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

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RISKS AND BENEFITS OF ESTROGEN PLUS PROGESTIN 159 Table 1. 8aseline Charactenstics of the Women's Heatth Initiative Estrogen Plus Progestin Trial Particpants (N = 16608) by Randomization Assignment E5trogen . POgesthn Pia.. bt P Chleosteicts (n 8506) In 81 02) Vahiet Age at sceeong. mean (SOL y 0 1 Age grqs- pt .on0rg. y 63.2(7.1) 63.3 (7.1) .39 90r59 2839 (33.4) 2683 (33.1) 60-69 3853 (45.3) 3657 (45) .80 70-79 184 21.3) 1762)217) Racsglomocily Whtoe 71409(839) 6805 (84.0) BLack 549(65) 575(7.1) HIspenic 472(5.5) 416(5.1) Anericrn Inoian 26 0.3) 30 (0.4) .33 Asr.aPacrc IsLunder 194 (2.3) 169 (2.1) twnkn 125 (1,S) 107 (13) _ Hormonet use Nove, 6280 (73.9) 6024 (744) Past 1674(19.7) 158)(19.6) I .49 CQarem:; 548 (6.4) 487 (6.0) J Daration of prir homnore use, y
ards analyses," stratified by clinical center, age, prior disease, and randomization status in the low-fat diet trial. Two forms of Cls are presented, nominal and adjusted. Nominal 95% Cis describe the variability in the estimates that would anse from a simple trial for a single outcome. Although traditional, these Cis do not account for the multiple statistical testing issues (across time and across outcome categories) that occurred in this trial, so the probability is greater than .05 that at least I of these Cls will exclude unity under an overall null hypothesis. The adjusted 95% CIs presented herein use group sequential methods to correct for multiple analyses over time. A Bonferront correction for 7 outcomes as specified in the monitoring plan (described herein) was applied to all clinical outcomes other than CHD and breast cancer, the designated primary and pnmary adverse effect outcomes, and the global index. The adjusted Cis are closely related to the monitoring procedures and, as such, represent a conservatave assessment of the evidence. This report focuses primarily on results using the unadjusted statistics and also relies on consistency across diagnostic categones, supportive data from other studies, and biologic plausibility for interpretation of the findings. Data and Safety Monitoring Trial monitoring guidelines for early stopping considerations were based on O'Brien-Fleming boundaries' using asymmetric upper and lower boundaries: a 6-sided, .025-level upper boundary for benefit and I-sided, .05-level lower boundanes for adverse effects. The adverse-effect boundaries were further adjusted with a Bonferroni correction for the 7 major outcomes other than breast cancer that were specifically monitored (CHD, stroke, PE, colorectal cancer, endometrial cancer, hip fracture, and death due to other causes). The global index of monitored outcomes played a supportive role as a summary measure of the overall balance of risks and benefits. Trial monitoring for early stopping consider- 02092 Anurica.n ledical As.sosialion. All rights resrvced. 160 RISKS AND BENEFITS OF ESTROGEN PLUS PROGESTIN Table 1. Baseline Characterstics of the Women's Health Initiative Estrogen Plus Progestin Tnal Partiopants (N 1 16 608) by Randomization Assignmenr (cont) Chaeacteftfol Gat model 5-year isk of breast cancer, % Estogen . Progeatn In -8508) PIatelo (n- 8102) P Value
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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
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82 Senator SMITH. Dr. Allen, as I h
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84 Now, when you are talking about
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86 The only thing the WHI proved wa
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88 Testimony Of T.S. Wiley before t
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Confusion and Media Hype 90 Instead
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92 see a doctor tell a diabetic nea
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94 the only compelling reason to ta
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96 identical hormones synthesized f
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98 The world as we know it, from ba
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100 thereby experienced long period
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102 Bio-identical progesterone repl
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104 had reached optimum theoretical
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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 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: Initially, the design allowed women
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
Page 185 and 186: 10000 isoor i I ea '° a wan 20-24
Page 187 and 188: ~SDt~rpa g~2~Q ~ !~fm~. b~e ~ ng jh
Page 189 and 190: Is associated with an Increased ris
Page 191 and 192: 188 Postmenopausal hormone therapy
Page 193 and 194: group (P= 04001), and In this subgr
Page 195 and 196: Treatmnent recommendations Based on
Page 197 and 198: 21.Grodsteln F. Manson JE, Colditz
Page 199 and 200: _ ORWIGNAL CONTIuBUTION 196 Postmen
Page 201 and 202: showed no striking differences in H
Page 203 and 204: (214 cases; P for trend=.72): howev
Page 205 and 206: 202 HORMONE THERAPY USE AND RISK OF
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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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