CMA CELLULAR EDICINEASSOCIATION
Vol. I January 2018
A Newsletter of the Cellular Medicine Association
Improve Healing and Profits with Cellular Medicine
How You Can Participate (And How You’re Already Participat ing)
I n early 2010, a salesperson called on me, John Deeds, and showed me a brochure about a centrifuge approved by the FDA to prepare PRP. He said, “Use PRP like Juvéderm. You get new volume and new blood flow, and there’s never been a serious side effect.” Now, eight years later, the members of the Cellular Medicine Association (CMA) continue to look for those “better places” as well as to think about better ways to prepare and inject the PRP. Since you’re a member of the CMA (by way of your participation in one or more of our provider groups — Vampire Facelift or Facial, Vampire Breast Lift, Vampire Wing Lift, P-Shot, or O-Shot), I thought that if I showed you the research we’ve completed and what we hope to finish, you may see how our organization is changing medicine and how you can help.
• The P-Shot procedure for Peyronie’s disease • The P-Shot procedure for growth of the penis • The O-Shot procedure both for female sexual dysfunction and for urinary incontinence+
We Could Use Your Help Filling the Following IRB-Approved Studies
• Double-blind placebo-controlled study of the O-Shot procedure for orgasmic dysfunction.+ We can use some help filling this study. • Double-blind placebo-controlled study of the O-Shot procedure for lichen sclerosus You can find the details of both of these studies at the following web page: CellularMedicineAssociation.org/ research. Also, we are surveying our patients prospectively. With around 2,000 members total in our groups, if even half of us put five people in the surveys, we’d then have enough data to make strong predictions to design the next IRB- approved studies. This data can be gathered from your patients by text messaging (so the spam filters don’t grab the emails), with your patient’s consent, of course. The text message provides a link that goes to a HIPPA-compliant encrypted double password-protected website. So, the data is not stored on my server or yours. And to play it triple safe, the survey does not ask for the patient’s name (but it does ask date of service, birthday, and the provider’s name, so you could find out who the person is if something interesting or worrisome is reported). It took me a couple of months of programming to tie our membership site to the engine that sends the text and to the private server that administers the survey. We survey women who receive the O-Shot with FSD-R and with open questions. We survey the men with the 25-point erectile function scale and with open questions. Survey Data
Something About Which You Can Be Proud
Because PRP is not a drug and you can’t patent it, no pharmaceutical company will step in and finance our research, so we’ve spent HUNDREDS of thousands of dollars — all financed by the members of our provider groups with the monthly membership fees. I think you can be very proud of our contribution to medicine.
As a reward for putting five people in the surveys, I will put an icon by your name on the provider directory identifying you as a “Center of Excellence.” This will increase the number of phone calls to your office. If you want your data to present at a meeting, to see how your people are doing, or if you think you’ve put five people in and don’t see the icon by your name (on oshot. info/members/directory), please call 1-888-920-5311 or contact Support@CellularMedicineAssociation.org.
Research Published So Far
• Links to all of the following studies to which we’ve contributed can be found here: Cellu- larMedicineAssociation.org/research. • The O-Shot procedure for female sexual dysfunction+ • The O-Shot procedure for lichen sclerosus (symptoms and dermatopathology improved)+ • The O-Shot procedure to improve the results of surgery for the phimosis of the clitoral hood seen with lichen sclerosus+ • The O-Shot procedure for lichen sclerosus (symptoms and dermatopathology improved)+
Watch a video that shows you how to put people into our surveys: CellularMedicineAssociation.org/surveys.
(Studies marked with a “+” were funded by the CMA.)
O f the female sexual dysfunctions, dyspareunia will most disturb a woman’s relationships. A woman can accommodate a decreased libido and anorgasmia, but she will often completely avoid any contact when she suffers from dyspareunia. But, when it comes to treating the various female sexual dysfunctions, anorgasmia offers the biggest challenge to cure. Testosterone helps some, the O-Shot helps some, therapy helps some — still, many women see no orgasm even with our best efforts. And, unlike with dyspareunia, where we have very specific algorithms, anorgasmia treatments seem less well-mapped. So, I thought we may benefit from having some of the teachers in our group talk about their ideas about orgasm and treating anorgasmia. The following excerpt from an interview with Dr. Michael Goodman (we will do an interview with a different physician each month) may be of help. You’ll find the whole interview on the following webpage (as a video/audio): oshot. info/goodman. Charles Runels: Dr. Goodman recently released a textbook that he edited about female genital plastic and cosmetic surgery. He’s one of the true pioneers who blazed the trail for the people who are doing it now, and I consider him to actually be one of the premiere physicians living today. He paved the way with some of his research for what's now widely practiced worldwide when it comes to cosmetic surgery in the female genitalia, and not just because it looks better, but because of how it actually contributes to a woman's functioning. I asked him to talk about the procedures he does, surgery versus the various devices, vs., of course, the O-Shot, how he uses those various modalities, combines them, and how he thinks about those modalities affecting a woman's sexual function. Of course, that has extremely far-reaching effects on her whole personality and her life, her family, and her
career; and all that research has been done. But specifically, I wanted to know how he combines these different modalities.
I review for some medical journals. I just reviewed an article for the Journal of Bioethical Investigation, one of the top bioethics journals. This article was done by a bioethicist, who is not a surgeon and who has no interest in female plastic and cosmetic vaginal surgery, and it looked into the area of adolescents and whether they should have labiaplasties.
Michael Goodman: Sexual dysfunction, or decreased sexual sensation, may be one of the first symptoms that women
I've had the opportunity to operate on a modest number of adolescents. We're talking about young women between the ages of 14 and 18, and adolescents really come in with the largest labia of all the women that I've operated on. They come in with their moms, who couldn't believe what they were talking about at first, but then they understand. Basically, what this article talks about is the feeling that other people have: "Well, if it's a big functional problem and it really causes infections and so forth, then maybe you should operate on it, but if it's a psychological problem, then you shouldn't." This group of bioethicists begged very strongly to differ, saying that we do a lot of procedures for people because of significant psychological situations, psychodynamic situations, and self- esteem situations. They felt that there's really no difference between functional and self- esteem or psychological reasons. Certainly, that is borne out in the literature. We did a study seven or eight years ago. It still is the largest study in the literature, and it covers over 250 women and 345 procedures, of which about 150 were labiaplasties.
suffer from in this progression from laxity to prolapse. There's ample evidence in the literature that prolapse and vaginal relaxation can create sexual dysfunction, and that repair may reverse these changes in many women. We're dealing with these early changes. With that introduction, what are the mechanics that we're talking about?
To see/hear the rest of this interview, go to the following webpage: OShot.info/goodman.
to understand this definition better, you can examine the new policies published by the FDA in November 2017. You’ll find them (along with an explanatory video) on the following website: cellularmedicineassociation. org/2017/11/22/fda-hair-scars/
“Is the Vampire Facelift or the O-Shot FDA-approved?” The FDA controls food, drugs, and devices. The FDA does not control your body fluids, your hair, your urine, or your saliva — those belong to you. Your fingers, your toes, and your skin also belong to you to do with as you will. However, if you do enough to the material (blood, urine, or fat), then it quits being your body and becomes a drug. Then, the FDA does have jurisdiction. For example, do enough to horse urine and it becomes Premarin. Do enough to fat and it becomes stem cells (both of which the FDA consider to be a drug). But, neither the urine nor the fat becomes a drug until you do things to turn them into drugs. To stay a body part or fluid and to not become a drug, the material must only undergo “minimal manipulation.” But, even though the FDA does not claim that PRP is a drug, the FDA does govern the devices used to prepare the PRP (as it should).
So, here’s the analogy I use with patients: If you want suture material to close a wound, you can’t just buy thread at Walmart. Instead, you must use sutures approved by the FDA for use in the human body. But when you hold that FDA-approved device (suture) in your hand, you (not the FDA) now determine how the wound will be sutured, because The FDA does not and never will govern medical procedures — not hysterectomies, not cholecystectomies, not O-Shots. The doctor supervises procedures with no input at all from the FDA. The only exception is which devices may be used.
In conclusion, the FDA does not govern medical procedures, and they do not govern body parts and body fluids.
So, how does the FDA delineate what they will govern? At what point does too much processing become more than “minimal manipulation” and turn a body tissue into a drug? To remain ungoverned by the FDA, the material must only undergo “minimal manipulation.” If you want
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CMA Research Overview
The Mystery of Orgasm
Is the O-Shot FDA-Approved?
When a Patient Isn’t Pleased With Their Results
A s far as I know, anyone who was unhappy with a procedure that I did (going all the way back to 2003 when I first went to an all-cash practice) was refunded every penny that they gave me. That feels good to me. It’s better than if I still had their money. People get nervous when I say that, but most of your patients are not dishonest. Yeah, people steal fromme, but if I based my whole life on keeping people from stealing fromme, it would be a limited life. If most people were dishonest, Walmart would be out of business in one week, because ever since opening they've widely advertised their 100 percent money-back guarantee for anything. Even when I did weight loss (and I would have three weight loss classes going simultaneously), I enforced a guarantee that you could have every penny back—all your doctor fees— up to 365 days from starting the program. And once or twice a year, someone would want all their money back. But, having that guarantee made me more careful about who I accepted and perhaps made me more attentive and better at what I did. Here’s the surprise side of a money-back policy: Being ethical, you will sometimes hesitate to take care of people if you’re afraid it won’t work. But, if you know in your heart of hearts that you’re not going to keep their money if it doesn’t work and
your cost of goods is relatively small compared to the patient fee (so that you’re going to make your money back on the next procedure even if people want their money back), then you are actually more willing to take care of the harder cases. You don’t worry about stealing from people if you’ve already made up your mind to return the money if they don’t love what you did. And, giving the money back still keeps you profitable on the next procedure if your cost of goods is less than half the price to the patient. But it’s best if it’s five times your cost of goods or more. Just make sure you don’t care for exclusively hard cases. Mix it up so that you mostly take care of the easy cases that you know will be successful. And, occasionally, take care of people for free (as we all do) or take care of the hard cases when you know your likelihood of success is less than 50 percent (just make sure you have enoughmarkup on your cost of goods that you’ll still be profitable on the next procedure). Then, you feel better about what you’re doing, you get better results, and you will take some hard cases and surprise yourself by being better than you think. You’ll find a detailed discussion of this on the video here: http://cellularmedicineassociation.org/2017/11/22/fda- hair-scars/
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