
Allison Smart, Alliance to Protect Insulin Choice president and T1D mom, on fighting to restore Levemir via biosimilar—why detemir matters, regulatory roadblocks, patient choice, and real-world impacts. Free (non Facebook) ** Use code...
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Welcome back, friends. You are listening to the Juice Box Podcast.
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My name is Allison Smart. I'm the president of the alliance to Protect Insulin Choice where you want to get a biosimilar of Levomir to the market. I'm also the mom of a teen with type 1 diabetes.
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This episode of the Juicebox podcast is sponsored by Skingrip™ durable skin safe adhesive that lasts your diabetes devices, they can fall off easily sometimes, especially when you're bathing or very active. When those devices fall off, your life is disrupted and it costs you money. But Skingrip patches, they keep your devices secure. Skingrip was founded by a family directly impacted by type 1 and it's trusted by hundreds of thousands of individuals living with diabetes. Juice Box Podcast listeners are going to get 20% off of their first order by visiting skingrip.com juicebox while you're listening, please remember that nothing you hear on the Juicebox Podcast should be considered advice, medical or otherwise. Always consult a physician before making any changes to your healthcare plan or becoming bold with insulin. Foreign the episode you're about to enjoy was brought to you by Dexcom, the Dexcom G7, the same CGM that my daughter wears. You can learn more and get started today at my link dexcom.com juicebox this episode is sponsored by the Tandem MOBI system, which is powered by Tandem's newest algorithm, Control IQ technology. Tandemoby has a predictive algorithm that helps prevent highs and lows and is now available for ages 2 and up. Learn more and get started today at tandomdiabetes.com Juicebox My name is Allison Smart.
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I'm the president of the alliance to Protect Insulin Choice where you want to get a biosimilar of Levomir to the market. I'm also the mom of a teen with type 1 diabetes.
A
Real how did you start getting involved in this?
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Well, should I start at the beginning?
A
I think that might be the best place. Yeah. Alliancetoprotectinsulinchoice.org Right. I just typed in Alliance Insulin and you came right up. That's very good marketing. Good job.
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I'm glad. Good, wonderful.
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Tell me your story.
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Okay. Almost four years ago, my then 13 year old daughter was diagnosed with type 1 diabetes. The first few months I think are similar. Most people that are diagnosed, you're just fumbling around trying to figure things out. Sure hated the wide blood glucose variations. You know, just felt calmer when things were in a narrower range and started doing a ton of research. I researched the different types of Levemir Insulin. You know, it's fascinating. At diagnosis, the physician said, find out what your insurance will cover and we'll make it work. But we looked into it, and there's actually real differences between the basal insulins. And I just found Levomir. And we started using that, and we made some lifestyle changes. And for the next several years, things were really going quite well. We really felt like things are dialed in. My daughter's a tennis player, plays tennis nearly every day. We had little disruption to her tennis from type 1. And then November of 2023, we heard the announcement that Novo Nordisk said they're discontinuing levemir from the US market effective December of 2024. And that's when I started calling people. I said, of course. Of course someone's gonna fix this. And called insulin manufacturers and pharmacists and even legislators and advocacy organizations and said, of course we're going to fix this. And I learned pretty quick that no one was going to. So I connected with many around the country and even around the world, and we started this 501c3 nonprofit called alliance to Protect Insulin Choice. And that started the journey. So it's been a year and nine months.
A
I have questions. So tell me, what year was your daughter diagnosed?
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20. 21.
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21. And how old was she at that point?
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13.
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13. Does she use MDI still today?
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Yes, she does. She did try a pump for several months. We did it for three months. And for her, I know everyone's different. It's all about you figure your own management. Right. For her, it worked great during the week, but when she played, she likes to play in tennis tournaments on weekends. That's common for us. And we just couldn't figure out how to keep our blood glucose in that narrow range that we're able to reach with Levemir. So we went back to mdi, and it's been great.
A
Okay, so she's had diabetes now for a handful of years. You started with Levemir, you had some success with it. So for everybody listening, why can't you just use Lantus?
B
So we did use Lantus the first about four months, and then I researched it and asked to switch to Levemir. We did try Basaglar, which is still glargine. It's a biosimilar of Lantus. We tried that last year for a few months, just again to see. See if we could easily make the switch. And again, it was tough. We keep things in a tight range with a menstrual cycle and with athletic Activity. We're able to slowly move Levomir up and then back down through a typical cycle for her. And she has less than 1% lows. She just. It's excellent management, and we have a more difficult time with Glargine.
A
Okay, and when you were on a pump, it worked all week, but it didn't work on the weekends. What pump were you using?
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It was the T slim.
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And were you using the algorithm?
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We used basal iq, and that's also been removed from the market. The thing I didn't like about control IQ was the 110 target, because she feels best when she's lower than that, and that's why we were using basal iq. But then on tennis tournament days, we'd try and figure that out, and it just was super difficult for us.
A
Okay, so my daughter used Levomir. Now, I'll give you some background here. My daughter's 21 now, and when she was first diagnosed, they gave her Lantus and. No. They gave her. Yeah. It's been so long ago, Allison. I don't really remember the pathway to it anymore. But we ended up with Leve. We had to split it. We would always split it because we found it didn't really last 24 hours. And so we'd give her half her dose of Levemir every 12 hours. And that, you know, worked well for us. Do you have any idea what it is about the injectable basal insulin that you're choosing that makes Leve like. I mean, because this is a pretty big thing you're doing here, right? Like, you started a 501C3. You're out there swinging hands, trying to get them to keep making Levemir. I don't imagine they're going to. Maybe you'll tell me you're having some success. We'll find out about that. They're phasing it out. Most people use what traceba now, like, those kind of more modern injectable basal insulins that kind of last more than 12 hours. The problem with Leather Mirror was It didn't last 24 hours. The problem with Lantus is that it doesn't quite last 24 hours. But are you using that somehow to your advantage? Is there something about the profile and the duration of Levomir that is advantageous? Can you explain to me why it's more successful for you?
B
Yes, I love that question. And first of all, I just want to address something else. You said people think we're trying to get Novo Nordisk to switch course and continue to make this that's not our goal. That's not going to happen. We want this manufactured by another manufacturer as a biosimilar, as a generic. We would like Novo Nordisk help. So far they're not helping, but if they would, and we are communicating with them, if they would assist, there are several different ways they could assist. And I could go into that if you want. But I want to go back to your other question of why we like Leve so exactly. Levemir is usually split for people. The flexibility of it, that's seen as a drawback for some is the huge advantage that we absolutely love. So most people that use Levemare use it twice a day. Some even use it three times a day, and there are some that use it once a day. And I'd like to just go into that a little bit, please. So Levemare lasts one injection, lasts approximately eight to 14 hours, which is awesome. And just an example. I've been to DC, I mean, 11 times in the last year and a half. I spent a lot of time in Senate and congressional offices. And there was one aide I talked to and she said, I just had a baby last year. I had gestational diabetes. I used Levomir. I took my injection at night. It was perfect because I only needed it at night, I didn't need it in the day, and it wore off when I didn't need it anymore. So that's just one example. And I do talk to women who are diagnosed later with lada, latent autoimmune diabetes in adults, and some of them will go for a while without needing insulin. And then when they start insulin, I talked to some women who love Levemir, the same reason they only use it once a day, because likely these women only need it once a day. I love the twice a day dosing because when my daughter's insulin needs start changing, we can see that and we can bump it up faster and there's not the overlap. So most people that use Glargine, which Lantus, Basiglar, Assemgle, even Tuheyo is extra strength glargine. But I'm talking about like Lantus, some people do split it, but there's a little more overlap. It doesn't take action right away. And Traceba, most people take that once a day, but it lasts 42 hours, so there's a much longer tail. It's difficult with Traceba to make quick changes. People that like pumps, we use Levemare a little bit like a pump. I mean, I know that you've said you love that you can kind of mess around a little bit and try a little more or a little less. That's exactly. We've just learned this trend with Levemare. To me, I picture it like riding a boat on a little gently rocking wave, and we will rock up. I don't make quick changes, we make slow changes. But if I can see the night before, it just wasn't enough, I'll bump it up for the day or vice versa. We have teen boys. It's pretty common that when some of them that have pretty tight control have much greater insulin needs in the day versus the night or vice versa, and they love that ability to titrate Levemir to those needs. So I guess in a nutshell, what some see as a disadvantage, that it's got a shorter time of action, is a huge advantage for many of us.
A
It's a tool, and you use it in a very specific way.
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Exactly.
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When you tell this to people, I'm imagining that they respond to you and say, well, yeah, you tried baza iq and you know, but, you know, there's a lot of new algorithms now. You don't want the target lower. Try the twist pump. It targets lower. Like, is that what they're responding to you with? Instead of saying, like, I want to help you figure out a way to keep this tool that you have that you. That you use and love, are they just trying to give you other ways? And if that's happened, have you had any quiet moments by yourself where you thought, maybe I am fighting the wrong fight and I should just try this again? Or are you. I guess I'm wondering how you got to this level of, gosh, what's the word I'm looking for? Like, I don't know, enthusiasm about it. Like, what's got you dug in for?
B
Sure. Love that question. So she hasn't wanted to try an omnipod for a couple reasons. And my feeling is she's going to need insulin for the next many decades. I know people will say that often, you know, we'll try this other pump or try this other algorithm. You'll get great control. I know we could probably do that. We probably could dial it in. To me, it comes down to choice. And you've talked about this before. I think if there are good options, we should have good options. And the conversation that is often the response I get in the diabetes community, outside of the diabetes community, I don't get that at all. But it goes further. Even people that use insulin pumps need backup long Acting insulin. I know there are people who have been able to successfully use a pump every day for 10 years, but I have many more who say I used to pump great, I can't anymore for whatever reason. We could go into that if you want, but I just think we need multiple options of backup insulin, even for people that use pumps. So to me, and here's the other bigger issue, this could happen with anything. What's to guarantee Trecebo will stay on the market? What's to guarantee one pump manufacturer will stay? I just think in this issue there's a company that wants to make this. They've been waiting to make it. What's in the way is the regulatory system. It's so difficult and expensive to get a generic to the market that it's almost cost prohibitive. And I just think that needs to change because we are heading into a world where our option is Glargine. And just one other thing I need to mention. Insulin manufacturing has been dominated by three manufacturers. It was two for a lot of decades and then the last couple it's been three. That's shifting. Two of the three insulin manufacturers now make weight loss drugs. They are not as focused on insulin anymore. So especially Novo Nordisk makes 52% of the world's insulin. Yet they're sending the message. They're saying we are consolidating our global insulin portfolio. So new manufacturers are coming to the market. We know of at least six manufacturers who are bringing generics biosimilars of insulin to the market. They are all working only on Glargine and on Aspart and Lispro. Aspart and Lispro are fast acting Hemolog and Novolog. The only long acting generic coming to the market is Glargine. So this is a problem. A company wants to make it, why can't we figure this out? And that's what I'm doing.
A
What company wants to make it?
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So it's a small company, they're called rbio. They've been working on bringing insulin to the market for about six years. They haven't yet. And so then the comment I often get is why don't you get an existing insulin manufacturer? And we have talked to most of them and most of them don't want to do Detymir. So Denimir is the generic name for Levemir though there's no generic. And that's a big question. We can go into that if you want.
A
My question is why don't they want to like they take yourself out of your predicament for a minute because now you're pretty steep in this. So you must understand it from a lot of different angles, right? Nobody doesn't want to make something they can make money with. So is there just not a lot of users for it or are you seeing them just say, kind of blindly, well, there's more modern, better insulins that last longer. We're going to focus on them. Like, where does their focus seem to be when you talk? This episode is sponsored by Tandem Diabetes Care and today I'm going to tell you about Tandem's newest pump and algorithm. The Tandem mobi system with control IQ+ technology features Autobolus, which can cover missed meal boluses and help prevent hyperglycemia. It has a dedicated sleep activity setting and is controlled from your personal iPhone. Tandem will help you to check your benefits today through my link tandemdiabetes.com juicebox this is going to help you to get started with Tandem's smallest pump yet that's powered by its best algorithm ever. Control IQ technology helps to keep blood sugars in range by predicting glucose levels 30 minutes ahead and it adjusts insulin accordingly. You can wear the tandemoby in a number of ways. Wear it on body with a patch like adhesive sleeve that is sold separately. Clip it discreetly to your clothing or slip it into your pocket head now to my link tandemdiabetes.com juicebox to check out your benefits and get started today. You can manage diabetes confidently with the powerfully simple Dexcom G7. Dexcom.com juicebox the Dexcom G7 is the CGM that my daughter is wearing. The G7 is a simple CGM system that delivers real time glucose numbers to your smartphone or smartwatch. The G7 is made for all types of diabetes, type 1 and type 2, but also people experiencing gestational diabetes. The Dexcom G7 can help you spend more time in range, which is proven to lower a 1C. The more time you spend in range, the better and healthier you feel. And with the Dexcom Clarity app, you can track your glucose trends and the app will also provide you with a projected A1C in as little as two weeks. If you're looking for clarity around your diabetes, you're Looking for Dexcom Dexcom.com Juicebox when you use my link, you're supporting the podcast Dexcom.com Juicebox Head over there now.
B
So they want to make the most common insulins and if you look at a pie chart, Glargine is the most common insulin made it has about 40% of the market. The next common are Aspart and Lispro, the short acting insulins. The next one, just as recently as 2022, was Dedamere. It had about 8% of the market. And then behind that at that point was Traceba. Now Traceva of course has surpassed that. Glargine's the easiest insulin to make, it's the cheapest. There's a clear path. Dedimir has not been a clear path. The patent was over in 2019. I talked to one insulin manufacturer in India and he said we were working on bringing a biosimilar of Dettimir to the market. But as soon as Novo Nordisk announced they would remove it from the US market, we stopped. They said it's not worth our time or our money to work on this. If you look at the history of insulin, many insulins have been removed from the market and they don't come back. And that's a complicated scenario too. The other thing, in the pharmaceutical industry, most big manufacturers are looking for the next blockbuster drug, the next Ozempic, the next billion dollar drug. That the talk is not about bringing back a generic to the market. That's just not, it's not what they're focused on. So yes, there generic manufacturers. One other example, there's a generic manufacturer called Civica in Utah and they're working same thing. They're working on Glargine, Aspart and Lispro. And I said, can you add Dettamere? And they said, only, number one, if Novo Nordisk helps US and number two, we would need an additional $50 million. So a lot of these companies, it's very expensive and they want something clear. And they look at the market and they say, look, we haven't had enough insulin. There just isn't a real acknowledgement that there are varieties of insulin. So we are heading to a world where when you say I use insulin, it is just insulin, because that might be our only variety. But I like to use the example. It's well known that some don't tolerate certain pain relievers or some don't tolerate certain antibiotics. Your physician doesn't bat an eye when you go and you say, I didn't love that pain reliever, I was nauseated or I was allergic to the antibiotic. They give you a different one. It's fundamentally about choice. Dedamere and Glargine have a different mechanism of action and different qualities. It's not just the duration of action, it's also the manner in which Your body uses that insulin, and we need that option. There are some that just don't tolerate. There are even some who tolerate Glargine for a while, and then they don't. I just think we need options.
A
Yeah. Make the counterargument to, like, I'm going to try to play devil's advocate for a while. So, like, I want to be clear before I start talking. I understand what you're saying. I'm with you. I completely get it when the argument is you could use a pump and use Novolog or Humalog or my daughter uses a Piedra, one of those fast acts, and just completely eliminate this basal insulin altogether. And you don't want to, and that's fine. But I don't want to spend $50 million to make leve, and nobody buys it. What's the argument there? Like, if you were in the room with Civica and they're saying, look, we need help that we can't seem to get from Novo, and on top of that, we need $50 million to make it happen, what do you say to them beyond what you've just said to me? You know, like. Which is all very touching, and I'm. I'm not heartless to it at all, but, like, I'm wondering, like, what's the argument beyond we should have it when their response is going to be, listen, there's Tresiba, there's Baz Lagar, there's Lanta. Like, there's other options for you. You're not going to die from this. So, like, how do you argue back against that?
B
Oh, I know that's a great question. So couple things again. People need backup for pumps, and there are physicians who prefer Levemir as a backup because of the shorter action. I have one physician who has a practice of pediatrics, and he feels like a lot of his teenagers have a lot of adjustment difficulties dealing with Type one. And if he helps them have pump breaks, like in the summer, and Levemir is the one he loves to use, people use long acting when they're first diagnosed. If someone needs an mri, you need backup. And when people say there are many options, there really aren't. There's really Glargine or Traceba. We haven't used NPH in our argument because that's an intermediate insulin. It's not seen as a realistic alternative.
A
Right.
B
And the other thing I need to bring up, it wouldn't be $50 million for every company to do that. That was just for a nonprofit company. If it's for profit, yeah, yeah. This company can do it for 20 million to get it started.
A
And they want to. Let me stop you. And they want to, because they're not making anything right now. So even a few percent of the insulin market for them would be a big deal. Is that right?
B
Yeah. And here's another thing. The larger market is going to be very divided. There will be six to ten producers of glargine in several years. So you take that 40% of the insulin market, divide it by up to 10 companies, they're looking at 4% of the market. The Levemir market is a bigger pie. Denim. Here's the other reason it would be cost effective. Now, I'm going to kind of take a little bit of a tangent.
A
Go ahead.
B
Insulin used to be over the counter. It didn't require a prescription at the federal level until 1996 when Humalog came out. And then Lantus came out in 2000. Deadmare 2005.
A
Allison. My friend Mike used to need a prescription for his syringes, but not for his insulin.
B
Yeah. Yeah. I've talked to people who have had diabetes for 50 years, and they've said, one woman in particular, she said, I was a struggling college student in the 70s with no job. I could go down to my pharmacy, buy my insulin for $2, no prescription. Asked. It was behind. You have to ask the. Had to ask the pharmacist because it's in the refrigerator. But she said it was easy to get as band aids. And she said, now I can't. As these new insulins came on the market, the argument was the newer analog and human insulins require more oversight. So we need a prescription and the request has to come from the manufacturer. When that happened is when our market for insulin, when it became really expensive, it was already dominated by these few manufacturers, but we really became at the whim of PBMs and insurance companies. And so here's the argument. Regular and NPH insulin have always been over the counter at Walmart. Right. So this manufacturer would be interested in having in requesting that this be over the counter. And the argument would be that this isn't a newer insulin anymore. It's been widely available for 20 years. Why can't we get this over the counter? Can you see how much more lucrative it is at this point? Even if it's a good price, your market becomes not just former Levemir users, who, most of which have moved on to other methods. But it's a much wider market, and it's part of our argument also we should Be able to have easy access to the insulins and even the method of delivery that we want. When you. You understand that once you have type 1 diabetes, you have to make changes pretty quickly on your own. And there has been no documented harm from having R and NPH stay over the counter. So that's part of our argument.
A
How much RNMPH is still being purchased throughout the country?
B
Do you know, I have a pie chart. I can't remember the exact. I mean, it went in that order. It went. Glargine was 40%. This is 20, 22.
A
Okay.
B
The next common were Aspart and Lispro, and then it was Levomir and then it was Tresiba, and then it is nph. NPH and R are still important for R is what's used in hospitals. And NPH still has a need to. NPH is used often in pregnancy. The pregnancy argument is a big part of why we're working on this also.
A
Okay, what is your level of belief that this is going to work out in a positive way for what you're trying to accomplish? Do you really think this is going. You're going to get somewhere and get this accomplished? And if so, what is the path to it?
B
I actually do. I absolutely do. Because I can't see a future without this. I can't see a future with just Glargine and who knows what happens to Tresiva. So here's the thing. If Novo Nordisk were to help us in some way, there are several ways they could. They could sign over the right to manufacture. They could involve, could help with some sort of contract manufacturing or license it. But you and I realize they may not help, right? Even if they don't help, then we need regulatory help and financial help. And as I am talking to many industry leaders about this, they recognize that this is important. And I think we're gonna be able to figure it out, really. So here's the bottom line. This has been widely available for 20 years. This company already knows how to make it. It is off patent. Novo Nordisk has stated they won't assert a patent against it, they won't litigate. I absolutely believe this is gonna get done. We just have to figure out how.
A
When you say they need to sign it over, is that the thing they're not doing right now? The company you mentioned is ready to make it? Or did they just need Novo to be like, oh, yeah, cool, here it is, and give it to them and that's not happening? Or what is the sticking point right at this moment?
B
So that could happen. But let me make it clear, we're not trying to force them, and I'm not trying to have US Government leaders force them. Our advocacy is more. How can we get our leaders to help us get this through the regulatory process? So Novo Nordisk has.
A
Wait, let me stop you. So you don't think that the pathway through this is finding somebody at Nova who just goes, ah, fine, all right, here you go. That's not what you're shooting for.
B
That's a pathway. But I just want to make it clear that that's not the only pathway. And we're not asking to force them.
A
Right, I understand. I'm asking what, like, functionally, what did they. If that's the pathway that ended up being the way that it worked, what would have to happen? Like, functionally, what needs to happen on Novo side to make it make this other company eligible to make the drug?
B
So you can actually sign over the FDA rights to manufacture something. It's actually a piece of paper, and it's more complicated than that. But if they were involved in the process, they could. So there was. And I want to make it clear I'm not badmouthing Novo Nordisk. I understand their business, and I understand it makes perfect sense that if you've got Ozempic and Wegovy that are much more lucrative, that you're going to devote more resources there. But if they were to assist us, we could get this done easily. But remember, that's not the only path. If we still get help on the regulatory angle, it shouldn't be this hard to bring something to the market. It's kind of silly that our regulatory process is so time consuming and so expensive to get through.
A
Well, I mean, listen, it occurs to me that you have a small problem and a big problem, and the big problem is not fixable by you, me, or anything we can do. But the person at Novo who could make that decision, are they aware of your desire?
B
Yeah, we're. We're talking about it. So when we started this, I emailed the former CEO several times, and either he or his care team did respond to me. So, a year ago, September 24, there was a Senate help hearing. And the purpose of that hearing was to talk. They brought in the then CEO of Novo Nordisk and discussed the high price of Ozempic and Wegovy. And several of us from my organization actually met with Novo Nordisk Executives in Washington, D.C. the day of that hearing. And we had worked for several months. So even though the purpose of that hearing was to Talk about the high price of Ozempic and WeGovy. Several of the offices told us, well, your issue is related and this could be brought up in the hearing. And it was. And we worked with constituents. There's 21 senators on the help committee and we worked with those Senate offices and three senators ended up addressing Levemir in that help hearing. So I want to fast forward since then. Lars Jorgensen, the then CEO, is not the CEO anymore. There's a new CEO. So I emailed him and asked if we could discuss some path forward. And we have had a meeting, several of us on both sides, and those talks are still ongoing.
A
I'm looking at something right now. I'm trying to do my best to figure out how much they're actually making selling levees. Are these numbers right? In 2023, Novo Nordisk reported 3.93 billion in sales of Levomir.
B
I know that in 2018 it was 1.8 billion. We know that in 2022 it was 649 million in the U.S. it's. It's a little hard to get those figures. So your figure of.
A
Wait, wait, hold on a second. I'm not sure I'm learning something more here. Oh, this is Danish Crohn's.
B
Yeah, it's different.
A
Yeah. So that turns into $571 million U.S. that sounds like a lot of money. But I think if you look at it this way, it not. In the fourth quarter of 2024, we go sales more than doubled year to year to 19.87 billion Danish Crohn's, which is 2.76 billion for that quarter. So I'm pretty sure that If I take 2.76 billion for the quarter in 2024, fourth quarter, and I subtract the $571 million that they made the entire year before in 2023, what I would come up with is it doesn't matter. Just let them make the insulin. Isn't that how it feels to you?
B
Right. Yeah, exactly.
A
What I feel like I'm hearing here is, is that this thing that they think of is as old and useless and not going to be used anymore. Right. They don't want to get. I imagine they don't want to give it away because what if. Right. It's the same reason I can't get my wife to throw out half the stuff in my closet, I imagine, is that she keeps thinking like, well, what if we need it one day and so couldn't they lease it?
B
There's all sorts there's. Not just one path. There are many things that could happen.
A
But for sure, yeah, because I'm imagining, like, what they were really concerned that, I don't know, something crazy was gonna happen. Like lease it off to this company for a decade, let them make it for 10 years.
B
Exactly. And that's basically what licensing is. And they could still get a profit from that.
A
Oh, and you can make money from it, right? Ah, come on. Okay. Okay, so what we need is for someone inside Inovo Nordisk to hear this.
B
That would help. That would help.
A
Yeah. Alison, I'm gonna take care of that for you right away. Don't worry. Okay. Okay, well, consider that part done. And you're making a good argument for them so that they can understand the reason. I'm going to still tell you. I'll play devil's advocate again. Alison, how old's your daughter?
B
She just turned 17.
A
17 years old. Send me with her to play tennis this weekend. Give me any insulin pump you want. I can make her blood sugar good. That argument there, because I'm sure you've bumped into it before, is are you sure you just don't know what you're doing? Explain to people. Either you, A, because my assumption is A, you just don't want to and it's a choice thing for you, or B, you know how to do it, and again, you don't want to wear a device or whatever, which is always fine, or C, the answer is you really don't know what to do, and that would be something. So can you be honest enough to tell me, is it? Is it? I don't want to. It's a choice thing. Or I really don't know how and I can't figure it out.
B
No, this is a great question, and let me give you a couple examples. So we were at a tournament a month ago, and on the port next to my daughter, while she was playing, there was another teen girl and her coach was saying, take insulin. Take insulin. He was yelling it. And it was interesting. The next day we talked to that coach. The tournament was several days. Turns out the coach was her dad. Turns out she was at a level of 550. She uses the Omnipod, has had type one for several years. This was a well experienced family. And I want to come back to that in a minute. There's another girl who we know, who's a friend who was diagnosed a year ago, who's a tennis player. She's not been competing the last few months. She's been using an omnipod. She's not been competing because they haven't been able to keep her blood glucose in a tight range for play. Now, I understand that some people can get this to work, but I do understand that sometimes there are pump failures, and sometimes things happen and people want backup. So it does come down to a choice issue for me. I'm sure if we tried that and figured it out, we could probably figure it out. I just feel like our method, say we use that and it doesn't work and we want to use backup. Glarging is just harder for us to handle. And there are some people who. There are other things about glarging that make it difficult for some people. I just. I really. It really comes down to choice. I think we should have the ability to choose.
A
Okay, so I'm going to make a different argument now. Okay. And I don't discount yours at all. And I'm on the side of your argument. I'm gonna say this. My daughter played high competition sports on an omnipod before the algorithms even, and she played most days at a 90 blood sugar, and she wasn't crazy low afterwards or didn't get high. I have never seen a 500 blood sugar in my life. If you're seeing a 500 blood sugar, I believe you're fundamentally misunderstanding how insulin works, whether they have a lot of experience or not. I can tell you that I've had conversations with people who've had diabetes for 20 and 30 years who have A1Cs and the 13s, and then I explained to them how insulin works, and then their A1C goes down to 6. So sometimes this is really a question of people don't have the right tools. And even if they have the tools, they often don't know the right way to use them. So it's a very common problem, especially with diabetes, that does not in any way negate your argument. I'm trying to tell people who are listening right now, who are probably some of them thinking, like, oh, come on, just get on a pump and figure out what you're doing, right? Like, if that's what somebody's thinking, that's not the argument. I appreciate your choice argument, and I actually think it's a bigger conversation than that. I hear you kind of going over it. You don't dig too deep into it. But what you're saying is, yeah, today it's Levomir, but maybe tomorrow it'll be something else. And what if 10 years from now it's this and there's no good replacement now? Right again, I'LL make the opposite argument. I told you about my friend Mike earlier. He was diagnosed when we were kids in the 80s. Mike's gone. Mike's not alive anymore. Somebody put him on regular mph and then the world changed. The Lantus and Novolog and Humalog. And he didn't change along with it. And by the time a doctor got ahold of him who understood how things were being done in a modern way, it was already too late for my friend and his kidneys didn't work. So you can also make the argument that, Alison, as much as this is working for you, there may be something over the horizon that's even better. We need to get to it. And we're not going to get to it if we're still making Levemir. However, that's not the case. It's not like you're asking us to tie ourselves to a rock and not move forward. You're saying, fine, go do whatever you're going to do with the rest of this stuff. But this is a very small financial outlay for somebody. They can still make a profit off of it. And for the people who want it, here it is. And I'll tell you, if they have the manufacturing space to do that, then why not like. Like you said, they're going to make $571 million is not a small amount of money. Right, but it is. You know, if you're making. What is the number here? 2.7 billion times four a year? What is that? 2, 4, 6, 8, 9? 10 and a half? Is that 10 and a half billion dollars on Wegovy in a year? Oh, my God. No way. You can't cut 571 off of that and just leave these people alone and let them have their insulin. And your arguments aside, whether they're right or wrong, and I'm telling you again, I'm coming out and telling you, Alison, fly me out to where you are. I'll get your kid's blood sugar straight for you. And I'm not saying you can't do it. I'm saying I can. But that's not what we're talking about today. And for anybody who thinks that, that's the argument to what Allison's saying. I think you're misguided. Your argument should be there's no reason not to do this and choice is important and all the other stuff, you know, like it's nice to say that insulin used to be $2 and it should be that again. It's never going to be like that.
B
Again, Right? Oh, I totally agree.
A
Right. Like, that's not how the world works. But you're not here making a Pollyanna argument, which I really appreciate because I've heard those arguments made before, you know, as an example, on behalf of, you know, the cost of insulin. It shouldn't be that much. I shouldn't have to pay for something that keeps me alive. You're all right. Like it. You're. I agree with you a million percent. But someone's making a lot of money off it. They're not going to stop. They're not going to stand up tomorrow and go, hey, you know what? I don't need the $10 billion. Just take it like, that's not how this is going to work. And I appreciate that you're not making that argument. And I'm wondering, what can people listening do to help you along the way? Is there something they could be doing to amplify your voice?
B
Yes. And I just want to address one other thing, please. I am not anti pump and I totally agree with what you're saying. I think, you know, if you try different things, you can find things that work. Pumps have been fabulous tools for many. I am not anti pump. I'm not.
A
I just think you don't come off that way. Yeah, I'm making all the arguments in the people's minds that are listening so that I can say at the end. But that doesn't really matter, does it?
B
Right.
A
There's still money to be made on Levemere. Let somebody go make it. And if it's not going to be you, then what are you sitting on it for?
B
Exactly.
A
Take a piece of it, give it off to that company. Ask them for a piece. They'll give it to you and let them go. Make Levemir for you and let Alison's daughter live her life and everybody else who uses it and take a little bit of money and be done with it. Why do you have a 55 year old typewriter in the top of your closet you're never going to pull down again? Because that's what this is to them.
B
So the other thing, we don't even need pens. We just want the liquid. Just little vials would be. Because that was an argument first. You know, they needed. I mean, the pens were needed for Ozempic and Wegovy. It's so much bigger. The more I've gotten into this worldwide development of insulin. It's just such a shame that it's been so consolidated. And the other thing with pumps, I know I'm A little bit all over the place.
A
No, you're not.
B
I think I would want to try some, but I just want good backup. Insulin. So I totally agree. And then what? Another thing you said, what can listeners do? So I do want to address this one. So we talk to legislators often. They know this issue. I wish they would hear it more. They'll hear us, and then they'll go, huh, this is a problem. So they'll talk to big advocacy organizations or others, and the message comes back, oh, this isn't that big of a deal. If more people would speak up about it, even people who aren't Levomir users. If people would. And send a message to your legislators. Because really, we need attention from the fda. So the FDA has viewed insulins as basically interchangeable, which has been a real problem. Some Senate offices reached out to the FDA last year when we came with a lot of physicians who specialize in diabetes and pregnancy who said, this is really important for pregnancy. So they went to Novo Nordisk and they said, how can you discontinue this one if we have physicians saying this is important for pregnancy? But since then. So we filed a citizen petition with the fda, with physicians and some small organizations in April, and then the FDA said, okay, well, now we have 180 days to respond, so they won't communicate with us. So we need help with the fda, and that needs to come from legislators. So everyone in the US has two senators and a congressional representative. So it would really help if you reach out to them. Reach out to our organization. There's a way on the website you can leave your email. That would really help us. We do not have. We haven't focused on the funding side, and we need to focus on that more. So back to your question of how can people help if they can reach out to the legislators and communicate with us and say, how can we help? Because it's changed over the last year and a half. The messaging has changed, and it's nice if people are interested in this. If they reach out.
A
Yeah. But in the end, what we really need is for Dalstar to just do this. Right? Like, it needs to get to the CEO. And I'm gonna tell you right now that if the CEO of Novo sits up tomorrow and says to somebody, hey, let's make it so that. What was the name of that company that wants to make the leve.
B
Our bio.
A
Yeah, let's work it out so our bio can make leve. It'll get done tomorrow.
B
Exactly right.
A
Like, he's gotta say it out Loud. And then it's gonna happen. And then $571 million comes off the sheet. Okay? You're gonna get a piece of it back, and you'll get a piece of it back for longer because you're going to stop making it anyway. So you can lose 571 a year for the next 10 years or take 10% of 571 for the next 10 years. That's just money coming in that you don't have to do anything for. But my other thing to say, you're like, if he was listening to me right now, I would say this. I'd be like, mike, listen, goodwill, man. Like, way to buy goodwill in the diabetes community. And don't discount that at all. In a world where people already think you're overcharging them for the thing that's keeping them alive. And they're right. In a world where they think that the only reason that insulin's getting cheaper is because somebody's making you make it cheaper. And they're right. And in a world where they think you're more worried about Wegovy and. And, you know, Ozempic and the fact that Manjaro seems to work differently and your stock price fell, like, where they think that's what you're worried about and they're right, why don't you do something nice for them?
B
Exactly.
A
Yeah. Why don't you just say something out loud in the middle of your office and make it happen? Wave your magic wand. Make it happen, and then go out in the world and tell them about it. Let me be cynical for a second. I'd run a campaign behind it if I was you. I'd be like, listen, here's what we did for you. My gut, like, how do you not see that from a marketing perspective? Reach out to the diabetes community and go, look, this was coming off the books, and most people don't use it. But here's Allison and her daughter and the other people who use Leve still. And even though it was not financially a good idea for us, we made sure that this still existed for you. You don't see what, like, the bright sunshine that would put on Novo in the diabetes community, by the way, a diabetes community that one day you're hoping is all going to use a GLP medication. You don't want them to, like, think Novo Nordisk did something good for us. So there's me being cynical and still trying to figure out a way to make this work for you. Unless I don't understand the downside of them signing off and letting this happen, maybe he could cop on here and tell me something. I go, oh, Allison, you're screwed. They can't do that. Like, maybe I don't know their side of something. And I completely am willing to believe that I don't really know a lot about anything. But from my perspective, from your story, from understanding the bigger world, I just don't get why they couldn't just do this. Just be cool, man. Like, how hard is it to just do a good thing once in a while, right?
B
Oh, I totally agree. We would praise them to the sky. I would love. I would love them to, of course, fix this.
A
Yeah, of course. I don't mean to say $571 million isn't a lot of money, but in. In this grand scheme of things, it's not. And especially if they're not going to make it anymore, right? Like, oh, gosh, this must be incredibly frustrating for you, Alison. What happened? Like, what. What. What moment did you have? A Slowly I turn decided to get this far into this. Like, how did you not just let this go and decide, like, ah, I guess it's not going to exist anymore?
B
Honestly, it's about choice. This is a tough diagnosis. And when someone finds a method that works. Look, I think if. If Omnipod went away or one of these companies went away, there would be a lot of people doing, I think, what I'm doing.
A
Yeah.
B
It's so important. And I. As I delved into, you know, the long action time of Traceva and. And some of the other things about Glargine. Glargine hurts. Like it has an acidic pH of 4. And that might seem like a small thing for people, but for others, it hurts. Denomir and Deglodex don't have that. So Levomere and Tresiba.
A
Allison. That's why Arden stopped using Lantus. It burned, right? Yeah. I couldn't remember why it burned, so we moved to Levemir.
B
Glargine has to crystallize subcutaneously and then produce this slow. That's how it gets the slow mechanism of action. It has to be acidic. To do that, it has to be in an acidic solution. And it's also less predictable if you inject Lantus accidentally into the bloodstream. It's rare, but you can have an unpredictable hypoglycemic event. Denimir and Deglodeq don't act that same way. They bind with the albumin. So there's so many reasons that I feel more comfortable with My daughter. And again, she's going to use pumps, I'm sure, in her life, but I want her to be able to fall back on Levemir, and this is worth the fight.
A
Okay. Well, that's awesome. That's a great reason. Yeah. I can't believe you just reminded me of that. That was a long time ago. Yeah. Yeah. Because she was so little, we didn't realize right away then she could articulate it. And we were like, oh, I think this is. This hurts her when she's using it. And someone said, oh, go, then try Levemir.
B
Yeah. And people, it's pretty common. Like, kids don't mind their meal, insulin shot, but when it's time for their, you know, their basal, it hurts. And that's because it's glargine.
A
Yeah. My daughter can't use. What are the two faster acting ones? I can't think of the names anymore. All that money you guys spent on that race car, and I can't even think of the name. That must piss somebody off. What was it called? The faster acting. Maybe Loomjev or Loomjev she can't use. But the novo one, too. The fiasp, she can't use that either. Oh, that's so crazy. I've seen a. I've seen an F1 car with FIASP written on it. I can't imagine what that cost. And I couldn't think of the word fiasch just now. It burns. She just can't use it. So, you know, it's. It's tough for somebody. And if you have the power to make it easier for somebody, and it's really, literally not going to cost you anything, actually, it'll make you money then. I mean, I just don't get it. Like, I'm not calling the guy out directly. He probably doesn't even know about this, but I hope he hears it or somebody who works for him hears it, and I can almost guarantee that somebody that works with him is going to hear it. So that guy's. What are you doing? Just sign the paper, give it off to whatever the hell that company is, and let them make the thing. And what do you care?
B
Right.
A
That's my message.
B
I totally agree. And then just one last thing. So Levemir can be diluted. You can't dilute glargine and deglodec. It's not commonly done, but it is done. Again, another Senate office visit. I had the aides. Sometimes the aides are fellows and they're physicians. And one of them was Actually a child psychiatrist. And she said, I've personally diluted Levemir for children in an inpatient psychiatric unit. And I've had others who have said that. And so there's just some lesser known. Honestly, Bottom, the insulins are different. We shouldn't be left with just glargine. Let's just figure this out.
A
Yeah, no, I get it. I wonder, too, how many users that $571 million represents, because we're hearing your story and you're doing a good job on your website, by the way of bringing other people's faces out, et cetera. But you don't know how many people. Does that really mean how many people have a story, something like yours?
B
So. And I'll tell you, I do have some numbers.
A
Hundreds of thousands, I would imagine.
B
Well, 2021, there were over a million users of Levemir. 2022, there were just under a million. And of course, it's decreased since then. It's been harder to get the figures since then because. So I've called around, there's actually some Levemir still in some pharmacies right now. You couldn't order it beginning earlier in this year in the US it's still available in every other industrialized country, but it will leave the worldwide market. But you can't, like, if you want to get it, it's not covered under most insurance plans, and the coupons don't work anymore. So it's back to being very expensive, if there's any left. But back to your question as far as numbers. Certainly most people have moved on to another method, but there just is a big core group of us who are just. I mean, I have one woman who I talked to recently who's got still a pretty good supply, and she just said, Allison, God help us, she can't tolerate. For her, it was more complicated of why a pump is difficult. Pumps are expensive, too. Not everyone can afford them. But again, even pump users need good backup. And if someone doesn't tolerate glargine and you need a pump break. I have one woman who talks to me who she needs frequent MRIs for a condition, and she says, levomer's perfect because you can see it ramp up and you can see it drop off in that short period of time. She can't tolerate glargine, and she says, Tresiba has just got this super long tail. So if I'm using it for a pump break, it's really difficult.
A
Isn't Novo making Livomir overseas?
B
Yeah, we haven't Been able to find exactly where it's manufactured. That's pretty tricky. But they do have manufacturing facilities in. They have a lot. Right. In Copenhagen. But there's also some in North Carolina. There's some in other countries, too.
A
I would imagine. They're probably trying to move people to Tresiba. Right.
B
Well, see, that's the thing. And Tresiba is still patent protected, so it is more lucrative than Levemir.
A
Yeah, no, I mean, I understand all the. So there's the other reason, like, if you stop making Levemir, let's say it's 300,000 people who are still using it in the US just make a number. Right. If that made up number is accurate, those 300,000 people are going to get off Levemir and go to Tresiba. And then. So they're not really losing the money, they're gaining more money. So that's their argument. Their argument is, if I give it away, then you're going to steal those customers from me who I was going to get a different way. Ah, there we go. That's the argument for their side, right?
B
Yeah, maybe.
A
Yeah, I got it. I couldn't. I was trying to figure out, like, why would you not just do this thing? And that's why. Because they'll lose those people.
B
So I do want to just. I think. I think I need to bring history into this, please. Animal insulins, there used to be different varieties, different concentrations. There was beef, there was pork. There was, you know, different concentrations. They were removed from the market. Then there was. There was the ultralenti Lenti, semi Lenti that was removed from the market. We really. It's a problem that we don't live in a world where we could still get some of those, you know, for the people who can't afford a pump or who go on vacation and, you know, something happens to your insulin and I just. Not good things have happened to the diabetes community. And this is time. We need to turn this back just a little bit.
A
Yeah, let's.
B
Let us have continued access to this one.
A
Well, I wish you a ton of luck. I have to tell you that as I try to put myself in everybody's shoes in this conversation, and I have obviously limited knowledge of everybody's motivators, but I think that's the least of your arguments. I think that's the one that's going to get the least movement. I really do. I think you have to find a way where there's something that good that comes out of it for them. Like, you know, yes, they're going to still make a piece of it if they lease it off or whatever they call it. You know, that's not going to be as much as if you transfer those hundreds of thousands of people over to traceba users. But the truth is, you're probably more going to transfer those people off to being pump users. And then, I mean, they're not going to use that. That basal insulin anyway. They'll. They'll use more Novolog, Humalog, maybe. It just feels like there's not enough in here to overwhelm the goodwill that you would get out of this. And I do think there'd be a lot of goodwill out of this. I think this is a thing you'd hang your hat on for a decade afterwards, you know, and maybe it would be a little. Would even feel a little hollow, but to most people, it wouldn't. Like, you know, like, you did a thing for somebody when they were struggling and it cost you a little bit of money, but you thought the people and their happiness were worth it. Like these marketing things. Right. Themselves. Like, why don't you try looking at a different perspective on how this can be valuable for you as a company? And listen, by the way, no joke, I don't know a ton about business, but the CEO that just left, is it Lars Jorgensen? Right. He didn't just, like, decide to leave. Like, the stock price dropped, and they. They told him, this is time to go now. Then they bring in this next person. He. He's not looking for the stock price to drop because he'll be told time to go now, too. I just don't know if this is a thing that touches that price. I don't know if this is part of that argument or not. And I don't know money like that. I'm probably the wrong person to ask, but I'm asking for the people who do understand it to look for a way to make this into a good thing that you're doing. And that's it. That's my thought there. Yeah. Good luck to you. Geez, Allison, how much of your time do you spend on this?
B
Oh, a lot. A lot. It matters. It's worth it.
A
It. Yeah. All right, listen, do it just to give Allison a break. Yeah. She got stuff she wants to take.
B
That's right. Exactly.
A
She's like to paint the living room. You know what I mean? Like, it tell people, too. This is not your idea of fun. Right?
B
Right.
A
Yeah. Like, you're not looking to have these conversations.
B
Right?
A
Right. Yeah. You just would like it to be over. Well, I, I hope this helps. I hope this conversation gets to the right people and that they, they have a change of heart and, and they do. They do something that, you know, maybe they don't have a financial reason to do, but would just be a nice thing to do. So hopefully that'll happen.
B
I sure hope so. And I appreciate this. Glad to. Thanks for letting me come on.
A
It's my, my pleasure. Thank you again. Hold on one second for me, okay.
B
Okay.
A
Dexcom sponsored this episode of the Juice Box Podcast Learn more about the Dexcom G7 at my link dexcom.com juicebox box did you know that Skin Grip has donated over $100,000 in scholarships to help people with diabetes? The people at Skin Grip, they know what it's like to live with type 1 diabetes. They know what it's like when your devices fall off at the absolute worst time. And they're here to help. Skingrip.com juicebox Save 20% off your first order when you use my link. That's what you get for being a Juice Box Podcast listener. Today's episode of the Juice Box Podcast was sponsored by the new Tandem MOBI system and control IQ technology. Learn more and get started today at tandomdiabetes.com Juicebox check it out. I can't thank you enough for listening. Please make sure you're subscribed or following in your audio app. I'll be back tomorrow with another episode of the Juice Box Podcast. If you're looking for community around type 1 diabetes, check out the Juice Box Podcast. Private Facebook Group juice box podcast type 1 diabetes but everybody is welcome. Type 1 type 2 gestational loved ones it doesn't matter to me. If you're impacted by diabetes and you're looking for support, comfort or community, check out Juice Box podcast type 1 diabetes on Facebook. I am here to tell you About Juice Cruise 2026. We will be departing from Miami on June 21, 2026 for a seven night trip going to the Caribbean. That's right. We're going to leave Miami and then stop at Coco Cay in the Bahamas. After that it's on to St. Kitts St. Thomas and a beautiful cruise through the Virgin Islands. The first Juice Cruise was awesome. The second one's going to be bigger, better and bolder. This is your opportunity to relax while making lifelong friends who have type 1 diabetes. Expand your community and your knowledge on Juice Cruise 2026. Learn more right now@juiceboxpodcast.com JuiceCruise at that link you'll also find photographs from the first cruise. The episode you just heard was professionally edited by wrong way recording wrongwayrecording.com.
Episode #1652: Save Levemir
Host: Scott Benner
Guest: Allison Smart, President of the Alliance to Protect Insulin Choice
Date: October 14, 2025
This episode, "Save Levemir," spotlights the urgent advocacy efforts to maintain patient choice in basal insulins—specifically the fight to keep Levemir (Detemir) available in the U.S. market. Host Scott Benner is joined by Allison Smart, a passionate advocate, mother to a teenager with type 1 diabetes, and president of the Alliance to Protect Insulin Choice, as she shares her journey and the broader implications of losing Levemir. Their discussion moves from Allison’s deeply personal reasons, through regulatory and business barriers, to wider questions of patient autonomy and pharmaceutical industry priorities.
“I started calling people. I said, of course. Of course someone's gonna fix this... and I learned pretty quick that no one was going to.” — Allison Smart [03:36]
“The flexibility of [Levemir]... is the huge advantage that we absolutely love.” — Allison Smart [07:29]
“Your physician doesn’t bat an eye when you go and say, I didn’t love that pain reliever... They give you a different one. It’s fundamentally about choice.” — Allison Smart [16:33]
“The only long acting generic coming to the market is Glargine. So this is a problem. A company wants to make it, why can't we figure this out?” — Allison Smart [13:38]
“There’s a clear path [for Glargine]. Dedimir has not been a clear path. The patent was over in 2019.” — Allison Smart [16:33]
Potential Pathways:
Legislative Work: Allison’s group (501c3) is petitioning Congress and the FDA, emphasizing physician preference for Levemir, especially in pediatrics and pregnancy ([13:38]; [37:59]).
“If Novo Nordisk were to help us... There are several ways they could. They could sign over the right to manufacture...contract manufacturing or license it.” — Allison Smart [24:16]
“It shouldn’t be this hard to bring something to the market.” — Allison Smart [26:13]
“Even people that use insulin pumps need backup long acting insulin.” — Allison Smart [11:19]
“It really comes down to choice. I think we should have the ability to choose.” — Allison Smart [32:31]
“You can lose $571 [million] a year for the next 10 years or take 10% of [that] for the next 10 years... That’s just money coming in that you don’t have to do anything for.” — Scott Benner [40:12]
“Way to buy goodwill in the diabetes community. And don’t discount that at all.” — Scott Benner [41:10]
“If more people would speak up about it... Even people who aren’t Levemir users. If people would send a message to your legislators... [that] would really help us.” — Allison Smart [37:59]
The conversation is deeply informed by empathy, mutual understanding, and lived experience. Allison is measured, data-driven, and consistently centers patient autonomy and real-world needs. Scott brings candor, humor, and pointed devil’s-advocate questions, always steering the discussion toward actionable change and real-world impact.
This episode captures a pivotal moment in the struggle to preserve insulin choice: a grassroots movement led by informed patients and parents, up against entrenched pharmaceutical and regulatory systems. At its heart, the discussion asks why basic medical options are shrinking, and points toward realistic, collaborative solutions—urging advocacy, business innovation, and regulatory sense.
Learn More: alliancetoprotectinsulinchoice.org
Get Involved: Contact your legislators, share your story, and stay connected with the Alliance.
End of summary.