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Interviewer: Millions of Americans with diabetes inject themselves with insulin every day or multiple times a day to manage their disease. While that's hard enough, the soaring price of the drug has made things that much harder. I'm talking with nurse practitioner and researcher Dr. Michelle Litchman, about living with diabetes and the lengths people are having to go to just to stay healthy. Hi, Dr. Litchman, thanks for joining us.

Dr. Litchman: Hi, thanks for having me.

Interviewer: Many people with diabetes can't live without insulin. Tell me about how people with diabetes rely on this drug for their health.

Dr. Litchman: Everybody with type 1 diabetes, and about a third of individuals with type 2 diabetes require insulin to stay healthy and well.

Interviewer: Why is that? What does the drug do for them?

Dr. Litchman: Insulin is required to lower blood sugar. It allows glucose to get into the cell and to be used for energy.

Interviewer: And so if they don't have those shots of insulin, what can happen?

Dr. Litchman: If glucose gets down dangerously high, it can result in complications. It can result in diabetic ketoacidosis, otherwise known as diabetic coma. And it can also lead to death.

Interviewer: This drug is necessary for these people to stay healthy, and yet it's getting harder and harder for them to get. The cost of insulin has risen a lot in the last few years. By how much? What are we talking about?

Dr. Litchman: In the last decade, it has at least doubled.

Interviewer: Which is quite a shift for patients who rely on this drug every day.

Dr. Litchman: Absolutely. Access to diabetes medications and actually also supplies is really challenging for people with diabetes. People are faced with a dilemma. Do I pay for the health-related expenses that I need – my medications, my supplies – to survive? Or they're having to make the choice of do I ration my medications and supplies so that my family can have the things that they need like the food, shelter, making my house payment, making my car payment, having gas to get from point A to point B. And so rationing happens on one end or the other. It's either on the side of health and diabetes medications and supplies, or it happens with the family basic needs.

Interviewer: And how crazy is that? Just to stay alive you can't live a normal life.

Dr. Litchman: Absolutely. People are under immense stress and guilt related to the cost of medications. A lot of people in our study felt remorse that they had to put their family in such situations. And it's not fair.

Interviewer: I mean, some people are even questioning whether they deserve to live.

Dr. Litchman: Absolutely. We found that people were feeling guilty about the cost and questioned whether or not their life was worth the cost of insulin to even continue living.

Interviewer: It's quite a thing that we've come to this point, don't you think?

Dr. Litchman: Absolutely. I mean, it should never be the cost of medications and supplies is worth somebody's life.

Interviewer: How are you going about even finding out this information? Is this through conversations at the clinic or something else?

Dr. Litchman:So as a clinician, I'm seeing this all of the time where patients are coming to me with concerns related to their ability to afford medication and supplies. It's actually consuming a lot of the visits not only for me, but also my colleagues. And so this is really affecting our visits.

From a research standpoint, we conducted a cross-sectional survey of adults living with diabetes or caring for somebody with diabetes like a child. And we found that many people are financially struggling. In fact, financial distress is higher among those with diabetes than those without diabetes. And we're also finding that financial distress is related to interpersonal issues because of the cost of insulin. So people are having disagreements or guilt-related issues with their family members because of the cost of diabetes.

Interviewer: So it's not only affecting their ability to get the care that they need, but it's affecting their family life in a lot of different ways.

Dr. Litchman: Absolutely. And when they go to a healthcare provider to seek help or discuss these issues, healthcare providers are somewhat limited in the solutions that they can offer. So clinicians can offer patient assistance programs that currently exists. Not everybody qualifies for certain patient assistance programs, but they're also very time consuming. So it's not just an easy one piece of paper to fill out, it's a lot of papers that needs to be collected and a lot of signatures that are required in order to make the paperwork process move.

Also people who have Medicare fall into the donut hole about halfway through the year depending on the person's circumstances, and not all patient assistance programs are for people with Medicare, and so that's a barrier as well. And we're also finding that some clinicians aren't aware of all of the services that are available, nor do they have all of the support necessary to make sure that patients get what they need.

Interviewer: And so a lot of patients aren't getting assistance. And what are they doing instead?

Dr. Litchman: Patients are having to go through unique channels to access what they need. So in our study for those patients who really want to stay well, some of them are engaging in trading behavior. So I'll trade you this if you can give me these supplies or that insulin. People are engaging in the purchase of medications and supplies from sources that are not approved to be selling those. So, for example, people are leaving the country or they're buying them on the internet.

One of the things that we found that was interesting is the altruism that people are having with regards to donation. So if people had extra supplies or extra medications they were willing to donate. We saw this not only in this survey, but we also saw this on crowdfunding sites where people would list in the comments, you know, if I live near you, I'm happy to send you some insulin if you really are in need.

Interviewer: Then, of course, that's not a long-term solution.

Dr. Litchman: Absolutely, not a long term solution. And people also would only spare the extra that they had, so they needed to make sure that they themselves had the insulin they needed to take care of themselves, and they could only spare the extra.

Interviewer: It seems like it's underground behavior, right? I don't know if it's quite criminal, but it's certainly not what healthcare providers would recommend. You know, it strikes me as being pretty dramatic if people have to resort to that.

Dr. Litchman: Well, again, people have to make a decision, do they stay well? And if so, what are the things that they need to do in order to stay well, and in some cases, people have had to go to extreme measures. One of the concerns that some people have had in these trading communities is that some of them are being shut down, and so that's causing even more access barriers to people. And so there's this ethical dilemma that we're facing, should people be able to access what they need through this underground trading? And if not, what are the solutions that exist so that people can actually get what they need without having to engage in this activity?

Interviewer: I'm wondering if you know, over the course of time that you've been performing these surveys, I mean, if you've seen some changes in attitude. I mean, I imagine people are getting pretty jaded, you know, jaded with the healthcare system, jaded with pharmaceutical companies. Do you observe any of that too?

Dr. Litchman: Absolutely. I see that in the research and I see that clinically. People are getting frustrated, and they want solutions. And they are almost feeling like there's no way out. And it's really sad to see.

Interviewer: Do you think there are downstream implications for that? Do you think it might erode the trust that some of these patients have? I don't know with who, with their providers, I don't know. If this alternative means of getting healthcare becomes a new norm for them, is that going to carry over for maybe for other conditions that they may be having too? Maybe they think, oh, if this works from treating my diabetes, maybe I can do some on the side trading to treat my migraine, to get drugs for treating my migraines or something like that.

Dr. Litchman: There is research showing that there are people who are trading for other conditions such as asthma, and so I think that it's absolutely true. If you can't access a medication and you need it for some reason, then people will go to extreme measures in order to make sure they have what they need, because they want to be healthy. I think that some downstream consequences is, you know, if we don't have a trading system, then we have people in the ER, every time they need a dose of insulin. And what does that do to this system? How much will that cost? We need to have solutions in place that don't just make sense financially, but for actual people that are on the receiving end.

Interviewer: In collecting this information, I mean, what do you hope to accomplish with that? What do you hope to do with that information?

Dr. Litchman: I think the first step is awareness and making sure that people understand what is happening not just on the patient and provider level, but on the health policy level as well. We need people who are willing to step forward to make sure that diabetes management is accessible and if we don't make insulin and other medications and supplies accessible now, we're going to have major consequences later, we're going to have a higher rate of complications and costly hospital stays, and even death. And we need to stop it.

Interviewer: I'm wondering, are there any specific stories that you've kind of picked up in your work that might illustrate this that you feel like you're able to tell?

Dr. Litchman: I've taken care of people who had Medicaid as a child, and who, once they became an adult no longer qualified for childhood Medicaid, and didn't have parents who had health insurance. And they are really struggling to afford what they need because they don't have insurance at all. They can't get adult insurance. And I've sat down with people to try and help them get Medicaid on my off hours because the application process isn't simple. You know, people oftentimes need help with this. And it's a struggle and that person struggles today.

Interviewer: And so have you seen people's health deteriorate as a consequence of what's happening?

Dr. Litchman: Absolutely. And it's not just the physical deterioration, it's the mental. I think that people feel like there's a system in place that doesn't care about them as a person. And despite our efforts, and in trying to find ways to access insulin that's affordable, it's still hard. And you know, people will argue that there is generic insulin that can be purchased without a prescription. But it's not the same as the medication, the insulin that has become the gold standard that's more physiologically matched to people who with food and the way that our liver puts up glucose. And so I think that we need to help people get access to the best medication possible for the diabetes that they have.

Announcer: Interesting, informative, and all in the name of better health. This is The Scope Health Sciences Radio.

Interviewer: A new smart insulin could change diabetes treatment. Up next on The Scope.

Announcer: Examining the latest research and telling you about the latest breakthroughs. The Science and Research Show is on The Scope.

Interviewer: I'm talking with Dr. Danny Chou, USTAR assistant professor in biochemistry at the University of Utah. Dr. Chou, your discovery could really make a big difference in the lives of people with diabetes. Tell us about what you found.

Dr. Chou: So, we used a chemical approach to modify the native insulin molecule, and what we're trying to do is to have insulin that will be activated when the blood glucose level is high, so in the way that further regulate blood glucose level better for diabetic patients.

Interviewer: So, already, your work in mice would suggest that what you've developed is, I think, better than anything that's out there right now. Is that true?

Dr. Chou: Yes, because right now in the market, there are fast-acting insulins for meal-time use and there are long-acting insulins for basal level use. So basically there's no such insulin in the market right now that could provide any kind of glucose-regulated or glucose-responsive way.

Interviewer: And it seems like the results that you saw in mice were pretty striking. What did you see?

Dr. Chou: So what we see is that we could only do one single injection of this modified insulin, and then what we see is we could do three glucose tolerance test, which is kind of like a meal for the mice, and then we could see that one injection could be good for three different meals within a 13-hour span. So we really think this a very amazing and a very exciting result. But as we just mentioned, this right now is only in mice work and then we would try to see whether we could prove the safety of these insulins and one day we could put it into the clinical phase.

Interviewer: So, how long do you think it might take to get to the clinical phase?

Dr. Chou: So, we are thinking about a three-to-five year range.

Interviewer: For those of us who may not be familiar with living with diabetes, can you explain what some of the problems are that you're trying to address?

Dr. Chou: So, in the case of Type 1 diabetic patients, they do not have any insulin production inside their bodies. So, people with Type 1 diabetes, they have to totally rely on external source of insulin. And insulin is a drug that is not like you could put as much as possible and then you would still be okay. The thing is that you need to maintain your blood-glucose level in the normal range. So, when you inject too much insulin, that will give you a case of hypoglycemia, which will kind of cause dizziness, or in coma, or even death. So that's why people are afraid of injecting too much insulin inside a body.
However, if you do not inject enough insulin, that will give you a constant high-glucose levels, which is called hyperglycemia, and in the long run, that will lead to diabetic complications like kidney disease, eye blindness, or amputations. So, that's why we are trying to develop a special insulin in the way that its activity could be controlled by itself. So, basically, the activity is controlled by the blood-glucose levels inside your body. So, in that way, people with diabetes, they do not need to worry about the high or low glucose levels because the insulin itself is smart enough to control the glucose level inside a wide range.

Interviewer: You know, as it is, what you've developed is really incredible, but it sounds like you're also going to work on improving it.

Dr. Chou: Yes. So right now, I think we have already done a pretty good job in developing an insulin that could be used to reduce the high glucose level back to normal range during the meal time. But I think what we could still improve is in the hypoglycemic end. So what we try to do is we try to have the ideal insulin that the activity of insulin will be stopped or blocked when the glucose level is around, say, 80 milligram per [inaudible 00:04:33]. So, we will never need to worry about inducing hypoglycemia with this insulin injection.

Announcer: Interesting. Informative. And all in the name of better health. This is The Scope Health Sciences Radio.

Announcer: Interesting, informative and all in the name of better health. This is The Scope Health Sciences Radio.

Interviewer: A lot of people with Type 1 diabetes believe that the insulin shots and a pump is enough, but there might actually be a better option, a pancreas transplant. We're with Dr. Paul Campsen, Surgical Director of Pancreas Transplant Surgery with the University of Utah. That option is pancreatic surgery.

Dr. Paul Campsen: That's correct. Right now we do pancreas transplants for Type 1 diabetics. Type 1 diabetics can't survive without insulin, so they give themselves shots and they can administer this sometimes through am insulin pump which is a very good way to keep them alive. The control that they get from that is not a replacement for the human organ, the pancreas. That's where the pancreas transplant comes into play in the sense that you can help yourself stay alive just like dialysis helps with kidney transplant, or with failure. A pancreas transplant gives you back the human organ that you actually need.

Interviewer: Plus, also a better quality of life.

Dr. Paul Campsen: A much better quality of life. Over the long term the pancreas transplant itself is completely correcting the diabetes, so any of the sequelae of diabetes, whether it be peripheral vascular disease, damage to your eyes, damage to your nerves, damage to your coronary arteries, all of that stuff is stopped with a pancreas transplant.

Interviewer: Not with the insulin shots or the pump?

Dr. Paul Campsen: No, I think that the insulin helps a lot. It slows down the damage. Obviously it literally saves their lives by giving them insulin, but it doesn't stop the diabetes because you're still a diabetic. The pancreas produces a variety of different enzymes and secretes many things that actually help the body including insulin, also glucagon, which keeps the sugars from going too low which can be life threatening, and any of the pancreatic enzymes that help with digestion. None of that' s given with the insulin pump. When you replace the pump with a human pancreas you get all of those benefits.

Interviewer: It sounds like a great solution. Why aren't more people doing it? Is it a dangerous surgery or is it fairly safe?

Dr. Paul Campsen: The diabetics who come to us hate their diabetes so much and they're so scared by it, and their so scared by brittleness of their, meaning they go too high with their sugar or too low, that they would do almost anything not to have to use insulin anymore, but they're scared because surgery is a big deal. The vast majority do very well with this surgery. It's very safe. They stay in the hospital for about a week afterwards, but the moment that they leave surgery they're not a diabetic anymore.

Interviewer: That's pretty amazing, isn't it?

Dr. Paul Campsen: It is pretty amazing. Many of the patients that come to us, their diabetes has also ruined their kidneys, so they're on dialysis at the same time. We'll do a simultaneous pancreas and kidney transplant. The moment that they leave the surgery the next morning they're cured of their diabetes and they're cured of the their renal failure and they're not on dialysis. The other thing that's very interesting in these patients is if you just give them a kidney transplant their Type 1 diabetes will still attack the kidney transplant.

Interviewer: It just kills that organ.

Dr. Paul Campsen: That's exactly right. The pancreas transplant added on top, because it cures the diabetes, actually protects the kidney transplant. Then both organs survive much longer.

Interviewer: Who would be a good candidate for this type of surgery?

Dr. Paul Campsen: I think anybody who has Type 1 diabetes. We're talking about unfortunate people who were diagnosed with diabetes probably before they were 20. We'd like to see these patients well before they get into their 30's. The earlier we see them the better.

Interviewer: OK. What are your final thoughts for somebody that has Type 1 diabetes and is a little on the fence?

Dr. Paul Campsen: I think basically this is a safe surgery. Coming and seeing us doesn't mean we're going to trap you and give you the surgery, but it's something where we can talk about it and see if this is the right surgery for you. If it is, we can cure your diabetes. If you have kidney problems we'll take care of those too.

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