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Turning Diabetes Treatment Upside Down

Turning Diabetes Treatment Upside Down

• April 25, 2012 • 8:55 AM

Dr. Jay Shubrook is flipping conventional insulin treatment upside-down—with startling results.

Jay Shubrook

Dr. Jay Shubrook

There is something eerily familiar about Athens, Ohio, even if you grew up in New York City. It’s the accessible beauty of Appalachia, which surrounds the town — the gentle hills, the long, flat fields, the meandering brooks and neat, smallish farms.

It’s something more nefarious as well: the profound rural poverty vivid in the mini-malls and convenience stores on the outskirts of town. It’s the curse of plenty — the deal with the devil that this area made long ago with large mining corporations and fast-food chains. And it’s the number of overweight and obese people of all ages in stores and on the streets. People in Athens are pleasant and helpful, but they seem exhausted and desperate, both from generations of poverty and hard physical labor on farms and in mines, but also from the hard work of moving with extra weight. The self seems buried, like a trapped animal, in the body.

The data is mind-numbing: two-thirds of all Americans are overweight or obese, putting them at increased risk for diabetes. Many of us already have the disease and don’t know it. It’s an epidemic: according to the Centers for Disease Control and Prevention, in 2010, one in 10 Americans had type 2 diabetes. And roughly one in every 10 health-care dollars is spent on diabetes every year.

Today, if you’re diagnosed with type 2 diabetes — the most common form — your treatment would likely go like this: Your doctor would tell you to change your lifestyle, exercise more, lose weight, eat more fruits and vegetables. You’d be given a device to check your blood-glucose levels, and you’d be told to come back in a couple of months. After an average of two years of checking your glucose levels, you’d be put on metformin, the most common medicine for type 2 diabetics. Then the disheartening process of “stacking meds” would start. In addition to metformin, which lowers blood sugar by reducing the amount of sugar produced by the liver and helps the body better use its own insulin, you’d be put on sulfonylureas, drugs that stimulate the pancreas to release additional insulin. As this combination became ineffective, you would be put on any of nine other classes of drugs, an average of one additional med every two years. At the end of 10 years, you’d finally be shown how to inject insulin several times a day to lower your blood sugar. If you’re like most patients, this is when you’d feel like a failure. And you’d have spent 10 years thinking you were the victim of a disease.

But Athens resident Jay Shubrook, an associate professor of family medicine and director of clinical research at Ohio University Heritage College of Osteopathic Medicine, is developing another story.

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When Shubrook goes to the grocery store, people stop him in the aisles to ask questions, or often to just say thank you. Although his two teenage daughters have come to dread these trips (a run to the store is never quick), he doesn’t mind: the encounters mean his patients trust him. And trust is critical for doctors working with patients who have a chronic disease, because success depends on the patients’ ability to manage their own health.

That ability is particularly important to Shubrook, because the multipronged approach he’s taking in his research on diabetes is revolutionary. He refuses to treat his patients as passive victims. He asks them to fight — to take certain risks, and face deep fears. And he is turning the practice of stacking meds upside down.

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In 1991, fresh out of the University of California, Santa Cruz, with an undergraduate degree in psychobiology, Jay Shubrook got on his bike and pedaled to Appalachia and Ohio University’s medical school. Shubrook can seem Zelig-like. With his blond hair, boyish face, and freckles, he’d fit right in on the beaches of Southern California. His succinct delivery wouldn’t be out of place in a fast-paced city. But he chose small-town Athens because Ohio University had an osteopathic medical school where the students were trained to look at the whole person rather than the specific problem or disease.

When he was a fourth-year medical student, Shubrook did an endocrinology rotation with Frank Schwartz, a doctor in private practice in nearby West Virginia. It was a pivotal meeting for Shubrook: Schwartz had spent almost two decades helping people with diabetes. “I loved my time with him,” Shubrook says. So much so that, in 1998, as a resident, Shubrook requested another rotation with Schwartz.

At the time, many people saw diabetes as a hopeless death sentence. “When I was in school, and even after, the more chronic the disease was, the less sexy — precisely because there is no magic pill,” Shubrook says. “My predecessors were fascinated with medicines. No one wanted to work on diabetes.”

Type 1 diabetes, an autoimmune disease that accounts for 5 to 10 percent of all cases, is diagnosed most often in children and teenagers. In this form of the disease, the immune system mistakenly attacks the beta cells in the pancreas that produce the insulin needed to maintain normal blood sugar, effectively shutting down insulin production. But 90 to 95 percent of all diabetes diagnoses are type 2 — the kind that can be brought on by obesity. People with type 2 can produce insulin, but their cells don’t recognize it, so blood sugar isn’t metabolized properly and rises and falls to dangerous levels.

Frank Schwartz

Dr. Frank Schwartz in his lab at Ohio University in Athens. (John Sattler/Ohio University)

In reality, Shubrook explains, there are more than just two types of diabetes; there are many types — and many misconceptions about them. A lot of people think only adults get type 2 diabetes and only kids get type 1. And a lot of people think you can treat all kinds of diabetes the same way. “I have had some families think they can cure their child who has type 1 diabetes with diet and exercise,” Shubrook says, “and this is just not the case.”

Type 2 diabetes rates have increased for all ages in this country, and among people in their 30s, it has risen by 70 percent in just the past 10 years. That has meant increases in the ghastly problems that can accompany diabetes: dental disease, kidney disease, nervous-system disorders, blindness, limb amputation, heart disease, and strokes. Because of the nation’s high obesity rates, type 2 diabetes — once only seen in adults — has become a common diagnosis in teenagers. In Ohio, more than 10 percent of the population has diabetes, and in Appalachian Ohio, that rate can be twice as high as in other regions of the state.

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In 2003, Schwartz was asked by Ohio University to start a diabetes center — which gave him an opportunity to return to diabetes research. Looking to develop a diabetes practice that focused on health and prevention, Shubrook and Schwartz opened the Appalachian Rural Health Institute Diabetes/Endocrine Center.

Since then, Shubrook, Schwartz, and the teams they hired have been transforming diabetes care in Appalachian Ohio. With nearly $1.3 million in funding from the National Institutes of Health, they partnered with Mary de Groot, of the Diabetes Translational Research Center at Indiana University, to start Program ACTIVE, which combines talk therapy and exercise for patients with type 2. The team also opened Athens’s Diabetes Free Clinic for people without insurance. And Shubrook launched programs for health-care workers and educators, and for obese children and their parents.

Schwartz and Shubrook also pursued new research. In 2004, Schwartz and a team of computer engineers, biologists, endocrinologists, and others began working on, among other things, artificial-intelligence software and smartphone applications that will automatically detect blood-glucose problems and recommend solutions. In 2009, Schwartz and a team of researchers received nearly $900,000 to develop a natural compound called phenylmethimazole (C10), which blocks proteins that can trigger abnormal cell responses and that play a role in a number of diseases.

Their work has won some 30 awards in the past decade. “Frank is the gas, and I am the brakes,” Shubrook says. Shubrook’s energy never seems to lag, so this statement seemed questionable. But then I spent a day following Schwartz: a 6 a.m. lecture, followed by a seminar, followed by a development meeting, followed by a lab meeting where Schwartz, who’d had only one cup of coffee, quietly directed scientists, facilitators, and students.

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All the while, Shubrook was well aware that patients were frustrated with the stacking of meds and how long lifestyle changes can take to have an effect. “We were always a step behind,” he says. “We were chasing the disease. The burden on patients was significant.”

Diabetes doctors sometimes see patients with such high levels of glucose, or hyperglycemia, that the treatment has to be aggressive, which means insulin is the only option. “We had these people who were really hyperglycemic, so we knew meds would not work quickly enough,” says Shubrook. “We put them on insulin first. We knew it wouldn’t harm them.”

Artificial Pancreas

How the Artificial Pancreas Eases Diabetes Therapy
A handful of researchers in America and Europe aim to change type 1 diabetes treatment with a simple-sounding solution: an artificial pancreas.
(Click the image to read the story.)

Shubrook wondered whether using insulin first would also work in patients who weren’t severely hyperglycemic. “That made a lot of people nervous,” he says. “I was told, ‘You can’t do that, because [blood-glucose levels] will drop too low,’ ” making the patient hypoglycemic, the opposite of hyperglycemic. Other doctors and researchers saw it as a shockingly aggressive approach. Shubrook almost didn’t get funding for his Insulin First study, because funders thought he’d never find participants who were willing to try first what had long been a last resort. But Shubrook understood his patients in this corner of Appalachia; he knew they were ready to try something, anything, different.

In 2006, Shubrook began a series of trials with a group of patients who’d been newly diagnosed with type 2. Instead of 10 years to build up to insulin, they were taught to give themselves four shots a day almost immediately.

The results were undeniable. In six to eight weeks, the patients’ blood-sugar levels started to normalize. Shubrook and his team then, with close monitoring, started to withdraw the insulin. In three to four months, the patients no longer needed the injections to regulate their blood sugar. And many were able to stay off all medicines for up to three or more years. Shubrook asked people to work at maintaining a balanced diet and as much exercise as they could do, but, “We did not ask them to do any more than we ask of all our patients,” he explains.

“I love taking people off medicine,” Shubrook says. When blood sugar gets high, he adds, it’s toxic to the pancreas; using insulin to get rid of that toxicity allows the pancreas to work again. “In the old way of thinking, it was just a matter of time before the toxicity would return. We believe that a pulse of 12 to 16 weeks of complete insulin replacement allows the pancreas to rest and recover. We see dramatic drops in glucose in the first few weeks.” He adds, “What is surprising is we tell patients that this may not last, and, at some point, we will likely need to treat them with some medications. But all of them have said they would prefer insulin if they need treatment. They like the lack of side effects and the control it gives them, and they prefer the notion of a ‘booster’ treatment.” Even if patients have to come in for insulin treatment every three to four years, he says, that’s still better than the slow stacking of increasingly ineffective meds.

Today, Shubrook is nearing the end of his second trial,  with 30 type 2 patients who were randomly chosen to receive either the standard care or a course of insulin replacement. Shubrook can’t release the full results until the summer of 2013, but he says that, so far, the rate of hypoglycemia, the dropping of glucose levels feared by doctors and funders, has been extremely low among the patients given insulin.

“We have learned that it is safe and effective to start with insulin,” he says. “We do not see increased rates of hypoglycemia, and we do not see the weight gain typically seen when insulin is used as a last treatment.”

What surprised Shubrook was that several of his other diabetes patients wanted to join the trial but didn’t want to run the risk of not getting insulin first by being randomly assigned to a meds-first group. Those patients are now part of his case-study work on insulin-first treatment. Their openness to using insulin as a first course of treatment amazed Shubrook and a lot of other diabetes health workers, because injecting insulin carries so much social stigma: it’s seen as a last resort and considered tantamount to an admission of failure.

“There’s always been a lot of fatalism in diabetes patients,” Shubrook says. “A kind of ‘it’s just a question of how long you keep them alive’ mentality. So many of our assumptions, including assumptions about the role of genes, no longer hold true. Many people assume that if they start on insulin, they’ll be on it for the rest of their lives. We don’t believe this is true.”

I got a sense of the shame that can come with diabetes when, as an experiment, a nurse at Shubrook’s clinic inserted a glucose sensor in my abdomen so that we could watch my blood-glucose levels for 24 hours. Keenly aware of the extra 10 pounds I was carrying, I kept a food and activity journal to see how I reacted to meals, exercise, and sleep. A glass of red wine caused a vivid spike on the graph that night, followed by a spike in the morning after coffee and a muffin. Normal, randomly taken blood-sugar levels range from around 70 to 145. My cup of coffee brought my blood sugar up to a whopping 170. Then Shubrook showed me how to inject myself (though not with insulin). The shot was painless, but there was a certain shame in grabbing the fat and puncturing it. I felt acutely aware of all the excesses in my life. I felt that I had abandoned my body, my health, for childish appetites and a lifestyle that wasn’t of my own design. I could imagine how closely depression and self-hatred might shadow this disease.

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Shubrook is “one of those oddballs that crosses disciplines,” says Darlene Berryman, associate professor of food and nutrition at Ohio University. “In just five years, he has brought these two cultures together.” She adds, “From a cultural perspective, it’s considered OK to be overweight here. There’s a real distrust of doctors. Jay is able to cross that barrier. He connects with the people in this community.”

On a crisp fall day, the Diabetes Center Clinic is in full swing by 7:30 a.m. Shubrook, who’s already been for a long run, has an appointment with the first patient in his second trial: Laura, a student who has type 2 diabetes. Laura went through the typical frustrating rounds with medication: she’d start on a new drug, but inevitably her blood sugar would go up again. “I felt like a failure,” she says. Shubrook put her on insulin, and her blood sugar stabilized. She’s now coming off the insulin trial, and Shubrook has put her on a brief fast. “Here, more than anywhere else, it’s not a blame game,” she says. “On the insulin, I felt energized, relaxed, and more able to focus. I ate better, exercised more because walking was easier, and I lost weight.”

Robert, another of Shubrook’s patients (a case-study patient), was put on insulin more than three years ago. Robert is a slurry technician in a brickyard, where a workday can include moving tons of shale manually. “Jay is an unusual doctor,” he says. “Old school. He doesn’t use big medical terms. He listens to me, and I can talk to him.” After six weeks of insulin shots, Robert says, he was sleeping better and had more energy. “We’re not calling it a cure,” he says. “We’re giving my pancreas a rest and calling it remission.”

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More-aggressive interventions at early stages of type 2 diabetes have gained in popularity, but Shubrook’s trials will need to be repeated and expanded before the use of insulin as a first response could be widely adopted. Finding better treatments is critical. Since Shubrook started studying diabetes, the number of people with the disease has only risen. The CDC predicts that by 2050, one in three Americans will develop diabetes if current trends continue. The rates probably will be higher in minority populations and in underserved areas such as Appalachia.

“We have our work cut out for us,” Shubrook says. “People have free will,” he adds, then shrugs. It’s an unusual gesture for such an impassioned man. “It’s not my disease. I give them information. I can’t do it all for them.”

Yet he’s committed to giving patients as much information as he can and to showing them how much they can do for themselves.

Shubrook and Schwartz dream of building a wellness center like the Joslin Diabetes Center in Boston or the International Diabetes Center in Minnesota. But they think their incarnation would be better. It would be a one-stop shop for people with diabetes. Patients would come in for several-hour appointments and leave with a medical strategy and a plan for changing their lifestyle. The clinic would be a place to exercise, read, learn to cook, undergo supervised physical activity in a gym. And there would be a restaurant with healthy choices and carbohydrate counts on the menu. There would be laboratories where researchers could do cutting-edge work, such as stem-cell research. There would be fellowships for visiting nurses and doctors. As Shubrook sums it up: “What if you came to the hospital four times a year to get well?”

This article appeared in the May-June issue of Pacific Standard under the title “Reversing the Course.”

Susan Salter Reynolds
A longtime LA Times book critic, Susan Salter Reynolds has also written for Salon and the LA Review of Books, among other publications. A New York native, Susan now splits her time between Los Angeles and Vermont.

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