Episode 190: The End of Compounded GLP-1s: What It Means for Your Weight Loss Journey

[00:00:00] Welcome back to the Back on Track Achieving Healthy Weight Loss, where I help you get on track and stay on track with your weight loss journey. I'm your host, Dr. Alicia Shelly. So let's get started.

[00:00:27] Welcome to the Back on Track Achieving Healthy Weight Loss podcast. I'm your host, Dr. Alicia Shelly. Did you know that millions of people are taking the compounded GLP-1 semaglutide and terzepatide medications? And soon, the compounded versions will be off the market. Many people opted to use the compounded versions because it was more affordable. Either their insurance didn't cover it, and so they were left to have to pay out of pocket.

[00:00:57] And the compounded versions were more affordable than the brand name medications. And so today, we're going to delve into what these compound GLP-1 medications are and what alternatives do we have when the compounded versions are no longer available. But first, let me just explain what is a compounded medication.

[00:01:18] So a compounded medication is a custom-made drug that's prepared by a licensed pharmacist or compounding pharmacy to meet the specific needs of an individual patient. Now, sometimes compounding is used if a commercial available medication is not suitable for a patient, like either it has certain additives that they're allergic to or different dosing requirements or a different formulation.

[00:01:46] Like instead of a liquid, they prefer a liquid instead of a pill or they want a cream. We often use compounded medications for creams for like pain control, hormonal replacement. I have patients where the compounded version just works better than the commercially available medication. And sometimes they want a cream or they want a liquid instead of a patch or a tablet. It's very helpful.

[00:02:10] But there are differences between what exactly a compounded medication is and a generic medication. Now, the compounded medication, even though they're using a commercial available medication or copying off of a commercial available medication, it does not have to be tested. It's not regulated by the FDA. And the FDA can't say that this compounded medication is effective.

[00:02:35] Now, there are certain compounding pharmacies that the FDA has oversight where they make sure the pharmacy is sanitary and has safe practices, but they're not testing the medication that the pharmacy is giving out to patients. And so they can't say if it's effective or not. And you don't know how much of a medication you're getting or not. You're just trusting that pharmacy.

[00:02:58] Now, a generic medication is also a copy of the brand name medication, but they have to submit testing that they have the same effect as the brand name. And in order for that generic to go to market, they have to submit studies and tests that their generic product will behave the same way as the brand name product.

[00:03:19] So the patient should be able to take the brand name drug on one day and the generic drug on another day and receive the same treatment effect of the generic medication has to submit that testing to the FDA. Now, if you're just a little bit confused on all these terminology, let me back up and start from the beginning. So when a pharmaceutical company decides to create a medication that they think will be beneficial and profitable, they submit a patent for this medication, especially if it's new.

[00:03:49] They submit a patent for this drug to the U.S. Patent Office. Now, from the time they submit that application, they have 20 years of exclusivity, meaning that no other company can copy this drug or use it in that same manner. Like they have 20 years of only them using this particular medication. But once the patent expires, then other companies can come in and produce an equivalent.

[00:04:14] And when we look at our medications in the U.S. today, almost 90% of them have a generic equivalent. Like you can walk into Walmart, Target, all the different stores, and you can see a medication for Advil is generic ibuprofen. A medication for Tylenol is generic ibuprofen. These generics are all over. And a lot of times, the tier one medications that are in our formulary at work, our drug formulary at work, all of them are generic equivalent.

[00:04:44] A majority of them are generic equivalents. So we use a lot of generic equivalents in our society today. And when we look at the patent, the patent for the Wagovi is set to expire in 2032 in the U.S. It will expire sooner, I believe, in China. The terzepatides patent expires in the U.S. at 2036. So just a few years from now, people will be able to have a generic for these medications.

[00:05:11] Now, how can you get a compound of GOP-1 if the Wagovi and the ZepBound, or another name for terzepatide is ZepBound, excuse me, are still under the patent? Because there's a loophole. There's always a loophole. If a FDA-approved medication is on the shortage list, then it is lawful to create a compounded version of that medication. And that is exactly what happened.

[00:05:37] When Wagovi and ZepBound came to the market, the companies knew that the demand for these type of medications that worked and that actually had significant weight loss was going to be higher than what they could produce. So they knew that this was going to happen. And it actually gave them time to kind of get their factories up and rolling so that they can be able to get off that shortage list. And they were only on the shortage list for maybe a little over a year.

[00:06:03] Now, when I say significant, these medications are a game changer. So when we looked at the average weight loss that you see with lifestyle change alone, that's around 5% to 10% at the highest. When you add in the oral pills that we have, like Phentermine, Cosemia, Contrae, now you're talking maybe 8% to 14%.

[00:06:25] But when you added Wagovi and ZepBound to the picture, now you're seeing weight loss between 15% and 26%, depending on which study you look at. So it was a game changer. It was more effective in helping people lose weight than what we had before. Hence why there was such a huge demand for it.

[00:06:46] But the problem with compounded drugs is that they pose a higher risk than the FDA approved drugs because they don't undergo FDA review for safety, effectiveness or quality before they are on the market. And then also we saw a lot of safety risks and errors and things that occurred with these compounded medications.

[00:07:08] In fact, the FDA had received multiple reports of adverse events requiring hospitalization because either people were not taking the proper dose. They were taking too many doses per week. Instead of taking one dose per week, they're taking it per day. Some of them were taking too much of a prescription. They are supposed to be at 10 units of the compound, but they took 25. They just misread the syringe. And some of them started tapering up too quickly.

[00:07:36] Now you're supposed to stay at one dose for a month before going up to the next dose. But some people wanted to override that because they wanted to lose weight so quickly that they titrated up. And guess what? They got sick. They had nausea, vomiting, diarrhea. Some of them had to be hospitalized so they can get rehydrated and gone back. And some of my patients had to do that too because they made errors while they were dosing. Also, there were counterfeit Ozempic that was marketed to the US.

[00:08:05] And there were other tests that were put out there when they had to investigate. Also, illegal online sales of these medications. I remember in prior podcast episodes before, I shared with you there was an Amazon account that was just selling GLP-1. Just GLP-1 shots. That's all it was selling. And we didn't know where it was coming from, what GLP-1 was in there. Like, people were just doing their best to sell. And they had like at least 600 people who bought it. So, who bought that medication.

[00:08:35] So, there was so much there. And sometimes with a compounding, you don't know if it's how much what's in there, whether it is the actual semaglutide or whether, you know, what type of ingredients that they use. It just was not regulated and ended up being a safety hazard, to be honest with you. I remember one of my nurses telling me that one of her friends would go behind a fertilizer shed to get a guy who was selling a compounded vial for $40. Now, $40, you know that's not the right.

[00:09:04] You're like, what are you really getting, right? Is there caffeine in there? Like, you just don't know. So, it became, you know, it definitely was a safety risk. Now, those who got their compounded from a state licensing pharmacy, those were definitely a lot better. But those people who got them from different sources that were kind of sketchy, they tended to have more problems. But now, like I said in the beginning, is that this is going to be taken off the market.

[00:09:30] So, like I said, the loophole was that as long as these medications are on the shortage list, then the compounded versions can be lawfully sold. But now, they're being taken off the shortage list. So, Trisepatide and semaglutide have now been taken off the shortage list. And so, they have for the Trisepatide, the state licensed pharmacies and physician compounding need to stop selling compounded medications as of February 18th, 2025.

[00:10:00] And for the outsourcing facilities who are creating these medications in bulk, they have until March 19th to stop selling now. And then also, for semaglutide, for the state licensing pharmacies and physicians compounding, they have to stop selling theirs by April 22nd and for the outsourcing facilities by May 22nd. So, by the end of May, all these compounding medications will be off the market.

[00:10:27] So, people, millions of people who are taking this, it's hard for us to even gauge how many people are taking it because there's so many different sources and they're not necessarily reliable as far as how many people are taking it. But all of those people are eventually not going to have an alternative for compounded medication. So, what can you do if you're taking a compounded medication and it is no longer available? Now, the first thing I tell everybody is that we definitely need to focus on our lifestyle habits.

[00:10:56] Even if you are on the brand name. When we look at those studies, everybody in that study, even people who were taking placebo, had lifestyle changes. So, they had to show that they were exercising at least 150 minutes per week. They were eating at least 500 calories less than what they normally do. And they had that. And so, even people in placebo lost weight. But when you added the medications, they lost even more weight. So, it is essential that you focus back on your lifestyle habits.

[00:11:26] Make sure you're eating a healthy, balanced diet. Making sure you're getting your fruits, your vegetables, your protein in most importantly. Making sure you're drinking enough water per day. That was the other thing. Because people don't feel as hungry. They are not drinking enough water. Making sure that you get plenty of sleep. And reducing your stress as best as possible. Also, talk to your doctor about other options that may be available for you and whether you're a candidate for them.

[00:11:53] And you may want to talk to them about whether you can space out the medications instead of taking it every week. Taking it twice a week in order to extend how long you have it until it's gone. But definitely make sure that you speak to your doctor about what your options are. The companies have come up with a new self-pay program. Because even though they're working very hard to get their medication on your insurance formulary.

[00:12:17] Many organizations like the Obesity Action Coalition, the Obesity Medicine Association and so forth. Have been working and advocating to get Congress to pass the TROA, the Treat and Reduce Obesity Act. So that everyone can get treated or be covered for obesity. In fact, just this year, Medicare and Medicaid, or the Centers of Medicare and Medicaid, or CMS,

[00:12:42] proposed a rule to cover weight loss or eating nutrition, exercise physiology for Medicare and Medicaid. However, I don't know where that is at this point, now that we have a new administration. But call your congressperson. Sometimes if your insurance, your employer is not covering it, sometimes we all need to take action. We can't just sit here and not do anything.

[00:13:06] So definitely call your congresspeople, call your HR people, and hound them, hound them, tell them that you want this. Have a petition and say, hey, listen, all of us would really want this benefit at work if you can cover these medications. Sometimes just being that advocate will first of all to help you, but it'll also help your fellow employees. And then for all of us to getting what Medicare starts to cover, usually other insurances will start to cover. So it's important that we be able to advocate for ourselves.

[00:13:36] The different companies have come up with a new self-paid program to help reduce because the prices were high. When they first came out, ZetBound with Govy, you had to pay out of pocket. It was costing like $1,500. But now, ZetBound just this week, they lowered it for the 2.5 milligram dose. It costs $349 and these are the vials. So 2.5 milligram vial is $349. For the 5, 7.5 and 10 milligram vials, it's $499.

[00:14:05] And so they only initially only had two, but now they have the other vials. If you wanted the pens, that's $650 a month. And these are all per month. And Wagovi pen is currently $650 a month. So those are the options if you wanted to self-pay for the brand name. The other thing not to forget too, they do have different pill form options, such as Phentermine, Quasemia, and Contrave, that you should talk to your doctor about whether that's an option for you as well.

[00:14:32] And usually Phentermine can run between $10 and $20, depending if you use that, like a pharmacy savings coupon. For self-pay for Quasemia, that's around $98 a month. And Contrave is $98 a month too. And usually that comes from their mail order specifically. So just because the compound medications will no longer be legally sold in the US, does not mean you have to stop your progress. Like I said, continue your lifestyle habits, continue to focus on that.

[00:15:01] Talk to your doctor about whether other medications will be beneficial for you. And then just take it one step at a time. I always tell people we didn't gain weight like this overnight, and we're not going to lose it overnight. So we just got to take it one step at a time, give ourselves grace, and make sure that we are incorporating our healthy habits. Well, I thank you so much for joining us on the Back On Track Achieving Healthy Weight Loss podcast. If you liked this episode, please share it with others, like it and subscribe. And don't forget to leave a five-star review.

[00:15:31] Have a fabulous day.