T.S. Wiley is Pioneer of Bioidentical Hormone Standardization

SANTA BARBARA, CA--(Marketwire - April 27, 2009) - Wiley Systems™, Inc., developer of The Wiley Protocol® rhythmic,compounded bioidentical hormones, has pioneered the standardization of the patent pending Wiley Protocol formulations using unique, standardized compounding procedures and color coded packaging, available to physicians and patients at recommended retail prices. The company's biomimetic hormone protocols must be formulated by a trained and registered compounding pharmacist.A recent March 19 Wall Street Journal article said, "There are 25 years of scientific research with hundreds of studies in the U.S. and Europe that have demonstrated that bioidentical hormones, estradiol and micronized progesterone, are equally or more effective than synthetics -- and safer."What's more, the latest research on bioidentical hormone replacement therapy (HRT) suggests that women must cycle their hormones and have a menstrual bleed to be truly safe from cardiovascular events. According to a recent *Danish study, a combined cyclic regimen with monthly bleeding creates a lower cardiovascular risk for women than continuous-combined estrogen/progesterone/progestin therapy, which does not cause a menstrual bleed. The study also found that overall there was no increased risk of heart attacks in current users of HRT compared to women who had never taken hormones.This research is significant validation of the value of cyclical (estrogen, followed by a combination of estrogen and progesterone) hormone therapy and that biomimetic hormone restoration therapy (BHRT) may actually be safer than statically dosed continuous-combined alternatives, whether bioidentical or synthetic. The Wiley Protocol is the only bioidentical hormone therapy that is biomimetic."The more familiar doctors and consumers become with the benefits of bioidenticals, the more important standardization will become. It has always been our goal that any woman in any city or town can pick up her prescription for the Wiley Protocol and it will be exactly the same as every other woman's, everywhere else," said T.S. Wiley, founder of the Wiley Protocol and Wiley Systems, Inc.In a statement about compounding standardization prepared by Dana Nelson, pharmacist in charge of the Wiley Protocol Pharmacy Consortium said, "It's important for patients who are taking compounded hormone therapies like the Wiley Protocol to understand that we have standardized the protocols for compounding so that we can be sure the Wiley Protocol doctors prescribe for patients is the same from each and every pharmacy across the U.S. and Canada. The Wiley Protocol is only available at compounding pharmacies that have been registered by Wiley Systems, Inc. in a licensing agreement."Registration for pharmacists means, in essence, a trade for the right to use the name Wiley Protocol for the product produced when a physician calls in a prescription for the Wiley Protocol, in exchange for a contract that specifies the methods, materials, packaging and recommended pricing of the Wiley Protocol at their individual pharmacies. As a part of the Wiley Protocol quality assurance program all contract pharmacies are required to submit samples of their compounds quarterly to an independent, outside laboratory for quantitative analysis. Strict standards must be met or the product cannot be dispensed. These requirements of good compounding (manufacturing) practices apply only to the production and compounding of the Wiley Protocol.California-based compounding pharmacist Mike Shah talks about the benefits of compounded bioidentical hormone therapy saying, "I have a couple of cancer patients, and it is their belief that the Wiley Protocol is holding off the cancer, and it's incredible to see... when you hear patients come back and they're happy with what they are doing and their quality of life has just improved vastly, and they're so excited about being and feeling like themselves again, it gives a great sense of achievement and accomplishment."In order for a pharmacist to become registered to compound and dispense the Wiley Protocol, Wiley Systems provides a training course taught by Dana Nelson, BS, MS, FASCP. Nelson is the pharmacist in charge of training the registered pharmacies for standardization and use of the Wiley Protocol methods and materials preparation. A Pharmacy Methods and Materials Preparation Manual of intellectual property is available only to registered pharmacies.Wiley has created the registered pharmacy system to circumvent the current lack of legitimacy and availability of bioidentical hormones for testing and study. Each registered pharmacy must donate a minuscule percent of total sales volume contractually. By standardizing the compounds in the Wiley Protocol and registering enough pharmacies, the Wiley Protocol can then be donated and studied by the IRB at University of Texas in a standard acceptable to the National Institute of Health (NIH), which dictates that a study substance must be donated.Upon registration, Wiley Systems will contact the pharmacist with training information and how to obtain the pharmacy version of the Clinical Practice Guidelines Manual shared by physicians everywhere. It is T.S. Wiley's goal that pharmacists and physicians be "on the same page" when answering the questions and adjusting the dosages of customers on the Wiley Protocol.Wiley Systems, Inc. distributes the following biomimetic dosing schedules: The Wiley Protocol™ for Women; Wiley Protocol for Men™, bio-mimetic DHEA and testosterone restoration; Wiley Protocol Thyroid™ for Women, biomimetic thyroid hormone restoration; Wiley Protocol Testosterone™ for Women, biomimetic testosterone restoration; and Wiley Protocol Face Crème™, which promotes a more youthful appearance by filling in fine lines with the body's own adiposities.T.S. Wiley is a medical theorist in environmental endocrinology and Darwinian medicine. She is a noted writer, researcher and lecturer on the effects of hormones, particularly in menopausal women as well as an accepted expert in chronobiology and circadian rhythmicity. Wiley's environmental endocrinology seminars, "Two Days Back on Earth" in Glendale, California are attended by physicians from around the world.About Wiley Systems, Inc. and the Wiley ProtocolWiley Systems, Inc. was founded in 2005 in Santa Barbara, California by T.S. Wiley, who is the developer of the Wiley Protocol®, a trademarked patent pending delivery system consisting of the biomimetic, bioidentical hormones estradiol and progesterone, or biomimetic hormone restoration therapy. Wiley Systems began as a project to fund the union of doctors and pharmacists in a common goal to standardize bioidentical hormones for academic research. Now in 2009, the Wiley Pharmacy Consortium numbers around 50 pharmacies and more than 250 doctors prescribing in the US and Canada.The Wiley Protocol is only available at compounding pharmacies that have joined the project for future National Institutes of Health (NIH) study and have contractually agreed to the standardized methods, materials, packaging and recommended pricing. In exchange, Wiley Systems provides intellectual property and provides 28WP logo-bearing packaging consisting of color-coded bags and applicators. The Wiley Protocol name assures customers that they are receiving authentic Wiley Protocol dosing rhythms based on original research.*Ellen Løkkegaard, Anne Helms Andreasen, Rikke Kart Jacobsen, Lars Hougaard Nielsen, Carsten Agger, and Øjvind Lidegaard. Hormone therapy and risk of myocardial infarction: a national register study. European Heart Journal, 2008; DOI:10.1093/eurheartj/ehn408Contact:
Kristin Gabriel
Director of Marketing
O: 323.650.2838
C: 213.840.6978
E: kgabriel@thewileyprotocol.com

Wiley Systems, Inc.
P.O. Box 50734
Santa Barbara, CA 93150
O: 805.565.7508
F: 805 456-3939
www.thewileyprotocol.com

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