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

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201 HORMONE THERAPY USE AND RISK OF CARDIOVASCULAR DISEASE Table 3. CteraP( Cardiovaswlar and G)obal Intdr Evrets5 No. 00 Carca (Annualzeod %i' * R Honnoos Therapy Placebo HR (n .13816) (n * 13531) (95% Clt Combineo Tdeh CHOD 396(04c) 379(0244) 1 07(09210 .23) prior hormone use or oophorectomv sta- -tus with in-trial hormone effects by age ~~~~~~~~~~~~Eotimalett d 86001810 or by years since menopause. However, ExctrssRiek per vasomotor symploms at baseline may 10000 Pea;0o,-Ye0 have influenced the results (or CHD by (959 both age and years since menopause. The 3.1H2. 6119.4) possible 3-way imteractions of vssomo- Stroke 327 (033) 239(029N 132( 12 1.06) 9.3(34 to 1S. 1" tor symptoms with hormone therapy ratal roMtaiy 546(063i s28(063) .02 (080101.15) 1 2(-6.) I1086) effects on the HR trend by age (P-.04) GlobairaeooIl 1601(1.94) 1467(1.81) 1.08(0.00 to1.61 14.0)1.7 to 28.2) and by years since menopause (P =.06) CEE Tnsa appeared to be due to trends across these CHDg Stoke GEE (n = 5310) 201(054) 160(0.45) Placebo In . 5429) 217 (0.57) 127(033) 0.95 (0.78 to 1.16) 1.33)1.01to1.60) 208-3) -2.9 (-13 30 20 3) 10.9816 categortes in the 12% to 17% of women in the irials with moderate or severe vasomotor symptoms (P for trend
202 HORMONE THERAPY USE AND RISK OF CARDIOVASCULAR DISEASE tial modification of hormone effects by COMMENT have adequate statistical power to asage or years since menopause. Other Although not statistically significant sess outcomes in the women aged 50 models suggested a time-dependent these secondary analyses suggest that to 54 years or less than 5 years since effect of hormone therapy in the com- the effect ofhormones on CHD may be menopause. As previously reported. bined trials for CHD (but not stroke), modifiedbyyearssincemenopauseand CEE appeared to be associated with with higherrisks in the first 2years and by the presence of vasomotor symp- lower risk of CHD than CEE + MPA.' decreasing risk thereafter (P= .01). Even toms, with the highest risks in women Importantly, the risk of stroke was not though power was limited by small whowere20ormoreyearssincemeno- influenced by years since menopause. numbers of events, the direction of pause (or aged 270 years). Coronary the presence of vasomotor symptons, time-dependent effects were similar heart disease tended to be nonsignifi- ordrugregimen, althoughtherewasno within categories of age or years since cantly reduced by hormone therapy in increased risk of stroke in women aged menopause, and there were no inter- younger women or women with less 50 to 59 years. actions of time-dependent effects on than 10 years since menopause, and the Our findings are consistent with find- HRs across the age or years since meno- risk of total mortality was reduced in ings from observational studies of the pause categories. women aged 50 to 59 years. We did not association of years sitce menopause Table 4. Cardiovascuitar and Global tnde" Events by Age at llaseline AUe Group at Randomiratio- 6 9 so-sa y 8- y 70-79 y i ~~~~~I I I, No. of Cases No. ol Case No. of Cases I I ~ ~ ~ ,I ~ ~ ~ ~~~~I P Haonrone I-Hkrroie Ho ne Valuse Therapy Placebo HR Therapy Placebo HR Thery Pi ..ebo HR for (n . 4476) In . 4358) (95% Ct) (i = 6240) tn e61 22) (95% Ct) (n e3100) (n . 3053) (95% CQlO Teenat C-oNbned Tlals CtiDt 59 61 0.93 174 178 0.98 183 131 1.26 .16 Stroke Totalimslty Global rda§ 44 69 278 37 g9s 278 1.13 (0.73-1.76) 070 (0.5-0.98) 0.98 (081-.14) 156 240 717 102 225 661 1.50 (1.17-1-92) 1.05 (087-1 26) 1.08 0.97-1 20) 127 237 608 100 208 528 1.21 .97 (0.93-1.59) 114 .06 (0.94-1.37) 1,14 .09 102-1.29) CHLlt GEE Placebo (n1637) tn=16731 21 34 083 036-1.09) CEE Trial GEE Placebo CEE ( I.n387) l 2465) (n.1286)5 96 106 0.94 84 (0.71-1.24) Placebo jnl291) 77 1.13 (02-i s4) .12 Stroke Tate]ornality Ook~oalsto-fe 18 34 "14 21 48 10 0.89 (0.47-1.69) 0.71 (0.49-1.11) 0.82 (.64-1.05) 84 129 333 54 131 342 1.62 (1.15-2.27) 1.02 (0.0-1.30) 1.01 (0.6-1.17) 66 134 300 52 113 262 1.21 (0584-1.75) 1.20 (0.93-1.55) 1.16 (0.981.37) .62 .18 .01 CEE, MPA Tria CEEvMPA Placebo CEE+MPA Placebo CEE+MPA Placebo (I. -28391 (26831 (n 38531)n=.3657) (n.1814) (n. 1762) CHDt 38 27 1.29 78 72 1.03 79 54 1.48 .70 (0.792. 21 (0.74-1.43) (1o04_2.11) Siroke 26 18 1.41 72 48 1.37 61 48 1.21 . (0.7-2.65) (0951-97) (0.82-I.78) Tote4 monttiy 35 47 0.69 III 94 1.09 103 95 1.06 .19 (0.44-1.07) (0.3-1 .44) (090-1 41) Global inttex§ 164 138 1.10 384 319 1.15 306 266 113 .98 (087-1.39 (0899-1.34) (0.9- 5133) Arerraso- CrE, raa I rr s as .esay narl or a. Ci t : HFI. 5azar rt5k lIPA rooboargslralae. car risrossul11151 illoSe 0r51al- 1080c c't svrave Isornor cws oacod 01 as vsosrd 0Žrdr05t (tD hrs MXlbO and ol, 115n Ions *oaIe txcttrentrtm ago 81.50.0,00004049 t1)e5=40. Gl40esas. onlatld rlyono59 iearuc5. or rdoiree sanr cr00h19 i-crn 6 0 s.951 0r S.D. s005.e4 05s Cr40. 0a10. trirorran orbolom t ctrolar onwol, octe aracor. ernicrelro teras 8 MPA s hot criy lop fr95r0cre dIttra, 1o 0r eeslr. 02007 Amerkae Medioal A.-odiaflo. All digbls res d. (ftpbtld) JoA, Apdl 4, 2007-V.t 297. N.. 13 1471 Downloaded born wswjacr.eoo at National ntsiaittr of Hlth, on Apil 5.2007
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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
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112 of set doses. The Wiley Protoco
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114 I'd advocate for either Accredi
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116 D.C., and established a goal to
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118 If this legislation passes, fed
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first and second finger on the barr
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122 These products that have been s
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124 Bcl-2, survivin and variant CD4
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126 These are experiments by other
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128 cerebro-cellular inflammation c
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130 Years # women *1>0.5 8 *1+ 9 *2
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*Breast cancer 132 -57 y.o. recurre
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134 *Labor intense for patient and
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136 Senator SMITH. Thank you very m
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138 makes these hormones uniquely s
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140 tomize the Wiley Protocol by ra
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142 "natural," because all lead to
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144 maceutical commerce, often with
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146 WHITE PAPER #1 DID YOU KNOW THA
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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
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: (214 cases; P for trend=.72): howev
Page 207 and 208: mal studies, and laboratory studies
Page 209 and 210: 206 HORMONE THERAPY USE AND RISK OF
Page 211 and 212: 208 HORMONE THERAPY USE AND RISK OF
Page 213 and 214: 210 ,lmcCII na: CLI I tr: tarty ver
Page 215 and 216: 212 ,mucmai rimi &ronos farty bstro
Page 217 and 218: 214 LntIucwu miau: rronos nary estr
Page 219 and 220: XVI. PNharmacy Licensure Requiremen
Page 221 and 222: XVI. Pharmacy Licensure Requirement
Page 223 and 224: 220 Roster of Board of Pharmacy Ece
Page 225 and 226: 050. 0l7404405400 Al-h. PeVbU 03283
Page 227 and 228: Conclusions * Age is a powerful ris
Page 229 and 230: Women's Health Initiative Trials of
Page 231 and 232: Hormone Therapy after WHI * Change
Page 233 and 234: Statement of the American Pharmacis
Page 235 and 236: 232 APhA Statement to the S
Page 243 and 244: 240 Written Testimony of Steven F.
Page 245 and 246: 242 STATEMENT OF DAVID G. ADAMS On
Page 247 and 248: 244 Report on State Laws and Regula
Page 249 and 250: 246 Only one state, Utah, requires
Page 251: 248 5. Compounding Copies of FDA-Ap
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Bioidentical Hormones - U.S. Senate Special Committee on Aging

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