Minnesota Health care News April 2014

April 2014 • Volume 12 Number 4

Medical research Jeffrey Miller, MD, and Timothy Schacker, MD

Pediatric fractures Steven W. Meisterling, MD

E-cigarettes

Barbara A. Schillo, PHD

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APRIL 2014 • Volume 12 Number 4

4 7 8 10 12 14

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News

People

Research

MINNESOTA HEALTH CARE ROUNDTABLE

From research to reality

By J effrey Miller, MD, and Timothy Schacker, MD

18 20

Calendar

Perspective Willis Navarro, MD National Marrow Donor Program

10 QUESTIONS Ruth Lynfield, MD Minnesota Department of Health

Public Health E-cigarettes

By Barbara A. Schillo, PhD

Pediatrics

26 28

Community caregivers 2014

aking a difference M in Minnesota and the world

By M innesota Physician Publishing staff

Pulmonology

Lung cancer screening y Lee Kamman, MD, B Cynthia Isaacson, and Jill Heins Nesvold, MS

Patient to patient Support groups

By Connie Sheely

Pediatric fractures

By Steven W. Meisterling, MD

Background and focus: As tools and techniques for treating chronic illness have expanded, so have methods and mechanisms of provider reimbursement. More people now have access to care, and with this comes a heightened awareness of the impact of social determinants on health. The transition to rewarding physicians for maintaining a healthier population is slow but the promise is clear. Treating chronic illness remains an area of high-volume use and, improperly managed, quickly becomes an area of high cost.

Objectives: We will evaluate changes that health care reform is bringing to chronic illness care. We will examine new community-based partnerships that are forming to address prevention, compliance, and better identification of risk. We will look at specific diseases and how workplace solutions, insurance companies, clinics, hospitals, long-term care facilities, and home care providers are working together to lower costs and improve outcomes.

Publisher Mike Starnes | mstarnes@mppub.com ASsociate Editor Stacey Bush | sbush@mppub.com

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Company Address City, State, ZIP

Minnesota Heath Care News is published once a month by Minnesota Physician Publishing, Inc. Our address is 2812 East 26th Street, Minneapolis, MN 55406; phone 612.728.8600; fax 612.728.8601; email mpp@mppub. com. We welcome the submission of manuscripts and letters for possible publication. All views and opinions expressed by authors of published articles are solely those of the authors and do not necessarily represent or express the views of Minnesota Physician Publishing, Inc., or this publication. The contents herein are believed accurate but are not intended to replace medical, legal, tax, business, or other professional advice and counsel. No part of this publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $36.00/ Individual copies are $4.00.

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News

U of M Health Services Rebranded The University of Minnesota, University of Minnesota Physicians (UMP), and Fairview Health Services have launched a new brand called University of Minnesota Health.

ical] School,” said Carolyn Wilson, president of University of Minnesota Medical Center, Fairview, in an interview with the Minnesota Daily.

“We’re committed to increasing our academic support as well, because that’s so important to us and to our patients in Minnesota, and our trainees.”

Discussion of rebranding started in 2011, with final legal agreements signed in June 2013, at which point the Board of Regents and branding consultants were brought into the conversation.

The partnership includes University of Minnesota Medical Center, Fairview; Amplatz Children’s Hospital; UMP clinics and service lines; and UMP clinics within Fairview Maple Grove Medical Center. The rebranding aims to streamline these facilities and services under one care model and one electronic medical record system to improve the patient experience, make care delivery more efficient, and lower medical costs, according to university officials.

“I think it elevates the university around the campus and the state of Minnesota,” said Richard Beeson, Board of Regents chair. “All the good that we do and having the university’s name associated with that will help everybody.”

Additionally, University of Minnesota Health will provide funding to the university’s medical school over the next 10 years through profits earned.

Newborn Screening Bill Introduced

Rep. Kim Norton (DFL-Rochester) and Sen. John Marty (DFL-Rose2013.pdf 6/12/13 legislation 15:23 ville)1introduced in late

“We’re always looking for even more collaboration with the [MedMSA - MN Healthcare July

February that would strengthen Minnesota’s newborn screening program.

According to the legislators, the bill is meant to reverse legislative changes that were made to the screening program in 2012 that limited the length of time the Minnesota Department of Health (MDH) can store newborn screening data.

Currently, newborn screening data is automatically destroyed when the child reaches age 2, and most newborn screening blood spots are destroyed before a child is 71 days old. There is concern this policy puts babies at risk.

“Saving newborn screening data and test results are critical to saving lives,” said Robert Jacobson, MD, president of the Minnesota Chapter of the American Academy of Pediatrics (MNAAP). “Long-term storage of this data assures proper diagnosis and timely follow-up for critically ill children. It also provides the basis for quality control and the development of new tests that can save even more lives.”

According to MNAAP, it can take up to six months to confirm a diagnosis from the blood spots.

Forcing MDH to destroy samples after 71 days ruins that opportunity. Jacobson said the screenings have saved more than 5,000 children from death or chronic illness since 1965.

“We are actually reversing what is a great travesty,” Jacobson said in an interview with ABC 6 News.

“We were the pinnacle, we were at the top, we were the leader in not just the U.S. but the world. Once this legislation is in place, it would actually protect the ongoing collection of data.”

Co-authors of the bill include Reps. Erin Murphy (DFL-St. Paul), Tom Huntley (DFL-Duluth), and Tina Liebling (DFL-Rochester), and Sens. Tony Lourey (DFL-Kerrick) and Jeff Hayden (DFL-Minneapolis).

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Minnesota Health care news April 2014

PrairieCare Expands to Rochester, Brooklyn Park In May, Maple Grove-based PrairieCare will open a new child and adolescent intensive outpatient psychiatric program in Rochester.

The health care company has leased a 6,500-square-foot space about five minutes from downtown Rochester. The program expects to occupy about 13,000 square feet in the building by 2015, according to Todd Archbold, chief development officer at PrairieCare.

Christopher Wall, MD, will lead the program, serving as medical director. Wall has worked in the psychiatry department at Mayo Clinic since 2000 and has a specific interest in treating resistant depression in youth.

Mayo Clinic offers intensive inpatient mental health care for children, and PrairieCare will serve those who don’t require hospitalization, but need services beyond therapy.

“We’re really complementing all the existing resources,” Archbold said.

In addition, PrairieCare recently submitted plans for a child/adolescent psychiatric care facility to the city of Brooklyn Park. The city council voted unanimously to approve the project development. The new 66,600-square-foot hospital is expected to open by the fall of 2014.

Saint Therese Receives Award for Cardiac Care Aging Services of Minnesota recently awarded Saint Therese of New Hope, a faith-based senior care and housing organization, its 2013 Leading Change Innovation Award for its cardiac care program.

Saint Therese’s program launched in May 2012 as part of an effort to prevent hospital readmissions for cardiac patients through a care model that involves nurses, social services, pharmacists, and dieticians. The goals of the program are to enhance the quality of life for patients and their families and reduce hospitalizations, while

spending funds effectively, according to organization officials.

So far, more than 450 patients have taken part in Saint Therese’s cardiac care program. According to facility officials, the average readmission rate while patients were under care at Saint Therese of New Hope was about 7 percent in the last quarter of 2013, whereas the national average for readmission of Medicare patients is 18 percent, according to Kaiser Health News.

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Studies Show Benefits of Health Care Homes A new report by the Minnesota Department of Health (MDH) and the Minnesota Department of Human Services found that 43 percent of primary clinics in the state are certified as health care homes, using a model that offers a team-based approach to improve the health and quality of life for patients, especially those with chronic or complex conditions.

Additionally, the University of Minnesota released results from a study that showed that, from 2010 to 2012, health-care home clinics outperformed clinics that weren’t certified as health care homes.

Comparison was based on measures of care related to cancer screening, asthma, diabetes, vascular care, and depression. According to MDH officials, the biggest difference was found in asthma care measures, where the health-care home quality rate was about 20 percent higher than the non-health-care home rate.

“These reports show Minnesota’s health-care home model has really helped clinics improve the quality of their care and helped patients meet their health goals,” said Minnesota Health Commissioner Ed Ehlinger, MD. “The model does this by allowing patient-centered care teams to focus on prevention and connecting the dots of our complicated health system.”

Clinics were able to become certified as health care homes and earn additional payments for care coordination beginning in 2008 with the launch of the state’s health-care reform act. As of Dec. 31, 2013, there were 322 certified News to page 6

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PUT THE SQUEEZE ON HIGH BLOOD PRESSURE If you have diabetes, controlling your blood pressure can help protect you from heart attack, stroke, blindness and kidney disease

• Track your blood pressure and share with your doctor • Medicines can make a difference... if you take them • Eat healthy and be active • Avoid salt • Do not smoke

Minnesota Diabetes & Heart Health Collaborative

The Minnesota Diabetes and Heart Health Collaborative: Working together to keep you informed

www.mn-dc.org Adapted from the Minnesota Diabetes and Blood Pressure Performance Improvement Plan postcard April 2014 Minnesota Health care news

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News from page 5

health care homes in Minnesota, and about 353,000 health-care program participants received care in a health care home in 2013.

“This latest information about health care homes is a strong example of how it is possible to achieve the aim of improving quality and experience of care, while at the same time lowering costs,” said Minnesota Human Services Commissioner Lucinda Jesson.

tobacco, according to Minnesota Department of Health officials.

Nationally, employers spend $93 billion in health insurance claims and $1.3 trillion each year due to lost productivity and absenteeism.

“We look forward to helping more businesses create healthy worksites … good for employees, communities, and the bottom line,” said Ed Ehlinger, MD, Minnesota Commissioner of Health.

Several business executives joined Gov. Dayton in February in the Capitol rotunda to promote workplace wellness, as part of an effort to improve workers’ health and productivity and decrease health care costs and absenteeism.

As part of the event, Dayton proclaimed 2014 the “Year of Worksite Wellness.” A CEO pledge effort supported by Anytime Fitness was also introduced. The pledge asks businesses to incorporate strategies to promote a culture of physical activity in the workplace.

“Healthier workers—and healthier bosses—will lead to improved company morale, lower health care costs, and increased productivity,” said Anytime Fitness CEO Chuck Runyon, who is spearheading the effort.

Minnesota spends almost $6 billion in excess health care costs each year due to obesity and

A 2012 survey found that 87 percent of Minnesota workplaces are interested in improving well-

State, Businesses Partner to Promote Worksite Wellness

6

Minnesota Health care news April 2014

ness, while only 23 percent currently offer workplace wellness efforts.

Poor employee health is correlated with a more than 50 percent decrease in overall productivity, which costs U.S. companies an estimated $225.8 billion annually, or $1,685 per employee each year.

Minnesota businesses that already support the effort include Schwan Food Co., Blue Cross and Blue Shield of Minnesota, Anytime Fitness, Dakota County Regional Chamber of Commerce, Connolly Kuhl Group, Lakewood Health Center, Lifetime Fitness, St. Paul Area Chamber of Commerce, Staywell Health Management, Taher Inc., and TEAM Industries.

Fairview Ridges Launches Campaign For Expansion Fairview Ridges Hospital has launched the public phase of fundraising for its specialty care expansion in Burnsville.

“This expansion is critical to Fairview Ridges Hospital’s ability to meet the health care needs of the growing and aging population in our region,” said Beth Krehbiel, hospital president. “This project will help us do just that, but we can’t do it alone. That’s why we’re embarking on the hospital’s first major fundraising campaign.”

The total cost of the project is projected to be $60 million. According to a press release, the hospital is covering the bulk of the expenses, but the Fairview Foundation intends to raise $3 million in donations by the end of 2014. Two million dollars has been contributed so far, including a $1 million donation from the owner of a local construction company.

The expansion will include remodeling the pediatric, laboratory, observation, and outpatient units; and enhancing capabilities of orthopedic and spine care, sports medicine, pain management, and rehabilitation departments. Officials expect the project to be completed in the fall of 2014.

PEOPLE David Dries, MD, an assistant medical director for surgery in HealthPartners Medical Group and a professor of surgery, a professor of anesthesiology, a clinical adjunct professor of emergency medicine, and the John F. Perry, Jr. endowed chair of trauma surgery at the University of Minnesota, has received the highest honor bestowed by the world’s leading organization of critical care physicians. Dries has been designated a Master of Critical Care Medicine (MCCM) by the Society of Critical Care Medicine. Since its founding in 1970, the Society has conferred this designation on only 53 individuals. MCCM is awarded to an individual who has been a Fellow of the American College of Critical Care Medicine for at least five years and has distinguished him or herself by achieving national and international professional prominence through personal character, leadership, eminence in clinical practice, and outstanding contributions to research and education in critical care medicine.

Louis Kazaglis, MD, has joined the Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center (HCMC), Minneapolis.

He completed medical school at the University of Illinois, Chicago; internal medicine residency at the University of Minnesota Medical School; and a fellowship in sleep medicine at HCMC. Also joining Louis Kazaglis, HCMC is Nathaniel Scott, MD. MD Scott graduated from the University of Minnesota Medical School and completed a combined residency in emergency medicine and internal medicine at HCMC. He is a staff member of both the internal medicine and emergency medicine departments. Andres Wiernik, MD, has joined Nathaniel Scott, HCMC’s hematology/oncology department and its MD Comprehensive Cancer Center. He earned a medical degree from Universidad de Ciencias Medicas, San Jose, Costa Rica; completed his internal medicine residency at HCMC; and completed a fellowship in hematology, oncology, and transplantation at the University of Minnesota. Wiernik also has a faculty appointment in the Department of Medicine at the University of Minnesota. All three physicians are Andres Wiernik, board-certified in internal medicine.

MD Lindsey Klocke, MD, board-eligible in otolaryngology, has joined Lakeview Health System’s Stillwater Medical Group. She earned a medical degree at the University of Iowa Carver College of Medicine in Iowa City and completed a residency in otolaryngology at the University of Nebraska in Omaha.

Hadi Shaaban, DO, board-eligible in surgery, has joined the Essentia Health–Duluth Clinic as a trauma surgeon. Shaaban earned his osteopathic degree from Midwestern University in Downers Grove, Ill. He completed a residency in general surgery at Michigan State University–Garden City Hospital in Garden City, Mich. He completed a Hadi Shaaban, surgical critical care fellowship at Loyola UniverDO sity Medical Center in Maywood, Ill., and a burn fellowship at the University of Iowa Hospital in Iowa City.

R E Q U E S T F O R N O M I N AT I O N S

2014 HEALTH CARE ARCHITECTURE & DESIGN

Seeking Exceptionally Designed Health Facilities in Minnesota Nomination Closing: Friday, May 9, 2014 Publication Date: June 2014

Minnesota Physician Publishing announces our annual Health Care Architecture & Design Honor Roll.

We are seeking nominations of exceptionally designed health care facilities in Minnesota.

The nominees selected for the honor roll will be featured in the July 2014 edition of Minnesota Health Care News, the region’s most widely read medical consumer publication.

Eligible facilities include any construction designed for patient care: hospitals, individual physician offices, clinics, outpatient centers, etc. Interiors, exteriors, expansions, renovations and new structures are all eligible.

In order to qualify for the nomination, the facility must have been designed, built or renovated since January 1, 2013. It also must be located within Minnesota (or near the state border within Wisconsin, North Dakota, South Dakota or Iowa). Color photographs are required.

If you would like to nominate a facility, please fill out the nomination form below and submit the form, three to eight 300 DPI resolution color digital photographs, and a brief project description (150-250 words) by Friday, May 9, 2014. For more information, call (612) 728-8600.

2014 HEALTH CARE ARCHITECTURE & DESIGN HONOR ROLL NOMINATION FORM FACILITY NAME TYPE OF FACILITY LOCATION OWNERSHIP ORGANIZATION OWNER CONTACT NAME and PHONE OWNER ADDRESS CITY, STATE, ZIP ARCHITECT/INTERIOR DESIGN FIRM ARCHITECT CONTACT NAME and PHONE ARCHITECT ADDRESS CITY, STATE, ZIP ENGINEER CONTRACTOR COMPLETION DATE TOTAL COST SQUARE FEET NUMBER OF COLOR PHOTOGRAPHS ENCLOSED (Note: please include a caption for each photo) NOMINATIONS PROCEDURE: Submit the information on this form, along with a project description (150-250 words), and 300 dpi resolution color 8" x 10" digital photographs (no more than eight) to amarlow@mppub.com For further information, please phone (612) 728-8600, fax (612) 728-8601 or e-mail comments@mppub.com

April 2014 Minnesota Health care news

7

Perspective

Minority marrow donation More diversity is needed

F

or people diagnosed with certain life-threatening cancers like leukemia, a potential cure exists: a donation of marrow or blood-forming cells that replaces the patient’s diseased marrow. But finding a suitable donor can be difficult because it requires a very close genetic match between patient and donor. Seventy percent of patients don’t have a family member who is genetically similar enough for donated marrow or blood to work. That’s when patients turn to Be The Match, a registry of people willing to be donors.

Willis Navarro, MD National Marrow Donor Program Dr. Navarro is vice president and medical director of Transplant Medical Services at the National Marrow Donor Program (NMDP), headquartered in Minneapolis.

NMDP is a nonprofit organization that matches patients with donors, educates health care professionals, and conducts research. It also operates Be The Match, which provides patients and their families one-on-one support, education, and guidance before, during, and after transplant. To find a recruitment center or marrow registry drive near you or to ask for a registration kit to be mailed to your house, visit www.BeTheMatch.org or call (800) MARROW-2.

Odds

The likelihood of finding a matched donor if you are: • African American is 66 percent. is 72 percent.

• Hispanic or Latino • Asian or Pacific Islander is 73 percent.

• Native American is 82 percent.

• Caucasian is 93 percent.

For example, a Minnesotan of Asian ancestry has a 73 percent chance of finding a compatible donor listed on the registry. But that means that more than one-quarter of Asian Minnesotans won’t find a donor.

Odds are even worse for members of certain other ethnicities or races if there aren’t many members of that group on the registry. Odds are also worse for people of mixed ethnic backgrounds.

Sadly, in a case that made Minnesota headlines several decades ago, a mixed-background daughter of Panamanian-born baseball icon Rod Carew died before a donor could be found.

Be The Match is a listing of people 18 years old or older who have said they’re willing to donate blood or bone marrow if needed. This registry also stores umbilical cord blood donated by women who have just delivered babies, which is used as a source of blood-forming cells.

To join the registry you simply fill out a form and get your cheek swabbed at a recruitment center or a marrow registry drive. The few cells collected by swabbing are Minnesota Health care news APRIL 2014

The donation process About two times out of three, donation is accomplished through peripheral blood stem cell (PBSC) donation. This nonsurgical procedure stimulates the donor’s marrow to make more PBSC via medicine called filgrastim. Blood is then collected via a needle in one arm and passed through a machine that collects only the blood-forming cells. The rest of the blood returns to the donor through a needle in the other arm; donors typically read or watch TV during this process. The other donation method collects bone marrow, typically a hospital outpatient surgical procedure for which the donor is given general anesthesia.

Then, a doctor uses a needle to withdraw marrow from the back of the hip bone and the donor goes home the same day. A donor quickly replenishes the donated marrow or PBSCs.

It’s important for more minorities to join the registry.

Among the more than 10.5 million potential donors listed on the Be The Match registry, there may be an unrelated individual whose genetics are close enough to the patient that a donation has a chance for success. However, the odds of finding a genetically matched donor vary.

How the registry works

8

tested to determine your HLA tissue type. (HLA tissue type is more complex than blood type and is the characteristic of marrow and blood cells that must match between donor and recipient.) If someone with a compatible HLA type needs donated marrow in the future, you may be asked to donate.

Misconceptions Some people mistakenly think donation is incapacitating and costly. It’s neither. While most people experience a sore lower back for several days after donating marrow, most feel fully recovered within three weeks. Those who donate PBSCs usually experience bone aches that typically subside within a week.

Donors never pay to donate. Medical, travel, and most nonmedical donation-related costs are covered by Be The Match or the donor’s medical insurance. Minnesota employers with 20 or more employees are required to allow employees who work at least 20 hours a week up to 40 hours of paid time off to donate.

Diversity’s good The vast majority of donors say it was worth it to have the chance to save another person’s life and that they’d do it again. Some do donate more than once. And it’s important for more members of ethnic and racial minorities to join the registry, because the greater the diversity of tissue types available, the greater the opportunity for all patients to find a match.

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Natural burial... an option.

A greener way to go

From preparing bodies to burying them in natural settings, the green burial movement is attempting to make death more environmentally friendly and, in some ways, closer to the way it was in the past.

A Comparison Standard burial

Natural burial

Burial use formaldehyde embalming and long-lasting caskets. They can easily cost $10,000.

The natural, or green burial method starts with the body preparation, which uses no embalming fluid or a non-formaldehyde-based formula.

Green burials can cost less than $2,000.

A Standard grave site, often landscaped and well-maintained, features a large headstone made of granite or flat bronze. Fertilizer and pesticides are used on the grass.

Below ground, a casket made of steel, finished wood and copper rests inside a concrete vault capped by a thick concrete lid.

Green graves deliver more value Prairie Oaks offers you • A less expensive burial option • A way to become a part of the land preservation • A spiritually rewarding experience for your family members

If there’s a headstone, it’s a rock or a piece of rough-cut limestone that’s flat on one side to easily identify the deceased. GPS coordinates are used to spot a grave’s location.

Caskets are made of wood, plywood, bamboo, cardboard, cornstarch or wicker. Sometimes only a shroud or quilt may be used to wrap the body.

651-300-9549 MNGreenGraves.com “Located” in Inver Grove Heights — on Argenta Trail between Hwy #55 and Hwy #149

10 Questions

Monitoring statewide health Ruth Lynfield, MD Dr. Lynfield is the state epidemiologist and the medical director of the Minnesota Department of Health.

What is epidemiology? Epidemiology is the study of the distribution, causes, and consequences of health and disease in specific populations.

The word is of Greek origin, meaning the study (logos) of that which is upon (epi) people (demos). Epidemiologists collect, analyze, and interpret data that provide insights into risk factors for disease and inform approaches to prevent and control disease.

Radioactive gas is a persistent health risk in Minnesota. What can you tell us about this? Radon is a colorless, odorless radioactive gas that occurs naturally in the soils of Minnesota. It can find its way into homes through cracks in walls or foundations. Approximately two in five homes in Minnesota have radon levels that pose a significant health risk. Radon is the leading cause of lung cancer in nonsmokers and the second-leading cause in smokers. Every home in Minnesota should be tested for radon by using a simple, inexpensive kit available from many hardware stores and sources listed at (www.health.state.mn.us/ divs/eh/indoorair/radon/rncontacts.html). If high levels are detected, a mitigation system can be installed in the home to vent radon outside.

Photo credit: Bruce Silcox

10

What can you tell us about the chlamydia epidemic in Minnesota?

Chlamydia is the most frequently reported infectious disease in Minnesota. More than 18,000 cases were reported to the Minnesota Department of Health (MDH) in 2012. Untreated chlamydia can lead to tubal pregnancies and infertility. Screening for chlamydia is the most effective way to detect cases, because 80 percent of females and 50 percent of males who are infected have no symptoms. It is easy to diagnose and treat, and is readily prevented through conscientious use of condoms. The age group at highest risk for chlamydia infection is 15 to 24 years old; the rate is higher among females.

Minnesota Health care news APRIL 2014

What is MDH doing about chlamydia?

MDH promotes increased screening and treatment in clinical settings. In addition, because many social and cultural factors are involved, MDH has coordinated the Minnesota Chlamydia Partnership, which engages individuals and organizations in communities to take action at the local level. This group released the Minnesota Chlamydia Strategy in 2011 (www.health.state.mn.us/divs/idepc/ diseases/chlamydia/mcp/strategy/index.html).

Why is antibiotic resistance considered an urgent public health threat? Because antibiotics have been used so much, we are starting to see infections that can’t be cured by antibiotics. Many of us do not remember the pre-antibiotic era, when it was common for people to die from infectious diseases. Antimicrobial or antibiotic resistance is the ability of a bacterium or other microbe, such as a fungus, parasite, or virus, to withstand the effects of antimicrobial drugs. These organisms can develop or acquire genetic changes that enable them to survive in the presence of antibiotics; this can result in treatment failure. High use of antibiotics in a community is associated with having more resistant bacteria in that community. The Centers for Disease Prevention and Control recently issued a report on antibiotic resistance (www.cdc.gov/ drugresistance/threat-report-2013/).

What can be done about antibiotic resistance? We can all play a part in safeguarding antibiotics’ effectiveness. Use antibiotics only when and how they are indicated. Do not pressure your doctor for antibiotics. Do not save antibiotics for another illness. Antibiotics for food animals should be used only under the supervision of a veterinarian, and antibiotics should not be used for growth promotion. Infection prevention practices, including careful hand washing, are important in preventing the spread of resistant bacteria. Vaccines also can play a role in decreasing resistance in bacteria. For example, widespread use of pneumococcal conjugate vaccine has decreased the incidence of resistant pneumococcal infections. Because it can take more than 10 years to develop a new antibiotic, we need to encourage research and development of new antibiotics now. In addition, we need to develop better technologies to identify the cause of an illness, so that we can improve the use of antibiotics. For more information on antibiotic resistance in Minnesota,

see the online report (www.health.state.mn.us/divs/idepc/dtopics/ antibioticresistance/index.html).

How is your department addressing prescription drug abuse? It’s a growing and significant problem. Prescription drug overdose in Minnesota is 7.2 per 100,000 people. MDH partners with other state agencies to address substance abuse through early interventions and education. We encourage Minnesotans to check their medicine cabinets for leftover prescription drugs and to dispose of them following state guidelines (www.pca.state.mn.us/index.php/ about-mpca/mpca-news/featured-stories/dont-flush-medicines-downthe-drain.html).

About three-fourths of prescription drugs involved in overdoses are obtained from friends or family; the Minnesota Board of Pharmacy is working to strengthen standards for monitoring prescriptions of these controlled substances.

in Minnesota to assess the health care impact of synthetic drugs. In 2012, President Obama signed into law the Synthetic Drug Abuse Prevention Act (www.whitehouse.gov/ondcp/ondcp-fact-sheets/ synthetic-drugs-k2-spice-bath-salts). Selling synthetic marijuana is a felony in Minnesota.

Please tell us about some of the key programs of your department. Our mission is to protect, maintain, and improve the health of all Minnesotans. We monitor infectious diseases and promote prevention strategies, including vaccination. We ensure the safety of drinking water, regulate food served by restaurants, and assess the quality of air inside public buildings. We track the rate of chronic diseases and work with health care partners to develop strategies to reduce people’s risk for these diseases. MDH assesses the quality and safety of care in health care facilities. We are involved in screening newborns for hearing loss and more than 50 rare disorders that would lead to disability and sometimes death if untreated. MDH also is addressing health disparities.

Our mission is to protect, maintain, and improve the health of all Minnesotans.

Are you concerned about synthetic “designer” drugs? Yes! Synthetic cathinones—so-called “bath salts”—and synthetic marijuana have become popular in recent years because of the completely incorrect belief that they are safe, non-addictive, and legal. Synthetics are often more potent than the original drug and can be mixed with a variety of substances that may increase toxicity. There have been deaths in Minnesota due to synthetic drugs. People who take these drugs can experience effects that include agitated delirium, respiratory failure, acute kidney injury, and seizures; and we do not yet know long-term effects. The MDH is working with the Poison Center and emergency departments

How can the public get involved in public health? People should understand the impact their individual choices have on their own health and the health of people around them. Get immunized, and choose to quit smoking, to exercise, to eat healthy foods, to breastfeed, to get screened for cancer, to wash your hands, and to cover your cough: All of these individual decisions make a big difference. Let’s work together to protect, maintain, and improve the health of Minnesotans.

APRIL 2014 Minnesota Health care news

11

P u b l i c H e a lt h

E-cigarettes A look at the facts

By Barbara A. Schillo, PhD

T

he world of tobacco is constantly changing as manufacturers develop new ways to keep customers addicted and buying.

One new product that has received a lot of attention recently is the e-cigarette.

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612-287-8781 12

Minnesota Health care news April 2014

What are they?

Unlike conventional cigarettes that burn tobacco, e-cigarettes use a battery to heat and vaporize liquid that the user inhales. E-cigarettes are designed to mimic the experience of smoking a cigarette, and although they do not contain leaf tobacco, the vast majority of vaporized solutions inhaled by users contain nicotine, the addictive chemical present in tobacco.

There is not yet a body of scientific evidence on e-cigarette use and its possible health effects. However, the majority of public health organizations, including Mayo Clinic and the Campaign for Tobacco-Free Kids, are concerned about the growing popularity of this type of device in Minnesota and across the United States.

Many unknowns The U.S. Food and Drug Administration (FDA) has not approved e-cigarettes as safe for public use, and solutions sold for vaporization in e-cigarettes are not subject to FDA oversight. Initial studies have confirmed the presence of heavy metals and carcinogens in vaporized solutions. This, combined with the varying levels of addictive nicotine these solutions contain, and their lack of regulation and ingredient disclosure, is cause for concern. No long-term studies have been conducted on e-cigarettes, so their lasting effects on users and on others exposed to secondhand vapor are completely unknown.

These unknowns should be of concern to anyone who uses e-cigarettes or is considering using them. Advocates for e-cigarettes say the devices are harmless, but there simply isn’t sufficient evidence to support that claim. Poisonings are another concern. From 2012 to 2013, the Minnesota Poison Control System experienced a tenfold increase in calls about poisonings related to the liquid vaporized in e-cigarettes. More than two-thirds of these incidents involved children or teens. The Minnesota Department of Health warns that e-cigarette liquid, if ingested, can be potentially fatal to small children.

Marketing The ways in which e-cigarettes are marketed by manufacturers are also troubling. Often, they are promoted not as alternatives to smoking, but as a way to help smokers evade smoking bans. This worries many tobacco experts because research has shown that concurrent use of multiple tobacco products (such as cigarettes and chewing tobacco) can complicate nicotine addiction and make quitting more difficult. And, unlike nicotine replacement therapy such as patches and gum, e-cigarettes are not medication.

No established treatment protocols exist for using them to move smokers away from cigarette use.

tine, a smoking-like delivery system, youth-appealing advertising, and kid-friendly flavors could result not just in increased use of e-cigarettes, but in youth using both e-cigarettes and real tobacco.

The three largest tobacco companies are investing significant resources in developing their own lines of e-cigarettes.

E-cigarette marketing also emphasizes these devices’ similarity to conventional cigarettes. The system for delivering nicotine—inhalation—is the same, and so is the glamorous and sexualized imagery used to promote them. Tobacco advertising has been heavily restricted in the U.S. for decades, but e-cigarettes are not subject to the same regulations, and many media commentators have noted the similarity between e-cigarette ads and vintage tobacco promotions, with their celebrity endorsements and aura of style and sophistication.

Unproven You may have heard anecdotal stories of people who used e-cigarettes to quit smoking. It is important to remember that these devices have not been approved as cessation tools by the FDA. There is no body of evidence proving that they are safe or effective cessation tools, and no best practices or treatment protocols exist for their use to help patients quit.

Proven At the same time, we do know what has been scientifically proven to help smokers stop using tobacco. Nicotine replacement therapy (NRT), available as nicotine gum, lozenges, and patches, has been approved by the FDA as safe for use. Studies show that NRT, when used in combination with counseling, is the most effective cessation treatment option available. NRT and counseling are available

CHOL–2clr 211 530 02.04.14

E-cigarettes to page 34

Actions taken by the tobacco industry clearly indicate that it views e-cigarettes as the wave of the future. The three largest tobacco companies (Philip Morris, R.J. Reynolds, and Lorillard) have purchased manufacturers of the devices and are investing significant resources in developing their own lines of e-cigarettes.

Youth Perhaps the area of greatest concern about e-cigarettes is their potential appeal to youth. Thanks to internal documents revealed during the Minnesota tobacco trial in the 1990s, there is detailed information about how the tobacco industry has marketed directly to youth. E-cigarette makers are using the same tactics: sexualized and glamorized advertising, promoting use of these devices as a normal part of society, and introducing sweet flavorings into the vaporizable cartridges. E-cigarettes are available in candy flavors such as bubble gum and cotton candy, and research shows that flavored tobacco products have strong appeal for children and teens.

No wonder e-cigarette use by kids has risen. Use by middle school and high school students increased between 2011 and 2012, and 76 percent of these young users also smoked conventional cigarettes.

There is serious concern among experts that the combination of addictive nico-

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P e d i at r i c s

Pediatric fractures Recognize the signs

By Steven W. Meisterling, MD

“I

s it broken or fractured?” This is a common question parents ask when their child has an injury. In fact, the terms broken and fractured mean the same thing. Parents also typically want to know the exact location and severity of the injury.

These are the same factors that an orthopedist—a doctor that treats fractures—uses to determine the best way to care for a child who has a broken bone.

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With warmer weather around the corner, children soon will be spending more time playing outdoors, climbing trees, and generally running a greater risk of breaking bones. In order to know what to do if this happens, let’s consider some frequently asked questions about broken bones in children: causes, symptoms, treatment options, healing, and how to decide whether to seek treatment.

Causes Frequently, children sustain fractures while playing sports or from falls at the playground. Other common activities that can lead to this type of injury include the use of ice skates, roller skates, skateboards, and bicycles.

Childhood fractures are common; an estimated one in three children will sustain a fractured bone during childhood. Studies have shown that boys may be more than twice as likely to fracture a bone than are girls, a discrepancy that likely relates to behavioral differences as well as the difference in activity exposure: Children with greater exposure to risky activities have a higher incidence of breaking a bone. However, this historic gender difference may be diminishing as more girls participate in activities that involve increased physical risk.

Types of pediatric fractures Upper extremity fractures (i.e., arms and hands) are much more common than lower extremity fractures. Among upper extremity fractures, wrist fractures are the most common type, followed by hand and elbow fractures. The tibia, or shinbone, is the most common lower extremity pediatric fracture.

Because a child’s skeletal system is in a state of growth, young bones behave very differently than adult ones. Pediatric bones therefore have different fracture characteristics and healing properties.

One major difference is that a child’s skeleton is more flexible than an adult’s. As a result, some injuries cause a child’s bone to bend before it breaks, resulting in a curved bone referred to as “plastic deformity.”

Other times, a bone bends far enough to partially snap while

14

Minnesota Health care news April 2014

remaining partially intact. You can visualize this as the way a small, living, green branch will only partially snap, but not break in half, when bent. This type of injury is referred to as a “green stick” fracture.

A “buckle” fracture typically occurs at the wrist after a child falls on an outstretched hand. The radius, or wrist bone, partially buckles under the pressure.

break occurred with metallic pins, screws, metal plates, or a combination of these aids. These implants are often temporary and can be removed once the fracture has completely healed.

Promote healing No matter what treatment is used, healing is enhanced by proper nutrition—a healthy diet that includes sufficient calcium—and by avoiding cigarette smoke. Even caregivers who do not smoke in the same room as the child expose the child to thirdhand smoke, which has been found to significantly delay the speed of healing. (Thirdhand smoke is the toxic residue on smokers’ clothing, hair, and skin, as well as on everything they contact.)

One in three children will sustain a fractured bone during childhood.

Growth plates Another important characteristic of the pediatric skeleton is the presence of growth plates. Growth plates, or physes, are located at both ends of most bones and are responsible for bones growing longer. When a bone is fractured and thus temporarily deformed, these active growth plates have the ability to correct the misaligned bone during future growth. A younger child has greater ability than an older child for this correction, due to physes’ tremendous growth potential.

Unfortunately, growth plates also represent a weak area of a child’s bone and therefore are prone to injury. Most injuries to this area will not affect the function of a growth plate. However, potential does exist for arrested growth due to an injured growth plate (physis). These injuries require special treatment to prevent or correct bone deformity.

Symptoms, diagnosis Often it is quite apparent when a child has broken a bone because there is significant deformity, severe pain, or both. Other fractures can show more subtle symptoms, making it difficult to determine if the child needs medical care. How can you decide?

Prevention, awareness Of course, the best treatment for pediatric fractures is prevention.

Proper use of protective equipment can prevent many of these injuries, but the fact remains that children break bones. Be alert to any body part that looks deformed or not quite right. Also remember that persistent and severe pain can indicate the presence of a fracture. If you suspect your child has a broken bone, he or she should be seen by a physician without delay. Prompt treatment will help the child resume a healthy, active lifestyle as soon as possible.

Steven W. Meisterling, MD, is board-certified in orthopedic surgery and practices with St. Croix Orthopaedics.

If a child has fallen and is experiencing extreme tenderness somewhere on his or her body, or severe pain out of proportion to the typical reaction to injury, that may represent an injury that requires professional care. If a child indicates verbally or behaviorally that pain is persisting for what seems like an excessive length of time, that, too, can be a sign of a broken bone. Evaluation by a doctor and X-rays are required to make a diagnosis in these situations.

Treatment There are multiple ways to treat a fracture, based on such variables as the type and severity of the break and the child’s age. Many pediatric fractures can be treated by simply immobilizing the bone in a cast or splint and giving the body time to rebuild the connection between the two broken ends. This treatment is typically used when the two ends of the broken bone line up correctly. Complete healing in these cases generally occurs in six to eight weeks.

More severe injuries may require the fracture to be “set” or “reduced” prior to immobilization. This treatment involves repositioning the broken bone, and may be necessary if the two ends of the broken bone do not line up, if bone protrudes through the skin, or if the fracture involves a joint. These procedures can be accomplished with local anesthesia or with sedation and general anesthesia.

Finally, some fractures require surgery. This generally involves realigning the fractured bone and stabilizing the area where the

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Research

From research to reality Bringing health care discoveries into practice

By Jeffrey Miller, MD, and Timothy Schacker, MD

W

e’ve all read about exciting health breakthroughs, but few people understand how breakthroughs are converted into new drugs, therapies, treatments, and diagnostic tools.

Unfortunately, it can take more than a decade to bring a break-

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Minnesota Health care news April 2014

through from discovery to availability. Making the leap from basic science to a treatment is formidable. The failure rate exceeds 95 percent, according to the National Institutes of Health (NIH). Powerful insights and promising solutions perish due to a lack of funding, support, research participants, and technical expertise. And those breakthroughs that prevail have a long road ahead, making their way from the lab to clinical trials and, ultimately, to the patient.

That’s why health researchers around the country, including those at the University of Minnesota, are transforming the way research is conducted by intensifying their focus on translational research. This approach is named for its emphasis on taking the most promising scientific discoveries and “translating” them into solutions that can improve and save lives.

Found in translation Virtually every researcher we have worked with is motivated to find real-world applications for their health research, but translational research places increased emphasis on this objective. Researchers think about translation earlier in the scientific process, and then take promising discoveries further along the path toward improved health.

A major catalyst for translational research occurred in 2006, when the NIH created the Clinical and Translational Science Awards (CTSA) program, its largest single investment in clinical research. The CTSA program aims to increase the speed and quality of translational research, providing support for the University of Minnesota and 60 other medical research institutions across the country.

The University of Minnesota has a history of bringing medical and scientific breakthroughs into practice, from pioneering HIV drugs to the first open-heart surgery. It intensified its focus on translational research when it established the Clinical and Translational Science Institute (CTSI) in 2009, and joined the CTSA consortium in 2011. We (the authors) serve on CTSI’s leadership team, drawing upon our own translational research experience to help

shape the young institute and build a single infrastructure that enhances the way research is conducted at the university.

From silos to teams Researchers traditionally trek the translational path alone or within a single academic department.

Without comprehensive support, services, and expertise along the way, the journey becomes even more difficult and time-consuming for the researcher who often is already juggling clinical, teaching, and research responsibilities.

unprecedented access to the information needed to study medical conditions, analyze patient outcomes, and pinpoint best practices across large populations, all while protecting patients’ privacy. To give a national example, researchers’ analysis of more than 9,000 breast cancer patients’ records led to the development of Herceptin as a treatment for breast cancer.

It can take more than a decade to bring a breakthrough from discovery to availability.

A brilliant medical researcher doesn’t necessarily have the knowhow to overcome the many regulatory hurdles mandated by the Food and Drug Administration and other agencies, the connections to form critical industry partnerships, or the time to devote to the many steps in a long, complex development process.

A dispersed research infrastructure, in which established, well-funded researchers or departments typically build their own research enterprises and others fly solo, creates inefficiencies and makes it more difficult to overcome common challenges to all researchers. These challenges include extraordinary costs and complexity, a lack of qualified investigators, and not enough volunteers for clinical studies. This can slow research to a crawl. While obstacles can’t be eliminated, research institutions can find more efficient ways to overcome them.

Poising researchers for success To speed up the process that translates an idea into health care practice, institutions need to ensure researchers can focus on their research, provide researchers with resources that streamline the process, and create a steady pipeline of qualified clinical and translational researchers.

At CTSI, there is just such a program, devoted to helping researchers make the leap from basic research to real-life application. Remarkable discoveries and ideas get the expertise and support they need to begin their journey and to potentially advance through the development pipeline. University researchers can get free guidance on how to develop their discovery; connect with complementary technologies, resources, and companies; and get funding that can lift promising early-stage projects off the ground.

In addition, CTSI is building resources to support researchers, including a clinical data repository that securely houses electronic medical records (EMRs) of more than 2 million patients. A planned repository will store bodily samples such as blood and urine, each specimen a source of valuable research information.

These resources give researchers

We are also thinking beyond the scientific process, with programs that provide researchers with career development and training and spur collaboration with communities to conduct, disseminate, and apply research.

For example, CTSI is funding a University of Minnesota researcher who is analyzing the health outcomes of Isis Rising, a local nonprofit’s project that provides doulas to pregnant, incarcerated women. Doulas provide expectant women with support, education, and training, and initial results indicate that doula care for inmates may be a promising approach to improving health outcomes such as birth weights and maternal mental health. This program has already helped vastly decrease cesarean delivery rates, an outcome that could reduce the risk of complications and save taxpayer dollars.

From research to reality to page 19

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www.schellerlegalsolutions.com April 2014 Minnesota Health care news

17

April Calendar 10

S urvivors of Suicide Support Group

Have you experienced the death of a loved one through suicide? This support group, hosted by Bradshaw Grief Resource Center, will connect you with other individuals and families who understand. For more information, call (651) 489-1349 or visit www.bradshawfuneral.com Thursday, April 10, 7–8 p.m., Bradshaw Group, 4600 Greenhaven Dr., White Bear Lake

15

Cancer Education for the Newly Diagnosed

Park Nicollet hosts this free education program for individuals who have been recently diagnosed with cancer, their family members, and friends. Come gain valuable information and resources to help cope with the changes.

Call (952) 993-5700 to register.

Tuesday, April 15, 3–4 p.m., Park Nicollet Frauenshuh Cancer Center, Curtis and Arlene Carlson Family Community Room, 3931 Louisiana Ave. S., St. Louis Park

24

H ow Do I Help My Child Who is Anxious?

Join this class offered by PACER Center to learn ways to help your child who may be suffering from anxiety. Speaker and author Rebecca Kajander, CPNP, MPH, will share practical take-home tips for parents. Free. To sign up, call (952) 838-9000.

Thursday, April 24, 6:30–8:30 p.m., PACER Center, 8161 Normandale Blvd., Minneapolis

29

D eaf Yoga

Tula Yoga & Wellness hosts this yoga class for individuals who are deaf or hard of hearing. Come learn the basic principles of letting go and meditation with a teacher that uses American Sign Language. Recommended donation minimum of $5. Contact the instructor at jessalyn@jessalynfrank.com for more information.

Tuesday, April 29, 7:15–8:15 p.m., Tula Yoga & Wellness, 99 Snelling Ave. N., St. Paul

Send us your news: We welcome your input. If you have an event you would like to submit for our calendar, please send your submission to MPP/Calendar, 2812 E. 26th St., Minneapolis, MN 55406. Fax submissions to (612) 728-8601 or email them to amarlow@mppub.com. Please note: We cannot guarantee that all submissions will be used. CME, CE, and symposium listings will not be published.

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Minnesota Health care news April 2014

National Autism Awareness Month In May 2013, all autism disorders were combined under one umbrella diagnosis of autism spectrum disorder (ASD) in the DSM-5, the handbook used by health care professionals as a guide to the diagnosis of mental disorders. The developmental disabilities associated with ASD can cause significant social, communication, and behavioral challenges. Because it is a spectrum, people with ASD can be affected to varying degrees, ranging from mild to severe.

ASD affects about one in 68 children in the U.S., according to the U.S. Centers for Disease Control and Prevention. It affects all racial, ethnic, and socioeconomic groups, but is almost five times more common among boys than it is among girls. Many parents of children with ASD notice a developmental problem before the child’s first birthday. Concerns about vision and hearing are more often reported during the child’s first year, and differences in social interaction and fine motor skills often become evident after 6 months of age.

Discovering that your child has ASD may feel overwhelming and can raise many questions about what to do next. Finding support for yourself and your family is important, and there are multiple ways to meet with others that can help. Contact the Autism Society of Minnesota for more information at (651) 647-1083 or www.ausm.org

8

Parents of Children with Autism Support Group

The Arc Greater Twin Cities offers this monthly support group for parents of children affected by ASD. Join to meet other parents who understand, and get tips, advice, and resources to help your child and your family. To sign up or for more information, call (952) 920-0855.

Tuesday, April 8, 7–8:30 p.m., Family Achievement Center, Ste. G, 8320 City Centre Dr., Woodbury

May 3

Youth Orthopedic Surgery Preparation Class

Gillette Children’s Specialty Healthcare presents this free interactive session for parents to learn how to prepare for their child’s orthopedic surgery and what to expect during the procedure. Register by April 26; call (651) 312-3198 or email preopclasses@gillettechildrens.com Saturday, May 3, 1–3 p.m., Gillette Children’s Specialty Healthcare, Wallace Cole Conference Room, 205 University Ave. E., St. Paul

5

Free Skin Cancer Screenings

5

Resolve: Support Group for Fertility and Adoption

8

Raising Kids with Celiac Disease

The University of Minnesota Dermatology Department hosts a day of free skin cancer screenings. Skin care sample and education will be available. No appointment necessary; screenings are offered on a first-come, firstserved basis.

Monday, May 5, 8 a.m.–3 p.m., University of Minnesota Dermatologic Surgery and Laser Center, Phillips–Wangensteen Building, 4th Flr., Clinic 4A, 516 Delaware St. SE, Minneapolis

This doctor-led support group offers a compassionate, confidential setting to share your experiences with others who are building their family through reproductive medicine, donor egg or embryo donation, or gestational carrier.

Free. RSVP required. Call (651) 226-4704 to sign up.

Monday, May 5, 6:30–8 p.m., office of Jeanette Truchsess, RN, PhD, 821 Raymond Ave., Ste. 240A, St. Paul

Twin Cities ROCK (Raising Our Celiac Kids) hosts this free support group for parents with children affected by celiac disease. Join others who understand to share tips, advice, and gluten-free resources. For more information, visit www.twincitiesrock.org Thursday, May 8, 7–9 p.m., Fresh & Natural Foods, Shoreview Village Mall, 1075 Hwy. 96 W., Shoreview

From research to reality from page 17

Challenges But challenges remain. One of the biggest reasons clinical studies fail is that too few people choose to be research volunteers. Participating in research is one of the most powerful, effective things someone can do to be part of medical breakthroughs that transform lives.

Take HIV, for example.

Someone who contracted the disease in the 1980s could expect to be dead within five years.

Research led to the development of drugs that allowed HIV-positive people to live significantly longer, rather than die from a rapid progression to AIDS. This would not have happened without the efforts of researchers and the willingness of people to volunteer for clinical studies.

There is always a need for research volunteers, whether it is donating a bio-specimen, such as blood or tissue from a tumor that is surgically removed; joining a clinical trial; or simply filling out a survey. Talk to your doctor about getting involved or visit CTSI’s Study-Finder site to search for University of Minnesota studies that need volunteers (www.studyfinder.umn.edu).

Forging ahead Future plans will make it easier for Minnesotans to get involved. The University of Minnesota is planning a clinic in collaboration with Fairview Health Services and University of Minnesota Physicians. This facility will have an increased focus on research and clinical trials, while streamlining the process for taking lab research to the bedside so discoveries can benefit patients.

One of the biggest reasons clinical studies fail is that too few people choose to be research volunteers.

However, HIV-positive people still face early mortality. At our university alone, hundreds of people, both healthy ones and those who are HIV-positive, have donated tissue to help researchers learn why HIV causes AIDS and to test treatments that could potentially save lives. So far, volunteer involvement has helped University of Minnesota researchers better understand the process that directly causes immune suppression in HIV, which has led to a new therapy—currently in clinical trials—with potential to reverse that process.

When we reimagine the way we conduct and collaborate on research here in Minnesota, we have the potential to improve human health around the world.

Jeffrey Miller, MD, is the deputy director of the Clinical and Translational Science Institute, deputy director of the Masonic Cancer Center, and professor of medicine at the University of Minnesota. Timothy Schacker, MD, is the associate director of the Clinical and Translational Science Institute, director of the Program in HIV Medicine, and professor of medicine at the University of Minnesota.

April 2014 Minnesota Health care news

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C o m m u n i t y C a r e g i v e r s 2 014

Making a difference in Minnesota and the world

Recognizing Minnesota’s volunteer physicians Each year, Minnesota Physician Publishing honors physicians who have volunteered medical services in recent years.

Through volunteer medical activities that span the globe, Minnesota’s volunteer physicians have provided medical care and medical education while expanding cross-cultural skills and understanding.

Their compassion, commitment, and generosity reflect deeply held values of Minnesota’s medical community.

By Minnesota Physician Publishing staff

20

happened onto this way of giving back when a friend in India called for advice on her mother’s cancer diagnosis. Malisetti was able to review the records via email and offer her perspective. Since then, she has been able to help several others in the same way.

Growing up in the Telugu culture and also knowing Western medicine, Malisetti tries to give advice that honors the beliefs of Telugu patients here and in India.

“I spend time explaining in the Rajini Katipamula-Malisetti, MD most basic terms what they are up against,” Minnesota Oncology explains Malisetti. “I try to foster the idea that they need to ask questions to understand what Translating Telugu they have and how to better manage their sympne night a few years ago, Rajini Katipam- toms.” ula-Malisetti received a phone call that The biggest challenge for Malisetti is the a man had been found unresponsive in a gap in cultural beliefs. “In American medicine, swimming pool. She met his family and friends people believe that only the patient has the right at the hospital and spent two hours helping them to choose or refuse treatment,” she observes. understand why they should have life support “This is different in our culture, where patients removed. The family was very grateful to her are often told what to do. It is very confusing for for explaining this difficult decision in their own them when they are given choices.” language.

Malisetti volunteers out of humility, obliThat language gation, and gratitude. is Telugu, spoken by “Having grown up people from Andhra in the Indian medical I try to foster the idea that Pradesh, a state in system, I am reminded they need to ask questions. southeastern India. It of how highly physiis also Malisetti’s first cians are regarded. This language. “Becomreminds me that I have ing a doctor was my greatest dream as a child,” to keep doing the best I can,” she acknowledges. recalls Malisetti. “And, with a lot of hard work, Malisetti’s contributions to the health and I was able to secure admission into a medical well-being of the Telugu people in Minnesota college in India.” and India have not gone unnoticed. Last year she Malisetti arrived in the U.S. in 1999 for her was honored with an award of excellence at the residency in Massachusetts and then completed annual convention of the Telugu Association of a three-year fellowship in medical oncology and North America (TANA). hematology at the Mayo Clinic in Rochester. She “My goal is to be able to do more of this,” now practices at Minnesota Oncology. shares Malisetti. “I have three daughters under While Malisetti is able to offer the occathe age of 10 so I am not able to spend more sional translation for Telugu patients, most of time volunteering. But as the kids get older, I her volunteer work consists of reviewing medical would like to become more involved in providing records for patients back home in India. She free care to those in need back home.”

O

Minnesota Health care news April 2014

Thomas Haus, MD

Glacial Ridge Health System

Providing care in Honduras

T

om Haus had always wanted to do a medical mission, but family obligations and other “excuses,” as he calls them, seemed more important. That changed when the family practice doctor from Glenwood, Minn., and his family traveled to Guatemala several years ago. “I observed the pro-

found need there for the most basic health care,” duras with his second daughter in 2015. Haus beHaus remembers. lieves that “you have to cultivate the idea of good Several of Haus’ coworkers at will in your children.” He continues, “I would Glacial Ridge Health System and fellow want someone to help me if I were in need. We are residents from Glenwood had been only as well, as a society, as our least well.” traveling to Honduras on medical misThe experience in Honduras opened Haus’ sion trips for the last 15 years. “I was eyes to the fact that most U.S. citizens take for gently encouraged to give it a try,” Haus granted their easy access to quality and safe medrecalls. ical care. He says, “People would go for months Haus’ daughter, Katie, a high without any medication or even the opportunity school junior to see a care provider. at the time, Simple life-saving prohad expressed cedures are often not an I would want someone to some interest in option because of cost medicine as a and travel barriers.” help me if I were in need. career and was Haus remembers a 9-year-old boy who also proficient showed signs of heart in Spanish. She was imfailure. There were no options for the family by mediately taken with the idea of a trip to Central America. “At that point I had no further excuses itself to get him to a larger city about three hours not to go,” concedes Haus. away. The local community leaders found a way to Haus traveled to Honduras with International fund his trip to see a heart specialist affiliated with Health Service (IHS, www.ihsmn.org), based in IHS, who was able to arrange more treatment. the Twin Cities. He spent two weeks working in “Many people there have so little but seemed medical and dental clinics in several rural villages to be willing to give as much as they could,” reflects Haus. “They are very generous and thankful. along the coast.

I look forward to returning to this beautiful counThe trip made such an impression on Haus that he became convinced it was an opportunity try with its kind people and playful children.” every person should have. He will return to Hon-

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April 2014 Minnesota Health care news

21

Richard Sveum, MD

Park Nicollet Health System

Serving children with asthma

“I

t’s a privilege to be a doctor,” says Dick Sveum, an allergist in the Department of Asthma and Allergic Diseases, Park Nicollet Health System, and an adjunct professor of medicine and pediatrics at the University of Minnesota School of Medicine. “With privilege comes obligation. The

obligation is to give back to the community.”

One of the benefits of Camp Superkids arose Sveum gives back by directing Camp Sufrom tragedy. In 1987 a child collapsed at camp, perkids, the summer camp for children with was evacuated and resuscitated, but later died. asthma held at Camp Ihduhapi, the YMCA Sveum and others thought this incident would camp on Lake Independence near Loretto, shut the camp down for good, but it didn’t. They Minn. Camp Superkids is sponsored by the talked about the incident and decided to create the American Lung Association in Minnesota, Consortium on Children’s Asthma Camps, now a national organization. The rewith additional sult is better monitoring and support from Chilcare of children at camp. dren’s Hospital.

The obligation is to give Spending time at the Sveum inherited back to the community. camp has directly affecthe position from ted Sveum’s clinical practice.

Richard Cushing, “There is nothing like getting MD, the Park to know my patients outside the clinic by living Nicollet allergist who founded the camp in with them at camp. I can see firsthand how asthma 1967. affects their lives,” explains Sveum. “When I see “We try to see the camp as community educapatients back in the clinic, we talk about their tion,” explains Sveum. “We have a nurse for every camp experience.” The time at Camp Superkids cabin, along with pharmacists and respiratory makes an impression: Former campers will come therapists on site. We incorporate asthma educaup to him and talk about it years later. tion into daily activities and have a program for Sveum received the Lifetime Achievement the parents, too, when they come to pick up their Award from the American Lung Association in children from camp.”

Minnesota, but stresses, “It’s not so much about Most of the campers come from the inner city me. It’s that there’s this thing—Camp Superkids— and receive scholarships, including some from health plans. Data have shown there are better out- that doctors do that’s rewarding for children. I want more people to be aware comes for children with asthma if they go to camp of it.” and learn about the disease.

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22

Minnesota Health care news April 2014

Jim Standefer, MD

University of Minnesota

Improving vision worldwide

E

arly in his second career as a volunteer, Jim Standefer visited Mongolia to perform cataract surgeries with two other ophthalmologists.

The chief ophthalmologist at the hospital said, “You need to come back next summer—we don’t know anything about glaucoma.” Standefer returned for four

weeks, and thoroughly enjoyed it. to teach others what I taught them.”

Standefer has always been interested in volStandefer has also brought ophthalmologists unteer work, but wasn’t able to make good on to the University of Minnesota for three-month that intention until his ophthalmology practice in observerships. “I usually teach about the eye bank.

Stillwater had grown to include multiple offices One resident from Lithuania went home and and doctors, and he felt the time was finally right started the first eye bank in Lithuania,” Standefer to embark on a new course. recalls, clearly pleased that the visiting ophthalmolStandefer’s gift and passion is teaching and ogist took his instruction to heart. treating glaucoma. CurrentCataracts are easy to ly an adjunct professor of see, diagnose, and treat. clinical ophthalmology at Surgery restores vision overTeaching is key. One the University of Minnesota, night, so patients in devellecture can do so much.

Standefer has taken his mesoping countries are thrilled sage throughout the developwith the “miracle.” “But not ing world, including Nigeria, so with glaucoma,” remarks Siberia, Yemen, Africa, and Vietnam. Pakistan, Standefer. “We can only reduce the pressure in the Iran, Oman, and Jordan are on the itinerary in the eyes.” Most glaucoma patients in these countries next few years. This April he will speak in Tokyo go untreated, and thus slowly go blind. Although at the World Ophthalmology Conference. “I’m there is no cure for glaucoma, at least the surgeons kept busy,” chuckles Standefer. in those countries can be trained to perform By the numbers, he has taught more than 42 pressure-reducing surgeries. workshops in more than 30 countries. “The variety “For me, the best method is still teaching of countries I’ve been to—that wasn’t by purpose,” ophthalmologists in these developing countries, he explains. “People would ask me, ‘Come teach,’ using the ‘trainer of trainers’ approach,” maintains and I would go.”

Standefer. “They should go and teach others in “I use the public health model of ‘teacher of their institutions as much as they can. teachers,’” Standefer explains. “I will ask for five “Teaching is key,” he emphasizes. “That is the ophthalmology residents from different training core of my message—my mission and my passion. centers in the host country. They come to me for One lecture can do so much.” two weeks with the understanding they will leave

April 2014 Minnesota Health care news

23

Brad Linzie, MD

Hennepin County Medical Center

Cancer screening for underserved

“I

remember several occasions when I showed women that their Pap test was completely normal and they immediately burst into tears. This was not the reaction I had anticipated,” recalls Brad Linzie, medical director of the

surgical pathology department at Hennepin Countance of getting appropriate screening tests.” ty Medical Center.

Linzie marvels at the contrast between his day The women explained to Linzie that they had job and his work at NorthPoint. “Normally when a huge amount of pent-up anxiety because they I am working, I am sitting in a quiet room alone had never had a Pap test before. “I have been very or with students while reading slide after slide for much changed by that sentiment,” Linzie reflects abnormal findings,” he explains. “I don’t get to see humbly. what impact this will have on a person. At the See, He gained this insight at NorthPoint Health Test & Treat health fairs, I am in the middle of a and Wellness crowded clinic Center in where I get to We physicians have an ethical obligation Minneapolis, bring the patient through the to the microscope to get appropriate medical information See, Test & and see her face and care to groups that need it.

Treat program when I explain sponsored by her finding.” the College of Linzie has American Pathologists. This national program pro- received the CAP Foundation’s newly created Gene vides cervical and breast cancer screening at health and Jean Herbeck Humanitarian Award, for his fairs aimed at underserved populations. leadership in providing outstanding direct patient At this screening, women are seen by a primaservices to individuals in underserved communities ry care provider, get a Pap test and results, and a through the See, Test & Treat program. screening mammogram and results, all on the same Linzie has this advice for fellow physicians: day. Any follow-up care based on an abnormal “We physicians have an ethical obligation to result can be scheduled for that day or whenever it get appropriate medical information and care to is convenient for the patient. groups that need it. Keep your eyes and ears open Participants also can view their own Pap test for opportunities to join a community outreach slide with a pathologist to see how cervical cancer effort that appeals to you or needs your unique talis detected and how cells are viewed through the ent.” He concludes, “Your soul will be rewarded microscope. “This educational opportunity is not in ways that help you feel creative and better able available anywhere else,” explains Linzie. “It is a to deal with the stress and burnout of your regular positive reminder for these women of the imporjob.”

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Minnesota Health care news April 2014

URGENT CARE

Bill Nersesian, MD

Fairview Physician Associates

Changing lives of the challenged

A

s his youngest child was finishing high school, Bill Nersesian realized he had extra time on his hands.

He started looking for the right outlet for giving back or, “what God would direct me to do,” he explains.

problems in society.

He found that outlet at a concert given by “Blue collar workers, forklift operators, also Minnesota Adult and Teen Challenge’s choir, stock brokers, pastors, physicians—I’ve come which sings at churches around Minnesota and across almost every level of society,” he marvels. whose singers speak about how they came back “It’s an eye-opener to see how pervasive drug and from the depths of despair and drug abuse. Nersealcohol problems are. No one is immune. My sian heard the choir at the time he was considering experiences at Teen Challenge have made me more volunteer work. aware of the signs and not to take anything for Nersesian decided to contact the organization granted.” and learned it needed someone to give physicals to In addition to providing physicals, Nerseincoming clients. That was the last thing Nersesian sian also mentors many of the young men in the thought he wanted to do—more of the same thing program. His greatest he did every day at his enjoyment comes from job—but he agreed to encouraging them. “I like it anyway. He discovI feel called to do this—it’s to point out to them some ered surprising personal almost like I couldn’t not do it. of the things I see that rewards as a result.

Minnesota state are good—their personallaw requires every ity, their potential, their inpatient who receives drug or alcohol addiction skills,” he shares. “If they can stay in the program treatment to have a physical exam and blood a year, 87 percent will not go back to drug or alcotesting. At least 80 percent of Minnesota Adult and hol addiction.

Teen Challenge clients are men. “I’ve been doing “I feel called to do this—it’s almost like I this for 11 years now, so I’ve helped about 1,500 couldn’t not do it,” explains Nersesian. “I find men,” estimates Nersesian. myself energized and rejuvenated. Even when I’m Nersesian finished his pediatric practice a few tired, or the weather’s bad, once I get down there, years ago and now serves as the chief medical offiI’m glad I went.” He continues, “I get rewarded by cer for Fairview Physician Associates. A departure visiting with these young men. When I leave, I feel from his day job, Nersesian’s volunteer work has like I’ve done what I should be doing. It’s a calling given him a greater awareness of drug and alcohol from God.”

April 2014 Minnesota Health care news

25

Pulmonology

Lung cancer screening New tool improves early detection

By Lee Kamman, MD, Cynthia Isaacson, and Jill Heins Nesvold, MS

L

ung cancer is one the deadliest cancers, killing 2,174 Minnesotans in 2011, according to the Minnesota Department of Health. One reason lung cancer is so serious

In the next issue...

• New drug therapies • Uterine cancer • Healthy aging

is that it usually is not detected until it has spread, at which point it is more difficult to treat. Because this disease often shows no symptoms until it is advanced, finding a way to detect it early has long been sought, especially for people at higher risk of developing it.

Now there is a test that can reduce death from lung cancer by early detection. By screening at-risk individuals before they have symptoms, the medical community believes it could prevent as many as 3,000 to 4,000 deaths nationwide each year, according to the National Lung Screening Trial (NLST).

The NLST compared low-dose helical computed tomography (commonly called a CT scan) and standard chest X-ray in detection of lung cancer. Results showed that participants who received low-dose CT scans had their lung cancers detected sooner than did people whose cancers were detected by X-ray. As a result, people screened by CT scan were able to start treatment for lung cancer sooner and had a 20 percent lower risk of dying from the disease than participants screened by standard chest X-ray. Chest X-ray is no longer recommended as a screening tool.

What is a CT scan?

This procedure produces multiple X-rays of your chest as you lie on a table that slides in and out of a machine that uses low-dose radiation. A computer then combines these X-rays into a detailed picture of the inside of your chest. This picture is scrutinized by a radiologist, who looks for nodules (bumps) that suggest the presence of cancer.

Who should be screened?

On Dec. 31, 2013, the United States Preventive Services Task Force recommended annual low-dose CT screening for individuals at high risk for lung cancer, which includes an estimated 9 million Americans. Screening is recommended for individuals who meet all

26

Minnesota Health care news APRIL 2014

of the following criteria: • Current smoker or former smoker who quit within the past 15 years • 55 to 80 years old • Have a smoking history of at least 30 pack-years (i.e., 1 pack/ day for 30 years, 2 packs per day for 15 years, etc.)

ity of CT screening in the context of their existing lung disease.

If you are wondering if you should get screened, the American Lung Association has launched a website to help you decide. This tool (LungCancerScreeningSavesLives. org) takes visitors through a series of questions that helps determine whether they meet guidelines for screening.

• No history of lung cancer There is no evidence at this time that other high-risk groups should be screened. Patients with lung disease, particularly COPD, should be evaluated by their pulmonologists regarding the advisabil-

Cost Because the NLST results are recent, health insurance companies and Medicare may not cover the cost of a CT scan to screen for lung cancer at this time. That means that you may have to pay for the procedure out of your own pocket. Be sure to check with your health plan before scheduling a CT scan, so that you know how much it will cost. Ask the facility performing the CT scan to clearly explain all scan-associated costs you may incur, not just the cost of the CT scan alone.

CT screening sites Be sure to seek institutions that have experience in conducting low-dose CT scans and use up-to-date CT technology. The institution should provide a link to an expert multidisciplinary team that can provide follow-up for evaluation of any nodules that may be detected. If the facility does not have that expertise on site, it should be able to refer you to appropriate institutions. Staff should also discuss results with you and how they will follow up with you after the screening. Minnesota clinics that provide CT screens for lung cancer include: • Consulting Radiologists–Edina and Plymouth • Suburban Imaging–Coon Rapids and Maple Grove • St. Paul Radiology–United Hospital, St. Paul, Eagan, Maplewood, Gallery Towers/ St. Joseph’s Campus St. Paul, and Woodbury/ Lake Elmo • Mayo Clinic–Rochester • The University of Minnesota/ Fairview–Minneapolis

Lung cancer screening to page 30

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27

Patient to Patient

Support groups Help from those who understand

By Connie Sheely

Shock Oct. 12, 1999, is a day I will never forget. It is the day that my life and the lives of the rest of my family were forever changed. That day, my mom called and as soon as she started talking, I knew something was terribly wrong.

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Minnesota Health care news APRIL 2014

Mom said she had gotten a call from the apartment manager where my brother, Joel, was living in Kansas City, Mo. The manager said to her, “A male body has been found in your son’s apartment and we think it is your son.”

We learned that Joel, 33 years old, was found shot to death in his apartment. His case remains unsolved. We still have no idea who could have committed such a terrible crime, or why. What a senseless and violent act.

Aftershock For several months afterward I was in a state of shock; I felt like I was walking around in a daze. This is something you hear about in the news and see on TV, it’s not supposed to happen to someone you love. Dealing with this trauma caused me to be distracted, and it was difficult to focus at work. Everything made me afraid. I lived alone at the time and didn’t want to be home alone. When I was home, I made certain that every door and window was locked. I slept with the light on, but sleeping was difficult and included disturbing dreams and nightmares. For a while, I existed in a state of near-paranoia.

Beginning to cope When forced to survive traumatic grief such as this, how can someone cope and transition toward a new normal? In addition to relying on my religious faith for comfort and support, it helped that my family was able to share our grief and lean on each other. Unfortunately, friends and co-workers weren’t really equipped to help me because they had no idea what I was experiencing.

However, I discovered one place that offered me the greatest comfort and opportunity for healing. That place was a support group associated with an organization called Parents of Murdered Children (POMC). POMC provides education and ongoing support for those who have suffered the murder of a loved one. Members meet monthly to share experiences and to support each other.

As hard as it was for me to go to my first meeting, it was the best thing I did to help me get through my traumatic grief. Grief is difficult, but the only way to find that new normal is to work through the feelings that accompany a loss.

Talking with others who had experienced similar tragedies was the most effective therapy I found.

on the heart, and other health problems. Not surprisingly, a study published by the American Heart Association in 2012 reported that people grieving the death of a loved one have a significantly higher risk of heart attack.

It’s also common for grieving people to feel depressed and isolated. But, according to Donald L. Rosenstein, MD, director of the comprehensive cancer support program at the University of North Carolina at Chapel Hill, there is a great deal of evidence that support groups help reduce anxiety, depression, and feelings of isolation in the people who belong to them.

Support groups help reduce anxiety, depression, and feelings of isolation.

Support for many challenges Support groups exist for a wide variety of challenges that people face, and tend to be organized along similar lines. Interactions within a support group focus on education and on emotional well-being. In a typical meeting, members who feel like sharing personal stories can do so, while members who prefer to listen are free to do that, too. Members are able to express emotions in the safe, understanding, confidential, and supportive environment that the group provides. Attendees also share information and resources, and encourage each other on their personal paths toward a new normal.

By helping other people in the group, participants become better able to heal, strengthen, and empower themselves.

Health benefits These groups also offer participants the opportunity to enjoy better health. This is important because grief causes elevated stress and anxiety, which can lead to high blood pressure, increased stress

How to help Most people are sympathetic and well-intentioned, but in attempting to be helpful may say and do things that do not help a survivor heal. Even if you haven’t experienced the traumatic death of a loved one, you can still play an important role for someone who has. Use these tips, based on those provided by the National Organization of Parents of Murdered Children, Inc.

1.

isten nonjudgmentally to the survivor re-tell details of L their trauma. This helps the person break through his or her denial of it. Your listening also helps the survivor start to rebuild trust in others.

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Support groups to page 31

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29

Lung cancer screening from page 27

Resources for lung cancer patients • Facing Lung Cancer from Day One provides educational and supportive help. www.mylungcancersupport.org • Lung Connection is an online community for people living with lung disease. www.connection.lung.org • Lung HelpLine answers questions about lung health and CT screenings. (800) LUNG-USA

Associated costs may include a fee for a radiologist to interpret the scan, for example.

However, screening may be covered by Medicare, and the Affordable Care Act may require many health insurance companies to provide the test free of charge. Currently in

Minnesota, Blue Cross Blue Shield of Minnesota is the only private insurance company that covers lowdose CT as a screening tool for lung cancer.

For patients whose scan is not covered by their insurance company, the average cost of this screen in the state is $150.

Before screening Considering lung cancer screening can raise questions. The American Lung Association has released new guidelines to help a patient and his or her physician decide whether lung cancer screening is right for that patient. CT scan screening is not recommended for everyone and has risks as well as benefits. It’s a complicated process that requires a patient to first: • Get a complete health history.

• Determine possible comorbidities (i.e., coexisting medical problems).

• Learn symptoms of lung disease and lung cancer.

Lung cancer screening to page 32

WHO’S A BIGGER BASEBALL FAN, YOU OR ME? You’ll find that people with Down syndrome have a passion for knowledge and learning that can rival anyone you’ve met before.

To learn more about the rewards of knowing or raising someone with Down syndrome, contact your local Down syndrome organization.

Or visit www.dsamn.org today.

It is the mission of the Down Syndrome Association of Minnesota to provide information, resources and support to individuals with Down syndrome, their families and their communities. We offer a wide range of services, programs and materials at no charge. If you are interested in receiving one of our information packets for new or expectant parents, please email Kathleen@dsamn.org or For more information please call:

(651) 603-0720 • (800) 511-3696 30

Minnesota Health care news APRIL 2014

©2007 National Down Syndrome Congress

Support groups from page 29

2.

alidate the survivor’s feelings. What survivors feel is V normal; don’t tell us what we should feel. Realize that there is no timetable for our healing, and don’t expect us to move on from obvious mourning until we are ready.

3.

sk the survivor if he or she wants to hear information A related to the traumatic event; if the answer is “yes,” give clear, accurate information. Don’t give misinformation or omit information in an attempt to protect us. Most survivors want to know everything.

4.

ffer simple choices to restore a sense of power over our O lives. For example, say, “Can I grocery shop for you or would you like to do it?” Or, “Would you like to shop with me?”

5.

cts of kindness restore our trust in others. Don’t paA tronize, but offer practical help such as cooked meals, babysitting, or yard work.

6.

7.

8.

S hare memories of the deceased. It’s okay to say the loved one’s name. Tears are okay, too.

Be sensitive around the time of birthdays, anniversaries, and holidays, as these remind survivors of their loss. ecognize that survivors need a balance of activity and R time alone.

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9.

S ometimes, just providing a human presence is what survivors need. We don’t necessarily need you to chat with us. We just need someone to be with us.

10.

ffer support, not criticism. It doesn’t help a survivor O to hear that he or she is going to the cemetery too little or too often. Nor is it helpful when someone comments on a survivor keeping mementos such as the deceased person’s clothing. Letting go is a long process.

11.

12.

he survivor needs to be patient with him- or herself T as well as needing patience from others. ecognize that everyday tasks such as driving may R be too much for the survivor to handle, because of a lack of concentration, lack of energy, or fear. Offering to drive the survivor to appointments or otherwise offering to help with everyday tasks is one way to support a grieving friend.

A new normal POMC has become a second family for me, although it is a family none of us chose to join. I will always miss my brother, but with the nonjudgmental understanding and information about resources that this group provides, I have found a new normal.

Connie Sheely is the chapter leader of the Southeast Minnesota Chapter of Parents of Murdered Children, which holds meetings in Rochester.

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31

Lung cancer screening from page 30

• Discuss with the doctor the benefits, risks, and possible procedures of screening.

Lung cancer detected early is much more treatable than cancer found in later stages. The goal of providing lung cancer screening to people at risk helps find the disease earlier, which can improve survival rates. The vast majority of screenings come back negative.

If lung cancer is detected, finding it early makes survival rates jump from 15 percent to 75 percent. If you meet the guidelines on page 27, getting screened is your best option.

• Discuss with the doctor the costs of screening, including financial, personal, and time costs.

• Quit smoking.

Interpreting results • A “positive” or “suspicious” result means that the CT scan shows an abnormal nodule, but many of these nodules are “false positive.”

This term means that the nodules found could indicate lung cancer or the presence of another serious condition, and additional procedures could be needed to confirm a lung cancer diagnosis.

Lung cancer detected early is much more treatable than cancer found in later stages.

• An “indeterminate” result will be monitored for a year or two before the doctor decides whether the nodule(s) is cancerous.

Lee Kamman, MD, is board-certified in internal medicine, pulmonary disease, and critical care, and practices at United Lung and Sleep Clinic, St. Paul. He is also chair of the lung cancer program at Allina Hospitals and Clinics. Cynthia Isaacson and Jill Heins Nesvold, MS, are the manager and director, respectively, of respiratory health with the American Lung Association in Minnesota.

Minnesota

Health Care Consumer Association

March survey results ...

Each month, members of the Minnesota Health Care Consumer Association are invited to participate in a survey that measures opinions around topics that affect our health-care delivery system. There is no charge to join the association, and everyone is invited.

For more information, please visit www.mnhcca.org. We are pleased to present the results of the March survey.

40 30 20 10 0

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No opinion

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Strongly disagree

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30 25 20 15 10 5 0

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No opinion

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Minnesota Health care news APRIL 2014

40 30 20 10 0

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No opinion

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5. F or some conditions, I feel that this kind of clinic would increase access to high quality care at a lower cost than traditional physician-staffed clinics.

Percentage of total responses

Percentage of total responses

4. G iven the opportunity, I would personally utilize this kind of health care facility.

50

30 25 20 15 10 5 0

3. I f the legislature approves this kind of health care facility, I feel that it should be covered by my health care insurance.

Percentage of total responses

50

2. S ince this issue is being heard in the current legislative session, I plan to contact my legislator take my feelings known on this issue.

Percentage of total responses

Percentage of total responses

1. I am in favor of advanced practice registered nurses being licensed to open privately owned freestanding clinics and prescribe certain medications without physician oversight.

Strongly agree

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No opinion

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60 50 40 30 20 10 0

Strongly agree

Agree

No opinion

Disagree

Strongly disagree

Minnesota

Health Care Consumer Association

Welcome to your opportunity to be heard in debates and discussions that shape the future of health care policy. There is no cost to join and all you need to become a member is access to the Internet.

SM

Members receive a free monthly electronic newsletter and the opportunity to participate in consumer opinion surveys.

www.mnhcca.org

Join now.

“A way for you to make a difference�

April 2014 Minnesota Health care news 33 NOVEMBER 2012 MINNESOTA HEALTH CARE NEWS 33

E-cigarettes from page 13

can contact QUITPLAN to be routed directly to their health plans for service.

And if you don’t know whether your insurance covers cessation treatment, contact QUITPLAN Services to be directly routed to cessation services either through your health plan or through QUITPLAN Services itself (888) 354-PLAN, www.quitplan.com).

to Minnesotans through QUITPLAN Services.

Anything that prolongs a smoking addiction or directs smokers away from proven cessation tools such as NRT is of legitimate concern. The FDA has not yet provided formal guidance on e-cigarettes; in the meantime, the University of Minnesota has announced its intention to conduct a study of the health effects of e-cigarette use and exposure.

Several Minnesota communities have placed restrictions on e-cigarette use and sales, and this year the Minnesota Legislature is considering bills to add these devices to existing tobacco regulations, including the statewide Minnesota Clean Indoor Air Act. To learn how you can help, visit ClearWay Minnesota’s Action Center (www.clearwaymn.org/action-center/) and sign up to receive updates and calls to action.

But for now, there remain too many unknowns. Simply put, until science suggests otherwise, tobacco users who want to quit should use proven options.

How to get help All Minnesotans can get help quitting smoking. People who are uninsured or whose insurance does not cover smoking cessation treatment can get free NRT and counseling by contacting QUITPLAN Services. People who do have insurance coverage for smoking cessation treatment

Barbara A. Schillo, PhD, is a vice president of ClearWay Minnesota, a nonprofit organization with a mission to enhance life in Minnesota by reducing tobacco use and exposure to secondhand smoke through research, action, and collaboration.

Communities taking action • The cities of Duluth, Mankato, and Hermantown, as well as Beltrami County, ban the use of e-cigarettes anywhere smoking is prohibited, including bars and restaurants.

• Hennepin County bans the use of e-cigarettes on county property.

• Housing and Redevelopment Authorities in St. Cloud, Eveleth, and Worthington include e-cigarettes in their smoke-free housing policies.

• Hennepin County Technical College and Bemidji State University ban the use of e-cigarettes on their campuses.

• Rock County requires that all e-cigarettes be sold behind the counter in retail stores and prohibits sampling in e-cigarette stores.

• Scott County includes e-cigarettes in its smoke-free workplace policy.

• Target Field, Target Center, Mall of America, and the Minnesota Zoo all prohibit e-cigarette use.

• Metro Transit prohibits e-cigarette use on public transit.

Now accepting new patients

A unique perspective on cardiac care Preventive Cardiology Consultants is founded on the fundamental belief that much of heart disease can be avoided in the vast majority of patients, and significantly delayed in the rest, by prudent modification of risk factors and attainable lifestyle measures.

Elizabeth Klodas, M.D., F.A.S.C.C is a preventive cardiologist. She is the founding Editor in Chief of CardioSmart for the American College of Cardiology www.cardiosmart.org, a published author and medical editor for webMD. She is a member of several national committees on improving cardiac health and a frequent lecturer on the topic.

We are dedicated to creating a true partnership between doctor and patient working together to maximize heart health. We spend time getting to know each patient individually, learning about their lives and lifestyles before customizing treatment programs to maximize their health.

Whether you have experienced any type of cardiac event, are at risk for one, or

are interested in learning how to prevent one, we can design a set of just-for-you solutions.

Among the services we provide • One-on-one consultations with cardiologists • In-depth evaluation of nutrition and lifestyle factors • Advanced and routine blood analysis • Cardiac imaging including (as required) stress testing, stress echocardiography, stress nuclear imaging, coronary calcium screening, CT coronary angiography • Vascular screening • Dietary counseling/Exercise prescriptions

To schedule an appointment or to learn more about becoming a patient, please contact: Preventive Cardiology Consultants 6545 France Avenue, Suite 125, Edina, MN 55435 phone. 952.929.5600 fax. 952.929.5610 www.pccmn.com

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Minnesota Health care news April 2014

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Victoza® (liraglutide [rDNA origin] injection) Rx Only BRIEF SUMMARY. Please consult package insert for full prescribing information.

WARNING: RISK OF THYROID C-CELL TUMORS: Liraglutide causes dose-dependent and treatmentduration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.

Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors [see Contraindications and Warnings and Precautions].

VICU3X1498_B_2_0_Journal_Ad_Tabloid_Resize_BS_r5.indd 1

for neutralizing effect against native GLP-1, and thus the potential for clinically significant neutralization of native GLP-1 was not assessed. Antibodies that had a neutralizing effect on liraglutide in an in vitro assay occurred in 2.3% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 1.0% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials.

Among Victoza®-treated patients who developed anti-liraglutide antibodies, the most common category of adverse events was that of infections, which occurred among 40% of these patients compared to 36%, 34% and 35% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. The specific infections which occurred with greater frequency among Victoza®-treated antibody-positive patients were primarily nonserious upper respiratory tract infections, which occurred among 11% of Victoza®-treated antibody-positive patients; and among 7%, 7% and 5% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Among Victoza®-treated antibody-negative patients, the most common category of adverse events was that of gastrointestinal events, which occurred in 43%, 18% and 19% of antibody-negative Victoza®-treated, placebo-treated and active-control-treated patients, respectively. Antibody formation was not associated with reduced efficacy of Victoza® when comparing mean HbA1c of all antibody-positive and all antibody-negative patients. However, the 3 patients with the highest titers of anti-liraglutide antibodies had no reduction in HbA1c with Victoza® treatment. In the five double-blind clinical trials of Victoza®, events from a composite of adverse events potentially related to immunogenicity (e.g. urticaria, angioedema) occurred among 0.8% of Victoza®-treated patients and among 0.4% of comparator-treated patients. Urticaria accounted for approximately one-half of the events in this composite for Victoza®-treated patients. Patients who developed anti-liraglutide antibodies were not more likely to develop events from the immunogenicity events composite than were patients who did not develop anti-liraglutide antibodies. Injection site reactions: Injection site reactions (e.g., injection site rash, erythema) were reported in approximately 2% of Victoza®-treated patients in the five double-blind clinical trials of at least 26 weeks duration. Less than 0.2% of Victoza®-treated patients discontinued due to injection site reactions. Papillary thyroid carcinoma: In clinical trials of Victoza®, there were 7 reported cases of papillary thyroid carcinoma in patients treated with Victoza® and 1 case in a comparator-treated patient (1.5 vs. 0.5 cases per 1000 patient-years). Most of these papillary thyroid carcinomas were <1 cm in greatest diameter and were diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Hypoglycemia :In the eight clinical trials of at least 26 weeks duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients (2.3 cases per 1000 patient-years) and in two exenatidetreated patients. Of these 11 Victoza®-treated patients, six patients were concomitantly using metformin and a sulfonylurea, one was concomitantly using a sulfonylurea, two were concomitantly using metformin (blood glucose values were 65 and 94 mg/dL) and two were using Victoza® as monotherapy (one of these patients was undergoing an intravenous glucose tolerance test and the other was receiving insulin as treatment during a hospital stay). For these two patients on Victoza® monotherapy, the insulin treatment was the likely explanation for the hypoglycemia. In the 26-week open-label trial comparing Victoza® to sitagliptin, the incidence of hypoglycemic events defined as symptoms accompanied by a fingerstick glucose <56 mg/ dL was comparable among the treatment groups (approximately 5%).

Table 5: Incidence (%) and Rate (episodes/patient year) of Hypoglycemia in the 52-Week Monotherapy Trial and in the 26-Week Combination Therapy Trials Victoza® Treatment Active Comparator Placebo Comparator None Monotherapy Victoza® (N = 497) Glimepiride (N = 248) Patient not able to self-treat 0 0 — Patient able to self-treat 9.7 (0.24) 25.0 (1.66) — Not classified 1.2 (0.03) 2.4 (0.04) — Add-on to Metformin Victoza® + Metformin Glimepiride + Placebo + Metformin (N = 724) Metformin (N = 242) (N = 121) Patient not able to self-treat 0.1 (0.001) 0 0 Patient able to self-treat 3.6 (0.05) 22.3 (0.87) 2.5 (0.06) None Insulin detemir + Continued Victoza® Add-on to Victoza® + Metformin Victoza® + Metformin + Metformin alone (N = 158*) (N = 163) Patient not able to self-treat 0 0 — Patient able to self-treat 9.2 (0.29) 1.3 (0.03) — ®+ Rosiglitazone + Placebo + Add-on to Glimepiride Victoza Glimepiride (N = 695) Glimepiride (N = 231) Glimepiride (N = 114) Patient not able to self-treat 0.1 (0.003) 0 0 Patient able to self-treat 7.5 (0.38) 4.3 (0.12) 2.6 (0.17) Not classified 0.9 (0.05) 0.9 (0.02) 0 Placebo + Metformin Add-on to Metformin + Victoza® + Metformin None + Rosiglitazone + Rosiglitazone Rosiglitazone (N = 175) (N = 355) Patient not able to self-treat 0 — 0 Patient able to self-treat 7.9 (0.49) — 4.6 (0.15) Not classified 0.6 (0.01) — 1.1 (0.03) Add-on to Metformin + Victoza® + Metformin Insulin glargine Placebo + Metformin + Glimepiride + Metformin + Glimepiride + Glimepiride (N = 114) Glimepiride (N = 232) (N = 230) Patient not able to self-treat 2.2 (0.06) 0 0 Patient able to self-treat 27.4 (1.16) 28.9 (1.29) 16.7 (0.95) Not classified 0 1.7 (0.04) 0 *One patient is an outlier and was excluded due to 25 hypoglycemic episodes that the patient was able to self-treat. This patient had a history of frequent hypoglycemia prior to the study.

In a pooled analysis of clinical trials, the incidence rate (per 1,000 patient-years) for malignant neoplasms (based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label study periods) was 10.9 for Victoza®, 6.3 for placebo, and 7.2 for active comparator.

After excluding papillary thyroid carcinoma events [see Adverse Reactions], no particular cancer cell type predominated. Seven malignant neoplasm events were reported beyond 1 year of exposure to study medication, six events among Victoza®-treated patients (4 colon, 1 prostate and 1 nasopharyngeal), no events with placebo and one event with active comparator (colon). Causality has not been established. Laboratory Tests: In the five clinical trials of at least 26 weeks duration, mildly elevated serum bilirubin concentrations (elevations to no more than twice the upper limit of the reference range) occurred in 4.0% of Victoza®-treated patients, 2.1% of placebo-treated patients and 3.5% of active-comparator-treated patients. This finding was not accompanied by abnormalities in other liver tests. The significance of this isolated finding is unknown.

Vital signs: Victoza® did not have adverse effects on blood pressure. Mean increases from baseline in heart rate of 2 to 3 beats per minute have been observed with Victoza® compared to placebo. The long-term clinical effects of the increase in pulse rate have not been established. Post-Marketing Experience: The following additional adverse reactions have been reported during post-approval use of Victoza®. Because these events are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Dehydration resulting from nausea, vomiting and diarrhea; Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis; Angioedema and anaphylactic reactions; Allergic reactions: rash and pruritus; Acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death.

OVERDOSAGE: Overdoses have been reported in clinical trials and post-marketing use of Victoza®. Effects have included severe nausea and severe vomiting. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms.

More detailed information is available upon request.

For information about Victoza® contact: Novo Nordisk Inc., 800 Scudders Mill Road, Plainsboro, NJ 08536, 1−877-484-2869 Date of Issue: April 16, 2013 Version: 6 Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark Victoza® is covered by US Patent Nos. 6,268,343, 6,458,924, 7,235,627, 8,114,833 and other patents pending.

Victoza® Pen is covered by US Patent Nos. 6,004,297, RE 43,834, RE 41,956 and other patents pending. © 2010-2013 Novo Nordisk 0513-00015682-1 5/2013

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INDICATIONS AND USAGE: Victoza® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Important Limitations of Use: Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis. Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings. The concurrent use of Victoza® and prandial insulin has not been studied.

CONTRAINDICATIONS: Do not use in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.

WARNINGS AND PRECAUTIONS: Risk of Thyroid C-cell Tumors: Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and/or carcinomas) at clinically relevant exposures in both genders of rats and mice. Malignant thyroid C-cell carcinomas were detected in rats and mice. A statistically significant increase in cancer was observed in rats receiving liraglutide at 8-times clinical exposure compared to controls. It is unknown whether Victoza® will cause thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors could not be determined by clinical or nonclinical studies. In the clinical trials, there have been 6 reported cases of thyroid C-cell hyperplasia among Victoza®-treated patients and 2 cases in comparator-treated patients (1.3 vs. 1.0 cases per 1000 patient-years). One comparator-treated patient with MTC had pre-treatment serum calcitonin concentrations >1000 ng/L suggesting pre-existing disease.

All of these cases were diagnosed after thyroidectomy, which was prompted by abnormal results on routine, protocol-specified measurements of serum calcitonin. Five of the six Victoza®-treated patients had elevated calcitonin concentrations at baseline and throughout the trial. One Victoza® and one non-Victoza®-treated patient developed elevated calcitonin concentrations while on treatment. Calcitonin, a biological marker of MTC, was measured throughout the clinical development program. The serum calcitonin assay used in the Victoza® clinical trials had a lower limit of quantification (LLOQ) of 0.7 ng/L and the upper limit of the reference range was 5.0 ng/L for women and 8.4 ng/L for men. At Weeks 26 and 52 in the clinical trials, adjusted mean serum calcitonin concentrations were higher in Victoza®-treated patients compared to placebo-treated patients but not compared to patients receiving active comparator. At these timepoints, the adjusted mean serum calcitonin values (~1.0 ng/L) were just above the LLOQ with between-group differences in adjusted mean serum calcitonin values of approximately 0.1 ng/L or less. Among patients with pre-treatment serum calcitonin below the upper limit of the reference range, shifts to above the upper limit of the reference range which persisted in subsequent measurements occurred most frequently among patients treated with Victoza® 1.8 mg/day. In trials with on-treatment serum calcitonin measurements out to 5-6 months, 1.9% of patients treated with Victoza® 1.8 mg/day developed new and persistent calcitonin elevations above the upper limit of the reference range compared to 0.8-1.1% of patients treated with control medication or the 0.6 and 1.2 mg doses of Victoza®. In trials with on-treatment serum calcitonin measurements out to 12 months, 1.3% of patients treated with Victoza® 1.8 mg/day had new and persistent elevations of calcitonin from below or within the reference range to above the upper limit of the reference range, compared to 0.6%, 0% and 1.0% of patients treated with Victoza® 1.2 mg, placebo and active control, respectively. Otherwise, Victoza® did not produce consistent dose-dependent or time-dependent increases in serum calcitonin.

Patients with MTC usually have calcitonin values >50 ng/L. In Victoza® clinical trials, among patients with pre-treatment serum calcitonin <50 ng/L, one Victoza®-treated patient and no comparator-treated patients developed serum calcitonin >50 ng/L. The Victoza®-treated patient who developed serum calcitonin >50 ng/L had an elevated pre-treatment serum calcitonin of 10.7 ng/L that increased to 30.7 ng/L at Week 12 and 53.5 ng/L at the end of the 6-month trial. Follow-up serum calcitonin was 22.3 ng/L more than 2.5 years after the last dose of Victoza®. The largest increase in serum calcitonin in a comparator-treated patient was seen with glimepiride in a patient whose serum calcitonin increased from 19.3 ng/L at baseline to 44.8 ng/L at Week 65 and 38.1 ng/L at Week 104. Among patients who began with serum calcitonin <20 ng/L, calcitonin elevations to >20 ng/L occurred in 0.7% of Victoza®-treated patients, 0.3% of placebo-treated patients, and 0.5% of active-comparator-treated patients, with an incidence of 1.1% among patients treated with 1.8 mg/ day of Victoza®. The clinical significance of these findings is unknown. Counsel patients regarding the risk for MTC and the symptoms of thyroid tumors (e.g. a mass in the neck, dysphagia, dyspnea or persistent hoarseness). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate the potential risk of MTC, and such monitoring may increase the risk of unnecessary procedures, due to low test specificity for serum calcitonin and a high background incidence of thyroid disease. Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza®, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation. Pancreatitis: Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with Victoza®. After initiation of Victoza®, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back and which may or may not be accompanied by vomiting). If pancreatitis is suspected, Victoza® should promptly be discontinued and appropriate management should be initiated. If pancreatitis is confirmed, Victoza® should not be restarted. Consider antidiabetic therapies other than Victoza® in patients with a history of pancreatitis. In clinical trials of Victoza®, there have been 13 cases of pancreatitis among Victoza®-treated patients and 1 case in a comparator (glimepiride) treated patient (2.7 vs. 0.5 cases per 1000 patient-years). Nine of the 13 cases with Victoza® were reported as acute pancreatitis and four were reported as chronic pancreatitis. In one case in a Victoza®-treated patient, pancreatitis, with necrosis, was observed and led to death; however clinical causality could not be established.

Some patients had other risk factors for pancreatitis, such as a history of cholelithiasis or alcohol abuse. Use with Medications Known to Cause Hypoglycemia: Patients receiving Victoza® in combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may have an increased risk of hypoglycemia. The risk of hypoglycemia may be lowered by a reduction in the dose of sulfonylurea (or other concomitantly administered insulin secretagogues) or insulin Renal Impairment: Victoza® has not been found to be directly nephrotoxic in animal studies or clinical trials. There have been postmarketing reports of acute renal failure and worsening of chronic renal failure, which may sometimes require hemodialysis in Victoza®-treated patients. Some of these events were reported in patients without known underlying renal disease. A majority of the reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration.

Some of the reported events occurred in patients receiving one or more medications known to affect renal function or hydration status. Altered renal function has been reversed in many of the reported cases with supportive treatment and discontinuation of potentially causative agents, including Victoza®. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment. Hypersensitivity Reactions: There have been postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema) in patients treated with Victoza®. If a hypersensitivity reaction occurs, the patient should discontinue Victoza® and other suspect medications and promptly seek medical advice. Angioedema has also been reported with other GLP-1 receptor agonists. Use caution in a patient with a history of angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to angioedema with Victoza®. Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

ADVERSE REACTIONS: Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Victoza® has been evaluated in 8 clinical trials: A double-blind 52-week monotherapy trial compared Victoza® 1.2 mg daily, Victoza® 1.8 mg daily, and glimepiride 8 mg daily; A double-blind 26 week add-on to metformin trial compared Victoza® 0.6 mg once-daily, Victoza® 1.2 mg once-daily, Victoza® 1.8

mg once-daily, placebo, and glimepiride 4 mg once-daily; A double-blind 26 week add-on to glimepiride trial compared Victoza® 0.6 mg daily, Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, placebo, and rosiglitazone 4 mg once-daily; A 26 week add-on to metformin + glimepiride trial, compared double-blind Victoza® 1.8 mg once-daily, double-blind placebo, and open-label insulin glargine once-daily; A doubleblind 26-week add-on to metformin + rosiglitazone trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily and placebo; An open-label 26-week add-on to metformin and/or sulfonylurea trial compared Victoza® 1.8 mg once-daily and exenatide 10 mcg twice-daily; An open-label 26-week add-on to metformin trial compared Victoza® 1.2 mg once-daily, Victoza® 1.8 mg once-daily, and sitagliptin 100 mg once-daily; An open-label 26-week trial compared insulin detemir as add-on to Victoza® 1.8 mg + metformin to continued treatment with Victoza® + metformin alone. Withdrawals: The incidence of withdrawal due to adverse events was 7.8% for Victoza®-treated patients and 3.4% for comparator-treated patients in the five double-blind controlled trials of 26 weeks duration or longer. This difference was driven by withdrawals due to gastrointestinal adverse reactions, which occurred in 5.0% of Victoza®-treated patients and 0.5% of comparator-treated patients. In these five trials, the most common adverse reactions leading to withdrawal for Victoza®-treated patients were nausea (2.8% versus 0% for comparator) and vomiting (1.5% versus 0.1% for comparator). Withdrawal due to gastrointestinal adverse events mainly occurred during the first 2-3 months of the trials. Common adverse reactions: Tables 1, 2, 3 and 4 summarize common adverse reactions (hypoglycemia is discussed separately) reported in seven of the eight controlled trials of 26 weeks duration or longer. Most of these adverse reactions were gastrointestinal in nature. In the five double-blind clinical trials of 26 weeks duration or longer, gastrointestinal adverse reactions were reported in 41% of Victoza®-treated patients and were dose-related. Gastrointestinal adverse reactions occurred in 17% of comparator-treated patients. Common adverse reactions that occurred at a higher incidence among Victoza®-treated patients included nausea, vomiting, diarrhea, dyspepsia and constipation. In the five double-blind and three open-label clinical trials of 26 weeks duration or longer, the percentage of patients who reported nausea declined over time. In the five double-blind trials approximately 13% of Victoza®-treated patients and 2% of comparator-treated patients reported nausea during the first 2 weeks of treatment. In the 26-week open-label trial comparing Victoza® to exenatide, both in combination with metformin and/or sulfonylurea, gastrointestinal adverse reactions were reported at a similar incidence in the Victoza® and exenatide treatment groups (Table 3). In the 26-week open-label trial comparing Victoza® 1.2 mg, Victoza® 1.8 mg and sitagliptin 100 mg, all in combination with metformin, gastrointestinal adverse reactions were reported at a higher incidence with Victoza® than sitagliptin (Table 4). In the remaining 26-week trial, all patients received Victoza® 1.8 mg + metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events. Only those patients who completed the run-in period with inadequate glycemic control were randomized to 26 weeks of add-on therapy with insulin detemir or continued, unchanged treatment with Victoza® 1.8 mg + metformin. During this randomized 26-week period, diarrhea was the only adverse reaction reported in ≥5% of patients treated with Victoza® 1.8 mg + metformin + insulin detemir (11.7%) and greater than in patients treated with Victoza® 1.8 mg and metformin alone (6.9%).

Table 1: Adverse reactions reported in ≥5% of Victoza®-treated patients in a 52-week monotherapy trial All Victoza® N = 497 Glimepiride N = 248 (%) (%) Adverse Reaction Nausea 28.4 8.5 Diarrhea 17.1 8.9 Vomiting 10.9 3.6 Constipation 9.9 4.8 Headache 9.1 9.3 Table 2: Adverse reactions reported in ≥5% of Victoza®-treated patients and occurring more frequently with Victoza® compared to placebo: 26-week combination therapy trials Add-on to Metformin Trial All Victoza® + Metformin Placebo + Metformin Glimepiride + Metformin N = 724 N = 121 N = 242 (%) (%) (%) Adverse Reaction Nausea 15.2 4.1 3.3 Diarrhea 10.9 4.1 3.7 Headache 9.0 6.6 9.5 Vomiting 6.5 0.8 0.4 Add-on to Glimepiride Trial Placebo + Glimepiride Rosiglitazone + All Victoza® + Glimepiride N = 695 N = 114 Glimepiride N = 231 (%) (%) (%) Adverse Reaction Nausea 7.5 1.8 2.6 Diarrhea 7.2 1.8 2.2 Constipation 5.3 0.9 1.7 Dyspepsia 5.2 0.9 2.6 Add-on to Metformin + Glimepiride Victoza® 1.8 + Metformin Placebo + Metformin + Glargine + Metformin + + Glimepiride N = 230 Glimepiride N = 114 Glimepiride N = 232 (%) (%) (%) Adverse Reaction Nausea 13.9 3.5 1.3 Diarrhea 10.0 5.3 1.3 Headache 9.6 7.9 5.6 Dyspepsia 6.5 0.9 1.7 Vomiting 6.5 3.5 0.4 Add-on to Metformin + Rosiglitazone Placebo + Metformin + Rosiglitazone All Victoza® + Metformin + Rosiglitazone N = 355 N = 175 (%) (%) Adverse Reaction Nausea 34.6 8.6 Diarrhea 14.1 6.3 Vomiting 12.4 2.9 Headache 8.2 4.6 Constipation 5.1 1.1 ® Table 3: Adverse Reactions reported in ≥5% of Victoza -treated patients in a 26-Week Open-Label Trial versus Exenatide Exenatide 10 mcg twice daily + Victoza® 1.8 mg once daily + metformin and/or sulfonylurea metformin and/or sulfonylurea N = 232 N = 235 (%) (%) Adverse Reaction Nausea 25.5 28.0 Diarrhea 12.3 12.1 Headache 8.9 10.3 Dyspepsia 8.9 4.7 Vomiting 6.0 9.9 Constipation 5.1 2.6 Table 4: Adverse Reactions in ≥5% of Victoza®-treated patients in a 26-Week Open-Label Trial versus Sitagliptin All Victoza® + metformin Sitagliptin 100 mg/day + N = 439 metformin N = 219 (%) (%) Adverse Reaction Nausea 23.9 4.6 Headache 10.3 10.0 Diarrhea 9.3 4.6 Vomiting 8.7 4.1 Immunogenicity: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients treated with Victoza® may develop anti-liraglutide antibodies. Approximately 50-70% of Victoza®-treated patients in the five double-blind clinical trials of 26 weeks duration or longer were tested for the presence of anti-liraglutide antibodies at the end of treatment. Low titers (concentrations not requiring dilution of serum) of anti-liraglutide antibodies were detected in 8.6% of these Victoza®-treated patients.

Sampling was not performed uniformly across all patients in the clinical trials, and this may have resulted in an underestimate of the actual percentage of patients who developed antibodies. Cross-reacting antiliraglutide antibodies to native glucagon-like peptide-1 (GLP-1) occurred in 6.9% of the Victoza®-treated patients in the double-blind 52-week monotherapy trial and in 4.8% of the Victoza®-treated patients in the double-blind 26-week add-on combination therapy trials. These cross-reacting antibodies were not tested

®

Victoza —a force for change in type 2 diabetes.

A change with powerful, long-lasting benefits

Reductions up to -1.1%a

Weight loss up to 5.5 lba,b

Low rate of hypoglycemiac

1.8 mg dose when used alone for 52 weeks.

Victoza® is not indicated for the management of obesity. Weight change was a secondary end point in clinical trials. c In the 8 clinical trials of at least 26 weeks’ duration, hypoglycemia requiring the assistance of another person for treatment occurred in 11 Victoza®-treated patients. a

b

A 52-week, double-blind, double-dummy, active-controlled, parallel-group, multicenter study. Patients with type 2 diabetes (N=745) were randomized to receive once-daily Victoza® 1.2 mg (n=251), Victoza® 1.8 mg (n=246), or glimepiride 8 mg (n=248). The primary outcome was change in A1C after 52 weeks.

The change begins at VictozaPro.com.

Indications and Usage

Victoza® (liraglutide [rDNA origin] injection) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Because of the uncertain relevance of the rodent thyroid C-cell tumor findings to humans, prescribe Victoza® only to patients for whom the potential benefits are considered to outweigh the potential risk. Victoza® is not recommended as firstline therapy for patients who have inadequate glycemic control on diet and exercise.

Based on spontaneous postmarketing reports, acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with Victoza®. Victoza® has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for pancreatitis while using Victoza®. Other antidiabetic therapies should be considered in patients with a history of pancreatitis.

Victoza® is not a substitute for insulin. Victoza® should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

Victoza® has not been studied in combination with prandial insulin.

Important Safety Information

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza® causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies.

Victoza® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors. Patients should be counseled regarding the risk and symptoms of thyroid tumors.

Do not use in patients with a prior serious hypersensitivity reaction to Victoza® or to any of the product components.

Postmarketing reports, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Discontinue promptly if pancreatitis is suspected. Do not restart if Victoza® is a registered trademark of Novo Nordisk A/S. © 2013 Novo Nordisk All rights reserved.

pancreatitis is confirmed. Consider other antidiabetic therapies in patients with a history of pancreatitis.

When Victoza® is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin serious hypoglycemia can occur. Consider lowering the dose of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.

Renal impairment has been reported postmarketing, usually in association with nausea, vomiting, diarrhea, or dehydration which may sometimes require hemodialysis. Use caution when initiating or escalating doses of Victoza® in patients with renal impairment.

Serious hypersensitivity reactions (e.g. anaphylaxis and angioedema) have been reported during postmarketing use of Victoza®. If symptoms of hypersensitivity reactions occur, patients must stop taking Victoza® and seek medical advice promptly.

There have been no studies establishing conclusive evidence of macrovascular risk reduction with Victoza® or any other antidiabetic drug.

The most common adverse reactions, reported in ≥5% of patients treated with Victoza® and more commonly than in patients treated with placebo, are headache, nausea, diarrhea, dyspepsia, constipation and anti-liraglutide antibody formation.

Immunogenicity-related events, including urticaria, were more common among Victoza®-treated patients (0.8%) than among comparator-treated patients (0.4%) in clinical trials.

Victoza® has not been studied in type 2 diabetes patients below 18 years of age and is not recommended for use in pediatric patients.

There is limited data in patients with renal or hepatic impairment.

In a 52-week monotherapy study (n=745) with a 52-week extension, the adverse reactions reported in ≥ 5% of patients treated with Victoza® 1.8 mg, Victoza® 1.2 mg, or glimepiride were constipation (11.8%, 8.4%, and 4.8%), diarrhea (19.5%, 17.5%, and 9.3%), flatulence (5.3%, 1.6%, and 2.0%), nausea (30.5%, 28.7%, and 8.5%), vomiting (10.2%, 13.1%, and 4.0%), fatigue (5.3%, 3.2%, and 3.6%), bronchitis (3.7%, 6.0%, and 4.4%), influenza (11.0%, 9.2%, and 8.5%), nasopharyngitis (6.5%, 9.2%, and 7.3%), sinusitis (7.3%, 8.4%, and 7.3%), upper respiratory tract infection (13.4%, 14.3%, and 8.9%), urinary tract infection (6.1%, 10.4%, and 5.2%), arthralgia (2.4%, 4.4%, and 6.0%), back pain (7.3%, 7.2%, and 6.9%), pain in extremity (6.1%, 3.6%, and 3.2%), dizziness (7.7%, 5.2%, and 5.2%), headache (7.3%, 11.2%, and 9.3%), depression (5.7%, 3.2%, and 2.0%), cough (5.7%, 2.0%, and 4.4%), and hypertension (4.5%, 5.6%, and 6.9%).

Please see brief summary of Prescribing Information on adjacent page.

1013-00018617-1

December 2013