Is Ozempic Actually Safe? CEO of Major Pharmacy Speaks Out | Shaun Noorian, CEO

Dr. Gabrielle Lyon: 00:00

Everyone is talking about GLP ones, and just as fast as the so called miracle drugs exploded in popularity, the shortages hit. That's when compounding pharmacies stepped in, offering lower cost, customizable versions of these weight loss injections. But are patients really getting the same thing or something more dangerous? Today, I'm joined by Shaun Noreen, CEO of Empower pharmacy, to answer the hard questions. Well,

Shaun Noorian: 00:30

that lines up with the fact that seven out of patients can't afford to take the medications. Seven out of how many? Seven out of eight cannot afford more than $500 a month. Well, someone has to fight for patients.

Dr. Gabrielle Lyon: 00:42

Are compounded. GLP, ones legit? Is anyone regulating the space and now in the media, we're hearing the FDA has banned compounded versions of these drugs. What does that mean for the millions of individuals using them? This episode is about power, profit, patient safety and pulling back the curtain on one of the most controversial moments in modern medicine. Shaun Noorian, welcome to the podcast. This is your second visit on the show, and I couldn't be more grateful to call you a friend, and also, quite frankly, the advocacy that you are doing in the world for patients. And to tee this up, I just want to preface this by saying you own, empower pharmacy, the largest compounding pharmacy in the world, and you are making medications accessible. You and I were chatting, what was it last week? Was it last week? And I was just asking you how you were doing, because I kept hearing in the news that GLP ones were no longer going to be made available by compounding pharmacies, and you sent me a message saying, I'm doing great. Eli Lilly just sued me, and I'm ready to take it on Absolutely.

Shaun Noorian: 02:08

Well, someone has to fight for patients, and this is no new story. You know, Big Pharma has been trying to maintain their monopoly since the beginning of Big Pharma. And how do they do that? They attack potential competitors, and they use their influence, both on Capitol Hill, with agencies, regulators and the media, to be able to attack their opponents. And why would they want to do that? To maintain monopoly so they can charge as much as they want for as long as they can,

Dr. Gabrielle Lyon: 02:43

how much of the market does Eli Lilly. And just to be clear, we are talking about GLP ones. We are talking about the hottest, most effective drug that has come on the market for weight loss. And by the way, I will mention that if you look at the history of weight loss drugs, this in the early 1900s they were using thyroid and actually DMP. Have you heard about DMP from the bodybuilders? So it was DMP, extremely toxic, increased metabolism, and that was banned by the late 1930s 1940s to 1950s the rise of amphetamines. Then, of course. So that was dexedrine. And then in the 1960s there were the rainbow pills that led to deaths. FDA cracked down in the 70s. And then, of course, the 80s, Fen Phen and orlistat. Finally, the 2000s we're talking about, you know, just to give you a perspective of how long we have been looking for a medication that can work in the long run for patients in a meaningful way. Finally, you know, we'll skip a Contrave and a couple more. We'll speed up to 2020, the 2020s GLP, one revolution happened, and that's semaglutide, tirzepatide zepbound. And to be clear, the older medications like phentermine, three to 5% of body weight loss with a side of heart heart issues, or list out three to 7% GLP ones looking at potentially 15% weight loss. Yeah,

Shaun Noorian: 04:22

it's been quite the revolution, and Americans in the world have never really had GLP ones before. They've had a method to be able to lose as much weight with as few side effects as were present with the previous drugs. And so we've seen, as soon as semaglutide was indicated for weight loss, it went on back order. And in late 2021, when it went on back order, patients started realizing that they couldn't get access to even they even if they could afford it, and only seven out of eight, one in seven patients can afford. Afford more than $500 a month. One

Dr. Gabrielle Lyon: 05:02

in seven patients can't afford so they were so the the cost of the medication was, what you're saying is over $500 well, when

Shaun Noorian: 05:11

it first came out, was 1000 and you know, as soon as company Novo Nordisk, Jane Ali realized that they were losing a massive amount of share, market share, two compounding pharmacies, Novo last year, decreased their price to about $500 a month, and Lily followed a couple months shortly thereafter and lowered their prices to $500 a month, more or less. How

Dr. Gabrielle Lyon: 05:36

who owns, what are the pharmaceutical companies that own the brand names of these drugs,

Shaun Noorian: 05:43

Novo Nordisk makes the brand name drugs bogovi and ozempic. Eli Lilly makes the brand name drugs, zeppbound and mongino. So which is the brand name for terzepatide and Novo Nordisk brand name drugs, the generic name, if you want to call that, is semegliatide. And you know, when they first came out with these drugs, they stated, you know, us, consumer, $1,000 a month is the best we can do. You know, we can't really lower the cost better than lower than that. It's not fair to our shareholders. Okay, well, in the same time, Novo Nordisk is a European company, and they were giving that same exact drug to Europeans for $100 a month, about on average. And so why is it? Why are they saying that US consumers have to pay 10 times more than the same human in Europe? What's and then as soon as they realized they had some real competition, they went and cut their price in half, which is still on a table for the vast majority of us, population,

Dr. Gabrielle Lyon: 06:48

times higher, right than Europe, right? And then

Shaun Noorian: 06:51

Lily follows shortly thereafter. I mean, it's obvious price fixing. They both come out with a drug at $1,000 a month, and then they only lowered when they see there is competition, and they follow each other's pricing. You know, that's not really that. That's pretty much a monopoly. And you know, when compounding pharmacy, when we make a drug, we look at the equation differently. We don't ask how, what's the most amount we could make off a certain population, given that that certain population can only afford so much, what we do is we say, what's the lowest we could possibly produce it for to bring as many patients into our system and make up that profits on volume, not on the most number of patients possible, not on the fewest number of patients possible. So compound providers and patients have flocked to compounding pharmacies because, not just because we're more affordable, but also because the medications, in many cases, can be result in better patient outcomes. They're personalized. They can be by different dosage form, different dosage strength, or different dosage combination to really dial in and potentially minimize some of the side effects that a patient may have by using a commercially available drug. So for example, let's say a doctor wants to start a patient on a micro dose,

Dr. Gabrielle Lyon: 08:16

because the patient ozempic, something like that, which is what we use in clinic,

Shaun Noorian: 08:21

absolutely. You know, the minimum dose for the starting dose is a single dose pen, and that's the dose the patient get. Can't go higher, can't go lower, like that first initial dose is that

Dr. Gabrielle Lyon: 08:31

dose. And I will say we with ozempic, there are a tremendous amount of side effects. By the way, it's a great drug. However, when typically increased based on the standardized pen dosing we see in clinic, and we've been using ozempic for quite some time. We had originally used sixnia When that was available. Now it's a little bit more obsolete. The side effects are tremendous, but when we have now been able to modify the dosing and go up slower, titrate differently, then we mitigate side effects, and patient outcomes are tremendous by way of weight loss, metabolic regulation, there's evidence for heart health, neurologic health, The list goes on, lowers inflammation, but I'm concerned when I hear that these are not going to be available, and that I have many colleagues that believe compounding pharmacies are going to all shut down, and they also believe that compounded medications in the GLP one family are illegal,

Shaun Noorian: 09:40

right? And dangerous as well. And dangerous, yeah? Is that true? Nothing could be further from the truth. While Big Pharma would want us to believe that anybody outside their system is illegal or dangerous. Now, there are so many regulations in place for the compound. Industry. I mean, we are manufacturing drugs as an outsourcing facility using good manufacturing practices, the same exact standards that big pharma uses. And our outsourcing, our compounding pharmacy, we compound medications under similar standards, and when you're when you're making drugs that are destined to be injected into humans, nothing is more regulated than that, and so we have 50 State Boards of Pharmacy overseeing us. We have the United States Pharmacopeia, and we have the FDA looking over our shoulders, making sure that we're we're doing what's right for patients. We're making medications that meet the standards for pharmaceutical manufacturing and compounding. This country so and company has been around for a very long time, since the beginning of time, all drugs were made. Since humans have existed. They've been made manual, using mortars and pestles, putting in herbs, other chemicals. And it wasn't until about 100 years ago when we saw a shift where Big Pharma started taking control and take and shifting the total addressable market of medicine from compounding pharmacies and apothecaries and druggists to the mass manufactured systems that they've created. That's

Dr. Gabrielle Lyon: 11:13

interesting. Was there a need for that? Is it similar to, you know, and I think about it in terms of medicine, so many small practices are now bought out by hospitals and individual physicians then sell their practice, the big brother then owns all of these little practices, allows them to function as a little practice, but ultimately, these hospitals own everything. Is that similar to and I'm not saying that that's happening across the country, but it definitely is happening in increasingly high rates. Is that the same with compounding pharmacies, where Big Pharma came in and bought out little or did they just come in and try to streamline it? Was there some benefit? Was it making medications more standardized? Was it making it faster. Was it meeting a need? It was it

Shaun Noorian: 12:02

was definitely making it more standardized. And we can see that the consolidation occurred fairly rapidly, where now only compound farms, where we used to make up, like 100 years ago, we made up 75% of all drugs dispensed in this country. Now we only make up 3% and what's happened? What we've seen has happened is what's known as regulatory capture, where Big Pharma and the regulators somewhat collude, where there's a revolving door, where regulators end up working at Big Pharma once they leave. So they want to protect Big Pharma interests, and then Big Pharma lobbying more than anybody else, more than any industry. By far, I think this year they're going to spend $380 million on lobbying. Why would they need to spend so much on lobbying? You know, are there are patients? Not are there problems where they're you know, the market is unfair to them. They want to make sure that they control industry this, it's all about control, being able to control who, who gets what, and how much they pay in order to get it and prevent competitors from coming in space so they can continue to charge that much so. And then, of course, there's, isn't there?

Dr. Gabrielle Lyon: 13:15

Wait, I want to, I want to ask you, this, is there a level of fairness? So if we were to look at it from again, I don't know what goes on in their head, but from their perspective, do they how much does it cost to bring a drug to market for

Shaun Noorian: 13:29

a farm steal company? Yeah, depends. But anywhere from hundreds of millions to billions of

Dr. Gabrielle Lyon: 13:34

dollars, that's a lot of money. Would they argue? Say, Well, we put up the money up front. We ran these phase one, phase two, phase three trials. We own the patent. Is it fair for other individuals or other compounding pharmacies, or anybody, any pharmaceutical, to then take what they have created? Would would you say that? That would be a feasible argument?

Shaun Noorian: 13:59

You know, I would ask them, in return, is it fair to charge one person in another country 10 times more, you know, and is it fair that seven out of eight more or less patients can't get access to that medication? I mean, what's, what's the purpose of a pharmaceutical company? Is it to make as much money off the expense of patients, or to help patients get access

Dr. Gabrielle Lyon: 14:27

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Shaun Noorian: 15:56

perfect perspective is that the purpose of our company is to be able to expand access to as many patients as possible, and cost is the factor, the number one factor for being able to get access to a medication. No other factor matters. The patient can even get the quality of the medication, the efficacy of the medication. It doesn't matter. The patient can't get the medication. And so, you know, when they say it's not fair, you know, I'd say, well, it was pretty fair to Novo Nordisk, you know, when they became the most valuable company in the in the in the Europe, off of a single drug. What was the drug, semaglutide, their GLP, one made them the most valuable company in all of Europe. That's pretty fair to me. That's unfair to everybody else, every other company in Europe, and every other patient that had to pay to make Nova, the most valuable company in Europe. So there's something very wrong with the system that we have in place, where people have been taught to believe that in order for them to get access to life changing medications, they have to bankrupt themselves as healthcare costs are the number one cause of bankruptcy in our country. So it's not very fair in our country. It's fair in others, the pricing controls that are in place in other countries, that's fair. Why

Dr. Gabrielle Lyon: 17:12

do we not have pricing controls? Because $380 million in lobbying, oh my gosh. And what are the lobbyists do? How does that work? Why would a pharmaceutical company lobby

Shaun Noorian: 17:24

so to convince legislators and regulators that their system is the only way that Americans can get access to these new molecules? So we're pretty much subsidizing the entire world's supply chain. You know, Americans, we're having to pay more, by far, more than any other human in this entire world, because if we don't, then we won't get any, any new drugs made. You know, I don't think that's true. I think if pharma lowered their prices and made drugs more accessible, they'd be able to make just as much or a little bit less than they're currently making, just by optimizing for access instead of optimizing for profit.

Dr. Gabrielle Lyon: 18:14

When they go to the lobby, when they go to to lobby is lobbying, convincing people to keep prices? Is it deciding what commercials can be shown? How do we know exactly what the purpose of what is the outcome of the lobbying?

Shaun Noorian: 18:34

So for one example, because do other

Dr. Gabrielle Lyon: 18:37

countries do commercials about one other

Shaun Noorian: 18:40

country? Okay, only one other country in the world, New Zealand, they've been able to and because pharma was able to convince our legislators that doing commercials letting patients decide pretty much for themselves what's in their best interests, whereas medical provider would more or less determine what's in a patient's best interest. Now patients are going to their medical providers and saying, I want this drug. And if you don't write it for me, I'm going to go to somebody else. So now, because we have this system in place, this is one of the reasons why pharma makes this is the largest pharmaceutical market in the world. You know, we spend about 50% of the world's money on drugs,

Dr. Gabrielle Lyon: 19:18

50% of the world's money on drugs when we make

Shaun Noorian: 19:21

up 4% of the world's population, I mean, that's

Dr. Gabrielle Lyon: 19:26

been 50% of the world's money on drugs, approximately, yes, and we make up 4% of the population, right?

Shaun Noorian: 19:31

And so that's why lobbying works. That's why pharma invests so much. It's a very good investment. It's one of the best investments you could possibly make is to convince a legislator to make rules that are in favor of your company and stifle competition.

Dr. Gabrielle Lyon: 19:49

Why would they? I mean, I guess it, suppose, supposedly, makes a ton of sense why they would try to shut down compounding pharmacies. But it's interesting because, for example, um. Um, the pharmaceutical owns. Some pharmaceutical companies own 75% of the shares of right of these compounds. Is that accurate? Yeah, it's a good

Shaun Noorian: 20:11

question. There. No one knows what the exact number is, because when patients are going to compounding pharmacies and outsourcing facilities for GLP ones, they're paying cash, and cash is not reported, like insurance based medications are. There is no database that we have to send our information to showing what patient got a non controlled substance at a certain price. It just doesn't so, but there are estimates, and so let's do the math. You know, it's estimated. I've heard that GLP ones make up about 50% of the US market share from compounding pharmacies. And let's do some more numbers. So Novo did about 30 billion. We'll do about 30 billion this year off of their semaglutide products, and Lily will do about 35 billion off of their trazepatide products, $65 billion a year off the US market. So if compounding pharmacies are and it's been also been estimated that GLP ones have added 6 billion in total addressable market to the compounding industry. Well, if compound pharmacies are charging, on average 110 the cost that a pharmaceutical company's company, the numbers match up perfectly 60 so 110 of 6 billion, that's 60 billion that they're losing, that's 50% of the market. So that's what they're fighting for. They're fighting for 60 billion off your back, so they can become not just the richest company in Europe, but the richest companies in the world. Companies in the world. And I think there's something wrong with that. And I think I think a lot of people think there's something wrong with that. They're

Dr. Gabrielle Lyon: 21:49

really misinformed, though, the which is why I wanted to have you on the show. We have a robust audience that cares. They care about transparent conversations when this happens, and we hear that compounding is no longer making ozempic, and I have colleagues that are believing that where does that information come from, and how come what's actually happening behind the scenes, which you're continuing to share, is so vastly different than what we are hearing in the media, what we are hearing online, it is a completely different story. All right, so

Shaun Noorian: 22:30

let's start when the shortage started, compounding pharmacies came in and helped patients get access to a medication that was on back order, and of course, you know, provided access to medication, there was a fraction of the cost that those pharmaceutical companies were charging immediately. We saw Big Pharma telling providers that don't use a compounding pharmacy or outsourcing facility, they're dangerous. Yeah, you know, you're putting your patients at risk. Many people still believe this, right? And of course, Nova and Lily petition the FDA to not allow compounding pharmacies or outsourcing facilities to make these drugs, because we don't know how to make drugs. Only they know how to make drugs the right way. We make them. Patients die. Well, actually, pharmaceutical companies a lot of patients die from their drugs. So the opposite is true. And you know? And then what happens? So during the shortage compounding pharmacies and 503 B outsourcing facilities, which is a type of FDA registered

Dr. Gabrielle Lyon: 23:28

say it again, because this is again, where a lot of the confusion comes in,

Shaun Noorian: 23:32

right? So 503 B outsourcing facilities are a type of FDA registered manufacturer that has to meet the same standards that traditional pharmaceutical companies have to make, but can make drugs that are contained within a list that the FDA has created called the 503 bucks list, and can make them in any strength, any dosage form, any combination, just like compounding pharmacists can without having to go through the traditional new drug application process, which takes Hundreds of millions of dollars or billions of dollars and years 10, about 10 years to complete. And so outsourcing to this can bring a product to market very quickly, especially during times of shortage. We are the only other legal avenue that B to B businesses end users can purchase these drugs on shortage from to be able to either redispense or administer to patients in office. And so think of outsourcing facilities as a way to make custom formulations for B to B clients,

Dr. Gabrielle Lyon: 24:31

and the FDA has to. So the FDA regulates 503 B. And do they regulate 503 A as well? They do, and the FDA also regulates pharmaceutical companies, large Novo Nordisk like the large companies as well,

Shaun Noorian: 24:46

absolutely and compounding pharmacies are primarily regulated by each individual state board of pharmacy that they serve patients in FDA primarily regulates outsourcing slits, but the FDA does have jurisdiction of both. Compounding pharmacies and outsourcing facilities, since the drug quality Security Act was passed in

Dr. Gabrielle Lyon: 25:04

2013 and their job, the FTAs job, is to make sure everything's up to standard, absolutely, that these companies, that which would make them friendly would right. In essence, they're not necessarily an enemy. They are there to figure out and make sure that Big Pharma is covered, that compounding pharmacies are covered, that they're doing the right thing,

Shaun Noorian: 25:27

right? That's the way the system should work. And the FDA is a great agency. I mean, they have saved more patients and created these standards to prevent snake oil salesmen from taking advantage in hurting patients at the end. That's why the FDA was created. What we've seen is, as I mentioned, regulatory capture, where, because the FDA gets about half their budget from user fees from pharmaceutical companies, and then because the revolving door and because what is regulatory capture? So regulatory capture is when a regulatory agency that's supposed to protect consumers ends up putting them in harm's way by preventing access, preventing competition, favoring one company over another, one industry over another, and this is what we've had, what we've seen in with compounding pharmacies and outsourcing facilities. What we're seeing is a coordinated attack by big pharma and using regulatory and legislative pressure to try and push out any potential competitors. So let me, let's go over some facts. So what happened about a week ago, on April Fool's Day? April 1, we were sued by Eli Lilly. The same day, there was a reduction in force at the FDA, where RFK Jr removed hundreds of employees. Healthy

Dr. Gabrielle Lyon: 26:54

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Shaun Noorian: 28:24

next day, we were served by the FDA with two warning letters, both for our compounding pharmacy and our outsourcing facility that has never happened before with any company in the history of our industry. And it seems odd that the day before they would do this, the day after they did the reduction of force. So, you know, it's, it seems like that the people that want that were about to leave and end up joining big Big Pharma, wanted to get these out right before they left. And,

Dr. Gabrielle Lyon: 28:56

you know, wanted to get what out exactly, the warning letters. The warning letters, yeah, yeah. Warning

Shaun Noorian: 29:01

letter is, is a letter that the FDA states, stating that we think your company is dangerous.

Dr. Gabrielle Lyon: 29:08

Did someone come and deliver it? Well, they send it via email. Oh, they send it via so no one's there showing up with like, cookies or something. And here's your letter,

Shaun Noorian: 29:16

right? Well, they show up for inspections, and they inspect us, on average, every year, and they list observations. Hey, you guys can do this better. This better. You know, please continue doing business, but let us know within 15 days what you're going to do to fix this. So

Dr. Gabrielle Lyon: 29:29

you get a letter from an email from the FDA on April Fool's Day, like this, baby, that's

Shaun Noorian: 29:37

real. The day after April Fool's Day was like, this is this must be a joke. But no, this is an example. Did you know it was coming? No, no, we were very surprised, you know. And the meant the things they mentioned in the warning letter, we have already remediated, and there were other things that they had never addressed before. And so, you know, it makes us wonder, well, why? Why is this happening at the same. Time that illegally is putting all this pressure on the on the FDA and legislators to be able to remove companies farms. Well, what do you do? You go after the largest

Dr. Gabrielle Lyon: 30:10

and this is teach them a lesson, or just because you guys are the most powerful, yep,

Shaun Noorian: 30:13

because we're the largest, we're the most powerful if they can shut us down, which they will not, but they believe if they can shut us down, they can shut us down, they can shut the rest of the industry. If they can shut down the largest, most powerful player, it will be easy to shut down the weaker ones,

Dr. Gabrielle Lyon: 30:27

our monopolies. Aren't they illegal in the US, just in general? I mean, I don't, I don't know, but from what I

Shaun Noorian: 30:35

have read, the pharmaceutical industry, but

Dr. Gabrielle Lyon: 30:37

they're illegal in other domains, everywhere else, except for pharmacy, except for the furniture. I mean, is there anywhere else that is legal?

Shaun Noorian: 30:46

No, it is not. I'm not aware of any place a monopoly is allowed in the United States, right?

Dr. Gabrielle Lyon: 30:52

It's not allowed for energy. It's not allowed for water, right, all of the things that we

Shaun Noorian: 30:56

use, right? And there's a reason behind that. No, there's this thing that we have in this country called capitalism and the own the only way capitalism works is if there is competition, because we know when there is only one company that controls a product or service, the price always goes up. You know,

Dr. Gabrielle Lyon: 31:16

makes me think of cancer patients, and it makes me think of people that cannot afford care, and they die from not being able. They get bankrupt. They cannot afford these outrageous let's say they're dropped from their insurance. They can't afford medication, life saving medication, right?

Shaun Noorian: 31:37

That's, you know. That's why healthcare costs are the number one cause of bankruptcy, and we don't see, you know, because the way the rules are in place, there's not much regulators can do. And

Dr. Gabrielle Lyon: 31:50

the regulators go in and they say, Shaun, we'd like to see more ventilated hoods. Or we is that what they do? They go and they have very specific things, I mean, just as an example, and then you have 15 days to address it. And once that is addressed, then they're, you know, from a legal standpoint, that is closed, correct is that kind of how the process plays out?

Shaun Noorian: 32:12

Well, you have to ask the agency to close the inspection, and there is no requirement for the FDA to close an inspection for a compounding pharmacy or outsourcing facility. I believe last time we checked, the average close time was two years, whereas for pharmaceutical companies, the average close time is 30 days. And so yeah, it's, it's, it's not fair. And then agencies regulatory other regulatory agencies say, Hey, why haven't you closed your warning letter? Or accreditors say the same thing, hey, we can't accredit you because you have this open warning letter, open 483, when it has when it's we don't control when we can when the agency has to close out one of these, these letters, what did the letter say? So they say we could do better for environmental controls. Primarily, they say that we should be sampling more often, which we already sample more than any other compounding pharmacy in the country. They're pretty much trying to, it seems like they're trying to instill full GMP at a pharmacy. What's GMP? Good Manufacturing Practice, the standards that Big Pharma has to meet. It's not a requirement for compounding pharmacies. And even though we exceed the standards there's there's no requirement. They're forcing that requirement. Seems like they're forcing that requirement on us, whereas they're not really doing it for the rest of our industry. And so this is why we think that. You know, this is tied Lily's lawsuit is tied with these warning letters, because we've never seen observations like this before, and

Dr. Gabrielle Lyon: 33:45

when you got sued by Eli Lilly, what did what did it say?

Shaun Noorian: 33:50

Oh, it said that we are doing false advertising, primarily that we're saying that our medications aren't personalized, that we are claiming that our drugs are better than theirs. We're not. We're saying that a provider is determining if a drug is better for his or her patient, as a provider has the right to do, and it's the provider. This is the beauty of the doctor patient relationship. You can decide where you send your patient. You can decide what's in their best interests. You don't have to take what Big Pharma gives you and and say that's the only option that's available. You can make whatever drug, whatever combination that you think is in the best interests of your patients.

Dr. Gabrielle Lyon: 34:32

And if Big Pharma was the only solution, then there wouldn't be a need for compounding pharmacies if we were not struggling with the doses that one size fits all for everybody. You know, you take my husband, who's 200 and some pounds, and you take another individual who is, I don't know, 120 pounds, yet they get the same dose.

Shaun Noorian: 34:56

If that's the only dose that's available commercially, that's the only. Only dose that patient could get unless that provider utilizes a compounding pharmacy. And so, you know, we know that personalization typically results in better outcomes. I

Dr. Gabrielle Lyon: 35:10

mean, I don't want to say always, but almost always right.

Shaun Noorian: 35:14

Why is that wrong? Why is Big Pharma trying to make us believe that personalized medicine is dangerous for us when actually maybe better for us in many cases. What do you think

Dr. Gabrielle Lyon: 35:26

happened? What do you think? What do you think is the connection? Or what is you what is your legal team? The think of the connection between what happened? You know, when RFK let go of all these people?

Shaun Noorian: 35:40

I mean, we don't know, we don't know what happened inside those closed doors. Yeah, but it's just very coincidental that all these things are happening practically at the same time, and it's never happened before with any other common pharmaceutical outsourcing facility in the history of

Dr. Gabrielle Lyon: 35:56

industry. How long have you guys been around 15 years in in 15 years, you've never gotten these letters of various comply, whatever the not

Shaun Noorian: 36:04

to both facilities at the same time, to both entities at the same time, both are pharmacy and outsourcing facility. That's never happened.

Dr. Gabrielle Lyon: 36:13

Just a crazy thought. The people that got let go, obviously, we don't know where they went to go work, but, um, there. Do we know where they regulators, what? What were they doing, or was it a whole host of various people that

Shaun Noorian: 36:28

got let go by RFK, we don't have, we don't have a full list, but we are investigating it,

Dr. Gabrielle Lyon: 36:32

and it would be curious as if those people then went to Big Pharma, and perhaps they knew that they were going to be let go, and Big Pharma said, Hey, you can come on over here. We're going to give you shares of ozempic or whatever, but this is we need you to do these last actions prior to that happening. Well,

Shaun Noorian: 36:49

Big Pharma has a good history of using revolving door tactics to be able to incentivize their regulators to favor them versus their competitors. What is a revolving door tactic? So hiring, hiring people as soon as they leave the FDA, as soon as they they're fired, or they quit, or whatever, or their terms up, or

Dr. Gabrielle Lyon: 37:10

they're recruited. Do you think that they are possibly recruited? Oh yes, of course, yeah. The many,

Shaun Noorian: 37:15

many FDA commissioners, practically all of them, practically all of them, have end up gone to work for big pharma after they left the FDA. Gosh.

Dr. Gabrielle Lyon: 37:28

What do you anticipate will happen? So this is not the first time that you guys have been sued, right? And it's also not the first time by Is it the first time by Eli Lilly?

Shaun Noorian: 37:38

It is the first time by Eli Yes. And

Dr. Gabrielle Lyon: 37:41

what do you anticipate? Do you feel that they think they have a chance of winning, or is it to scare other smaller pharmacies like, Hey? Are they coming for us too? We

Shaun Noorian: 37:53

will defend our position as we always have, that what we do is perfectly legal and has always been legal. Since pharmacy, the practice pharmacist, has been in place, and that it's the doctor's decision what is in the best interest of their patients, not what Lily thinks is in the best interest of patients. And if Lily thought, in my opinion, if they were really thinking about the best interests of patients, they would lower their costs. We know that their drugs cost about $5 to make. There's no need to charge 500 you can still, you could charge 1/5 is that, and still have one of the best margin products

Dr. Gabrielle Lyon: 38:34

out there. Do they have an answer for that?

Shaun Noorian: 38:36

No, not that I'm aware of. What about why in

Dr. Gabrielle Lyon: 38:39

Europe? Why is it that they're sucking American dollars?

Shaun Noorian: 38:42

Well, because we can afford it, we have to subsidize the rest of the world. Otherwise, no new medications will get created, which is nonsense. That's not true, right? That's what they would want us to believe.

Dr. Gabrielle Lyon: 38:55

What about the difference in the 503, the variations in compounding pharmacies. Also, who seeds that information that compounding pharmacies are dangerous. Where is that information coming from? So

Shaun Noorian: 39:09

the largest advertiser of the media is Big Pharma. About 20% of all revenue for traditional media comes from pharmaceutical ads. This is why, every single time you turn on TV, every other commercial is a pharmaceutical ad. And so they have a lot of influence with the with the media outlets. And media outlets aren't going to really go hard on their number one advertiser. They're going to throw them softballs. And because they have so much influence, they listen to them on what's really going on. They don't really go many of them don't do a full investigative report to find out what's the actual truth. In

Dr. Gabrielle Lyon: 39:46

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Shaun Noorian: 41:22

so we've seen since the shortage has been resolved. What that means is that compounding pharmacies can no longer make essential copies and outsourcing facilities. What's

Dr. Gabrielle Lyon: 41:31

an essential copy for the listener? An essential copy is

Shaun Noorian: 41:35

what pretty much an exact copy, meaning

Dr. Gabrielle Lyon: 41:38

the commercial drug 2.5 milligrams exactly in this dose. Yep,

Shaun Noorian: 41:42

yep. Compounding pharmacies, in order for us to make a drug legally, it has to be differentiated from the commercial product by either dosage strength, dosage form, or dosage combination. And so compounding pharmacies that were making exact copies or essential copies of the commercial drugs could not make them anymore, but compounding pharmacies that made different products, differentiated products. We're still, are still allowed to make these medications, just like we are allowed to make them for every other FDA approved drug that's out there. And so what we saw is, you know, media outlets were coming out with stories that these drugs are no longer available under any circumstances. You've got to go back to Big Pharma. That's the only way you can get them when nothing was further than the truth. And I would get questions from our doctors saying, Shaun, what are we going to do? I have hundreds of patients on these medications, and nine tenths of them can't afford the commercial medication. What are we going to do? Like, hold on a second. Where did you hear that from? Oh, I heard it in this story that I read online. Okay, don't believe that story. You know, this is just an example of Big Pharma utilizing the media to control the message and trick.

Dr. Gabrielle Lyon: 42:56

Big Pharma using the media to control the message.

Shaun Noorian: 43:00

Absolutely. Now, this isn't, this is nothing new. This is it's a very wise investment for Big Pharma to be able to control that message, because it gives them hundreds of billions of dollars. When the people that are hearing that message, the American consumer, turns on the TV and that's what they hear, or they go online, that's what they read, is telling that that's their only option. So it's very monopolistic behavior. Is

Dr. Gabrielle Lyon: 43:25

there anything that you deeply want people to know that is happening behind the scenes as well? So you've shared a lot. Is there anything? Is there something particular that you think man, physicians need to know this, patients need to know this.

Shaun Noorian: 43:40

It is that we have options. You know, we can decide what is in the best interests of our patients, and in many cases, that can be better a better patient can be better served by utilizing this new healthcare system that's being built outside of the traditional healthcare system that involves so many unnecessary middlemen that just increase cost and complexity, but this new system utilizing telemedicine and utilizing functional medicine, where patients can get to the root cause at an affordable cash price that goes down over time, not up, like the traditional system,

Dr. Gabrielle Lyon: 44:19

and what is the relationship between insurance companies. So I'm looking here at the average retail price of what COVID And this, this number I have is $1,300 a month. Ozempic is 936 a month without insurance, and only one in five US insurance insurers currently cover GLP ones for obesity, even though we have a population that the majority of the population is either overweight or obese. Do we know? And I will also say I have this. This is in JAMA that 12% of the US adults have used a GLP one drug, which is, I'd like to see it higher. What? Frankly, and my next thought would be, if insurance companies care deeply about the health and well being of their patients, they would then cover the regular quote, prescription drug from big pharma and from compounding pharmacies do the big pharmaceuticals and the insurance agencies? Do they have a relationship that we know of,

Shaun Noorian: 45:27

not really, you know, insurance companies just have, they have no choice. It's either they pay what Big Pharma tells them to pay, or they don't get access to their patients. And the Big Pharma is not incentivized to lower their costs for any insurers. They're not incentivized alone cost for anybody, which is why, you know the whether you're an insurance company or the US government or a patient, you we all have to pay the same exact price. We can't negotiate with big PHARMAC against the rules. So, you know, you said, Did you write 12% of patients you know that are taking these medications in our country? Well, that lines up with the fact that seven out of patients can't afford to take the medications. Seven out of how many, seven out of eight cannot afford more than $500 a month. Seven out

Dr. Gabrielle Lyon: 46:13

of eight patients cannot afford these at the prices that they're currently at. I think a lot of the information out there, when people are criticizing the use of GLP, ones are done so for, I don't want to say for a reason. I mean, listen it, there are people that have spent their whole life working very hard and losing weight, and then I think that there is this component of, well, I don't know, you get to take this medication and you were cheating, or, who knows what it is, but the reality is, the outcomes and the safety these drugs have been around for decades, over 20 years, used for other issues, and are now approved for weight loss, so that there is a high safety profile with ozempic and terzepatide. Would you agree with that? Oh,

Shaun Noorian: 47:02

absolutely, much, much safer than the previous classes of weight loss medications that were approved.

Dr. Gabrielle Lyon: 47:07

And then when someone is listening to this and they hear that the FDA have have banned compounding pharmacies, is that an accurate statement? So I have a series of statements here that we looked up we were just seeing. And it was that the FDA, and maybe that the FDA, removed number one, they removed, is that bound in moderna from the shorted list, the shortage list, and they then banned compounding pharmacies from making it is that true? That

Shaun Noorian: 47:40

is not true. They ban compounding pharmacies for making the exact copy which is there, which

Dr. Gabrielle Lyon: 47:46

is fine, which, I mean, sure, so you can't

Shaun Noorian: 47:50

make the same medication that's commercially available. But what a lot of these articles don't mention is that patients can still get access to compounded GLP ones as long as long as they're differentiated from the commercial products. And that is, I don't read many articles that that say that the articles that I read that do say that are ones where the reporter has reached out to a compounding pharmacy or our trade association to find out the truth. There are articles where reporters don't even reach out to the actual stakeholders to find out what is going on. They just listen to what an expert has told them.

Dr. Gabrielle Lyon: 48:28

What would you say in terms of any foreshadowing? Do you have foreshadowing on what? Because, first of all, I know you personally, as a friend and as a human, and you are just full force in I mean, this is you are so dedicated to providing access to people. What do you think is going to be coming down the pike?

Shaun Noorian: 48:51

Well, I think it's a lot of the same. I mean, Big Pharma has been going after the competitors since Big Pharma existed. That is their MO that's how monopolies are created. And so even since I started this company 15 years ago, I've seen Big Pharma attacking us, other compounding pharmacies, outsourcing facilities, what I what we see started happening now is now that I think Big Pharma has realized this new administration is not going to lay back and be their Ponzi, and they're going after the states. Now tell me about that. So each individual state has its own individual Board of Pharmacy, and those Boards of Pharmacy make the rules that compounding pharmacies and outsourcing facilities have to abide by. And what we've seen, for example, last week, we heard that Massachusetts had passed a memo, a memo, that outsourcing facilities can no longer sell medications to compounding pharmacies, or any pharmacy for that matter, as well. And we're seeing a. Their states. So

Dr. Gabrielle Lyon: 50:00

pause and tell the listener what that is to the outsourcing. The outsourcing manufacturing is where the drugs are made.

Shaun Noorian: 50:08

So outsourcing sellers are one type of entity that can make drugs and then sell them to B to B, end users, pharmacies, hospitals, clinics, practitioners. And now we're seeing states are starting to say and outsource themselves. Were created in 2013 because of a compounding pharmacy, NECC, that had made a bad batch and killed many patients. What's that? And New England compounding centers was a compounding pharmacy that had made an intrathecal injection, methylproduct, acetate that was contaminated with a fungus and ended up killing about 70 people from fungal meningitis, which is a terrible way to die. And because of that, the FDA passed laws to create a new type of manufacture called a 503 B outsourcing facility that met much higher standards than traditional compounding pharmacies met, and in order to meet to sell these drugs to providers which were then administering them large patient populations, those drugs would meet that higher quality standard. So put a level, a much a higher level of safety for patients. Now Massachusetts, which is where any CC actually happened, I see now they're saying 503 B's are dangerous. 503 B shouldn't be selling their drugs to pharmacies or any other B to B N users. Let's let pharmacies do that instead. This is the type of influence that Big Pharma has, and we heard that big pharma didn't even the board. The Master's board wasn't even aware of this. This was the staffers that had passed this memo without their knowledge.

Dr. Gabrielle Lyon: 51:44

What would that mean for what would that mean for the outsourcing facilities, well and pharmacies?

Shaun Noorian: 51:53

It means that outsourcing facilities can't sell their drugs, and it means that patients within that state are getting lower quality access to medications. Big Pharma doesn't care about quality. They don't. They attack us on quality, but then they get, they get the regulators to prevent any potential higher quality competition from being able to do business with them. So the

Dr. Gabrielle Lyon: 52:20

503 B outsourcing facility, this is where compound This is where medications are made. In the in Big Pharma, do they have a 503 B,

Shaun Noorian: 52:29

A, Big Pharma has have? They just have what's called either a contract manufacturing organization or their own pharmaceutical manufacturing facility, I see, but both outsourcing facilities and traditional pharmaceutical manufacturers have to meet the same exact standards known as Current Good Manufacturing Practices,

Dr. Gabrielle Lyon: 52:47

and the 503 B is just a way for other providers, other pharmacies, like small mom and pop pharmacies, other places to get the medications. Is that fair? Yeah.

Shaun Noorian: 53:01

So think of a, 503 A, compounding pharmacies as B to C. Business. We're selling medications directly to patients, to consumers, 503 B, outsourcing facilities are doing B to B. We're selling to businesses, right? The hospitals, the practitioners, the clinics and pharmacies as well. And so by being both a 503 and a 503 B, we can touch every single pharmaceutical end user in the entire country, and bypassing the traditional system in place. And this is what has pharma scared. They don't want any potential competitor doing business with their stakeholders,

Dr. Gabrielle Lyon: 53:39

and the stakeholders would be hospitals and other physicians, correct, and patients as well. And patients as well. The in Massachusetts where that 503 where they pass this memo, it pushes individuals to pharmacies. Is that so pharmacies then making medications? Is that how that works? Or right? So it's

Shaun Noorian: 54:00

saying that 503 so 503 so five or three weeks could sell the medications to pharmacies, for them to then distribute, dispense. Yeah, absolutely. Now we, we can't do that in Massachusetts anymore, only for how do they get the medication? How do those people in Massachusetts from company, from company pharmacies making their medications themselves, which is a lower quality system than a, 503, B would so Pharma is saying that the compounding industry don't use it because the quality standards are less than their own, but at the same time, they're preventing other competitors that have the same quality standards as Big Pharma to try and enter the market.

Dr. Gabrielle Lyon: 54:38

Is there a world where the big pharma companies compete against each other, or do they seem to create an alliance to then monopolize everything else? Well,

Shaun Noorian: 54:49

in the generics industry, where many competitors can come in and make a medication, we see those costs go down over time. In the when there is. Very little competition. We see those prices go up over time. And

Dr. Gabrielle Lyon: 55:04

give me an example. I mean, just

Shaun Noorian: 55:08

GOP once with Novo and Lily, you know, when they first came out, they both decided that about $1,000

Dr. Gabrielle Lyon: 55:15

a month, and they decided together what the cost is going to be. Well, essentially, they can't, they can't decide

Shaun Noorian: 55:20

together, but they see what each other charges, and then they determine, well, you know, same efficacy, you know, patients should pay about the same and the reason we, you know, we see this because we first came out, they said they couldn't lower the cost. $1,000 a month. Was the right price. It was a perfect price for Americans. And then as soon as Novo came out with a lower cost product, because there was so much they were losing 50% of their market share to compounding pharmacies and elsewhere to lose, they cut that price in half. And as soon as they cut that price in half, Lily followed suit about a month later. And so they're not saying that, not telling the truth, they could lower these drugs so much more. They just don't want to, because they don't have to.

Dr. Gabrielle Lyon: 56:04

In terms of generics, there is generic testosterone, right? There's generic, you name it, there's probably a generic of it. Will all drugs eventually become generic?

Shaun Noorian: 56:18

Eventually? Yes, so drug companies are given a certain amount of time to make a new molecule before generic companies can come in and mimic that medication, and they're given a very long time to be able to charge whatever they want in this country. And that's and but what we see is a lot of pharmaceutical companies extend that patent. We just saw this with Novo they extended their patent for more years so they can keep charging even think about it, 35 $30 billion eventually become 35 and then 40 as time goes by. And if they succeed at preventing compounding pharmacies that just doubles every year that they're able to hold on to that patent, that's another $40 billion ish that they're getting. Of course, they're going to do everything. They're incentivized to extend their patent and prevent Americans from getting access to affordable medication. It's

Dr. Gabrielle Lyon: 57:14

interesting that there's such a variation between our country and other countries. And guys, I swear this, if it doesn't make you mad, I don't know, let me send my mother in law to you, but this is a big deal. It's a big deal because if it monopolizes access to care, then we cannot get patients better. And someone listening might be well, like GLP, ones are not the answer I am telling you, in almost 20 years of practice, I have never seen a medication profoundly impact people's lives at the very low doses. I am not talking about these doses for weight loss. I am talking about very small micro dosing, and here's how I've seen it impact people's lives. Number one people that have obsessively thought about food and had binge eating disorder and had issues with alcohol and drugs. I have seen these medications remove that drive. That's

Shaun Noorian: 58:17

right, you know, GOP ones work in a very interesting manner. They they cure medication, they cure addiction. And what is binge eating? Binge Eating is an addiction to food. You know, alcohol is an addiction to that substance. And so we're seeing, you know, there are a lot of studies coming out that are showing that GLP, ones used in microdoses, can be used for the treatment of addiction, whatever type of addiction that is. So I think we're going to see a lot more indications come out for the treatment of I agree certain drug addictions. I agree

Dr. Gabrielle Lyon: 58:51

will is there an opportunity for Lily to succeed in shutting down compounding pharmacies? I'm teeing you up for this one.

Shaun Noorian: 58:58

I mean, there is always an opportunity to make it harder for patients to get access. People

Dr. Gabrielle Lyon: 59:06

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Shaun Noorian: 1:00:12

quality, affordable medication. And in the 15 years I've been doing this, I've seen this game played many times before, usually pharma loses. Usually, there are some cases where pharma wins. Pharma is able to convince a legislator, a regulator or legislator, that they are the only solution and that any other potential competitors would put patients at risk.

Dr. Gabrielle Lyon: 1:00:39

Have you ever seen them push this hard, or is it just this drug? Because this drug is so effective,

Shaun Noorian: 1:00:47

no other pharmaceutical company has ever lost more revenue from any drug in the history of compounding than from GLP ones. Has

Dr. Gabrielle Lyon: 1:00:56

any drug ever been as effective for a massive issue than this,

Shaun Noorian: 1:01:02

not that I'm aware of. No this. This is a game changer. People are calling a miracle drug for a reason. I mean, for patients that can't lose weight, for patients that, you know have never been able to cure sleep apnea. I mean, they're sure there's, there's showing that it helps. Alzheimer's, you know, there's studies showing that, as mentioned, helped cure addiction, and the list just keeps growing and growing. And so as you said, the majority of the US population qualifies today for GLP ones, but the majority of the population is not on GLP ones. Why? Because only one in eight can get access to GLP ones. It's

Dr. Gabrielle Lyon: 1:01:43

really tremendous, and it's a tremendous conversation, and I would love for you to sum up, and I'm going to ask you these questions, are compounding? GLP ones being shut down?

Shaun Noorian: 1:01:57

No, they're compounding. Is perfectly legal. It always has been. It always will be. There is always a case where a patient could benefit from a compounded medication that's been personalized to their whatever issue their provider thinks is could be better served from a personalized medication. So while the rules always get strict over stricter over time. Compounding is going to be around for a very long time, and I think it's going to become the next generics industry. As we just see, farmers will cost in the traditional system skyrocketing, and there doesn't seem any solution out there except for compounding. It's

Dr. Gabrielle Lyon: 1:02:36

confusing. It's confusing as to why that cost would continue to go up because, in essence, we would be more efficient, just like with agriculture, our ability to become more efficient at producing cattle is there. How is it that these costs, the cost should technically go down, they

Shaun Noorian: 1:02:53

should, but what we have are so many entrenched middlemen, and in order for this cost of medication, every single one of those middlemen would have to decrease their costs, decrease their pricing. They're not going to do that. Their stock prices would plummet. And if their stock prices plummet, their CEO will get fired, and then they'll put in

Dr. Gabrielle Lyon: 1:03:15

place another CEO hire them.

Shaun Noorian: 1:03:19

We don't hire from big pharma. That's the one industry we stay away from. You know, it's just people that have grown up in that system. Don't think of how to expand access. They were, they were trained to restrict access through any means possible. And so, you know, whether it's pharmaceutical sales rep or an executive from pharmaceutical company, we don't, we haven't been able to find one. Able to find one that gets this new system, because they've never been part of it.

Dr. Gabrielle Lyon: 1:03:46

If you were sitting with RFK or someone from the administration, what? What do you need them to know?

Shaun Noorian: 1:03:53

Well, there are solutions out there, you know, and they are available today. I mean, we could lower the cost of Medicare Medicaid save patients so much money so they can spend it on other things that are really important, like their health, their shelter, their education, their food. But we're taking that away from them and giving it to a small subset of that US population, the CEOs, the executive team of pharmaceutical companies and the system. It's an easy fix, in my opinion, an easy fix. Just introduce competition like we have done. What's made this country so great today is because we are capitalistic environment, and we give everybody a fair chance to be able to innovate and create better products and services without competition, that innovation doesn't occur or doesn't occur as quickly as it could. And so my message is, just do be American. Do what made us great. If you want to make us great again, just do what made us great in the first. Place competition, low taxes, low prices, and give the benefits to the consumers, and the consumers will then grow the economy.

Dr. Gabrielle Lyon: 1:05:07

I love that. I love that Shaun. I think it's it's really smart, as we are hearing and up against the media. How can they vet information? So you do have a website? I feel so fortunate when I hear these things. I call you, but we know that the media gets 20% of their funding or their money to be able to go do these things from big pharma. Often times, once something gets planted, for example, in social media influencers, tiktokers, whatever it is, run with it, and it creates this wave of misinformation. How do you suggest people listening to this podcast begin to question what they are hearing when it comes to medication,

Shaun Noorian: 1:06:01

it's a great question. You know, we are so lucky today to have AI, and so I would just run, and I do, I run everything through AI before I believe it. And just for my own knowledge, I want to research something. I mean, it's you can we can get the answer. How do

Dr. Gabrielle Lyon: 1:06:20

we know if it's correct? How do we know if, for example, AI isn't, I don't know, hoodwinked or influenced by, you know, just like Facebook and Twitter and all of these things, there were things happening behind the scenes. They were censored. There was information plugged in. How do we have any sense of, if it is a neutral

Shaun Noorian: 1:06:44

I would I would prompt specifically, get very specific than what is it, for example, I would say, would is, instead of saying, is this drug available from compounding pharmacies, I would Say, Is this drug available from compounding pharmacies that that wouldn't be available after a shortage, because that's that's two step. That's two separate prompts. One is saying post during a shortage, and one is after a shortage. And the AI may not know the difference. They may not know what you what you intended. So it's just being very specific. And of course, doing deep research, you know, the deep research function. So you

Dr. Gabrielle Lyon: 1:07:23

turned me on to that. So we basically, Shaun and I and Shane were working out. And then Shaun, you ruined my workout buddy. You showed me this deep research feature on chat, GPT, and it was game over. Oh, that was it. I was, yeah, you kind of ruined my life there. But it's okay, and it does. It pulls together data, which is really fascinating. So for example, let's say you wanted to learn more about these medications, specifically these GLP ones. There are a handful of trials. For example, there's a step one, trial sustain eight, surmount one. Trial surpass three. There's all of these studies that, if someone is listening and wants to learn more about the medication, you can put this into, you know, ask deep research to go ahead and put together a table for you. It's extraordinary, right? You can

Shaun Noorian: 1:08:11

have a, you know, 1000 PhDs at your fingertips, and let, instead of just one subject matter expert telling you what's the truth, now you have 1000s. And so I think AI is going to help patients really unleash what is true and what is not. If that patient utilizes AI to find out or has a trusted resource that has not been misinformed, it's

Dr. Gabrielle Lyon: 1:08:34

really fascinating. Do you think that so? You are the lar you are the largest compounding pharmacy in the world. There are a bunch of other smaller ones. Is that true? And in order for them to function, do they have to follow the same standards of the 503, B, so

Shaun Noorian: 1:08:53

compounding pharmacies are required to follow the United States Pharmacopeia standards, which are not as strict as good manufacturing practices are, which is what good 503, B's have to meet. So in different states, have different variations of the standards, but they're all more or less the same. More they all more or less follow USP, and those standards have become stricter and stricter since the United States pharmacovia was founded, and today, I mean the latest revision, you know, makes them so strict, like the revision came out a couple years ago, that is, you know, adds so much more quality levels, environmental monitoring, sampling, testing requirements for these medications. So they're actually and since these standards come out there, there have not been many compounding pharmacies that have made tainted drugs. And the states are very strict when it comes to inspecting compounding pharmacies. They're typically expected once a year, and the state, the state board. Then goes through all the requirements and the records to ensure that that compounding pharmacy are meeting the rules and regulations within their state.

Dr. Gabrielle Lyon: 1:10:07

Are there certain states that are more strict than others? Oh, absolutely

Shaun Noorian: 1:10:11

California. California makes up rules that are completely non compliant with USP and go and go above and beyond in the way that they regulate, which caused a lot of problems for patient access. You know, there there were several at one point, you know, several years ago, there are hundreds of sterile compounding pharmacies in California. Yes, now I think there's like five, like the California State Board. It's no secret that they are not friendly to compounders, whether they're within their state

Dr. Gabrielle Lyon: 1:10:46

or physicians, frankly,

Shaun Noorian: 1:10:49

right? Yeah, there, you know, there's, there's a balance that needs to be made, you know, with protecting patients from safety issues and protecting patients from losing access. And we've seen, unfortunately for patients in California, they've the they've been put in a very unsafe position, because now they can't get these medications anymore

Dr. Gabrielle Lyon: 1:11:12

unless they travel. They could always travel to see another physician out of state, like here in Texas. However, certain places will then not ship to California. Oh,

Shaun Noorian: 1:11:24

exactly, you know. And so it's very unfair for the patient. They that only the ones that can afford to travel outside the state can get access to these medications. And so, I mean, it's a problem, but the rate, the rules are very strict. No matter what state you're you're operating or shipping medications to, you know the rules and the rules are consistent. They've been they've been practiced fairly in in most states, and patients have benefited from this because now they can get access from medication that they couldn't because either orphaned, discontinued, it's not commercially available in the right strength dosage form, a combination or whatever reason that the provider thinks could benefit that patient using a personalized medication.

Dr. Gabrielle Lyon: 1:12:09

Well, Shaun, Noreen, I could talk to you for hours. We will have you back on you are a welcome guest at any point in time. I think what you are doing is tremendous. I support you. I hope people that are listening to this podcast, please share this podcast. If you are a podcast host and you would like Shaun as your guest, Joe Rogan, reach out to me and I will connect you, because we need to have your voice out there. Otherwise, my biggest fear is that patients lose access and the elite will be able to afford medication. And if it happens for the GOP ones, it's only a matter of time that it happens for other medications, you're

Shaun Noorian: 1:12:57

absolutely right. And thank you, Gabrielle, for letting me get this message out to patients like myself that you know have been lucky enough to change our lives for the better because we were able to get access to these medications, and one thing that I've learned is that if you don't fight for your access, it will be taken away from you. So I think it's very important that we all band together, let our legislators and regulators know that we know what's going on and we don't like it, and we expect them to do what's in patients best interests, because at the end of the day, that's the only person that matters.

Dr. Gabrielle Lyon: 1:13:35

Shaun Noreen, you are such a pleasure to interview. Thank you again for coming on. I will link all the information as to where to find you. Thank you again. Thank you. Gabrielle, appreciate you. Shaun, thank you for joining us and helping us make sense of one of the most important and most misunderstood health stories today. For those of you listening, if you've ever taken a GLP one are considering it, or know someone who is I hope this gave you a deeper understanding of what's happening behind the headlines. This isn't just about weight loss, it isn't just about safety, it's about access and having a healthcare system that truly puts patients first. If you found this episode valuable, please share it with someone who needs to hear it. You can also subscribe to the show on YouTube, Spotify or Apple podcasts, and head to drlion.com for more science based insights and resources. And remember You are the champion of your own life. Stay strong, stay curious, and I'll see you next time on the Dr Gabrielle Lyon show you.