Minnesota Physician October 2019 by Minnesota Physician Publishing

MINNESOTA

OCTOBER 2019

PHYSICIAN

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXIII, No. 07

Minnesota Mobile Medical Teams A statewide disaster safety net BY DONALD SHELDREW, MSW, LICSW

t is a sunny, summer day in Minnesota with storms predicted for later in the day. The sun starts to be covered by clouds, which eventually turn dark and look full of rain. There is thunder and lightning in the distance. As the storm moves towards the community, the tornado sirens start. A few minutes later the winds pick up, rain seems to be blowing sideways, and it sounds as if a train is approaching. Everyone who can do so has sought shelter. Eventually the noise subsides, things seem to be back to normal, and people begin re-appearing.

Labeling and medicating children A new epidemic BY REP. GLENN GRUENHAGEN AND CHRISTOPHER M. FOLEY, MD, ABIM Part One: a legislatorâ&#x20AC;&#x2122;s perspective

rior to my election to the Minnesota House of Representatives in 2010, I served on my local school board for 16 years. During that time, I developed an interest in the increasing practice of labeling and medicating children who showed signs of Attention Deficit Hyperactivity Disorder (ADHD). I learned that the procedure used to diagnose these children was primarily based on a series of questions from educators, which Labeling and medicating children to page 104

Once back in the light, what once was a quiet community is now in shambles. The destruction seems surreal. As people start to head towards the Minnesota Mobile Medical Teams to page 124

OCTOBER 2019 MINNESOTA PHYSICIAN

ND 52 SESSION

OCTOBER 2019

Volume XXXIII, Number 7

COVER FEATURES Labeling and medicating children

Minnesota Mobile Medical Teams A statewide disaster safety net

By Rep. Glenn Gruenhagen and Christopher M. Foley, MD, ABIM

By Donald Sheldrew, MSW, LICSW

A new epidemic

DEPARTMENTS CAPSULES

MEDICUS

INTERVIEW

NEUROLOGY 20 Epilepsy Evolving diagnosis and treatment options

CLINICAL AND NON-CLINICAL CARE TEAMS Improving interoperability

Optimizing medications for patients

By Tim Feyma, MD

Terry McInnis, MD, MPH President and Co-Founder, GTMRx Institute

CARDIOVASCULAR DISEASE 22 The “Million Hearts” initiative

Thursday, March 5, 2019, 1–4 p.m.

PUBLIC HEALTH 14 The MN FEET program

Addressing heart attacks and strokes

The Gallery, Hilton Minneapolis | 1001 Marquette Avenue South

Birth disparities and prenatal mercury exposure By Kate Murray, MPH; Jessica Nelson, PhD, MPH; and Courtney Jordan Baechler, MD, MS

MEDICINE AND THE LAW 18 The Supreme Court’s Albrecht decision Unclear implications for adverse reaction warnings By Elie Biel, JD

By Stanton Shanedling, PhD, MPH

ONCOLOGY 24 Prostate Cancer Research A promising new class of drugs By Charles Ryan, MD

BEHAVIOR HEALTH 26 “Flip the script” on opioids and pain management Starting difficult patient conversations By Jeff Schiff, MD, MBA, and Sarah Rinn, MPH

BACKGROUND AND FOCUS: As health care costs constantly rise, containment strategies involve care teams. Many individuals are now part of every physician-patient encounter. Some are hands-on with the patient, some the patient never sees. New entities become part of care teams, offering services from chronic care management, to behavioral health screening, to care coordination, to coding, charting and much more. With goals of lowering costs, increasing reimbursement, and improving outcomes, clinics can customize teams to individual patient needs. Keeping up with this rapidly evolving landscape can exceed the capacity of many medical groups.

OBJECTIVES: We will examine the diversity of care teams and how they interact. We will explore benefits that could result from improved coordination of these care teams. We will identify the barriers to this improved communication, such as incompatible EHRs and data privacy issues, and ways around them. We will provide examples of successful integration of clinical and non-clinical care teams and a road map for adopting and scaling these models for all elements of our health care delivery system.

PANELISTS INCLUDE:

www.MPPUB.COM PUBLISHER

______________________________________________________________

Vivi-Ann Fischer, DC, Chief Clinical Officer, Fulcrum Health Mike Starnes, mstarnes@mppub.com

EDITOR___________________________________________________ Richard Ericson, rericson@mppub.com

Christopher “Kit” Crancer, Senior Director of State Legislative Policy, Center for Diagnostic Imaging SPONSORED BY:

ART DIRECTOR_______________________________________________Scotty Town, stown@mppub.com Minnesota Physician is published once a month by Minnesota Physician Publishing, Inc. Our address is PO Box 6674, Minneapolis, MN 55406; email mpp@mppub.com; phone 612.728.8600; fax 612.728.8601. 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 the publication may be reprinted or reproduced without written permission of the publisher. Annual subscriptions (12 copies) are $48.00/ Individual copies are $5.00.

PURCHASE YOUR TICKETS AT MPPUB.COM MINNESOTA PHYSICIAN OCTOBER 2019

CAPSULES

Clinic provides free Narcan directly to patients Nura Pain Clinic now provides free Narcan kits and training directly to select patients who take opiate analgesics. Narcan, generically known as naloxone, is a medication that can be used to reverse an opioid overdose. The clinic has long advocated for multidisciplinary alternatives to opioids for pain management. “We do everything we can to reduce and eliminate the need for opioids in our chronic pain patients,” said Peter Schultz, MD, MPH, a partner in the practice with his brother and clinic founder, David Schultz, MD. “Nonetheless, some patients are referred to us on high dose opioids and it may take us weeks or even months to transition them away from opioids and into more effective and safer alternatives. During this transition period, we believe that access to, and education about, naloxone will help keep these patients safe as we taper opioids over time.”

Underscoring Nura’s new initiative is an August CDC announcement calling for increased access to naloxone, and reporting that only one naloxone prescription was dispensed for every 70 high-dose opioid prescriptions nationwide. In 2018, the Minnesota Department of Health reported 331 deaths due to opioid overdose. While Minnesotans can now obtain naloxone without a prescription, there are still social stigmas and financial barriers to its access and use. Nura began testing its program in August and is now looking at rolling it out to all of its opioid-using patients.

Air pollution linked to violent criminal behavior Exposure to high levels of air pollution is known to cause asthma attacks, cardiovascular disease, and other health problems in people. New research from the University of Minnesota School of Public Health and Colorado State University shows that

breathing dirty air—even for just a day—also likely causes people to become more aggressive and violent. Their findings were recently published in the journal Epidemiology. The researchers examined the association between daily violent and non-violent crimes and shortterm increases in air pollution across 301 counties in 34 states during a 14-year period. Data for the study was gathered from the FBI’s National Incident-based Reporting System and the Environmental Protection Agency’s Air Quality System. Daily pollution levels were determined based on the amount of fine particulate matter— such as diesel exhaust chemicals— and ozone in the air. The study found: • Increases in daily air pollution levels raised the risk of violent criminal behavior, such as assaults.

• Air pollution did not increase the risk of non-violent crime, which are crimes that do not involve force, threats or injury (e.g., property theft). • The risk of violent behavior increased even at low pollution concentrations that are usually considered safe for people to breathe. Results were consistent across different community types, including regions with different socioeconomic status, racial diversity, and age. In other words, it is not the community driving this relationship. “While our study cannot identify the exact processes that link air pollution and violent behavior, we believe that exposure to air pollution has immediate effects on the brain, which results in behavioral changes,” said study lead author and Assistant Professor Jesse Berman. These effects may increase the impulsivity of people and escalate

Mary likes finding new ways to motivate her employees. So she loves health plans with programs that reward them with up to $1,000 for doing more of what they already do: walk. Which, by the way, may help them be more productive, too. Health plans with something for everyone to like. Contact your broker or visit uhc.com/mn to learn more. Insurance coverage provided by or through UnitedHealthcare Insurance Company or its affiliates. Administrative services provided by United HealthCare Services, Inc. or their affiliates. 8566965.0 3/19 ©2019 United HealthCare Services, Inc. 18-10761-A

OCTOBER 2019 MINNESOTA PHYSICIAN

CAPSULES

what is known as their “fight or flight” stress response. Everyday minor conflicts, such as an argument with a neighbor, may become quickly heated and result in more serious physical altercations.

Allina Health joins UCare Individual and Family plans network UCare, a community-based, nonprofit health plan, has expanded its provider network to include Allina Health for Individual and Family plan members. The Twin Cities-area Allina Health system includes 11 hospitals, 90+ clinics, and 6,000 associated and employed physicians. UCare’s Individual and Family plans available through MNsure will be the only health plans to feature three major care systems—Allina Health, Fairview Health Services, and Park Nicollet—in their network. Allina Health and UCare share a common mission to improve the health of communities through exceptional care and service. Both organizations put the member/patient at the center. UCare currently has the largest enrollment of Individual and Family plans through MNsure—32,000+ members. Since MNsure’s opening in 2014, UCare has been committed to offering and expanding plans for people who buy health insurance on their own. UCare Individual and Family plans are available in 28 Minnesota counties and offer some of the lowest rates on MNsure.

Senior care organizations partner to offer Medicare Advantage plans Seniors living in 78 Twin Cities-area long-term care and assisted living communities will have a new Medicare Advantage health coverage option to select for 2020 coverage if they qualify for its requirements. Medica Advantage Solution PartnerCare (HMO I-SNP) is the new

Institutional Special Needs plan offered through a collaboration between Genevive, Medica, and 10 of the largest senior care organizations in the region. The plan is designed to meet the often complex health needs of adults living in long-term care, assisted living, and memory care settings. The plans will be available for a Jan. 1, 2020, effective coverage date. They are the first in the region to offer Genevive’s integrated care team expertise aligned with Medica’s care model experience across a diverse number of residential settings. The plans will be offered exclusively to eligible individuals residing with the 10 senior care providers: Benedictine Health System; Cassia, an Augustana/ELIM affiliation; Catholic Eldercare; Episcopal Homes of Minnesota; Goodman Group; North Cities Health Care Inc.; Presbyterian Homes & Services; Saint Therese; Volunteers of America; and Walker Methodist. Genevive, co-owned by Allina Health and Presbyterian Homes & Services, will provide primary care and care management services and act as the contracting agent on behalf of Medica, with the participating senior care organizations representing approximately 5,500 eligible individuals. Medica has designed and offers the health insurance plan, which includes coverage for prescription drugs, transportation, dental, vision, and hearing care. Medica-participating providers will provide hospital services, subject to appropriate placement based on clinical considerations and patient choice.

New M Health Fairview brand launches Following a recent announcement of a joint clinical agreement between the University of Minnesota, University of Minnesota Physicians, and Fairview Health Services, the organizations on Oct. 1 launched a new M Health Fairview brand. M Health Fairview represents the best of academic and community medicine,

NOV 25

Tickets at 612.377.2224 • guthrietheater.org

NOV 26

NOV 24

Spyro Gyra

Contemporary Jazz Icons

Bobby Rush: Solo

NOV 27

DEC 7-8

Mesmerizing Jazz Gospel and Pop

DEC 15

Bonerama

Rock Funk Brass Explosion

BoDeans

w/St. Paul Peterson & Classic American Rockers feat. Patty Peterson Southdale YMCA Fundraising Event

Nicholas David’s

DEC 6

Annual St Nick’s Day Show

The King of the Chitlin’ Circuit

Tuck & Patti

A Night of Classic Rock

DEC 11

Holiday Swing w/Maria Muldaur & John Jorgenson

DEC 18

Alexander O’Neal’s Holiday Concert

One of R&B’s Most Iconic Names

DEC 21-22

Acclaimed Heartland Rock

612.332.5299 dakotacooks.com

DEC 23

George Maurer Group 21st Annual Holiday Show

Clever Contemporary Christmas Tunes

1010 Nicollet Mall Mpls MN MINNESOTA PHYSICIAN OCTOBER 2019

CAPSULES

bringing world-class medical research and advances to thousands of Minnesotans as part of one of the state’s largest health care networks, providing expanded access to breakthrough care. M Health Fairview closely links the University of Minnesota Medical Center—a hub for medical research—with Fairview’s extensive network of 10 hospitals, 60 primary care clinics, and numerous other services to provide top-tier care. M Health Fairview focuses on creating an easier, simpler health care experience for patients, designing the care experience around them—an approach built on significant learning and collaboration, including educational visits to the National Aeronautics and Space Administration (NASA), Southwest Airlines, and FedEx. Each service line organizes around specific health conditions rather than traditional boundaries, such as geographic areas or departments. Led by a single leadership structure pairing

academic physicians with operations leaders, the service line approach translates health care innovations developed at the University of Minnesota into care at the community level.

Children’s Minnesota receives grant to bolster program addressing community health Children’s Minnesota has received a $500,000, two-year grant from Kohl’s Cares to support the health system’s Community Connect program, an initiative that goes beyond basic medical care to support the social determinants of health impacting kids. Community Connect is transforming Children’s approach to health care by connecting families to existing community resources, including housing, food, and other needs. Beginning with the proactive social determinants of health screening, clinicians at Children’s make real-time

referrals to onsite Resource Navigators who can design a responsive plan of action to help families on an on-going basis. Available resources include food access, transportation services, legal assistance, housing support, early childhood education programs, employment search assistance, and more. “As a pediatric health care system, it’s important that we support kids beyond the care we provide in our hospitals and clinics, and recognize the multitude of factors that contribute to their health, said Gigi Chawla, MD, chief of general pediatrics at Children’s Minnesota. “Improving a child’s overall circumstances can make all the difference when it comes to outcomes.” Research shows that: • Eighty percent of kids’ health happens outside clinic walls—where they live, learn, and play. • Early childhood development dramatically

We treat your patients like you treat your patients. The smartest choice in GI care. Doctors like you can take comfort in knowing MNGI is the recognized leader in GI diagnosis, quality and care. Referring your patients is painless and secure when using our referrals.mngi.com portal or calling 612-870-5400. 6

OCTOBER 2019 MINNESOTA PHYSICIAN

impacts a child’s future, as the brain grows most rapidly from ages 0–3. • Additionally, the American Academy of Pediatrics recommends 12 well-child visits before age 3, giving health care providers regular and frequent opportunities to support children and families. These visits are particularly critical for very young children before they are connected to other supportive systems, such as schools. Community Connect is currently available at Children’s St. Paul and Minneapolis Primary Care clinics as well as the Adolescent Health, Asthma and Endocrine Diabetes specialty clinics in Minneapolis and St. Paul. The grant from Kohl’s Cares substantially funds Community Connect at Children’s hospital-based Primary Care clinic in Minneapolis.

MEDICUS

Uzma Samadani, MD, PhD, has joined CentraCare Neurosciences, where she will practice general adult neurosurgery, including brain and spine procedures. Dr. Samadani comes to CentraCare from Hennepin Healthcare and the University of Minnesota. She continues to serve as an associate professor in the Department of Bioinformatics and Computational Biology, School of Engineering, and is a graduate faculty member in Neurosciences.

Osmo Vänskä /// Music Director

Leila Josefowicz Plays Stravinsky Nov 1–2

Michael Reyes, MD, has joined Essentia Health–St. Joseph’s Medical Center in Brainerd, where he will practice anesthesiology. Dr. Reyes earned a medical degree from Vanderbilt University School of Medicine in Nashville, Tennessee, and completed a residency in anesthesiology at Mayo School of Health Sciences in Rochester, as well as a fellowship in pain medicine at the University of Iowa.

Sarah Clausen, MD, has joined St. Luke’s Obstetrics & Gynecology Associates in Duluth. Dr. Clausen received her medical degree at the University of North Dakota School of Medicine and Health Sciences in Grand Forks. She is board-certified by the American Board of Obstetrics & Gynecology. In addition, St. Luke’s Rheumatology Associates has hired Adam Elisha, DO. Dr. Elisha received his medical degree from Arizona College of Osteopathic Medicine in Glendale, Arizona. He completed his residency in internal medicine at Providence Internal Medicine Residency in Spokane, Washington, and a fellowship in rheumatology at the University of Pittsburgh Medical Center.

Vaughan Williams’ Dona Nobis Pacem Nov 14–16

OS M O VÄ N S K Ä

Melena Bellin, MD, pediatric endocrinologist for University of Minnesota Physicians and professor in the University of Minnesota Medical School’s Department of Pediatrics and Surgery, has been named a recipient of the Presidential Early Career Awards for Scientists and Engineers (PECASE) by President Donald Trump. The award is the highest honor bestowed by the federal government to science and engineering professionals who are beginning their independent research careers.

Nov 29–Dec 1 Sarah Hicks, conductor

Save 25% on kids' tickets! © Disney and Pixar

612-371-5656 / minnesotaorchestra.org Orchestra Hall / #mnorch Social icon

Circle

Only use blue and/or white.

For more details check out our Brand Guidelines.

The Movies & Music series is made possible by

MINNESOTA PHYSICIAN OCTOBER 2019

INTERVIEW

Optimizing medications for patients Terry McInnis, MD, MPH President and Co-Founder, GTMRx Institute Please tell us about the mission of the Get the Medications Right (GTMRx) Institute.

event in 2018, resulting in 4.8 million outpatient visits, more than 660,000 ER visits, 280,000 hospitalizations, and 9,000 deaths. Many patients also experienced confusion, falls, nursing home stays, and poor quality of life. The Lown Institute report (https://tinyurl.com/mp-gtmrx2) also said that “Older adults are hospitalized for adverse drug events at a greater rate than the general population is hospitalized for opioids.”

Our vision and mission are very simple, but our mandate is profound. Our vision is to enhance life by ensuring appropriate and personalized use of medication and gene therapies. Our mission is to bring together critical stakeholders bound by the urgent need to optimize outcomes and reduce costs by “getting the medications right.” Our key initiatives involve active workgroups focused on practice transformation and care delivery, HIT/ analytics and AI enablement, precision medicine and advanced diagnostics integration, and policy and payment alignment.

Our founders include leaders, innovators, and stakeholders spanning the health care ecosystem, as well as payers and patient advocates. All of us believe passionately that we have the perfect storm to realize our mission as we move from fee-forservice to value-based care. One of our founders, Dr. Paul Grundy, may have summarized this perspective best when he said, “Effective use of medications is the issue of the decade.” What can you tell us about the amount of money now spent on medications that are not “right” for patients?

In a study published in the Annals of Pharmacotherap (https://tinyurl.com/mp-gtrmx), my colleagues and I found that illness and death resulting from untreated indications, drug interactions or adverse effects, subtherapeutic or toxic dosing, non-indicated therapy, and non-adherence—what we call “non-optimized medication therapy”—cost an estimated $528 billion in 2016, representing 16% of total U.S. health care expenditures. That figure includes only direct medical costs; it doesn’t include transportation, caregiving, lost productivity, or disability from non-optimized medication therapy. We also examined medical resources utilized when drug therapy isn’t optimized, such as additional medications and avoidable trips to an emergency

OCTOBER 2019 MINNESOTA PHYSICIAN

“...”

Effective use of medications is the issue of the decade.

“...”

What are some perspectives on this mission from the organizations you worked with to found GTMRx?

Please describe comprehensive medication management (CMM).

department, hospitalization, and care in long-term facilities, all of which totaled $256.8 billion. While many focus on non-adherence to prescribed medications, this is not the top drug therapy problem. Many patients need additional medications, differing doses, or—especially among the elderly—“deprescribing” or reducing dosages because of overuse. Until we make sure the medications are indicated, effective, and safe, nonadherence will only contribute to the problem. How many patients suffer morbidity and mortality due to non-optimized medication therapy?

Our study revealed another tragic number: 275,689 avoidable deaths were tied to nonoptimized medication use. Unfortunately, we believe this to be a conservative figure. Other statistics from the Lown Institute highlighted “medication overload,” which they defined as the “use of medications for which the harm to the patient outweighs the benefit,” in elderly patients. The institute reported that one in five older adults (10 million total) experienced an adverse drug

Under CMM, physicians and pharmacists ensure that all medications are individually assessed to ensure that each one is appropriate for the patient, effective for the medical condition, safe given the comorbidities and other medications being taken, and able to be taken by the patient as intended. This boosts cost-effectiveness and ensures that all conditions are effectively managed, building the bridge from uncoordinated “trial-and-error,” population-based medication use to personalized, science-and-data-driven medication therapy. It’s important to distinguish between CMM and other forms of medication therapy management (MTM). CMM is patient-centric, based on optimizing the clinical goals of therapy, reiterative (not “one and done”), and consistent with the definitions of the Patient-Centered Primary Care Collaborative. Our website lists 10 specific elements of CMM (https://tinyurl.com/mp-gtrmx3). Many organizations have taken to calling what they do “comprehensive medication management.” They may do two or three components, but no more. How can physicians and pharmacists better coordinate medication-based care?

In advanced team-based care models, clinical pharmacists are part of the care team and work collaboratively with physicians, nurses, and other providers. Six of the 15 organizations we featured in our national “Get the Medications Right” snapshot of expert practices are in Minnesota: Goodrich Pharmacy, HealthPartners, North Memorial Health Care, Fairview Pharmacy Services, Hennepin Healthcare, and University

of Minnesota Physicians. The University of Minnesota team at the Health-systems Alliance for Integrated Medication Management (HAIMM) has not only developed a way to successfully integrate the care team, they’ve also led the important work to measure patient satisfaction.

and pharmacist are working under the same roof, interacting with the same patients, and accessing the same platform, coordination is much greater.

We also can learn a lot from the Department of Veterans Affairs (VA)’s work to systematically integrate clinical pharmacy specialists (CPS) into the care team to accomplish CMM within both the primary care and specialty teams. More than 4,350 of their CPS (all in non-dispensing roles) provide CMM services, accounting for almost 6 million patient encounters yearly.

Created by our membership, the Blueprint for Change—to be released in early 2020—will guide our work by laying out specific actions we can take to be a catalyst for change. We’ve established four workgroups focused on practice transformation and care delivery to support CMM implementation, policy and payment changes necessary to support the practice, and steps to ensure that precision medicine and advances in diagnostics are realized at the point of care, with the health information technology and AI necessary for clinical decision-making and workflow practice support. Members and nonmembers can learn more at https://gtmr.org.

How can in-house pharmacies inform physicians about new medications?

In-house pharmacists can not only help physicians keep pace with the continuous stream of new medicines entering the market, they can help put those new therapies in context of what other medications their patients are taking. The dispensing pharmacists can also ensure that the clinical pharmacists in collaborative practice settings are advised when adherence issues or formulary changes arise. When the physician

In your first year, you have been developing a “Blueprint for Change.” Please describe this.

What other core message would you like to share with physicians?

Physicians know that 80–85% percent of the way they treat and prevent disease is through medications. Physicians are very good

at prescribing drugs for individual patients, but when you factor in all of the drugs prescribed by various specialists and primary care providers, it can lead to the current drug therapy problems. Also, we are at a key inflection point as we move from population health/clinical guidelinebased care to precision/personalized medicine influenced by advances in genomics, tumor genetics, the microbiome, and more. The fact that over 70% of the medications in the pipeline have complementary or companion diagnostics means that we have to not only implement CMM into practice, but make sure we have the HIT/analytics and evolving AI to inform decision-making for medications and diagnosis at the point of care. Physicians must lead this transition so our patients are confident they have the most effective, appropriate medications and evolving gene therapies as we optimize health. Join us! Terry McInnis, MD, MPH, is President and Cofounder of the GTMRx Institute and President of Blue Thorn Inc. She is board-certified in preventive and occupational medicine and is a Fellow of the American College of Occupational and Environmental Medicine.

MEDICAL MALPRACTICE ATTORNEYS

Angela Nelson

Matthew Frantzen

Ryan Ellis

Marissa Linden

Jennifer Waterworth

Tracy Jacobs

MINNESOTA PHYSICIAN OCTOBER 2019

3Labeling and medicating children from cover then resulted in a subjective judgment call and a recommendation to a physician to prescribe psychotropic medications. In almost all cases where students are diagnosed and subsequently labeled with a disorder, there is no objective medical evidence to determine this diagnosis. Special education programs—which include children labeled as having ADHD—is financed at about 80% of actual costs through state and federal funds, which creates major funding problems for local school districts that must fund the remaining 20%. In addition, schools are under increasing pressure to improve their metrics on grades and standardized test scores. These two factors can lead schools to turn to what appears to be a quick fix: medicate in hopes of managing behavior— and, potentially, improving test scores—all the while contributing to a dramatic increase in drug sales involving kids.

these messages on to parents, resulting in visits to physicians who may trust the recommendations of non-physician educators and write prescriptions without conducting a thorough assessment of the child’s needs. The result is a steep and rapid increase in psychotropic prescriptions.

Spotting trends and concerns

Ten percent of all school-aged children are now labeled with ADHD.

The pharmaceutical industry promotes the value of this approach, visiting school boards and educators to stress the benefits of psychotropic medications to manage behavioral health concerns and increase test scores. Pharmaceutical representatives can no longer promote their products to physicians, but they can visit educators—and increase their profits, with estimates ranging as high as $7 billion annually for psychotropic drugs. Educators and counselors pass

In 2006 I obtained a book coauthored by Nicholas A. Cummings, PhD, ScD, a former president of the American Psychological Association, entitled, “Destructive Trends in Mental Health: The Well Intentioned Path to Harm.” Two chapters piqued my interest: “Warning, Psychiatry can be Hazardous to your Health” and “The Diseasing of America’s Children.”

A March 2012 Psychology Today article, “Why French Kids don’t have ADHD,” stated that only one-half of one percent of French kids are labeled and medically treated for ADHD, compared to over 9% of American children. In France, diagnosis of ADHD takes into consideration the underlying causes in the child’s social context, addressing these through psychotherapy or family counseling, whereas the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders does not specifically include these underlying causes. The result is a much larger number of medicated American children. A recent article on the front page of the Minneapolis Star Tribune reported that 10% of all school-aged children are now labeled with ADHD. Then in November 2018, FEE (Foundation for Economic Education) published an article titled “Harvard Study Shows the Dangers of Early School Enrollment,” which warned about the dangers of labeling and medicating preschool children. The article stated that the Centers for Disease Control and Prevention estimated approximately 11% of children are diagnosed with ADHD in the U.S. It also included numerous other concerns of early school enrollment.

Lifetime impacts Another disturbing fact is that the use of psychotropic drugs on the developing brains of children seriously impairs their ability to serve in the military. I have visited with several military recruiters over the last several years who confirmed that the use of psychotropic drugs can result in denial into our military branches. The reason they are denied is that one of the negative side effects of long-term use of psychotropic drugs is violent outbursts of uncontrollable rage. It should be evident why the military has serious concerns regarding the use of these drugs on developing children. In addition, there is a crisis of young people committing suicide. It would be interesting to study how many were on psychotropic drugs at the time of death. Finally, probably the most serious concern is the growing evidence of the connection between young mass shooters, both in and out of our schools, who also have a history of long-term use of psychotropic drugs.

Action steps I am aware that this is an extremely controversial issue with psychiatrists and pharmaceutical companies who deny that there is any possible connection— however it is one of the primary reasons I authored a bill (HF713) in the Minnesota House of Representatives, which would create a study group of experts to research some of the previously mentioned concerns.

OCTOBER 2019 MINNESOTA PHYSICIAN

My concerns are also partially based on the 2013 report of the OLA (Office of the Legislative Auditor), which identified that Minnesota has more than 170 additional laws and regulations over and above the federal requirements on special education. These additional laws have never been evaluated for costs or effectiveness! During the 2019 legislative session, I also offered an amendment (A173) on the House floor with additional language specifically addressing the excessive labeling and medicating of children. The amendment passed on a strong bipartisan vote; however, this language did not make it into the final educational omnibus bill signed by the governor. I intend to try again in 2020.

individuals taking these drugs. The breathtaking element here is the utter lack of scientific scrutiny for safety and efficacy, particularly when given on a long-term basis (longer than six months).

Trends in diagnoses

Many drugs used to manage mood and behavior in children ... have a very undesirable risk-to-benefit ratio.

A personal note Whether you agree or disagree with the above information, I think we should all agree that an in-depth study should be done on the costs and effectiveness of Minnesota’s special education requirements. Let me stress that I do not want to hurt any special education students. I have relatives who were in special education programs, but I am committed to finding factual answers to the above concerns. Part Two: a physician’s concerns

s a general internist with a special interest in pharmacology, nutritional and botanical medicine, and complex illness, I have grown especially concerned with the misapplication of drugs—often many in the same patient. The rapid evolution of the physician (and other provider) workplaces with computerized medical records and the compulsion to practice medicine by “drop down menu” has added to the propensity to overprescribe. Nowhere is this more apparent than in the inappropriate overprescribing of psychotropic drugs for children—often by physicians who have not adequately examined the child.

Another overriding concern is the growing number of individuals using these medications. Much of this goes back to the publication of the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) in 1994. When this now-revised fourth version came out, reported rates of ADHD, autism, and childhood bipolar disorder increased dramatically, largely because of the then-new DSM definitions. Some have called this “diagnostic inflation,” a phenomenon that is strongly promoted by pharmaceutical companies in concert with the psychiatry profession and those who write the DSM revisions. As soon as an illness is codified this way, spending for pharmaceutical solutions skyrockets.

The current DSM-V was published in 2013, and, predictably, started a new epidemic of childhood mental disorders by introducing a new diagnosis: Disruptive Mood Dysregulation Disorder (DMDD). A recent editorial in the Journal of the American Academy of Child and Adolescent Psychiatry goes to great lengths to distinguish between ADHD, childhood Labeling and medicating children to page 344

Questions about effectiveness Many drugs used to manage mood and behavior in children either have very little scientific basis (never tested thoroughly in youth under 18) or have a very undesirable risk-to-benefit ratio. This latter item is rarely, if ever, fully disclosed to the patients or their legal guardians in the spirit of informed consent. Examples include medications like Risperidone, a drug now in relatively common use for schizophrenia and other related thought disorders that has profound implications when given long term. It can actually cause permanent brain damage, resulting in irremediable tardive dyskinesia (an involuntary movement disorder that is both humiliating and disabling). The so-called “serotonin reuptake inhibitors,” long in use for the management of depression and anxiety (Prozac, Zoloft, etc.) in fact have very little scientific basis for their action. They are routinely given for anxiety and depression, particularly in children who suffer various types of posttraumatic stress disorder from abusive homes, injuries, medical conditions, and other factors. There is very little validated evidence that they are safe or effective in children. In fact, there is a boxed warning regarding both homicidal and suicidal ideations on several of these drugs that are commonly used. A recent expose disclosed that a majority of mass shootings have been perpetrated by

Physician Coaching That Works! Just as top professional golfers improve by hiring a swing coach, physicians can improve by hiring a professional coach. - Physician in Crisis? - Provider Suffering from Burnout? - Practice Partnership Challenges? - Develop Physician Leaders - Need to Improve Metrics? 24 years of experience have proven our evidence-based coaching consistently produces positive outcomes. Coaching Works! Even in the most challenging situations. Call for a FREE consult. Timothy R. McClernon, Ph.D. CEO, Managing Partner 612.321.8066 (cell) Learn more: PeopleArchitects.com

Physician Coaching Leadership Coaching Clinical Team Building

MINNESOTA PHYSICIAN OCTOBER

3Minnesota Mobile Medical Teams from Cover

or other unplanned events. The MN MMT is a group of highly trained medical personnel, all of whom are currently practicing. The 53-person local hospital with injured and scared loved ones, they find that the local roster consists of providers from across the medical field, including hospital was not spared from this carnage. Its roof was torn away, the power physicians, nurse practitioners, nurses, paramedics, respiratory therapists, was destroyed, and the water supply was damaged. lab technicians, pharmacists, and other support It is no longer capable of functioning as a hospital. personnel located throughout the state. Disasters are dynamic and ever-changing, and the diversity When disaster strikes of our staff allows us to use their expertise and This scenario may seem improbable, but it has knowledge to better fit the needs of the disaster at happened in more than a few communities in the Natural disasters do happen and hand. From level-one trauma physicians to rural United States. Most notably in 2011, a hospital seem to be happening at providers, we have a team that can fit the mold in in Joplin, Missouri, was destroyed. Here in an increasing pace. most situations. Minnesota, there was a near miss on the medical community in Wadena. The community was Quick responses severely impacted but, luckily, the hospital was In the immediate aftermath of a disaster, local able to continue operations. Across the country, health care, EMS, and other responders will work hospitals and community health care facilities to care for those immediately in need. The disaster have a history of being impacted, whether by a tornado, straight-line winds, may impact the existing health care facility structurally, requiring the MN flooding, blizzards, or wildland fires. Natural disasters do happen and seem MMT to come in within 24 hours of the event and set up at a location to be happening at an increasing pace. Weather is the most common type identified through consultation with local emergency management and of disaster, but these events and others—albeit less common—can render a facility staff. We have the ability to set up to a 50-bed unit including three health care setting unusable. critical care beds, and can provide services such as portable ultrasound, labs, X-ray equipment, and more. We have a full pharmaceutical formulary Minnesota is rich in health care resources in comparison to many other provided by St. Cloud Hospital that is ready to be pulled and re-supplied locales. We are also fortunate to have an internal resource known as the upon request. Our team has its own internal, self-contained command Minnesota Mobile Medical Team (MN MMT), which exists to provide center that includes secured internet, 800Mhz/single band radio systems, continued health care to a community that has been impacted by a disaster logistics, and supply areas. If there is no structural damage to the health care facility—but the circumstances in the wake of the crisis have left it without adequate personnel available to function—the MN MMT can integrate with the facility and provide resources to ensure the facility has the staff to provide care. The response team is self-contained and able to operate independently, but the goal is to work with local health care personnel, since they know their patients and community better than anyone else. Integrating them into this operation is something we encourage if so desired by the facility. The MN MMT is intended to be a buffer while local personnel can get back up and running and ensure that the community maintains access to health care.

Funding and operations The MN MMT operates through a federal grant managed by the Minnesota Department of Health (MDH). The grant is through the federal Assistant Secretary for Preparedness and Response (ASPR)’s office, which supports states and territories. MDH divides up the funding to the eight regional health care coalitions in Minnesota. Each health care coalition gives a portion of its funds off the top to support the MN MMT. Because of this relationship with the coalitions, the MN MMT is also in touch with the coalition located in the region where an incident might occur. These coalitions are well connected in their region as well as with the other regions and therefore have a wealth of support capabilities that the MN MMT can draw upon, such as the potential for additional supplies, communication abilities, EMS, and more. These relationships have been a great success for all involved. While there are definite positives to these assets and relationships, there are limitations that make utilization of the team restrictive to true emergent situations.

OCTOBER 2019 MINNESOTA PHYSICIAN

If a true emergency were to happen, the MN MMT would be allowed to mobilize quickly once the request has been approved by the governor. The team exercises at least once a year, and sometimes twice yearly, during which periods the team will work with a local facility, community, and others in simulating an event and doing a functional or full-scale exercise. Since team members are all actively practicing health care professionals, these exercises and team educational times are designed to allow for team building and developing team expectations. Several of these exercises last two to three days rather than the usual one-day events.

Success stories As mentioned previously, Minnesota is very fortunate in its rich health care assets and has been fortunate to have had very few disasters that have impacted health care facilities. Those that have occurred have been mitigated quickly. The team was deployed in 2009 when a skilled nursing facility was evacuated due to the Red River floods. Once beds in the state were exhausted, there were approximately 30 residents that still needed care. The team was asked to care for these individuals at a shuttered wing of a hospital. The team received these residents and cared for their needs for seven days prior to them being able to return to the facility they came from. The MN MMT also was asked to participate by local personnel at a Minnesota air show, where it provided first aid services. The care given by a team of medical personnel was lifesaving for at least one person in attendance. While the team hopes it never has to deploy, it is capable and confident in its abilities. The team has also been held up as a model for other states that are looking to develop similar programs.

The federal government has a marvelous National Disaster Medical System that includes Disaster Medical Assistance Teams, which provided the model for the MN MMT. Their assistance should never be dismissed, but having an internal, local team ready and able means that responders typically can mobilize faster, know the local personnel, have strong identified local relationships, and can act as the stop gap until additional assistance can be brought in if needed. The mechanism for utilizing the team is through Minnesota Responds, part of the national Medical Reserve Corp. While there are many volunteers in Minnesota, this system allows us to cover liability and workers compensation once we are activated. Since all team members are currently practicing health care personnel, they are up to date on current standards and skills. Health care personnel wishing to learn about the teams or to join either the Central MMT (based out of the Central region) or the Metro MMT (based out of the Metro region) may visit https://tinyurl.com/ mp-mobile-medical-teams. This webpage also includes a link to online training materials. Donald Sheldrew, MSW, LICSW, is the Central Minnesota Healthcare Preparedness Coalition Readiness and Response Coordinator and regional coordinator for the Central Minnesota Healthcare Preparedness Coalition. An active paramedic for more than 30 years, he has worked with the development and implementation of many coalition activities throughout the state. He also currently serves as the co-leader of the Minnesota Mobile Medical Team.

Indian Health Services Hospital in Red Lake, MN is enhancing their healing environment with this beautifully illuminated patient foyer. This 11,200 SF renovation of existing space also includes exam rooms, provider space, and medical lab.

Opening 2020

EAPC.NET/IHS-RED-LAKE

MINNESOTA PHYSICIAN OCTOBER 2019

PUBLIC HEALTH

The MN FEET program Birth disparities and prenatal mercury exposure BY KATE MURRAY, MPH; JESSICA NELSON, PHD, MPH; AND COURTNEY JORDAN BAECHLER, MD, MS

he jar of skin lightening cream looked innocuous enough, but investigators found that merely opening its lid released enough mercury vapor to create unsafe living conditions in the home. Using a Lumex portable mercury detector, partners with the MN FEET program (Minnesota Family Environmental Exposure Tracking) found a reading of 800 nanograms per cubic meter of mercury in the air—more than twice the chronic exposure limit set by the Environmental Protection Agency. Fortunately, a few days of fans and open windows were enough to bring the readings down to safer levels. The home visit was part of a voluntary follow-up investigation with a study participant found to have high levels of mercury in her urine. Environmental epidemiologists with the Biomonitoring Program at the Minnesota Department of Health (MDH) hypothesized that the exposure had come from an imported skin lightening product, and the Lumex readings supported their hunch.

Solutions through experience and collaboration

The Gray Plant Mooty Health Law team knows the health care business. Partner with us for smart, practical solutions to all of your legal challenges.

OCTOBER 2019 MINNESOTA PHYSICIAN

Residents at the house had been at risk from mercury, which can damage the central nervous system, kidneys, and liver. While health consequences vary on the amount and duration of exposure, fetuses and young children are particularly sensitive to mercury, too much of which can cause lasting problems with understanding and learning. While the MN FEET study wrapped up last year, surveillance and prevention efforts are far from over. Findings from the study reveal important information for health care providers to be aware of and discuss with the patients they serve. Here, we share key findings from the MN FEET study and discuss how we are piloting a mercury screening program for pregnant women with two St. Paul clinics.

The MN FEET study Investigators with MN FEET measured mercury, lead, and cadmium in pregnant Twin Cities women and their newborn babies in hopes of learning more about preventing chemical exposures that could impact fetal brain development. Prior to the study’s inception, community concerns and outcomes from other biomonitoring studies suggested that some populations were experiencing marked disparities in exposure to certain chemicals, but more investigation was needed. With oversight from the Environmental Health Tracking and Biomonitoring (EHTB) Scientific Advisory Panel, researchers from the Minnesota Biomonitoring program at MDH designed and implemented the study with an eye on advancing health equity. Collaboration with health care and community stakeholders proved essential to the study. The HealthPartners Institute and Health for Somali, Latinos, and Hmong (SaLaHmo) Partnership for Health & Wellness at Minnesota Community Care (then known as West Side Community Services) recruited pregnant women who were patients at select local clinics and who planned to give birth at Regions or Abbott Northwestern Hospitals. In accordance with community and advisory panel recommendations, recruitment focused on women who identified as Asian, East African, Latina, or White. “This is part of our effort to ensure that every baby has a healthy start,” said Kathleen A. CulhanePera, MD, medical director of quality and co-director of communitybased research at Minnesota Community Care. “What we learn from MN FEET will be important to the communities, families and patients served at our clinics.” Recruits who consented to being part of the study answered a phone questionnaire about their living conditions, eating habits, use of skin lightening creams, and other factors that could influence exposure levels. When the participants’ babies were born, hospital staff collected urine samples from the women and a small amount of umbilical cord blood, which were then analyzed by the MDH Public Health Laboratory. Some ethnic groups had more women in the study than others: the largest groups were Latina and White women, followed by Asian women, with East African women representing the smallest group. Participation by

East African women was unintentionally hindered by different aspects of the study design, including non-face-to-face recruitment methods and sample collection at two partner hospitals where these women were less likely to deliver. Exposures to lead and cadmium were measured in cord blood samples, and were generally low and not of great concern for women in MN FEET. Cadmium exposure occurs primarily through smoking cigarettes. Lead exposure typically comes from contact with lead-based paints, along with some jobs, hobbies, and products like glazed ceramics with lead. Mercury, on the other hand, showed more troubling and complicated results. The type of mercury detected in cord blood is most often organic mercury, found in fish. The type of mercury detected in urine is usually inorganic mercury, which can come from skin lightening products, light bulbs, and old thermometers. Researchers found elevated levels for both forms of mercury and identified specific populations at higher risk.

fish that are low in mercury and other chemicals. MDH provides guidelines in a number of languages and formats to help people choose which fish to eat and how often in order to keep mercury exposures low. MN FEET measured mercury in the cord blood of 395 participants and found that women who ate particular species of fish—Walleye, Northern Pike, Bass, White Bass, or King Fish—more than once per month had more mercury in their babies’ cord blood than women who ate fish less often. MDH guidelines advise pregnant women and children to eat these types of fish once a month or less. Nine women had high levels of mercury in their babies’ cord blood. Phone follow-up revealed that most of them ate species of fish with higher The MN FEET program to page 164

Mercury from skin lightening products MN FEET measured mercury in the urine of 396 participants. Women in the study who said they had used a skin lightening cream in the past had more mercury in their urine than those who did not. Such products often do not list mercury on the label, and it cannot be seen, felt, smelled, or tasted by the consumer. In the United States, it is illegal to sell skin lightening products that contain mercury, but they can be ordered from the internet or carried across borders and are available at some ethnic markets. Many women who use the creams are unaware of how hazardous they can be, but it’s a complicated and painful issue with roots in colorism and colonialism. Amira Adawe, founder of the Beautywell Project and key community partner for the study, says that removing the products from markets is not enough—consumer education and a cultural shift around beauty standards are needed. “Skin lightening practice is an issue that is impacting immigrant and communities of color,” says Adawe. “Lighter skin is considered beautiful compared to other skin tones; because of this, many dark-skinned women believe having lighter skin will increase their chances of being accepted in society and in their communities.” Globally, the skin lightening product market exceeds $10 billion annually and is expected to double by 2030. For MN FEET, six of the nine women with elevated urine mercury levels agreed to take part in further investigation via home visits. With help from St. Paul–Ramsey County Public Health and the Minnesota Pollution Control Agency, the participants’ homes were tested for mercury contamination. The Lumex analysis revealed that airborne mercury was putting everyone in the home at risk, and not just the women using the creams. Additionally, their washing machines could become contaminated from laundering towels that contained traces of the creams, potentially spreading the mercury to other clothing and linens.

When loved ones need to be close

THE SAINT PAUL HOTEL has a long-standing special pricing policy for guests with loved ones that require hospital stays. If you have patients from either out of state of suburbs that require hospitalization at any of the outstanding St. Paul area hospitals, please let them know that family members and loved ones are welcome to our discounted health care stay pricing.

All nine women with higher mercury in their urine chose to speak Hmong or Spanish in their surveys, and all were born outside of the United States. The group of East African women tested was too small to draw statistical conclusions from their results, but they had the second-highest mercury levels in their urine after Hmong women.

Mercury from eating certain fish The benefits of fish consumption outweigh the risks when people choose

SAINTPAULHOTEL.COM | 651.292.9292 | 350 MARKET ST., ST. PAUL MINNESOTA PHYSICIAN OCTOBER 2019

3The MN FEET program from page 15 mercury more than once per month. All nine of them were Hmong women, though Asian groups in general had higher cord blood mercury than other groups.

Call to action: from research to practice

MN FEET reveals an important opportunity to halt or prevent mercury exposures in pregnant women, their babies, and their households. Health care providers can help patients understand potential sources of these harmful chemicals that Exposures higher in some women may otherwise go unnoticed. Dr. Culhane-Pera Asian women in MN FEET, and especially Hmong agreed: “The MN FEET results shed light on some women, had the highest levels of mercury. This really important exposure prevention information was true for mercury in urine and cord blood, Many women who use [skin that we as health care providers need to share with suggesting that some Hmong women in Minnesota lightening] creams are unaware the patients, families and communities we serve.” may have high mercury exposures from using skin of how hazardous they can be. MDH has information sheets available in Spanish, lightening products with mercury and from eating Somali, Hmong, and English about both skin fish higher in mercury. lightening product use and choosing fish wisely, “The evidence from MN FEET that some as well as a fact sheet for health care providers groups in Minnesota may be having higher mercury (https://tinyurl.com/mp-mdh-mercury) that lists exposures, especially Hmong women and women symptoms and provides recommendations for doctors about discussing skin from other ethnic/immigrant communities, is concerning,” said Mao Thao, lightening products and mercury exposure with patients. Hmong Health Coordinator with St. Paul–Ramsey County Public Health. After sharing the study results with participants, the biomonitoring “It is critical that we work with these communities to find the best ways to team disseminated the findings to partners and stakeholders before rolling share the information and reduce exposures in women and babies.” out a community report and press release. Outreach is ongoing in the Although relatively few women overall had elevated levels, the seriousness communities most impacted by the results. More multi-faceted, targeted of potential effects from mercury exposure, widespread use of products messages and messengers are still needed—especially for women who containing mercury, and increased burden in some vulnerable subgroups speak languages other than English and/or were not born in the United garner significant public health concern. States. Community-led programs continue to be instrumental as well, and

Minnesota Physician digital access now available Never miss an issue · New reader-friendly format · Instant access anywhere · Read back issues

Visit mppub.com to activate your digital subscription and read us online wherever you go.

www.mppub.com

OCTOBER 2019 MINNESOTA PHYSICIAN

a bill passed earlier this year will help fund local outreach and awareness campaigns to reduce the use of skin lightening products. Communications with patients in clinic can bolster these efforts.

Hospital, Abbott Northwestern Hospital, St. Paul–Ramsey County Public Health, Minnesota Pollution Control Agency, EHTB Advisory Panel, East Africa Health Project, and Amira Adawe. All funding provided by the State of Minnesota.

And while prevention begins with awareness, an offshoot clinic-based project is conducting routine urine mercury screening of all prenatal patients at two St. Paul community clinics and offering exposure reduction assistance to any women found to have elevated exposures. An additional project with a clinic that serves a large East Health care providers can African population is in the planning stages. These help patients understand potential sources of these projects will help determine the effectiveness and harmful chemicals. feasibility of this type of screening, and will move toward integrating the issue into clinical practice, where exposure reduction will be most effective. “Mercury exposure can be a significant health concern, but in this case the good news is that those groups we found to be at elevated risk have the power to reduce that risk,” Minnesota Commissioner of Health Jan Malcolm said. “This study shows that we have an opportunity to help people better understand the potential dangers of using skin lightening products and frequently eating fish higher in mercury.”

Kate Murray, MPH, is a communications planner for the environmental epidemiology unit at MDH. Her breadth of experience includes creative and technical writing, multimedia production, and community engagement. She holds a Master of Public Health degree in Administration & Policy from the University of Minnesota.

Jessica Nelson, PhD, MPH, is Program Director and Epidemiologist with the Minnesota Biomonitoring Program at the Minnesota Department of Health.

She was a Principal Investigator for MN FEET, the MDH biomonitoring study that measured mercury, lead, and cadmium in pregnant women and babies.

Courtney Jordan Baechler, MD, MS, is a board-certified internist and

Get more information about the study and resources for patients at www.health.mn.gov/MNFEET.

cardiologist who focuses on the prevention of heart disease and change that

MDH would like to thank the following partners: MN FEET participants, SoLaHmo/Minnesota Community Care, HealthPartners Institute, Regions

to the community. She is passionate about helping individuals, families, and

supports overall well-being. Her interest is on prevention from the bedside communities to find their highest state of well-being—body, mind and spirit.

V Alzheimer’s is now an approved condition V

HAVE YOU REGISTERED WITH THE MINNESOTA MEDICAL CANNABIS PROGRAM? Registration can be done online; there is no fee and it takes only a few minutes. Visit the registry website: mn.gov/medicalcannabis Your account will provide access to medical cannabis purchasing information from patients you certify. Once you are registered, you will be able to certify patients with a variety of conditions, including: • Cancer, Glaucoma, Tourette Syndrome, HIV/AIDS, and ALS

• Inflammatory bowel disease, including Crohn’s disease

• Seizures, including those characteristic of Epilepsy

• Terminal illness, with a probable life expectancy of less than one year

• Severe and persistent muscle spasms, including those characteristic of MS

• Intractable Pain

• Obstructive sleep apnea

• Post-Traumatic Stress Disorder

• Alzheimer’s

• Autism

Cannabis Patient Centers are now open to approved patients in Minneapolis, Eagan, Rochester, St. Cloud, Moorhead, Bloomington, Hibbing, and St. Paul.

OFFICE OF MEDICAL CANNABIS (651) 201-5598: Metro (844) 879-3381: Non-metro P.O. Box 64882, St. Paul, MN 55164-0882 health.cannabis@state.mn.us

Many patients have reported improvement in their health status from medical cannabis — some describing dramatic improvements. Smoking cannabis is not allowed under the program. Visit our website for educational resources about cannabinoids and the endocannabinoid system and for scientific literature on the efficacy of medical cannabis in treating certain conditions.

See our website for a detailed first year report. mn.gov/medicalcannabis

MINNESOTA PHYSICIAN OCTOBER 2019

MEDICINE AND THE LAW

The Supreme Court’s Albrecht decision Unclear implications for adverse reaction warnings BY ELIE BIEL, JD

en years ago, the U.S. Supreme Court held that a drug manufacturer would not be liable under a state-based failure-to-warn theory if “clear evidence” showed that the FDA would not have approved the patient-plaintiff ’s preferred product warning label. But in the years since that decision came down, lower courts have struggled to consistently determine what meets the requisite “clear evidence” threshold. So last summer, many in the drug and device industry cheered when the High Court agreed to review the Third Circuit’s controversial In re Fosamax (Alendronate Sodium) Prod. Liab. Litig. decision, as the case provided a rare opportunity for the Court to clarify its prior pronouncement and reshape a heavily litigated area of the law. Unfortunately, however, the Court’s resultant ruling in Merck Sharp & Dohme Corp. v. Doris Albrecht, et al. (May 2019) failed to provide the degree of clarity that most industry observers had hoped for.

Background The Albrecht litigation involves Fosamax, a drug widely used to treat osteoporosis in postmenopausal women. Fosamax combats the effects of osteoporosis—the development of weak or brittle bones due to a progressive

Compassionate, Comprehensive, & Personalized care for adult and pediatric patients with neurological conditions, including:            

Head Injury/Concussion Epilepsy/Seizures Headache/Migraine Neck/Back Pain Sleep Disorders Movement Disorders Parkinson’s Disease Tremors Alzheimer’s Disease Dementia Muscle Weakness Carpal Tunnel Syndrome

        

Sciatica Neuromuscular Disease Muscular Dystrophy Dizziness Numbness Stroke Multiple Sclerosis ALS And other neurological disorders

612.879.1500

OCTOBER 2019 MINNESOTA PHYSICIAN

loss of bone cells—by slowing a patient’s rate of bone cell loss, allowing the body time to replace lost bone cells, thereby decreasing the risk of osteoporotic fractures. But like all medications, taking Fosamax is not without risk. Indeed, one potential risk—and the one at issue in Albrecht—is that long-term Fosamax users run the risk of developing an atypical femoral fracture. Though present-day prescribers are (hopefully) aware of this risk, such was not always the case. FDA first approved Fosamax in 1995. At the time of its approval, the drug’s label did not warn of the then-speculative risk of an atypical femoral fracture. But once on the market, evidence began to accumulate that some long-term Fosamax users were experiencing such fractures. As a result, in 2008, Merck applied to FDA—the federal agency charged with regulating drug labels—for preapproval to add certain language to the Adverse Reactions and Precautions sections of the Fosamax label. Specifically, Merck sought to include reference to the risk of a “lowenergy femoral shaft fracture” in the Adverse Reactions section and a separate discussion concerning the risk of “stress fractures” in the Precautions section. FDA approved Merck’s proposed Adverse Reactions language but rejected the proposed Precautions language, asserting that Merck’s justification for the proposed Precautions language was “inadequate.” In fact, the case record showed that FDA representatives told Merck to “hold off ” on the Precautions language and that the agency “would then work with . . . Merck to decide on language for a [Precautions] atypical fracture language, if it is warranted.” After receiving this feedback, Merck added the requested language to Fosamax’s Adverse Reactions section in 2010 but made no corresponding changes to the label’s Precautions section. The following year, after further communications with FDA, Merck revised its Precautions section to include language mentioning Atypical Subtrochanteric and Diaphyseal Femoral Fractures. The plaintiffs (more than 500 individuals who took Fosamax and suffered atypical femoral fractures between 1999 and 2010) sued Merck, asserting that the company had failed to warn them about the risk of atypical femoral fractures. Merck, relying on its prior communications with FDA, sought dismissal of such claims, arguing that “clear evidence” demonstrated that prior to 2011 FDA would not—and did not—approve of such a warning. The implication being that the company should be immunized from such a claim because it was legally impossible for Merck to comply with state tort law without violating the Constitution’s Supremacy Clause, which holds that in the event of a direct conflict between federal and state law, federal law takes precedence. Though the District Court agreed with Merck, the Third Circuit did not, notably holding that: (1) to satisfy the “clear evidence” standard, Merck needed—but failed—to show that it was “highly probable that the FDA would not have approved a change to the drug’s label”; and (2) whether FDA would have rejected Merck’s proposed label change was a fact question for the jury. Merck’s appeal thereafter followed.

To Albrecht and beyond!

“’to reflect newly acquired information’ if the changes ‘add or strengthen a ... warning’ for which there is ‘evidence of a causal association[.]’” The implication being that a failure-to-warn claim may only be barred if a drug manufacturer tries to make a label change pursuant to the CBE regulation, but is then thwarted from doing so by the FDA.

Many people have the mistaken view that all Supreme Court decisions are contentious and narrowly decided by a razor thin margin, but the reality is that in most cases the justices widely agree on the outcome. Albrecht is a good example. Though the justices did not uniformly join the majority opinion, all nine Second, though the issue was neither before the of them agreed to vacate the Third Circuit’s Court nor decided, the opinion appears to suggest decision. In so doing, the Court rejected the Third that only formal FDA actions, or similar agency Circuit’s attempt to characterize or define “clear actions carrying the force of law, matter to this The drug’s label did not warn of evidence” in terms of evidentiary standards and analysis. That is to say, informal communications the then-speculative risk of an further rejected the contention that a layperson (e.g., calls or emails) between FDA and a drug atypical femoral fracture. jury—as opposed to a judge—was best situated manufacturer regarding a proposed label change to determine whether FDA would (or did) reject may not be of significance. Should that indeed a proposed label change. Interestingly, the Court be the case, it would be quite notable, not only chose not to decide the ultimate question of due to its potentially chilling impact to Albrecht whether Merck was liable, electing instead to on remand, but also because it would contradict remand the matter for further proceedings. some existing lower court views. It may very well be the case that this issue—the “question of disapproval ‘method’”—will mark the next chapter Taken together, the Albrecht decision amounts to a mixed bag. One of this ongoing saga. the one hand, the decision may result in a modest decrease in existing product liability suits because, by vacating the Third Circuit’s decision, the High Court erased a key authority used by plaintiffs to survive dismissal. Moreover, the decision should force otherwise reluctant judges to decide a potentially dispositive, purely legal issue as opposed to punting the matter to a jury. But on the other hand, the decision amounts to a missed opportunity.

Elie Biel, JD, is an attorney at Faegre Baker Daniels LLP, where his practice is devoted to drug and device litigation and the defense of health care systems and professionals in professional liability matters.

For years, lower courts have struggled to consistently determine the meaning of “clear evidence.” And unfortunately, with the exception that the Court rejected the Third Circuit’s attempt to equate “clear evidence” with an existing evidentiary standard (e.g. “preponderance of the evidence” or “clear and convincing evidence”), the opinion made no effort to define an otherwise undefined term. Instead, the Court’s guidance essentially amounted to characterizing “clear evidence” in “I know it when I see it” terms, which is akin to no guidance at all. As a result, as was the case before Albrecht, lower courts will likely need to determine what satisfies the “clear evidence” standard on a caseby-case basis. And doing so, as one lower court has remarked, will likely require courts to evaluate several factors, including but not limited to “the regulatory history of the drug or drug class at issue, temporal gaps between FDA action and accrual of a plaintiff ’s claims, citizen petition submissions and rejections, available scientific data, and whether the FDA has reviewed the particular harm at issue and the consistency of any resulting conclusions.” Needless to say, such an individualized, multifactorial analysis will inherently involve some degree of subjectivity, which may yield inconsistent or haphazard results. Two additional points bear mentioning. First, Albrecht continues to underscore the difficulty drug manufacturers face in asserting that a state-based failure-to-warn claim is precluded where the FDA may have considered—but did not adopt—the proposed label change. Indeed, the Court pointedly noted that such claims are only barred if the drug manufacturer, who “bears responsibility for the content of its label at all times,” is prohibited by federal law from adding the requested warning, and that under the FDA’s Changes Being Effected (CBE) regulation a drug manufacturer may, without prior approval, unilaterally change a label

OB & GYN CARE FOR ALL STAGES OF LIFE Low- and high-risk obstetrics,

Menopause Clinic, including

including advanced maternal age.

management of peri-menopause

Certified nurse midwifery.

Center for Urinary and Pelvic Health, including urodynamics.

Gynecologic care, including well-woman screenings and in-office procedures

Gynecologic surgeries,

including minimally invasive surgeries and robotics for conditions such as endometriosis and pelvic organ prolapse

Nutrition and wellness consultations.

Infertility evaluation and

treatment.

Early, late, and Saturday appointments

763-587-7000

OakdaleOBGYN.com

M A P L E G R O V E • B L A I N E • P LY M O U T H • C R Y S T A L

MINNESOTA PHYSICIAN OCTOBER 2019

NEUROLOGY

Epilepsy Evolving diagnosis and treatment options BY TIM FEYMA, MD

pilepsy, like so many medical conditions, is a mix of scientific truths and curiosities, diagnostic clarity and confusion, treatment successes, and profound treatment failures. The word “epilepsy” derives from the Greek verb epilambanein, meaning to be seized, to be overwhelmed by surprise. Epilepsy has historically been described as a disease, a magical curse—and even, at times, a sign of divinity. Increasing recognition of epilepsy as a disorder of brain electrical activity, combined with the development of more effective treatment, has begun to improve the disease course and lessen stigma. Despite these advances, until the 1970s, it was legal in the United States to deny persons with seizures entry to restaurants, theaters, recreational centers, and other public places.

Defining epilepsy Better understanding of epilepsy parallels a deepening understanding of brain physiology and anatomy. The brain is a complicated mix of collaborative cells organized in interwoven networks that work together to modulate consciousness, thought, and well-being. An epileptic seizure is a transient occurrence of symptoms due to abnormal excessive neuron firing in the brain. Diagnostic terms have evolved. The terms “generalized” and “partial” seizures are still used by many to describe seizure, but the newest definition describes seizures as focal, generalized, or unknown onset, with modifiers that further describe seizure features. “Seizure mimics”—symptoms that appear to be seizures—are common and can include panic attacks, sleep-related phenomena, migraine auras, and syncopal episodes characterized by fainting or passing out. Conditions like hypoglycemia, hyponatremia, and alcohol withdrawal can invoke seizures in earnest, but in such cases the seizure is provoked and not thought to represent a predisposition towards recurrent seizures qualifying for the diagnosis of epilepsy in the majority of such cases, although such events may “unmask” a cohort disposed to developing epilepsy. Utilizing the most current definition of epilepsy proposed in 2014 (Epilepsia, 55(4): 2014), Epilepsy is defined as being a diagnostic term when: 1. At least two unprovoked (or reflex) seizures occur more than 24 hours apart. 2. One unprovoked (or reflex) seizure and a probability that further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures will occur over the next 10 years.

The burden of epilepsy & SUDEP Epilepsy is not an uncommon disease. The most recent data suggests that it affects one in 26 people. Per 2015 census data, an estimated 53,700 Minnesotans have epilepsy. In a more recent meta-analysis pooling 222 studies, the lifetime prevalence of active epilepsy was 7.60 per 1,000 persons

OCTOBER 2019 MINNESOTA PHYSICIAN

with an annual cumulative incidence of epilepsy of 67.77 per 100,000 persons. The prevalence of epilepsy did not differ by age group, sex, or study quality. This exceeds the incidence of conditions such as colon cancer (38.0 diagnoses / 100,000 people) or lung cancer (57.5 diagnoses / 100,000 people), per 2015 CDC surveillance data. Epilepsy burden can also affect employment. In a retrospective review of the Medical Expenditure Panel Survey using data from 1998–2009, 42% of people with epilepsy over age 18 reported employment, in comparison to 70% of people with no epilepsy. Epileptics missed an average of 12 days of work because of illness or injury, as compared with four days in the nonepileptic cohort. It was estimated that epileptics had a loss of productivity of $9,504 in 2011 dollars compared with people without epilepsy. In comparison, diabetes was associated with annual average lost productivity valued at $3,358 and depression at $3,182. Additionally, this data does not fully address the extension of burden for parents or caregivers whose work is interrupted to care for minors or loved ones with epilepsy. Epilepsy is also associated with increased psychiatric diagnoses and diminished cognitive functioning in excess of the general population rates of adults without epilepsy. The interplay of memory and mood challenges induced by therapies to prevent seizures may even further compound such matters. Part of epilepsy’s psychic impact may be due to the fact that sudden unexpected death in epilepsy (SUDEP) is the most common cause of epilepsy-related death in children and adults. SUDEP affects approximately 1 in 1,000 people with epilepsy each year. Risk mitigation strategies include reducing seizure frequency, optimizing therapy, and the use of nocturnal supervision/seizure detection devices.

Diagnostic challenges While some patients may present with a clear seizure history and confirmatory testing (imaging plus neurodiagnostic testing), some epilepsies can be tough to diagnose. There are some with focal seizures who may only report recurrent paroxysmal psychic or sensory changes. Such events might occur and impair consciousness for the patient in a manner that would not be perceived to observers. The tests we rely on, such as electroencephalography (EEG) and brain imaging, cannot always help perfectly with diagnosis. An EEG may consist of a 30-minute recording of brain activity using scalp electrodes. EEG after a first seizure shows an abnormality 12% to 73% of the time, yet a normal EEG may be seen in up to 50% of people with epilepsy. Brain imaging utilizing magnetic resonance imaging (MRI) as the preferred investigation in those with epilepsy may reveal causation of epilepsy, but also has a false negative rate, as the resolution of MRI still cannot tease out the detailed circuitry of the brain. Our understanding of the role of genetics in epilepsy continues to advance. While the term “genetic” often makes people think of inherited

disorders, many mutations causing epilepsy can happen spontaneously after conception in a manner that will lead to an affected child born to unaffected parents. It is thought that genetic factors account for 40% of epilepsy causes.

Medical treatment The mix of options available to treat epilepsy has expanded considerably. No longer are we limited by a handful of medical options with, at times, intolerable side effects. The goal of treatment is to provide optimal seizure control with minimal drug side effects. At a very basic level, epileptic patients should have an emergency rescue medication available, such as a form of benzodiazepine to prevent prolonged seizures.

Lastly, compliance affects treatment failure. In a 2008 study of adults, 29% percent of patients self-reported being non-adherent to antiepileptic medications in the prior month. Non-adherence was found to be associated with reduced seizure control, lowered quality of life, decreased productivity, seizure-related job loss, and seizure-related motor vehicle accidents.

Cannabis Epilepsy is not an uncommon disease.

When judging the success of medical management of epilepsy, it is hoped that epileptics will attain seizure freedom in 47% of the cases with a first medication trial. An additional 14% will see seizure control with a second or third medication trial if the first trial fails. The current line of thought is that once two optimized medical trials have failed, an epileptic will be thought to have “intractable” epilepsy. For these patients, the hope is to contain, but perhaps not control seizures. In 3% of epileptics, two medications may completely control seizures. Despite the introduction of more than 15 new anti-epileptic drugs in the last 20 years, it is not clear that the treatment success rates with medications are substantially changing.

Few topics have generated as much attention and excitement as has cannabis for the management of health conditions, including epilepsy. Recent research has shown benefit of cannabis fractionated into cannabidiol (CBD, one of many cannabinoids produced naturally in a cannabis plant) in treating severe epilepsy caused by Lennox Gastaut Syndrome (LGS) and Dravet Syndrome.

For Dravet Syndrome, CBD reduced median frequency of convulsive seizures per month from 12.4 to 5.9 versus placebo. Five percent of patients on CBD became seizure-free versus none with placebo. For LGS, the median percentage reduction in monthly drop seizure frequency from baseline in a study was 43.9% in the CBD group and 21.8% in the placebo group. While CBD shows benefit and promise for those with difficult epilepsy, we still need more data to show how this treatment modality will help those with other forms of epilepsy. Epilepsy to page 324

A Superior Option For Patients Needing an MRI We provide open-sided upright MRI. Your patient can be scanned while sitting, standing, leaning, bending and yes – even laying down. Our multi-position imaging options maximize the probability of finding a problem which may not be seen in a traditional lay-down MRI. Our images provide better insight into the nature and severity of the problem.

Sitting

Standing

Bending

Neck

For patients with no insurance, or high deductibles that may discourage having an MRI, we offer a cost of just $600. Our open-sided architecture removes concerns of claustrophobia and can a ccommodate patients up to 500 Lbs.

For more information or to schedule a patient appointment please call

(763) 521-5000 | (877) 521-5001 | 604 Lilac Drive North, Golden Valley, MN 55422 | www.sumamri.com MINNESOTA PHYSICIAN OCTOBER 2019

CARDIOVASCULAR DISEASE

The “Million Hearts” initiative Addressing heart attacks and strokes BY STANTON SHANEDLING, PHD, MPH

reventing one million heart attacks and strokes over five years is a powerful call to action— one that was taken on in 2012 by the U.S. Department of Health and Human Services, and co-led by the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) under the Million Hearts initiative. While Minnesota is known as a heart-healthy state, heart disease and stroke are still among our leading causes of death. That’s why the Minnesota Department of Health (MDH) is a partner in the Million Hearts initiative, to further the state’s efforts to promote healthy lifestyles and behaviors, create healthy environments and communities, and increase access to early and affordable detection and treatment. Minnesota is working alongside 120 official Million Hearts partners, 20 federal agencies, the remaining 49 states, and the District of Columbia. More than 12,000 individuals and organizations have pledged their support to reduce heart attacks and strokes, and more than 50 public and private organizations have made specific, actionable commitments to fight cardiovascular disease.

Goals The initiative scales up proven clinical and community strategies, bringing together existing efforts and adding new programs to improve health across communities—and, ultimately, to help Americans live longer, healthier, more productive lives. For the first five years, the initiative had two primary goals: • Keeping people healthy through healthier habits and environments by ensuring fewer people are smoking, cutting back on sodium in processed and commercially prepared food, and eliminating transfat in the food supply. • Optimizing care by encouraging health systems and professionals to focus on the “ABCS”: Aspirin use when appropriate, Blood pressure control, C holesterol management, and Smoking cessation.

ABCS: by the letters Our focus on ABCS is turning the curve on the impact of cardiovascular disease here in Minnesota. In 2014, CDC and Million Hearts recognized two of the project’s health practices—St. Luke’s P.S. Rudie Medical Clinic and Essentia Health, Duluth—that achieved blood pressure control for at least 70 percent of their adult patients with hypertension. MDH also partnered with Healthy Northland, a regional public health collaborative, to implement a Million Hearts project to enhance the ability of clinics to identify and manage patients with hypertension using a team-based approach focusing on three main evidence-based strategies from the Guide to Community Preventive Services:

22 October 2019

MINNESOTA PHYSICIAN

• Measuring blood pressure accurately. • Adopting a hypertension treatment protocol with clinical decision supports. • Implementing a home blood pressure monitoring program. To ensure that Minnesota clinics are better able to identify and manage patients with undiagnosed hypertension, MDH encourages implementation of NQF 18: Controlling High Blood Pressure. We provide support to clinics and their staff in developing a process to pull data that can guide treatment. Those data points can help clinics to bolster their services based on the ABCS: Aspirin use. The rates of Minnesotans following an aspirin regimen for optimal diabetes/vascular care are high, according to 2016 dates of service data collected by MN Community Measurement: 99.4 percent of Minnesota patients ages 18–75 with diabetes (both type 1 and type 2) and comorbid ischemic vascular disease (IVD) take a daily aspirin, unless contraindicated, as do 93.4 percent of patients ages 18–75 with vascular disease. Those local numbers compare favorably with national statistics. The CDC’s 2013 Behavioral Risk Factor Surveillance System (BRFSS) reports the percentages of men ages 45–79 and women ages 55–79 who reported that they took aspirin daily or every other day: • 26.6 percent overall rate for men and women • 27.0 percent rate for men • 26.2 percent rate for women Blood pressure. 2015 dates of service HEDIS (Healthcare Effectiveness Data and Information Set) data—calculated from a sample of Managed Care patients and published in MN Community Measurement’s 2016 Health Care Quality Report—show that 76 percent of Minnesota patients ages 18–85 with a diagnosis of hypertension or high blood pressure had adequately controlled blood pressure based on the following criteria: • Patients ages 18–59 whose blood pressure was lower than 140/90 mmHg. • Patients ages 60–85 with a diagnosis of diabetes whose blood pressure was lower than 140/90 mmHg. • Patients ages 60–85 without a diagnosis of diabetes whose blood pressure was lower than 150/90 mmHg. Cholesterol management. 2016 dates of service data on statin use collected by MN Community Measurement show that 90.1 percent of Minnesota patients ages 18–75 with vascular disease are on a statin medication, unless allowed contraindications or exceptions are present. Smoking. The CDC’s 2016 BRFSS and the 2014 Minnesota Adult Tobacco Survey (MATS) show that the state’s smoking rate is slightly lower than the national average:

• 15.2 percent adult (18+) smoking rate (BRFSS) • 14.4 percent adult (18+) smoking rate (MATS) While Minnesotans and their physicians are already following many of the ABCS—and maintaining our reputation as a heart-healthy state— Million Hearts strives to improve outcomes through education and advocacy.

Although daily sodium intake has not dropped significantly in the past five years, widespread implementation of healthy food purchasing policies and voluntary industry adoption of recommendations for lower sodium food choices are expected to help all Americans eat healthier in the years ahead. Partially hydrogenated oils will be removed from the food supply in 2018. This action is expected to prevent thousands of fatal heart attacks every year.

The national impact According to the Million Hearts Meaningful Progress 2012–2016 report, during the first two years of the initiative, about 115,000 cardiovascular events were prevented. That number is relative to the expected number of events if 2011 rates had remained stable.

The state’s smoking rate is slightly lower than the national average.

Although final numbers will not be available until 2019, CDC estimates that up to half a million events may have been prevented from 2012 through 2016. These outcomes were fueled by these achievements by Million Hearts and health care advocates: Seven million fewer people smoked cigarettes in 2015 than in 2011. Quitting smoking immediately reduced their risk for a heart attack or stroke. Guidance was drafted and issued in June 2016 for the food industry to voluntarily reduce sodium in processed and commercially prepared food. The intention of this step is to help Americans gradually reduce their sodium intake to the recommended level of less than 2,300 mg per day, which will improve their blood pressure.

Million Hearts mobilized health care systems to deliver high value care for people at risk of cardiovascular diseases by focusing on the ABCS in clinical quality measures.

A focus on the ABCS has generated slow but steady improvement in aspirin use, blood pressure control, and statin use among people who are eligible, based on current guidelines. Electronic health records have helped to identify more than half a million people who may have hypertension.

Million Hearts 2022 priorities The work to prevent heart attacks and strokes is far from complete. Million Hearts is continuing and expanding its priorities to meet the aim of preventing The “Million Hearts” initiative to page 304

MEDICAL ILLUSTRATION AND GRAPHIC DESIGN

PERFECT CIRCLE CREATIVE is a full service Minneapolis-based design studio specializing in the needs of the healthcare delivery system. Whether it be for academia, marketing, patient education or corporate communication, we'll work with you to create technically accurate, deeply detailed and aesthetically pleasing images that clearly convey information and messaging to your target audience.

PERFECTCIRCLECREATIVE.COM custom illustration • graphic design • web design • online marketing • promotional merchandise phone: 612.986.2371 email: pete@perfectcirclecreative.com MINNESOTA PHYSICIAN OCTOBER 2019

ONCOLOGY

Prostate Cancer Research A promising new class of drugs BY CHARLES RYAN, MD

rostate cancer kills 30,000 men in the United States every year. Of those patients, many live with the disease for five to 15 years prior to dying from it. Others live to their normal life expectancy while receiving treatment for advanced prostate cancer, and then die of other causes.

Until recently, the number of deaths per year was declining, but we are seeing a recent increase in the number of prostate cancer-related deaths per year. The reason is unclear and likely multifactorial. Clinicians are concerned about the possible rise in the number of patients presenting with metastatic disease, potentially as a result of a decline in routine prostatespecific antigen (PSA) screening of healthy men. Most men diagnosed with prostate cancer have a curable form of the disease that can be treated with radiation or surgery, which then leads to their disease being eliminated. Even with optimal initial therapy, up to 20% to 30% of patients will experience a relapse after surgery or radiation. Of those patients, most will be treated with and respond well to hormonal therapy (treatments intended to reduce the stimulation of testosterone on the tumor). Because of the effectiveness of hormonal approaches, many

ENGAN ASSOCIATES

Creating Healing Environments for 40 Years

men will be able to live to a normal life expectancy without facing the life-threatening form of the disease, but a substantial proportion of those treated with hormonal therapy will develop a resistant, and lethal, form of the disease. Death from prostate cancer comes from the confluence of two events. The first is “castration resistance,” or worsening of the disease despite treatments that lowered the level of testosterone. The second is from metastasis. Some patients develop castration-resistant prostate cancer without metastasis— however, they live with a high risk of the eventual formation of metastatic tumors in the bone, lymph nodes, or organs.

Genetic and molecular drivers New research on the genetics of prostate cancer is revealing that as the disease progresses into castration-resistant prostate cancer (CRPC), multiple different genetic and molecular drivers lead to heterogeneous disease outcomes. Among these drivers is the recent recognition of the role of alterations of the cellular processes involved in the repair of damaged DNA. Recent studies have shown that upwards of 25% of patients with advanced prostate cancer harbor some mutations or alterations in the genome that lead to impaired DNA repair. This includes mutations in the critically important BRCA2 gene. The BRCA genes (BRCA1 and BRCA2) play important roles in preventing cancer from forming by repairing the damage done to the DNA in our cells on a daily basis (through inflammation, ultraviolet radiation, and other processes). If the BRCA2 gene is lost or mutated, minor mutations do not get repaired and get propagated, leading to the risk of cancer. It may also render existing cancer to be resistant to conventional treatments. One of the positive consequences of the mutation is that tumors may be sensitive to a new class of drugs called poly-ADP ribose polymerase (PARP) inhibitors. PARP is an enzyme in cells that helps repair DNA when it is damaged. PARP inhibitors are used as a cancer treatment in hopes of blocking the PARP from repairing the damaged DNA, causing the cancer cells to die—a process called “synthetic lethality” (as the cancer cell tries to replicate, or synthesize, its DNA, the cell dies because it cannot make repairs). Several PARP inhibitors are in clinical development in a variety of clinical settings.

New studies

“We wouldn’t hesitate to work with Engan Associates again.” (Matt Reinertson, Heartland Orthopedic Specialists)

OCTOBER 2019 MINNESOTA PHYSICIAN

At the University of Minnesota, we are one of the leading sites for the TRITON3 study, which is a phase 3 registration study that is enrolling patients with BRCA1, BRCA2, and ataxia telangiectasia mutated (ATM) alterations. These patients are required to have already been treated with the standard of care androgen receptor-targeted therapies. We are also participating in the TRITON2 study, which is already showing promising results that have been presented at international meetings. The drug being studied in the two TRITON studies is rucaparib, and it has achieved breakthrough designation status from the U.S. Food and Drug Administration (FDA).

option, but being aware of the alteration is still advantageous as it allows Additionally, Arpit Rao, MD, in the Department of Medicine, Division of one to monitor the situation. Closer surveillance would hopefully result in Hematology, Oncology and Transplantation at the University of Minnesota earlier detection of the tumor. Medical School, is developing a phase 3 study that will test rucaparib in combination with enzalutamide in patients who do not have altered DNA Early data from the TRITON2 study is showing promising results repair in the form of the mutation. The basis for for patients with metastatic castration-resistant this study is the observation that the androgen prostate cancer. Results from this study could lead receptor itself may contribute to DNA repair. We to not only more possible treatment options but hypothesize that inhibiting the androgen receptor also more effective treatment options. with enzalutamide, an FDA-approved standard Any patient with newly diagnosed Summing up care of therapy, will lead to temporary loss of metastatic disease should be Researchers are optimistic that an understanding DNA repair function in the tumor cell. Therefore, offered genetic testing. of DNA repair, the BRCA gene, and its impact we think that co-targeting the tumor with a PARP on the risk of lethal cancer among men can inhibitor and an androgen receptor inhibitor may lead to an improvement in outcomes. From an lead to beneficial results compared to targeting the oncology perspective, it represents one of many androgen receptor alone. In fact, this paradigm new developments. We are understanding that has also already shown some preliminary efficacy the molecular basis for the cancer’s progression is in a study done in the United Kingdom with leading to changes in treatment that can benefit patients. We’re getting a abiraterone and olaparib, a different PARP inhibitor. deeper understanding of the molecular heterogeneity of prostate cancer. That Genetic assessments understanding is altering our ability to offer effective treatments for patients. This leads to a consideration of how and when we would test prostate cancer for an alteration in DNA repair. As we begin to understand the importance Charles Ryan, MD, is a Professor of Medicine and Director of the Hematology, of these agents in patients with altered DNA repair, the guidelines are Oncology and Transplantation Division in the University of Minnesota Medical evolving toward recommending earlier testing for involved patients. Now, School’s Department of Medicine. He holds the B.J. Kennedy Chair in Clinical any patient with newly diagnosed metastatic disease should be offered Medical Oncology. genetic testing. Genetic testing for these DNA-impaired genes comes in the form of either germline testing (testing family genetics) or somatic testing (testing the genetics in the tumor itself). Germline genetic testing is very easy and can be done with a cheek swab. We recommend that patients who undergo testing have their results interpreted with a genetic counselor. Genetic counselors can help other family members get tested to see if it was passed down, and can help guide the patient’s management. It is important to consider that not all prostate cancer patients with BRCA mutations in their tumor will have familial BRCA2 alterations, but most patients who have prostate cancer and who have a BRCA2 alteration will have it in their tumor as well. If the BRCA mutation is found in all of the prostate cancer patient’s normal cells, the gene is hereditary, and it can continue to get passed down to his children. In addition to increasing the risk of prostate cancer, BRCA mutations are known to increase the risk of breast cancer, ovarian cancer, and pancreatic cancer. Women who are found to be carriers of the BRCA2 mutation need to seriously consider these risks, as these cancers can be prevented. Catching cancer early is crucial. There is no good screening test for ovarian cancer, so by the time ovarian cancer becomes detectable, it may have already spread to other parts of the body. There is fairly convincing data that women carriers should undergo an ovariectomy as well as a prophylactic mastectomy. It has been shown that by doing that, those women are less likely to die of breast and ovarian cancer. Men that inherit the BRCA2 alteration are at an increased risk for prostate cancer. Men with the inherited mutation who already have developed localized prostate cancer have a higher risk of recurrence of the disease after surgery or radiation therapy. Preventative removal of the prostate is not an

Specialists in Musculoskeletal Pain Treatment

Effective Non-Opioid Treatment Evidence-based Biopsychosocial Approach Active Therapy Multidisciplinary Care Team Quality Outcome Reporting

PDR Outcomes

• 67% of patients rate their pain reduction between 50-100%

• 74% of patients rate their headache reduction between 50-100% • 64% of patients rate their use of medications decreased 50-100% • 109% increase in Lumbar Extension ROM & strength • 165% increase in Cervical Rotation ROM & strength

Scheduling 952.908.2750

Edina | Chanhassen | Burnsville Coon Rapids | Maplewood

www.PDRclinics.com MINNESOTA PHYSICIAN OCTOBER 2019

BEHAVIORAL HEALTH

“Flip the script” on opioids and pain management Starting difficult patient conversations BY JEFF SCHIFF, MD, MBA, AND SARAH RINN, MPH

The need for action

t’s time to change the narrative around opioid therapy and pain management in Minnesota to better support patients dealing with pain. The Minnesota Department of Human Services (DHS)’s “Flip the Script” education campaign is intended to do just that. The campaign is designed to support health care professionals treating patients in pain, share tools and resources to help patients understand the role of opioids for pain management, and ensure that the benefits of opioid therapy outweigh the risks. The goal is to support Minnesota prescribers with resources on how to manage patient pain while making sure they stay safe, particularly for those who may feel overwhelmed after years on the front lines of the opioid epidemic.

The opioid crisis has taken a significant toll on our local communities, state, and nation. In 2017 alone, 422 Minnesotans died of a drug overdose—187 of which involved a prescription opioid, according to a 2017 DHS report. Although many of these tragedies involved heroin and fentanyl, the majority of the deaths began with pills prescribed by providers. We can do better.

Discussing opioid therapy with patients can be difficult—opioid therapy and pain management are emotional topics for patients and health care providers. The conversations can feel uncomfortable and may take repetition. However, having these conversations is the right thing to do to ensure patient safety, improve their ability to self-manage pain, and increase their quality of life. See below for tips to start these difficult conversations.

The medical community has made significant progress in understanding the appropriate role of opioid therapy in acute and chronic pain management. Opioid analgesia remains an important option for managing pain following severe, acute events and for managing cancer-related pain and pain at the end of life. However, we also know that a significant amount of opioids prescribed after acute events goes unused; the risk of long-term opioid use begins after only a few days on opioid therapy; long-term opioid use is associated with significant adverse outcomes; and variation in health care professionals’ opioid prescribing cannot be fully explained by differences in patient diagnoses, demographics, or health care specialty. The medical community has also learned more about the pathophysiology of chronic pain and the appropriateness of treating it with long-term opioid therapy. Opioids are not proven to be effective for chronic pain and may even make pain worse.

Telephone Equipment Distribution (TED) Program

It’s the law

Do you have patients with trouble using their telephone due to hearing loss, speech or physical disability?

The 2015 Minnesota Legislature authorized the Opioid Prescribing Improvement Program to address dependence and misuse related to prescription opioids. The program requires the state to develop: opioid prescribing guidelines for acute, post-acute, and chronic pain; annual prescribing reports for providers who prescribe opioids to Minnesota Medicaid and MinnesotaCare members; an opioid prescribing quality improvement program for providers who care for Minnesota Medicaid and MinnesotaCare members; and a provider campaign directed at speaking with patients about opioid therapy and pain management.

If so…the TED Program provides assistive telephone equipment at NO COST to those who qualify.

To develop its campaign, DHS collaborated with the medical community, including metro area and Greater Minnesota providers from both large health systems and small clinics recognized for their expertise in opioid therapy. Other project partners include the Minnesota Medical Association, Minnesota Hospital Association, and University of Minnesota.

Please contact us, or have your patients call directly, for more information.

1-800-657-3663 ted.program@state.mn.us mn.gov/dhs/ted-program Duluth • Mankato • Metro Moorhead • St. Cloud The Telephone Equipment Distribution Program is funded through the Department of Commerce Telecommunications Access Minnesota (TAM) and administered by the Minnesota Department of Human Services

OCTOBER 2019 MINNESOTA PHYSICIAN

Case study The Flip the Script campaign features a video testimonial from a Greater Minnesota doctor who altered his opioid prescribing practices, improved his relationship with patients, and changed how he thinks about his work. Dr. Paul Kietzmann, a primary care physician with Alomere Health in Alexandria, transformed his approach to prescribing opioid therapy after reviewing his personal opioid prescribing data and patterns made him question why his prescribing differed from his peers. Coupled with increased knowledge about pain management and patient safety and the support of his clinical practice, he began to reframe conversations with his patients about pain and opioid therapy around safety, function, and achieving goals.

Dr. Kietzmann made changes to his prescribing with his patients in a way that maintained their trust, provided them control over the process, and took their unique needs into account.

Help doing the tough stuff Conversations about opioid therapy and pain management take practice, require patience, often require repetition, and do not always end on a positive note.

“There is now evidence that long-term opioid therapy is no more effective than other types of pain management options, yet it has significant risk of harm. It is my responsibility as a health care professional to provide you with the most effective care that I can, while keeping you safe.” “I am concerned about your safety if we continue to rely on opioids to manage your pain. I know that your pain is real, and it is difficult. However, the longer you take opioid pain medications, the greater your risk for addiction or accidental death.”

Experts in the medical community stressed In addition to these conversation starters, Discussing opioid therapy with the importance of developing an education patients can be difficult. develop a personal strategy to care for patients campaign with a framework that works for experiencing chronic pain. Specific tips: providers, informed by key messages, conversation Be your patient’s partner in this journey. starters, and strategies that you can return to when Validating pain is an important first step. Listen needed. These resources, along with a free podcast and reflect what you have heard the patient say on Minnesota’s opioid prescribing guidelines about his or her pain experience. that provides continuing education credit, can be found at mn.gov/dhs/ flip-the-script. Educate patients about pain management and opioid therapy. Ask what they understand or have heard in the news about opioids. Among the resources are specific “conversation starters” for multiple stages of patient care: Acute pain. Health care providers should exercise caution in prescribing opioids during the one–four days after a severe injury or a severe medical condition and up to seven days following a major surgical procedure or trauma. During this acute phase, consider telling your patients: “Pain is a normal part of the healing process after an injury or surgery. We cannot eliminate all pain, but we can help you manage the most severe parts.” “In many cases, using opioids to manage severe pain during the healing process is appropriate and the standard of care. I will prescribe you an amount that will be enough to get you through the first few days of the most severe pain, and then transition you to non-opioid pain relievers.” “It is important that you discard any leftover pills in a safe way. Medication disposal resources are available on the Minnesota Pollution Control website.”

Motivate the patient to make a change. Use motivational interviewing skills to help elicit behavior change. Reassure the patient and express confidence that he or she will be successful. Activate the treatment plan. “Flip the script” on opioids and pain management to page 284

HARDWOOD FLOORS ARE THE SUPERIOR CHOICE FOR FLOORING.

Post-acute pain. This period, extending up to 45 days after the onset of pain, represents a critical period for secondary prevention of chronic opioid use and substance use disorder. It is imperative that a prescriber work with the patient to limit the days of opioids prescribed following an acute event. In speaking with patients who request opioids during this period, consider these conversation starters: “As we learn more about opioids, we now know that dependency and other risks of long-term use begin much earlier than we previously thought. There may also be things going on in your life other than your injury that affect the pain.” “Let’s talk about some of the other factors that may contribute to your pain after the healing process has begun. We do this with all of our patients recovering from an injury or surgery, and it helps us to provide the most effective treatment.” Chronic pain. The risks increase for patients experiencing chronic pain. You might start your conversations with: “The medical community’s understanding of pain—especially chronic pain—has changed. We understand that acute pain and chronic pain are different, and that chronic pain is often very complex. What maintains your chronic pain isn’t typically the same as what initially caused your pain when you first became injured or ill. It is important that we manage all kinds of pain, but we need to manage them differently.”

They do not hold dust, dander or pollen like carpet and are much easier to clean. They are surprisingly affordable and increase the value of your home. Properly maintained they should last 100 years. We service metro area residential and commercial projects of all sizes. We offer a wide range of wood options and custom designs for new or existing homes. We also refinish existing wood floors.

Providing superior service, value and old-world craftsmanship for over 35 years. Please call to request a free estimate | 763-784-3000 | davesfloorsanding.com

MINNESOTA PHYSICIAN OCTOBER 2019

3“Flip the script” on opioids and pain management from page 27 Non-opioid pain management conversation starters Flipping the script also involves educating patients about non-opioid options. Suggested conversation starters:

Tapering patients off opioid therapy should never be forced. Tapers must be tailored to the individual patient’s clinical and personal situation, and the taper plan should follow evidence-based recommendations to minimize risks and avoid severe side effects.

“Your care needs to be comprehensive. Chronic pain is complex, and we need to treat different aspects of the pain with different types of therapy.” “Unlike opioids, these other treatments will help you be more active, stay functional, and do things you enjoy. Some of the therapies I am suggesting do not provide an immediate sense of relief. However, over time, they produce long-term and safe improvement.”

Tapering conversation starters: “I am concerned about your safety if we continue your opioids at the current dose.”

The longer you take opioid pain medications, the greater your risk for addiction.

Talking about tapering A significant challenge faced by health care providers is the ongoing care of patients who have been exposed to opioid therapy for many years—some of whom receive daily doses that far exceed the recommended daily dosage. For many of these patients, a thorough risk benefit analysis, coupled with ongoing discussion of their goals and concerns, may reveal an opportunity to taper their daily dosage. However, there are patients for whom tapering will destabilize and expose them to additional risk of harm. In April 2019, the U.S. Food and Drug Administration (FDA) released a safety warning about tapering opioid therapy for physically dependent patients.

Quality Transcription, Inc. Setting the standards for excellence

Quality Transcription (located in Minnesota) maintains a professional office environment, thus the confidentiality of your work is strictly maintained. We provide medical transcription services on a contract or overload basis.

“The medical community has learned in the past few years that your risk of harm increases with the amount of opioids you take and with the length of time you take them. I want to reduce the risk associated with your opioid dose while we focus on a long-term plan to manage your pain and improve your function.”

“It is healthy and good to once in a while test how much you need this dose. You may be surprised that you do as well or better on a smaller dose.” “I will support you in your effort to taper. We can work on this slowly and gradually reduce the amount you take over time.”

Continuing education DHS partnered with the University of Minnesota Medical School’s Office of Continuing Professional Development to develop a podcast of the Minnesota Opioid Prescribing Guidelines. The free podcast educates listeners on prescribing recommendations and offers continuing education credits to physicians, dentists, nurses, and pharmacists. DHS also partnered with the Minnesota Medical Association to develop a series of webinars that provide a deeper dive into the guidelines, the sentinel measures, and the opioid prescribing report program. These webinars are available on the Opioid Prescribing Improvement Program provider education website at mn.gov/dhs/flip-the-script and through the Minnesota Medical Association.

It’s time to flip the script

We are experts in our field. We deliver on time. We have experienced staff. We monitor the quality of our work.

The conversation you have with your patient about pain management and opioid use can represent a dramatic turning point. There are ways to reframe the conversation about pain management and opioids with your patients, avoid pitfalls, catch trouble signs, and keep your patients on the right path. Flip the Script provides the tools, education, and resources you need to give your patients the chance to write a far more positive life story for themselves, while helping you get back to the work you do best—helping your patients get and stay healthy.

We provide services tailored to your needs and will do whatever it takes to get the job done.

Jeff Schiff, MD, MBA, is an emergency medicine physician at Children’s

Our equipment is state of the art with 24 hour dictation lines and nationwide accessibility.

Hospitals and Clinics in St. Paul and a clinical assistant professor in the Department of Pediatrics at the University of Minnesota. Until recently, he Quality Transcription, Inc. 8960 Springbrook Drive, Suite 110 Coon Rapids, MN 55433 Telephone 763-785-1115 Toll Free 800-785-1387 Fax 763-785-1179 e-mail info@qualitytranscription.com Website www.qualitytranscription.com

OCTOBER 2019 MINNESOTA PHYSICIAN

served as medical director at the Minnesota Department of Human Services.

Sarah Rinn, MPH, is the Opioid Prescribing Improvement Program Coordinator at the Minnesota Department of Human Services. She holds a Master’s in Public Health in health policy from the George Washington University in Washington, DC.

STAY FOCUSED AMONG THE DISTRACTIONS.

Minimize the things that get in the way of why you’re in healthcare to begin with. A focus on reducing lawsuits is just one way we do this. For more information or your nearest agent, contact us at 800.225.6168 or through coverys.com. M E D I C A L P R O F E S S I O N A L L I A B I L I T Y I N S U R A N C E  A N A LY T I C S  R I S K M A N A G E M E N T  E D U C A T I O N

Insurance products issued by ProSelect® Insurance Company and Preferred Professional Insurance Company® MINNESOTA PHYSICIAN OCTOBER 2019

3The “Million Hearts” initiative from page 23

Together we can help ensure a well-informed Minnesota population that recognizes the signs and symptoms of heart attack and stroke. At the same time, we can promote proven practices that prevent heart attacks and strokes from happening in the first place, while also managing risks and using interventions that prevent people from having another event.

one million heart attacks and strokes by 2022. These actions will align with the development of Healthy People 2030: Objectives for the Nation. Million Hearts 2022 will continue focusing on the goals to keep people healthy and to optimize care. The initiative is placing new emphasis on efforts to increase physical activity and focusing specifically on highly affected populations. These populations were selected based on data showing a significant cardiovascular health disparity, evidence of effective interventions, and partners ready to act. These include African Americans 35 to 64 years of age, people who have had a heart attack or stroke, and people who have a mental illness or a substance use disorder.

While Minnesota is known as a heart-healthy state, health is not shared equally across all populations. MDH is committed to health equity for all Minnesotans, where all communities are Clinicians and health care systems have an integral role to play. thriving and all people have what they need to be healthy. For those who are at higher risk of cardiovascular disease because of economic, racial, or other societal factors, we need to continue identifying strategies that effectively reach these individuals, reduce disparities, and increase opportunities for health.

The role of providers

Stanton Shanedling, PhD, MPH, is the supervisor of the Cardiovascular

Clinicians and health care systems have an integral role to play in meeting the goals of Million Hearts, including:

Health Unit at the Minnesota Department of Health. In this role he advances the MDH agenda to improve cardiovascular health and reduce the burden of

• A commitment to system-wide excellence in the ABCS.

heart disease and stroke across Minnesota.

• A focus on team-based care and using technology to effectively measure, report on, and improve ABCS outcomes. • Partnerships between the medical and public health arenas.

Carris Health

is the perfect match

Carris Health is a multi-specialty health network located in west central and southwest Minnesota and is the perfect match for healthcare providers who are looking for an exceptional practice opportunity and a high quality of life. CURRENT OPPORTUNITIES AVAILABLE FOR BE/BC PHYSICIANS IN THE FOLLOWING SPECIALTIES: • • • • • •

Anesthesiology Dermatology ENT Family Medicine Gastroenterology General Surgery

• • • • • •

Hospitalist Internal Medicine Nephrology Neurology OB/GYN Oncology

Loan repayment assistance available.

FOR MORE INFORMATION: Dr. Leah Schammel, Carris Health Physician

AUGUST 2019 MINNESOTA PHYSICIAN

Shana Zahrbock, Physician Recruitment Shana.Zahrbock@carrishealth.com (320) 231-6353 | carrishealth.com

• • • •

Orthopedic Surgery Psychiatry Psychology Pulmonary/ Critical Care • Rheumatology • Urology

PRACTICE WHERE BEAUTY SURROUNDS YOU

Family Practice Physician Join a provider-driven not-for-profit organization in our Cook, MN location. Work in a well-established, modern facility. Participate in on-call schedule, share in-patient and after-hours care, (no OB). BC/BE and current or eligible for MN license required. National Health Service Corps loan repayment potential.

WORK-LIFE BALANCE: • Competitive salary • Significant starting & residency bonuses • 4-day work weeks • 51 annual paid days off Ski, hike, run, fish, canoe, kayak, camp and more in nearby state parks, Boundary Waters Canoe Area, Voyageurs National Park and Superior National Forest. Please contact: Travis Luedke, Cook Area Health Services, Inc., 20 5th St. SE, Cook, MN 55723 tluedke@scenicrivershealth.org 218-361-3190

SHARE YOUR INSPIRATION.

On the U.S. Army health care team, you will enjoy the satisfaction of providing quality care to Soldiers and their families, in a setting with innovative technologies, robust resources and a dedicated, supportive team.

Learn more at healthcare.goarmy.com/nz72

Family Medicine & Emergency Medicine Physicians • • • • •

Great Opportunities

Immediate Openings Casual weekend or evening shift coverage Set your own hours Competitive rates Paid Malpractice

Urgent Care Physicians HEAL. TEACH. LEAD.

At HealthPartners, we are focused on health as it could be, affordability as it must be, and relationships built on trust. Recognized once again in Minnesota Physician Publishing’s 100 Influential Health Care Leaders, we are proud of our extraordinary physicians and their contribution to the care and service of the people of the Minneapolis/St. Paul area and beyond. As an Urgent Care Physician with HealthPartners, you’ll enjoy: • Being part of a large, integrated organization that includes many specialties; if you have a question, simply pick up the phone and speak directly with a specialty physician • Flexibility to suit your lifestyle that includes expanded day and evening hours, full day options providing more hours for FTE and less days on service • An updated competitive salary and benefits package, including paid malpractice HealthPartners Medical Group continues to receive nationally recognized clinical performance and quality awards. Find an exciting, rewarding practice to complement all the passions in your life. Apply online at healthpartners.com/careers or contact Maly at 952-883-5425 or maly.p.yang@healthpartners.com. EOE

763-682-5906 | 763-684-0243 michelle@whitesellmedstaff.com www.whitesellmedstaff.com MINNESOTA PHYSICIAN OCTOBER 2019

3Epilepsy from page 21 an increase in seizure reduction over time with this therapy by 38% after six months to 78% after 120 months in a long-term follow-up of 65 patients.

Dietary therapies for epilepsy Ketogenic diets have been trialed for intractable epilepsy. In such patients, 90% of caloric intake may include fat as the main macronutrient of nourishment. Such a diet typically involves care by a multi-disciplinary team skilled in this modality. There are various other diets that can help epilepsy; see the Charlie Foundation website at https://charliefoundation.org/ for examples. In a recent study, it was found that those trialing a ketogenic diet or a modified Atkins diet saw a 63% response rate by one month and maintained a 41% response rate by 24 months.

Surgical options When epilepsy becomes intractable, a patient should consider a surgical workup. While many neurology practices treat epilepsy, not all can provide a surgical opinion with advanced diagnostic testing that may lead to intervention upon the zone of seizure onset. In Minnesota, we are lucky to have multiple sites that can perform this expert evaluation. With advanced neurodiagnostic techniques, more patients are being considered for such surgical therapy than ever before. Control of seizures in the best of epilepsy surgery centers ranges from 15 to 75 percent. Select surgical procedures can provide hope through electrical stimulation of the nervous system. Electrical nerve stimulation of the vagus nerve (VNS) in the neck via an implanted stimulating device can lessen seizure burden and provide a “rescue” intervention. VNS gives an electrical pulse when activated with a magnet passed over the device to help prevent a seizure from becoming prolonged. A recent VNS follow-up study found

Responsive neurostimulation was approved in 2015. In this procedure, electrodes are placed in the brain to read patient brain activity and identify electrical signatures that may precede a seizure, allowing for a triggered electrical stimulation pulse to prevent seizure development. Five-year responder rates can be in excess of 60%. This therapy can be individualized to a patient’s needs. In 2018 deep brain stimulation of the anterior nucleus of the thalamus was approved for treatment of epilepsy. In a randomized controlled trial, seizure reduction ranged from 21.3% following electrode insertion to 40.4% in the third month of treatment, compared to 14.5% in a non-stimulated control group. Long-term follow-up without a control group revealed a median seizure reduction at five years with treatment of 69%. The group of patients remaining on treatment declined from 105 after one year to 64 after five years.

The Future Research in epilepsy continues to grow and expand as new drugs are developed, surgical options get refined, advances in genetic testing help us to better understand causes and tailor therapy, and stimulation parameters for newer electrical stimulation devices are optimized. Tim Feyma, MD, is a child neurologist who specializes in medically complex children with neurologic conditions at Gillette Children’s Specialty Healthcare. He is also the current chair of the professional advisory board for the Epilepsy Foundation of Minnesota.

Practice Opportunities throughout Greater Minnesota: Our nation faces an unprecedented number of individuals who having served their country now receive health care benefits through the VA system. We offer an opportunity for you to serve those who have served their country providing community based health care in modern facilities with access to world-leading research and research opportunities. We provide outstanding benefits with less stress and burnout than many large system policies create. We allow you to do what you do, best – care for patients.

Minneapolis VA Health Care System Metro based opportunities include: • Chief of General Internal Medicine • Chief of Cardiology • Cardiologist • Internal Medicine/Family Practice • Gastroenterologist • Psychiatrist

Ely VA Clinic

Hibbing VA Clinic

• Tele-ICU (Las Vegas, NV)

Current opportunities include:

• Nephrologist

Internal Medicine/Family Practice

US citizenship or proper work authorization required. Candidates should be BE/BC. Must have a valid medical license anywhere in US. Background check required. EEO Employer.

Possible Education Loan Repayment • Competitive Salary • Excellent Benefits • Professional Liability Insurance with Tail Coverage

For more information on current opportunities, contact: Yolanda Young: Yolanda.Young2@va.gov • 612-467-4964 One Veterans Drive, Minneapolis, MN 55417

OCTOBER 2019 MINNESOTA PHYSICIAN

•

www.minneapolis.va.gov

Helping physicians communicate with physicians for over 30 years. MINNESOTA

AUGUST 2018

PHYSICIAN

THE INDEPENDENT MEDICAL BUSINESS JOURNAL

Volume XXXII, No. 05

CAR T-cell therapy Modifying cells to fight cancer BY VERONIKA BACHANOVA, MD, PHD

niversity of Minnesota Health is now among the few selected centers in the nation to offer two new immunotherapy drugs for the treatment of diffuse large B-cell lymphoma. Both drugs—Yescarta and Kymriah—are part of an emerging class of treatments, called CAR T-cell therapies, that harness the power of a patient’s own immune system to eliminate cancer cells.

Physician/employer direct contracting

CAR T-cell therapy involves drawing blood from patients and separating out the T cells. Using a disarmed virus, the patient’s own T cells are genetically engineered to produce chimeric antigen receptors, or CARs, that allow them to recognize and attach to a specific protein, or antigen, on tumor cells. This process takes place in a laboratory and takes about 14 days. After receiving the modification, the engineered CAR-T cells are infused into the patient, where they recognize and attack cancer cells. Kymriah received initial FDA approval in 2017 for the treatment of pediatric acute lymphoblastic leukemia. CAR T-cell therapy to page 144

Advertising in Minnesota Physician is, by far, the most cost-effective method of getting your message in front of the over 17,000 doctors licensed to practice in Minnesota. Among the many ways we can help your practice: •

Exploring new potential BY MICK HANNAFIN

ith the continuing escalation of health care costs, large and midsized selfinsured employers are once again looking for an edge to manage their medical plan costs and their bottom line. They understand that they are ultimately funding health care as they pay for their population’s claims.

•

Many of these employers have employed the same overarching set of strategies: shop for a new carrier that is willing to lower the administrative costs or underprice the risk, Physician/employer direct contracting to page 124

•

Share new diagnostic and therapeutic advances Develop and enhance referral networks Recruit a new physician associate

Advertise! IN MINNESOTA PHYSICIAN www.mppub.com

(612) 728-8600

SICIAN

with a Mankato Clinic Career Established in 1916, physician-owned and led Mankato Clinic is 100 years strong and seeking Family Physicians for outpatient-only practices. Over 50% of our physicians are involved in leadership positions and make decisions for our group. Full-time is 32 patient contact hours and 4 hours of administrative time per week. Four-day work week available. Clinic hours are Monday-Friday, 8 a.m.-5 p.m. OB is optional. Call is telephone triage, 1:17, supported by a 24/7 Nurse Health Line. Market-competitive guaranteed starting salary, followed by RVU production pay plan. Benefits include 35 vacation / CME Days annually + six holidays, $6,600 annual CME business allowance and a generous profit-sharing 401(k) plan. We’re just over an hour south of the Mall of America and MSP International Airport. If you would like to learn more about building a Thriving practice, contact:

Dennis Davito Director of Provider Services 1230 East Main Street Mankato, MN 56001 507-389-8654 dennisd@mankatoclinic.com

Apply online at www.mankatoclinic.com

A Place To Be Your Best. Dr. Julie Benson, MN Academy Family Physician of the Year

POSITIONS AVAILABLE:

OB GYN & FAMILY MEDICINE – Full-scope practice available (ER, OB, C-Section, Hospitalist, Clinic) • Independent/growing system • Located in the heart of lakes country, Staples, MN • Critical access hospital with 5 primary clinics and a senior living facility • 15 family medicine physicians and 16 advanced practice clinicians • Competitive salary, benefits, and sign-on bonus available Contact Michael Paul at 218.894.8633, or michaelpaul@lakewoodhealthsystem.com

MINNESOTA PHYSICIAN OCTOBER 2019

3Labeling and medicating children from page 11 manic-depressive disorder, and DMDD in order to help distinguish specific treatments that should be studied and applied in each individual illness. What I find astonishing is that doctors are taking the advice of school employees with no medical training and writing prescriptions without demanding more evaluation by trained professionals. Arguably, it is a bit more work for the medical team to look at nutrition, specific biomarkers such as vitamin D, toxins in the environment, subtle infections including Lyme disease, and even exposure to specific frequencies of light (especially near-infrared and red light). There is scientific evidence that many of these factors are related to the prevalence of adolescents with severe mental illness. When physicians prescribe psychotropic medications that could do harm based on a recommendation from educators, without conducting their own assessment of the child’s needs and home life or seeking a second opinion from a behavioral health specialist, the result is the current explosion of labeling and medicating—creating a situation not unlike the opioid epidemic. Parents may not have the resources to seek second opinions, or may live in areas with shortages of psychiatrists, but this follow-up would serve schoolchildren best.

The issue is that thoroughly evaluating a child for underlying causes of aberrant behavior is simply more labor-intensive than writing a prescription. However, that should not deter physicians from finding a better way to evaluate and treat rather than contribute to yet another explosion of psychotropic drugs that are poorly studied in children—many of which can have lifelong side effects and implications. A growing number of physicians, including myself, are doing such detective work, often coming up with solutions that obviate the need to use psychotropic drugs. This needs to be encouraged, studied much more extensively, and, as a policy, prioritized as a healthier way to approach childhood neuropsychiatric problems rather than just reaching for a prescription pad. Glenn Gruenhagen (R) represents District 18B in the Minnesota House of Representatives and served on the Glencoe-Silver Lake school board for 16 years. He owns an independent insurance agency and is a Chartered Financial Consultant and CLU. A USMC veteran, he also participated in prison ministry for 13 years.

Recommendations for evaluation and treatment It was not that long ago when many practitioners failed to test children with behavioral disorders for a condition called PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections). This condition is of a neuro-immune nature, much like rheumatic fever, but the brain is the target, instead of the heart and joints. It can result in profound

Sioux Falls VA

mood changes, night terrors, enuresis, and severe obsessive-compulsive tendencies. I have seen many children with this illness who are treated quite quickly and incorrectly with Zoloft or some similar drug with no appropriate investigation. Rarely is such detective work performed when a child is referred by a teacher to a psychiatrist for evaluation and treatment. That consultation almost always results in a prescription based solely on the educator’s assessment.

Christopher M. Foley, MD, ABIM, has practiced internal medicine since 1979 and pioneered one of the first integrative medical clinics in the Midwest in 1995. He is a former instructor in the University of Minnesota Medical School and lecturer in the College of Pharmacy at the University of Minnesota.

HEALTH CARE SYSTEM

Working with and for America’s Veterans is a privilege and we pride ourselves on the quality of care we provide. In return for your commitment to quality health care for our nation’s Veterans, the VA offers an incomparable benefits package.

The VAHCS is currently recruiting for the following positions: ★ Cardiologist (part-time)

★ Oncologist

★ Endocrinologist

★ Podiatrist

★ Gastroenterologist (full & part-time) ★ Pulmonologist ★ Neurologist

★ Psychologist

★ Nephrologist (intermittent)

★ Vascular Surgeon

apply online at www.USAJOBS.gov 34

OCTOBER 2019 MINNESOTA PHYSICIAN

(605) 333-6852 ·

www.siouxfalls.va.gov

3 things every Minnesota physician should know about treating chronic pain.

1. Opioids are a problem. They can also be part of the solution. According to the CDC, opioid overdose is now the leading cause of injury-related death in the United States. Yet opioids have a rightful place in treating chronic pain, as some patients achieve life-changing improvement with minimal side effects on long-term opioids. Even at high dosage levels, opioids do not harm the body’s organs, unlike NSAIDS and acetaminophen. And thanks to the micro-dosing capability offered by implanted spinal drug pumps, many of the most challenging cases can be treated effectively without risk of addiction.

2. There is no silver bullet. One of the challenges in treating chronic pain is the patient’s sometimes-overwhelming desire for a silver bullet, a “cure” or a magic button to turn off their pain. While that desire is understandable, in complex chronic pain there is rarely a single perfect answer. At Nura, we’ve

found that a comprehensive approach which addresses the physical and psychosocial components of chronic pain is the best solution. So in addition to earning national recognition for leadership in implantable pain technology, we offer behavioral counseling, physical therapy and opioid management, all designed to help the most challenging pain patients.

3. Learn more about chronic pain while earning CME credits. Together with the Minnesota Medical Association, Nura is sponsoring a Chronic Pain Conference where a variety of specialists will share tools, strategies and expertise on managing pain patients. This year’s CME conference takes place on Friday, November 8, at the Westin Galleria Edina, and will provide new perspectives on providing care in the midst of the opioid epidemic. To learn more about our comprehensive approach to chronic pain or to register for the Chronic Pain Conference, please visit nuraclinics.com or call our Provider Hotline at 763-537-1000.

Edina & Maple Grove | NuraClinics.com | 763-537-1000

MINNESOTA PHYSICIAN OCTOBER 2019

10 HOSPITALS 60 CLINICS BREAKTHROUGH CARE CLOSER TO HOME When youâ&#x20AC;&#x2122;re referring, consider the system that offers your patients access to the finest of academic medicine, with deep delivery-of-care expertise at the local level.

BILLY D. WYATT, MD, FAAFP

Learn more at mhealthfairview.org