#1652 Save Levemir
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Scott Benner 0:00
Welcome back, friends. You are listening to the Juicebox podcast.
Allison Smart 0:14
My name is Allison smart. I'm the president of the Alliance to protect insulin choice where you want to get a biosimilar of levimer to the market. I'm also the mom of a teen with type one diabetes.
Scott Benner 0:29
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Allison Smart 2:04
My name is Allison smart. I'm the president of the Alliance to protect insulin choice where you want to get a biosimilar of leva mere to the market. I'm also the mom of a teen with type one diabetes, real.
Scott Benner 2:16
How did you start getting involved in this?
Allison Smart 2:19
Well, should I start
Scott Benner 2:20
at the beginning? I think that might be the best place. Yeah, alliance to protect insulin choice.org. Right? I just typed in alliance insulin, and you came right up. That's very good marketing. Good job.
Speaker 1 2:33
I'm glad,
Speaker 2 2:34
wonderful. Tell me your story.
Allison Smart 2:36
Okay, almost four years ago, my then 13 year old daughter was diagnosed with type one 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 levermere insulin. You know, it's fascinating. At diagnosis, we 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 levamire, 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, you know, things are dialed in. My daughter's a tennis player. Plays tennis nearly every, every day. We had little disruption to her tennis from type one. And then November of 2023, we heard the announcement that Novo Nordisk said their discontinuing levamira from the US market, effective December of 2024, and that's when I started calling people. I said, of course, of course, someone's going to fix this. And called insulin manufacturers and pharmacists and even legislators and, you know, advocacy organizations, and said, you know, of course, we're going to fix this, right? 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 501, c3 nonprofit called alliance to protect insulin choice, and that started the journey. So it's been a year and nine months,
Scott Benner 4:18
I have questions. So tell me what year was your daughter diagnosed? 2021, 21 How old was she at that point? 1313, does she use MDI still today?
Allison Smart 4:29
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 her blood glucose in that narrow range that we're able to reach with levamire. So we went back to MDI, and it's been great.
Scott Benner 4:54
Okay, so she's had diabetes now for a handful of years. You started with Levites. You had some success with it. So for everybody listening, why can't you just use Lantis?
Allison Smart 5:05
So we did use Lantis the first about four months, and then I researched it and asked to switch to levimere. We did try basal Glar which is still Glargine. It's a biosimilar of Lantis. We tried that last year for a few months, just again, to 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 levamere 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 that, with clargen,
Scott Benner 5:42
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? It was the tea slim, and we're using it out the algorithm we used basal
Allison Smart 5:53
IQ, and that's also been removed from the market. I didn't 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
Scott Benner 6:11
for us. Okay, so my daughter used levamire. Now my 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 leva mere. 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 leva mere 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 levimir? Like, I mean, because this is a pretty big thing you're doing here, right? Like, you started a 501, c3, you're out there swinging hands trying to get them to keep making levamire. 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 levemere that is advantageous? Can you explain to me why it's more successful for you?
Allison Smart 7:29
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. Okay, 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 levimer. So exactly, levamire 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 levimer 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 leave me a last one injection lasts approximately eight to 14 hours, which is awesome. So, and just an example I was, I've been to DC, I mean, 11 times in the last year and a half, spent a lot of time in Senate and congressional offices. And there was one aid I talked to, and she said, I just had a baby last year. I had gestational diabetes. I used levimer. 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 Lata, late in autoimmune diabetes in adults, and some of them will go for a while without needing insulin, and then when they start insulin, I talk to some women who love levamire, 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 so and there's not the overlap. So most people that use large gene, which Lantus, basal, Glar assembly, even to Hao, is extra strength glarging. But I'm talking about like Lantus. Some people do split it, but there's a little more overlap. It doesn't sure take action right away, and traceba, most people take that once a day, but it lasts, you know, 42 hours. So there's a much longer tail. It's difficult with traceba to make quick changes. People that like pumps, we use levimer A little bit like a pump. I mean, I know that you've said you love that you can, you can kind of mess around a little bit and try a little more, a little less. That's exactly we've just learned. This trend with leva mare, 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, you know. 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 to titrate levamere to the 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.
Scott Benner 10:35
It's a tool, and you use it in a very specific way, exactly when you tell this to people, I'm imagining that they respond to you and say, Well, yeah, you tried basal like you 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 at Target slower. 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, yeah, what's got you dug in
Allison Smart 11:19
for sure. Love that question. So she hasn't wanted to try an Omnipod and and 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 bumper, 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 tracebo will stay on the market? You know what's to guarantee one pump manufacturer will stay? I just think in this issue, we have a 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 glarging And just one other thing I need to mention. So 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 cube log and novalog. Yeah, the only long acting generic coming to the market is glarging. 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. What company wants to make it? So it's a small company. They're called our bio. They have not 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, you know, an existing insulin manufacturer, and we have talked to most of them, and most of them don't want to do dedemere. So dedemere is the generic name for levere those though there's no generic. And that's a big question. We can go into that if you want.
Scott Benner 14:04
My question is, why don't they want to, like, 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 tandems, newest pumping algorithm, the tandem mobi system with control iq plus technology features auto Bolus, 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, tandem diabetes.com/juicebox, this is going to help you to get started with tandem. Smallest. Pump yet that's powered by its best algorithm ever control iq plus technology helps to keep blood sugars in range by predicting glucose levels 30 minutes ahead, and it adjusts insulin accordingly. You can wear the tandemobi 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, tandem diabetes.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 smart watch. The g7 is made for all types of diabetes, type one and type two, 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 a 1c 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
Allison Smart 16:31
head over there now. So they want to make the most common insulins. And if you look at a pie chart, Glargine is the most common insulin made 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 dedemere. It had about 8% of the market. And then behind that at that point was traceva. Now traceba, of course, has surpassed that. Glargine is the easiest insulin to make. It's the cheapest. There's a clear path. Dedemere 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 basal of deta mere 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 work 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. Yeah, and that's a complicated scenario, too. The other thing in the pharmaceutical industry, most big manufacturers are looking for the next blockbuster drug, you know, the next Omnipod, 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 are 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 lisbro. And I said, Can you add dedemere? 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, you know, I didn't love that pain reliever, I was nauseated, or I was allergic to that antibiotic, they give you a different one. It's fundamentally about choice. Dedemere and large gene 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 large gene for a while and then they don't. I just think we need options. Yeah, make
Scott Benner 19:00
the counter argument 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 Pedra, or 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 levamere, 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 traceba, there's basal gar, there's Lant. Like, there's other options for you. You're not going to die from this. So, like, how do. Argue back against that?
Allison Smart 20:02
Oh, I know that's a great question. So couple things. Again, people need backup for pumps, and there are physicians who prefer levimer 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 Levi's the one he loves to use. People use long acting when they're first diagnosed. If someone needs an MRI, you need you need backup. So and when people say there are many options, there really aren't. There's really Glargine or traceva. We haven't used NPH in our argument, because that's a intermediate insulin. It's not seen as a realistic alternative, right? 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.
Scott Benner 20:57
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?
Allison Smart 21:06
Right? Yeah. And here's another thing, the glarging market is going to be very divided. There will be six to 10 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 lever market is a bigger pie. Dedemere. Here's the other reason it would be cost effective. Now I'm going to kind of take a little bit of a tangent. Go ahead, 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 dead mayor, 2000 of fine Allison,
Scott Benner 21:43
my friend Mike, used to need a prescription for his syringes, but not for his insulin. Yeah, yeah, yeah.
Allison Smart 21:49
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, yeah. And she said, Now I can't, as these new insulins came on the market, the argument was, these are newer, 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 ins, our market for insulin, when it became really expensive, it was already dominated by these few manufacturers, but it became, we really became at the whim of, you know, 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 levamire 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 one diabetes, you have to make changes pretty quickly on your own, and there has been no documented harm from having our and NPH stay over the counter. So that's part of our argument.
Scott Benner 23:34
How much R and mph is still being purchased throughout the country? Do you know
Allison Smart 23:37
I have a pie chart. I can't, I can't remember the exact I mean, it went in that order. It went large. Gene was 40% this is 2022, the next common were aspart and lispro, and then it was levimer, and then it was traceba, 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 the pregnancy argument is a big part of what why we're working on this.
Scott Benner 24:04
Also, okay, what is your level of belief that this is going to work out in a in a positive way for your 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?
Allison Smart 24:16
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 traceva. 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 it. 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 and as I am talking to many industry leaders about this, they recognize that this is important, and I think we're going to be able to figure it out, really. I 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, they won't litigate. I absolutely believe this is going to get done. We just have to figure out how,
Scott Benner 25:13
when you say they need to sign it over, is that? Is that the thing they're not doing right now, the company you mentioned that is ready to make it, or do they just need no vote 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
Allison Smart 25:30
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. Yeah, so Novo Nordisk has
Scott Benner 25:46
Wait. Let me stop you so you don't think that the pathway through this is finding somebody at Novo who just goes, Ah, fine. All right, here you go. That's not what you're shooting
Allison Smart 25:53
for. 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, right?
Scott Benner 25:59
No, 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?
Allison Smart 26:13
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 a here, and I want to make it clear I'm not bad mouthing Novo Nordisk. I understand their business, and I understand it makes perfect sense that if you've got omnipody 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.
Scott Benner 26:51
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 may or anything we can do, but the person at Novo who could make that decision? Are they aware of your desire?
Allison Smart 27:03
Yeah, 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 Omnipod and wegovy and several of us from my organization actually met with Novo Nordisk executives in Washington, DC 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 levamire in that help hearing. So I want to fast forward since then, Lars Jorgenson, the then CEO, is not the CEO anymore. There's a new CEO, so I emailed him and asked if we could discuss, you know, some path forward. And we have had a meeting, several of us on both sides, and those talks are still ongoing.
Scott Benner 28:10
I'm looking at something right now, like I'm trying to do my best to figure out how much they're actually making selling levamire. Are these numbers right in 2023 Novo Nordisk reported 3.9 3 billion in sales of levamire.
Allison Smart 28:22
I know that in 2018 it was 1.8 billion. We know that in 2022 it was 640, 9 million. In the US, it's a little hard to get those figures. So your figure
Scott Benner 28:32
of Wait, wait, hold on a second, I'm not sure I'm learning something more here. Oh, this is Danish Crohn's. Yeah, it's different, yeah. So that turns into $571 million US. That sounds like a lot of money, but I think if you look at it this way, it's not in the fourth quarter of 2024, we go V sales more than doubled year to year to 19.8 7 billion Danish Crohn's, which is 2.7 6 billion for that quarter. So I'm pretty sure that if I take 2.7 6 billion for the quarter in 20 24/4 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? Right? Yeah, exactly 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 there, 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?
Allison Smart 29:42
There's all sorts there. There's not just one path. There are many things that could happen, right for
Scott Benner 29:47
sure? No, yeah, because I'm imagining, like, what they were really concerned that I don't know something crazy was going to happen, like, lease it off to this company for a decade, let them make it for 10
Allison Smart 29:55
years exactly. And that's, that's basically what licensing is, and they could still get a profit. From that.
Scott Benner 30:00
Oh, and you can make money from it, right? Come on. Okay, okay, so what we need is for someone inside a Novo Nordisk to hear this. That would help. That would help, yeah, Allison, I'm gonna take care of that for you right away. Don't worry. Okay, well, consider that part done, and you're making a good argument for them, like so that they can understand the reason I'm going to still tell you I'll play devil's advocate again. Allison, How old's your daughter?
Speaker 1 30:26
She just turned 1717. Years old.
Scott Benner 30:29
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.
Allison Smart 31:07
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 court next to my daughter, while she was playing, there was another teen girl, and her coach was saying, take insulin. Take insulin. He was, 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 just, I want to come back to that in a minute. Yeah, 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 you can 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. Barging 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
Scott Benner 32:30
choose. Okay, so I'm going to make a different argument now, okay, and I don't discount yours at all, and I'm on, I'm on the side of your argument. I'm going to say this, my daughter played high competition sports on an Omnipod before the algorithms even and i She played most days at a 90 blood sugar, and she wasn't crazy low afterwards, or couldn'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 a one CS in the thirteens, and then I explain to them how insulin works, and then their a 1c goes down to six. 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 that'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 levamire, 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 and mph. And then the world changed, the Lantus and Nova log and Humalog, and he didn't change along with it. And by the time a doctor got a hold 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 Allison, 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 levimir. 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 I've. 570, $1 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? 24689, 10 and a half? Is that 10 and a half billion dollars on we go V 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 in your arguments aside whether they're right or wrong. And I'm telling you again, I'm coming out and telling you, Allison, fly me out to where you are. I'll get your kids 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 again, right? Oh, I totally agree, 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 you're I agree with you 1,000,000% 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? Yes.
Allison Smart 36:44
And I just want to address one other thing. 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 I just
Scott Benner 36:58
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? Right? There's still money to be made on levamere, like, let somebody go make it. And if it's not going to be you, then what are you sitting on it for? Exactly, 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 love a mirror for you, and let Allison's daughter live her life, and everybody else who uses it and take out, take a little bit of money and be done with it. Like, 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
Allison Smart 37:35
to them. 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. I just 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. You're not. 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? Yeah, 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 say they'll hear us. And then they'll go, Huh, this is a problem. So they'll talk to, you know, 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 levamire users, if people would, you know, 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 with physicians and some small organizations in April, and then the FDA said, Okay, well now we have 180 days to respond, so they 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 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
Scott Benner 39:50
out, yeah. But in the end, what we really need is for Dow star to just do this right like it needs to get to the CEO. And I'm going to tell you right now that if the CEO of node. Ovo 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 levamire our bio? Oh, yeah, let's, let's work it out so our bio can make love America. It'll get done tomorrow, exactly, right? Like you just got to say it out loud, and then it's gonna happen. And then $571 million comes off the sheet. Okay, I'm you 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 here, 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 is getting cheaper is because somebody's making you make it cheaper. And they're right in a world where they think you're more worried about we go V 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? Exactly, 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 marketing campaign behind it. If I was you, I'd be like, listen, huge. 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 levemere 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, the 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?
Allison Smart 42:28
Right? Oh, I totally agree. We would praise them to this guy. I would love, I would love them to, of course, fix this.
Scott Benner 42:35
Yeah, of course. I don't mean to say 570, $1 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. Allison, what happened? Like, what moment did you have, a slowly eye turn, where you decided to get this far into this? Like, how did you not just let this go and decide, like, I guess it's not going to exist anymore.
Allison Smart 42:59
Honestly, it's about choice. This is a tough diagnosis, and when someone finds a method that works, look, I think 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, yeah, it's so important. And I as I delved into, you know, the long action time of traceiva and and some of the other things about Glargine. Glargine hurts like it has an acidic pH of four. And that might seem like a small thing for people, but for others, it hurts. Detamir and deglodex don't have that, so levamire and traceva
Scott Benner 43:31
Allison. That's why Arden stopped using Lantus. It burned, right? Yeah, I couldn't remember why it burned. So we moved to levimere.
Allison Smart 43:39
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 has to be in an acidic solution, and it's also less predictable. If you inject Lantis accidentally into the bloodstream, it's rare, but you can have an unpredictable hypoglycemic event. Dedemer and degli deck don't act that same way. They bind with the albumin. So there's just, 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 levamire. And is this is worth the fight?
Scott Benner 44:16
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 11 mirror.
Allison Smart 44:30
Yeah, 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 that's because it's clergy,
Scott Benner 44:41
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. Oh, what was it called? The faster acting maybe loom JEV or loom JEV, she can't use, but the Nova one too, the fee. ASP. 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 Fiat 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 like, Guys, 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? Right? That's my message.
Allison Smart 45:38
I totally agree. And then just one last thing, so levamire can be diluted. You can't dilute Glargine and degli deck. It's not commonly done, but it is done like I 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 levamire 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 line, the insulins are different. We shouldn't be left with just glory gene. Let's just figure this
Scott Benner 46:13
out. Yeah, no, I get it. I wonder too, how many users that 570, $1 million represents, because we're hearing your story, and you know you're, you're doing a good job on your website, by the way, of bringing other people's like, you know, faces out, etc, but like, you don't know, how many, like, how many people does that really mean, right? Like, like, how many people have a story something like yours?
Allison Smart 46:36
So, and I'll tell you, I do have some numbers I would imagine. Well, 2021 there were over a million users of levamire. 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 there, I've called around. There's actually some levamire Still in some pharmacies right now. You couldn't, 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 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 it's back to being very expensive, if there's any left. But as 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. You know, 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 if even 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, Levi'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, you know, traceva has just got this super long tail. So if I'm using it for a pump break, it's really difficult.
Scott Benner 48:04
Isn't Novo making live and mirror overseas? Yeah, we haven't
Allison Smart 48:07
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
Scott Benner 48:18
countries, I would imagine they're probably trying to move people to tracebo, right?
Allison Smart 48:22
Well, see, that's the thing, and traceva is still patent protected, so it is more lucrative than levamira.
Scott Benner 48:28
Yeah, no. I mean, I understand all the so there's the other reason, like, if you stop making levamere, let's say it's 300,000 people who are still using the US just make a number, right? If that made up number is accurate, those 300,000 people are going to get off love a mirror and go to traceba and then, so they're not really losing the money. They're gaining more money. So that's their argument. Their argument is, 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? Yeah, yeah. I got, I couldn't find I was trying to figure out, like, why would you not just do this thing, and that's why, because they'll lose those
Allison Smart 49:03
people. 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 ultra lenti, lenti, semi lenti that was removed from the market. We've really it's, 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. Let's let us have continued access to this one.
Scott Benner 49:46
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 1000s of people over to traceba users. But the truth is, 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 Nova log, 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 from 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 at large, Jorgensen, right? He didn't just like decide to leave, like the stock price dropped, and they, they told him, time to go now. Then they bring in this next person. 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 you know, that's it. That's my thought there. Yeah, good luck to you. Geez, Allison. I How much of your time do you spend on this? A lot,
Allison Smart 51:48
a lot. It just, it matters. It's worth it. Yeah?
Scott Benner 51:51
All right, listen, do it just to give Allison a break, yeah, she got stuff she wants. That's right, exactly like to paint the living room. You know what I mean? Like it. Tell people to this is not your idea of fun, right? Right? Yeah, like, you're not looking to have these conversations, right? Right? Yeah, you just would like it to be over. Well, I hope this helps. I hope this conversation gets to the right people, and that they have a change of heart, and they do, they do something that, you know, maybe they don't have a financial reason to do, but just be a nice thing to do. So hopefully that'll happen.
Allison Smart 52:21
I sure hope so, and I appreciate this. Glad to thanks for letting me come.
Scott Benner 52:24
No, it's my pleasure. Thank you again. Hold on one second for me. Okay, okay.
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