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

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RISKS AND BENEFITS OF ESTROGEN PLUS PROGESTIN 163 dependent covariate, detected no trend some evidence for an increasing risk of with time for CHD, stroke colorectal breast cancer over time with estrogen cancer, hip fracture, total mortality, or plus progestin (z= 2.56 compared with the global index (TABLE 4). There was a nominal z score for statistical signifi- Figure 3. Kaplan-Meier Estimates of Cumulative Hazards for Selected Clinical Outcomes togW.n 850 8303 t 5 8133 i 70784 4321 20 814 epo 8102 7859 7 7788 789 883g 3R8 1758 523 0803 so X R8w Pi21noe.y Embousni HR7.213 95% .0. i.32 5 X orz2Z PRya 8Ks'B 8382 280 8174 7884 4285 2108 820 7m 82 102 8813 7524 7825 8879 3973 1770 528 Iff coio4 cannot H78. 0.83 am 783. l 43.0 2 95%8C 8.32 1.24 I 8-221 nus -o. o Cm73nawy amp Han ~~~~same 2 a 3 4 5 8 7 No8 021 8 B rg.-, rooWmw 8KB( 8378 8787 8182 7073 4382 2117 802 7azz 812 8X23 70'8 7814 6888382 1 758 87 2 85080375 8277 8185 7M2 4272 2088 814 8.28i 5 73X2 2804 rtis 3980 779 5N24 HR. * 28 95%2. 88.1.88 886 8378 8277 8s82 7080 4234 2D64 901 8102 83801 MI 7772 M818 3922 1778 523 Hip Fn H1 1.06 85% Ca 845-0398 M5%oci.088 23, 8 * 2 3 2 5 8 7 rTim. y 80 88282 8288 8180 7073 4305 2178 828 8102 e8m 7015 7807 sa5s 3858 1783 825 HR idkatdes h.nd l8, 1a7o; -Ukn. 781i8t-17; adn1 0, Odiusted 88den1e 88881178 cance of 1.96) and a decreasing risk of VTE with time (z=-2.45). These results must be viewed cautiously because the number of events in each interval is modest, the data in later years are still incomplete, and later year comparisons are limited to women still at risk of their first event for that outcome. Subgroup Analyzes Cardiovascular Disease. A small subset of women (n=400; average followup, 57.4 months) in WHI reported conditions at baseline that would have made them eligible for HERS, ie, prior Ml or revascularization procedures. Among these women with established coronary disease, the HR for subsequent CHD for estrogen plus progestin relative to placebo was 1.28 (95% Cl, 0.64-2.56) with 19 vs 16 events. The remainingwomen, those without prior CHD. had an identical HR for CHD (145 vs 106; HR. 1.28; 95% Cl 1.00- 1.65). Few women with a history of VTE were enrolled, but these data suggest a possibility that these women may be at greater risk of future VTE events when taking estrogen plus progestin (7 vs 1; HR. 4.90; 95% Cl, 0.58-41.06) than those without a history of VTE (144 vs 66; Hk, 2.0U; 95% Cl, 1.54-2.76). For stroke, prior history did not confer additional risk (1 vs 5 in women with prior stroke; HR, 0.46; 95% Cl, 0.05-4.51; 126 vs 80 with no prior stroke; HR, 1.47; 95% Cl. 1.11-1.95). No noteworthy interactions with age, race/ethniciy, body mass index, prior hormone use, smoking status, blood pressure, diabetes. aspirin use, or statin use were found for the effect of estrogen plus progestin on CHD, stroke, or VTE. Breast Cancer. Women reporting prior postmenopausal hormone use had higher HRs for breast cancer associated with estrogen plus progestin use than those who never used postmenopausal hormones (among never users. 114 vs 102; HR, 1.06; 95% Cl, 0.81-1.38; for women with
years of prior use, 11 vs 2; HR, 4.61; 95% Cl, 1.01-21.02; and for women with >10 years of prior use, 9 vs 5; HR, 1.81; 95% Cl, 0.60-5.43, test for trend, z= 2 .17). No interactions between estrogen plus progestin and age, race/ethnicity, family history, naritvy age al first birth hbdv ma-s ~- 164 RISKS AND BENEFITS OF ESTROGEN PLUS PROGESTIN mone use ('as treated,' allowing for a period when the unopposed-estrogen 6-month lag) produced more modest component was open to women with changes to these estimates. Analyses ex- a uterus and analyses stratifying by encluding women randomized during the rollment penod did not substantially igeure 4. Kaplan-Meriy Esbonates of Cuanutbve Hazands for Globat Index and Death ''-1 -6s - - . . . . ...... index, or Gail-model risk score were O.'s G(O.lobalndor Death observed for invasive breast cancer. HA. .15 FR 0.08 Further Analyses 98s 5, e t5 .399 95% ac: o 70 1 32 Because a number of women stopped study medications during follow-up, several analyses were performed to ex- e amine the sensitiity of the pnncipal HR , //E.=9EgnPt.estimates to actual use of study medications. Analyses that censored a woman's event history 6 months after becoming nonadherent (using
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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
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108 Estradiol and Analytical Resear
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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 and 162: Initially, the design allowed women
Page 163 and 164: ards analyses," stratified by clini
Page 165: year). These 'drop-in" rates were a
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
Page 207 and 208: mal studies, and laboratory studies
Page 213 and 214: 210 ,lmcCII na: CLI I tr: tarty ver
Page 215 and 216: 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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