A small wand instantly detects straggling cancer cells during surgery. A person with a chronic disease, living far from a hospital, sends his avatar to the doctor’s office. The general public becomes trained in providing first aid for those with mental health problems.  Pioneering Milwaukeeans are working on making these – and other – breakthroughs […]

A small wand instantly detects straggling cancer cells during surgery. A person with a chronic disease, living far from a hospital, sends his avatar to the doctor’s office. The general public becomes trained in providing first aid for those with mental health problems. 

Pioneering Milwaukeeans are working on making these – and other – breakthroughs a reality. For their enterprising work, they are prepared to be hated (for creating a co-sleeping device for babies), ignored (for improving the city’s public health) or loved (for keeping older heart patients alive with a new treatment).  

What will be their legacy? Only time will tell. But this much is already known: The men and women in these 10 stories reflect the spirit of the likes of Jonas Salk (who developed the polio vaccine in 1952) and Florence Nightingale (who founded the world’s first secular nursing school in 1860). They are smart, driven, ambitious. And in the world of health care, they are breaking new ground.

1. The little wand that could

On a Thursday afternoon in November, a pea-sized lymph node from a mastectomy patient is brought into the crowded office of Dr. Gerald Smith, laboratory medical director at Aurora Sinai Medical Center. While the patient remains in the operating room, Smith freezes, slices, stains and microscopically examines the tissue for cancer. His conclusion will help determine if more of the woman’s breast tissue or lymph nodes are removed. The process takes about 20 minutes. 

Smith’s possible replacement for this procedure rests atop a table near his microscope – the FastPath Residual Cancer Probe. It’s a cancer-detection device that inventor and physicist Bill Gregory, the chief science officer of NovaScan LLC, compares to a metal detector. Sized and shaped like an electric toothbrush, the device is held by a surgeon to a patient’s surgical cavity during a mastectomy. By detecting the electrical characteristics of individual cells, the cancer probe alerts doctors to remaining cancer cells. If successful, the 20-minute wait time plummets to nearly zero. “It instantaneously detects cancer,” Gregory says.

The probe has kept pace with pathologists so far. In 187 tests, it recognized cancer cells 100 percent of the time. If it aces the next testing phases – two in the United States and one tentatively planned in Europe – the future of breast cancer surgery could include not only faster surgeries but also fewer second and third surgeries to remove residual cancerous cells. Between 20 and 40 percent of breast cancer patients undergo second operations, and 6 percent have third operations to remove straggling cells, says Gregory, who is also the retired dean of the University of Wisconsin-Milwaukee’s College of Engineering and Applied Science. If the cells stay in place, they may not be life-threatening, he explains. But studies show as much as 90 percent of cancer deaths are caused when these cells set up shop elsewhere in the body.

The patented device has cost $3 million to develop, says Gregory, and it’s supported in part by Aurora Health Care. He hopes it will be on the U.S. market by 2018.

2. The end of open-heart surgery

At 92 years old, Ed Miller of Oconomowoc would not normally have been an open-heart surgery candidate because of his age. He suffered from severe aortic stenosis – one of his heart’s four valves was dangerously narrowed – and doctors said he could expect to live another year or so with debilitating shortness of breath and fatigue. 

But on June 18, 2012, Miller took a chance and entered a clinical trial, becoming the 13th patient to undergo a nonsurgical valve replacement at Aurora St. Luke’s Medical Center. “For me,” Miller says, “13 is a lucky number.” 

Replacing a diseased aortic valve is tricky business, as it’s anatomically hard to reach. Open-heart surgery has traditionally been the only option but one inaccessible for patients who aren’t strong enough to withstand it, like Miller. So without opening his chest cavity, surgeons routed a replacement valve through an artery in his leg and into his heart, where it was deployed. Miller was home two weeks later. “I have the pleasure of enjoying grandchildren and great-grandchildren,” says Miller, who lives alone in a house overlooking Okauchee Lake. 

For patients with severe aortic stenosis, the emerging treatment of transcatheter aortic valve implantation (TAVI) offers not only swift recovery but also prolonged life. “This is a game-changer for older patients,” says Dr. Tanvir Bajwa, an interventional cardiologist and co-principal investigator for the clinical trial at Aurora St. Luke’s. “We didn’t have solutions before.” Most people, he explains, die less than three years after the diagnosis. 

About 100,000 cases of severe aortic stenosis are annually diagnosed in elderly Americans, and one-third are too frail for open-heart surgery. The hallmark of the condition is a narrowing valve between the heart and aorta that allows blood to leak backward. Its symptoms – fatigue, dizziness, chest pain, shortness of breath, heart palpitations and fainting – become progressively debilitating. Bajwa says by age 65, 15 percent of the population has some degree of aortic stenosis, and about 5 percent of that group requires treatment. TAVI marks a “new era for these patients,” Bajwa says.

Hear more about Medical Breakthroughs on WUWM’s “Lake Effect” Feb. 6 at 10 a.m.

TAVI also may offer a solution for younger patients who are ineligible for open-heart surgery because of other health conditions. At age 62, Diane Mann of Racine became the youngest patient in the Aurora St. Luke’s clinical trial. Prior to surgery, Mann had marked the progressive narrowing of her aortic valve after annual physician visits. “Each year, it opened less and less,” she says. Constantly short of breath, she found walking through the grocery store too difficult. “I had no ambition to go anywhere. Not even to a movie.” Lupus and other medical conditions precluded her from open-heart surgery, and her valve shrunk to about three-tenths of its healthy size. Death, when it eventually came, would be quick, she reasoned. “I would have gone to bed and not woken up.” 

On her 41st wedding anniversary in 2011, she was sitting outside with her husband, John, at 6 p.m. when she received the phone call: She could enter the clinical trial and undergo surgery in three days. “I considered not doing it,” she says. “I was really scared. But I couldn’t leave John with a burden alone. We lost our only daughter to a drunk driver six years ago, six weeks before her own wedding. Maybe I won’t leave behind any grandkids. But maybe someone will learn something from my experience. This could be my legacy.” 

3. The pod for safe co-sleeping

On average, about two babies die each month in Milwaukee while co-sleeping with adults. Wisconsin state Rep. Samantha Kerkman (R-Randall) has sought to criminalize co-sleeping while impaired, but a nurse researcher is going at the problem in another – rather controversial – direction: Make co-sleeping safer for those who insist on it. 

Jennifer Doering’s device, the I-SleepPod, is a portable bassinet outfitted with face protection (to prevent suffocation) and a battery-operated alarm (to alert an adult if the device tips). It’s designed for placement on several sleeping surfaces.

“People have told me to get ready for hate mail and being called a baby killer,” says Doering, associate professor at UWM’s College of Nursing. “But criminalizing co-sleeping is not the answer. The consequence will be that the practice will just go underground. More babies will die.” 

Doering says at least 20 percent of babies who die of sudden infant death syndrome nationwide do so in unsafe sleep environments: sleeping on a recliner with dad, a couch with mom, a shared family bed with pillows, blankets and large, heavy bodies capable of blocking an infant’s airway. “Many parents feel that anywhere outside the bed is more dangerous,” Doering says. “They are worried about bullets, dogs, cats, other children, other adults.”

Working with the national organization Cribs for Kids, four local hospitals and the Milwaukee Health Department distribute free Pack ’n Plays to parents unable to afford cribs. But during home health visits with new parents, Doering says she’s often witnessed a little-known downside of the popular, portable crib that measures about 18 cubic feet. “Parents who don’t have storage space in their homes use them to store baby supplies – diapers, clothes, baby gifts,” she says. “The I-SleepPod is my response to that.”

As she developed the device, Doering tracked the Milwaukee Journal Sentinel’s reports on co-sleeping deaths for two years, including one about a baby who was electrocuted after falling from an adult mattress onto a baseboard heater and several about babies who died of suffocation from parents’ bodies, blankets and pillows. “As I accumulated the stories, I’d ask myself, ‘Would my device have saved this baby?’ The answer was always, ‘Yes.’” 

A prototype of the I-SleepPod, funded by a $35,000 grant from the UWM Research Foundation, is being created at UWM’s College of Engineering and Applied Science. Three versions are in the works: one very low-cost model for use in third-world countries, one with a sales price of $50 and a “Cadillac” version for higher-income clientele. Testing on sensor dummies begins this month, and Doering hopes the final product will be on the market within a year. Meanwhile, she’s bracing for controversy. 

“I’m ready to defend it.”

4. The bank that’s changing medical practice

Physically, the room is no bigger than a bungalow’s kitchen. Two freezers and some robotic equipment sit in the windowless area, which is tucked away in an unglamorous section of Aurora St. Luke’s Medical Center. It’s all rather unassuming.

But the contents of those freezers could change the way medicine is practiced. Locked within is a library of DNA samples – donated by people with various medical conditions – that could help eliminate guesswork in medical prescribing. One goal behind the biology databank, or biobank, is personalized medicine, meaning prescriptions would be tailored to a patient’s genetic makeup. Bada bing, bada boom. No trial and error.
The biobank, officially called the Open Source Robotic Biorepository and Informatics Technology or ORBIT, began in 2009 at Aurora Health Care. It’s still small – Aurora spokesman Adam Beeson says just five researchers have tapped into its capabilities – but if its supporters are right, its reach will someday be broad and remarkable.

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To a certain degree, personalized medicine is already here. Genetic tests, for example, can predict whether a patient will respond well to warafin (an anticoagulant, or blood thinner) or the breast cancer drug Herceptin. Individual medical researchers have maintained their own biobanks for years. “Biobanks aren’t new. The scope is new,” says Ryan Spellecy, associate professor of bioethics and medical humanities at the Medical College of Wisconsin.

Recently, dozens of large for-profit and not-for-profit biobanks have sprung up (including one at the Medical College in 2011) that store human tissue and fluids, including bone marrow, urine, tumors and organ cells. They also store patients’ de-identified medical records. Combined, they have spawned questions about medical ethical issues. Can privacy be ensured forever? Does consent for “future, unspecified use” of a donation mean agreement to any tests done on those cells? When research from biobanks leads to a profitable discovery, who gets the money? “There will be more legal issues,” predicts Dr. Arthur Derse, director of the Center for Bioethics and Medical Humanities at the Medical College.

But no one is flat-out against the idea, Derse says, just against proceeding without caution. Proponents say biobanks save scientists time and money, as they can easily tap into a wealth of data to study how genes influence disease and drug therapies. Natalie Polinske, ORBIT’s manager, says ORBIT could eliminate the lengthy process of recruiting volunteers and seeking their consent, one study at a time. “This allows a researcher access to a large sample in a short amount of time,” she says.

Now, when patients at Aurora have their blood drawn, they are asked if they want to donate to ORBIT any blood that remains from medical tests. (Leftover blood is usually discarded.) If they sign a consent form – as do 70 percent of people asked – one sample of blood, 400 microliters in volume, is coded to electronically link to the patients’ medical record. Their identities are stripped from the samples and the medical records, and a firewall is built between investigators and data collectors. The samples, each of which can be used dozens of times, will then be stored with about 5,000 other donor samples in a freezer set at minus-4 degrees Fahrenheit. Patients will never know if a researcher uses their DNA or medical records, learns something from them or even develops a life-saving treatment based, in part, on a study that included their blood or data.

5. A blanket to keep you cold

In 1999, 29-year-old Anna Bågenholm was submerged in an icy stream for 80 minutes and survived. Although she endured a long recovery, the accidental hypothermia helped ward off brain damage, in part because the brain needs less oxygen when it’s cold.

Her story went down in medical textbook history, and doctors now use induced hypothermia to stave off brain damage for victims of heart attacks and strokes, among other health crises. Milwaukee neonatologist Dr. Charles Potter is bringing that treatment to the field with his thermochromic cooling blanket. 

Potter hopes the blanket will someday treat common traumas – heart attack, stroke, head trauma, heat stroke and heat exhaustion – when dramatically lowering a person’s temperature might prevent brain damage. There is no standard way to do this outside of a hospital, he says. Potter envisions the single-use blankets being used about 100,000 times a year by emergency medical technicians and, like automatic external defibrillators, by laymen as they wait for medical personnel.

“I think it will have a real impact on the outcomes of patients who have oxygen-deprivation to the brain,” says Randall Lambrecht, senior vice president of research and academic relations at Aurora Health Care. “We have emergency room physicians very excited about it.”  

The blanket’s prototype looks like a flak jacket, with a dozen or so cooling cells, and works like a giant, regulated cold pack. In an emergency, first responders would wrap the victim in the jacket, estimate his or her weight, then follow instructions printed on the jacket as to how many cells to activate. Labels with thermochromic ink (think mood rings, Coors cans) on the jacket indicate its temperature and instruct the user to activate or remove cooling cells.

With financial support from Aurora Health Care, two prototypes of the thermochromic cooling blanket were built in 2012. Next steps: Find sufficient funding to test it and bring it to market. As of now, there are no takers, and Potter’s blanket is itself trapped somewhere between life and death. 

6. The next generation of public health

In his rearview mirror, Bevan Baker sees a defining moment of his eight-plus years as Milwaukee’s commissioner of health: the 2009 mass vaccination against H1N1, a global pandemic that resulted in 18,500 lab-confirmed deaths. (A recent CDC study estimated total global deaths could be as high as 575,000.) Thousands of Milwaukee-area residents, young and old, queued up each day at makeshift clinics for vaccinations against the so-called swine flu. 

Ahead, Baker sees the city’s next big public health success: a new model of public health. “Long after those of us in public health are gone, we will say that 2012-2013 was the time when the most significant change in Milwaukee public health emerged,” he says.

Rather quietly in 2012, the 146-year-old health department became part of Wisconsin’s first alliance between a public health system and academic institution, setting the stage to turn around the city’s dismal public health statistics. The 270-employee-strong Milwaukee Health Department formally joined forces with academia, specifically the burgeoning UWM Joseph J. Zilber School of Public Health. This newly planted and briskly growing school on the abandoned grounds of the Pabst Brewery opened in 2009 with just seven students. It now boasts 45 and will graduate its first student in May. 

In this new model, the health department and academia work side by side to tackle things that affect Milwaukeeans’ health and well-being: social factors (poverty, access to jobs, transportation, violence, public safety), behavioral factors (practicing safe sex, walking and biking instead of driving, smoking cessation) and environmental factors (the extent to which asthma rates are linked to ozone and availability of parks, swimming pools and recreation centers). 

The school’s dean, Magda Peck, says her vision for the  new partnership is nothing less than making Milwaukee one of the nation’s healthiest cities. That’s a lofty goal, for it bumps against deep-rooted Wisconsin culture (the state leads the nation in binge drinking), issues related to poverty (43 percent of Milwaukee’s children live in poverty, the fourth-highest rate nationwide) and a political climate in which support for public health funding is increasingly divided along party lines. According to a study funded by the Robert Wood Johnson Foundation, Wisconsin ranks 49th among states and the District of Columbia in public health care funding per person, at just $8.71. The national median is $30.61, and the Midwest median is $17.36. The nation’s healthiest state, Vermont, spends $75.42 per person. “The healthiest cities have good public health systems,” Baker says. Milwaukee, however, is “in a time warp. People don’t get it.”

It wasn’t always so, says Mayor Tom Barrett, who championed bringing a school of public health to Milwaukee six years ago. “There was a time when Milwaukee was on top of public health indicators, in the ’40s and ’50s,” he says. Barrett hopes the new partnership will be the catalyst to turn around the city’s disheartening rates of infant mortality, teen pregnancy, sexually transmitted diseases and more.  

The catch: If Milwaukee’s new public health efforts are successful, they may go unnoticed by the general public. Prevention seldom makes headlines, and when it does, it quickly fades from memory. You may recall rolling up your sleeve for the H1N1 vaccine, for instance, but not the enormous efforts of a public health system that kept millions of us free from a potentially deadly case of the flu.

7. Mimicking life for high-tech learning

In a space that looks every bit like a labor and delivery room, a mother gives birth, and a nursing student places the crying newborn in a high-tech incubator. But just two minutes later, the mom begins to hemorrhage, and the baby turns blue. The student has to respond.

In another room, a boy lies in a hospital bed strewn with GI Joes and comic books. “How are you?” the student asks. “I’m tired,” the boy responds. The student asks another question, but the boy does not respond. He has gone into cardiac arrest, possibly from a drug overdose.

These intense, real-life situations play out every day at the new $4 million Wheaton Franciscan Healthcare Center for Clinical Simulation, located at Marquette University’s College of Nursing. But the patients are played by high-tech, computer-programmed mannequins that lie in hospital beds and have conversations with attending nurses and students through wireless mics connected to instructors in a control room. These “patients” regularly give birth, talk back, have allergic reactions, code out.

Down the hall, another simulated patient, programmed to have skyrocketing blood pressure and a weakening pulse, lies in bed. When a student approaches with a syringe, the mannequin scans its bar code – for the medicine and the dose – and responds with the appropriate medical indicators.

After each scenario concludes, several students and a professor meet in a debriefing room and, not unlike a football team, review the tape, play by play. It’s easy to see how such training leaves the written medical scenario in the dust. “It’s one of the most advanced centers in the nation,” say Brenda Bowers, senior vice president of organizational change and leadership performance at Wheaton Franciscan Healthcare. “The demands on everyone in health care are higher, and we all have to think differently.”

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The center opened in August and was financed by Wheaton Franciscan, GE Healthcare (which donated $440,000 for patient monitors and technological equipment) and a fundraising campaign by Marquette’s College of Nursing. It’s used by Marquette to train students and by Wheaton Franciscan for continuing education of its nursing workforce. But one of its most fantastical uses will be to replay the real and rare in-hospital occurrences that involve entire medical teams, including doctors, respiratory therapists, labs, blood banks and emergency technicians, says Bowers.

The notion of high-fidelity simulations is rooted in the airline industry, where pilots perfect routine skills and practice for rare occurrences, such as landing a plane on a river, according to Margaret Callahan, dean of Marquette’s College of Nursing. “The center lets us re-create rare events in a way that is controlled and risk-free,” she says. “The goal is to dispel belief.”

8. Med school’s extreme makeover

Just a decade ago, doctors thought hormone replacement therapy protected women’s hearts. It doesn’t, and some studies have shown it might actually increase the risk of heart disease. Doctors also thought vitamin E protected men from prostate cancer. Recent studies conclude it can increase the risk. It’s said that as much as half of what medical students learn will prove wrong or irrelevant in just a few years, and doctors who can make order out of today’s tsunami of shifting knowledge will be the most successful in treating patients, says Dr. Jose Franco, professor of medicine and director of the Discovery Curriculum at the Medical College of Wisconsin.
Today’s unprecedented rate of new knowledge, new medical technology and new pharmaceuticals is part of the reason why the Medical College, for the first time in decades, has given its curriculum an extreme makeover, he says.

The college’s new Discovery Curriculum marks the end of the “two-plus-two” model, the century-old archetype of U.S. med-school training that kept students in the classroom for their first two years (lectures, rote memorization) before opening the doors to clinical experiences. Now, with iPads in hand, first-year students step into outpatient primary care and specialty clinics for hands-on experience at Froedtert Hospital, the Zablocki VA Medical Center, Children’s Hospital of Wisconsin and other locations within the community. “No student is allowed to see patients without supervision,” Franco says. “They can’t diagnose and can’t prescribe.”

With this dose of early apprenticeship, students can learn to think outside of academic silos. As new knowledge emerges, Franco says students will be more successful if they understand how the principles of basic science, clinical practice, drug therapies and other concepts are woven together. 

First-year student Jamie Schneider, 31, of West Allis, describes a typical class: “Twenty students were discussing the biochemical and social pieces of a case. But we didn’t know enough about a certain drug.” There is, of course, an app for that. So she turned to her iPad. “If I get the answer right away, it sticks better,” she says. “It’s like a clicker for dogs.”

Several years in planning, the Discovery Curriculum is also a response to the changing face of health care delivery (goodbye lone general practitioner, hello health care team) and new insights into how people best retain information. Studies have shown that after two weeks, people remember about 10 percent of what they read, 20 percent of what they hear, 30 percent of what they see, 50 percent of what they see and hear, 70 percent of what they say and 90 percent of what they do. “We can’t increase the time students spend in medical school, but we can increase retention by adding clinical experiences early,” Franco says. The Discovery Curriculum was developed with input from faculty, students and recent graduates. Franco says it’s different than when he went to college in the ’90s, and it’s nearly unrecognizable from the time-worn model created by Abraham Flexner, which standardized U.S. medical education requirements 100 years ago.

Applications to the Medical College have been climbing for several years. This year, the school received about 7,000 applications, will accept 463 students and will admit 204 – an acceptance rate of just 7 percent.

9. The virtual way to visit the doctor

The patient logs in from home, using a computer equipped with audio-visual capabilities and technology that transmits vital signs to the doctor. She guides her avatar – dressed anonymously in black pants and a white top – around the virtual campus, enters a building marked Medical Clinic Office and comes to rest in a large, sunlit room with floor-to-ceiling windows. She sits in one of the 12 chairs arranged in a half-circle. Other chairs are occupied by anonymous avatars representing patients with the same chronic condition. Her doctor enters the room at 10 a.m. The patient’s vital statistics are already available for the doctor to look at, and if either party wants to talk or see one another, they can.  

If researchers at UWM and the Medical College of Wisconsin are successful, this could be the way certain diseases are managed in the future. They hope to create virtual doctor visits for people with chronic, stable medical conditions – though researchers imagine other possibilities. If successful, a patient’s avatar could interact with his or her physician’s avatar in cyberspace. Researchers say the benefits include lower health care costs (the CDC estimates 75 percent of health care dollars are spent on chronic disease), more accessible health care for people in rural areas, and an answer to the problem of physician shortages in Wisconsin and worldwide. 

“A major part of the doctor-patient relationship is trust,” says Dr. Reza Shaker, the project’s primary investigator at the Medical College, and professor and chief of gastroenterology and hepatology at the Medical College and Froedtert. “It is developed when you’re face to face. We look each other in the eye. That is how medicine has been practiced since the days of Socrates.”

That trust could be easier to come by for younger patients. In the first phase of testing, 37 student volunteers reported they trusted the virtual system. “The new generation can easily do that,” Shaker says. “Seventy-year-olds, not so much, but this is not aimed at them.” 

A cyber visit could be a hard pill for many patients to swallow, but the traditional system simply cannot meet patient demand, Shaker says. “The problem is in the math. The world population is 7 billion. There are physician shortages everywhere.” 

According to F. Mariam Zahedi, principal investigator and professor of information technology management at UWM, cyber visits would not only increase health care access, they would lower costs – time off work, brick-and-mortar locations, health care personnel. “You can have your cake and eat it,” she says. 

Since it began in 2008, the project has received about $150,000 from the Clinical and Translational Science Institute of Southeast Wisconsin, which gives financial assistance to local researchers, with the hope that they’ll later secure major funding to continue their research. Last fall, the program received a $100,000 grant in the form of the John and Jeanne Byrnes CTSI Award.

10. First aid for mental health

In 2012, Rosanne Norwood became the first person to offer a specific type of first-aid training in Milwaukee. But the course was different than the familiar American Red Cross first-aid training. Norwood, a certified mental health first-aid instructor, held a 12-hour training course to instruct people on how to deal with mental health emergencies. “One in four people will have a mental health disorder during any given year,” says Norwood, who manages Project Bridge at Community Advocates. “It’s your neighbor. Relative. Co-worshipper.” 

The course was designed to train people to recognize and respond to someone dealing with a psychiatric crisis or an untreated mental health or substance abuse issue. Mental health first-aid courses have been taken by individuals in the general public and by groups including college resident advisers, faith community leaders, law-enforcement professionals and primary care professionals.

The most prevalent conditions, Norwood notes, are anxiety and depression but also include suicidal behavior, psychosis and eating disorders. Norwood’s initial classes were held for people working at homeless shelters, but she quickly started to field calls wanting the course offered elsewhere, including at two local colleges.
Mental health first aid originated in Australia in 2000 and has since spread to at least 20 other countries, according to Susan Partain, director of mental health first-aid operations at the National Council for Behavioral Health in Washington, D.C., the agency that oversees most of the programs in the United States. “The growth has been tremendous,” she says. Since 2008, when the program reached the U.S., more than 2,500 instructors in 49 states have trained 80,000 people to be mental health first-aid responders. On average, about 100 people complete the evidence-based program daily.   

In 2012, Norwood rolled out a program for people who work with youth 12 to 18 years old. The current class teaches students how to connect with a person in crisis and how to encourage the person to seek help. The class also includes community resources and a lesson in mental health literacy – understanding and recognizing various disorders. “After training, people feel more confident to provide help,” Partain says. “They are better at recognizing when there is a problem and how to help the person.”

Norwood was Milwaukee’s first mental health first-aid instructor, but seven other instructors have been trained in Wisconsin to handle this facet of emergency health care. “Only 41 percent of people with mental health issues ever get treatment during their lifetime,” Norwood says. “It could take weeks, months, years. The median time for people to get help is 10 years. It doesn’t have to be so.”