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David Kazarian, BSPharm, CP, RPh - 17th April 2019 (LDN, low dose naltrexone) from LDN Research Trust on Vimeo.
Linda Elsegood: Today my guest is David Kazarian, who is a pharmacist and CEO of Infuserve America. Thank you for joining me today, David. You were telling me before we started that your father was a pharmacist. Can you tell us about what it was like for you growing up?
David Kazarian: Thank you for asking me to join you. Well, when I was eight years old, I used to make capsules in the back of the drug store. My dad worked for a chain back in those days, and he decided to open up his own pharmacy right across the street from them. And that's what he did. I was born in 1941 during the war, which kept my dad out of the war because he had a son; and I grew up delivering prescriptions, helping my dad. He was ahead of his time. He would make penicillin kits. I recall 100,000 units of penicillin would kill anything. And now we've got 2.4 million units and we've got some things that it won't kill. But as a child, I made capsules in the back of the store. I helped my dad with deliveries. I did everything there was to do. And I got interested in the pharmacy market, as time went on. I was always restless. My dad passed away and I learned how much I didn't know when he died. I thought I knew everything up until then. And my dad got real smart after he died. He used to tell me I’ll hear the things he’s telling me after he’s gone. He died in the early seventies, and I still hear that.
I got interested in infusion therapy, so in the 80s we started that, hence the name Infuserve America. That was the genesis of the name. We did infusion pharmacy, but as time went on, we got blown sideways into compounding. Well, I shouldn't say that, because back when I got out of school, compounding is what pharmacists did.
That was 50% of what I dispensed - we compounded it. It wasn't a speciality back then, it was what pharmacists’ profession was. As time went on, there was less and less of it.
And then as time went on, all of a sudden, it started up again. But this time it started as a speciality, and that's why we've been a compounding pharmacy ever since.
Linda Elsegood: So when did Infuserve America become a company?
David Kazarian: In 1989 I left Connecticut and moved to Florida. I sold my pharmacy there, came to Florida, and I was immediately bored because I was used to working 16 hour days. So I started a little infusion pharmacy called Infuserve America, and in 1994 we incorporated. I suppose you can say Infuserve was born in 1994.
Linda Elsegood: So, what does the company do now, David? How big is it?
David Kazarian: Well, that's a good question. We have 53 staff, several pharmacists who we can call compounding pharmacists, and one staff member who taught at a college of pharmacy and also taught courses in compounding for companies that sell chemicals. One pharmacist had been compounding for multiple years in a compounding pharmacy, and he is our pharmacy manager. We were a small company when we started. We had four employees, and now we're over 50. Wow, it's amazing, isn't it? What's amazing is the payroll. I get frightened every time I look at it. I've been practising pharmacy for over 50 years and I've worked with a lot of people, and I have to tell you, this group of individuals is probably the best of the best that I've ever worked with. They're amazing people. They don't know a time clock. They come to work early, they leave late. They do whatever it takes for us to satisfy our customers. They understand that we're here for the patients that we serve.
Linda Elsegood: And when did you first hear about LDN?
David Kazarian: Well, that's very interesting because I will tell you that a doctor by the name of Horowitz called and asked if we could compound it. And I said, of course, we can compound it. And when I got off the phone, I turned around to our pharmacist and I said, what's that?
Linda Elsegood: Oh, that's funny.
David Kazarian: Fortunately, one of our staff knew exactly what it was, and that was a while ago. I've learned more about it ever since. It's a very interesting drug. And of course, your organization has brought out a lot of information concerning the properties of LDN, what it can do.
But you know, I have to tell you, when I was in pharmacy school, we had an old professor, Dr Lauder, and Dr Lauder said, and by the way, he was well known - Dr Lauder formulated Kaopectate for the Upjohn company, at least that's what I was told. At any rate, he was one of my professors and he said to not pay attention to what the drug companies tell you about how good a drug is. Pay attention to how much it sells, because if it's a good product, it'll sell; if it's not a good product and it doesn't work as it's supposed to work, people won't buy it. And I will tell you since we started making LDN, we sell more every month. I believe that the product works, and I think it has been a well-kept secret.
Linda Elsegood: And how do you compound it? Do you do capsules, sublingual liquid, tablets?
David Kazarian: We do mostly capsules. Tablets require a tablet press. Making tablets, if somebody's not paying attention, tablets can be pressed too hard and they won't dissolve. Capsules, on the other hand, will always help. Unique formulations can go into capsules and they work. We have made tablets, but we haven't had much call for tablets. As a matter of fact, I don't even think we have the tablet press anymore.
Linda Elsegood: Do you get to meet your patients? Do you know for which condition your population is using LDN?
David Kazarian: When you asked if I get to meet the patients, I have to tell you an interesting story about my dad. When I got out of pharmacy school, I was working the bench. And a physician called and ordered a vaccine. So my dad put it up, and he told me to take it up to the doctor’s office because he had spoken to that doctor on the phone for 16 years and didn't know what he looked like. So I went up and his receptionist was very kind, let me walk into his office and shake his hand. You reminded me of that.
And because we ship all over the United States and the fact that we are licensed in all 50 States and the district of Columbia, most of our things are shipped. So do I speak to the patients? We do speak to our patients, but I mostly don't meet them face to face. Sometimes I'll go to a meeting and somebody will come over and they'll say they want to shake my hand and say they’ve known our company for years and they’d like to meet me. But most of the time we speak over the phone. I'll tell you a great majority of our patients use LDN for Lyme disease.
Linda Elsegood: I wondered when you mentioned Dr. Richard Horowitz. He took part in our Lyme disease documentary, so I did wonder if Lyme disease was a big part of your pharmacy.
David Kazarian: When we started, that was our only business, our total focus. It was 100% of our patients. Now it's probably 20 to 25% of what we do. But we still do have a large Lyme disease population, and it's sad because these folks get abused by the system. I've seen many cases where these patients had Lyme disease for years and were never diagnosed, and they were told that they had imaginary pain.
As a matter of fact, early on in my career of treating patients with Lyme, I met a psychiatrist that was ordering antibiotics, and I went to his office and on the wall were these degrees in psychiatry, and I'm wondering why a psychiatrist is ordering antibiotics? He told me that he got many referrals for patients that physicians thought were nuts, so he examined them and thought there's something organic going on, and he treated them with antibiotics and they improved; and his practice moved from psychiatry to Lyme disease, which was very interesting. People were diagnosed as having a mental disorder, when in fact they were infected with bacteria. Well, I'm sure there are some people who have mental issues who do present with maybe Lyme-type symptoms. But there are a number of people who contact me who find it difficult to get off the sofa, that they have difficulty in thinking they have lots of pain, et cetera, et cetera. And then to be told on top of feeling like that, that it's imaginary. You know, you're just depressed.
Linda Elsegood: It must be absolutely soul-destroying when nobody believes you.
David Kazarian: You have no idea. I've heard this story so many times I could regurgitate it by memory. People go for years, they're told their pains are imaginary.
David Kazarian: Then their insurance companies refuse to pay, and that's another thing we did. We started this pharmacy because I was involved with another company where I had a partner who enjoyed making money. Uh, I worry about the patient more than making money and some of her practices I didn't agree with, so I said we can't be partners anymore, and I moved to Florida and started this company. I tried to sell products that were used for Lyme disease as cheap as I could because these people broke my heart. They pay for insurance and insurance says, no, we've treated you for 30 days, you don't need any more treatment. So they've got to put their hand in their pocket and pay for these drugs themselves. So we tried to keep our prices as low as possible, and that was the genesis of Infuserve America. That's why the company really started. I felt bad that I was a part of a company that may have charged patients a lot of money who were hurting, and I wanted to repent for my sins, and that's why I started this company. The staff meets once a month, and at least quarterly I remind people why we're here. I tell them we're not here to make a profit, although I'd like to make a profit. We're here for one reason, and that's to treat the patients we serve.
A lady called because she had a vitamin mixture and I got a call from my case management office. They told me she dropped the bag of IV solution and broke it. It was her fault. It slipped and broke and she needed to order it. It was $165 for that bag of a vitamin mixture that she destroyed, and she had asked if we could ship it to her without charging her for shipping because a FedEx refrigerated box is expensive. I told my person to tell her we'll just give it to her, no charge. Because my heart breaks for these folks there. I don't care. And we've got some wealthy people that are customers of ours, but how many months of paying hundreds of dollars can you sustain? I don't care how much you've got, that hurts. And there are some people who are on Medicaid and they can't get the drugs on Medicaid, so their families are helping them so that they can get the drug. That breaks my heart when these folks have to pay a lot of money for medication. So we've tried to keep our prices low.
But the other thing that's happened, the regulatory environment has changed a great deal since I started the company. Many things have happened where regulations have actually increased prices of drugs. 'm often amused when people come out, senators and our president and Congresspeople, come out and say we've got to find a way to get prices lower. And when I hear that, I scream at the television or radio for them to look in the mirror, that they are the reason prices are so high is because their regulations have created so many problems for us.
I'll give you one example. We are licensed in 50 states and the District of Columbia. So we get a very rigorous inspection by the Florida Board of Pharmacy. In the old days, that's all that was required. The Board would come in, inspect us, we'd send a copy of the inspection report to the other states and they would accept that. Well, now they won't accept that. Now we're inspected by the boards of pharmacy in Florida, California, Texas; the pharmacy compounding board, the accreditation board. We have to send all of these inspections out when we go to get licensed from that particular state. Now those things cost. In California for instance, we have to pay for the airline ticket for that person to come here. We have to pay for their time when they're here, and then they grab some compounded products that we've made and they send it out for testing. All of that costs money, and it happens over and over and over. Somebody said it won't be long before there'll be an inspector in here every month.
All of these inspections and all of these are things that they make you do. You can't use non-sterile gloves; now you have to use sterile gloves. You can't use a smock; you must use a sterile smock; you can't recycle this sterile smock. When it used to be - put it on, go into the cleanroom, come out to lunch, hang up that bunny suit that you're wearing, come back in and put the same bunny suit on. Now it's gotta be new. So in bunny suits alone, we're spending over a thousand dollars a month that we never spent before. Well, this trickles down to the patient - that poor person that's sticking their hand in their pocket and pulling out money to pay for their drugs.
Linda Elsegood: Do you have to be inspected by all 50 states every year or, or is the license longer than 12 months?
David Kazarian: It depends on the state. Some are annual, some are semi-annual. It really depends on the state.
Linda Elsegood: But you would think, wouldn't you, there would be some inspection that all the states agreed on, that these are the boxes that have to be ticked for California, these are the boxes that need to be ticked for Texas, for example, and that must be more or less the same, even if some States wanted to add on some extra things. And they had an independent inspector to make sure that you were completely compliant for all 50 states, and that one piece of paper would suffice.
David Kazarian: Well, it appears to be moving in that direction. There is a group that represents an association that represents all the boards of pharmacy. And that organization inspected us for the state of Texas, and if you use that inspection, that was more money but did exactly what you said. They had little checkboxes for each of the states that would accept their inspection. It wasn't all 50 states. I think it was 12 or 13 maybe that would accept that inspection, but hopefully we're moving in that direction. And of course, there will be some states that I can't imagine will ever accept it. California comes to mind because their regulations are so different. We have to keep two inventories, one for California because their rules are so different.
Linda Elsegood: I mean, cause it would make sense even if you had to pay double for the inspection that you had paid just for one state, if they were doing a thorough one, even if you had to pay double, but then it was able to be used everywhere, it would still be cheaper. It would be less disruptive for you because it must be terrible having all these inspections. You can't continue your normal pattern for your pharmacy when you've got strangers in the building.
David Kazarian: You’re exactly correct. You pull out your key people to be with the inspectors and they ask questions. There are some inspections lasting two days, someone day. Some tell you they're coming. The Pharmacy Compounding Accreditation Board is a longer inspection, but you have to prepare for going through what their criteria are. And it's not so much that you're scrambling to do new things or change the way you do things, but what you're scrambling to do is, getting able to answer a question like - where in your policy manual does it say you do a particular thing. So you want to be able to find it for when the inspector comes in, to tell him it's policy, say, 105.2 where it explains what we do. So the preparation for these things takes a lot of time. And you want to do that before the inspector’s here because if you don't find it and it's there, he'll write down that you're not doing that, that is not in your policy.
And we've had that happen. Several years ago, the Board of Pharmacy in Florida changed their inspection and they found 23 things that were wrong. Of the 23 things, there were two that were actually wrong, both of which had we had addressed. But they waited until the 11th hour to ask us about how we handle an issue, and we're scrambling trying to find the policy that addressed the issue, and they said we didn't have it and they walked off. And that was problematic because now when you send that inspection report to other states, it puts you in jeopardy. So we send a book to every state explaining that the inspector didn't see this policy. We illustrated the policy and the date of the policy, which was long before the inspection was here.
So there's a lot of things that go on for the inspections. And I'm not saying the inspections are bad. We signed up voluntarily for the Pharmacy Compounding Accreditation Board, which is a very rigorous inspection. I wanted to do that to make sure that we did do things even above as we should be doing.
One little example: in all of my clean rooms I have UV lights. UV light kills bacteria, mould, and fungus. Those UV lights go on at 11 PM for 20 minutes, and they go on at 7:00 AM for 20 minutes. to make sure that if any bacteria do get through the system, they get killed. This is not a requirement, but we do it. We had our clean rooms inspected twice a year when the rules were annual. We do fingertip testing and we do a lot of things on a weekly basis that the regulations say you should do every six months. So we've always tried to be ahead of the curve, and as I said, I don't disagree with inspections.
Linda Elsegood: So is your facility huge?
David Kazarian: Is it a really large facility considering we can ship throughout the US. We've got a 32,000 square foot building and we occupy all but 2000 square feet of that. We have one tenant in their building and will use that space when they move out.
Linda Elsegood: Wow, that is really big. So you are a sterile and a nonsterile pharmacy?
David Kazarian: We compound - well actually, there are three things that we do. We compound sterile, we compound non-sterile, we do clinical trials, and we also have a testing lab to test the products that we make, not only for us but for other pharmacies in the United States. They'll send us products that they have mixed and we'll tell them if it's sterile and whether it has endotoxin.
Linda Elsegood: I can remember meeting a gentleman at one of the conferences back in 2009 I think, and he said that he could bring in some LDN into the UK from India at a fraction of the price. So he sent a sample, which I sent off, and it came back it wasn't compliant in any which way, shape, or form. It just was not acceptable. So I told him, thank you very much, but no. And he said, well, can I get them to up the standard and do it again. Well, he insisted and he sent this second sample - and as you know, testing samples isn't cheap - and it was slightly better, but it still didn't reach any standards. So he had the cheek to ask if he could do it for the third time? And it was like, no, because the quality had not been good enough, even on the first batch; and maybe one batch might be okay, but then from then on, every batch would need to be tested to make sure that they hadn't slipped.
David Kazarian: Well, that's something. There are a couple of components of testing. First is you test the product that you're buying. There is this other product that we use, glutathione. There was a shortage and we used a company that we had never used. We tested it and found a high level of endotoxin in the product, so we wouldn't use it. We just told our patients we couldn't get it. We didn't want to use this product. That was a couple of years ago, and the FDA just came down and said compounding pharmacists should not use this company's product. We never did.
So you've got to test the raw material to make sure the raw material is good. Then once you've compounded it, you've got to test the end product to see if the end product is what you say it is, the right weight, the right strength; and with sterile products you have to test the sterility of every batch you make; and the product potency. You test once and as long as you make it with the same product, you test that potency only annually. Now with LDN, it's a non-sterile product. So you check the powder for bioburden to make sure it's not contaminated, and then you check the product. We check the product once to make sure that it's what it says it is, and then you can compound it. Bioburden testing is done every time you get a large batch of raw chemicals. The potency testing, we do on an annual basis.
Linda Elsegood: For the people that are listening, who might be considering buying off the internet - I'm always saying that if you buy something that has bypassed any testing, it can be anything. The MHR, which is the medicines regulatory body here in the UK, says that of drugs that have been imported into the UK, that they have seized, that 85% are counterfeit. And some of them are just a placebo, but some of them are harmful. So I mean, you are inspected, you test all your products. So when people have their prescriptions filled with you, they know that they are getting a very good quality product.
David Kazarian: Well, you have to do testing because that story I told you about the product that had endotoxin came from a reasonably reputable firm. The company is well known in compounding circles. They have a lot of products. They sell some of the products we use. So yeah, that's why you've gotta be very careful. We are getting pushed by the FDA more and more to be like a manufacturer. And a lot of the things that we're doing is what a manufacturer would have to do.
When we started compounding a lot of things, I went to a friend of mine who has a pharmacy manufacturing firm right down the street, and I asked him about FDA visits and a lot of things, and we watched what they did. And they said when they get raw powder in, they have to test the square root of the powder plus one, of what they got. So if they got four barrels of morphine powder, they'd have to test the square root, which is two, plus one. So they'd test three of them. One barrel wouldn't be tested because if it all was the same lot number, you're testing enough to be able to determine that everything there is safe. We don't get so many things that we have to do that, but we do test our powders when they come in, for bioburden, to make sure that they're okay. And we only buy it from firms that we trust and have faith in the company.
Linda Elsegood: I'm going to have to say, David, we’ve actually overrun. I'm going to have to end it there, but we will another day interview some of your pharmacists and find out from their point of view what they do.
David Kazarian: I would welcome that.
Linda Elsegood: Well, thank you very much for being an amazing guest and enlightening us in the world of compounding.
David Kazarian: You're welcome very much, and I look forward to seeing you at one of your meetings.
Linda Elsegood: Well, perhaps we can get you to come to Portland the 7th to 9th of June, the LDN 2019 conference.
David Kazarian: Actually, I won't be there, but one of my pharmacists will. I'll be in China.
Linda Elsegood: Ah, okay. Well, again, thank you very much for being with us.
This show is sponsored by Infuserve America, an independently owned speciality compounding and infusion pharmacy serving patients in all 50 states since 1994; PCAB accredited and NCPA inspected. A+ Rated by the Better Business Bureau. They have a history of excellent customer service. Visit infuserveamerica.com.
Any questions or comments you may have, please Contact Us at https://ldnresearchtrust.org/contact_us. I look forward to hearing from you. Thank you for joining us today. We really appreciated your company. Until next time, stay safe and keep well.