Episode 590: Compounding Pharmacy for Lyme Disease – David Kazarian, RPh | LIVE from ILADS

So please, first share with us the name of your company and talk to us a little bit about what you do.

Well, our company is InfuServe America.

InfuServe.

InfuServe America. That's like infusion and service tucked together with America on there.

Okay, cool, cool.

That's because originally we were an infusion company.

Okay.

And we've been helping the Lyme disease community for about 27 years, plus or minus. And what we do—

So you're an OG.

Yeah, yeah, we are the original old gangsters as far as this is concerned.

All right.

We really truly are. And what we do is we compound medications that aren't easily found, and we also compound medications without certain types of fillers and other things that lots of myeloma disease patients are sensitive to.

All right, so I'll walk it back even, even further. So what is compounding?

Compounding is both a science and an art.

Okay, okay, so give us the science piece.

The science piece is it's You're a chemist and you're taking raw materials and you're putting them together so that they can be absorbed properly in a human being.

Okay.

Okay.

And, and, and give us the art.

The art is knowing exactly how much of those things go together and how they should be used in certain people, because nobody's the same, right? So there's different routes of administration, there's different kinds of excipients that you can use to make sure that the drugs maintain their potency or their sterility or both. So it's, again, there's a lot, there's a lot more to it than you might think.

All right, so I want you to build that up for us, right? So this is a patient podcast, right?

Sure.

And patients are always looking for some way of improving their health. So talk to us about what you would be able to help someone with uniquely. What is unique about your approach?

Our approach that would benefit Lyme patients the most would be to basically have almost like a conference with them or speak to them or speak to their doctors relative to what sensitivities they have. Now, with Lyme folks, they have a whole host of things that they can't tolerate— dyes, certain types of fillers like magnesium stearate or titanium dioxide that are commonly found in a lot of different commercial products. Okay, and they need those products, but they don't need the fillers. So what happens is, is they— their practitioner or the patients themselves contact me, and we talk about how we can get them the medication that they need in a form that best benefits them.

So give us, give us the spectrum of forms, right? One of the things that I've learned and I didn't understand before I started doing this podcast is in many cases, in order to be able to get a get something that someone needs into their system. For example, you may need a carrier oil, right? When I first started learning about CBD, for example, you know, what I believed, you know, as a layperson was that I would just get CBD oil. And then what I learned from one of the practitioners that I interviewed is that he said to me, oh no, there has to be a carrier oil.

That's right.

And the carrier oil is going to have an impact on the way it is ultimately going to be absorbed.

Yeah.

Some patients will benefit from coconut oil, others will— and you gave me this whole spectrum. So, give me the spectrum of options that we have available generally, and then how you have teased out scientifically and artistically which carrier, if I'm using the term properly, tools that are being used in order to be able to get to the patient what they need in a way that they would best they'd get the best outcome?

Sure, that goes under the general heading of excipients.

Excipients?

Excipients, yeah. It's a fancy chemistry term for all the stuff that's not the API or the active ingredient. And you need excipients for all kinds of different reasons. Sometimes you need them to weigh it properly to get the proper dose. And then other times you need it to make sure that the medicine is preserved or doesn't expire in too short a time.

So it's not necessarily carrying it from the ingestion to where it needs to go in order to—

That's another aspect to it. Okay, so give us that aspect.

So it could be getting it from your lab to my house.

Right.

You want to make sure that it's preserved.

Exactly. Exactly. The other part of that is that you need to think about what kinds of things that you're using that could affect the patient's health. In other words, if they're allergic to dyes, well, we use a lot of clear dye-free vegetable capsules.

Okay.

Okay? And the question, well, why vegetable capsules? Well, why can't you use normal capsules? Well, normal capsules are animal-based. Okay, and a lot of people don't know that. Some patients that have a particular problem called alpha-gal cannot tolerate gelatin capsules. So for the most part, we use vegetable dye-free capsules because again, our patient population is highly sensitive.

Very interesting.

Now, that's just the capsule. On the inside of the capsule, you have all the excipients that we're talking about, or carrier oils. We use those too. Now I have a whole bunch of people that are allergic to peanut oil, for example. So I'm not going to use that as a carrier. But I have all kinds of different choices. I can use MCT oil. I can use almond oil. I can even use olive oil. There we go. Okay. Now this goes for some of the other excipients that I use in capsules that come in powders. I've even used carrot powder. I've used coconut powder. I've used all kinds of other things so that it It's rather bespoke. It's rather, it's for that particular patient. So if they have a particular problem with something, we can work through it so that I can get them the medication. Now, I've just mentioned just capsules. We have all kinds of other different routes of administration as well. There's topical, there's rectal, vaginal, there's different kinds of suppositories, different kinds of topical creams. And sometimes the excipients that you use in those have different effects on how the drug is absorbed. And that's an important part of it too.

Is that the purpose of having a carrier oil, for example?

Part of it, part of it, yeah. Part of it. Now carrier oils specifically, I'll talk about this as microemulsions.

Micro what?

Microemulsions.

Okay.

Okay. Most people talk about liposomal things, okay, and liposomes You can't really call it a liposome. You need it, you know, that's a commercial product. Eli Lilly has hundreds of thousands of dollars worth of equipment to make things like that. But what I can do is I can make a microemulsion, and that's basically wrapping the drug in fat. It's like wrap it in bacon, but I use carrier oils to do that. And why would I do something like that? 2 reasons. Number one, With some drugs that are lipophilic, the carrier oils increase the absorption. Okay? Sometimes you don't need that. And other times I wrap it in fat because the drug can irritate the stomach or can irritate the intestinal tract. So that's another reason to use a carrier oil specifically or make a microemulsion out of that drug. Now, you'd have to be a pretty good chemist to know which ones that those were. And that's what we do.

Okay. So now let's talk about Lyme disease generally.

Sure.

Alright, so let's define Lyme disease for the purposes of this conversation.

Right.

Meaning, I define Lyme disease, or I should say we at Tick Boot Camp define Lyme disease as a polymicrobial, multisystemic, chronic infectious or post-infectious disease.

Right.

Give me your thoughts on our definition of Lyme disease, and would you define Lyme disease differently than we do?

Here's the thing, having done this for quite some time— You're an OG. I wouldn't pigeonhole it necessarily as Lyme disease writ large.

Okay.

I would position it as tick-borne illness.

Okay.

And the reason for that is that we treat Lyme disease itself, but that's only part of what happens. Tick-borne illness involves all sorts of co-infections. Babesiosis.

That's why we call it polymicrobial.

Polymicrobial. So it's not just, in other words, it's not just Lyme disease.

It's not just Borrelia, right? No, no, no. So we certainly reject the idea that it's just one bacteria, right?

No.

Or one strain of one bacteria, right?

It's certainly not.

It is polymicrobial.

It's polymicrobial. Now, if you want to go one step further, further, okay, and this is something that has been kind of creeping into our understanding over the years, is that there's this huge immunological component to Lyme disease.

Absolutely.

Okay. And in order to understand all of that, there are about 16 or 17 different points of differential diagnosis for this, 6 or 7 of which are specialties. In other words, there are doctors that devote their lives to just that portion of the disease state. So, it's incredibly complex and it's hard to find practitioners that have the knowledge base to embrace all of that difficulty because it's so large.

It is, and it's one of the reasons why we have so many brilliant doctors here at iLabs. And again, one of the most brilliant doctors we interviewed is Dr. Stein, who wanted us to meet you and wanted us to talk with you about the work that you're doing here. So let's stay with, rather than just agreeing that we're in the Stein fan club together—

We are, we are definitely.

Which is awesome. Let's say focus on now the definition of disease. So it is a polymicrobial disease. And one of the things that you said earlier that caused my antenna to be raised is that you were being sensitive to the possibility that someone, because it's polymicrobial infection, that they may have alpha-gal, right? And alpha-gal may be an element and is often an element of somebody's tick disease journey.

Of course.

So, so what do we— let's just acknowledge generally, what types of things do you observe that are unique in the Lyme community that you don't see in other communities, and how are you helping Lyme patients to have tools that they would otherwise not have if they were working with a large pharmaceutical company as opposed to working with a compounding company like yours?

I can give you a really good example of that.

Please.

Okay. With most Lyme disease patients, it is, it's a journey and it takes a long time. The most interesting part about that is, I'll go back to the immunologic portion of what we're talking about. And to make it simple, what happens in a lot of Lyme disease patients is as they go through their journey, they start to get allergic or sensitive to things that they were never sensitive to before.

Absolutely.

And this happens again and again and again.

Yes.

I mean, it's almost inevitable that this is going to happen. They wake up one day and it's like, I can't tolerate this type of food or I can't tolerate this particular excipient. Oh, that's why. This is where we come in, okay? Because that doesn't happen all at once. It happens in stages. So while the patient is visiting their practitioner, all of a sudden something— hey doc, I can't tolerate my commercial branded thyroid medication anymore. Okay, well, I know a guy. That's me.

So tell me what, using your example, what process are you now going to go through to determine how you're going to compound for that particular patient that you had given the example of, right? What are the different elements that you're going to be looking at?

Well, let's absolutely look at that. Let's take thyroid for an example because it's a really good one. What you're going to do is you're going to run a complete thyroid panel, okay? And I really mean complete. Because most of the time when you go to the doctor and you get an annual physical, they'll run what's called a T4 and a TSH. That's it. Okay, well, there are 2 different kinds of thyroid. There's T4 and T3.

Yeah.

Well, they didn't measure that. There's also reverse T3. Also, the thyroid medication is protein-bound, which means there's free portions of T3 and T4, and then there's protein-bound portions. And you have to know what those are in order to be able to diagnose the patient properly. And a lot of it gets missed if you're only doing 2 tests.

Okay.

So that's where you start.

So the first recommendation that you would be making to a physician you're working with is that they—

Expand the testing.

Expand the testing.

Expand the testing.

Now, once the testing is expanded, what data are you now going to be looking to when you're going to come up with a compound that's going to allow the patient whose thyroid medication is now causing them to—

That is a fantastic question because there are about 5 different points within that testing that you can look at to see if there's potential problems. I already mentioned it was protein-bound, so the first thing you're going to look at is, is that, is what's my free T3 and free T4 compared to the total? Okay, then I'm going to look at what's called reverse T3 because that's an important component to tell me how the body is processing T4 to T3, because that's another thing most people don't understand. T4 is what they call a prodrug. It doesn't do anything, okay? T3 is the active thyroid component. But if your body doesn't convert T4 to T3 well, you're hypothyroid. You're not— you think you're producing enough, but you're not really, okay? Then go on to iodine, which is the building block of the T4 and the T3. It's like having lumber for a house. Okay, if you're building a house and you don't have the proper lumber, you're not gonna get a house. All right?

Right.

Then you're looking at something called ferritin, and this is something that's most of the time overlooked by everyone. Now, most of the time they're concerned about how the thyroid gets to the cells. and gets to the receptors. Well, thyroid is also transported inside of cells, and one of the things that does that is something called ferritin. And it's easily measured, but if it's low for any reason, the transport of the thyroid that you're trying desperately to get to the cells doesn't get to the little tiny organelles inside of the cells. Pretty complex, right?

It is complex.

All right, so now I've named off 3 or 4, almost 5 different things relative to that. Now, if you don't know all of those patterns and you don't have the proper testing, you can't start figuring out why this patient's having symptoms.

All right, so let's now bring it back to the Lyme patient.

Right, now let's go back there.

But I want to say with your example because I think it's instructive, right? So we have somebody who has been dealing with a thyroid-related issue for some period of time. They're taking a thyroid medication that is provided to them by a pharmaceutical company that is providing a treatment protocol for people who suffer from this illness generally.

That's right.

Now this patient is now suffering from Lyme disease, and as a result of now this Lyme infection, this polymicrobial infection, now they're responding adversely to a medication that they had been taking for a long time.

That's right.

So now tie that together for us, because what you would now have to do is 2 things, right? In working with a practitioner, the first thing you're gonna have to do is you're gonna have to identify what in the general pharmacy medications they were using, what is causing the adverse response, and now design a new approach to treating that. And we have to come up with some tool to Yeah. The Lyme disease, right?

Yep. Well, exactly. And here's the thing, we're treating one thing at a time. Remember I told you there's 16 different points of differential? This is just one tiny bit of a complex, complex organism. But let's stick with the thyroid thing because it's a great example. So all of a sudden, this person has trouble with their thyroid because they're on a commercially branded thyroid medication. thyroid medication.

Yeah.

Okay, let's call it like NP thyroid. Okay, well, those come from both bovine and porcine sources. Okay, well, we were talking about immunology earlier, right? Now all of a sudden the Lyme disease patient has trouble with animal sources like alpha-gal.

Well, certainly signaling to us that they may have alpha-gal, right? Which is really—

So now they're having difficulty because they can't tolerate that, that particular kind of medication. Well, this is where I come in. Not only can I address what the dosing is, but I can also address how they're getting it. So we don't have to use bovine or porcine sources. We can use what's called bioidentical. And what does that mean? That's important to know what that means.

I need you to define terms here.

It's not natural, okay? It's bioidentical. And what does this mean? This means that if I took thyroid T3 out of your body and I compared it chemically to the stuff that's in my jar on my shelf, they are identical. That's what it means by— to be bioidentical. And it's— the stuff in my jar doesn't come from cows or pigs. It's not bovine or porcine sources. So now we're going to be utilizing something that the patient isn't sensitive to or allergic to, but we're also going to be able to dose it in the proper amount because when they take it from those sources, the ratio of T4 to T3 is animal-based. Okay, it's 1 to 3.3. Well, for humans, that's not the correct ratio. I can make that correction When I compound it myself, not only can I make it the proper ratio, but when I'm making it, I can make it in dye-free vegetable capsules. Okay? I can also do some pretty other interesting things to it. I can put it in an excipient that they're not allergic to. I can also, through chemical processes, make it sustained release.

Okay.

And this is important because thyroid is dosed at very small dosages, microgram quantities, and sometimes it's not absorbed very well. And absorption is a problem for people with Lyme disease.

So let's pause here for a second.

Sure.

We absolutely need to schedule a long-form podcast.

Understood.

You and I.

I got it.

There's a lot that we need to dig in on. We've just grasped the surface. I do want to touch on 3 things though for the purposes of this conversation.

Of course.

Because as a patient podcast, I can tell you there are people that are hanging on the edge of their seat waiting for me to ask you a couple of these questions.

Of course.

Because there are some validation pieces here that are important. And again, I would ask you to be open to having a 90 to 120-minute conversation so we can dig into this.

Of course.

So let me talk about the first piece. The first piece is Lyme patients are invalidated regularly. They're gaslit regularly as a result of one important thing. thing, which is, which is they'll walk into a doctor's office one day with one symptom and then they'll come into the doctor's office next month with another symptom. And, you know, these— so these migrating symptoms, which are very typical in Lyme disease, are something that does cause a lot of gaslighting and invalidation. One of the things that you've just alerted me to that I'd never heard of in the 5 years we've been doing this is one of the reasons why folks may now have migrating symptoms is not just because of the dispersion of the disease or the microbes, but it could also be the reaction to medications that they were taking that they can no longer take because of the altering immune function.

Of course. The immunological portion that I mentioned, I alluded to, is very poorly understood but is incredibly important to all of the things that we're seeing.

So, I mean, it's just another example of of a migrating symptom that a doctor in many cases simply wouldn't understand.

This is correct.

And could be the basis of a doctor disbelieving a patient or disbelieving their symptom. But now there's a second piece of this that I want to highlight, which is another brilliant observation, which is it could also give us insights into diagnostic challenges. We have a great many diagnostic challenges in this community. There aren't many great tests. for a lot of different reasons for disease. But you, in many cases, what you're able to do is at least highlight some other testing that needs to be done and validating maybe symptomology that's not otherwise being validated with objective testing. So, and the example that you had given was the reaction to these bovine-based carriers that could signal an alpha-gal allergy.

And again, that's just an example.

Yeah, no, it's a brilliant example.

There's all kinds of other things that could trigger a Lyme disease patient for any number of reasons. And again, it's not just Lyme disease. There's so many different facets to it that you have to take these kind of one at a time.

Yeah, no, no, it's, you know, this is medical detective work. that should cause patients to believe that there's another person that can help them, another expert, a professional that can help them and help their doctor to get to a place where they can get the outcomes that they need. So, let me give you the last piece that I'd like you to talk about and just so that we can wind down this short form that we're doing today.

100%.

And that is, I always want to end a podcast on a hopeful note. I don't want to scare let people think that, you know, let people think that, you know, there's not something very positive that can come out of this. And here's another positive piece. So we've highlighted one, which is, which is of course you could, you could be helping with the diagnostic process, right? Another is you can help with the validation of this, of these migrating symptoms, and give that some context.

Of course.

But I think that the third piece of this is, is that they can work with you And they can get the products in the carrier form, to use my lay description.

Oh, sure.

And come to a very positive outcome. They don't have to rely on Big Pharma. They can work with someone like you and get exactly what they need to get to the health outcome that they're looking for.

There's all kinds of— that is absolutely true, but it also adds one extra aspect.

Please.

Okay, and it's, it's compounding pharmacies writ large are able to put tools into the toolbox of the practitioner. Okay, a lot of what I do during the day is I perform consults. So what happens is a practitioner, a doctor, or somebody will call me and say, look, I've run out of moves. I've got this particular problem. What else can we think of, whether it's changing excipients, changing route of administration, a different active ingredient? What can we do to assist this patient? Because whatever the commercial products are, they're either not working or it's simply not available. Okay, and Lyme disease is a lot like that. There's a lot of outside the box thinking. There has to be because it's so large. You couldn't just— there's no recipe. You have to take it one patient at a time.

It has to be precision medicine. It has to be precision. And there are a number of different professionals that they have to work with in order to be able to put themselves in a position where they can get the best outcome, and I'm really excited to have introduced them to you and to someone who has your expertise and your very unique perspective. I, again, it's always exciting to just look at the elephant from a different angle every single time we have a conversation like this. So, talk to us before I let you go, because again, folks are gonna want this information.

Of course.

How can folks in the patient community have their doctors work with you, and is there, is there a an opportunity for them to work directly with you without necessarily having a practitioner involved?

I encourage the practitioners to be involved.

I do too.

That's usually the best way of doing it. Putting us in between the patient and the practitioner isn't necessarily the way to go. I need the practitioners, I need their expertise, okay? This is— we don't prescribe medication. Okay, I'm there to basically help the practitioner help the patient. So the best way is to have the practitioner call us. Okay, so that, you know, NephewServe America, we're online, we're very easy to talk to, we answer our own phones. Okay, you'll get a brief message at the beginning, but the next person you talk to is going to be either a pharmacist or a pharmacy technician.

So last question, are there any general tools that you offer to folks in the Lyme community, or is it only the precision tools that you were just describing for us today?

No, I mean, we have all kinds of different tools because our pharmacy is both sterile and non-sterile.

Okay, describe what that means.

Non-sterile stuff is the things that we've been talking about— capsules and topicals and tablets and all kinds of other fun things. Now, sterile is a different thing. These are the things that you would typically find in a hospital. Okay, and we've been doing this for a long period of time. This, this is born out of what they used to call home care, where they would send a nurse in and the person would have a PICC line or a port or some other IV access, and you would provide the medications that you would normally find in a hospital. Now, this is an advantage for any number of different reasons, right? There's different intravenous antibiotics that in certain cases work much better than the orals in certain cases. There are all kinds of different IV things that are typically good for symptoms, like Myers Cocktail, for example, which is a nutritional supplement that's given intravenously. Intravenous high-dose vitamin C, for example, is— and there's all kinds of other different versions of that that are helpful. hard to find and need to be prepared by somebody who's been doing it for a long time.

So I want to make one observation before I let you go, and we are going to have to do a part 2 here because folks are going to be frustrated on some level with a lot of what we tease but unfortunately can't give them the full explanation on because of the short nature of the podcast. But, you know, I'm one of the people who objects to big pharma advertising generally. I watch a football game, And there is this advertisement for a medication that 99% of the people watching that would not benefit from. And I have a brother who's a doctor, and he shares with me that in many cases, with the limited amount of time that he has to spend with a patient, especially a new patient, he'll have some of that time, in fact, in some cases half of that time wasted with my brother describing why a particular medication that was advertised during a football game is not going to be for them.

That's right.

And I think what I'm really enjoying about meeting you and this conversation is you sort of stand that on its head, where you're now in a place where patients can go to their doctors and say, hey, there's a way for me to get precision medication that applies to me and will work for me.

That's right.

And perhaps, doctor, you should be working with this type of a company and this particular company, because rather than me trying to take a medication that's not going to work for me, that is not designed for me, and that I shouldn't be asking you about. Now there's a new tool for you, doctor, where we can work together with somebody who can help us have the precision outcome that we need.

And the important part about that, in my view, is that we're putting the impetus for this, or the reason for doing this, right back where it should be, which is with the doctor, with the practitioners. Take advantage of the people that you're going to as far as your doctor or your practitioner. They trained long and hard. Utilize that. Get them to put all of their, you know, their interest and all of their education into getting you better. And if we're a tool for that, if we can help, that happen, that's where, that's where we come in. You need your doctor.

Thank you.

You need your practitioner.

Thank you for coming to talk to us today. This is really an awesome interview, and I look forward to our next time together.

It's my pleasure. Have a great day.