwenk is VP for Integration and most important: tracking data, knowing Chair of Mayo Clinic’s IT Committee.

Privacy concerns what data is being viewed by others. ElecSchwenk notes the high value placed tronically we can do that, in the paper reon the protection of individual privacy in the US as another potential cords we couldn’t. Stringent policies are also needed to enforce it problem factor. “Individuals don’t want their information shared and if there are breakages, as well as audit functions to make sure that feel privacy is a human right, and are fighting a form of specifying we’re keeping on top of that. So there are two issues regarding priidentification via a number. The government has therefore put it on vacy: one is hijacking or theft of the data, where technical security the back burner and hasn’t addressed it, and has gone so far as saying and policies need to be in place, and the second is confidentiality. they will not address it. Again, if you look at it in terms of patient safety “The public is also concerned about the ability of insurance comand healthcare, we’re going to need to readdress it to see how can we panies to access patient health records. What’s in my record makes a get there from here.” big difference. If I do a genetic profile and find out I have a huge risk of The issue of privacy is always going to be intrinsically linked with cancer in my forties, who will insure me? Or, what if I find I already have patient fear of information safety: with more things becoming elecHIV in my blood test result, who will insure me? I think that becomes tronic, there are going to be concerns as to the likelihood of access to a valid point, and certainly then becomes an employability issue if my that information. “Within Mayo Clinic, we deal with security in many employer has access to that data. Those are two other privacy issues ways,” Schwenk says. “We have policies to keep a check on who has that are going to need to be addressed by legislation as opposed to access to that data, and the appropriateness of that access. Also, if technical security.” we’re transmitting data, we ensure that we’re using appropriate en-

Personalized medicine

In his healthcare proposals, Obama has also pledged to promote public healthcare by requiring an increase in coverage of preventative services, such as cancer screenings. But, what will be the effect of personalized medicine on EHRs? Schwenk points out that Mayo Clinic has been in the business of delivering individualized healthcare since the last century. “When you saw a patient, you took their life circumstances into consideration, you looked at their financial situation to assess what they could afford in terms of healthcare, and you looked at what their specific disease pattern or multiplicity of diseases was.

Then you formulated a treatment or a management plan.

“The difference today is that we cannot continue in that paradigm, it’s simply not scalable anymore because of the volume of information. The amount of data is so huge that I don’t think any one person or physician or brain can synthesize all the information that’s available and bring it to bear for that patient; this is the benefit of EHR. How do we understand or synthesize genomic data, which is incredibly complex? We need algorithms to even understand what the meaning is, and then how does that apply to this particular patient?

“Clinical decision support is very important. From viewing all of

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the patient’s data in electronic format, as a care provider, I receive alerts regarding drugs and dosages, according to the patient’s medical background. That’s the kind of individualized medicine that will help in the electronic era, so that’s one form of patient specific care.

“We can create more problems and increase the health risks and safety issues because we can’t specifically identify individuals” “The other type is that once we start collecting this data in an integrated manner, we can go back and query it, viewing the treatment given to other patients within Mayo Clinic who were administered under the same disease. What were they given, and what were their outcomes? From comparing one patient’s genetic profile versus another’s, I can use that information to tailor the treatment for the patient in front of me. For that we need the capability of analyzing data in real time.”

It remains to be seen how the new administration will take those first steps to begin the transformation of the healthcare infrastructure, and whether the idea of computerizing all health records within five years is achievable. For Schwenk, it depends on how much money is invested.

“Dollars will get us there, but it’s also how the process flows and

the buy-in. A two-physician clinic may ask why they should put the money in to computerize their records. Well, here’s the reason: What does that EMR actually do? Is it just collecting patient data, or is it helping you manage and solve clinical decision problems? This is the next step, and I believe that is Obama’s agenda. Once the information is in a digital format you can start using clinical decision support, as reminders and alerts for other physicians.

“There are all of those pieces; that’s where the value will be. The computerizing, we can probably get there by brute force, by giving dollars to go ahead and do it, but the real value will be in improving the quality of the care, and by merely putting computers in, we’re not going to solve the problem.”

Just like with the building of the national railroads, it may take some time to get there, but the results will change our country immeasurably for the better. n

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Comment

Information overload Thanks to the new administration’s proposals for healthcare reform, electronic health records are suddenly a hot topic. The terms HIT, EHR, EMR will be bandied about with increasing frequency. But what do they really mean, and can they deliver on the tremendous things expected of them?

W

e’re going to be hearing a lot this year about electronic health records. The recently passed American Recovery and Reinvestment Act contains nearly $20 billion in funding for health information technology (HIT), and the budget promises incentive payments starting in 2011 for physicians and hospitals using a certified electronic health record (EHR).

The introduction of a nationwide EHR has also been touted as a method of realizing enough cost savings to stop the recovery spending from spiralling out of control.

What’s it all about?

What’s the difference between HIT, EHR and EMR? Both the electronic health record (EHR) and electronic medical record (EMR) have gained widespread use in describing patient care records that have been put on a computer, although some people assign the term EHR to a global concept and EMR to a discrete localized record. For most people, however, the terms are interchangeable.

HIT, on the other hand, refers to the overall framework used to describe the comprehensive management of health information and its secure exchange between consumers, providers, government and quality entities and insurers.

How much will it cost?

In his pre-election proposal, Obama says his reform plan will cost between $50-65 billion a year when fully phased in. The $19 billion of this allocated to health information technology includes money to establish HIT Policy and Standards Committees comprised of public and private stakeholders (physicians) to provide recommendations on implementation; standards and certification criteria for the electronic exchange and use of health information; and financial incentives through the Medicare program to encourage physicians and hospitals to adopt and use certified electronic health records.

Funding would also be provided for Medicare incentive payments based on an amount equal to 75 percent of the Secretary’s estimate of allowable charges, up to $15,000 for the first payment year after an initial set of standards are available, as early as 2011. Incentive

payments would be reduced in subsequent years to: $12,000, $8000, $4000, and $2000, ending in 2015.

Will it work?

Up to a point, yes. By computerizing patient records, hospitals and other health-related entities will streamline follow-up procedures, reduce errors and save money in the long-term. There are, however, several challenges. The lack of a single patient identifier is one – without this, there is still the potential for confusion between people with similar names. Any attempt to introduce a system of identifiers is likely to be met with strong resistance.

Another issue is the lack of standardization of electronic record systems between institutions. Even if all hospitals and doctors’ offices in the country put their records in electronic format, this does not necessarily mean they will be able to exchange and read each other’s files.

Who’s using it?

Estimates put the current usage at about four percent nationwide, mainly in large hospital and healthcare systems. Take up has been slower among small physician offices, mainly for reasons of complexity and cost.

What’s the timescale?

President Obama has pledged to put all patient records online within fi ve years. Funding incentives will be provided to encourage this, with penalties kicking in after 2015 for noncompliance. Given the current rate of take up and the logistics involved, such a timescale seems optimistic.

What’s the bottom line?

There are likely to be tremendous implementation challenges, particularly among the large percentage of offices consisting of four physicians or fewer. It requires a large outlay of taxpayers’ money, with payback coming only over the long-term. And there are potential security issues related to opportunities for outsiders to hack into electronic systems, or the ability of people outside a hospital to request a transfer of records without proper authorization. 

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INFORMATION MANAGEMENT

STAYING INFORMED Linda Kloss, CEO of AHIMA, tells EHM of the changes and challenges in health information management.

P

rior to joining the American Health Information Management Association (AHIMA), I spent nearly 20 years working in quality measurement and reporting and while there has been greater focus on the critical need to address safety and quality, progress is still too slow.

The computerization of health records has been a particular interest for me since the 1970s, when I joined the staff of one of the very early companies developing a patient-centered computerized record.

The technology was not ready for the challenge of an electronic record, but the vision was right, then and now, and it is the use of electronic health information for quality improvement that is the most important destination of this very long journey, which continued into AHIMA. I’ve been operating in my current role as the Chief Executive Officer since 1995, and during this time we have been engaged in important work to support the transformation from paper to electronic health records (EHR) and an information-rich healthcare system.

The association was founded to improve the quality of medical records and standardize the content of health data. Today’s vision is quality healthcare through quality information and the aim of AHIMA is to be the professional community that improves healthcare by advancing best practices and standards for health information management, and by being the trusted source for education, research and professional credentialing.

FoRE This is mostly done through AHIMA’s Foundation, which was founded in 1962 and has been a source of student scholarships, information resources and research through the years. Despite the difficult economic situation, the Foundation of Research and Education

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(FORE) is engaged in a capital campaign ‘FORE the Future’ to expand its programming in four key areas. Firstly, it aims to extend support to students and faculty in health information management academic programs, by providing applied research for evidence-based guidance for Health Information Management (HIM) practice and information policy development. The Foundation is also responsible for leadership development programs. AHIMA focuses on delivering public service information for consumers so they understand the value of health information and their information rights, and that now is the time for knowledge renewal.

The US has not undertaken a classification update for over 30 years and the last one was before DRG-based payment. So the transition to an ICD-10 system will not only be significant, but one that is absolutely necessary. ICD-9-CM has become obsolete and can no longer support either the country’s current or future health information needs, including interoperable electronic health information exchange. ICD-10 has been used for US mortality data since 1999, so there is no comparability between mortality and morbidity data.

Since most of the rest of the world has already moved to ICD-10, US morbidity data are incompatible with international standards.

ICD-10-CM will enable the development of smart applications in electronic health records, such as data reporting, computer-assisted coding and other applications that will improve data quality and reduce labor-intensive processes.

Challenges The challenges we may face during the transition will include the requirement for education at many levels, from coders to those who use the data. Clinician education to improve documentation so that more specific and most appropriate codes are supported will also be important. Software upgrades will be necessary to accept codes that are longer – seven digits instead of fi ve and alpha-numeric. ICD-9 codes have been used across multiple systems as a standard way to

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express diagnosis and procedures, so a thorough review of systems impacted will be one of the first steps an organization will need to undertake. Internal data management will also be required in the transition to ensure comparability of information across time, and like other major projects, this will take organization-wide planning and project management. Critical to this transition will be the required coordination with suppliers and payers, including testing of software and data transmission. Proper planning and preparation will mitigate potential problems and lead to a smoother transition.

Reform of the healthcare system is high on President Obama’s agenda. The American Recovery and Reinvestment Act includes $20 billion to invest in health information technology, which has the potential to reverse the underinvestment that has been one factor in limiting progress in healthcare reform. The investment will be directed at building the governance and the supporting architecture for electronic health information exchange, investing in the training of health information specialists and healthcare professionals, and to provide grants to institutions and providers to acquire certified health IT products. Health information management can contribute to progress by helping to meet the forecasted need for an additional 40,000 IT workers through expanding the network and capacity of accredited health information management academic programs at the Bachelor’s, Master’s and Associate degree levels, and also through expanding certificate training programs.

By supporting the deployment, implementation and most importantly the optimization of health IT so the US recoups the investment it is making, health IT can also contribute to progress. Being part of the team of experts, offering regional technical assistance and contributing to the body of knowledge about optimal workflow, develops the best practices in using health IT and improves the value of the information that is available in an electronic infrastructure. Contribution to critical policy and standards development work so health information is protected, accurate and available when needed is also important.

A continued focus on establishing a nationwide health information network has placed the use of IT under debate. Building such a network for secure information exchange is more about sound governance, policies and standards than it is about technology. The technologies are of fi ve types: electronic health records or other source systems that capture the data in digital form; internet protocols for communication and exchange; data storage and aggregation solutions; security and authentication tools; and data analytic and reporting applications. It is likely that there will be considerable trial and error as technologies develop and adapt to the changing requirements of health information exchange. 

Linda Kloss is Chief Executive officer of AHIMA. Prior to joining AHIMA in 1995, Kloss served as one of the founding officers for MediQual Systems, Inc. She was recently named by Modern Healthcare as one of the top 25 influential women in healthcare, and has been on their list of the 100 most influential people in healthcare for the past several years.

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About AHIMA

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he American Health Information Management Association (AHIMA) is an association of health information management (HIM) professionals. AHIMA’s more than 53,000 members are dedicated to the effective management of personal health information required to deliver quality healthcare to the public.

Founded in 1928 to improve the quality of medical records, AHIMA is committed to advancing the HIM profession in an increasingly electronic and global environment through leadership in advocacy, education, certification and lifelong learning.

With the national focus on health information and the need for comprehensive and interoperable information technology across the country, AHIMA is qualified to shape the national agenda. Change is happening on four fronts:

The challenges entailed in building a reliable network governed for the public good and guided by sound policy is surely the nexus of the work of the Office of the National Coordinator in the Department

of Health and Human Services in the coming years and it can be expected that the majority of the $2 billion in funding for that office will be directed to the network. It will require strong leadership to ensure that the national, state and local goals are aligned and that all stakeholders play by the rules, some of which have yet to be developed.

Risk limitation The issue of medical identity theft has gained increasing prominence, but there are steps healthcare institutions can take to limit its effect on patients, such as ensuring appropriate background checks of employees and business associates and establishing patient verification processes, which may include obtaining and storing photo IDs, or other means of identity verification or authentication if utilizing email or internet access.

Risk can also be limited by minimizing the use of Social Security numbers for identification; instead health institutions should store individually identifiable health information in a secure manner and ensure that administrative, technical and physical safeguards are in place, such as restricted access and locks. Within the institutions themselves, organizations should implement and comply with standardized policies and procedures that provide safeguards to ensure the security and privacy of individually identifiable health information collected, maintained and transmitted electronically.

This can be done through various means. For example, organizations can create an ‘alert’ process for medical records, where identity verification may be required upon patient admission. They can also develop a proactive identity theft response plan or policy that clearly outlines the response processes, along with developing ongoing staff training programs to ensure workforce understanding of organizational policies and practices developed to provide protection and appropriate use and disclosure of individually identifiable health information.

With regard to the current economic crisis, it is too soon to know how the recession will impact HIM workers, but we are beginning to hear of layoffs at hospitals and other provider

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rivacy and security P Standards for data interchange and system interoperability The electronic health record (EHR) The overall national health information infrastructure AHIMA remains at the forefront of this progressive agenda.

The association works to accomplish the full realization of the benefits of information technology in healthcare.

With HIM’s overriding goal in mind – ensuring the availability of health information to facilitate real-time healthcare delivery – AHIMA is involved in initiatives advancing the role of HIM in informing clinical practice, developing standards to improve data quality and facilitate information exchange, and helping healthcare organizations migrate to EHR.

organizations due to lower patient volumes. Some of these layoffs are coming from HIM, though not necessarily involving experienced and credentialed HIM staff, but rather the clerical staff working for them.

Human resources There is a documented shortage of experienced credent HIM professionals who fill managerial or knowledge worker roles and most of these are not impacted by patient volume, so we are hopeful that the cutbacks will spare HIM. AHIMA has been concentrating on expanding the workforce by recruiting students and second career individuals.

We have showcased workforce shortages and the need to invest in the health information management and informatics workforce through advocacy and alliance projects.

Our own research and that of other organizations shows that to achieve the full benefits of health IT, an additional 40,000 health information specialists, such as informatics, health information management and IT professionals, will be needed. Survey data shows that healthcare organizations are slowing IT projects and spending, and this could affect the HIM professionals working for HI vendors and consultants and in other IT roles.

However, we are hopeful for the future. The $20 billion in the stimulus bill is the first substantial funding that has been made in the US for this important area, and there will be new investment in health IT-related initiatives including the deployment of broadband and wireless capability for telemedicine, grants and incentives for EHR adoption, and support for standards development, research and workforce training. n

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CASE STUDY

The path toward optimal cash posting performance

paper-based payments and manually key the posting amount into the hospital’s patient accounting system.

Compounding the challenges, the department suffered from a necessary reliance on temporary billing staff, varying from as few as five, to as many as nine people, in addition to its full time employees. With high turnover and a lack of available skilled temporary workers – an expensive resource at $30 an hour – overhead costs and cash posting productivity were not up to desired standards.

“Because we were very manual, it required a large quantity of FTEs to post and reconcile payments,” said Jason Adams, MultiCare’s Vice President of Revenue Cycle. “Our cash posting challenges were resulting in excessive amounts of unposted cash – literally millions of dollars unposted each day. In addition, we might have had patient payments in the bank, but because of our cash posting lag time, our billing follow-up staff didn’t know it.”

According to Adams, all too often, patient accounting representatives were calling payers to find out why a payment hadn’t yet been made, only to find out it just hadn’t yet been posted to the account.

The solution

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ationally acclaimed MultiCare Health System (MultiCare) is a not-for-profit, leading-edge, integrated health organization comprising four hospitals, numerous primary care and urgent care clinics, multi-specialty centers, hospice and many other services. Its 93 locations serve patients across four Pacific Northwest counties.

MultiCare is currently one of the nation’s few health systems to implement a comprehensive electronic health records system. Despite being a recognized health information technology leader, it faced a never-ending struggle to streamline patient billing posting workflows.

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The challenges In particular, MultiCare found itself challenged with excessive amounts of unallocated payments. MultiCare, like other providers, receives payment notifications in a variety of formats, including paper-based Explanation of Benefits (EOBs) and electronic ANSI 835 remittance advice transactions. Each transaction can contain remittance information for hundreds of individual patient claims.

MultiCare’s billing office managed both hospital and physician cash postings, which meant its billing staff had to manage a lot of unique payer resources. Their existing system required staff to pull up scanned images of

Almost concurrently to MultiCare’s recognizing the need to address this issue, CareMedic representatives introduced health system administration to its newest solution offering, Payment Management, an ASP-based, all payer solution for managing remittances. By leveraging CareMedic’s expert staff and existing market-leading solutions, Payment Management offers users an efficient solution for managing and automating payment processes and a single point of access to insurance payment data. Eliminating the challenges of managing information in various formats, Payment Management works with the provider’s existing lockbox service to offer a totally paperless remittance processing solution from claim adjudication through posting into the provider’s patient accounting system. It captures electronic and paper explanations of benefits (EOBs), converts them to the standard electronic format (ANSI 835s), automates posting and provides views of single-patient 835s. Its data mining capabilities provide advanced dashboard

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reporting that allows management to easily analyze remittance and payer issues, including root causes of denied payments.

MultiCare already had an established and highly satisfactory relationship with CareMedic. The health system had realized tremendous results as a long-timer user of the company’s document management and denial management solutions, as well as its Virtual Business Office (VBO) services.

“Statistically, I knew that for every dollar spent on temporary workers, we were spending too much, but without any other viable option, we were prepared to throw more bodies at the cash posting issue,” said Adams.

“But then we viewed the demo on CareMedic’s Payment Management solution. Their offering presented us with a cost-effective, non-disruptive way to automate processes, defer the heavy information technology lifting and steer our staff to work to exceptions.”

Adams added that he viewed the decision to adopt Payment Management as a result of CareMedic’s established ability to deliver results over the last 10 years.

Putting the solution in place Working with MultiCare’s key senior management, motivated billing staff set about adopting Payment Management at the end of 2007 by developing well-defined goals for completing the implementation in a short timeframe. A cornerstone of the plan and its rollout was to first address the payers with the largest remittance volumes, with a stated objective to a transition of 80 percent of its payers within six months, and from there, to work in the smaller payers over time.

MultiCare’s staff was pleased about the minimal need for support from internal IT staff throughout the implementation, as CareMedic performed the bulk of the transition work. “We used existing resources that we had in place,” explained Adams. “We did not incur the typical added expense from a labor perspective in adopting this technology solution.”

Once its goals and timeframe were established, MultiCare provided CareMedic’s expert staff with the necessary mappings and payer proprietary codes. Next, CareMedic worked on converting unique payer forms into the ANSI standard format, and then the 835s were tested to ensure they could be posted cleanly

The results

Jason Adams is System Vice President of Revenue Cycle for MultiCare Health System, a Board Certified Healthcare Executive and a Fellow of the American College of Healthcare Executives. He has held various leadership roles in a number of healthcare provider and vendor organizations, and earned an MBA with a healthcare concentration from Rivier College Graduate School of Business.

and directly into MultiCare’s patient accounting system (an Epic solution). Because MultiCare already was a user of CareMedic’s document management solution, the adoption process was reduced by approximately 20 days, as there was no need to establish scanned document capture.

The organization’s first payer was live on the solution in January 2008. With its phased approach, by April 2008, MultiCare had payments from multiple payers running through the Payment Management system.

“The benefits of Payment Management began to feel real within 60 days,” said Adams.

“As our unallocated cash backlog became smaller and smaller, our permanent staff was able to handle the volume of exception work and we were able to start phasing out our temporary staff in that timeframe.”

Today, MultiCare’s paper and electronic lockbox payments are converted to standard 835s and transmitted the next day into its patient accounting system. By adopting CareMedic’s full-service, end-to-end solution, MultiCare has reduced its average un-posted funds per day to $100,000, versus the millions of dollars it was experiencing before.

What had been 22 positions in cash posting is now down to 15. Because of the streamlined workflow and accelerated posting achieved through the Payment Management solution, MultiCare was able to eliminate seven FTE positions occupied by temporary workers – an immediate saving of approximately $400,000 a year. Moreover, because the department was able to reduce headcount, it successfully avoided permanent staff layoffs to meet 2009 budget reductions.

Softer benefits have been realized in limited turnover, high staff satisfaction due to working accounts by exception, nearly zero backlog, and more effective and targeted communications by patient billing follow-up workers.

In addition, the adoption of Payment Management presented the means to consolidate and integrate the activities of MultiCare’s two central business offices into one.

“After implementing CareMedic’s Payment Management Solution, we’re operating in an optimal performance environment,” reports Adams. “By enabling our staff to work accounts by exception, we’ve been able to phase out unskilled and expensive temporary staff and vastly improve productivity by avoiding unnecessary follow-up work on payments we had received but just hadn’t yet reconciled.”

Results MultiCare’s achievements were: • $400,000 savings in expense from temporary staff workers • Daily unallocated cash reduced from anon average $1.5 million to $100,000 • Improved posting accuracy • Elimination of unnecessary follow-up calls to payers • Elimination of seven FTE positions, with added benefit of averting the need to lay off permanent staff to meet new department budget reductions. n

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EXECUTIVE INTERVIEW

Managing your data effectively How healthcare institutions can use technology to improve their quality of care.

By Quentin Gallivan EHM. Companies and organizations in the healthcare sector are operating in an increasingly complex environment, dealing with a huge amount of electronic data. Why it is important for them to ensure this data are managed efficiently?

Quentin Gallivan. It’s a big challenge, because most companies in the healthcare industry are challenged with rising costs and increasing mountains of data. Those companies that have gained insight into their data and efficiencies into their processes try to simplify by linking the business owners with IT and focusing on specific areas of opportunity... not trying to boil the ocean with massive data warehousing projects.

Two of our customers, Guardian Home Care and Kool Smiles, have done just that. In partnership with PivotLink and their technology department, they’ve gained great insight into improving patient care and reducing costs.

EHM. What technology solutions can institutions use to manage their quality of care monitoring, complaint analysis and treatment and outcome data?

QG. Most healthcare institutions are good at capturing large amounts of information but struggle in extracting and summarizing this data to understand trends or surface exceptions in ways that allow them to systematically improve the quality of care and reduce the overall costs.

Guardian Home Care utilize a business analytics and reporting system to improve the quality and consistency of care delivered to the homes of their patients by tracking more than 5000 episodes at any one time. They use PivotLink to allow their supervisors to go in and look at all these cases in their region or in aggregate to spot trends and exceptions and discover best practices. These supervisors don’t have time to learn a complicated BI tool; the solution has to be intuitive to use but still provide them the ability to drill down into the detail needed and interactively investigate the data.

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Quentin Gallivan, CEO of PivotLink, is a prominent SaaS industry executive, having been instrumental in the growth of VeriSign from $30 million to $1.5 billion in revenues. As the former CEO of Postini, the leading email security SaaS company, Quentin built the company to large scale with over 11 million users and over 30,000 customers prior to its eventual sale to Google in September of 2007.

EHM. How can healthcare organizations reduce the cost and complexity of their management reporting?

QG. Understand that less is more. Since healthcare companies have so much data coming in, it’s important to have the business managers focus specifically on what business processes they want to improve, and make sure they partner with the right technology company to deliver that information effectively.

For example, Kool Smiles, run into a large network of dental offices, and focused on providing dental care to underprivileged children.

They mine all the data they have, using the PivotLink service, to understand the correlation between good preventive care and the total cost of care. For those patients that don’t have rigorous preventive care programs, more of them end up in emergency rooms or require more invasive treatment, which increases the overall cost of care for the patients, providers and payers.

Conversely, those patients that take advantage of preventive care programs reduce the systemwide cost of care and enjoy better dental health.

Kool Smiles has all analytical data to prove this in PivotLink and can see what regions or areas have the greatest need for their services – and that’s how they look to expand their network.

EHM. How do you see the future of healthcare data management developing over the next few years?

QG. A big opportunity to support the healthcare industry’s need to reduce cost and improve the quality of care lies in moving more data to the cloud. The healthcare industry is an ecosystem of many different participants, from the provider to the payer to the manufacturer, so having information in the cloud that all these parties can access securely will break down information silos without costly set-up fees or licensing costs of traditional approaches.

The other advantage of cloud computing for the healthcare industry is the elimination of capital expenditures for IT infrastructure, freeing up CAPEX to be re-deployed to medical equipment technology that directly improves the quality of care. Additionally, cloud computing services provide a more cost-effective platform to process and store large volumes of data. What cloud computing needs to do, and what we are focused on, is ensuring that our security infrastructure for all healthcare information is transferred, stored and then accessed from the cloud meets or exceeds the standards healthcare companies maintain in their own systems.

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THE REFORMER’S TASK Stephanie Reel of Johns Hopkins Medicine outlines the task facing the nation as it moves forward with the computerization of patient health records.

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hen asked about the feasibility of President Obama’s plan to computerize all health records within five years, Stephanie Reel, CIO of Johns Hopkins Medicine, quotes Niccolo Machiavelli: “There is nothing more difficult to manage, more dubious to accomplish, nor more doubtful of success . . . than to initiate a new order of things. The reformer has enemies in all those who profit from the old order, and only lukewarm defenders in all those who would profit from the new order.”

Reel’s point is that, “We have our work cut out for us. We are making very real progress in our institution, and in institutions like ours across the country and around the world. In fact, I would suggest that we are making even better progress at some smaller institutions that are not dealing with the level of complexity that is pervasive in academic medical centers, or integrated health science centers. But that progress is often isolated to a local institution or a local geography.

“To make greater progress we need a commitment to collaboration of their information. “We are currently deploying Microsoft Amalga and around standards, and then adoption of solutions. We need open archiMicrosoft HealthVault across our enterprise, to satisfy the need to aggretectures that allow our systems, and our data, to interact.” gate, analyze and share data between locations and providers. It's a bit One of the challenges facing the establishment of a nationwide elecearly to know how comprehensive this solution will be, but we are making tronic system for patient records is the fact that there is currently a lack progress, and are optimistic that we have at least a partial solution.” of consistency in the types of systems used by individual institutions.

With this higher level of computerization can come an increased This means that even if all health records are computerized, hospitals focus on security. There is debate about whether putting data in elecwon’t necessarily be able to exchange information electronically. tronic form poses more of a risk than the traditional paper format. “I Reel says the solution is partially related to the adoption of stansuspect we have realized gains and losses in this area,” says Reel. “We dards, yet equally important is the value of data and the meaning of have a responsibility to serve as custodians for patient information, and data in its context. “We need standard, usable and sharable data. If and we take this responsibility very seriously. If we can empower patients when we achieve this, real knowledge and and encourage them to become more engaged in the maninformation can be aggregated, analyzed agement of their health, and the management of their health “We need standard, usable information, we may be able to reduce the angst associated and shared. If we also incentivize providers for sharing information, and if we empower with this topic.” and sharable data. If and individuals to take control of their own Another area that has been influenced by electronic when we achieve this, real health-related data, we may make real medical records is the rapidly developing field of personalknowledge and information progress.” ized medicine.

In Reel’s view, the major goal that healthcare can be aggregated, Another issue is the lack of a single providers must embrace is the integration of genomic inanalyzed and shared” patient identifier. Reel believes that such formation into clinical repositories. “If we can identify and an identifier would allow the healthcare store genetic variants in our clinical systems, we can avoid sector to focus on the problems at hand, without being distracted. She useless treatments, and focus on targeted interventions. We can know says that while it not be critically important, it would serve the industry that a specific therapeutic intervention will do no good, or that it may do well to be able to focus more on standards and interoperability, and less harm. We can know which investments to make and which to avoid. We on identifiers. can provide real-time, relevant decision support and save money. We can undoubtedly eliminate waste and reduce harm. This cannot happen without data aggregation, integration and sharing.”  On the move As patients increasingly move between institutions, Johns Hopkins is using a variety of technologies to support the corresponding mobility

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Stephanie Reel is CIO and Vice President for Information Services at Johns Hopkins Medicine.

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EXECUTIVE INTERVIEW

Keeping score Helping healthcare organizations quantify their services and provide the best care to consumers. By Steven Berger EHM. The public needs to understand clinical and quality outcome metrics. Can you define what some of those are or should be?

Steven Berger. There are now hundreds of various clinical and quality metrics available to be used by the industry. For hospitals, this would start with the Joint Commission’s use of Core Metrics, typically defined as 17 process measures and one clinical outcome (mortality), now also being used by the Medicare program to determine hospital Pay for Performance. But it extends to the Leapfrog Group’s use of the National Quality Forum’s (NQF) 27 Endorsed Set of Safe Practices, the many clinical and quality metrics being reported by various states (see the Oregon PTCA Death Rates) and other governmental, quasi-governmental (NQF) and professional associations.

issues, such as transportation availability, costs, risk assessment, etc., the decision will be different. So scores, per se, are parts of a decision process, not the end point.

EHM. Isn’t there a best practice method for healthcare providers and healthcare consumers to understand if the healthcare organizations are producing high quality outcomes?

SB. Yes there is. Let’s call it the Scorecard method. It involves reporting specific metrics around various aggregated dimensions such as clinical, quality, patient satisfaction, growth, best people, community, financial and any other. These dimensions form a framework for utilizing specific metrics, or measures, in an effective way. The INSIGHTS software from Healthcare Insights (www.

“When information like this is available on demand and on time, decision-makers have the information they need to make quick and reasonable decisions” EHM. Once these metrics are utilized by government and various clinical rating agencies, how can the public determine where they need to go for their medical and health care?

SB. Now that is a more difficult question.

There are many ways to analyze health outcomes, and many ways to monitor the outcome data and many ways to act on the information. Each individual is likely to take action differently. For example, suppose you are a consumer about to have an elective surgery who learns, on a website, that your local hospital has received a median score on ‘complication’. A hospital located two hours away received a higher (better) score on complications. Do you go to your local hospital or opt to travel two hours? That’s the question. Now, based upon each consumer’s

hcillc.com), permits a hospital to develop Scorecards for each major dimension and sub-dimension beneath them. Scorecards can be used by hospital administrators and boards to make better decisions in a valueadded way.

Even greater value is realized when the healthcare organization can drill down into the aggregate results to review the detailed indicators. When information like this is available on demand and on time, decisionmakers have the information they need to make quick and reasonable decisions based on actual results. This information was not avaialble in a concise way before the Scorecard was developed.

Scorecards provide information that is both useful and actionable, but some hospi-

Steven Berger is President and Founder of Healthcare Insights (HCI). HCI provides the state-of-the-art INSIGHTS business intelligence software service and support tool plus training services to the healthcare industry. Berger, a hospital finance executive for several hospitals over a 20-year span, is the author of four books and several award-winning articles about healthcare general and financial management.

tals consider this information private or even secret and look for ways to secure it tightly within the organization. Government and consumer groups want to see much of this information made public. Hospitals that still believe their information should never leave their four walls should note that many hospitals and health systems post complete clinical and quality metrics on their websites. I would suggest that more and more hospitals will be doing this in the near future.

EHM. It sounds like there is still much that can be done in the preparation, implementation, reporting and monitoring around clinical (and financial) metrics.

SB. Much more. Goal setting is an important step toward achieving the outcomes the organization is looking for. I will be expanding on how to set effective goals within indicators in an accompanying article on the EHM website. n

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INDUSTRY INSIGHT

Why Pat was nearly right

By Stefanos Damianakis

Lessons from the bleeding edge of EHR You remember Pat. She was the Associate Director of Medical Records who retired several years ago when the EHR system was new and everyone dismissed the problems as ‘teething pains’. Except Pat. She didn’t think the EHR was ever going to deliver what the vendors promised, and didn’t mind sharing her opinion with anyone who’d listen.

Some of the younger administrators were relieved when she retired, but the medical staff mourned her leaving because somehow Pat could always find the right jacket regardless of how badly it was misfiled. Just two examples, of hundreds over the years: A baby admitted as ‘Lisa Haver’ was actually Louisa Javier, and Pat personally delivered the correct file to the OR to make sure they realized the baby was allergic to the anesthetic they were about to administer.

Stephen Fitgreld and Steve Fitzgerald were the same man. Just in time, Pat stopped a set of duplicate tests that were ordered when the patient’s file couldn’t be found. His insurance company would surely have refused to pay for them, so she saved the hospital a couple of thousand dollars in an instant.

Pat felt that she was essential to the smooth operation of the hospital, and didn’t believe that any computer would be able to replace what she did.

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The EHR hadn’t delivered the promised benefits. It was a constant struggle to match patients with their medical records. Admitting staff had to deal with patients who showed up in pain, or were old and sick, and might not have proper IDs. No wonder they sometimes made errors.

Of course, the environment had gotten tougher for Pat, and she was relieved to retire.

When she started, she worked in an independent hospital. The record room contained 52,000 paper jackets, of which only a few thousand were active at any given time. As Pat became a supervisor, she was able to train every person who ‘touched’ the files.

By the time Pat retired, 35 years later, her original hospital was now the tertiary care facility in an integrated delivery network combining seven formerly independent hospitals, plus nursing homes, primary care clinics and physician groups. Now there were over four million files, of which 750,000 were active.

It was impossible to enforce uniform standards across the entire system, and when there were inconsistencies, the computer system failed to link records, and made it hard to find the right patient record.

What Pat didn’t know Last year, the hospital’s CIO, and the new Director of Medical Records, decided they had to stop making excuses, and do something

about the problems with the EHR. Their first step was to understand the problem. A consultant analyzed their data, and discovered the Master Patient Index contained over 20 percent duplicates. The CIO and Director were shocked, until the consultant confirmed that 20 percent (or higher) was pretty typical for a hospital system their size.

On the consultant’s recommendation, they contracted to integrate Netrics for Healthcare software into all of the major patient management systems. Pat didn’t believe that a computer could ever do what she did, which was recognize the patterns of similarity in different patient files, and match them up despite errors, variations and inconsistencies.

But it turns out that this is exactly what the Netrics software does. Integration also turned out to be pretty straightforward, because new software could seamlessly augment their exiting EHR without large-scale IT changes.

Now admissions and medical staff almost always find the right patient record on the first try. Furthermore, patient safety is no longer compromised, costs are reduced by eliminating repeated tests, and overall care delivery is significantly improved.

Now everyone has confidence in the EHR. And Pat is remembered fondly, among the oldtimers, as the person who used to make everything work, before we had the EHR. n

Stefanos Damianakis, is the CEO of Netrics and a prominent thought leader in the field of EHR/EMR record technology and its organizational impact. He holds PhD and MA degrees in computer science from Princeton University and a BSc degree in computer science from McGill University.

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Going digital The introduction of digital technology has revolutionized the way in which imaging is being used, and as Chairman of the Board of the largest organization of radiologists in the world, the Radiologic Society of North America, no one is better qualified to make such a judgment than Burton Drayer.

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ith the introduction of digital imaging, the use of film has been eliminated, and all images are now examined using computer screens on a workstation, which provides tremendous advantages. “The main advantage is that film can only be in one place at one time. If you’re at a large hospital or if you have multiple referring physicians, there’s only one set of film so they all have to borrow those films and bring them back to a certain place. This can lead to films getting lost, and many other difficulties,” says Drayer, who is also Chair of Radiology at Mount Sinai Medical Center.

The accessibility of digital images for numerous physicians across numerous locations means the technology can only benefit the patient. If the patient is seen in London and then referred to a hospital in New York, their movements are followed by the digital images via technology, so the patient no longer needs to transport the image with them overseas. Instead there is immediate transmission of the images to the physician.

For Drayer, this is a drastic improvement: “Within minutes after a study is done we can have the results. The images provide results that are accessible to all individuals: those who have to interpret them and those who have to treat based on those interpretations. All of this is available immediately. In addition, all of our modalities – CT, MRI, PET scanning – have digital outputs, so it is a very efficient way of running day-to-day operations over a radiology department.

“It’s a move away from the requirement to have a darkroom when using film, and there is also no longer the need for chemicals that were used during the processing of the film.”

Burton Drayer is Chair of Radiology at Mount Sinai Medical Center in New York City and Chairman of the Board of the Radiologic Society of North America.

begin transferring images. We have the provisions of HIPAA –the Health Information Portability and Accountability Act – where we have to look Double-edged sword at patient privacy, which is incredibly important to us. So we have to deal However, it is its own advancement as a technology that is rewith those additional issues when transferring images,” says Drayer. sponsible for certain challenges in using digital imaging. Drayer notes Drayer’s team is using the technological advances to further rethat although digital imaging is perceived to be straightforward, that search into early detection of Alzheimer’s, Parkinson’s and brain funcis not always the case. With each institution at a different stage of tions. “We’re looking at modalities very similar to what are looked at all implementation of a digital system, and with a wide variety of systems over the world right now. Magnetic Resonance Imaging (MRI) continues between hospitals, the transfer of images is not to be extremely important in both Alzheimer’s always flawless. and Parkinson’s and is probably of greatest “The challenges come when there are fireimportance in diagnosis, as it provides signifiwalls at different institutions. Everyone is not cant information to exclude other diseases that of the US population will be on the same system. This is a huge focus for might mimic Alzheimer’s or Parkinson’s. the Radiologic Society of North America, which “For example, if someone has a brain over 55 by 2030, leading to sponsors a very large project called Integrating tumor or a stroke and it appears to the clinia substantial increase in the Healthcare Enterprise (IHE), and what that cian as though it’s Alzheimer’s or Parkinson’s, Alzheimer’s and Parkinson’s does is provide connectivity. It supports conbut really it’s not – it’s a brain tumor, stroke, nectivity between different types of machines, subdural hematoma or some other type of different types of software, different types of modalities, different disorder. It’s hugely important to ensure that it’s not something that types of information, and tries to give us a common pathway, allowing may be treatable by a different means. Then you use some of the everyone to share information.” fancier tools that we have with MRI to determine if it cannot be diagGenerally, the transfer of images within the same institution is seamnosed to any of those, to confirm if it is Alzheimer’s or Parkinson’s. less, as the same system is likely to be used throughout. “The problems For this we use profusion imaging. We use what we call diffusion simply require cooperation from the vendors who are making the equiptensor imaging and functional MRI. Through the use of different ment and from the physicians who are interpreting the images. There types of techniques, we can better understand not just the anatomy are obviously patient privacy issues that are incredibly important as you or the structure of the brain but also its function.

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Imaging definitions “Another thing we use a lot of is positron emission tomography (PET), which we use with fluorodeoxyglucose for Alzheimer’s disease.

There are new agents for Alzheimer’s disease that are now being used that bind to amyloid. These are very exciting because they may be more specific for Alzheimer’s disease using PET,” he explains.

Prevention At least one third of the US population is predicted to be over the age of 55 by the year 2030, leading to a substantial increase in the number of patients needing treatment for Alzheimer’s and Parkinson’s. “Our goal is to detect the disease early before it becomes symptomatic, and then hopefully be able to treat it and prevent it from actually occurring. That’s why imaging is so exciting. We have the potential to find the disease not four years after it’s pretty obvious to anyone who speaks to the patient, but four years before they develop symptoms.

“That’s where the excitement occurs, which is what healthcare should be in many ways. It’s prevention. It’s looking at how we can detect a disease through imaging – whether it’s through your genetic makeup, your anatomic makeup, your functional makeup or your metabolic makeup – just as you might use a cholesterol or lipid to look at cardiac diseases, and conduct preventive measures,” says Drayer.

Excitement is the operative word for Drayer and his team, given the recent election of the new administration in Washington and its focus on healthcare reform. However, Drayer notes the limitations of placing

MRI Magnetic resonance imaging (MRI) is a non-invasive procedure that uses powerful magnets and radio waves to construct pictures of the body. Unlike conventional radiography and computed tomographic (CT) imaging, which make use of radiation (X-rays), MRI is based on the magnetic properties of atoms.

A powerful magnet generates a magnetic field roughly 10,000 times stronger than the natural background magnetism from the earth. A very small percentage of hydrogen atoms within a human body will align with this field. When focused radio wave pulses are broadcast towards the aligned hydrogen atoms in tissues of interest, they will return a signal. The subtle differences in that signal from various body tissues enables MRI to differentiate organs, and potentially contrast benign and malignant tissue.

PET Positron emission tomography, also called PET imaging or a PET scan, is a type of nuclear medicine imaging.

Nuclear medicine is a branch of medical imaging that uses small amounts of radioactive material to diagnose or treat a variety of diseases, including many types of cancers, heart disease and certain other abnormalities within the body.

A PET scan is a diagnostic examination that involves the development of biologic images based on the detection of subatomic particles. These particles are emitted from a radioactive substance given to the patient. The subsequent views of the human body are used to evaluate function.

increasing importance on IT in the current economic climate. “One thing the new President underestimates is the cost of information technology. When you’re using computer-based systems, it’s expensive. It’s terrific. It’s fantastic for patient care but has its costs and these costs are recurring. You have to upgrade the equipment all the time.

“On top of all this, you have all these contrast media and new imaging agents being developed that are attempting to make us more specific in order to potentially detect disease at an earlier stage or detect the type of disease that might be more dangerous. For instance, because a blood vessel has atherosclerosis in it doesn’t mean that you’re at risk for a heart attack or a stroke. The question is which of those plaques that we see are vulnerable. When we start to make those determinations, that’s where imaging can play a tremendous role.”

Research Drayer’s research team is primarily focused on highlighting the model of prevention through the development of detection, and its work with the new Translational Molecular Imaging Institute is an expansion of their research activities. Drayer notes that the current buzzword within imaging is molecular. Molecular imaging looks at not just the structure of a disease or the normal individual, but also the function and the metabolism through the use of imaging. This not only detects disease but also follows the progression of treatment, and

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determines if the treatment is successful. This is of the highest importance to the Institute and is one of the three-pronged approaches that it is using to conduct research.

“The second area that is always important with imaging is physics and engineering, and as we develop these fantastic machines – MRIs, PET and CT scanners – that are faster and better and show us smaller structures, this takes tremendously advanced physics engineering.

“Then the third direction we’re taking is image management. One of the advantages of using information technology and PACS, from which we read images on workstations, is being provided with a tremendous amount of information, which keeps doubling and quadrupling every year. However, we need better systems to manage all of this information and process it in a form that we can use in a more efficient fashion.”

Training In order to ensure research is carried out in the most efficient and beneficial way, the radiology faculty concentrates heavily on high level, informative training of its next generation of diagnostic and interventional radiologists. Drayer explains that the traditional teaching method is to use one-on-one teaching while interpreting images, along with research and clinical conferences.

“We also try to use all of the available online materials. More and more the RSNA, along with other societies, is trying to provide as much online material as possible, and one of the exciting things is

now you can look at some of this online material while you’re reading your images. While you’re doing your interpretation it’s like having a textbook in front of you to read about all the other nuances that might be available, which has been a very good teaching tool,” he explains.

As radiology changes in its function, so do the methods of research and the training tools. Radiology is no longer simply a process of diagnosis, there’s now a tremendous amount of therapeutic treatment with interventional radiology, which has led to more and more minimally invasive techniques to treat many diseases.

“We have the potential to find the disease not four years after it’s pretty obvious to anyone who speaks to the patient, but four years before they develop symptoms” As a preventative model becomes endorsed across our healthcare system, radiology is expected not only to meet these new methods, but to become active in the therapy of diseases too. Only time will tell if Drayer’s team are able to meet such demands, but with a wealth of knowledge and a multitude of experience, the odds are definitely in their favor. n

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IMAGING

Location, location, location Mayo Clinic’s Richard Robb explains how advances in three-dimensional digital imaging help surgeons locate their targets with pinpoint accuracy.

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t all starts with a 3D image. Modern scanners are wonderfully capable of providing the data for making 3D images because they scan very fast adjacent, thin slices. These slices might be less than a millimeter apart around the anatomic region of the body of interest. I then get these stacks of slices of CT scans and MR scans in my lab – one way to think of them is like stacks of pancakes.

We then render three-dimensional images from this using computer algorithms, which make the fundamental transformation from this stack of slices into a recognizable three-dimensional image that then can be displayed in a variety of ways, rotated around, measured and manipulated.

That’s where we start, with the development of a 3D rendition of this stack of slices provided by the medical imaging scanners.

How it’s different from conventional X-ray imaging, which we’ve had available for a long time, is that it’s quantitative. When you take a typical X-ray you get a visual depiction of the inner organs superimposed upon each other, but the CT scanner and the MR scanner and other 3D scanners take images at individual little pixels or boxels inside the body, so we have truly a three-dimensional array of data that is a bag of numbers.

In the three-dimensional space we have numbers for every small piece of tissue that was seen by the scanner.

That may seem like a simple thing, but it’s a tremendously powerful advantage that digital imaging has over conventional X-ray imaging, because now we can put these data into a computer, which understands and can make measurements from numbers, and can create new displays from them.

Modern scanners are calibrated well enough, and understood well enough, that these numbers correlate to certain things about the tissues that we’re imaging, including as important an issue as differentiating normal from abnormal tissues, and detecting disease and how bad the disease is. This gives us a quantitative representation of what’s going on inside of the body, not just a picture.

Another advantage of having a digital image and having it in the computer is we can manipulate it. The computer can turn it around or can cut into it and can display any view of interest to the physician, to the surgeon, to the scientist or engineer, or whoever might be using the image.

And finally, images are very valuable in medicine for providing two major new capabilities that we didn’t have two decades ago. One of these is computer-aided diagnosis – we can assist the physician in making a more accurate, sensitive and specific diagnosis of the disease from these

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© Images provided courtesy of Mayo Clinic

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This information is now used to plan the surgery. The big benefit of that is not only a better outcome to the patient, because the tumor is removed, but it also reduces morbidity, which means there’s less risk and less chance that you’ll do damage you don’t want to do in the operation.

It’s done faster because you know exactly what you’re going to do before you go in, there’s no time wasted on exploring around and figuring out what you’re going to do after you get into the operating site.

Targeting is a term we use that says we know not only where the bad guy is, we also know where the good guys are.

That is, we have the bad tumor but we have the good tissue that has not been invaded by the tumor yet. I sometimes think of surgeons as being like real estate agents – everything to them is location, location, location.

It isn’t just knowing where the tumor is, it’s knowing where it isn’t, and where the other critical structures are – in the brain it could be language centers or cognitive centers, and you don’t want to accidentally cut or remove that brain tissue if you don’t have to.

This is a tremendous benefit to the patient, but it’s of tremendous benefit to the healthcare industry, too, because this whole procedure has taken less time, and it has less morbidity so you don’t have the same length of hospital stay. And the whole process costs less.

Adding up

IGI system for ablation of cardiac arrythmias quantitative images.

The images themselves can also be used in the therapy process. They are increasingly used to navigate and target surgery or radiation treatment, for example, with much more precision and reproducibility in less time than we before.

In the neighborhood Let’s take one of the examples that is pretty familiar to everybody: a brain tumor. When a patient presents with headaches and has a brain tumor, two or three decades ago you took X-ray pictures, and the surgeon often had to do exploratory surgery to find the tumor and to remove it.

Now with 3D imaging and the high resolution we get with CT scanners and MRI scanners, we can look inside that patient painlessly and non-invasively and eliminate exploratory surgery. A patient who has a brain tumor now can have an MRI and a CT scan and maybe also a PET scan, which tells us something about the function. Before the surgeon operates he or she knows precisely where the tumor is, how large it is, what kind it is, and what are the adjacent critical structures that need to be considered and avoided in attempts to remove the tumor.

Imaging is high resolution and fast and able to discriminate a brain tumor and other kinds of abnormal tissues from the normal tissues.

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Sometimes technology gets blamed for the high cost of healthcare, but I think you have to be very careful about that presumption and evaluate what would have been the real cost of the morbidity and extended hospital stays if you didn’t have the technology. My view is that three-dimensional imaging technology helps in diagnosis and helps in therapy and also reduces healthcare costs.

Yes, these scanners cost hundreds of thousands of dollars – some more than a million dollars.They’re a big, expensive capital equipment item. But you have to compare that cost of the initial capital investment with the savings in the services that this instrumentation provides.

Another exciting area is multi-modality imaging: any one imaging system does not provide all the information that we’re able to get by combining imaging systems. For example, a CT scan tells us something a little different about the brain than an MRI scan. If we can put them together, it’s truly a synergistic situation. One plus one is greater than two.

Two images together tell us a lot more about the normal brain and the abnormal brain than either image on its own. We call this process image fusion: putting multi-modality images of the same patient together so we get more information about what’s wrong with the patient or where the problem is, so that we can more effectively diagnose and treat the patient.

Let me give you an example. For a long time, patients with epilepsy who had intractable seizures that didn’t respond to medication had a low quality of life because they had several seizures a day. The only treatment that was effective was removal of the small parts of their brains that were causing these seizures.

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The diagnostic and therapeutic challenge and problem is where is that in the brain? What part of the brain is having aberrant electrical activity giving rise to these seizures? It isn’t dense like a tumor, so if you use a CT scan or an MR scan, it will look like normal brain tissue because it’s really just electrical activity in a piece of brain tissue. The question is, how do you find that?

We do a functional image scan with a PET scanner or a SPECT scanner.

These imaging systems show us function in the brain rather than morphology or anatomy. We inject a radionuclide into the bloodstream and while that radionuclide is circulating in the blood in the brain we take an image with a SPECT or a PET scanner, and it finds out where this radioactive tracer lodges in the brain. It turns out that if you inject this in a patient with epilepsy shortly after a seizure, this radionuclide bunches up and collects in the region of the brain that’s over-excited because of the increased blood flow there, and this is the region of the brain that’s causing the epileptic seizure.

This is a low-resolution image and it’s not an anatomic image. It’s like a flashlight in a tunnel. It’s like looking down in a cave and you see a flashlight somewhere – you’re in the brain and you see where the problem is, but you can’t see the rest of the brain. That’s what this functional image shows us. With fusion, we take that image and register it to combine it with an MR image, which gives us exquisite information about the anatomic detail of the brain. © Images provided courtesy of Mayo Clinic

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Exact science We superimpose this flashlight, this region of interest, through our mathematical algorithms directly on to the brain surface where that radionuclide collected during the scan after the seizure. Now we have an Image fusion: CT + MRI + PET image that we can use to show the neurosurgeon exactly what piece of brain tissue to remove.

Image fusion is a technique that was developed by my lab, in working with the neuroradiologists, neurologists and neurosurgeons here at Mayo Clinic in the 1990s. It is used routinely three or four times a week to treat a lot of pediatric patients successfully with highly improved outcomes and with lower costs. It is now used in almost every major medical center in the world to treat patients with intractable epilepsy.

There is another wonderful technology that has come about in the last decade, which we call 3D printing. It’s an actual printer, like you would attach to your computer, except it prints three-dimensional models. It makes models out of special materials, and the input to this printer is not a string of alphabetic characters or numbers, it’s the surfaces of an object that we have segmented from a three-dimensional CT scan.

For example, it could be the brain, it could be the liver, it could be the heart, it could be part of the skeleton system, like the spine, or any part

of the body in which the surgeon is interested in operating.

Pre-operatively, we can take the CT scan not only to plan how to do the surgery but to see a replica of that patient’s skeleton. Let’s say a spine surgeon has a patient with a serious fracture in the lumbar spine and he’s going to put in screws and plates and braces to shore up the damage.

With a CT scan not only can he plan how to do that using the images on the computer screen, but we can print an exact model of that patient.

We call this patient-specific imaging. We can make a life-sized model on this 3D printer. We feed it the CT, we process the CT scan where we have segmented out the bone: all of the spine in the region where the spine surgeon is going to operate.

Making models We send that data to this 3D printer and it takes about an hour, depending on how large the model is, for it to lay down very thin layers of this special material. The material is soft, and when we take it out it takes a while to cure and dry. Then it’s an exact replica of that patient’s anatomy.

How does the surgeon use that? There are a variety of ways.

Sometimes he or she just looks at it to confirm his or her suspicions. It’s one thing to look at a three-dimensional image on a computer screen, and it’s quite a different thing to hold in your hands the actual spine or liver or heart of that patient and understand how big it is, where the grooves are, where the curves are, where the damage might be, and see exactly and hold exactly what you’re going to see when you open up the patient to treat the condition. It’s a very valuable part of the rehearsal for the operation.

Let me give you another example. My lab has been very fortunate, on five different occasions since the early 1990s, to be involved with a Mayo team of physicians, radiologists, scientists and engineers in separating conjoined twins.

And imaging, which was never designed specifically for the purpose of aiding in the process of planning a separation of conjoined twins, is in fact the primary modality and capability that we have to make these surgeries successful in every instance, and the end of the story is these were successful surgical separations at Mayo.

What our laboratory did was take these twin babies’ scans while they were together and process them in many of the same 3D ways that I’ve been describing, to show the pediatric surgeons exactly what the babies looked like inside, how they were joined, where they were joined, what organs they might share and how far away certain vital structures were in one baby versus the other.

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By contrast Contrast material always plays an important role in imaging. It is used to tag tissues, when we can’t see with our normal imaging devices the things that the contrast material will enhance in the image.

Examples might be iodine injected in the bloodstream to see the coronary arteries, or gadolinium injected into the bloodstream to highlight tissues with MRI scanning. Or the radionuclide tracer that will flow through the body and preferentially be taken up by excited tissues, which we couldn’t see otherwise without the injection of the contrast material.

There are times when we don’t have to use contrast at all, but sometimes it’s still necessary and there has been an improvement in contrast materials so that you can use low doses of the contrast, and it tags the information, the tissues, the functions that you want to see better than previous contrast materials or higher doses. This is a very important advance in medicine.

The whole field of biomarkers is also exciting, where you selectively inject substances into the body and they only light up when they get to their target.

They’re targeted to certain kinds of cells, certain kinds of biological elements inside the body, and these substances roam around in the body until they find them and then turn on the flashlight and we can image that.

If you think of the surgeon as a person who has to navigate through the body in three dimensions, going around, under and missing things to get to the target, then knowing where the target is is one thing. You know it’s in there and you can figure out a path to it, but you have to get to it efficiently.

That oversimplification explains how 3D imaging helps reduce the procedure time because you don’t have to spend much time figuring out the most safe path or running into things that you didn’t expect and having to back out and do something else. You have this precise 3D roadmap of pathways that you can pursue that will get you to the target efficiently and safely. And this reduces time.

“Instead of seeing a 2D projection we have the true 3D relationships of all the organs” That reduction in time not only improves the outcome, but it also reduces the risk of collateral damage, which historically has always been the challenge of surgery; even in a good surgeon’s hands sometimes that happens.

Improved care The way digital imaging technology has improved patient care compared to non-digital technologies like film, is quantitation – numerical, quantitative assessment of the patient’s disease.

The second thing is that it’s 3D, and even 4D. Instead of seeing a 2D representation or projection like an X-ray film has, we have the true threedimensional relationships of all of the organs and structures in the body that are provided by the imaging scanner.

And the third is that the digital image means that we can use the power of computers and the creativity of human beings who know how to program those computers to visualize that anatomy and pathology in ways that cannot be visualized or seen with plain film, with X-rays or non-digital techniques.

It provides these wonderful opportunities for what I call computeraided diagnosis and image-guided interventions, and both of those

Richard Robb is Director of Mayo Clinic’s Biomedical Imaging Resource. He has been involved in the development and application of computer systems for the processing, analysis and display of biomedical image data for more than 30 years.

things have significantly impacted and improved clinical diagnosis and treatment.

Images are often used in therapy monitoring, too. You’re not necessarily done imaging the patient after you’ve treated them, especially if they have cancer or another serious condition and they come back, or if you didn’t treat them with surgery or they were given a drug or radiation to try to reduce the tumor or remove the tumor. The way you assess that treatment regimen over time is through imaging.

You image the area again to see what the effects of the treatment are.

This means that if the treatments aren’t effective, we don’t have to submit patients to a long drug trial, for example, or have them stay on the same drug that isn’t making any difference. We image them every month or six weeks or whatever the protocol requires and if it’s not working we change the dose, or change the drug or change the radiation orientation. Imaging plays a significant role in deciding if whatever therapy is chosen is effective and then modifying that therapy if necessary.

What has driven me and my laboratory in all of this over the years is a comment that a neurosurgeon made to me when I came to Mayo Clinic in the early 1970s, when this type of 3D imaging first became available here in the US. I began working with imaging in Dr. Earl Woods’ lab, and I remember showing a famous neurosurgeon, Thoralf Sundt, these images and how we might be able to show him tumors in 3D. They weren’t very good quality then, but he got it right away, and he said to me something that I’ll never forget: “If I can see it, I can fix it.”

That became a mandate for my career. I thought, “Okay, I want to show it to you. I want to show it to you better and better and better and more often and accurately, so you can fix it.”

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ROUNDTABLE

Developments in contrast imaging EHM speaks to a panel of industry experts about the opportunities and challenges that currently exist in the contrast imaging space.

EHM. With respect to research and development, can you explain how your efforts are currently aligned with the needs of your customer in the imaging space?

Anthony Lombardo. Our customers need, and want, solutions that enable them to get good images; better understand how to treat all patients, particularly those at high risk; maintain and even reduce costs; and manage the entire process smoothly and in a way that is tailored to the individual needs of each patient.

Customers are looking for a partner that can help them deliver the right contrast, for the right procedure, for the right patient, with the right protocol and at the right cost. This is the guide we use to manage our pipeline of products.

Our objective is to tailor our existing products to new technologies while managing our R&D pipeline to respond to future developments in the industry. As an example, we’re carefully watching ultrasound contrast imaging, already being used in Europe, and we’re also watching with great interest the use of biochemically targeted drugs that are just now coming into wide therapeutic use.

Richard Lytle. At Covidien, we design our research and development activities to correlate with the market feedback we receive. Our goal is to meet our customers’ requirements and support their efforts to meet their patients’ needs.

In fact, since Covidien’s split fromTyco International in 2007, we have more than doubled our research and development investment in the imaging space.

We are committed to helping clinicians diagnose disease as early as possible with innovative ‘best-in-class’ products and services focusing on cardiology, oncology and delivery systems. Our partnership with customers is the inspiration for product innovations that meet the needs of healthcare professionals and patients.

Kathleen Deardorff. Our R&D efforts must support the daily clinical decisions that are made by physicians and not just individual products. To that extent, we have a rigorous process that drives our R&D program from close contact with key luminaries in various therapeutic disciplines to the types of imaging procedures completed and challenges that are trying to be solved. This foundation has GE focused on three main areas: cardiology, oncology and neurology. It also has put us at the forefront of the evolution of imaging from a ‘one size fits all approach’ to an ‘individual need’ as we increase investment in the future of molecular imaging as well.

Melissa Buchanan. Guerbet invests nine percent of sales and 160 employees into research and development, focusing on cardiovascular disease, oncology and inflammatory/neurodegenerative conditions. These efforts and our work with a worldwide network of scientific partners, allow us to bring high-quality product solutions to customers across the globe.

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Anthony A. Lombardo is Chief Operating Officer of Bracco Diagnostics Inc., and has been involved in the diagnostic imaging industry for nearly 25 years. In his role at Bracco, Lombardo leverages his extensive experience running global business units in the healthcare industry and his intimate understanding of both domestic and international operations.

Richard A. Lytle is Vice President and General Manager, Imaging Solutions, Covidien. He is responsible for directing the US sales, marketing, pharmacy operations, sales training and distribution functions for the Imaging Solutions Division of Covidien. The Imaging Solutions Division is a leading manufacturer of contrast media, delivery systems and nuclear medicine products and services.

Kathleen P. Deardorff has held several strategic marketing leadership roles in GE’s Medical Diagnostics business. Presently, she is the Head of the Global Marketing Organization and Product Acquisition and Licensing. Deardorff is responsible for providing leadership and marketing direction for the Medical Diagnostics team, building on its heritage of a strong marketing focused organization. She is also a member of the Medical Diagnostics Executive Committee.

Melissa Buchanan is Associate Brand Manager at Guerbet LLC. Buchanan has an undergraduate degree in Business Operations through the Kelley School of Business at Indiana University, and earned her Master of Business Administration from Butler University in 2008. She has worked in the pharmaceutical industry for the past seven years.

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Guerbet’s offering in the US includes Oxilan (ioxilan injection) and Hexabrix (sodium and meglumine ioxaglate), two low-osmolar and low viscous imaging agents, which provide patient comfort, visibility and safety. We anticipate exciting new data on the renal safety of both products in 2009.

First, Dr. Per Liss shared preliminary information at RSNA 2008 confirming the renal safety of Hexabrix within one year after injection. In addition, we look forward to the American Journal of Cardiology June 2009 publication of registry data compiled by Dr. Refat Jabara at St. Joseph’s Research Institute. These data address renal safety and support Oxilan as an effective and safe contrast media.

EHM. What are the most critical factors, as your company identifies them, that you feel need to be communicated, integrated and executed at the clinical level from a medical diagnostics perspective?

AL. One critical factor is the efficacy and safety of contrast media, especially in the wake of media coverage of contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF). We’re already conducting clinical stud-

ies, and we will share the results so medical professionals can better inform patients and improve their practice.

We’re seeking to place relevant, life-saving data at clinicians’ fingertips, whether through innovative web platforms or making protocols available on advanced delivery systems. We also offer a robust portfolio of educational offerings. In fact, many of these educational offerings help physicians, technologists and nurses fulfill their continuing medical education (CME) requirements.

Another important factor is helping customers better understand how to manage high-risk patients. As the US population ages, radiologists will see an increasing number of high-risk patients in the over-65 age group.

They’ll need to understand these risks and how to address them.

The reality of the current reimbursement situation also creates challenges for radiologists as they seek to increase workflow and throughput while also focusing on providing patients with quality healthcare. We’re helping customers deal with the financial realities of reduced reimbursements.

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RL. Risk reduction is one of the key challenges facing the radiology comcontrast, “Any true difference between the agents (in terms of the rate of conmunity. As the number of CT procedures performed each year continues to trast-induced nephropathy) is small and not likely clinically significant.” rise, so does the potential for medication errors in radiology departments.

We are working with leading industry physicians to demonstrate that Advancements in injector and integrated delivery system technologies can the viscosity of the contrast media is also an important property, which help address the concern for medication errors and patient safety within must be considered. Dr. Michele Voeltz coined a new contrast media clasthe hospital setting. sification distinguishing low viscosity contrast media (LVCM) from high At Covidien, we continuously work toward solutions designed to help (HVCM) in her article published in the Journal of Invasive Cardiology, which enhance patient safety, reduce medication errors, prevent infection and inhighlights the important role that viscosity can play. Guerbet is proud to crease efficiency. For example, our RFID-enabled system (the Optivantage offer two contrast media products, Oxilan and Hexabrix, which provide a dual head CT contrast delivery system combined with the Ultraject prefilled balance of low viscosity and low osmolality. syringes and RFID technology) creates an intelliIn addition to this balance, Hexabrix also progent interface between the contrast media syvides the unique anti-coagulant properties of a low ringe and the power injector. This, when both osmolar ionic contrast media, as demonstrated in components are RFID-enabled, helps radiology several clinical and in vitro studies such as those technologists ensure that each patient receives

by Grines et al (JACC 1996) and Le Feuvre et al the prescribed concentration and programmed (Catheter Cardiovasc Interv 2006). With the indose of a contrast media-related drug during a creasing focus on prevention of thrombotic events, procedure. we hope to help make physicians aware that When properly used, this system helps safeHexabrix is the only proven option, which provides guard against certain life-threatening medication an added layer of protection for their patients. errors, prevents accidental air embolism from using an empty, used syringe and prevents acciEHM. What are the main challenges facing the dental patient cross-contamination from using a contrast imaging business in the short-term, and partially used syringe in another patient exam. how are you addressing these challenges?

In addition, the concern over meeting qualiAL. Clearly, many clinicians’ concerns now revolve ty standards in radiology is ever growing. We are around the Deficit Reduction Act (DRA) and the inKathleen P. Deardorff committed to helping radiology departments correct perception that imaging is an overused and comply with standards set by the Joint often unnecessary medical procedure.

Commission, an independent, not-for-profit orgaIn 2008 alone, there was a projected loss of nization that certifies more than 15,000 health$1.2 billion in Medicare technical payments due to care organizations and programs in the United DRA, and $1 billion due to the CMS contiguous States. Using Covidien’s prefilled syringes helps body part reductions. Bracco is one of many comradiology departments meet the requirement to panies that remain steadfast in activities that comuse the most ready-to-administer product, reducbat the perceptions and fight for reimbursement ing the need for hand labeling compared with that policies that reflect the reality of healthcare today for manually filled syringes and decreasing the and better serve the patients who place their trust Melissa Buchanan number of steps necessary for compliance with in caregivers. these national patient safety guidelines.

How does Bracco enable its customers? We do this using a three-pronged approach: KD. Things move fast and decisions must be made quickly. Communicating outcome data is vital, but the complex na1. Solutions in contrast: We provide a variety of products/sizes that are taiture of clinical trials, data, evidence-based medicine and clinical experience lored to customer needs in MRI, CT, oral imaging and upcoming uses such cannot be summed up in five-minute sound bites. We believe that underas dysphagia, and integrate them with delivery systems standing what goes into a clinical trial, how there are differences in struc2. Science: We back up this portfolio with valuable clinical evidence to adture and results and what can be taken away from trials in the name of dress the issues, old and new, that are facing our customers patient management is vital. Communicating this and how our products fit 3. Services: We provide our products along with the science behind the into overall clinical practice is essential. products through an articulated system of well-trained sales consultants, clinical specialists and medical professionals.

MB. Guerbet believes strongly that the choice of contrast media has an important impact on patient outcomes. The discussion of contrast media has RL. Economic pressures are challenging businesses, industries and most centered on a product’s osmolality, which is an important factor, but certainimportantly, our customers, throughout the world. Covidien is commitly not the only factor. Research by Dr. Richard Solomon in the CARE study sugted to helping our customers manage through these challenges by maingests that when comparing iso-osmolar contrast media with low osmolar taining its focus on delivering innovative and cost-effective clinical and

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economic healthcare solutions, which help to both enhance the quality of life for patients and improve outcomes for our customers and our shareholders.

KD. There is no question that imaging, particularly in well-developed markets such as the US, is undergoing a scrutiny unlike anything we have witnessed in prior cycles. One of the main challenges, and opportunities, is to work together – manufacturer, hospital, society and government – to not only identify the vital role that imaging has in today’s patient management but also the vision that it provides for the future in terms of aiding the prevention of disease earlier and managing it earlier, both significantly improving outcomes and ultimately overall healthcare costs.

There also is a tendency to be focused on cost for the sake of cost alone. These are pharmaceutical products that are used on people every second of the day – we must make sure we never forget that, and understand patients for the individuals they are and identify the best overall imaging solution for them.

MB. For the next 12 to 18 months the contrast imaging business is facing challenges very similar to that of the medical industry as a whole.

Increasing economic pressures, such as reduced Medicare/Medicaid reimbursements, are forcing our country’s hospitals, imaging centers and clinics to make difficult cost-cutting decisions. We see increased consolidation in the industry across all players, including healthcare providers, group purchasing organizations and imaging companies.

At Guerbet, we address these challenges by furthering our expertise as an imaging specialist company and investing in our customer relationships. This commitment to our customers allows us to be a true partner; we can then work together to find solutions to these challenges.

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RL. Continuing to provide innovations to customers that bring value and help to improve the diagnosis of disease will be a challenge for the industry over the next few years. To do this, we need to engage in activities that drive a culture of quality and compliance. As a pioneer and innovator, Covidien will foster growth in our research and development pipeline to bring forth new technologies that advance insight for customers every day, providing critical knowledge and furthering their understanding of each case, to help them make insightful diagnoses.

We will continue to provide the products needed to assist practitioners in the early diagnosis and treatment of disease to deliver better patient outcomes and improve lives.

Anthony A. Lombardo

Richard A. Lytle

EHM. Taking into consideration technology and paradigm shifts, patient profiles and new compounds – what are the main challenges facing the contrast imaging business in the next two to five years, and how are you preparing to address these challenges?

AL. There are increasing calls for healthcare reform in the United States and other countries. As the Obama Administration begins to shape its healthcare agenda, the two themes that have emerged thus far are preventing errors and using technology to improve and co-ordinate care. What better way to prevent errors than to have an accurate diagnosis in the first place? The imaging industry will have an increased and important role to play in that regard. But we also must make certain that we fully communicate the safety and efficacy of contrast imaging solutions. That means continuing our research and clinical studies. We also need to work together with the device manufacturers

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so that we can supply clinicians with what they need to optimize imaging procedures.

KD. We must consistently remind ourselves and all affected parties of the importance of imaging on the patient, and the only way to do this is to have an open, honest dialogue about imaging, agents, safety, appropriateness and working together to deliver healthcare in a more efficient manner.

New procedures and diagnostics will provide improved healthcare and be sought after and it is important to work collaboratively to allow this to occur in a way that keeps the patient in mind.

MB. I would say that there are more opportunities than challenges facing the contrast imaging business in the next two to five years. Magnetic resonance (MR) procedures are growing, which is fuelling growth in the MR contrast media market.

This growth, however, is somewhat tempered by the rising concern over nephrogenic systemic fibrosis (NSF). Guerbet is currently conducting clinical trials in order to bring an MR product to the US. Although the X-ray contrast media market is somewhat more mature, we continue to expect modest but stable growth. Emerging technologies such as drug eluting stents and increasing use of computed tomography angiography (CTA) are driving the conversations among industry leaders, and contrast selection can play an important complementing role. Guerbet is focused on being a resource partner for our customers; supplying them with specialist product knowledge and contributing to their long-term success.

Patient information for Guerbet LLC Oxilan NOT FOR INTRATHECAL USE Please see full prescribing information at www.guerbet-us.com.

Hexabrix NOT FOR INTRATHECAL USE Hexabrix is contraindicated for use in myelography.

Please see full prescribing information at www.guerbet-us.com.

EXECUTIVE INTERVIEW

Meeting customers’ needs Kathleen Deardorff explains why innovation is important in challenging times.

EHM. This is a challenging environment for healthcare. How has your strategy transformed during these times and do you see the future differently for GE Healthcare Medical Diagnostics?

Kathleen Deardorff. As we always do, we are being as responsive as possible to our customers. We are offering an expanded array of products to meet every need: diagnostic, medical and financial.

But the most important thing we’re doing to help our customers through these challenges is continuing to innovate. Last year, we submitted AdreView for approval, and received a priority review and approval. This year, we plan several more submissions to meet myriad imaging challenges, from Parkinson’s disease to congestive heart failure.

GE Healthcare is not only positioned well for our business, but we’re well-positioned to meet our customers’ needs.

EHM. Let’s talk for a moment about your vision – particularly for medical diagnostics.

Why GE? KD. That’s a great question. The vision is simple: to lead the way in providing quality medical diagnostics that impact the lives of patients. It’s really our mission and helps remind each of us every day why we are doing what we are doing. Our medical diagnostics team has a portfolio that spans modalities, and more importantly, therapeutic disciplines.

GE is a unique entity in our ability to bring every discipline of healthcare infrastructure to our customers. From the electrical systems that power our imaging devices to the cyclotron that produces the molecular imaging agent, to the security system that keeps it all safe, only GE is capable of being such a one-stop shop for everyone who touches healthcare.

Additionally, our expertise is first rate.

We have imaging representatives who have worked here for more than 20 years. You can’t hold a track record like that without

to meet it. This year our R&D efforts will pay off with submissions for diagnosing neurological ailments, cancer and heart disease.

Our best bets lie in those areas, though we look to succeed in several others as well.

“The vision is simple: to lead the way in providing quality medical diagnostics that impact the lives of patients” listening and responding to your customers.

So, “Why GE?” is simple: we are a company that can truly re-imagine the way healthcare is delivered, and we have the people, the products and the resources to do just that.

EHM. Times are tight for all business today.

Are you investing, and what are your best bets?

KD. Absolutely. In fact, these are exactly the times when the greatest returns on investments are earned. We continue to invest heavily in research and development – $20 million more than last year, in fact. We are looking out on the horizon for the next medical need and developing an imaging product

EHM. What is the outlook for your contrast media business? Are you investing here, as well?

KD. Definitely. Our X-Ray portfolio (Omnipaque and Visipaque) and MR (Omniscan) are not only core to our business but to a great majority of hospitals and clinics, as well.

Evidence-based medicine is comprised of both clinical data and physician experience.

Our main goal is to continue to partner with physicians to understand the critical nature of understanding various risk factors (cardiovascular, nephrological, etc.) in the patients they see as well as the adverse event profiles of various agents and make the best decisions for their patients. This takes time to really understand that not all clinical data are the same. Similarly, there are many clinical issues that cannot be summed up in five-minute soundbites with complexities that may drive more questions than answers. We continue to ensure that these products are researched, as well as work with customers to help them truly understand the issues required for good patient management. n

Kathleen P. Deardorff has held several strategic marketing leadership roles in GE’s Medical Diagnostics business. Presently, she is the Head of the Global Marketing Organization and Product Acquisition and Licensing.

Kathleen is responsible for providing leadership and marketing direction for the Medical Diagnostics team, building on our heritage of a strong marketing focused organization. Kathleen is also a member of the Medical Diagnostics Executive Committee.

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INDUSTRY INSIGHT

SMALL ANIMAL IMAGING IN THE ERA OF MOLECULAR MEDICINE New technologies for imaging molecules are increasingly being used to understand the complexity, diversity and in vivo behavior of diseases. By Staf C. Van Cauter

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hile various genomic and proteomic approaches are providing comprehensive ‘snapshots’ of biological indicators, or biomarkers, of many disease states, non-invasive imaging can take this information a step further, showing the activity of these markers in vivo and how their location and activity changes over time. Advances in experimental and clinical imaging are therefore likely to improve our understanding of diseases at the systems level, which will ultimately lead to efficiency improvements in the development of new therapies. In this respect, in vivo imaging is unique in that it is able to track and monitor biological processes of an animal over a period of time and throughout the body, thus aiding in the analysis of drug distribution, side effects and the effects of therapy.

Over the past few decades, multiple new technologies have been introduced into the field of non-invasive imaging. These have included anatomical techniques such as X-ray CT (X-ray computed tomography), US (ultrasound) and MRI (magnetic resonance imaging) imaging, and molecular or functional imaging techniques such as SPECT (single photon emission computed tomography), PET (posi-

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tron emission tomography) and non-invasive optical imaging. Some of these imaging technologies have seen clinical use for decades.

Indeed, anatomical technologies such as CT, US and MRI have become diagnostic staples of current clinical practice. Likewise, the functional imaging modalities PET and SPECT have found broad clinical use in cardiac function testing and in oncologic disease diagnosis and staging. These decades of experience have progressed an understanding of the utility of these methodologies to clinical assessment, disease progression monitoring and treatment response. Advances in clinical understanding have been accompanied by technological advances in instrument performance and image reconstruction software, resulting in improved image quality, visibility and interpretation.

Human non-invasive imaging is now a mature technology with proven clinical applicability. However, what has been a challenge in the molecular imaging field is overcoming the limitation of human PET and SPECT scanners for use with small species. Indeed, the main challenge in PET and SPECT scanner development for small animals is the design of systems with high spatial resolution (in the nanoliter range) and high sensitivity (in the picomolar range) at the same time. Opti-

cal imaging technologies on the other hand have the required sensitivity, but limited penetrability into living organisms. While this favors small animal work, it complicates the translation of results to humans. This in turn is a significant disadvantage of the use of optical imaging for the development of new therapies.

Translational challenge Functional imaging modalities include optical (bioluminescence and fluorescence) and PET and SPECT. Optical imaging represents the low-cost option and is capable of efficient, high throughput functional assays in rodents. However, it has limited spatial resolution and 3D imaging capabilities and suffers from a severe depth of penetration limitation, making the technology unsuited for translational studies. As for imaging rodents, most optical techniques are limited to imaging xenografts. The obvious advantage of the flank model is the convenience of measurement, but this convenience comes at the cost. It has been well documented that many xenograft models lose their tissue-specific characteristics and can be considered primarily a general model of cancer, most useful for identifying broad-spectrum cytotoxic drugs aimed at widely shared cellular processes such as proliferation or basic metabolism. In the emerging age of targeted therapeutics, this is increasingly problematic.

Unlike optical imaging techniques, PET and SPECT can probe subtle molecular signals deep within tissue, making these technologies suited for use with both xenografts and spontaneous cancer models, and applicable to both small and large subjects. The ability of PET and SPECT to penetrate large subjects has lead to the establishment of these modalities as clinical standards of care and therefore, pre-clinical discoveries and developments using these technologies are more likely to translate into the clinic. Although the theoretical capabilities of SPECT and PET are

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ideal for translational imaging purposes, the practical use of SPECT and PET for imaging very small animals such as mice presents several challenges beyond those faced in clinical faculties. First, because mice are 1500 times smaller than humans, small-animal imaging must achieve sub-millimeter resolution so that images in mice can be obtained with the same visual acuity as in humans. Second, a high level of detection sensitivity is needed to minimize the amount of radioactive probe to such an amount that it can be injected, and at the same time, to allow procedures to be completed within a time period of maximum 30-45 minutes during which small animals can be anesthetized safely.

With the recent introduction of new ‘nano-technology’ based nuclear imagers, the NanoSPECT/CT and NanoPET/CT systems, it has become possible to obtain images from subjects such as mice with virtually the same detail as can be obtained from human scanners used in the clinic (see images below).

These modern nuclear imagers meet these challenges by combining nanoliter volumetric resolution with picomolar detection sensitivity, and by automatically fusing high-contrast PET and SPECT images with the anatomical details of X-ray CT.

Molecular imaging technology While optical imaging represents the lowcost option and is capable of efficient, high throughput functional assays in rodents, its application is limited by depth of penetration, 2D rather than real 3D tomographic images,

Mouse D2 receptor Uptake

Neuroscience

limitations in labeling strategies and a lack of applicability in translational studies. The new nuclear technologies embedded in the NanoPET and NanoSPECT systems on the other hand, represent high resolution, high sensitivity functional methodologies well suited for translational applications from mouse to man. PET and SPECT each possess relative strengths and weaknesses. PET isotope and tracer availability is more limited than for SPECT, but PET is essential for imaging small molecule drugs, due to the characteristics of its available isotopes. SPECT, on the other hand, offers easier access to longer-lived isotopes which are well suited for labeling biologics (peptides and antibodies) and for use with biomarkers.

For an introduction to the power of functional imaging, optical imaging is hard to argue against, except that its suitability for cancer models other than flank models remains largely unproven. For the most general range of applications, X-ray CT combined with PET or SPECT are the most appropriate technologies, with PET offering small molecule studies and SPECT more applicable in a biologics-oriented laboratory, or for monitoring the therapeutic effect on biomarker response. In this respect, a second important consideration is the kinetics of the drugs under study.

For drug candidates with slow kinetics, the best approach is to use SPECT tracers because of the longer half-life of these radioisotopes. These drugs fall usually in the category of biopharmaceuticals; larger

Human Healthy control

ADHD: nonresponder

Dopamine wl [99mTc] TRODAT

(99mTc) MIBI

Cardiovascular

Stress [99mTc] MIBI

(99m Tc) Minigastrin

Oncology

Renal Cell Carcinoma

Staf C. Van Cauter is Executive Vice President of Bioscan Inc in Washington, DC. Prior to joining Bioscan, Van Cauter was Corporate Vice President and Chief Technology Officer of Packard BioScience Company until its acquisition

by PerkinElmer, Inc. He served as a strategic consultant to PerkinElmer from 2001 until 2003. He holds a Masters Degree of Science in Industrial Engineering from the Higher Institute for Technology in Mechelen-Leuven, Belgium, and completed post graduate studies in Business Administration at the University of London.

molecules for which the addition of a SPECT radioisotope does not impair the action of the drug or biomarker. For small molecules on the other hand, the PET isotope 11-C is the ideal radioisotope since it can be synthesized in the candidate drug. Unfortunately, the very short half-life and the low specific activity of this tracer restricts the use of C-11 tracers to molecules that can be relatively quickly synthesized and for imaging studies of short duration. For other small molecule applications, radiohalogens for PET and SPECT may have to be used instead. In this respect, one of the advantages of using radiohalogens for SPECT is the ability to use I-125 and I-131 tracers used commonly for in vitro and clinical in-vivo studies respectively.

Since NanoSPECT/CT has the unique ability to handle both these isotopes equally well, the system can be used to bridge both the in vitro to in vivo gap and the translational mouse-to-human gap. Indeed, maintaining a consistency in the imaging protocols and the biomarkers used at the bench and in the clinic is a prerequisite for speeding up translational research. n

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PHARMACEUTICALS

PATIENT POWER In these turbulent times for the health sector, good communication with patients is more important than ever. Millennium’s Isabelle Mercier tells EHM about the rising power of patient influence in the realm of pharmaceutical marketing.

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s we continue stumbling through times of uncertainty, the call for transparency and accountability has been heightened throughout society, from senators who don’t pay their taxes, to over-the-top executive bonuses. The same is true for the coordination of marketing in the health and pharmaceutical industries, as the power of patient desire for information is determining the way in which pharmaceutical companies operate.

“Patients have become much more aware of and assertive in finding information about their disease and their treatment options,” says Isabelle Mercier, VP of Marketing at Millennium. “What’s changing, from a marketing perspective, is the way in which we provide additional information and insights to the patients, allowing them to become more informed and educated about their treatment options.

“From a marketing perspective, we have to be prepared to engage them differently: traditionally it’s been more the healthcare team being the conduit of information to the patient, but increasingly you hear of the patient coming in with printouts from the internet, with information they heard on the radio or saw on TV, demanding more from their healthcare team. We as a pharmaceutical company have an opportunity to play a role in educating patients, which is probably the most striking change in the pharmaceutical marketing.”

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More responsibility Pharmaceutical companies are now facing the responsibility of providing patients with treatment information and must take on a more informative role than they have previously. “The most relevant trend is that of demand for full disclosure of information, which is becoming more stringent. That full disclosure is an opportunity for the pharmaceutical company to enhance the understanding of the treatment options and/or the particular therapeutic option that the pharmaceutical company has to offer,” says Mercier. A greater role of responsibility, if seized upon with an opportunistic approach, can allow pharmaceutical companies to approach healthcare with an element of creativity as they provide more valuable and insightful information.

In her new role as Vice President of Marketing, Mercier will be leading and developing the US and global marketing strategy for the commercialization of late phase development products, along with oncology market products. “Millennium is specific to oncology and has a vision of developing and delivering first class therapeutic agents, aiming to offer more patients across the globe new innovative therapeutic agents to advance cancer care.

“When you look at the portfolio of pipeline agents, the late phase products, as well as currently marketed products, are either best or first in class,

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MILLENNIUM HISTORY Millennium Pharmaceuticals, Inc., was established in 1993 as a genomics company applying world-class recombinant technology to the discovery and development of innovative new therapies in a broad spectrum of diseases.

Millennium has since grown into a fully integrated biopharmaceutical company with a pipeline of investigational drug candidates, as well as a commercialized medicine derived from Nobel Prizewinning science that is now approved in more than 87 countries worldwide.

In May 2005, the company's leadership changed as Founder Mark Levin turned the helm over to Deborah Dunsire. For the next several years, significant refocusing and reconfiguration took place within the company, as well as improvements in the scale and strength of its commercial operations.

In May 2008, Millennium was acquired by Takeda Pharmaceutical Company Limited. Takeda is the largest pharmaceutical company in Japan, and a global enterprise with an important presence in key markets.

Millennium now operates as an independent subsidiary, serving as the global center of excellence in oncology under its new name: ‘Millennium: The Takeda Oncology Company’.

which speaks volumes to the engagement that Millennium has. This is done from a scientific perspective of understanding the specific mechanisms that lead to cancer genesis and targeting the ones that are the most relevant to counter that cancer development, providing that option to offer more patients treatment across the world.”

“Larger pharmaceutical companies, may struggle because they don’t focus on a single therapeutic area: on a single disease, or disease state.

Since every cancer is different from each other, they face an identity barrier between the therapeutic options they offer and their organization as a whole. As a specific oncology company, Millennium is a therapeutic agent entirely dedicated to advancing cancer care, and therefore we avoid that identity barrier.”

Strategic decisions As a company that has demonstrated how to successfully build a corporate brand, Millennium has made strategic decisions that have allowed it to project a specific image. “Branding is a question of what the company wants to be known for. We want to be known for having the ability to take high-level science and transform it into therapeutic options for patients, and we have already demonstrated this through currently marketed products, such as the delivery of Velcade. So the concept of bringing science from the bench to the clinic is something that’s very familiar to us.

“Other organizations tend to identify themselves more as pharmaceutical companies and do not necessarily have the predefined identify of being a pharmaceutical company that is known for its science. We have transitioned from that perspective because we are focusing on cancer care,” says Mercier.

As Mercier explains, the development of marketing strategies is not about to change in a dramatic way, both for the industry and Millennium itself. “Understanding to a greater extent your customers, understanding their needs, their wish lists, and designing and assessing how you can address those needs and wishes is what is subject to change.

Specialized approach “What will evolve is the development of personalized medicine, especially in cancer care. It’s a significant trend, so from a pharmaceutical company perspective our need is to be laser-focused on the disease, on the customer and on the patient, and the positioning of a brand will need to be there to address those needs. We’re going to take even more of a specialized, customized approach, just as medicine is evolving in that direction.

“This specialized approach will involve targeting specific diseases with specific characteristics, avoiding the over-treating of patients that probably would not benefit from the therapy, and providing maximum benefit with balancing the risk associated with any therapeutic for a better defined group of patients and/or diseases that your therapy might be best suited for.”

Such marketing techniques of focusing on specialized products and the development of personalized medicines have certainly benefited Millennium’s branding, as it continues to align its strategies on cancer care. “This is a tremendous opportunity for Millennium to be part of the transforming of cancer care into a chronic disease,” says Mercier. “Cancer survival has improved dramatically in the past 10 years, but there’s a lot more to be done and certainly we are very much engaged in being part of making that happen.”

“Patients have become much more assertive in finding information about their disease and their treatment options” Millennium’s approach to branding is very different to that of other pharmaceutical companies. As their entire focus is cancer care, the link between the product and the company vision is inherent. “Due to the fact that we are solely focused on cancer care and interested in serving the patient with high level science therapeutic options, that potential conflict between corporate branding and actual therapeutic agents is not an issue,” says Mercier.

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Making

the leap Brian Kotzin, Vice President of Medical Sciences at Amgen, tells EHM how biomarkers help translate basic science into medicine, and how increased funding for research has led to an explosion in innovation.

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rian Kotzin is the first to admit that his background is a little unusual compared to that of his senior colleagues at Amgen. “I was at the University of Colorado, at The National Jewish Center for Immunology, now called the National Jewish Medical and Research Center,” he explains. “I was a physician scientist and did the usual things they do in academic medicine. I’m a clinician, a rheumatologist, so I saw patients within the internal medicine and rheumatology setting. I also ran a laboratory, and I did a lot of teaching.”

Kotzin’s appointments were in medicine, immunology and genetics. Over 25 years, he headed clinical immunology and rheumatology groups, as well as a center of excellence devoted to autoimmune diseases. As this research developed, he realized the next step would be to develop it into a therapeutic, which can be hard to do in an academic setting.

“At some point in your career, you want to do something that’s a little bit more broadbased and has more applicability to more people, and this seemed like a great opportunity,” he says. “When I came to Amgen, I headed up the development group for inflammation therapeutics. The main therapeutic that Amgen had at that time was Enbrel, which is a TNF inhibitor, which had dramatic effects for certain diseases like rheumatoid arthritis. After a short time, I became Vice President of Medical Sciences, which was a much larger group focused on the early development of Amgen’s pipeline in all therapeutic areas and the science needed to put molecules into humans. My background seemed to be suited for this job – it seemed a natural position for me because it is right at the interface between research and clinical development.”

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Much of the work that Kotzin and his team carry out in medical sciences is related to biomarkers. “Our group is composed of combined groups from research and clinical development,” he points out.

“For example, we have a molecular sciences group that’s devoted to molecular biomarkers, we have an imaging sciences group that’s devoted to advanced imaging biomarkers, we have a clinical immunology group that includes a group focused on cellular biomarkers, and we have the development group. It’s a very biomarker-oriented function here in medical sciences.”

The goal of Kotzin’s studies is to maximize the information he gets from early clinical trials.

Because the therapeutics are being introduced into a small number of people, it’s important to get as much information as possible, which is accomplished by dividing biomarkers up into different categories. “One of our biomarker-directed questions is, when we introduce a therapeutic into people, did we hit the target? Did we do what we really thought we did?” says Kotzin. “Then we ask, did we cover the biochemical pathway? Were the intracellular signaling pathways inhibited to the full extent that we thought they were?

higher than we need, or was it the right dose, or was it not enough?

By having the information that says yes, we did hit the target, or we didn’t even reach the dose that we needed to hit the target, this will tell us what the next step is in terms of trying to develop something for the same pathway.”

Kotzin and his colleagues have had successes in which they have used biomarkers that predict the clinical effect. For example, instead of going to a several hundred-patient study that measures hemoglobin A1c for a diabetes drug, he has been able to measure the effect in a study with only 20 to 30 subjects, using biomarkers. “We were able to come to the conclusion that the drug really didn’t work, and it wasn’t going to work even if we studied many more subjects. That’s a great help. It’s much faster, and we expose fewer people to the therapeutic.

Predictions

“We get to make our conclusion earlier and faster, and we get to move on to other molecules within the portfolio. Within our cancer therapeutics, we’ve been able to see tumor shrinkage. We’ve been able to measure the Brian Kotzin joined Amgen in Clinical studies death of cancer cells within the tumor. And 2004, as Vice President and Head, “Then we have biomarkers that are a measure that’s really important early information that Global Inflammation Development, of clinical activity. We can’t do large clinical studsays, ‘Yes, this potentially important cancer before transitioning to his current ies where we use a clinical endpoint, like survival therapeutic should be moved forward, so position as Vice President, Medical – we don’t do that in these early clinical trials. that we do larger studies and measure cliniSciences. He leads this integrated Instead, we try to incorporate biomarkers that cal effects like progression-free survival and function comprised of Early Clinical will give us a clue as to whether we have a clinical overall survival.’”

Development, Molecular Sciences, effect. For example, if it’s a cancer therapeutic, Kotzin’s definition of translational mediImaging Sciences, Clinical Immunology, did we shrink the tumor, or were the tumor cells cine is very closely tied to medical sciences. and Computational Biology. Medical killed within the tumor?

He defines it as the interface between reSciences is responsible for the “The last group of biomarkers that we try to get search and clinical development. “When I planning and execution of early-phase insight into are those that might predict who’s going think of the term ‘translational medicine’, I clinical development as well as the to respond to a therapeutic. We call them stratificathink of discovery research: animal studies, discovery and implementation of tion biomarkers or predictive biomarkers.” basic research at the bench. And then you pharmacodynamic biomarkers in One other important category of biomarker move that science into clinical trials, trying clinical studies at Amgen. is that related to safety. Most therapeutics at to understand whether there’s going to be a this early stage do not work out: they fail for one benefit in patients. Translational medicine is reason or another, and the importance of being that interface, moving it all forward. And it’s able to make a strong conclusion regarding that failed molecule is all the science that goes along with that transition. critical. The team needs to know, if it has a failure, is it because the “It’s this interface of translating the discoveries you have – either target that they chose was not the right target, or is it because the in cell culture or in animals – into human disease. It’s a very difficult therapeutic they developed wasn’t the right therapeutic? thing because the animal models are frequently not predictive of the “By knowing whether you hit the target and whether you covered human disease. the pathway, this gives you essential information you need to know “We’re measuring pathways in animals, and we have to measure whether the approach is going to be useful. If there was no effect on the same pathways in humans. All of the science we do here is centered the disease, we don’t want to develop another molecule to hit that around how do we take what we’ve learned in the animal studies, or particular target. And you only discover that by having those bioin the preclinical studies, and move that into humans, so that we can markers that tell you whether you did hit the target. truly understand things. And it’s much more difficult. In an animal “We may have a molecule, for example, where we have a safety study, you can look at the whole animal to see whether your drug has concern. The question is, did we use it at a dose that was much had an effect. But in human studies, you may be limited to sampling

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blood. You have to be very ingenious, very innovative in how you get the information. This whole process is translational medicine.

Approval How difficult is it to get approval to carry out these early clinical trials? Kotzin explains that there are extensive regulations that govern this process. This is to ensure the safety of the participants when investigating a therapeutic that has never been put into people before.

Patient safety is paramount. Because of this, there are many regulations regarding what doses you can start at and what types of animal preclinical studies you need in order to know that the therapeutic is likely to be safe.

These regulations have become much more stringent in the last few years, because of the tragic outcome of TeGenero’s TGN1412 study. TGN1412 was a therapeutic that was designed to target T-cells, but instead of inducing the lymphocytes to not respond, it triggered them to release massive amounts of cytokines. One of the study’s major flaws was in the decision to inject all of the participants at the same time, and all who received the active drug became seriously ill.

“That catastrophe understandably colored early development around the world,” says Kotzin. “Although at Amgen we’re very stringent and we like to believe we would not have done anything like that, everyone became afraid of approving new therapeutics, especially biologics. Now nearly every time we apply to put a new biologic into people, the specter of the TeGenero catastrophe comes up. This has resulted in new regulations being put into place around the globe that delay the process.

“I remember traveling to the MHRA and presenting a molecule that was an immunologic molecule, and we arrived shortly after the TeGenero tragedy. The regulatory group in the UK just didn’t know what to do. They were faced with the results of this tragedy and how to prevent something like that from ever happening again.

“It became almost an irrational fear of new clinical trials, and we had to get beyond that using really strong science to convince people that our trials are safe. We’ve been trying to convince regulatory groups – for example, when we come forward with a new therapeutic – that the science predicts that this will be safe. We’ve been successful, but sometimes there has been an inordinate delay related to the fact that people are still afraid.”

Certainly one way to improve safety is not to inject all study participants at the same time at the beginning of the study. Instead, one individual is exposed to a very low dose, and if that causes no ill effects, researchers can feel more comfortable about exposing several people to that therapeutic. The dose can be gradually increased after the first subjects have been safely dosed.

Animal studies are often carried out to provide enough information to ensure that the compound will not cause problems in people.

But as Kotzin explains, sometimes a negative result in animals will not necessarily translate into humans.

“This is challenging because we’re sometimes faced with situations where we have an animal toxicity which we don’t believe will translate into humans. When this happens, we have to figure out how to get beyond the problem and convince ourselves, investigators and regulators that this shouldn’t prevent us from going into people, especially when the illness is grievous, such as a cancer therapeutic.

“Another example of regulations that have been challenging is related to biologics. Amgen is a leader in the development of biologic therapies, and these types of molecules are a major portion of our portfolio., Sometimes, regulatory groups apply principles used for small molecules, the usual types of drugs taken orally, to biologics. Sometimes, these regulations are just not applicable. It’s a teaching process. You have to explain to them why the same rules that they use for small molecules don’t apply to these large protein molecules.”

“It became almost an irrational fear of new clinical trials, and we had to get beyond that using really strong science to convince people that our trials are safe”

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Developments There has been an explosion in basic science, which has had a big impact in translational medicine, because there are so many new ideas and new discoveries that can now be translated to humans. As Kotzin says, “The whole understanding of disease has been an important development for translational medicine. That’s very dependent on new research technologies, which give us the ability to develop new

molecular techniques.

“There have been tremendous advances in proteomics, and in how to measure intracellular pathways by measuring proteins that get phosphorylated. And there’s been a tremendous explosion in genetics in terms of the tools you can use. Now, you can screen the whole genome for polymorphisms that might affect whether your therapeutic will work in certain people and not others.

“There are also new sequencing machines that sequence at an unbelievable rate, something that nobody even a few years ago could believe that we could do. And that’s added to the information we can add in our early clinical trials. We can sample tumors, for example, and do unbelievable amounts of sequencing of all the different genes that have changed in those tumor cells.”

“We’ve also become more innovative in our clinical trials. We’re no longer fixed into the same type of experiments. We’re doing clinical trials where we learn as we go, right in the same clinical trial. We’ve combined different, single dose and multiple doses in the same trial.

Again, ensuring safety at the same time we go, but increasing the information that we get, as well as the speed that we can move in terms of getting the information that we need.” n

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PHARMACEUTICALS

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he Clinical Data Interchange Standards Consortium (CDISC) is a global, open, multidisciplinary, nonprofit organization whose aim is to establish standards to support the acquisition, exchange, submission and archiving of clinical research data and metadata. Originally formed in 1997, CDISC was incorporated as a nonprofit in the US in 2001, and has now grown in to a global organization with over 240 members around the world.

David Iberson-Hurst, CDISC’s VP of Technical Strategy, explains that as an officially accredited standards development organization (SDO), CDISC enjoys a formal liaison status with the International Standards Organization (ISO), which enables it to establish standards within the clinical trials arena.

And as Tim M. Jaeger, Chairman of the European CDISC Coordinating Committee, and Head of Divisional Medical and Scientific Affairs at F. Hoffmann-La Roche Ltd., points out, the fact that CDISC is vendor neutral and technology neutral, and works on a consensus-based approach, helps it to develop standards that are usable by and attractive for the majority of stakeholders in the organization.

HIGH STANDARDS Clinical trials play a vital part in the development of life-saving medicines, and healthcare reform has placed their conduct under even more scrutiny. In times like these, the establishment of an international set of standards for data exchange has become an important goal, as CDISC’s Dave Iberson-Hurst and Tim Jaeger tell EHM. “These stakeholders encompass the pharmaceutical industry, clinical research organizations, the device and diagnostics industry, electronic health record vendors and the big academic institutions. Then there are regulatory bodies like EMEA and the FDA. We cover the full range and breadth of organizations working in the standards arena, and we try to ensure through our processes and through our organization that all these partners are heard, and that standards that are robust and relevant to all of these groups are developed and adopted.”

By joining CDISC, companies and institutions have the opportunity to drive the direction of the development of standards, as well as seeing a financial benefit in terms of discounts on training. More importantly, Jaeger fully expects that one day bodies like the FDA will expect companies to submit and capture all their data in CDISC standards. “It’s critical and relevant for all of our partner organizations to have their say, and to be able to help shape standards, and it’s a true advantage if you’re sitting at the table when new standards are developed or existing standards are advanced, to be aware of the ongoing discussions with EMEA and the FDA and other important institutions. Things that are being considered and talked about at these levels today will come out as draft guidance in two to three years.

“In today’s world, no matter what area you’re working in, be it pharmaceuticals, medical devices or diagnostics, designing a trial or protocol and gathering and working with the data, then submitting and archiving it,

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Dave Iberson-Hurst Dave Iberson-Hurst is founder of Assero Limited, with 25 years experience of computer system development within a number of industry sectors. Iberson-Hurst is active within CDISC and was appointed as VP for Technical Strategy in September 2007 to oversee all technical work within CDISC. He is Vice Chair of the European CDISC Coordinating Committee (E3C), co-leads the CDISC Technical Advisory Committee (TAC) and is co-lead of the CDISC electronic Source Data Interchange (eSDI) group that is working with the Food and Drug Administration (FDA), examining the difficult topic of electronic source documents and data.

is a long process. During this process you will have to liaise with literally dozens of other groups, organizations and contractors. Only if you’re able to seamlessly exchange your data across time and across this multitude of partners can you ensure that in the end you have good robust data, something that EMEA or the FDA will accept.”

Mission control CDISC’s official mission is to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.

“We need the platform, independent, vendor neutral, global data standards that help us to streamline data flow from a protocol design to submission and archival of the data,” says Jaeger. “We need this level of interoperability and compatibility not only within the clinical research environment, but also on the edges where clinical research borders with healthcare. There are synergies with the healthcare arena, where many patients are treated within clinical trials, following certain trial protocols.

“There is always the challenge when you’re identifying potential candidates for trials of whether you need to re-collect and re-document all the data points that already exist within the electronic health records, or are there ways to bridge the worlds of clinical research and healthcare? At CDISC, we believe it’s of vital importance to build that bridge.”

Iberson-Hurst adds that the growing public pressure for drugs to be developed with fewer side effects and adverse events has in turn put increased pressure on regulatory bodies to provide better safety monitoring.

“They need data to perform that oversight function, and given the multitude of companies that produce drugs, they need to do it in a standardized way. They can’t monitor 4000 drug companies without standards, so that oversight function is driving standards.”

Global reach CDISC is working to develop global standards that will work equally in countries around the world, though as Iberson-Hurst explains, different areas have different requirements. “For every drug submission, companies in the US must submit all of the data, whereas in Europe they need only submit the reports produced from the data. There is an increased need in the US for an additional data standard, but even if you’re not sending in that final block of data, your processing around how you get to that point should be the same. It’s much easier for companies oper-

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ating internationally to have a common process that fulfills the needs of all regulatory authorities.

“We are developing a continuum of standards, which are designed to support the process as a whole. These include a protocol standard, which is there to support the writing of clinical trial protocols and have them in such a format that they can be consumed not only by humans in document form but also by a machine. We will have the high level model of that available toward the end of this year, with an XML implementation probably early next year.

“There is also the Clinical Data Aquisition Standards Harmonisation (CDASH) standard. This is a standard that lays out the minimum set of content that pharmaceutical companies and biotechs should be collecting when they collect data. This makes it easier to combine data when we bring trials together within a pharmaceutical company or within a regulatory authority, and also to start reusing data collection forms. This will make setting up trials quicker, has had a lot of support from the FDA, and is also applicable across the globe.”

Another standard CDISC is working on is the study data tabulation model (SDTM). These are the data tabulations that pharmaceutical companies submit primarily to the FDA, but which are also embedded in the way a pharma company works. These tabulations are the cleaned raw data that are collected from trials, organized in a standardized way so that the regulatory authorities can understand what has been collected. The analysis data model (ADaM) is the standard for presenting analyzes based on the raw data found in SDTM: how you took the raw, cleaned data and through your analysis show the efficacy and safety of the product that you’re submitting for approval.

There is also an operational data model (ODM) used as the basis to pass standards from machine to machine, and a laboratory model (LAB) dedicated to the passing of laboratory data from the central laboratories through to pharmaceutical companies.

Keeping in touch One of CDISC’s mandates is to act as a kind of intermediary between companies and regulatory bodies like the FDA and EMEA. “We have a very good working relationship with both EMEA and the FDA,” says IbersonHurst. “We work to find the best solutions that meet the needs of both groups: the pharmaceutical companies, biotechs and academic institutions, and the regulatory bodies.

“We work with them through Health Level 7 (HL7) and ISO to move standards forward internationally. We do tend to be more heavily involved with the FDA because of its requirement to submit the underlying data. However, we are also working with regulatory bodies across the globe on projects such as standardizing the data required for clinical trial registries.”

Working in different geographic areas and within a variety of regulatory authorities can present challenges, as Jaeger explains, “CDISC was originally very much a US-centric organization, because a lot of the critical pharmaceutical activity was taking place in the US, and the FDA tends to have the ‘highest’ authority, in that it influences much of the work in Europe.

However, we increasingly see that trial activities are shifting. If you look back 10 or 15 years, a lot of trial activity went from the US to Western Europe, then Eastern Europe, and now it’s going into India, China, and other places.

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“There are good reasons for that: the availability of patients, the possibility of running large trials, and of course the fact that these are emerging markets and companies want to have a presence there. CDISC supplies global standards for global organizations, to allow them to work seamlessly across these borders.

“One important area of this is electronic data capture, which allows you to work fairly independently, because all you need is a laptop with an internet connection and you can start accessing data regardless of where you are. This is something that we want to promote and enable with the establishment of global standards that help companies use a lean front end, and that allows them to collect data in a robust and compliant fashion all the way through the process. We want to eliminate the situation toward the end of the process where historically people would pull up in trucks in front of the FDA and deliver, via forklift, literally tons of paper.”

“The FDA always wants to be able to check source data, and if you do this via 10, 15, 20 different applications, via a number of organizations, institutions, contractors or parties, and if you do this across 10 years, how can you provide access to all that original data without having to provide mountains of paper? Doing this electronically and providing standards that allow you to reach into the data is obviously very valuable and helpful.

One of the big challenges is getting the paper out of the process,” says Iberson-Hurst. “The other challenge is that when you have a clinical program over 10 years, technology moves on and process improves, so some of the data you’re working on toward the end is quite old.”

Implementation What, then, can companies do to implement CDISC standards? According to Jaeger, there are a number of possibilities. “CDISC offers a wide range of informational and educational activities from very broad introductory courses, to extremely specialized and detailed tutorials, that potentially take you into the most finely granular level of any specific standards. CDISC has very appropriate, attractive and up-to-date educational events and courses for both novices and experts, that people can use to build their understanding of this area.

“There’s also the opportunity to attend the meetings that CDISC organizes, including the international interchange – a two-day meeting plus three days of courses, tutorials, and other educational events held every autumn in the US – and the similar European CDISC interchange in April. We’ve also recently started interchanges in China and other countries.”

Jaeger explains that companies with a presence in Europe can also get involved with user groups organized by language, along with a large number of groups that are independent of CDISC but whose members are heavily involved with establishing standards in their organizations and using them as part of their daily work.

The main way, of course, to benefit from CDISC’s activities is to become a member. Members have privileged access to all materials and events at attractive rates, and CDISC will even design programs especially for you, come to your company and educate your people and set up specific courses to meet your needs.

Looking ahead CDISC’s future plan is to move toward ensuring the continuum of standards is well implemented, works together and is easily adopted by pharmaceutical companies and everyone else within the industry. This will make

it easier for companies to work with their partners to, for example, exchange protocols and the collected data, because the data will be exchanged in a form that everyone can use and understand.

“It’s all about making the move into the data much more smooth within companies and across company boundaries,” Iberson-Hurst explains. “This is one of the reasons we work with bodies like the National Cancer Institute, because they have a lot of academic institutions who all want to share and pool data so they can see things that maybe they’re not seeing in their own data.

“Our aim is to ensure that they can use the data quickly without having to worry about how do I get the data and how do I merge it with my data and how do I combine it, and can I even combine it? Our task over the next 10 years or so is to look at how people can get the data they need to make better safety decisions. The right data needs to be visible to the right people and supported by the standards we’re developing.”

Jaeger names three key themes for CDISC: simplification, globalization, and a broader approach. “First, we need to simplify a very complex process, with all the different parties involved, all the different data types over a long period of time with different applications. We aim to simplify that through the use of commonly accepted and globally adopted standards.

“We’re also working on simplifying our own standards. We started with a range of standards that became a continuum, and those now are being integrated into something that is increasingly simple.

“The second theme is globalization. CDISC was originally US-centric, but we have made strong, bold moves over the past few years to venture out into other parts of the world, beginning with Europe, where there’s a lot of activity and a strong foundation for CDISC. Some of our European activities are now at the same level as the US ones, and we’re moving into India, China and other areas.

“The third theme is to carefully broaden some of the activities CDISC carries out. We’re working to better define the convergence between healthcare and clinical research and to provide to this area the standards, the insights, the expertise and the experience that CDISC undoubtedly has. We also want to move from the traditional pharmaceutical research model into models for the diagnostics of the medical device world, and other areas where there is a different type of research going on compared to the traditional big pharma model of running big trials in multi-national environments. These are the three big themes that CDISC is driven by over the next few years.”

Tim Jaeger Tim Jaeger is Chairman of CDISC’s European Coordination Committee, a member of the CDISC Board of Directors and a member of its global strategy committee. He joined the Diagnostics Division of F.Hoffmann-La Roche Ltd in November 2005, and is currently he is Head of Divisional Medical and Scientific Affairs and develops and coordinates Divisional medical strategies.

Jaeger establishes and maintains relationships with key thought leaders, investigators and institutions strategic to Roche Diagnostics.

He also is the business owner for the global Diagnostics Clinical Information Management System, where currently more than 500 trials are registered and conducted electronically.

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COMMENT

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Caught in the act It is unfortunate that the greatest issue plaguing the new US administration since Obama’s inauguration is not the criticism of his policies, but the transparency of his government.

ince the election, Obama’s cabinet appointments have been dominated by nominee withdrawals due to investigations over tax payments, one of which involved the original nominee for Secretary of Health and Human Services, Tom Daschle.

Daschle, a former South Dakota senator and former US Senate majority leader, was nominated by President Obama following his 26 years service in Congress. However, the emergence of the fact that he had failed to pay more than $128,000 in taxes led to public pressure for him to step down, and he withdrew his nomination on February 3.

The taxes Daschle owed were for his free use of a car and driver – provided to him by a prominent businessman and Democratic fund-raiser, Leo Hindrey Jr – and no use of his renowned softspoken and reassuring style could get him off the hook. Despite the fact that he admitted he owed the taxes, filed the amended return forms and paid more than $140,000, Obama’s criticism of untrustworthy lobbyists gave Daschle no other option than to withdraw.

Daschle was not the only nominee to be brought down by a tax problem. Nancy Killefer, who was nominated for the position of Chief White House Performance Officer, withdrew just hours before Daschle, after it emerged that she had failed to pay taxes on her household help. And in January, Bill Richardson also withdrew his nomination as Obama’s choice as Commerce Secretary, following reports that he had been investigated by a grand jury focusing on his gubernatorial office.

It’s hard to believe that a man as wealthy as Daschle, with ambitions in the national political arena, would try to defraud the IRS of a relatively small amount. It also seems very unlikely that Daschle does his own taxes. Rather than a criminal or unethica action, this

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sounds more like an error, probably committed by his accountant.

Daschle’s withdrawal can only serve to solidify the idea that cabinet secretaries should be chosen based on criteria other than their leadership skills and qualification for the role. It is widely know that Daschle was to be a key player in Obama’s cabinet and in his plans for radical healthcare reform. He had strong relationships with the senators he once led, and a detailed grasp of legislative strategy and procedure. He also had firsthand knowledge of what went wrong during Bill Clinton’s health reform attempt in 1993/94.

Three withdrawals from appointment to a democratic Administration is a damning situation for Obama, hypocritical to say the least. But has Obama picked a cabinet of dishonest tax dodgers, or has he been targeted by those looking for embarrassing facts or political problems, in an attempt to disrupt the formation of a new democratic government?

Most previous administrations have had some famous instances of nominee withdrawal due to ‘forgetful’ moments regarding tax returns. Similarly to Killefer’s withdrawal, Zoe Baird was famous for failing to pay her Social Security taxes for both a nanny and a chauffeur, keeping her from becoming President Bill Clinton’s attorney general in 1998.

The phenomenon of Cabinet nominees failing to pay their taxes is not unique to Obama’s administration, but is typical of nearly every administration to ever be elected. Although a heightened sense of transparency is needed in current times of economic recession, we also need to remember that governments should be elected for their policies, rather than the personalities, and that forcing talented people to withdraw for relatively minor infringements may do more harm than good. 

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Healthcare in France Travel in the country with the best healthcare system in the world.

FAST FACTS

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he World Health Organization’s report of the world’s healthcare systems in 2000 named France the “best overall healthcare” in the world. Like many of the countries in Europe, France has a system of universal health care, financed mostly by the government, and includes a national health insurance package. The average expenditure of its GDP on health care in 2005 was 11.2 percent/ $3,926 per capita.

Although physicians in private practices provide general health care, their in-

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come is drawn from the revenue drawn from publicly funded insurance policies. The government takes responsibilities for the funds, both financially and managerially, and generally refunds patients 70 percent of their health care costs, and 100 percent in cases of longterm ailments.

Until only recently health care coverage become universal. It was previously provided only to those who contributed to social security, i.e. workers, until the government of Lionel Jospin extended the coverage to all those classed as legal residents of France.

TOTAL POPULATION: 65,073,482 million TOTAL AREA: 260,558 square metres GDP ESTIMATE: $34,262 per capita CURRENCY: Euro (€)

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Hospitals Approximately 62 percent of French hospitals are publicly owned and managed institutions. The remaining percentage is split evenly between the non-profit sector hospitals and the for-profit institutions.

Assistance publique – Hôpitaux de Paris (AP-HP) is the public hospital system, covering the whole city of Paris and its suburbs.

Not only does it provide healthcare services, but it is also a center for research, prevention, education and emergency medical services, incorporated in over 52 branches. It employs more than 90,000 people. The most notable hospitals of APHP is the Hotel-Dieu–the oldest hospital in Paris, Hôpital de la Pitié-Salpêtrière – Paris and Europe’s largest hospital, and Hôpital Necker – Enfants maladies – the

world’s oldest pediatric hospital.

Pitié-Salpêtrière Hospital is a hospital famous the world over for its teaching. It is part of the Assistance publique and is credited as one of Europe’s largest hospitals. It boasts great physicians in its history, such as Jean-Martin Charcot – founder of modern neurology, Pierre Janet – the famous psychologist of the 19th century, and Christian Cabrol – a cardiac surgeon who most famously performed Europe’s first heart transplant in April 1968.

Hôpital de La Grave is located in the SaintCyprien quarter of Toulouse, Southwest France. It is almost three times the size of the Hotel-Dieu, and is the second largest hospital institution within the region. It is noted for its history during the plague years that ravaged Toulouse: the hospital was enlarged to cope with the mounting epidemic, and then later

underwent a transition to confine and care for the city’s poor.

Hôpital d'instruction des armées Percy, meaning ‘Percy Training Hospital of the Armies, is a military hospital, situated in Clamart, near Paris. Managed by the health services of the armed forces, it cares for both military and civilian patients. It had treated several head of states and noted individuals, such as Yasser Arafat, Palestinian leader, and Zambian president Levy Mwanawasa.

Health Insurance Based on a social insurance model, 95 percent of the population is covered by three main schemes. One for commerce and industry workers and their families; another for agricultural workers and a final scheme for the self-employed non-agricultural workers.

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UPCOMING

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International Events A roundup of health-related conferences and events in the US and across the globe.

13 Jul - 14 Jul The World Health Care Congress 5th Annual

1 Apr - 2 Apr Healthcare Ireland

Leadership Summit on Medicare Westin Grand, Washington, DC, wcreg@worldcongress.com www.worldcongress.com

RDS, Dublin, Republic of Ireland HealthcareIreland@stepex.com www.healthcare-ireland.com

28 Oct – 30 Oct Next Generation Pharmaceutical Summit The Ritz Carlton, Amelia Island, FL www.ngpsummit.com

7 Jun - 11 Jun APIC 2009 Annual Conference Ft. Lauderdale Convention Center, Ft. Lauderdale, FL apicinfo@apic.org www.apic.org

7 Dec - 10 Dec The 4th International Jerusalem Conference on Health Policy ICC Jerusalem Convention Center, Jerusalem, Israel nihp@israelhpr.health.gov.il www.israelhpr.org.il

7 Oct - 9 Oct West African Health 2009 Expo Hall, Eko Hotel & Suites, Lagos, Nigeria wale@westafricanhealth.com www.westafricanhealth.com

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30 Sept – 2 Oct CIO Healthcare Summit Inverness Hotel and Conference Center, Denver, CO www.ciohealthsummit.com

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18 Jul - 20 Jul 2nd Annual World Summit of Antivirals Beijing Continental Grand Hotel, Beijing, China chris@bit-wsa.com www.bitlifesciences.com/wsa2009/default.asp

14 Apr - 16 Apr The 6th Annual World Health Care Congress Marriott Wardman Park Hotel, Washington, DC wcreg@worldcongress.com www.worldcongress.com

1 Apr - 9 Apr Hospital Build Asia Exhibition & Congress 2009 SUNTEC International Exhibition & Convention Centre, Singapore hospitalbuild@iirx.com.sg www.itsm-online.com

28 May - 29 May 3rd Asian New Drug Development Workshop Tower Hall Funabori, Tokyo, Japan diajapan@diajapan.org diahome.org

2 Nov - 13 Nov The World Health Care Congress 4th Annual Obesity Congress TBD, Washington, DC wcreg@worldcongress.com www.worldcongress.com

4 May - 5 May Hospital Authority Convention 2009 Hong Kong Convention & Exhibition Centre, Hong Kong hac@ha.org.hk www.ha.org.hk

10 Sep - 12 Sep ExpoMEDICAL Centro Costa Salguero, Buenos Aires, Argentina info@expomedical.com.ar www.expomedical.com.ar

29 Apr - 30 Apr Redesigning the Healthcare Workforce 2009 Harbours Edge, Darling Harbour, Sydney, Australia enquire@iqpc.com.au www.iqpc.com

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IN REVIEW

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On the shelf In these turbulent times for healthcare, what does the current crop of health-related titles have to offer in the way of advice?

The Innovator’s Prescription A Disruptive Solution for Health Care

By Clayton M. Christensen Christensen – a professor of Business Administration at Harvard Business School and known for his previous books on disruptive innovation – brings his unique outlook to healthcare. The book explains how precision medicine can reduce costs and make good on the promise of personalized care; and how disruptive business models can improve quality, accessibility and affordability.

EHM says: Comprehensive, well-organized and thought provoking. Lays out an alternative strategy for fi xing our broken health system. Instead of arguing about blame, it suggests positive methods for moving forward.

Strategic Management of Health Care Organizations

By Linda E. Swayne A new edition of the classic text for healthcare students, managers and leaders, providing further guidance and focus on strategic thinking, strategy formulation, implementation and control. The fourth edition reflects the importance of leadership in contemporary healthcare organizations, and the authors have further developed their map and compass theme to foster strategic thinking.

EHM says: Provides a framework to integrate the most important concepts in modern management with cases from health services. A valuable resource for students, managers and others working strategically in the healthcare field.

Healthcare, Guaranteed: A Simple, Secure Solution for America

By Ezekiel J. Emanuel Healthcare, Guaranteed outlines an innovative approach to a comprehensive healthcare system reform that was originally conceived by Emanuel, who is Chairman of the Department of Medical Bioethics at the NIH , and Victor Fuchs, Professor of Economics at Stanford University.

EHM says: Emanuel puts forward a specific proposal for healthcare reform and presents compelling evidence why a single payer/insurer scheme is inferior to his visions of a voucher system that is funded by a dedicated value-added tax.

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FACE OFF

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Healthcare reform Two views on the feasibility of the new government’s proposed changes to the health sector.

Kent Conrad, Senior Senator, North Dakota and Chairman of the Senate Budget Committee

C

onrad’s main agenda is the problem of national debt, and he has been incredibly vocal, both in the Bush and Obama Administrations, about the spending policies adopted by both the Republican and Democratic Presidents.

A Democrat, Conrad veers toward the right side of the party.

He was one of the first Senators to endorse Obama as the Democratic candidate for the 2008 Presidential race.

Following a recent private meeting of the Senate Finance Committee, Conrad made it known that he disagreed with the administration’s plan to fund the reform of the healthcare system with tax money. Specifically, Conrad was critical of the proposed $3000 tax credit for companies that hire or retain workers: “If I’m a business person, it’s unlikely if you give me a several thousand dollar credit that I’m going to hire people if I can’t sell the products they’re producing.”

Conrad criticizes Obama’s proposal within the stimulus package for limiting tax deductions to the wealthiest 1.2 percent of taxpayers. Obama predicts the plan will produce more than $318 billion over the next decade. Conrad says that this is an ideal and could be very far from the actual outcome. He believes the 10-year stimulus package would not do enough to reduce the future of the national debt, and that the administration must simply find another source with which to raise the revenue needed.

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Timothy Geithner, Department of the Treasury Secretary

G

eithner is to be found at the forefront of the economic stimulus package debate, defending Obama’s healthcare provisions.

During the same recent Senate Finance Committee meeting attended by Conrad, Geithner enforced the healthcare proposals and responded to concerns from lawmakers regarding the budget proposals around the tax increases needed to help finance the 10-year plan. Geithner explained that the tax increases will reduce federal budget deficits, and reassured those concerned about the affect of this on the current state of the economy. The tax increases would not take effect until the US has declared the economy in a state of recovery, which is predicted to be 2011.

Geithner informed the House Budget Committee that even when actualized, the proposed limit would affect only a very small number of taxpayers but still allow the administration to take a 28 percent rate; almost the same level as that in the Reagan years.

Geithner believes the proposal to be fair and reasonable, and that the impact it may have on charitable giving is likely to be small.

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Next Generation Pharmaceutical Approximately 50% of new drug development fails in the late stages of phase 3 – while the cost of getting a drug to market continues to rise.

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Financial Services Technology Providing for its customer’s needs and demands is the goal of financial institutions now more than ever. But it is a tricky remit to fulfill. Your customers want it all – security, cost-efficiency, speed, added functionality and, most of all, convenience.

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COMMENT

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Business in the Year of the Ox At first glance, Pfizer’s plan to swallow Wyeth may look like a good strategic move, but closer examination reveals it to be a missed opportunity. By John Singer

A

ccording to the Chinese zodiac, 2009 is the Year of the Ox. The sign of prosperity through fortitude, the Chinese say the Ox works methodically, a born leader possessing an innate ability to achieve great things. A good time then, for natural leaders in the healthcare sector to step forward and make big, creative moves on behalf of their companies and institutions.

Despite its size, however, Pfizer’s plan to swallow Wyeth feels more routine than imaginative, more tactical than strategic. The deal looks like a linear move at the operational level. And its center of gravity – the focal point for overall competitive capability – is still squarely sitting on a commercial model whose success depends on promoting the features and benefits of individual drug brands in an operating environment that sees little value in, and does not trust, pharmaceutical promotion.

Pharmaceutical companies face an adaptive challenge to a nected to everything else in complex systems of behavior. changed context for business. The whole framework for getting The winners will know how to work with all this interconnecnew medicines approved is evolving, the amount of revenue tivity, the chaotic, and the nonlinear. They will know how to generated by new drugs is dropping, and atomizing ‘custombuild whole new forms of collaboration, like P&G and Google, ers’ are awash in information and competing data claims. The who recently exchanged employees in a move to spark marketplace is moving away from accepting laboratory meamarketing innovation. surements as evidence of real clinical benefit, focusing instead The future of the pharmaceutical industry is broader than on improving health outcomes. pharmaceuticals; it also lies in servicing health. More speThere are fi ve classes of drugs that all control blood sugar cifically, it lies in transitioning from an industrial-era view of effectively, yet the incidence of adults with diabetes has tripled a business focused on manufacturing and promoting physical from 1980-2005. There are more than 150 products (i.e., drug brands), to a model drugs for high blood pressure. From the based on organizing industry environperspective of the insurers (these are the ments around shared marketspace. This is John Singer is the founder customers, like states and the federal about creating new wealth by forging new of Blue Spoon Consulting, government, that buy in bulk), many medibusiness ecosystems: Pfizer linking with a strategy and marketing cines are commodity inputs to electronic Dole Foods to invent a new standard of care consultancy. treatment algorithms, which are being in diabetes; Pfizer connecting with Apple used by huge integrated delivery networks to design a unique aggregation of health to standardize care. information; Pfizer aligning with IBM to deThe meltdown in the world economy, as it moves from velop a new health infrastructure in Africa. These are the kinds link to link, engulfing industries and commercial relationships of creative strategic moves that will address the unmet needs from which no one seems immune, reveals the potent netof patients, physicians, and customers around the world. working effect that encompasses economic and technological There is opportunity in this Year of the Ox to transform connectivity. It also highlights a central feature to strategy in the life sciences sector. But it will take a different kind of an advanced economy: the concept of separation – between strategy and action, an evolutionary leap to adapt to a new people, between markets, between governments, between world where there are no easy answers, no proven routines countries, between ideas – is bankrupt. Everything is conand no straight lines. 

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