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

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129 Slides of Recurrence Rates of Cancer Patients on the Wiley Protocol Clinical Characteristics *67 women on hormone therapy Identified *54 women Wiley Protocol -Premenopausal = 2 -Postmenopausal = 52 *Natural = 22 *Surgical = 24 *Chemo Induced = 5 -Other = 1 Clinical Characteristics: Age 20 - 29 = 2 Years Duration 30 - 39 = 2 40 - 49 = 12 50- 59 = 25 60- 69 = 8 70- 80 = 5
130 Years # women *1>0.5 8 *1+ 9 *2+ s18 *13+ 13 *>4 6 Clinical Characteristics Invasive Breast Cancer 28 *Stage I 10 "Stage II 12 *Stage III 2 *Stage IV 4 *Non-invasive Breast Cancer 5 Invasive Receptor Status -ER + 24/28 -ER - 4/28 *Non-Invasive -ER + 4/5 -ER - 1/5
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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
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58 between science and hearsay and
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60 How can we determine whether bio
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62 doctors-are not getting the obje
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64 27. Writing Group for the PEPI T
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66 Dr. MANSON. Well, I think that m
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68 Statement of Leonard Wartofsky,
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70 in the WHI. In fact, no study as
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In summary, the Endocrine Society i
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74 The FDA also regulates aspects o
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Statement of Loyd V. Allen, Jr., Ph
Page 81 and 82: Statement of Loyd V. Allen, Jr., Ph
Page 83 and 84: 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 and 112: 108 Estradiol and Analytical Resear
Page 113 and 114: 110 A controlled systematic pilot c
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: 128 cerebro-cellular inflammation c
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
Page 163 and 164: ards analyses," stratified by clini
Page 165 and 166: year). These 'drop-in" rates were a
Page 167 and 168: years of prior use, 11 vs 2; HR, 4.
Page 169 and 170: trogen plus progestin exposure. Clo
Page 171 and 172: 168 RISKS AND BENEFITS OF ESTROGEN
Page 173 and 174: EFFECTS OF POSTMENOPAUSAL ESTIROGEN
Page 175 and 176: EFFECTS OF POSTMENOPAUSAL ESTROGEN
Page 179 and 180: pEyECTS OF POSTMENOPAUSAL ESTROGEN
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EFFECTS 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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