Bioidentical Hormones - U.S. Senate Special Committee on Aging

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109 Who's Watching Women Using the Wiley Protocol? We are also waiting for our "study number" from the University of Texas at Tyler's Nursing School's IRB <strong>Committee</strong>. Contactjanithwilliamsl(,msn.com The proposed study is a longitudinal, observational study measuring many of the parameters of the WHI in women currently using the Wiley Protocol. Though many physicians have been prescribing them for decades, there is a paucity of data in our literature due to the fact that there has not been any pharmaceutical support for plant-based products (considered food and therefore not patentable). They can be compounded by a pharmacist. Another point here is that the same compounded hormone prescription can vary widely from pharmacy to pharmacy, making them virtually "un-studiable." Progesterone (P4) and Analytical Research Labratories Results 120.00% 11&50% * 115.00% .... ._.. ffi ~~109o%_ tiQ.80%__ 11o%109.80% .16 1105.00% i- ~08 .1.%D8o% 100.00% IN OL 95.00%- !1 - s 90.00% -- Phafrnacy's Phurmacy's Providing Wiley Protocol i. I t" Thus no standardization exists in this area of hormones for research heretofore.
110 A controlled systematic pilot clinical study of the most promising few plant based hormone therapy alternatives would quickly yield to a well-organized national multi- centered clinical trial of a large heterogeneous cohort. A short duration observational study with biologically correct endpoints associated with menopause and with periodic measurements of clinically significant biochemical markers should be the next step to jumpstart the WHI-2. All Wiley "Registered" Pharmacies use ingredients that are all purchased from the same supplier. At the Registered Pharmacies, The Wiley Protocol® is made in small batches (lot# identified) in uniform standardized steps outlined in the Wiley Protocol® Methods and Materials Training Manual and packaged in our unique color-coded identifying system of purple and green for progesterone and estrogen, respectively. I have recruited these Registered Pharmacies, not only to insure quality control on a very variable treatment - BHRT, but to make sure that in the future a real and legitimate study could be affected on the Wiley ProtocolS by requesting 10 pro bono prescriptions per pharmacy for a national study. Also, BHRT has never been studied in any Standard of Care controlled environment because the "study substance" in any legitimate trial has been mandated by the NIH to be donated to the participants. Of course, no small compounder can bear the economic burden of donating 4000 compounded prescriptions, however; the eventual 400 or so Wiley Registered Pharmacies can and will, together. The donations will have been standardized to Good Compounding Practices, so the results of such a study can be taken seriously at any level of scrutiny. Who's Watching Wiley? In the spirit of financial disclosure and complete transparency, I trade the Pharmacies the use of my name and list them on the website thewileyprotocol.com in exchange for their commitment to make the bioidentical hormones used in the Wiley Protocol in the standardized method I require and agree to donate a percentage of their volume to a future national study of the Wiley Protocol. They must buy the packaging (purple and green stamped with a 28WP logo) from my company Wiley Systems. The proceeds from the sales of packaging have built the website and paid for the development of the University of Texas study, so far. I take no personal income from Wiley Systems.
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S. HRG. 110-129 Bioidentica
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CONTENTS Page Opening Statement of
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2 The sale of bioidentical hormone
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4 ever, as Dr. Wartofsky points out
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6 with every stage of the disease:
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8 I am pleased to appear before thi
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10 When the trials began, many rese
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Women who began treatment more than
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14 One small trial using oral estra
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16 FDA is aware that a growing numb
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18 DEPARTMENT OF HEALTH & HUMAN SER
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20 safety and efficacy. However, as
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22 adulteration and misbranding pro
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24 The 2002 CPG reflects FDA's curr
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26 Equally concerning are claims by
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28 concerned about the use and mark
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30 Part I: Materials and Partnershi
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32 drugs, when the compounding of t
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34 Our staff identified 34 Web site
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1. Introduction 36 Chairman Kohl, R
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diet and fitness products. 5 For ex
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include "natural" progesterone crea
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42 unique to the computer age, such
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computer users to spam(ftuce.0ov -
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46 accuracy of advertising for heal
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48 Now, you have identified in your
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50 claim." Therefore, since the ter
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52 Such quality control problems ha
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54 Statement Before the U.S. <stron
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in the U.S., whereas WHI participan
Page 61 and 62: 58 between science and hearsay and
Page 63 and 64: 60 How can we determine whether bio
Page 65 and 66: 62 doctors-are not getting the obje
Page 67 and 68: 64 27. Writing Group for the PEPI T
Page 69 and 70: 66 Dr. MANSON. Well, I think that m
Page 71 and 72: 68 Statement of Leonard Wartofsky,
Page 73 and 74: 70 in the WHI. In fact, no study as
Page 75 and 76: In summary, the Endocrine Society i
Page 77 and 78: 74 The FDA also regulates aspects o
Page 79 and 80: Statement of Loyd V. Allen, Jr., Ph
Page 85 and 86: 82 Senator SMITH. Dr. Allen, as I h
Page 87 and 88: 84 Now, when you are talking about
Page 89 and 90: 86 The only thing the WHI proved wa
Page 91 and 92: 88 Testimony Of T.S. Wiley before t
Page 93 and 94: Confusion and Media Hype 90 Instead
Page 95 and 96: 92 see a doctor tell a diabetic nea
Page 97 and 98: 94 the only compelling reason to ta
Page 99 and 100: 96 identical hormones synthesized f
Page 101 and 102: 98 The world as we know it, from ba
Page 103 and 104: 100 thereby experienced long period
Page 105 and 106: 102 Bio-identical progesterone repl
Page 107 and 108: 104 had reached optimum theoretical
Page 109 and 110: 106 and the patient can be can reas
Page 111: 108 Estradiol and Analytical Resear
Page 115 and 116: 112 of set doses. The Wiley Protoco
Page 117 and 118: 114 I'd advocate for either Accredi
Page 119 and 120: 116 D.C., and established a goal to
Page 121 and 122: 118 If this legislation passes, fed
Page 123 and 124: first and second finger on the barr
Page 125 and 126: 122 These products that have been s
Page 127 and 128: 124 Bcl-2, survivin and variant CD4
Page 129 and 130: 126 These are experiments by other
Page 131 and 132: 128 cerebro-cellular inflammation c
Page 133 and 134: 130 Years # women *1>0.5 8 *1+ 9 *2
Page 135 and 136: *Breast cancer 132 -57 y.o. recurre
Page 137 and 138: 134 *Labor intense for patient and
Page 139 and 140: 136 Senator SMITH. Thank you very m
Page 141 and 142: 138 makes these hormones uniquely s
Page 143 and 144: 140 tomize the Wiley Protocol by ra
Page 145 and 146: 142 "natural," because all lead to
Page 147 and 148: 144 maceutical commerce, often with
Page 149 and 150: 146 WHITE PAPER #1 DID YOU KNOW THA
Page 151 and 152: 148 WHITE PAPER #2 Pharmacy Compoun
Page 153 and 154: 150 bleeding of the bowel, locate t
Page 155 and 156: 152 compounding standards can be en
Page 157 and 158: 154 I. The FDA's definition of a "N
Page 159 and 160: 156 ORIIGINAL CONTrMIBTION JANMA-EX
Page 161 and 162: Initially, the design allowed women
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ards analyses," stratified by clini
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year). These 'drop-in" rates were a
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years of prior use, 11 vs 2; HR, 4.
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trogen plus progestin exposure. Clo
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168 RISKS AND BENEFITS OF ESTROGEN
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EFFECTS OF POSTMENOPAUSAL ESTIROGEN
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EFFECTS OF POSTMENOPAUSAL ESTROGEN
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pEyECTS OF POSTMENOPAUSAL ESTROGEN
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10000 isoor i I ea '° a wan 20-24
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~SDt~rpa g~2~Q ~ !~fm~. b~e ~ ng jh
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Is associated with an Increased ris
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188 Postmenopausal hormone therapy
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group (P= 04001), and In this subgr
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Treatmnent recommendations Based on
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21.Grodsteln F. Manson JE, Colditz
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_ ORWIGNAL CONTIuBUTION 196 Postmen
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showed no striking differences in H
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(214 cases; P for trend=.72): howev
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202 HORMONE THERAPY USE AND RISK OF
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mal studies, and laboratory studies
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210 ,lmcCII na: CLI I tr: tarty ver
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212 ,mucmai rimi &ronos farty bstro
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214 LntIucwu miau: rronos nary estr
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XVI. PNharmacy Licensure Requiremen
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XVI. Pharmacy Licensure Requirement
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220 Roster of Board of Pharmacy Ece
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050. 0l7404405400 Al-h. PeVbU 03283
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Conclusions * Age is a powerful ris
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Women's Health Initiative Trials of
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Hormone Therapy after WHI * Change
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Statement of the American Pharmacis
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232 APhA Statement to the S
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240 Written Testimony of Steven F.
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242 STATEMENT OF DAVID G. ADAMS On
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244 Report on State Laws and Regula
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246 Only one state, Utah, requires
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248 5. Compounding Copies of FDA-Ap
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Bioidentical Hormones - U.S. Senate Special Committee on Aging

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