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Laurie Kaiser: Raised in a holistic household that abstained from traditional medications and vaccines, Nicole Albanese: didn't even know what a pharmacist was as a child. But she was good at science and math, and when her aunt died from Type 1 diabetes, that became her “why” to pursue a degree in pharmacy.

Nicole Albanese: She would not have lived past being a teenager if she didn't have insulin and medication.

Laurie Kaiser: Today, Albanese is a clinical associate professor in the Department of Pharmacy Practice at UB, with a research focus on diabetes, obesity and nutrition. As such, she has a lot to say about Ozempic, Wegovy, and the other popular drugs for diabetes and obesity, and how they're impacting people's lives.

Welcome to Driven to Discover, a University at Buffalo podcast that explores what inspires today's innovators. My name is Laurie Kaiser, and in this episode, I'll be talking to Nicole Albanese about the pros and cons of modern weight-loss drugs.

Thank you for joining us today, Dr. Albanese. Before we get into the weight-loss drugs, I'd like to know a little bit more about your background. It's fascinating to me that someone who was raised without medications became a pharmacy researcher.

Nicole Albanese: Yeah, it's interesting to me too. You know, when I was thinking about what to do with my life, I was going to school at Canisius for business. I did not enjoy it at all, and not doing well in the classes. And I was working at Wegmans, and they put me in the pharmacy just to, like, cash out because they were short people or whatever. And this happened, you know, kind of week after week, and I just sort of got to know the people back there. And the pharmacists were great, and the technicians were great. And as I talked to them more about, like, what is pharmacy? What do pharmacists do, and what is this, and how do you get into it? It aligned with the things that I knew I was good at. I then switched my path and started taking math and science courses, and, you know, then just felt more at home and at ease and did well in the coursework and such.

So that's what really started me on that path, and for me, it's not like I was going against the way that I was raised. As a child, I wanted to have sugar and all the other things. I remember vividly having a friend in grammar school, this must have been second or third grade, and I would go to her house every day after school because her mother would give us peanut butter and jelly on white bread. White bread is something we didn't have in the house, nor was jelly, and nor was the cool peanut butter that she had, right? Because we had the natural peanut butter that you had to mix. When I think about that, and I think about the way that I raise my kids now, it's a little bit similar. Like, I don't have white bread in the house. We do use the natural peanut butter. So there's a lot of things that I've carried forward that's more on the, like, nutritional end and not the medication end. There's a lot of medications that are saving lives and keeping people healthy. There's a lot of medications that just make it easier to live your life.

Laurie Kaiser: So let's talk about the GLP-1s, which are the class of diabetes and weight-loss drugs that include Ozempic, Wegovy and so forth. How do these drugs work in the body versus some of the older drugs for weight loss?

Nicole Albanese: Yeah, so these newer medications are hormone-based. Older medications more worked on the cellular level. So they would go in, certain meds would go in and just, like, sort of wake up the pancreas and say, Hey, pancreas, make more insulin. This person has high blood sugar, they need more insulin. And that's important, because the amount of sugar and the amount of insulin in the body kind of needs to be equalized. And so those older drugs work at that cellular level where these newer medications are working on replacing hormones.

So we have these incretin hormones. GLP-1 is one of them. GIP is another one, which is part of the Tirzepatide, which is one of the medications out there. And these hormones are released when we eat food. And they actually do a lot of different things in different parts of the body. They go to the pancreas and say, Hey, let's make some insulin, they just ate. They'll go to the brain and say, Hey, we're full, stop eating. And they go to the heart and help the heart too. They go to the kidneys and help the kidneys. So they kind of disperse themselves, which is amazing. People who have Type 2 diabetes, probably some Type 1 diabetes too, and who are overweight or obese are lacking this hormone, so they don't make enough of it. And so that becomes a problem, then, right? Because then your brain never turns on and says, Hey, stop eating. And that's where you can overeat.

So that's how they're working, just like on a higher level, and then probably in the not-so-distant future, we're going to go to, like, the next level, and immunotherapy is probably the next place that diabetes is going to be treated. Immunotherapy is used for a lot of different diseases and seems to be a place that it could work well here for obesity and diabetes.

Laurie Kaiser: That’s interesting. Now, Morgan Stanley has estimated that as much as 9% of the U.S. population will be taking these drugs by 2035. What is it about these drugs that have made them so popular?

Nicole Albanese: Well, it's probably two things. The first is, they're an easy fix, right? Take a medication, lose weight. Sounds amazing, right? Because the traditional way to lose weight is not easy. It's difficult. And Americans like an easy fix. We're accustomed to like, hey, let's take a medication and see if it works. It's no different than, like, when statin medications came out for cholesterol years ago. Everyone talked about, Let's put it in the water. We’ll save everyone from having cardiovascular disease and heart attacks and strokes and all that. So I think these drugs are like, an easy way to, like, get people going. But if they want long-lasting results, they're going to have to do a little work, a lot of the work, on their own.

Laurie Kaiser: And Nicole, what was the second reason that they become so popular?

Nicole Albanese: I think social media. I mean, there were a lot of influencers on social media who figured out that this drug works really well and started putting it out there. And then everyone just sort of fell on it, and were like, oh, I didn't even know this drug existed. And, you know, that's a good and a bad thing, I guess, but at the end of the day, we still want patients to be evaluated properly, so that we know the right people are getting the right drug. I mean, that's like my whole job—the right person getting the right drug at the right time. And the wheels have sort of fallen off that wagon when it comes to these drugs.

Laurie Kaiser: So when you say the wheels are falling off, what are you referring to, exactly?

Nicole Albanese: What I mean by that is, in the last few years here, access to these medications has become extremely difficult, and there have been shortages for multiple years. And that is extremely problematic because our Type 2 diabetic patients, who need these medications to keep their disease under control, aren't able to get them because patients with obesity and who are overweight—and I'm not saying that's less of a disease state at all—but it is usually patients whose BMI is only in the overweight category, or maybe not at all, but they were able to get their physician to prescribe this medication. And they’re flying off the shelves, again because of the social media that was happening. And there wasn't any left over for our Type 2 diabetic patients.

And it took a while for our health care system and our insurance companies to catch up with that, to realize, oh, all these people are getting a drug, Ozempic, which is semaglutide, but it is only indicated for patients with diabetes. But then that same molecule, semaglutide, is Wegovy, which is the brand name indicated for obesity and overweight. It's all the same drug. There's literally no difference. So, you know, why couldn't you try to get the Ozempic covered if you could say your blood sugars were high, or you’re pre-diabetic, or something like that? And that's what was happening. And then the patients who really needed it couldn't get it.

Then we caught up and the insurance companies started putting limitations on it, but they swung the pendulum way far over. So they were sort of allowing everybody to get it, and now it's super strict, and people who actually kind of need it now aren't able to get it. They've put all these restrictions on the obese and overweight population. Most companies are looking at an initial BMI of over 40 to even start the medications, where really it's indicated, just really over 30.

Laurie Kaiser: Earlier, you mentioned that these drugs are not an easy fix, despite people's perceptions of that. Can you talk a little bit about why that is?

Nicole Albanese: Well, the side effects are not for the faint of heart, right? Commonly, patients will have nausea, vomiting, diarrhea or constipation, and we say these things sort of flippantly, but like, a lot of patients who are on these medications spend the majority of their day managing those side effects. Like, what can I do to not be nauseous today? Should I just eat some plain crackers? What can I do to not be constipated today? And then you're taking other medications, or you have the diarrhea, so you're taking other medications. They're managing those side effects all the time.

But then there are certainly more serious side effects, right? Pancreatitis, gallstones, abdominal distension. There's issues with contraception. If you're a woman of childbearing age and you use oral contraceptives, you have to be careful there. There's some retinopathy. There was a new warning that came out from the FDA related to suicidal thoughts and ideations with these medications. They're saying right now that there doesn't seem to be a direct linkage, but they would like people to be aware of it and report anything that happens with their patients who are using this medication.

So these things are happening. Those are more rare, for sure, but I don't think that people who are starting these medications are really being counseled on everything that could happen. And it's not meant to scare you. You just have to think about the risk benefit, right? You know. And for a diabetic patient, the benefit outweighs the risk. And for an obese patient, the benefit should outweigh the risk. But for somebody who wants to lose 10 or 20 pounds because they're overweight, probably the benefit does not outweigh the risk.

Laurie Kaiser: What about the long-term success rates? Do people keep the weight off if they stop using the drug?

Nicole Albanese: Not really. So there's definitely some studies looking at this. There was one study in particular that looked at patients on semaglutide for an entire year. And then half of the cohort they kept on the drug, and the other half they took off the drug and gave a placebo injection. And those people who were taken off the drug, so this was after a year of using it, the majority, 50, 60% of them, like, gained all the weight back, or almost all of the weight back.

The issue is, if you're not being proactive on these drugs when you start them, with changing your lifestyle, what you're eating, how much you're eating, and exercise, the drugs work so well that they're eating up all the fat, but they're eating up your muscle too. And so patients who are using this probably have heard this term of, like, “Ozempic face.” That's because they're losing all of their muscle in their entire body, and you can't sustain weight loss without muscle. And so, if you haven't been doing from day one when you started the medications a significant weight-lifting journey, you're going to lose that muscle. And it's very difficult to build muscle back once you've lost it, so most people are going to gain the weight back.

But you know, that was a study that looked at using it for a year. I feel like you probably need longer than that. You know, food is an addiction. Let's be clear about what we're saying here, like there are scans of the brain that show that the same parts of your brain light up when you eat sugar as do when you do cocaine and other drugs, heroin, etc. So it's the pleasure center of the brain that keeps us coming back for more. You have to break that cycle somehow, and these hormones seem to do that, right? So, I think you probably need to be on the drugs a lot longer, five years maybe. And then maybe it's a scale-down program where you can microdose and give smaller portions. But I think you probably need a little bit forever.

But you also need to, like, retrain your habits in terms of eating. If you were somebody that always gravitated to sugar and larger portions, it's going to take a lot longer than a year to retrain your brain and your body to not want sugar and not want large portions, and to order the healthier foods and to not go out to the fast food restaurants and to make your food at home—like all the things that you're supposed to do for a healthy lifestyle. So you just can't, like, come off it and think it's gonna, everything's gonna be great.

Laurie Kaiser: And there's also the issue of access, which you mentioned. So how can you stay on it for a year or longer if your insurance is not going to cover that, or Medicaid is clearly not covering it.

Nicole Albanese: Yeah, that's really tough. All the federal programs don't cover it. And when I say federal, I think most people are going to think like Medicare and Medicaid, but you have to think about all of our like VA employees, they're on federal programs as well. So none of those programs currently are covering any of these medications for obesity and weight loss.

Laurie Kaiser: There may also be some unexpected benefit to these drugs outside of their intended use. Can you speak to that?

Nicole Albanese: Yeah, you know, I mentioned earlier that, you know, sugar really is an addiction, so pretty early on, people realized that, Oh, I wonder if these medications would work with other addictions, substance abuse, alcohol. So there are some studies that have shown some benefit there. And the people that I talk to who use these medications for obesity say that their cravings for everything is different. So a lot of people who, maybe, you know, over-drink, like on the weekends—I wouldn't consider them to be alcoholics, but they drank a decent amount of alcohol—now have no taste for it and don't drink anymore. So the more people I talk to, I really do hear that, and the initial studies are showing us something interesting there.

And then there's some early talk about Alzheimer's. There definitely is a link between Alzheimer's and diabetes and blood sugar, so that makes sense to me on paper, but I don't know enough about that and haven't seen any of the studies on that yet.

Laurie Kaiser: I would imagine there would be more studies going forward in all these areas.

Nicole Albanese: Yeah. Oh for sure, yeah.

Laurie Kaiser: Given all of the both the bad and the good, what potential do you think these drugs actually have to reduce the incidence of diabetes and obesity-related illnesses going forward?

Nicole Albanese: I think huge. But to me, this is just version 1.0, right? So I think if we can figure out the best way to use these drugs long term, and figure out how to make them affordable for the people who actually need them, I think if we can figure that out, that's great.

But this is just version 1.0. Already in clinical trials we have like triple therapy happening. So that Tirzepatide is dual therapy really, it's a GLP-1 and that GIP that I mentioned earlier, that just kind of like ramps up, it just works a little bit better. Well there are clinical trials with three drugs now occurring for obesity and overweight patients. And so those are going to be like version 2.0, and then I really do think that immunotherapy will come through.

And so, you know, one of these days, we're going to be talking about, you know, Tirzepatide and how cheap it is, because we're going to have all these other drugs.  So I think it has great potential. It's hitting obesity and overweight patients where the problem is by replacing that hormone that they're deficient in. But I think we're just at the beginning of it.

Laurie Kaiser: Well, thank you so much, Nicole. This has been extremely interesting.

Nicole Albanese: Thank you.