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CMA CELLULAR EDICINEASSOCIATION
Vol. III APR 2018
A Newsletter of the Cellular Medicine Association
Cell Doctor News Improve Healing and Profits With Cellular Medicine
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Why when someone says, “The O-Shot® is not FDA approved,” what they are really saying is “I do not know what the FDA does.”
WHICH IS NO MORE REGULATED THAN THEIR HAIR OR URINE. PRP obtained from a 510(k)-cleared device is unregulated because it's just blood. Basically, you've isolated the platelets, but you've done very little to them. On the other hand, when it comes to stem cells, the FDA says that any procedure in which human cells are manipulated is subject to clinical oversight. More than “minimally manipulated” IS the exact phrase. If they're more than minimally manipulated, then it must be treated like a drug. Here's the approach of the authors of this article: see references at VampireFacelift. com/ prp-fda . They discuss it with the patient. They review the research. They have a consent form that people sign in which they promise them no guarantee, that their options include not treating the condition at all, and that they encourage the person to talk to their primary care physician, which I always do. I'll even make phone calls to the primary care physician so other physicians are involved in the conversation. Then, in the days following the injection, you follow up with phone calls and records. This is what we will be doing with some of the surveys that'll be sent out so we can collectively pool our data. These authors say, "To date, we've not observed any serious adverse events or unanticipated effects that fall outside the scope of what you would expect from an injection." For a detailed video about the FDA stance on PRP and stem cells — with multiple references
Charles Runels: When it comes to the Vampire Facelift®, the O-Shot®, and the Priapus Shot® and the FDA, you will want to think about exactly what the FDA regulates. Many pathways can be used to bring a drug or a medical device to market. Most of the FDA- approved PRP-preparation kits came through a 510(k), where a device is given clearance because it's equivalent to a previous device, and these devices were approved to prepare platelet-rich plasma for use in bone, for mixing with bone transplants, and they've been shown to help. There are numerous PRP preparation systems on the market with FDA clearance. Nearly all of them are cleared for producing platelet-rich plasma mixed with bone graft materials to enhance the take of that. I am grateful that the FDA does regulate both of the following: (1) the device is safe/sterile and (2) the device actually isolates platelets. A PRP system with clearance indicates a device is safe in that it does not create a preparation that's hazardous or dangerous, which could happen if you used a lab kit that's made to isolate platelets for analysis (not for re-injection back into the body), because the level of sterilization is different. So, the FDA-approved devices that we use prepare the plasma in a way that it is safe for the patient. The second thing the FDA examines concerning the PRP kits is the capability to actually isolate the platelets from the whole blood. Though the two above-listed attributes should be required by the FDA — AND THIS IS KEY — when it comes to our procedures, the FDA does not regulate the practice of medicine — the FDA does not regulate procedures.
The FDA does not regulate cholecystectomies, hysterectomies, O-Shot®, or Vampire
Facelift® procedures. Never, ever, AMEN.
Even when it comes to drugs, clinicians are free to use a product off-label. We do this VERY FREQUENTLY because we know that, if there is research to support the idea, then we do the research and the FDA lets the doctor decide. Over half the drugs that are prescribed by oncologists are off-label. In some studies, 20–30 percent of the prescriptions written by a family practitioner are off-label. But when you use PRP, you’re NOT even using it off-label — THERE IS NO LABEL — IT’S THE PERSON’S OWN BLOOD,
written by the FDA — go to VampireFacelift.com/prp-fda .
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The Mystery of Orgasm and HowWe Can Help Part 3 of a 7-Part Series G eorge presented to my clinical practice at age 40, when he decided to settle down. He was marrying a beautiful and accomplished woman in a few months. There was Loneliness has been shown to increase vascular resistance, elevate blood pressure, and lead to an early death. You're more likely to die from loneliness than you are from obesity or excessive alcohol consumption. When I educate women, I say, “If you're not having sex with your husband, someone else may.” They get upset, and they say that I'm blaming women for men's bad behavior when in
home parent, that quick swipe right can lead to a passionate, online love affair. From texting to sexting to secret phone conversations, the more two people communicate online, the more likely an in-person encounter is to occur — but you can always blame your genes. The gene DN4N has been isolated in cheaters, and the sexless marriage is just the environment to turn on that gene. It's based on a system of pleasure and reward. The stakes are high, the rewards substantial. It is the perfect cocktail to turn that love drug PEA back on, and the cycle begins again. Historically, marriage was not based on mutual love but was rather an institution to acquire things in law, like property and physical labor. At the turn of the 20th century, in America, egalitarian ideals and the emerging Hollywood movie industry burdened marriages with the promise of romantic love forever. Now we're living forever. Fantastic! Congratulations, you get to have sex with the same person for the rest of your life. The second most common question that I hear from patients is, "When does sex end?" Well, a 44-year-old asked me, "When does sex end, Maureen, 65?" I answered him this way: “A 22-year-old asked me, ‘When does sex end, Maureen, 35?’” Everybody's older until you get there. I'm here to tell you that sex never ends. If you're healthy, you can have a great sex life well into your 80s and 90s. Sex is good for you, sex is healthy, yet sex is shrouded in shame. In the ancient aristocracies, the wealthy men had courtesans for pleasure and concubines for quick sex. The way we're going, computers will be our concubines, internet pornography our mistress of the day. Technology is replacing human connection at high speed. So how do you rev up the sexless marriage? To see the full video, go to the following website: Oshot.com/sexless .
only one problem: George was gay. George could not bear to tell his family that he was gay because he felt it would have shamed the entire family. I said, “George, you're going to end up in a sexless marriage!” He said, “Tell me something I don't know!” George told me his plan was this: “Well, when my parents die, I'm then going to divorce this woman and I'm going to marry the man that I love.” And I said, “George, you are not thinking straight.” Sex is the barometer of the state of affairs in a marriage. People who live in sexless marriages report feeling frustrated, unloved, undesirable, unattractive, and worst of all, lonely.
actuality I'm doing a community service. You see, men in sexless marriages cheat to remain in that marriage in general. Women cheat to leave a sexless marriage. Women cheat too. Nobody ever thinks we do, but we're just sneakier about it. We just don't get caught or socialize very differently — this is one thing we have on you guys. Women cheat with other men and women cheat with other women. Technology has made cheating accessible for everybody. From the politician to the stay-at-
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“Vaginal Reconstruction” vs. “Vaginal Rejuvenation”
the appearance of the vaginal opening (the type of perineoplasty often performed by plastic surgeons.) In the hands of a properly trained cosmetic gynecological or urogynecological surgeon, a PP involves a meticulous removal of all of the scar tissue from an episiotomy or lacerations from childbirth, bringing together, with strategically placed strong sutures, the stretched muscles of the outermost portion of the vagina, of the vaginal opening, and of the “perineal body,” the area of the opening and vulvar vestibule, along with a meticulous aesthetic reconstruction of the appearance of the vaginal opening including the base of the labia, hymenal ring, and vulvar vestibule. Laser or RF “wands” do none of this. –Michael Goodman, MD, FACOG If you wish to be listed for FREE as a provider on VaginalReconstruction.com , you may do so as long as you are a qualified surgeon doing these procedures AND a member in good standing as part of the O-Shot® provider group. Send an email letting us know that you’d like to be listed for free to DrRunels@Runels.com.
The following was submitted by Dr. Michael Goodman. You can find the remainder of the following article at VaginalReconstruction.com . “Noninvasive” (nonsurgical) Vaginal Rejuvenation (“VRJ”) is not vaginal reconstruction. It is, literally, “vaginal skin resurfacing.” These procedures may be performed by practitioners not trained or experienced in true vaginal floor surgical reconstruction so long as they understand how to place the “wand” in the vagina, utilize proper power settings, and step on a foot switch. Both radiofrequency (RF) and laser treatments require a total of three visits a month apart for full effect. These modalities act to stimulate the generative layer of vaginal skin, the “dermis,” to regenerate more collagen and elastin “connective tissue” for modestly greater “springiness” of vaginal skin for a limited length of time … (requiring ~ 3 visits annually) … A true vaginal reconstruction includes the surgical procedures of “vaginoplasty,” “perineoplasty,” and something called a “posterior repair,” or “posterior colporrhaphy,” a procedure usually performed as part of a surgical vaginoplasty, whereby the hernia
“bulge” of a woman’s rectum upwards into the vagina (caused by weakness and separation of the levator muscles) is corrected. A vaginoplasty is a combination of surgically bringing the widely separated levator (“Kegel’s”) muscles back together (aka “levatorplasty”), reconstructing the rectocele hernia, and reconstructing the stretched-out fascial layer. A true perineoplasty (“PP”) involves much more than simply revising
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The FDA and the O-Shot ®
The Mystery of Orgasm and HowWe Can Help “Vaginal Reconstruction” vs. “Vaginal Rejuvenation” Helpful Tools 12 Reasons You Should Offer Altar ™ to Your Patients
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12 Reasons for Offering Altar™ to Your Patients
… Including THREE Profit Models and Very Outstanding Science
4. Third profit model: Vending machine profit. Don’t need a prescription, so you can sell in an online store or staff can sell without your time involved. 5. It works (SBD-4 backed by $2,000,000 NIH study). 6. Altar™ advertising will help feed the procedures (as procedures will help feed the cream). 7. Your patients WILL buy creams for their face. Make it something from you and something that they cannot buy next week on Amazon. 8. Celebrities WILL be talking about Altar™. 9. You will not be billed until it ships. 10. The first 100 to order will receive a free sample.
11. Only those who order will be listed on the directory of Altar™ providers ( VampireSkinTherapy.com/members/directory ). You will still be listed on the Vampire Facelift™ or Vampire Facial™ directory. 12. Supported by world-class production and marketing. When we see that this product does well, then we can invest money to develop new products. But the people we are working with will not continue to work with us if we do not show results (the same people who did Proactiv). Suggested lowest retail price to your patients: $147 per 1.7-ounce bottle. Yes, we can ship to some countries other than the U.S. For a video explanation of the above points and to order Altar™ at wholesale prices, go to VampireSkinTherapy.com/members/altar- order .
For a video explanation of these 12 points, go to VampireSkinTherapy.com/members/altar-order . 1. You will be one of the few who carry this brand. (It will not be sold to physicians outside our group.) 2. First profit model: Trademark Profit. Altar™ matches your Vampire Facial™ and our Vampire Facelift™ O-Shot® … Vampire Wing Lift™. 3. Second profit model: Installed base profit. Ongoing profit to refill the base installation.
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