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The Dr. Gabrielle Lyon Show
Is Ozempic Actually Safe? CEO of Major Pharmacy Speaks Out | Shaun Noorian, CEO
01:14:50
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- [00:00]
Gabrielle Lyon
Everyone is talking about GLP1s. And just as fast as these 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 Sean Norian, CEO of Empower Pharmacy, to answer the hard questions.
- [00:30]
Sean Nohrian
Well, that lines up with the fact that seven out of patients can't afford to take the medications.
- [00:36]
Gabrielle Lyon
Seven out of how many?
- [00:37]
Sean Nohrian
Seven out of eight cannot afford more than $500 a month. Well, someone has to fight for patients.
- [00:43]
Gabrielle Lyon
Are compounded GLP1s 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. Shaan Nohrian, 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 GLP1s 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.
- [02:08]
Sean Nohrian
Absolutely. 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 a monopoly so they can charge as much as they want for as long as they can.
- [02:43]
Gabrielle Lyon
How much of the market does Eli Lilly have? And just to be clear, we are talking about GLP1s. We were 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 DNP. 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. Just to give you a perspective of how long we have been looking for a Medicare 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 GLP1 revolution happened, and that's semaglutide, tirzepatide, Zepbound, and to be clear, the older medications like phentermine, 3 to 5% of body weight loss with a side of heart issues. Orlistat, 3 to 7% GLP1s looking at potentially 15% weight loss.
- [04:22]
Sean Nohrian
Yeah, it's been quite the revolution. And Americans in the world have never really had GLP1s before. They've never 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 backorder. And in late 2021, when it went on backorder, patients started realizing that they couldn't get access to it even if they could afford it. And only seven out of eight, one in seven patients can afford more than $500 a month.
- [05:03]
Gabrielle Lyon
One in seven patients can afford. So they were. So the, the cost of the medication was what you're saying is over $500.
- [05:11]
Sean Nohrian
When it first came out, it was 1,000. And as soon as Novo Nordisk and ilily realized that they were losing a massive amount of market share to compounding pharmacies, Novo last year decreased their price to about $500 a month. And Lilly followed a couple months shortly thereafter and lowered their prices to $500 a month, more or less.
- [05:37]
Gabrielle Lyon
How, who owns, what are the pharmaceutical companies that own the brand names of these drugs?
- [05:44]
Sean Nohrian
Novo Nordisk makes the brand name drugs, Wegovy and Ozembic. Eli Lilly makes the brand name drugs Zepbound and Manjiorno. So which is the brand name for Tirzepatide in Novo Nordisk's brand name drugs, the generic name, if you want to Call it that is semaglutide. And when they first came out with these drugs, they stated, US consumer, $1,000 a month is the best we can do. We can't really lower the cost lower than that. It's not fair to our shareholders. At 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. Why are they saying that US consumers have to pay 10 times more than the same human in Europe? And then as soon as they realized they had some real competition, they went and cut their price in half, which is still unattainable for the vast majority of the US population.
- [06:49]
Gabrielle Lyon
Four times higher than Europe.
- [06:51]
Sean Nohrian
Right. And then Lilly 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's pretty much a monopoly. And you know, when compounding pharmacists, 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 result in better patient outcomes. They're personalized. They can be by different dosage form, different dosage strength, 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 microdose because the patient hebozempic, something like.
- [08:19]
Gabrielle Lyon
That, which is what we use in clinic.
- [08:21]
Sean Nohrian
Absolutely. You know, the minimum dose for the starting dose is a single dose pen, and that's the dose the patient gets. It can't go higher, can't go lower. Like that first initial dose is that dose.
- [08:32]
Gabrielle Lyon
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 Penn dosing we see in clinic, and you know, we've been Using Ozempic for quite some time. We had originally used Saxenda 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, that I have many colleagues that believe compounding pharmacies are going to all shut down. And they also believe that compounded medications in the GLP1 family are illegal.
- [09:40]
Sean Nohrian
Right. And dangerous as well.
- [09:42]
Gabrielle Lyon
And dangerous, yeah. Is that true?
- [09:45]
Sean Nohrian
Nothing could be further from the truth. While Big Pharma would want us to believe that anybody outside their system is illegal or dangerous, there are so many regulations in place for the compounding 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 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 pharmacopoeia and we have the FDA looking over our shoulders, making sure that we're doing what's right for patients. We're making medications that meet the standards for pharmaceutical manufacturing and compounding. This country. And compounding has been around for a very long time.
- [10:46]
Gabrielle Lyon
How long?
- [10:47]
Sean Nohrian
Since the beginning of time. All drugs were made. Since humans have existed, they've been made manually 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 shifting the total addressable market of medicine from compounding pharmacies and apothecaries and druggists to the mass manufactured systems that they've created.
- [11:13]
Gabrielle Lyon
That's interesting. Was there a need for that? Is it similar to, 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 that 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?
- [12:03]
Sean Nohrian
Yeah, it 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's 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? Are patients not. Are there problems? The market is unfair to them. They want to make sure that they control industry. It's all about control, being able to control who gets what and how much they pay in order to get it and prevent competitors from coming in space. And so they can continue to charge that much. So. And then, of course, there's.
- [13:15]
Gabrielle Lyon
Is there. 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.
- [13:28]
Sean Nohrian
A drug to market for a pharmaceutical company? Yeah, depends. But anywhere from hundreds of millions to billions of dollars.
- [13:35]
Gabrielle Lyon
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 you say that that would be a feasible argument?
- [14:01]
Sean Nohrian
I would ask them in return. Is it fair to charge one person in another country 10 times more? And is it fair that seven out of eight, more or less, patients can't get access to that medication? I mean, 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 with all the.
- [14:28]
Gabrielle Lyon
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- [15:56]
Sean Nohrian
My 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. If a patient can't 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 when they say it's not fair, 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 Europe off of a single drug.
- [16:26]
Gabrielle Lyon
What was the drug?
- [16:27]
Sean Nohrian
Was it Semaglutide? Semaglutide, their GLP one made them the most valuable company in all of Europe. That's pretty fair to me actually that's unfair to everybody else. Every other company in Europe and every other patient that had to pay to make Novo 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.
- [17:13]
Gabrielle Lyon
Why do we not have pricing controls.
- [17:15]
Sean Nohrian
Because $380 million in lobbying.
- [17:18]
Gabrielle Lyon
Oh, my gosh. And what do the lobbyists do? How does that work? Why would a pharmaceutical company lobby so.
- [17:25]
Sean Nohrian
To convince legislators and regulators that their system is the only way that Americans can get access to these new molecules. You know, so we're pretty much subsidizing the entire world 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.
- [18:15]
Gabrielle Lyon
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?
- [18:35]
Sean Nohrian
So for one example, because.
- [18:37]
Gabrielle Lyon
Do other countries do commercials about one other country?
- [18:41]
Sean Nohrian
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 a 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.
- [19:18]
Gabrielle Lyon
50% of the world's money on drugs.
- [19:21]
Sean Nohrian
When we make up 4% of the world's population.
- [19:25]
Gabrielle Lyon
I mean, we spend 50% of the world's money on drugs.
- [19:29]
Sean Nohrian
Approximately, yes.
- [19:29]
Gabrielle Lyon
And we make up 4% of the population.
- [19:32]
Sean Nohrian
Right. You know, 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.
- [19:49]
Gabrielle Lyon
Why would they? I mean, I guess it's supposed. Supposedly makes a ton of sense why they would try to shut down compounding pharmacies. But it's interesting because for Example, the pharmaceutical owns. Some pharmaceutical companies own 75% of the shares of right of these compounds. Is that accurate?
- [20:11]
Sean Nohrian
It's a good question. No one knows what the exact number is because when patients are going to compounding pharmacies and outsourcing facilities for GLP1s, 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 GLP1s 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 lilly will do about 35 billion off of their tirzepatide products. $65 billion a year off the US market. So if compounding pharmacies are. And it's been also been estimated that GLP1s have added 6 billion in total addressable market to the compounding industry. Well, if compounding pharmacists are charging on average 110 the cost that a pharmaceutical company's company, the numbers match up perfectly. 60. So 1/10 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. And I think there's something wrong with that and I think a lot of people think there's something wrong with that.
- [21:49]
Gabrielle Lyon
They're really misinformed though, 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.
- [22:28]
Sean Nohrian
All right, so let's start when the shortage started. Compounding pharmacies came in and helped patients get access to a medication that was on backorder and of course providing access to medication that 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. You're putting your patients at risk.
- [22:57]
Gabrielle Lyon
Many people still believe this, right?
- [22:59]
Sean Nohrian
And of course, Novo and Lilly petitioned 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 503B outsourcing facilities, which is a type of FDA registered manufacturer, what is it?
- [23:29]
Gabrielle Lyon
Say it again. Because this is again where a lot of the confusion comes in.
- [23:33]
Sean Nohrian
503 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 pharmacies 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.
- [24:03]
Gabrielle Lyon
Right?
- [24:04]
Sean Nohrian
10, about 10 years to complete. And so outsourcing skills can bring a product to market very quickly, especially during times of shortage. We are the only other legal Avenue that B2B 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 B2B clients, hospitals.
- [24:33]
Gabrielle Lyon
So the FDA regulates 503B and do they regulate 503A as well?
- [24:39]
Sean Nohrian
They do.
- [24:40]
Gabrielle Lyon
And the FDA also regulates pharmaceutical companies, large Novo Nordisk, the large companies as well.
- [24:47]
Sean Nohrian
Absolutely. And compounding pharmacies are primarily regulated by each individual state board of pharmacy that they serve patients in. FDA primarily regulates outsourcing solutions. But the FDA does have jurisdiction of both compounding pharmacies and outsourcing facilities since the Drug Quality Security act was passed in 2013.
- [25:05]
Gabrielle Lyon
And their job, the FDA's job is to. To make sure everything's up to standard.
- [25:10]
Sean Nohrian
Absolutely.
- [25:11]
Gabrielle Lyon
That these companies that which would make them friendly. 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.
- [25:28]
Sean Nohrian
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 and 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 of 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 seen with compounding pharmacists 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. This is what happened about a week ago on April Fool's Day. April 1st we were sued by Eli Lilly. The same day there was a reduction force at the FDA where RFK Jr. Removed hundreds of employees.
- [26:54]
Gabrielle Lyon
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- [28:23]
Sean Nohrian
The very 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, you know.
- [28:57]
Gabrielle Lyon
Wanted to get what out exactly?
- [28:59]
Sean Nohrian
The warning letters.
- [29:00]
Gabrielle Lyon
The warning letters out?
- [29:01]
Sean Nohrian
Yeah. Warning letter is, is a letter that the FDA states said stating that we think your company is dangerous.
- [29:09]
Gabrielle Lyon
Does someone come and deliver it?
- [29:10]
Sean Nohrian
Well, they send it via email.
- [29:12]
Gabrielle Lyon
Oh, they send it. So no one's there showing up with like cookies or something. And here's your letter.
- [29:16]
Sean Nohrian
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.
- [29:29]
Gabrielle Lyon
So you get a letter from an email from the FDA on April Fool's Day.
- [29:35]
Sean Nohrian
Yeah, they did.
- [29:36]
Gabrielle Lyon
You're like this. Maybe it's real.
- [29:38]
Sean Nohrian
The day after April Fool's Day was like this. This must be a joke. But no, this is an example.
- [29:42]
Gabrielle Lyon
Did you know it was coming?
- [29:43]
Sean Nohrian
No, no, we were very surprised, you know, and 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 Eli Lilly is putting all this pressure on, on the, on the FDA and legislators to be able to remove compounding farms. Well, what do you do? You go after the largest and this.
- [30:10]
Gabrielle Lyon
Is what, do you teach them a lesson or just because you guys are the most powerful?
- [30:14]
Sean Nohrian
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 the rest of the industry. If they can shut down the largest, most powerful player, it will be easy to shut down.
- [30:27]
Gabrielle Lyon
The weaker ones are monopolies. Aren't they illegal in the US Just in general? I mean, I don't, I don't know, but from what I.
- [30:36]
Sean Nohrian
Not in the pharmaceutical industry, but they're.
- [30:39]
Gabrielle Lyon
Illegal in other domains, everywhere else. Except for pharmacy.
- [30:44]
Sean Nohrian
Except for the pharmacy.
- [30:45]
Gabrielle Lyon
Are you sure? I mean, is there anywhere else that is legal?
- [30:47]
Sean Nohrian
No, it is not. I am not aware of any place a monopoly is allowed in the United States.
- [30:52]
Gabrielle Lyon
Right. It's not allowed for energy, it's not allowed for water. Right. All of the things that we use.
- [30:57]
Sean Nohrian
Right. And there's a reason behind that. You know, there's this thing that we have in this country called capitalism. And 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.
- [31:16]
Gabrielle Lyon
You know, it 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.
- [31:37]
Sean Nohrian
Right. 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.
- [31:50]
Gabrielle Lyon
And the regulators go in and they say, sean, we'd like to see more ventilated hoods. Or 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?
- [32:13]
Sean Nohrian
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 not fair. And then agencies, 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.
- [32:54]
Gabrielle Lyon
What did the letter say?
- [32:56]
Sean Nohrian
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.
- [33:17]
Gabrielle Lyon
What's gmp?
- [33:18]
Sean Nohrian
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 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 this is tied. Lily's lawsuit is tied with these warning letters because we've never seen observations like this before.
- [33:45]
Gabrielle Lyon
And when you got sued by Eli Lilly, what did. What did it say?
- [33:50]
Sean Nohrian
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 know, 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 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.
- [34:33]
Gabrielle Lyon
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.
- [34:57]
Sean Nohrian
If that's the only dose that's available commercially, that's the 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.
- [35:11]
Gabrielle Lyon
Oh, I mean, I don't want to say always, but almost always.
- [35:13]
Sean Nohrian
Right. Why is that wrong? Why is Big Pharma trying to make us believe that personalized medicine is dangerous for us when actually may be better for us in many cases?
- [35:26]
Gabrielle Lyon
What do you think happened? What do you think? What do you think is the connection, or what is you. What is your legal team think of the connection between what happened, you know, when RFK let go of all these people?
- [35:41]
Sean Nohrian
I mean, we don't know what happened inside those closed doors, 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 company, pharmacy, or outsourcing facility in the history of industry.
- [35:56]
Gabrielle Lyon
How long have you guys been around?
- [35:58]
Sean Nohrian
15 years.
- [35:59]
Gabrielle Lyon
In 15 years, you've never gotten these letters of various compliance, whatever the.
- [36:04]
Sean Nohrian
Not to both facilities at the same time, to both entities at the same time. Both our pharmacy and outsourcing facility, that's never happened.
- [36:14]
Gabrielle Lyon
Just a crazy thought. The people that Got let go. Obviously we don't know where they went to go work, but they're. Do we know, were they regulators? What were they doing? Was it a whole host of various people that got let go by rfk?
- [36:30]
Sean Nohrian
We don't have the full list, but we are investigating it and would be.
- [36:33]
Gabrielle Lyon
Curious is 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.
- [36:49]
Sean Nohrian
Well, Big Pharma has a good history of using revolving door tactics to be able to incentivize their regulators to favor them versus their competitors.
- [37:00]
Gabrielle Lyon
What is a revolving door tactic?
- [37:02]
Sean Nohrian
So hiring, hiring people as soon as they leave the fda, as soon as they're fired or they quit or whatever, or their terms up or they're recruited.
- [37:12]
Gabrielle Lyon
Do you think that they are possibly recruited?
- [37:14]
Sean Nohrian
Oh yes, of course. Yeah. The many, 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.
- [37:25]
Gabrielle Lyon
Gosh. 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?
- [37:39]
Sean Nohrian
It is the first time by Eli, yes.
- [37:41]
Gabrielle Lyon
And 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?
- [37:54]
Sean Nohrian
Yeah. We will defend our position, as we always have, that what we do is perfectly legal and has always been legal since pharmacy. The practice of pharmacy has been in place and that it's the doctor's decision what is in the best interest of their patients, not what Lilly thinks is in the best interest of patients. And if Lilly 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 5th as that and still have one of the best margin products out there.
- [38:35]
Gabrielle Lyon
Do they have an answer for that?
- [38:37]
Sean Nohrian
No.
- [38:37]
Gabrielle Lyon
What about that?
- [38:38]
Sean Nohrian
Not that I'm aware of.
- [38:39]
Gabrielle Lyon
What about why in Europe? Why is it that they're sucking American dollars?
- [38:43]
Sean Nohrian
Well, because we, we can afford it. We have to subsidize the rest of the world. Otherwise no new medications will get created, which is Nonsense.
- [38:52]
Gabrielle Lyon
That's not true. Right.
- [38:54]
Sean Nohrian
That's what they want us to believe.
- [38:56]
Gabrielle Lyon
What about the difference in the 500 and the variations in compounding pharmacies? Also, who seeds that information that compounding pharmacies are dangerous? Where is that information coming from?
- [39:09]
Sean Nohrian
So 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.
- [39:46]
Gabrielle Lyon
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- [41:23]
Sean Nohrian
And 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.
- [41:32]
Gabrielle Lyon
What's an essential copy for the listener.
- [41:34]
Sean Nohrian
An essential copy is what's pretty much an exact copy, meaning this commercial drug.
- [41:40]
Gabrielle Lyon
2.5 milligrams exactly in this dose.
- [41:42]
Sean Nohrian
Yep, yep. Compounding pharmacies, in order for us to make a drug legally, it has to be differentiated from the commercial product by their 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, 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, sean, what are we going to do? I have hundreds of patients on these medications and 9/10 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 Big Pharma.
- [42:57]
Gabrielle Lyon
Using the media to control the message.
- [43:00]
Sean Nohrian
Absolutely. Yeah. This is, 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 that turns on the TV and that's what they hear, or they go online, that's what they read, is telling them that that's their only option. So it's very monopolistic behavior.
- [43:25]
Gabrielle Lyon
Is 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.
- [43:41]
Sean Nohrian
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 patient can be better served by utilizing this new health care system that's being built outside of the traditional health care 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.
- [44:20]
Gabrielle Lyon
And what is the relationship between insurance companies? So I'm looking here at the average retail price of WeGovy and this, this number I have is $1300 a month. Ozempic is 936amonth without insurance. And only 1 in 5 US insurance insurers currently cover GLP1s 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 GLP1 drug, which is, I'd like to see it higher, quite 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?
- [45:27]
Sean Nohrian
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 incentivizing low income for anybody. Which is why, whether you're an insurance company or the US government or a patient, we all have to pay the same exact price. We can't negotiate with big pharma. It's against the rules. So you're right. 12% of patients 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.
- [46:08]
Gabrielle Lyon
Seven out of how many?
- [46:09]
Sean Nohrian
Seven out of eight cannot afford more than $500 a month.
- [46:13]
Gabrielle Lyon
Seven out 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 GLP1s are done so for, I don't want to say for a reason. I mean, listen, 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're 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 there is a high safety profile with Ozempic and Tirzepatide. Would you agree with that?
- [47:02]
Sean Nohrian
Oh, absolutely. Much, much safer than the previous classes of weight loss medications that were approved.
- [47:08]
Gabrielle Lyon
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 Zepbound and Mongerno from the shorted list, the shortage list, and they then banned compounding pharmacies from making it. Is that true?
- [47:40]
Sean Nohrian
That is not true. They banned compounding pharmacies for making the exact copy, which is not a ban.
- [47:47]
Gabrielle Lyon
Which is fine, Which, I mean, sure.
- [47:50]
Sean Nohrian
So you make can't 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 GLP1s as long as they're differentiated from the commercial products. And that is. I don't read many articles 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.
- [48:28]
Gabrielle Lyon
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?
- [48:51]
Sean Nohrian
Well, and what are we going to do about that? 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 M.O. 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 we see start 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.
- [49:28]
Gabrielle Lyon
Tell me about that.
- [49:29]
Sean Nohrian
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 other states, so pause.
- [50:01]
Gabrielle Lyon
And tell the listener what that is. So the outsourcing, the outsourcing manufacturing is where the drugs are made.
- [50:08]
Sean Nohrian
So outsourcing sellers are one type of entity that can make drugs and then sell them to B2B end users, pharmacies, hospitals, clinics, practitioners. And now we're seeing states are starting to say, and outsourcing soldiers were created in 2013 because of a compounding pharmacy, NECC, that had made a bad batch and killed many patients.
- [50:32]
Gabrielle Lyon
What's that? What's that?
- [50:33]
Sean Nohrian
And New England compounding centers was a compounding pharmacy that had made an intrathecal injection, methylprednisolino 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 manufacturer called a 503B 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 NECC actually happened, I see now they're saying 503Bs are dangerous. 503B sure shouldn't be selling their drugs to pharmacies or any other B2BN 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 Massachusetts board, wasn't even aware of this. This was the staffers that had passed this memo without their knowledge.
- [51:45]
Gabrielle Lyon
What would that mean for, what would that mean for the outsourcing facilities?
- [51:52]
Sean Nohrian
Well, and pharmacies, 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.
- [52:20]
Gabrielle Lyon
So the 503B outsourcing facility, this is where compound. This is where medications are made in the, in big pharma. Do they have a 503B Big Pharma?
- [52:32]
Sean Nohrian
They have what's called either a contract manufacturing organization or their own pharmaceutical manufacturing facility.
- [52:39]
Gabrielle Lyon
I see.
- [52:39]
Sean Nohrian
But both outsourcing facilities and traditional pharmaceutical manufacturers have to meet the same exact standards known as current good manufacturing practices.
- [52:48]
Gabrielle Lyon
And the 503B is just a way for other providers, other pharmacies, like small mom and pop pharmacies, other places to get the medications. Is that fair?
- [53:01]
Sean Nohrian
Yeah. So think of 503A compounding pharmacies as B2C business. We're selling medications directly to patients, to consumers. 503B outsourcing facilities are doing B2B. We're selling to businesses, the hospitals, the practitioners, the clinics and pharmacies as well. And so by being both a 503 and a 503B, 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.
- [53:40]
Gabrielle Lyon
And the stakeholders would be hospitals and other physicians. Correct.
- [53:43]
Sean Nohrian
And patients as well.
- [53:44]
Gabrielle Lyon
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?
- [53:59]
Sean Nohrian
Or. Right. So it's saying that 503s. So 503s 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 five.
- [54:11]
Gabrielle Lyon
So how do they get the medication? How do those people in Massachusetts from.
- [54:14]
Sean Nohrian
Compounding from company pharmacies making their medications themselves, which is a lower quality system than a 503B 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.
- [54:38]
Gabrielle Lyon
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?
- [54:50]
Sean Nohrian
Well, in the generics industry, where many competitors can come in and make a medication, we see those costs go down over time. When there is very little competition, we see those prices go up over time.
- [55:05]
Gabrielle Lyon
Give me an example.
- [55:06]
Sean Nohrian
I mean, GLP1s with Novo and Lilly, you know, when they first came out, they both decided that about $1,000 a month.
- [55:17]
Gabrielle Lyon
And they decided together what the cost is going to be.
- [55:19]
Sean Nohrian
Essentially, they can't decide 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 when it first came out, they said they couldn't lower the cost. $1,000 a month was the right price. It was the 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 pharmacists and outsourcing solutions. They cut that price in half. And as soon as they cut that price in half, Lilly followed suit about a month later. And so they're not saying that they're not telling the truth. They could lower these drugs so much more. They just don't want to because they don't have to.
- [56:04]
Gabrielle Lyon
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?
- [56:18]
Sean Nohrian
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. 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. I mean, think about it, 35, $30 billion eventually become 35 and then 40 as time goes by. And if they succeed at preventing company pharmacies, that just doubles every year that they're able to hold onto 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.
- [57:15]
Gabrielle Lyon
It's 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 GLP1s 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.
- [58:17]
Sean Nohrian
That's right. You know, GLP1s work in a very interesting manner. 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 GLP1s 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 certain drug addictions.
- [58:49]
Gabrielle Lyon
I agree. Is there an opportunity for Lilly to succeed in shutting down compounding pharmacies? I'm teeing you up for this one.
- [58:59]
Sean Nohrian
I mean, there is always an opportunity to make it harder for patients to get access.
- [59:07]
Gabrielle Lyon
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- [60:15]
Sean Nohrian
And in the 15 years I've been doing this, I've seen this game played many times before. Usually PhRMA loses. Usually. You know, there are some cases where PhRMA wins. PhRMA is able to convince a legislator, a regulator, or a legislator that they are the only solution and that any other potential competitors would put patients at risk.
- [60:41]
Gabrielle Lyon
Have you ever seen them push this hard or is it just this drug because this drug is so effective?
- [60:48]
Sean Nohrian
No other pharmaceutical company has ever lost more revenue from any drug in the history of compounding than from GLP1s.
- [60:56]
Gabrielle Lyon
Has any drug ever been as effective for a massive issue than this?
- [61:03]
Sean Nohrian
Not that I'm aware of, no. This, I agree. This is a game changer. People are calling it a miracle Drug for a reason. I mean, for patients that can't lose weight, for patients that have never been able to cure sleep apnea, there are studies showing that it helps Alzheimer's. There are studies showing that, as mentioned, it helps cure addiction. The list just keeps growing and growing. And so as you said, the majority of the US population qualifies today for GLP1s, but the majority of the population is not on GLP1s. Why? Because only 1 in 8 can get access to GLP1s.
- [61:44]
Gabrielle Lyon
It's 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 GLP1s being shut down?
- [61:57]
Sean Nohrian
No. 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 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.
- [62:37]
Gabrielle Lyon
It's 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.
- [62:54]
Sean Nohrian
They 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.
- [63:16]
Gabrielle Lyon
Put in place another cb Hire them.
- [63:20]
Sean Nohrian
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 that gets this new system because they've never been part of it.
- [63:47]
Gabrielle Lyon
If you were sitting with RFK or someone from the administration, what do you need them to know?
- [63:53]
Sean Nohrian
Well, there are solutions out there and they are available today. 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 U.S. population. The CEOs, the executive team of pharmaceutical companies and the system. It's an easy, in my opinion, an easy fix. Just introduce competition like we have done. And 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.
- [65:08]
Gabrielle Lyon
I love that. I love that. Sean. I think 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 for from big Pharma. Oftentimes, 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?
- [66:02]
Sean Nohrian
It's a great question. 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, if I want to research something, I mean, we can get the answer in a minute.
- [66:21]
Gabrielle Lyon
But how do 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 neutral?
- [66:45]
Sean Nohrian
I would prompt specifically you get very specific in what I say. 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 wouldn't be available after A shortage, because that's two separate prompts. One is saying during a shortage and one is after a shortage. And the AI may not know the difference, they may not know what you intended. So it's just being very specific and of course doing deep research. You know, the deep research function.
- [67:23]
Gabrielle Lyon
So you turned me on to that. So we basically, Sean and I and Shane were working out and then Sean, you ruined my workout buddy. You showed me this deep research feature on ChatGPT and it was game over. Oh, that was it. I was, I'm. 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 GLP1s. 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 ask Deep Research to go ahead and put together a table for you. It's extraordinary, right?
- [68:11]
Sean Nohrian
You can have 1000 PhDs at your fingertips and let instead of just one subject matter expert telling you what's the truth, now you have thousands. 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.
- [68:34]
Gabrielle Lyon
It's really fascinating. Do you think that. So you are the lar. You are the largest compounding pharmacy in the world. There are a, 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 503B?
- [68:54]
Sean Nohrian
So compounding pharmacies are required to follow the United States pharmacopoeia standards, which are not as strict as good manufacturing practices are, which is what good 503Bs have to meet. So, and different states have different variations of the standards, but they're all more or less the same. They all more or less follow usp. And those standards have become stricter and stricter since the United States Pharmacopeia 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, add 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 inspecting once a year and 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.
- [70:08]
Gabrielle Lyon
Are there certain states that are more strict than others?
- [70:11]
Sean Nohrian
Absolutely. California. California makes up rules that are completely non compliant with USP and go above and beyond in the way that they regulate, which cause a lot of problems for patient access. You know, there, there were several. At one point, you know, several years ago there were. There are hundreds of sterile compounding pharmacies in California.
- [70:34]
Gabrielle Lyon
Yes.
- [70:34]
Sean Nohrian
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.
- [70:46]
Gabrielle Lyon
State or physicians, frankly.
- [70:49]
Sean Nohrian
Right, yeah, they're, you know, 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 been put in a very unsafe position because now they can't get these medications anymore unless they travel.
- [71:13]
Gabrielle Lyon
They could always travel to see another physician out of state. State like here in Texas. However, certain places will then not ship to California.
- [71:24]
Sean Nohrian
Oh, exactly. You know, and, and so, 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, it's, it's a problem. But the rate this, the rules are very strict no matter what state you're, you're operating or shipping medications to. And the rules are consistent. They've been practiced fairly 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 or combination or whatever reason that the provider thinks could benefit that patient using a personalized medication.
- [72:10]
Gabrielle Lyon
Well, Sean Nohrian, 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 Sean 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 GLP1s, it's only a matter of time that it happens for other medications.
- [72:57]
Sean Nohrian
You're absolutely right. And thank you, Gabriel, 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 patient's best interest. Because at the end of the day, that's the only person that matters.
- [73:35]
Gabrielle Lyon
Sean Norrian, 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.
- [73:45]
Sean Nohrian
Thank you, Gabrielle.
- [73:46]
Gabrielle Lyon
Appreciate you, Sean. 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 Drli.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.