JCPM 2018March14.FDA.Altar™.AllergicGranulomatous.Profit.VolumaVsJuvederm.CaCl

Topics Discussed Include the Following...

-FDA Talks about PRP & Stem Cells in the NEJM "Balancing Safety & Innovation for Cell-Based Regenerative Medicine.
-Altar™. Vampire Skin Therapy™.- Protocol for Vampire Facial™ Combination.-How it Works
-Facial Allergic Granulomatous Reaction and Systemic Hypersensitivity Associated With Microneedle Therapy for Skin Rejuvenation
-Installed Base Profit Model & How the Pharmacist Makes Off with the Booty
-Can you use Voluma® instead of Juvederm® when doing the Vampire Facelift® procedure?
-Calcium Chloride Sources and Mixing

Video/Recording of CMA Journal Club, Pearl Exchange, & Marketing Tips

Transcript
FDA--PRP & Stem Cell Guideline Summary

Charles Runels: So, if you look ... So, we're talking offshore havens, polar extremes, medicines wild west, unlicensed stem cell clinics ... When I saw this article come out, this is when I started becoming extremely careful, or ... I'd already been careful, but more careful in warning those in our group to be careful [00:00:30] about the words used. These articles, by the way, are often written, including the one we'll cover today, by people who work for the FDA, basically telling you how they think, how to play by the rules, and what's not playing by the rules. In other words, "We're coming after you if you don't play sweet."

Balancing Safety and Innovation for Cell-Based Regenerative Medicine (click)<--

So, this one is extremely important. Let's go ahead and open it up and get to it because [00:01:00] it lays down the rules, and if you want to go deeper, it tells you where to find it. So, both of these guys ... By the way, if you scroll to the bottom, you can see they are from the FDA. So, that's where they're affiliated from. So, this is great. You're getting it straight from the people who are making the rules.

I just want to point out a couple things. Most of you guys know this already and you're looking at it, but those who aren't, [00:01:30] just a few things to notice. If you look down here somewhere in here, they say that the definition of stem cells are obviously ... Depends on who you're speaking with. And they make a big point in here, but they make a big point out of the fact ... I'll just quote it. It says, "Even in the absence of serious, adverse events, the use of therapies that are of unproven efficacy is a disservice to patients in public health. [00:02:00] An increasing number of safe ..." I'm reading from somewhere in here. I don't know where it ... One of these paragraphs. It says, "An increasing number of safe and effective therapies," I'm back to quoting this, "are becoming available on the basis of the findings of well-designed clinical trials."

But then, if you pop above that, it says, "Two explanations [inaudible 00:02:20] should be safe and effective for so many different conditions, and [inaudible 00:02:28], and that they can [00:02:30] differentiate appropriately based on the environment to which they're introduced, but we now know with reasonable certainty," I'm still quoting this, "from the scientific literature that this is not always the case." And if you search through the New England Journal alone, you'll find a few scattered articles where they talk about the wrong tissue growing in the wrong place.

FDA Guidelines About HCT/Ps<--

So, this article is part warning, but thankfully, mostly explanatory about how [00:03:00] to know when you're safe and how to play by the rules. And I'll just go ahead and say, the punchline is down here in the fine print. In this, they give you where the rule books are: four guidance documents, and here's where to find them. Right there. Okay?

So, by the way, this is a free ... You don't even have to be a subscriber to read this article in the New England journal. They make it available to you.

So, two other quick points, and then we'll come off of this. Definitions ... [00:03:30] So, pull this up. Right here. Okay? And all these section numbers and everything ... I'm gonna try to simplify this. I don't claim to be an FDA expert, but I want to make sure I know the rules well enough to play and keep them from knocking on my door. So, section 351, there's two basic things that make ... Where the FDA gets to govern how we talk [00:04:00] about human tissue. Right? They don't have any rights obviously on your hair, your urine. That belongs to you. So, when does it become FDA business?

It becomes business, and this is the paragraph that outlines it for you, when it becomes "a biological product," which is sort of nebulous to me. That's 351. And 361 is "when there may be risk of infectious disease." And so, [00:04:30] then they define this HCTP right here. So, regulatory human cells, tissues, cellular tissue-based products, that's the acronym for that.

So, the fun thing is that they make a big point of telling you in this chart what doesn't even ... In other words, we don't look at it. It's not even on our radar. Human milk is not even ... Because it's not even considered HCTP, [00:05:00] so those two regulations, 351, 361, that have to do with biological products and transmission of infectious disease do not apply to anything on this list.

And the last on the list, whole blood or blood components including platelet-rich plasma. So, if you're looking for something in writing that lets you know the FDA's not going to be knocking on your door when you're using platelet-rich plasma, there it is. The other thing that sometimes comes up, "Well, do I need the [inaudible 00:05:30] [00:05:30] waiver or something that says that I have a laboratory clearance to be able to do this?" You do not because you're not analyzing it, so you do not need that. So, here's your in-writing thing. This comes up sometimes from IRBs who are replying for research. Sometimes the institution review boards are still not sure exactly what has to be done to be able to do this. There it is in writing.

Now, when you get up to this area, this gets divided based [00:06:00] on what you're doing. If it's a biological product, then it has to be approved or regulated, I should say, to make sure it's been manufactured in an acceptable way, but it does not have to be approved like a drug. If you start manipulating it, then it becomes a drug, and they can rough you up about it.

So, it's a really nice article. Most of you guys ... That's all you need [00:06:30] to know or all you want to know, but if you start to do any research or your attorney, or whoever's doing your keeping you out of trouble person in your office, needs to read the definitive article, that's it. And I'm happy to put ... I'll just go ahead ... I'll put a link in the replay of this on the page where this video will sit inside our website. And I think that's all I want to say about it.

Next thing I wanted to talk about that might be helpful [00:07:00] has to do with a really deep dive into what it means to be having stall-based profit model, and how that helps your practice, and how the pharmacies are sort of ... They're walking away with the booty because they've got an interesting set-up which I'll dive into in a minute and tell you better how you can take advantage of it. [00:07:30] But let's ... In a way that helps your patients, and helps you keep the lights turned on, and puts your kids through college ... But let's answer a question quickly, and we'll come back to that.

So, not so many questions this week, which is good because it gives us time to dive deeper into how the profit gets made, and our most profitable members of our group, and what I think is going on in some of the groups that struggle. And I've learned this from being [00:08:00] beaten up, you really understand, as you guys know if you get hit by a left hook, you start to watch for the left hook, so I don't ... Anyway, we'll get to that. Let's answer a question.

Can You Use Voluma® Instead of Juvederm Ultra Plus® When Doing the Vampire Facelift® Procedure?

This is a good one. So, "Have you used Voluma ..." Let's open this up where we can see it better. Here we go. "Have you used Voluma instead of Juvederm Ultra Plus during the Vampire Face Lift, particularly in the cheek region of the procedure? I thought I saw this question, but I can't seem to find it. [00:08:30]

Further, any suggestions for a micro-needling device for the Vampire Facial?" Two very good questions.

Recommended device for the Vampire Facial® procedure

First of all, the device question is simple and easy because as of literally a week or two ago, there's only one device that has become FDA-approved for micro-needling in the way that we're using it for scarring, and not tattoo removal. Now, that doesn't mean you can't have another one out there, but if you want the only, at this present moment, FDA- [00:09:00] approved device, it's the SkinPen. And they don't pay me to say that. No device company gives me one penny. I keep it that way even though lots of pennies are offered to me.

But as of two weeks ago, that's it. And the reason that's important is because they had to prove to the FDA that the blood is not being pulled up into the handle, and is therefore contaminating the device and cross-contaminating, of course, with other patients, which some of the old devices did. Not good. So, [00:09:30] if the FDA was ever going to come in and look at a device, in my opinion, it should be the one that knocks holes in your face and has the possibility of transmitting disease from one patient to the other. Horror of all horrors. So, I'm not pushing hard for that. If you've got one that you trust is not cross-contaminating, go for it, but I'm highly recommending ... If you're ready to buy a new pen, they're the only ones that are FDA-approved at [00:10:00] the present moment. Others may be coming.

Voluma vs. Juvederm Ultra Plus

Now, back to the first part of the question, Voluma versus Juvederm Ultra Plus ... And any of you guys that have done hands-on training with me know that I tend to be more of a minimalist. Even if someone wants to have an exotic look, I like to achieve that with minimal amounts of material, and product, and puncture wounds, and such. And I think when you combine Juvederm Ultra Plus with [00:10:30] PRP, you get the effects of Voluma. I was lucky enough to train with [Mark Bailey 00:10:35] before Juvederm was approved in the US. We only had Restylane, and we started ... This was up in Canada, where I trained with him, and at the time, he was the top [inaudible 00:10:47] at least in North America, maybe the world. I'm not sure.

And we were using Juvederm Ultra Plus, like many of you, the way Voluma is taught now. [00:11:00] Of course, Voluma lasts longer, but I think that Juvederm lasts, at least a similar amount when you're combining the platelet plasma with it. I haven't proven that, but that's what I think. I also feel more comfortable using Juvederm all around the face, in tuning up the mouth and such. So it's just more versatile, but it can definitely be used, many of our people do use it and I really think it's very similar to internists [00:11:30] who has 200, maybe not that, let's say 50 different beta blocker, blood pressure medicines and hypertension use. But only has to become expert with one or two out of each class and the rest just be good with whatever it is you're using.

To expand upon that I don't think the research backs up as well combining plate rich plasma with Ray DS because just the structure of the gel, of the [00:12:00] liquid gel that's in an HA, I think provides a better substrate on which the pluripotency stem cells to migrate and mature verses the calcium hydroxide [inaudible 00:12:11] crystals that are in ADS. Not saying Radius is a bad product, I'm just saying when you're doing this, the fame part face lift where you are creating a sculpture that you have to augment and improved with plate rich plasma. I think using your favorite HA, whatever it is, and combining that with plate rich plasma works. So the answer to that question is, yes, is [00:12:30] the short answer.

Installed Base Profit Model

So let's go back to a little bit about profit, since we don't have as many questions this time. So we covered an update about the research. One question, let's talk about what install based profit is. So, some of you guys may have bought computers where they give you the printer. And course the reason they give you the printer is that now, you have [00:13:00] to buy the ink from them. And that know that they're going to make enough profit on the ink, that they can afford to give you the printer. So that's install base. So you put a base in and then people have to buy something to substitute. Something works with the razor, you buy the razor, that the Gillette razor, that cost you only 15 or 20 Bucks. But the next time you buy about refills it's $40 to get four little razors. [00:13:30] The thing is that people are more sensitive, this is an important point about this, I'm diving deeper than I've ever done with this model even in our hands on classes where we talk about this. But you are very sensitive to price point when you buy that initial thing.

Let's say you're buying printers, it costs more, they all have lots of different options. And so [00:14:00] because of that, you shop around to save $50 on the printer and look at all those options. This is very important, here. This is how people have made fortunes outside the medical world. So you shop like crazy, but now once you have the printer, you don't shop at all because there's one kind of in that fits it. And it's a lower priced item, maybe some of the more frugal people find some way to refill it or get a knock off version on Amazon, [00:14:30] but then it clogs your printer and go back to the brand name. You're just not as sensitive because you've already made the decision for the printer and now you need what fits it. Alright so hold that thought, you have the more sensitive higher priced item that you purchase and now you have a less expensive item that fits the thing you purchased. That's important, it fits the thing you purchased, so it's the thing you want. It's called [00:15:00] installed base. Here's where we get ripped off.

Another quick example is, you don't need another example you guys have got it. I will give you. Another one is you buy the Lamborghini and you have to buy the insurance. Now that one's interesting because two separate people sell it. You've got the Lamborghini guy who is flashy and good looking, or the woman who's good looking and [00:15:30] you buy the fricking car that costs more than a house. At least in some parts of Alabama. Then you gotta have insurance, and the person who sells the insurance to you is not so flashy. But selling insurance on a bunch on Lamborghini's and now he's getting, or she's getting money every month. Not so flashy, the insurance guy maybe he's flashy but he's probably going to have a big streak [00:16:00] of sort of accountant nerd in him and look straight laced and more secure and less flashy because he's selling security on that $150 000 investment. SO you have two people, one sells you the installation installed base, and the other one is you the thing that makes possibly more profit than selling the car, because its recurrent monthly.

Next Workshops with Live Models<---

Now here's doctors have been duped. It's so bad when you think [00:16:30] about this, imagine if you did this. I almost used the F word, because it makes me angry, because it happens every day. What if you sold the Lamborghini but you got paid $130 and then they walked down the street and gave the $150 000 to another person. How would that go? See [00:17:00] that's us. So you're riding and that other person gets to sell the insurance too. You just got to sell, you made 130 with one zero dollars to sell the Lamborghini, but then they go down the street to pick up the Lamborghini. You guys know where I'm going with this right? They go pick up the Lamborghini down the street, and that guy who didn't have anything to do with the sale, makes [00:17:30] the cash. And then gets recurrent payments on the same Lamborghini every month. Right? You know where I'm going?

I'll tell you exactly how it's happening. You go drive about a mile from here and a one quarter on a four lane highway, you'll see four pharmacies. All of those buildings much bigger than the local family practitioner, who's getting paid $130 to figure out what medicines grandmother needs with [00:18:00] three organs failing. And she goes down there and you better believe refilling those prescriptions, is like the Lamborghini literally, in price. And the pharmacies getting the money. So you have a big B, Walgreens, Win Dixie Pharmacy and Walmart Pharmacy literally all within a stone's throw. So that's installed base only we don't get it. Now I worked around that, in Alabama you can have a pharmacy and for awhile I did. And [00:18:30] you better believe, it put me right in cross hairs. So even though it's so called legal, you try doing it and if you think your colleagues are jealous of their turf, you better believe the pharmacies are jealous of your turf. Even though they can go do fricking free shots all day long, and put their toe on your turf. Control the money, you control power. And so when it's time to make the the laws. [00:19:00] Now I'm getting more off on the politics, but you guys know the physicians get their pay cut more than the pharmacies do. Okay. Anyway.

That's installed base, you get it? Now to understand it, and you understood it before, but now you see sort of how I'm diving into it. How do you do that with these procedures? You want a base and they're going to shop and kick the tires and "Do I want a Vampire facelift or I just need to get a facial [00:19:30] down the street from the whatever." And so they're price sensitive, "Do I get this light therapy or what do I get?" That's equivalent, of course, to shopping for the printer. The lost opportunity for us has been that once they do the thing, some of you guys are selling lots of aftercare products or the residuals, like the Lamborghini insurance. You're already doing that and you're making something match. [00:20:00] I'm not saying you quit doing that, but for eight years I have wanted a residual that match the base. So, we finally have it. And some of you guys already know it. You've seen it on my emails, but we have vampire skin therapy now, that is the after care products that fits our procedures. The first one we're rolling out, is altar, A-L-T-A-R. Play [00:20:30] on words. So this would be the aftercare product for the vampire facial.

 

I have a word of warning, though. One of our providers, I think it was Sylvia, sent me a picture where someone had some sort of something put on their face and then micro-needled and had a reaction [Facial Allergic Granulomatous Reaction and Systemic Hypersensitivity Associated With Microneedle Therapy]. I haven't seen the person, so I wasn't sure if it was urticaria [or something else].

 

 

 

 

 

There are two cases we've had in our group and there's a couple [00:21:00] of mentions in the research about urticaria happening from your PRP. We're not sure why that happens, but you just Medrol Dose pack, it goes away.

We've had it in one one face and one [inaudible 00:21:10] in the inner. But this look like it could be actually some sort of granulomatous thing and there's an article in the research showing that, that happens. And it's treated with antibiotics & steroids. And it's because your micro-needling actual particles into the face.

So, the protocol [00:21:30] for this would be doing your micro-needling. If you have an HA that you're using, that's fine micro-needling that, but nothing particulate, including this cream. Even though I think you could probably micro-needle it in on the foot side, I do not recommend it. We have not checked that out. The research that goes with this, if you go to our, let me see if he's on the call. He [00:22:00] didn't make it today, but we had him, Dr Glassman. I'll get him on one of the future calls. He brought these to me, and we have a ... Thanks to our collaboration with Dr. Glassman, we have the exclusive on the patent to the material that's an extract that has been proven in clinical trials, and a $2 million NIH study looking at wound healing to decrease the numbers of senescent cells and increase [inaudible 00:22:27] activity and such.

So if [00:22:30] you want to see the details on that, here's some of the research. I actually found some before and after pictures from the research which I'll post on the recording here.

 

 

 

This is the guy who invented it. He's got a pedigree that can with anybody, multiple research studies, and we have the exclusive on this. So now you have many blades that match the razor and you can offer, alter, a Vampire Skincare [00:23:00] therapy as an aftercare product after the facial or the face lift.

So the protocol would be you usual way of cleansing the skin, I vote for hydrochlorous, which you get on Amazon. It's very cheap, and I think it's easier to use, it doesn't irritate the eyes.

Hydrochlorous Acid

Vampire Facial® Protocol that Includes Altar™

Whatever you do to cleanse the skin. You apply your PRP micro ... And the plus, minus HA micro needle it in, and then your PRP after that, and then alter [00:23:30] on top of that, and then they use that, could use it, perpetually. If they're prone to acne, they should not, cause it has ... We're not sure what it does with acne, but if you have oily skin you'll find it has a heavier feel to it. The before and after pictures on people have who have been radiated, or have dry, cracky skin from either age or exposure to the cold and heat and such, or even some psoriasis and [00:24:00] with diabetic wounds, are absolutely amazing. So, anyway, that's the protocol and this is now install based.

1. Cleanse the skin (after topical anesthetic cream).
2. Apply PRP
3. Microneedle
4. Apply PRP
5. Apply Altar™ twice a day for 3 weeks then every night perpetually (suggested retail is $147 per 1.7 ounces).

Where to buy Altar™ (click)<--

 

 

 

 

 

 

We'll be making install based products for the O Shot, for hair, for other things. So stay tuned, we'll probably have a peptide cream and the, my ... The reason it's taken me eight years is because, in my opinion, nothing really was new under the sun that I thought was up to par. [00:24:30] I've owned the name Vampire Skin Therapy for at least five years, and ... But I just didn't think anything was up to par.

So to buy this, I'm going to put a link in here. The suggested retail price, which you know what you do in your privacy, if you want to give it to your mother-in-law or sell it occasionally to a special person for less, or give it as a bonus, that's fine. But that should be the one off, and the only advertised retail price should be $147 [00:25:00] or more. That's for the 1.7 ounces, and that gives you over doubling of your ... You'll see, you could do the math on it. But it gives you more profit than you get on any of your other products. Not saying throw everything else out, but there you have it. That's our new thing and ...

Oh, last thing, we have some people with pretty nice audiences in the million range of followers. A couple of celebrities that are going to [00:25:30] be talking about this in the next week or two. We've got two press ... Possible press publishing that will happen. We're sending samples to a couple of fairly popular magazines, print and online. So this is not ... It will not ship until April the 12th. So if you order it, they won't bill your credit card until they ship it. It does go throughout Europe if you're listening to this, and you can get ... [00:26:00] If you're not in Afghanistan or something where you're shooting at people, we can get it to you, and I think that's about it.

Let's do another question or two and then we'll shut it down.

Can you do the O-Shot® on  someone with ITP?

I get this a lot. I have a patient with ITP. Her platelet count runs in the 70 to 90,000 and she's interested in having the O Shot. You know, here's the thing, we're still obviously in the early stages of proving how things [00:26:30] work, and I honestly don't know. My feeling is that you have nothing to lose by trying with this woman, and a lot to gain.

My warning is this, if you're starting out, stick to the easy, easier cases. Nothing is 100%, because I highly recommend that if someone is not happy with what you do, you give [00:27:00] them every penny that they've paid to you back. And if you're going to do that, and you're treating only the difficult cases that we're not sure how things are going to go, and you're giving people their money back, you'll be frustrated. Especially if you haven't been doing it long enough to see it's benefits. You don't even know with confidence that it's helpful.

So stick to the easy cases with the O Shot, which is the younger to ... Younger as far as structure goes. Women [00:27:30] who have ... Younger to mean is, you know you could be 70, but you usually it's the 35 to 55 year old woman who her cervix is not falling out of her vagina, and she's got incontinence. She can have an orgasm, but it's not what it used to be. She's got dyspareunia, because we do well with that for some reason, but it's not a surgical cause of dyspareunia, and Lichen Sclerosus. Those are easy wins [00:28:00] for us, and course they're difficult wins for other people so that's why people are going to like our stuff.

Something like this, I would treat it, and I often do treat it just because I want to help people. What you guys do, I don't see a downside for it. But just if you're new to the groove, I would stay away from the harder cases. For example, we've also had some anecdotal reports treacle incontinence women when they've had the big tearing. Things that can go in the grade [00:28:30] four or five, I think, when they a postpartum tear. And we have ... I know of two very definite, excuse me, three very definite anecdotal reports of that improving after one, in one case three different injections to help that. So anyway, stick to the easy cases.

Calcium Chloride Sources and Techniques

So Terry says, "On the calcium chloride question." And there's a video out there where I show to transfer it from the ampules in your crash cart in to a 10 CC syringe. Can you just leave it in the glass ampule instead of transferring it? You could, I think it's just obviously I think a cut testament to how careful our FDA is when it's difficult [00:29:30] to find people to serve you salt water, which is of course what calcium chloride is.

Source of Calcium Chloride <--

But I usually transfer it, of course, to a sterile syringe, cap it, and then I just don't let anything that's not sterile touch that and use it as a multi-dose vial. But I can usually get vials from McGuff and many of the people in the group are telling me they also will get it, so go to our supply list and check out McGuff if you're in the US. Those outside the US probably [00:30:00] don't have as much trouble coming up with that.

Let's see if ... I don't see any other questions, and I want to thank you for being here and posting your comments. It would help, you know I don't want to be the sole source, I want to hopefully do a lot with helping you guys talk to each other, so anything that gets posted here, gets discussed, if not before at least during our conversations. I'll post links to everything we talked about, and you guys have a wonderful week. Thank you very much.

Charles Runels, MD
Charles Runels, MD (photo)

Cellular Medicine Association
1-888-920-5311

Order Altar™ at Wholesale Prices (click)<--

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