Stay Off My Operating Table

Levemir Discontinuation Crisis: Alison Smart Fights for Insulin Choice 160

• Dr. Philip Ovadia • Episode 160

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In this urgent episode of Stay Off My Operating Table, Dr. Philip Ovadia and guest Alison Smart discuss the critical issue of Levemir insulin discontinuation. Smart, a passionate advocate, reveals how this decision by Novo Nordisk threatens the health of over a million diabetes patients, particularly pregnant women, and calls listeners to action in the fight to keep this vital medication available.

KEY POINTS

  • Levemir's unique properties make it essential for precise diabetes management, especially for pregnant women and those requiring tight blood sugar control
  • The discontinuation of Levemir could have global implications, affecting millions of patients worldwide
  • Congressional action is needed to prevent the discontinuation and ensure continued access to this crucial insulin option
  • Listeners can support the cause by contacting their representatives and supporting the Alliance to Protect Insulin Choice


RESOURCES 

  • Alliance to Protect Insulin Choice website: https://www.alliancetoprotectinsulin.org/
  • GoFundMe page for the Alliance to Protect Insulin Choice (link not provided in transcript)
  • YouTube video explaining the importance of Levemir (link not provided in transcript)

TIMESTAMPS
00:00:00 - Introduction and background on Levemir discontinuation
00:05:30 - Explaining Levemir's importance and how it differs from other insulins
00:15:45 - Advocacy efforts and challenges faced
00:25:20 - Impact on pregnant women and gestational diabetes
00:35:10 - How listeners can help and take action

CONNECT
• Alison Smart:
  - Facebook: Alliance to Protect Insulin Choice
  - Instagram: Alliance to Protect Insulin Choice
  - Twitter: @insulinchoice

GUEST BIO
Alison Smart is a dedicated advocate for insulin choice and mother of a daughter with Type 1 diabetes. She founded the Alliance to Prote

Send Dr. Ovadia a Text Message. (If you want a response, include your contact information.)

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Written & Performed by Logan Gritton & Colin Gailey
(c) 2016 Mercury Retro Recordings

Any use of this intellectual property for text and data mining or computational analysis including as training material for artificial intelligence systems is strictly prohibited without express written consent from Dr. Philip Ovadia.

Speaker 1:

Thanks for joining us folks. It's the Stay Off my Operating Table podcast with Dr Philip Ovadia, and you are hearing us right now in a rare situation. We are recording this on Friday, september 6th and this show is going to drop on Tuesday, september 10th. We never deliver shows that fast, never, phil. Introduce our guest and let's get into why we're making an effort to get this show out so fast.

Speaker 2:

Yeah, definitely Really excited to have Allison Smart on with us today. I met Allison back in January at Low Carb USA conference and she bought to light at that conference and was doing advocacy around a very important problem. I'm not going to give away the problem, but and you know, because of all the various things that happened, here we are. It took us seven months to get her on the podcast, but it turns out that this problem has now reached a crisis point and there are some very important events coming up around it. We really this is one of the episodes where we're going to ask people to kind of do some stuff, do some advocacy around this problem that needs to be addressed and needs to be fixed. I'm going to let Allison introduce herself and then she can kind of talk about what the issue is, what the problem is that she's been so passionate about addressing.

Speaker 3:

Thank you, philip and Jack. It's great to meet you both and I just really appreciate you letting me be here on the show. It was great to meet you, philip, in January. That was when our journey was just beginning. So I'm going to go back a little bit.

Speaker 3:

About three years ago, my then 13-year-old daughter was diagnosed with type 1 diabetes and the first few months are a blur. You kind of do what you're taught and take whatever insulin and medication you're suggested to use. But within a few months I did a ton of research. I researched every type of insulin, the pros and cons, how long they last, and I learned that there are three basal insulin types. If you're not using an insulin pump and you have type one diabetes and you need insulin, you need a basal insulin that runs in the background and you need bolus insulin, which is the fast acting insulin with food, and I'm only talking about the long acting insulin, this basal insulin that runs in the background.

Speaker 3:

There are only three types available. They come by different names, but there are three, and the one that we used is that we I asked for is called Levomir, and Levomir is a shorter time of action. It's ideal for many populations because it can be adjusted. So most people are not static in their insulin needs, but especially women with a menstrual cycle, teenagers with growth hormones, teenage boys and girls often have insulin needs that, but especially women with a menstrual cycle, teenagers with growth hormones, teenage boys and girls often have insulin needs that fluctuate, that change, and this Levomir insulin has this short time of action, so I'll just get back to-.

Speaker 1:

By short time of action, it kicks in fast.

Speaker 3:

No, that's a great question.

Speaker 1:

Okay, does it last very long then?

Speaker 3:

Exactly so. There are three types, and Levomir lasts about 12-ish hours. It depends on the person and on the dose, so obviously you're going to need to do this more than once in a day, and the other two last longer. One lasts 20 hours, one lasts 42 hours, and that's key for being able to easily adjust, and so it works great for us. My daughter's doing fabulous, excellent management. She's an athlete, she plays tennis almost every day, she competes often.

Speaker 3:

And then just briefly back to my journey. So on last November the 8th, novo Nordisk is the only one that produces this insulin, levomir insulin and they announced that they will discontinue this insulin by this December. So we'll be forced onto one of the other two insulins or onto an insulin pump, and I can explain a little bit why, in a nutshell. Not every option works for everyone. You need to be able to choose, and this one's perfect for me. So then, philip, when we met in January, I had just kind of gone on a flurry of thinking someone's going to fix this right, someone is going to take care of this and this is going to get better and I'm not going to have to worry about it. But I realized pretty quickly, called everyone I knew every organization. I called physicians, I called the American Diabetes Association, jdrf which is now Breakthrough T1D and pharmacists and I said look, someone's going to fix this right. I need this insulin. And they said actually no.

Speaker 3:

We got busy. I created a petition that now has over 4,500 signatures, and we created an organization called the Alliance to Protect Insulin Choice, and I'm now working with many across the country and across the world on educating and asking. The main thing we're asking for is that NovoNardis slows down. This discontinuation produces it for three more years. That will give time for a biosimilar or a generic to come to market. I mean, we can get into that later if we want. It's very tricky for a company to bring a new insulin to the market, and we're thinking this could be done in several different ways. Novo Nordisk could license this to another company. Mark Cuban's company has volunteered to package and distribute it. We've got all sorts of ideas. We're in contact with several manufacturers who would like to make this, and so our job is to ask for this, but also to educate and let people know they are not the same. I think people think insulin is insulin and there are distinct differences.

Speaker 2:

Yeah. So maybe, before we get to the specific issue around this form of insulin, levomir, let's unpack the background a little bit. Your daughter type 1 diabetic and one of the alternative ways of referring to that is what's known as an insulin-dependent diabetic. Right, she's one of a type of diabetic who doesn't her body does not make insulin, and this primarily affects children, but actually can affect adults as well. And of course, the children go, you know that developed this initially, go on to be adults thanks to the miracle of you know, being able to synthesize insulin. And you know this history is something we never actually have gotten into on this show and it's kind of interesting and I forget exactly the year, but you know, I remember I know it's University of Toronto and it's Dr Banting and Best that first figure out how to synthesize insulin and one of the interesting things is that they refused to commercialize it. Basically, they just basically today we would call it open sourced their discovery and just said you know, whoever wants to make insulin, this is how you do it Go ahead and make insulin.

Speaker 2:

Prior to that, people with type one diabetes, you know, weren't able to live very long. The primarily interesting in the context of our discussion. The primary therapy for type 1 diabetes, or insulin dependent diabetes, prior to being able to synthesize insulin, was a low carbohydrate diet. But so Banting and Best come along, insulin gets produced and you know it was one of truly, you know, one of the sort of modern medical miracles, because it really changed the course of this disease, which was uniformly fatal, usually in teenagehood. Most people didn't survive to maybe go into a little bit. Give us a sense you know, of what your daughter's life is like around being able to manage her sugars, how she uses insulin and maybe a little bit more detail about the different types of insulin that you know patients like your daughter utilize to try and keep their blood sugar under good control.

Speaker 3:

Sure. So I think it's interesting. I think you and I think I think people think we can do without food or even, you know, water, for a couple of days. If my daughter were to go without insulin for one day, she would land in the hospital. I mean and we watch it really closely she needs Levomir is ideal because it needs to be dosed more than once a day. She we can, because she is a teenager and has a menstrual cycle and is an athlete. She fluctuates, fluctuates. We can't just stay at the same dose. I'm always looking with her and talking about it and saying, look, huh, you were a little high today, so we're going to increase our dose tonight or in the morning. You know we're going to. We're going to lower it a little bit, so it's fabulous for that.

Speaker 3:

The other two so you can use an insulin pump. Many use an insulin pump. We actually used one for three months a year ago and for us it did. We were able to get comparable results we get. We keep her blood glucose pretty tight so that she can be an athlete and do whatever she wants. She has not had scary episodes of, you know, seizures or going high. We're able. Of course there are times where it's not as great, but that's why we're able to adjust our insulin for the next time. We just keep it kind of tight and when we were on the insulin pump we got similar results during the week.

Speaker 3:

But she plays frequently in tennis tournaments on the weekends and I found that the pump in her case not everyone is the same. I think with all the activity at these tennis tournaments sometimes you can play up to you know, four matches a day and they can last a half hour or three hours, you just don't know and with all the activity and sweat and heat, I think the cannula was probably getting just I don't think it was delivering the insulin as much and so we would need to take it off several times and go back to shots. So in our case shots are just easier. She can do what she wants. She has an active lifestyle. We just went a few weeks ago with her high school tennis team. She went to, you know, a weekend tournament and she was swimming and doing all sorts of things and we have it so well dialed in that that nothing was a problem. But her, you know, she always needs, she needs multiple shots a day because she also takes shots with her food.

Speaker 3:

I think a lot of people think if you have type one diabetes, the whole goal is to take fewer shots and for some people that is the case. Some people really have a needle phobia and don't want to take many shots. Others just get used to it. It's not a big deal for her. She just takes what she needs, and shots kind of mean life when you have type one, I mean if you're avoiding those shots. That's why it's great. It is great that we have pumps that some people can use and they need to change those every two or three days when they use those, but in her case it just works great for us, this type of insulin.

Speaker 2:

And you know, ultimately the goal is for her to be able to control her blood sugar as much as possible, because we certainly know that the complications from diabetes, things like heart disease, things like, you know, eye disease, blindness, vascular disease in the extremities that can lead to amputations, infections, all of these things are, you know, related. The risk of these things are related to how well you can keep your regimen. That will result in poorer or more difficult blood sugar control has very real ramifications for her life.

Speaker 3:

Yeah, I want to say something about that. I think a big realization for us was that those complications that everyone knows about retinopathy, neuropathy, you know, nephropathy, what's that.

Speaker 3:

Oh sorry, problems with your kidneys, with your eyes, with your limbs. They are not a result of having diabetes. They are a result of having high blood sugar from diabetes. So if you have diabetes but you keep your blood sugar in a good range, you are not more prone to those than anyone else if you're able to keep it in a normal range. So our goal for my daughter is to keep her blood sugar around 80 to 120. Does it always stay there? No, but that is the goal.

Speaker 3:

So, yes, having tools that don't allow us to get in that tighter range make life more difficult for us. And she's even said she says I play tennis better when I'm at a great range If I, and so she's careful about it. And just during the day when she's with her friends, she doesn't want to risk being high or low and not feeling great amongst her friends. So she I think some people think I'm not, this isn't just me saying this is what you have to do. You know she is saying look, I'm a teenager, I want to feel great, I want to do whatever I want and not worry about complications and not so we're worrying about how we feel now and later. You know she feels great now, when she's in that good range and we're not worried about the future. I like to say my goal for her is that she will still be playing tennis in her 90s with her siblings and she will not have complications from this, and that is an actual, realistic goal. It is realistic.

Speaker 2:

Yeah, certainly this specific form of insulin, levomir. How long has that been on the market?

Speaker 3:

Since 2005. So the two alternatives Glargine is one of the alternatives and that became available in the year 2000. That one comes by many names. The most familiar name is Lantus, but it's insulin glargine. It's also basiglar and resviglar and semgly, and tuheo is an extra strength.

Speaker 1:

I swear to God, it just sounds like you're just making words up.

Speaker 3:

Sorry, sometimes I need to be careful about spouting out the names, but bottom line, there's three options. So Levomir became available in 2005. The Glargine insulins were available in 2000. So they came first, and then the more recent one that's also only produced by NovoNardisk and is still patent protected for several years is Traceeba or Degladec. You don't have to remember those names, just know that it's this that one lasts about. That one came about in 2015 and that one lasts about 42 hours. The Glargine's last about 20 hours and Levomir lasts about 12 ish hours. So that's, those are some of the main differences, and each of the insulins has a generic name and then a brand name. So the Glargine insulins are the only one that several companies make and come by different names. The other two, levomir and Traceeva, are only made by Novo Nordisk right now.

Speaker 2:

Yeah, and ultimately the differences in these insulins, like you said, is basically how quick they kind of kick into action, how long they last, and you know, for a diabetic this is a game of you know. You're both trying to predict and react to what is going to be happening in your day when you're trying to manage your blood sugar.

Speaker 3:

Absolutely Every day is kind of a. Everything about type one diabetes is about the future. So if we look back today, huh, we were a little low. You know, we'll adjust our insulin. Or you know, maybe that meal dose wasn't quite right, we'll fix it a little tomorrow. So it's always about trying to stay in that sweet spot. You don't want to go too high, you don't want to go too low.

Speaker 2:

Okay, that brings us to. Why is it that Nordisk, this company that makes that, is the only one that makes this form of insulin, as you mentioned? Why have they decided to discontinue it?

Speaker 3:

They gave three reasons in the press release on November 8th. Number one they said there are global manufacturing constraints. We can talk about that if you want. Number two, they said we're sure that people will be able to find available alternatives. And number three they said what was number three? It'll come back to me. So it was global manufacturing strengths. You've got available alternatives. Oh, and the third one was formulary losses. They're saying that this has been disappearing from formulary plans, so that basically means more people are unable to get that under their insurance.

Speaker 3:

And that actually happened to me. So we were fine getting this Levomir in the few years that we've had it. But then we got a letter in November Actually, this isn't going to be covered on your plan anymore. So I just got on the phone and called and they said, ok, you can have it back on. And then a month later I got another letter. I got back on the phone. They said, ok, you can have it back on for a premium.

Speaker 2:

Yeah. So just to be clear on that, it's not that less people want to use this medicine, it's that less insurance companies have decided that you know they're going to pay for this medicine.

Speaker 3:

Exactly. And unpacking, that is a trick, right, because there's the manufacturer and then there's the pharmacy benefit managers and exactly, there's a lot of blame. It's their fault. You know it's a complicated it's complicated.

Speaker 2:

Okay, so this medicine's been on the market now for 20-ish years and that means that it's no longer protected under a patent, so generic manufacturers could make this form of insulin, could make this form of insulin. This same company has an alternative form of insulin that is still patent protected and therefore can't be made generically. One could certainly start to hypothesize that there might be some other financial incentives in discontinuing this form and pushing people towards the still patent protected form of insulin.

Speaker 3:

Absolutely, and every part of this journey has more details behind it and I don't know how far we want to go into it, but that statement that this is not any longer under patent is the tricky one.

Speaker 3:

So when this came out in November, we had patent lawyers look into the patent and I had other insulin manufacturers look into the patent and the feedback I got was that, yes, novo Nordisk FDA exclusivity ended in 2021 on Levomir, but Novo has been clever about filing additional patents on the process and on the device.

Speaker 3:

So even this year, it wasn't clear if the patent was over and Novo has been saying look, anybody could have made this. And that is not the case. And there's a reason the majority of the insulin in our country and in the world is made by three manufacturers and that's it. So the argument well, anybody else could have made this is not correct. But now they did. Novo Nordisk said in private emails to several Senate offices and to myself in March of this year they said we will not assert a patent against a biosimilar. So they're basically saying look, we're not going to take legal action against somebody that makes this which is real because this company has been known to do that in the past and companies have been afraid to bring this to the market at Biosimilar.

Speaker 1:

Sure.

Speaker 2:

I want to unpack that a little bit. So basically, I guess up until that letter, that email, it sounds like it was unclear as to whether or not it was under patent. So therefore that discouraged the generic drug manufacturers from trying to make this medicine generically. And then they say we're discontinuing it and now anyone can make it. They very well know that's not a quick process, right, it takes a couple of years, like you said, for an additional manufacturer to spin up the process and, you know, get something out to market. So it sounds and again, you know you can certainly correct me here, but it sounds to me like they kind of played a little bit of a game as to we're going to, you know, make it seem like no one else can do this, then we're going to stop doing it ourselves. And now we say anyone else can do it. But they know, by the time anyone else does it, all of the patients that were using this will probably kind of moved on to other things and there won't be as much demand for it anymore.

Speaker 3:

And if I could, I would love to address that part. So I did talk to one company this past week. Who's been, who was working on this company told me it takes us eight years to bring an insulin to market. It's different. The timeframe we're hearing from manufacturers is between three and eight years. But this company I talked to said we were actually working on bringing a generic slash biosimilar to the market prior to the announcement of the discontinuation because it takes them so long. But they said as soon as we got that announcement that they were going to pull it. We stopped working on it. The reason is you cannot bring a product to the market without an existing base and expect to get your money back, so it takes upwards of $10 million to bring this new product to the market.

Speaker 3:

And then they bring it and everyone. Even though this is ideal for so many populations, people will have been compelled to invest in a pump or one of the other two insulin regimens and even if they're not as great, it's a hassle to make sure what you're using is covered. If you've invested in a pump, you've now, you're now that's like a $6,000 investment and even if your insurance is paid for it, you can't get another one for four years. There's so much involved that the companies there's just no incentive. They just they can't do it and recoup their money. It's just not financially feasible.

Speaker 1:

Makes sense, all right. So now what?

Speaker 3:

Now what? Okay, so we've been working on so bottom line. Back when we started in November and December, everyone said, look, there's nothing we can do, our hands are tied. And we said there's got to be something, someone they can do. And they said, okay, your elected representatives can address this. So in February we went to DC.

Speaker 3:

I went back in March, again in May, again in July, just at my own expense, and have been meeting with Senate offices and congressional offices.

Speaker 3:

We're talking to everyone we can and it's coming down now there is a Senate help committee hearing on September 24th. So in the United States there are two senators for every state and then so there's a hundred senators and 21 of these are on a committee called the HELP Committee and that stands for Health, education, labor and Pensions. Bernie Sanders from Vermont chairs this committee and last year he did a hearing in March of last year on the high price of insulin and he brought in the heads of the three insulin manufacturers and said can you decrease the price of insulin? And they said, sure. And in fact Novo Nordisk said at that meeting a year and a half ago they said, and look, we're going to decrease the price of Levomir by 65%. So it was eight months after that that they said actually we just don't want to make it anymore. But back to this hearing. So Bernie Sanders, this time is bringing in Lars Jorgensen, who's the CEO of Novo Nordisk.

Speaker 3:

Novo Nordisk makes Ozempic and Wegovy the GLP-1 blockbuster right now and he's bringing him in to say, hey, why are you charging so much for Ozempic and Wegovy? And his aide told me. He said look, senator Sanders likely won't address the Levemeyer situation because the whole point of this hearing for him is the high price of these GLP-1 drugs, but any of the other 20 senators on this committee could address this how the hearings work. Each senator gets allotted time to ask questions. The reason we think this will help.

Speaker 3:

If several senators will mention this, it will get picked up by the press. Also, nova will know that our leaders are watching. I mean, unfortunately, the FDA only says you have to give six months. If you're going to discontinue a pharmaceutical drug, you have to give six months. Now you and I know that should be changed. It should be changed to three years because another company needs to be able to bring this to market. But we feel that if Novo is pressured by the press and by our leaders and if they're saying, hey, this is going to cause harm. And at some point, when you're ready, I'd love to talk about the pregnancy aspect and some statements we've had from physicians and what effect this will have, not only on pregnant women, but on teens, children and adults who need. This will make pregnancy or make diabetes lifestyles harder, and outcomes will decline.

Speaker 2:

So do you have a sense of? You know how many patients are using this?

Speaker 3:

Yep. So three years ago was the last year we could get definite numbers. Three years ago, in 2021, over a million in the US were using Lev Yep. So three years ago was the last year we could get definite numbers. Three years ago, in 2021, over a million in the US were using Levomir. There are fewer than that now because, for the same problem I mentioned, some people haven't been able to get it. But that same year, in 2021, there were 6.3 million in the US using long-acting insulin and over 1 million of those were using Levomir. And just to kind of put it in perspective, the most using long-acting insulin and over 1 million of those were using Levomir. And just to kind of put it in perspective, the most common long-acting insulin is the Glargine insulins and there were over 4 million using that. And then Levomir there were over a million. Traceeba there was just under a million. And then there's an intermediate insulin called NPH that there were about 500,000 at that time using it. We haven't even used that one in our argument because it's not thought really as a realistic long acting insulin alternative. But I want to mention one other thing. So those are US statistics.

Speaker 3:

We feel that if this discontinuation happens by this December. That will be followed by a worldwide discontinuation. Just because when you study the history of insulins, that's kind of how it goes and I don't have numbers for how many are using it around the world. But we feel this affects the million that used it in the US three years ago, the many more worldwide and the many in the future who will need this insulin. No one else is working on bringing a short acting insulin similar to this to the market. What they're working on now is a once aweek basal insulin, which wouldn't work for someone like my daughter or anyone with basal insulin needs that change if they want tight control. But it will be great for someone that's in really poor control and doesn't want to take a shot as often. So I don't want to diminish any insulin. I think we need many on the market. I'm not trying to criticize any, I'm just saying look, we are all different. We need different types For those in tight control. We really need this option.

Speaker 1:

You used the word biosimilar rather than bioidentical. How's this going to work? Let's assume we can get the ball across the finish line in terms of keeping this on the market until a biosimilar is available. What the heck does that mean?

Speaker 3:

So the more commonly understood term is generic, but specific to insulins they're now called biosimilars. That's just the term. So a biosimilar basically is a generic and they just don't use the term bioidentical when they're talking about insulin.

Speaker 1:

So it's the same chemical, just manufactured by somebody not under and allegedly no longer protected by patent.

Speaker 3:

Yeah, I think of it as kind of like pain medication. You can take Tylenol, acetaminophen extra strength, Tylenol take. Walmart brand. It's all the same thing.

Speaker 1:

Gotcha, gotcha Okay.

Speaker 2:

So I guess maybe it would be interesting to hear you know what you've already done. I'm just thinking about the process that has led you to this. You know, I assumed you, you know, maybe reached out to the company and got some sort of response from them and you know. And then, what got you into the sort of public advocacy? How did that come about? Do you have any sort of background in that? Or because, you know, just kind of flying to Washington to try and meet with senators and representatives? I imagine is not, is not an easy thing to do either.

Speaker 3:

This has been so random for me. I've never done anything like this before. All I know is that I called the FDA, so this is on the World Health Organization list of essential medicines. I called all of these companies. I called Novo Nordisk, I emailed. They all said Novo Nordisk didn't have this response. But the World Health Organization, the FDA, pharmaceutical companies said look, the only ones who can change this are our senators and congressional representatives. So I said okay, if that's the only way I will be that, I will mold myself into whatever they want to get this. So I've become an advocate and it's interesting. I've learned a whole lot over this year and it's possible.

Speaker 2:

And you mentioned earlier. You said that you know you're anticipating a global discontinuation of this. So that means that as of now they're only talking about discontinuing this in the US. Now they're only talking about discontinuing this in the US and again, have they given any explanation as to you know? I could kind of you know. It would make more sense to me if the company just says we're not making this anymore worldwide, but to say we're not going to make it or I mean I'm sure it's actually not physically made in the US anyway, we're not going to distribute it to the US basically anymore, but we're going to keep distributing it around the world. That seems honestly, it seems counterintuitive, because what I know is for most medications they get paid the most in the US. You know they get better repayment for it in the US than they get in other countries. So it would seem okay if supplies are short. As a company you would want to prioritize distribution to the US, where it's going to be the most profitable.

Speaker 3:

And I don't have the full answer to that, only that this has happened in the past. Other insulins have been discontinued, and they're often first discontinued in the US and then worldwide, but there is more to that, I'm not sure. So the FDA says you need to give us six months and they're saying, look, we gave you a year. I think in Europe that's longer. I've just had a conversation this past week with the manufacturer about that. So that would be a question I'd actually hope senators might ask at this. Help hearing why is this just being discontinued here? What's your plan next? And you know what will happen next? So some people have said, look, just go get your lavemeer from Canada. I don't want a short-term solution, I want a long-term solution.

Speaker 3:

So the long-term solution is To have other companies be able to make this, but how do we get from where we are right now to there?

Speaker 1:

What has to happen with the folks currently making it?

Speaker 3:

We need them to agree to give us longer. And if they won't agree, there are a couple avenues our senators and congressional representatives, and even President Biden, could take. I don't know if they would take these actions or not, but I wish for the health of those of us that need it that they would, especially the pregnancy argument that resonates. Can we go there for a minute?

Speaker 2:

Sure, yeah, please dig into that.

Speaker 3:

Okay. So the FDA used to recommend used to give letter grades to insulin, to any drug used in pregnancy. They changed this in 2015,. But it doesn't change the fact that in 2015, all three basal insulins were on the market and the only one that they approved for pregnancy with a B rating, which meant there was no harm shown in animal studies, was Levomir. They did not. They gave Glargine and Traceeba a C rating, which meant studies are inconclusive or have not shown that it's going to be safe in pregnancy. And Novo is saying the FDA doesn't use this ruling anymore. Why does it matter? It matters because we have physicians who've said that gave us comfort, knowing this was safe in pregnancy. Now all three insulins are used in pregnancy.

Speaker 3:

It's better to use insulin than not if you need it during a pregnancy, but it doesn't change the fact that this is the safest, and one of the reasons is it's short time of action, so pregnant women often have different insulin needs in the day versus the night. I have a niece right now who was diagnosed with gestational diabetes a few months ago. 10% of all women who are pregnant are diagnosed with gestational diabetes. Of those with gestational diabetes, 30 to 40% need insulin. This is the insulin. That's easier because, like specifically so this niece of mine, she only needs insulin at night for her fasting blood glucose levels, not in the day, so Levomir is perfect. She can take it in the evening. One of the Senate aides I met with a few months ago said oh, that was the same with me. I had a baby a year ago and I only needed insulin at night. My physician knew Levomir would be perfect. That's what I used. I had the baby and I don't even need insulin anymore. So specifically for gestational diabetes, they're not going to use an insulin pump and the two insulins that last longer are not as proven. I need to get into something else.

Speaker 3:

So the American Diabetes Association has stated that in their standards of care for 2024, they've said insulin studied in randomized controlled trials are preferred over those studied in cohort studies, which are preferred over those studies in case reports only. So you can do case reports on any insulin in any drug. It's not that hard. It's usually just over one person or a cohort study is just a few people. A randomized controlled trial has to include a certain amount of people and it's comparing one insulin to another.

Speaker 3:

Nph was approved as an intermediate insulin early on for pregnancy. And then there have been several randomized controlled trials showing that Levomir is safe. And in fact, just last year there was a study with over 1,450 women comparing NPH and Levomir in pregnancy, and the study found that those using Levomir had fewer episodes of hypoglycemia and less rates of prematurity. So Levomir is just it's ideal and insulin needs. Not only are they often different in the day and the night for pregnant women, they fluctuate greatly throughout the pregnancy and that's why Levomir is ideal.

Speaker 3:

You can titrate it to match that. If you're using something like Traceeva, that lasts much longer, which some women do in pregnancy, but it can be more problematic. For example, right after delivery, insulin needs plummet to about a fourth of what they were before. If you have a shorter acting insulin, it's so much easier because if you don't have it right, you know you're only going to be dealing for a couple hours. But if you're taking a longer acting insulin that you don't have the right amount in your body and it lasts for three days, you're left taking sugar or a shot of fast acting insulin every few hours if you want to be at good levels.

Speaker 1:

All right, I think I understand the medical side. I've got an idea about the business side and there's nothing I like quite as much as dragging the people who pretend to be in it just to help people over the coals, because they're clearly in it to get as rich as fast as possible on the backs of sick people. But I'm not going to do that. I want to know if there's any precedent for what you're asking be done precedent for what you're asking be done?

Speaker 3:

There was. So in Australia. One of the companies was going to pull a fast acting insulin several years ago and there was such outcry that they said okay, you can still have it, I just we there. So here's the other thing. The three insulin manufacturers are becoming distracted. They want to make. All three of them are working on GLP ones, which are much more lucrative, and they're thinking you know this can help so many more people. The type one community is fairly small relatively speaking, but if we can make more GLP-1s, which are super in demand, we can make much more money off of them. We'd rather make them.

Speaker 3:

This is a problem. It's actually bigger than Levomir. I mean, for one thing, just to get rid of the insulin that three years ago one in every six we're using. But in addition, just insulin in general is not as lucrative. We need more companies. We can't rely on the big three to make all our insulin anymore. So if we can bring in some other smaller biosimilar manufacturers, not only will it help with Lavimere, but it will help with insulin security in general insulin security in general.

Speaker 1:

Any idea what the top line revenue would be for such a company that was providing that kind of insulin for a billion Americans annually?

Speaker 3:

So I do know from talking to a pharmaceutical manufacturer last week that even as Levamir is being squeezed right now, there are smaller people using it Worldwide. It's still. Levamir alone is a $2 billion market, so there is incentive. That's why I'm talking to several manufacturers who are saying we'd like to make this. We know people want it and need it and there is money there.

Speaker 1:

Does Congress actually have the authority to force? What's the name of the company? Novo Nordisk? Is that even an American company?

Speaker 3:

companies subject to all US laws, rules and regulations. As far as force, the only thing that could really force Novo to do this would be if Biden would enact the Defense Production Act. So this is an act that was used during COVID to increase manufacturing of ventilators and it was also used in 2022 to increase production of baby formula. So, basically, biden said to these companies look for the health of our babies, we need more baby formula. So, basically, biden said to these companies look for the health of our babies, we need more baby formula. You need to make more baby formula. He could say look, novo Nordisk, for the health of our pregnant women and other people who need this insulin, you need to make this until a biosimilar is available. Would he do that?

Speaker 1:

I don't know, I mean okay, All right, I'm going to put on my marketing hat now. You just found the gold. That's the gold. There are all kinds of arguments that can be made against what you're asking to be done, and they're logical arguments. You can win this using the emotional argument which is hey, if you take this off the market, you're putting our pregnant women and their children at a higher level. We can prove a higher level of danger. Don't you love the babies? Do you want to kill the babies? Is that what you want to do? Is it worth that much money to you to kill the babies? Is that what you want to do? Is it worth that much money to you to kill the babies? But that's.

Speaker 1:

I'd come up with a marketing plan, something similar to that. I would pitch it that way You're going to kill the babies. Is it worth it to you? And although the spreadsheet junkies in the corporate offices are going to say, yeah, the guys in the marketing department are going to say, no, we don't need to do that. That's the way I'd go after it.

Speaker 3:

I love it. I think it's great.

Speaker 1:

I realize this ain't science, but this is how the human brain operates. We got to get them. We got to get people attached emotionally to the outcome yeah, jack's marketing brain certainly a use, I guess.

Speaker 2:

With that being said, allison for those in our audience that don't want to be baby killers. What can they do? What do you want them to do?

Speaker 3:

They need to hear. Senators are busy, Congressional representatives are busy. They're hearing from people all the time but they tell me look, if I get 20 emails from constituents, I listen. If I hear their story, I listen. And it doesn't need to be just Levin-Mayer users. Certainly, if people are Levin-Mayer users or have type one, I hope they reach out. But even if you're concerned, I hope that people will take the time. So when you live, if you live in the U, you have two senators and one congressional representative. It's as easy as Googling who's my congressional representative and you put in your zip code and it'll tell you. And if you can send a message that say please pay attention to Lev Amir, Please bring this up in the help committee hearing on September 24th, or even if you're listening to this after that, please make sure that we have a biosimilar of this insulin made for the health of our loved ones before this leaves the market. Please do all you can. We'd really appreciate that.

Speaker 2:

Are there. I mean, obviously you said there are 20 senators or 21 senators on this committee. Should people be reaching out to them in particular? Or you really just need to reach out to your senator and then they kind of relay to the people on the committee that this is something that's important to our constituents?

Speaker 3:

No, I'm glad for that question because all of the above, yes, specifically, we'd like these 21 senators to hear about it. But how it works I've learned now, on Capitol Hill they're talking to each other. So if you live in California and California doesn't have a senator on this committee, if you'll still reach out to your representatives, I'm still thinking there might be something the house could do. On the congressional side, there are committees that have different jurisdiction that I think might be able to help. Can I read out this the States and the senators really quickly?

Speaker 1:

Sure 21.

Speaker 3:

Okay, so it's Bernie Sanders in Vermont. These are the ones that are on this help committee that will be in that hearing in two weeks, on the 24th. Patty Murray in Washington, bob Casey Jr, pennsylvania, tammy Baldwin, wisconsin, christopher Murphy, connecticut, tim Cain, virginia. Maggie Hasson, new Hampshire, tina Smith, minnesota, ben Ray Lujan, new Mexico, john Hickenlooper, colorado, ed Markey, maine, bill Cassidy, louisiana, rand Paul, kentucky, susan Collins in Maine, lisa Murkowski, alaska, mike Braun, indiana, roger Marshall, kansas, mitt Romney, utah, tommy Tuberville, alabama, mark Wayne Mullen, oklahoma, and Ted Budd, north Carolina.

Speaker 3:

You know, maybe you don't live in one of those states, but you could still reach out to your own representatives, or maybe you have friends and relatives that live in those states that you could say hey, help us out. And I want to plug. So we have a website, we're called the Alliance to Protect Insulin Choice, and you can. We have a contact form. If you want a script, we'd be happy to give it. You can reach out to us. We are on Facebook and Instagram, Alliance to Protect Insulin Choice, and on X, insulin Choice, and I want to give a little plug.

Speaker 3:

I think, philip, you and I both know Nayeri Massissian of Low Carbon Fasting. She's fabulous. Low Carbon Fasting has been one of our sponsors. They've helped with the website and on our website we've got a YouTube that's hour long that's listing that has many parents and individuals who are saying why this insulin is unique and important. So if you could watch that but we would love that and we could use. We have a GoFundMe and a donate page. We've been doing this all at our own funds. We could use some partnerships or help donating too, but just wanted to give that little plug. But I would love if you could. And if you don't know how to reach out and you're thinking how do I do this or what do I say, please reach out to us and we'd gladly help.

Speaker 2:

Amazing, I say please reach out to us and we'd gladly help. Amazing, and you know I'm just going to kind of. We touched a little bit on this, but I think it's worth pointing out. Right, this is not just about Levamere. This is really a demonstration of the kind of you know how the pharmaceutical companies have people over the barrel, so to speak. Right, because they can just make these decisions and it can have real world implications on people's lives.

Speaker 2:

It's, you know, it's unfortunate that we find ourselves in these situations, that we're so dependent on these companies. And I know you know on a related manner right, you were at the low-carb conference. You're interested in people doing what they can to reduce their dependence on pharmaceuticals, but obviously, with this particular disease type 1 diabetes you can't completely eliminate the need for pharmaceuticals, and the way that these companies act is, in my mind, somewhat irresponsible at times. So I think it is a broader issue and the more that we can push back against what these companies try and do, the better we'll all be. Again, it's the Alliance for Insulin Protection.

Speaker 2:

Alliance to Protect Insulin oh sorry Alliance to Protect Insulin, and we'll have all those links available in the show notes. Thank you, allison. Thank you for taking on this important battle and for all the advocacy work that you've done, and again for everyone listening. Take some action. Check out the website, educate, educate yourself and reach out. For those of you in the US, reach out to your representative or senator to bring up this important issue.

Speaker 3:

Thank you, Philip. I can't tell you how much I appreciate this and for all you do to increase awareness of health and issues and just really appreciate you and great to talk with you and Jack.

Speaker 1:

We're glad you were here.

Speaker 3:

Thank you so much.

Speaker 1:

All right, this has been the Stay Off my Operating Table podcast. We appreciate you joining us For Dr Philip Ovedia. We'll see you all next time.

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Dr. Philip Ovadia

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Jack Heald

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