#1798 Is Alison Saving Levemir?!

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Alison Smart returns to share vital updates on the ongoing fight to save Levemir insulin. Discover recent FDA progress, bipartisan support, and why this insulin remains crucial for healthy pregnancies. Alison is a returning guest, 1652 Save Levemir.

Key Takeaways

• Alison Smart has spent over two years advocating for the continued production of Levemir (detemir) insulin, securing bipartisan congressional support and engaging in positive, high-level meetings with the FDA.
• Levemir is critical for many individuals because of its unique profile (binding with albumin, lasting 8-14 hours), which avoids the unpredictable hypoglycemia and long-duration issues that can occur with glargine and degludec.
• Levemir is highly proven and widely prescribed during pregnancy for managing both gestational and type 1 diabetes without causing complications linked to poorly controlled blood sugar.
• Novo Nordisk has signaled a willingness to assist a new manufacturer with ingredients, though finding the right non-competing partner capable of navigating the complex biosimilarity process remains the final hurdle.
• Despite excitement surrounding potential future cures like islet cell transplants, ensuring steady, reliable, and accessible insulin production remains a critical necessity for current and future patients.

Resources Mentioned

• Alliance to Protect Insulin Choice
• Juice Box Podcast - Small Sips Series
• Eversense 365 CGM
• Juice Cruise 2026
• Wrong Way Recording
• Juice Box Podcast Type One Diabetes Facebook Group
• Chicago Policy Review article (mentioned in episode)

FULL EPISODE TRANSCRIPT

Introduction and Podcast Updates

Scott Benner (0:00)

Welcome back, friends, to another episode of the Juice Box podcast. Well, everybody, we're gonna jump right in. I'm back with Alison Smart. She was in episode sixteen fifty two called Save Levemir. It actually was out in October 2025, and she's back with us today to give us an update about what's happening and where are you right now.

If you'd like to hear about diabetes management in easy to take in bits, check out the small sips. That's the series on the Juice Box podcast that listeners are talking about like it's a cheat code. These are perfect little bursts of clarity, one person said. I finally understood things I've heard a 100 times. Short, simple, and somehow exactly what I needed.

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And the reviews, they all say the same thing. Small sips makes diabetes make sense. Search for the Juice Box podcast, small sips, wherever you get audio. Nothing you hear on the Juice Box podcast should be considered advice, medical or otherwise. Always consult a physician before making any changes to your health care plan.

Today's episode of the Juice Box podcast is sponsored by the Eversense three sixty five, the one year wear CGM. That's one insertion a year. That's it. And here's a little bonus for you. How about there's no limit on how many friends and family you can share your data with with the Eversense Now app?

No limits. Eversense. Well, everybody, we're gonna jump right in. I'm back with Alison Smart. She was in episode sixteen fifty two called Save Levemir. It actually was out in October 2025, and she's back with us today to give us an update about what's happening. And where are you right now?

The Advocacy Journey in DC

Alison Smart (2:07)

I'm in Washington DC right now working on this.

Scott Benner (2:10)

How long have you been at this now total?

Alison Smart (2:13)

It has been two years. Well, just over two years. We started November 8 was the announcement that this insulin, Levemir insulin, would be discontinued in The US, and we started really later that month. So it's been just over two years.

Scott Benner (2:26)

Okay. And what what has you in DC today?

Alison Smart (2:30)

There are several conferences this week, and I've had some appointments with congressional offices. So conferences with, health and human services members, and, it's it's been a good week.

Scott Benner (2:41)

Okay. What what do you think I I guess, why don't you catch me up on what's happened since you were on the podcast last?

Alison Smart (2:48)

Great. Yep. So this is just so we're in March, and it was October. So in just the last several months, we've had a lot of progress. We've had, bipartisan congressional support. Congressional members of both parties have sent letters to health and human services asking for a path forward for production of Determa insulin. We've had high level meetings with the FDA that have been a much different reception than we had when we started this two years ago. Two years ago, there was the FDA is used to dealing with large large companies, not not a small patient advocacy group. Mhmm. Well, small. We're we're getting a lot bigger. And the reception with leadership of both the drug shortage staff and the office of biologics and biosimilars was very positive, very understanding, and caring. The response now is we understand you've made it very clear that there's a distinct need for this insulin, and we're hearing about it from more than just your organization, which is excellent. And they said they really want to emphasize there's a clear path forward. If Novo Nordisk will come and assist, there are multiple pathways that could work, not just one. Okay. So congressional letters, FDA meetings, physicians are reaching out. We have maternal fetal medicine specialists and those that specialize in diabetes and pregnancy specifically and other physicians who are reaching out about the need for this insulin and willing to be, part of meetings with congressional staff. We also have multiple manufacturers that we're talking with ready to go that could make this insulin if they get the needed help from Novo Nordisk. And then at this point, we are asking health and human services to engage Novo Nordisk executives in discussions for production of this insulin. So that's that's our progress.

Scott Benner (4:37)

That's astounding, especially because it started with, what, you in your living room?

Alison Smart (4:42)

Well but yeah. But I was already initially, you know, communicating with others who needed this, and all of us were saying, ah, what do we do?

Scott Benner (4:50)

Right. Right. Yes. You you pulled together some voices who were concerned. And if it takes two years to get them to, okay. We understand this is a thing we should be supporting. I mean, does it take two more years to get the next step? Is it do you think this is gonna go more quickly? Do you think Novo Nordisk is gonna be receptive to this?

Alison Smart (5:12)

So they're signaling recently that they will help. They've signaled to some congressional offices that we will be willing to assist with drug ingredients with the right partner. I don't know. You know, we're we're I I don't know. I don't know the timeline and but I just boy, we're making great progress, and there's a real need.

Scott Benner (5:30)

That's so cool. So I don't wanna be, sour, but but let me ask you a question. So when you go to Novo Nordisk and say, hey. Stop don't please don't stop making this or let somebody else make it. They go, we don't care. And then you get some congress people to write some letters to some people and somebody calls somebody on the phone, and now suddenly it's a thing they care about. I mean, is it that simple, or is there more to it than that?

Alison Smart (5:56)

Honestly, I think it might be that simple. I I do. I I just I've I've stopped. Our organization is not reaching out as much on our own. It it needs to come from bigger voices.

Scott Benner (6:07)

Mhmm.

Alison Smart (6:07)

But I it absolutely makes a difference. I mean, manufacturers care. They care what people think, but they really care what influential members of health and human services and the and our administration think for for certain.

Scott Benner (6:19)

So so is this a situation where it's just kind of like business where, okay, it's not really something we want to do, but people who we count on for pathways, decisions, etcetera, seem to think it's important. If it's important to them, it's important to us. It's like that.

Alison Smart (6:35)

I'm hoping.

Scott Benner (6:36)

Wow.

Alison Smart (6:36)

We'll see. Right?

Scott Benner (6:37)

Is it funny how the world works?

Alison Smart (6:39)

It is.

Scott Benner (6:42)

So when you're down there in those meetings, give me give me an example of, like, you're gonna you you have a meeting today, for example?

Alison Smart (6:48)

Don't this afternoon. I have a conference this afternoon I'll be attending.

Scott Benner (6:51)

A meeting you were at previously in days past. You walk in. Are these people that you've met previously? Are you giving them updates? Are these new people you're trying to get on board?

Alison Smart (7:01)

All of the above. We're we're in contact with quite a few congressional staff at this point that we've been working with for quite some time. Had a meeting yesterday afternoon with a congressional aide that I've been communicating with for over a year. But some of them are new, and sometimes it's just me, but often will include virtually physicians at the last minute or or others, you know, maybe constituents. So it's all different.

Scott Benner (7:26)

Explain to me how you go from a person, you know, a few people focused on something to a slightly bigger group of people to someone who can get a congressional staffer to sit in person with you. How do you build that? Because you're basically a lobbyist now for one very small idea. So, like, how does that work?

Alison Smart (7:46)

It takes time. It takes connections, and it takes constituents reaching out. So, you know, we've been saying a lot. You know, reach out to your congressional representatives. It works best if we work in conjunction if constituents reach out to their cons congressional aids. And it even just to get to the right aid or the right staffer is difficult. You get to that point, and then if they can talk to our organization, then we can reach out here from Washington DC, and it it works better if it's if it's in conjunction. And and but sometimes the staffers will talk to each other through connections. It's it's been quite the journey.

Scott Benner (8:21)

Does it need to be it's funny because I'm I'm thinking about the, you know, kind of everything you're hearing people talk about about islet cells right now

Alison Smart (8:29)

Mhmm.

Scott Benner (8:30)

Right, as an example. So, you know, there's, you know, couple of people here and there on social media who are like, you should write a letter to somebody and, you know but, I mean, that's not very coordinated. Like, do uncoordinated things do you think somebody like you who understands this needs to kinda grab hold of those ideas and coordinate them? Is that is that really the key to getting it off the ground and and getting it taken seriously?

Alison Smart (8:53)

I do. I it's easy to disregard a form letter or a form email. These congressional staffers get many, many emails. And so if it's just forwarding some form letter, it doesn't get very far. It needs it needs some some personal contact, you know, constituents or just a real you know, maybe some offices are more concerned with certain areas than other, and it it yeah. It's it's interesting.

Scott Benner (9:19)

So it's it's as easy like, just sending off, a you know, I don't know. Some guy on Instagram told me to send this somewhere, and I found it. That you don't think that's gonna get much traction?

Alison Smart (9:30)

Not necessarily unless there are many, many. Just a few here and there. People people get frustrated when they'll say, well, I sent one message. One message doesn't get very far.

Scott Benner (9:39)

Yeah. Hey. How many? Many what is many many?

Alison Smart (9:43)

You know, I mean, I've asked that myself, and and some have said, you know, if I get 10 or 20 letters, I pay attention. I think it depends.

Scott Benner (9:52)

Right. 10 or 20 letters makes them pick up makes the staffer pick up their head and say, I wonder if I shouldn't mention this to the congressman. That kind of

Alison Smart (9:59)

thing. Or or you can have a few that are really persistent. Just sending one or two messages is really not gonna bend move the needle. Yeah. But persistency and volume makes a difference.

Scott Benner (10:13)

Time. Not and maybe not just months either, but maybe years.

Alison Smart (10:17)

You know, it depends.

Understanding Insulin Profiles

Scott Benner (10:18)

Yeah. Well, you're you're I mean Your thing is I mean, I guess, take two minutes here for people who maybe didn't hear your last episode and tell them how this started, what the impetus was that got it all moving for you, and why you thought it was so important to do.

Alison Smart (10:33)

Sure. So my daughter was diagnosed with type one diabetes at age 13, four and a half years ago, and we started on a glargine. So let me just lay out the the different insulins just as a update. Mhmm. You can newly diagnosed are typically placed on a glargine insulin, which is Lantus and biosimilars, and even TUJO is a is glargine, but but it's more concentrated. Those are those are 40% of the market. So they're the largest part of the insulin market. Some don't tolerate glargine well, and the two alternatives are just made by Novo Nordisk. They are Levemir, which is Dedamir, or Tresiba, which is deglidec. And I'll use the the second the generic name even though there aren't generics of those insulins. The basic differences, they they have different pharmacokinetics. Glargine insulins need to form microprecipitates under the skin and have a slow release, and that can be a problem if glargine insulin is injected into a blood vessel. It can produce an unpredictable hypoglycemic event. Also, if if glargine is exposed to heat, it can also produce unpredictable hypoglycemia from a shower or a sauna, and it's also acidic. So some people don't tolerate well the inconsistency of glargine, and some just don't feel well using it. So then some will use and glargine lasts approximately twenty hours. Detamir lasts approximately well, eight to fourteen hours. So it's typically given more than once a day, but there are some people who only need insulin at night for fasting blood glucose. So that's why that insulin is ideal for many. It also acts differently. It binds with albumin. It doesn't form those microprecipicepts, so it doesn't have that same potential for unpredictable hypoglycemia if injected into the bloodstream or if exposed to heat. Mhmm. Degladec lasts forty two hours approximately, which can be a real problem with people who are used to being able to change the amount of insulin to correspond with different times of the day or to correspond with a menstrual cycle, or teenage boys often have multiple more needs in the day versus the night. Pregnancy, we'll we'll talk about pregnancy in a minute. Mhmm. And then we're we haven't included NPH in our argument, but NPH is needed for pregnancy, but it doesn't have a stable profile. Defined peak that can be difficult for type one diabetics but is needed for gestational and type two diabetes. And then there are insulin pumps. Less than half of those who need insulin use insulin pumps, and even insulin pump users need backup insulin, and women with gestational and type two diabetes would not typically use an insulin pump. So those are the insulins that are available. Back to my journey, my daughter initially used Glargine, switched to Levemir, had excellent management for several years. We went back and tried Glargine again. It's just more difficult for her to maneuver with being a she's an athlete and dealing with a menstrual cycle. She also tried an insulin pump, and in her case, it made the activity difficult. I understand some people can make it work, but, we have many in our organization who used an insulin pump for years who appreciate the ability to go back to shots. And then just back to the journey, so two years ago, it was announced that Novo Nordisk would be removing Levemir insulin from The United States. We started working on this, formed a nonprofit. Our goal is continued access to this insulin produced by a new manufacturer. Of course, we'd love it if Novo Nordisk would just continue to make it. They're not going to, but they're signaling that they might help a new manufacturer make it. That's kind of the journey. Can I talk about pregnancy for just a minute?

Scott Benner (14:09)

Yeah. I wanna talk about pregnancy. Give me one second, though.

Alison Smart (14:11)

Great.

Scott Benner (14:12)

If I take you in a time machine back three years and ask you to explain insulin, do you go, I don't know. There's fast acting and long acting? And now

Alison Smart (14:19)

Oh, absolutely.

Scott Benner (14:20)

And now you have a a granular understanding of it? Yeah. My question would be, when you talk to somebody at Novo Nordisk, did they always have this understanding? Like, is is there a world where this got this far because four people in a room said, why do we need this old one? We have the new one, and didn't have that understanding. This episode of the Juice Box podcast is sponsored by Eversense three sixty five. And just as the name says, it lasts for a full year. Imagine for a second a CGM with just one sensor placement and one warm up period every year. Imagine a sensor that has exceptional accuracy over that year and is actually the most accurate CGM in the low range that you can get. What if I told you that this sensor had no risk of falling off or being knocked off? That may seem too good to be true, but I'm not even done telling you about it yet. The Eversense three sixty five has essentially no compression lows. It features incredibly gentle adhesive for its transmitter. You can take the transmitter off when you don't wanna wear your CGM and put it right back on without having to waste the sensor or go through another warm up period. The app works with iOS and Android, even Apple Watch. You can manage your diabetes instead of your CGM with the Eversense three sixty five. Learn more and get started today at eversensecgm.com/juicebox. One year, one CGM.

Alison Smart (15:49)

The variety of understanding is fascinating to me. So Novo Nordisk executives, some understand it, some absolutely don't. The pregnancy piece, some understand, some don't. Here's another fascinating group to talk to. Former, drug reps from who worked for Novo Nordisk, they were extremely well versed in the differences of pharmacokinetics of glargine versus desmir versus deglidec. That was prior to 2015. 2015. So levemir came out in 2005. Tresiba came out in 2015. And at that point, Novo Nordisk reps were switched to promoting Tresiba to physicians. So it's older reps who really, really understand the value of Levemir insulin. But, yeah, the the level of understanding is certainly different.

Scott Benner (16:36)

Well, I was

Alison Smart (16:36)

depending on

Scott Benner (16:37)

That's interesting. So I wonder if everybody can, like, understand. I'm sure if you're in a business that's, you know, a a huge company like Novo or other companies like that, you makes sense to you. But for the average person walking around who's running a cash register somewhere or, like, you know, listening to this while they're plumbing, like, it's it seems crazy to think that the company that makes the insulin might not completely understand the value of the insulin. And to understand that the the reps were the ones that were really educated about it, and they were probably the ones keeping the doctors educated, which kept the need up.

Alison Smart (17:13)

Exactly.

Scott Benner (17:13)

Right?

Alison Smart (17:14)

Exactly.

Scott Benner (17:14)

Yeah. Yeah. And then and then you lose that pathway or things become digital. I I also you know, I I'm not lost that you that what you said earlier was you need to look I don't know if you used this phrasing or if it's how it popped in my head, but, like, if you wanna get somebody on your side and get them to understand what you're talking about, you have stand with them in a room and look them in the eye. You can't send them an email or and say, this is really because you seem crazy, like, when you do stuff like that. Like, I'm watching people now, again, with the eyelet thing. I think it's very important. I I don't talk a ton about politics on the podcast, and I probably never will, to be perfectly honest. But, you know, in that eyelet thing right now as an example, you know, they're like, you should have somebody talk about it. I keep saying, I'm waiting for, like, an ad. I shouldn't say this like this, but, you know, I'm waiting for somebody who doesn't look crazy to to be talking about it. Like, right now, I just see people ranting on social media, and I'm like, I'm not interviewing you. I want Alison who can sit down and go, wow. Here it is. You you what know I mean? Like, wanna have an adult conversation about it. Not that I don't think those people are well intended or that, you know, their efforts might, you know, bear fruit or anything like that. Just when I sit and talk about it, I want somebody who can break it down the way you you can. And that person then needs to be in the same physical space as the person they're trying to explain it to because look at all the words you just used. Glargine, the like, you know what mean? Like, deglade like, who under no one understands that. And so, like, you know, you what are you trying to get a congressional staff? What are those people, like, 23? They've been out of college for eight minutes. Right? And you're, and you're, like, degladeck, and they're, lady, listen. Know, like, I I I don't know what you're talking about. Right? It's hard work, but it's really important.

Alison Smart (18:58)

Well, yeah. And I just gotta say it varies. Some of the congressional staff are college interns, you know, majoring in political science, but some congressional and senate representatives will hire a physician, a fellow to be the one conducting these meetings. I had a recent meeting. No.

Alison Smart (19:14)

Go ahead.

Scott Benner (19:14)

No. That's just awesome. I'm sorry. Like, yeah, tell me. I'm sorry. Recent meeting?

Alison Smart (19:17)

Well, I had a recent meeting with with and the physician who was meeting with me, and there were a few others. She's a nephrologist, which is specializes in kidney conditions. And she says, oh, we don't use Tresiba with our advanced kidney failure patients because of the long duration of action. So it you know, that and so it was interesting because we were able to just sit down and really go the nitty gritties of this this insulin. But you're right. Often, I've had to learn to, I used to when I started this, I think, well, let me give give me ten minutes to really explain the situation, and now I have to be able to concisely present this in two minutes sometimes.

Scott Benner (19:52)

I wanna just tell you, you're better at it now than the last time I spoke to you, actually. Like, I can Thank you. Yeah. Like, you can tell that it really felt I'm glad you brought that up because I didn't wanna say it without you saying it, but it felt like it felt like you sat in a room and you thought, I need an elevator pitch for this.

Alison Smart (20:08)

Right.

Scott Benner (20:09)

Yeah. Because because that was, like, super clear. Like, that would that that was really awesome. Like, you're doing that's awes You know what? I I I keep imagining. We're talking about the islet cells and, like, you'll get this you get this insulin back on the market, and they'll find a way to, like, do that, like, the aisle itself that your kid will get that. You'll be like, oh my god. Are you kidding me? How old is your daughter now?

Alison Smart (20:30)

She's 17.

Scott Benner (20:31)

17. Do you think that she understands the the value of this, like, in the amount of work and effort you're putting into it? Because, I mean, this is most of your time now at this point. Right?

Alison Smart (20:43)

Oh, for sure.

Scott Benner (20:44)

Yeah.

Alison Smart (20:44)

She does. She's great. She's she's very supportive, and she'll occasionally talk about it. But she's much happier to just live her life and let me do my thing. Yeah. As you can probably understand.

The Importance of Levemir in Pregnancy

Scott Benner (20:55)

No. No. Please. My kid doesn't, you know, care about the thing I'm doing either. Okay. I'm sorry. Go back to pregnancy. Why why is this so important for pregnancy?

Alison Smart (21:03)

Okay. So I wanna bring this up in light of the Isla Act because I think people dream of this day when insulin is no longer needed. Right?

Scott Benner (21:11)

Mhmm.

Alison Smart (21:12)

Pregnancy is a unique situation where there are pregnant women with gestational diabetes. Over a hundred thousand women in The United States a year have a pregnancy with gestational diabetes and need insulin for just the duration of that pregnancy. We're not gonna you're not gonna inject someone with islet cells that's pregnant with gestational diabetes. Right?

Scott Benner (21:34)

Yeah.

Alison Smart (21:35)

So this is a unique situation. For example, let me just give you another example as I talk about the pregnancy situation. Yesterday, I talked to a maternal fetal medicine specialist who's an OBGYN who leads a diabetes and pregnancy program at a major university, and he sees their their division sees over fifteen hundred women, pregnant women each year having pregnancies that require insulin, and Levemir has been their go to for pregnancy. NPH has been a back up if the woman has gestational or type two diabetes, but NPH is difficult for type ones because of its defined peak. But he said you know? And he he even considered glargine and deglidec as off label for pregnancy. He said and and they always wanna emphasize any of these agents is more important than nothing, but we're losing the one that's that works well because a main need when someone has gestational type two diabetes, they often need most insulin for their fasting blood glucose levels at night. So you want this, you know, eight to fourteen hour insulin. So that's just an example, but I'll just lay out the pregnancy argument. Everyone should be aiming for good blood glucose control, but when a woman is pregnant, that nine month period of time, if she has chronically high blood sugar, she has a much higher likelihood of a a large baby that's early, you know, preeclampsia in the mother. A lot of complications come from not well controlled blood sugar in pregnancy, and that's why the need for levemir in pregnancy is so clear. It was well it was shown by the FDA to be proven in pregnancy. It was involved in multiple well done randomized controlled trials, which glargine was not. There's been one randomized controlled trial with Tresiba in pregnancy, but that study was problematic. It didn't it didn't show, outcomes, and the pregnancy argument is huge. And that's why we have physicians, many of them specializing in diabetes and pregnancy, that wanna be part of these discussions and be able to explain why this insulin is needed for pregnancy.

Scott Benner (23:30)

Right. And even you know? I mean, listen. I've I've talked to plenty of people, who have had type one diabetes and used a pump through pregnancy with success. I've also talked to some who offset that pump use with an injected, you know, basal insulin. There's a lot of different ways to to get to the end. You know what I mean? And taking the tool away does seem ridiculous. Also, the idea that, you know, I like the way you started with that. Like, you know, everybody hopes that one day we just won't need it. But the process to get to that, even though they have you know, I just had someone on the podcast, I don't know, a couple weeks ago, right, who's had the islet cell, transplant. They're using the new Tego, autoimmune sup the immune suppressant thing that's not having a lot of side effects or none maybe they're saying so far. And, you know, big success, it it seems like this is a trial. It's not FDA approved. They don't have, you know, a a warehouse full of islet cells to pump into all the people who have type one diabetes. It it hasn't gone through the process of, you know, scaling up or trying to get it through, you know, the insurance process. I always like to say, like, if they figured that out today, if it was perfect, if they had, you know, they had a building full of islet cells to cover for everybody, and they'd still be ten years away from figuring out how to get it to you. And when it got to you, it might not be affordable to you to begin with.

Alison Smart (24:56)

Exactly. Totally agree.

Scott Benner (24:58)

Yeah. And it's fine to like, I live hopefully constantly. I think it's I think it's actually very important. But I get scared that there are people out there that are like, oh, I heard they cured type one diabetes in this. I I don't really need to take great care of myself anymore because this will probably be over pretty soon. Right. I I do worry about it because it it does happen to people. They get a little laxed in their care because they think, oh, it's common. You know what I mean? Like, they'll figure it out.

Alison Smart (25:26)

And Totally agree.

Scott Benner (25:27)

Yeah. So it's just important to keep your eye on the real way things work. I mean, Allison just explained that it took her, like, the better part of two years to get people to, like, take her seriously

Alison Smart (25:38)

Right. Exactly.

Scott Benner (25:39)

To get through that system. So when you reached out, what did you wanna share? I'm I'm I'm asking you a bunch of questions, but I wanna make sure that there's not some like, a message that you wanted to get out or or something you wanted to tell me about.

Alison Smart (25:52)

That's honestly, that's the main thing. Just that and if we can if anyone wants to reach out, it it really works best as a coordinated effort. So if if people are interested in this, they can reach out to our organization, to me, and then we can work on it from both angles. That would be super helpful. There was and I also just want to let you know if anyone kind of wants a overview of the situation, there was a recent article by the Chicago policy review that maybe I could send you the link for that that just really explains the the problem well. This does require funding. If people are interested, if you could could reach out with that, you can just reach out to our website, alliancetoprotectinsulinchoice.org. I just wanted you to know that there we really have had a lot of momentum, especially in the last few months. So if we can get some more, both physicians, patients, just everyone reaching out about this, it really helps. More hands makes this work a lot better. So and I just kind of wanted to describe the situation again that with all the with all the focus on as you exactly as if you said, you know, this excitement about possible cures, we're not gonna outgrow the need for insulin. We're just not. The newly diagnosed, the pregnant people just and and even the typical type one patient, it's we're years away from that solution. So if we lose sight of maintaining access to insulin I even had I had a physician reach out to me that in her state, NPH was removed from basically the Medicaid formulary, which having an insulin removed from a form from a major state run formulary plan is often the first step to discontinuation. Can you imagine if they removed NPH? I'm I know in our type one community, it's not looked on highly, but, boy, it's used a lot around the world, and it's very important for pregnancy. And new manufacturers are working on glargine. I mean, that's we're gonna be left with glargine. And glargine works well for a large amount of people, but for some, it definitely does not. And so removing choice and not focused on just being able to have sustainable manufacturing of this product that is required to sustain life and pregnancies is problematic. So just wanted to spread the word about that.

Scott Benner (27:55)

Alliancetoprotectinsulinchoice.org.

Alison Smart (27:59)

Yes. Uh-huh.

Scott Benner (27:59)

Okay. And you said things have been picking up recently. What do you attribute that to?

Alison Smart (28:03)

Initially, two years ago when we wrote so for example, when we reached out to the FDA, the FDA didn't wanna meet with us. They basically sent a response that, oh, you've got available alternatives. We were getting the response from Novo Nordisk. Oh, you've got seven alternatives to Levemir. You can take glargine. You can take Semglee, Resvaglar, Basaglar, TUJO. They gave us several names for the same drug, and occasionally, that still happens. So here's another example. The Utah Medical Association, I'm from Utah, voted in favor of resolutions that would enable manufacturing of this insulin. And then when when or or that organization went to other states and other organizations, there was a lot of pushback. And they basically said, no. There's all these alternatives, and we know of one physician who's doing fine with pregnant women using glargine. I think so back to your question, why the recent, momentum? I think more physicians are reaching out and more patients are reaching out as they're being forced to switch and saying, I'm my control is worse. I have I have a man who just reached out who said, I've had type one for twenty five years. And the first twenty years, I had horrible control. I just thought I had this horrible condition. I got on Levemir, and I was able to dial it in, and I had great control. And then I've had to switch back again, and it went back to those initial twenty years of that horrible control. I think the increased momentum and the increased interest is people reaching out. Yeah. I think that's what it is.

Scott Benner (29:23)

That's awesome. Well, has this been a uplifting experience for you, or does it show you a side of life that is depressing? I mean, how do you think of if you can step out of it for a second, are you motivated by what's happening, or is it is it taking the life out of you?

Alison Smart (29:43)

Oh, I'm motivated for sure. But, absolute everything you've said. I mean, it's every part of the journey. It's the highs and the lows, the certain I've got this big you know, we've got this big meeting coming up. This is gonna be the golden ticket. And then, you know, it doesn't always happen, but excellent advancements that we didn't think were gonna happen, and then certainly disappointments from others that we we organizations or, you know, entities that we thought would be engaged and involved that aren't. I wouldn't change it for anything other than I would change. I I want this done. I want this to get done, but I wouldn't go back and say, wish I hadn't done this. This this this has to be done. This this needs to happen.

Finding a Manufacturing Partner

Scott Benner (30:19)

Well, you're pod committed now. There's no way out now. You you gotta you gotta fall through to the end. Hey. You said, that Novo said if the right company comes along to make it, do you have an eye on who that is, and are they happy with that choice?

Alison Smart (30:34)

That is the mystery. So that's why we're compiling multiple because we're hoping for the opportunity to come before them and say, okay. These are the all the ones that we've talked to that are ready to go. But, of course, it could be someone they choose. But that's been a big mystery. We've wanted to be able to present the an optimal idea to them, and I don't know if we've reached that yet. We're hoping. This is definitely it's like it's like working a detective novel, trying to see inside someone's mind. Okay. What what situation will be ideal for you? And we're we're trying.

Scott Benner (31:05)

What do you think the time frame is to to finding out if they're agreeable? Because I I I guess for people to understand completely, they've got a kind of I'm gonna use the wrong terminology here, but they've gotta release something or okay something so another company can it's about ingredients. Right? So they probably have Exactly. Well, they probably have what stuff that's their formula that they don't wanna just give away to somebody else unless they get to a situation where they feel comfortable doing it. For whatever reason, they'll feel comfortable doing it. Do you think that's a thing that you'll know about in months, or what's the

Alison Smart (31:39)

Absolutely. Yeah. I so I used to view this as a puzzle with a lot of missing pieces, And now I picture this puzzle in my head, and all the pieces have clinked into the place into place even just the last month or two, especially the FDA piece was huge. Meeting with several departments with their leadership was a big deal. So all these puzzle pieces are linking into place except for the main one, the Keystone. Yeah. You know? Nova but because all we felt like we had to get all those other pieces in place so we would be ready, and we are. So now is the time. I really think this will happen soon.

Scott Benner (32:12)

What do you think their main focus Nova's main focus is on choosing? Do you think it's do you think they're trying to put themselves in a position with a partner that they're helping or giving themselves a financial win out of this? Do you have any idea what their goals are before they say yes?

Alison Smart (32:29)

I think it's, all of the above. I want them to come out looking, you know, the hero in this Mhmm. And and to find the right situation where that's the case. And then just to just to step back, some people wonder why another company can't make this without their help. Even though Dedomere is now off patent, for a new manufacturer to make this would take five to eight years and $200,000,000. I mean, it's just and the uncertainty of proving biosimilarity to the FDA to a product that's not no longer available, a company is just not because I've had people say to me, certainly, companies in India or China are working on this, and they were. But to our knowledge, they're not now. So it will require it will absolutely require assistance from Novo Nordisk. It will require them sharing some drug ingredients for a few years and sharing some of the knowledge, and and the right partner to do that will involve someone that won't be a competitor for them. We'll put them in the best light, and we're doing our best to find that right solution. And we we really feel like we have multiple options that that would be good good options.

Scott Benner (33:35)

Yeah. I do wonder if people listening understand that when when a company develops a drug, right, like you said, there's ingredients in it. But it's not like, hey. I use, King Arthur flour, the, the bread flour, and I use, Domino's sugar. And I you know, it's not it's not like there here's a list, and then I can go out and buy that same stuff and whip it together in the same way you describe in your recipe. Like, it's if if if a company says, oh, I wanna make those cookies too, you know, they have to go buy the cookie and then break it down in a lab and figure out what's inside of it and then remake it. And they never remake it exactly the way it was made the first time. They they make a similar of it, which is, you know, where I guess where the word biosimilar comes from. But it's not as easy as like, oh, just tell me. So you're actually asking them like, hey. You've got a you know, you've got the recipe for the flour here, and and you have they you gotta tell us what that is so we can make it. Because we don't want somebody making a similar that doesn't work the way the original works. We want it to be the original. And then Novo has to give away those secrets, and that's scary to them because that's probably something that they've, you know, they've made money on and and developed, and they probably just don't wanna give it away. And I think I understand that too.

Alison Smart (34:56)

So You explained that super well. Exactly the way you explained. I kind of think of it as, you know, grandma makes amazing cookies, and you can try your best to make them, but you just can't get it just right. But if she shows you how to make those cookies Yeah. It it it goes much better. And and the way you explained it is is exactly right.

Scott Benner (35:13)

Because it's not just as easy as, like, whip the concoction for sixty seconds. Like, it's it it's happening in a certain mixer, in a certain temperature. The number of variables that go into making a medication and then reproducing it over and over again, it's much more complicated than somebody might imagine.

Alison Smart (35:30)

Absolutely. And it required so much, research and and studies to bring this to the market. But to be fair, you know, they there was some taxpayer money involved in that, and and I just think there's there's obligations on both sides.

Scott Benner (35:46)

If you're making me vote for my personal voice, I say, what are you doing, Novo? Just let it be. Like, you you know what I mean? Like, just let somebody do it. Right. If if you ask me to sit here as the host of the podcast, I can see everybody's side in it. Yep. I I know why they don't wanna give it away, and and I understand why we need them to and and all the reasons in between. So yeah. I mean, get off your ass and do it. Like, let's go. Yep. Allison's gotta go home. She what are gonna do after this? Do you think you've made a skill that you'll continue to use, or do you think you'll, like, you know, head back to the farm and stare out the window?

Alison Smart (36:22)

I have no idea. I it will be nice to use some free time to do some take my dogs for a walk. You know? It's been a fascinating educating journey for sure, but we're just feel like we're close. We're not there yet.

Final Thoughts and Resources

Scott Benner (36:36)

If someone else came to you a year from now, you're done with this. It's all working and we you worked the whole thing out. And somebody else came to you and said, hey. We'd like to hire you to do this again for us. Is it something that you found invigorating, or is it not something you'd wanna be involved in twice?

Alison Smart (36:51)

I can't even go there. I'm just so focused on this end goal and exactly what you said, though. Three years ago, I never ever, a million years, would have thought I'd be doing what I am now.

Scott Benner (37:01)

Yeah.

Alison Smart (37:02)

But I just feel like this need, I have to do it, and I have to do it well. The motivation for me, I really feel like lives are at stake absolutely now and in the future. And the more I get into this, the more people talk to me. I mean, I really feel the literal lives are hanging in the balance, and the pressure is huge to succeed.

Scott Benner (37:20)

I can't wait. I I please keep in touch with me. Like, I I wanna know, like, yeah. I wanna know if you end up working, like, in a Michael's Craft and Floral Warehouse next. And you're just like, I needed something with just just fun, Scott. Or if if this has ignited something in you. Because what did you do before this? I'll let you go after this, but what did you do previously?

Alison Smart (37:37)

I was a part time physical therapist. I don't know. I just

Scott Benner (37:41)

It sounds

Alison Smart (37:41)

did my thing.

Scott Benner (37:42)

You know? Allison, that's awesome. And a part time physical therapist who just spoke about insulin in a way that probably made somebody from Novo think we should probably hire her. She seems to really understand this. That is really awesome. I appreciate you giving me an update. Tell me the website again.

Alison Smart (37:59)

Alliancetoprotectinsulinchoice.org.

Scott Benner (38:02)

And you're looking for people's stories, their money, their whatever they can give to to help?

Alison Smart (38:08)

Honestly, biggest thing, their ability to to reach out and say, k. I I wanna I wanna help. I wanna reach out to congressional offices. But, yeah, funding helps with that, but, your time, you're really saying, k. This this this is worth some of my time to reach out to congressional offices to coordinate with this organization and help this happen.

Scott Benner (38:25)

Yeah. I don't know if this will actually ever impact my daughter, but I really do appreciate all the effort and, you know, just your of your life that you've put into this so far.

Alison Smart (38:34)

Oh, thank you, Scott. I I really appreciate this. You're you're doing great things spreading education, and it's just it's just the world needs people who are willing to engage and share and make good things happen.

Scott Benner (38:46)

Well, I appreciate you putting your foot forward on this one. Thank you so much, and thank you for the kind words. Hold on one second for me. Okay?

Alison Smart (38:51)

Okay. Thanks.

Scott Benner (38:59)

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