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

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Evrdence-based Cardiology So.Mosca L Rationale and overview of the Raloxilene Use for the Heart (RUTH) trial. Ann N YAcad Sd2t01949.181-5. 57.Pagantnl-Htil K Hornone replacement therapy and sroe: risk, protection o no effect? Maulunfa2sl,3&:243-61. 58.Hodls HN, Mack WI, Lobo RA etat Estrogen in tihe prevention of atherosclerosis. A randomized, double-band, placebo-controlled trial. Ann Internmed200l;1l3939-53. 5SOAngerer P. Stork S, Kotiny W, Schmitt P, von Schacky C. Effect of oral postmenopausal hormone replacement on progesslon of atherosclerosis a rendomized, controlled trial. Artfoscier 77Tromb VascB16lo200l;2:262-8. 6.Slnmon JA, Hsba 1, Cauly IA et at Posennnopausal hormone therapy and risk of stroke: The Heart and Estogen-progestin Replacement Study (HERS). Ckciarton200l;103:638-42. 61.Castetlsague 1, Perez Gutthann S, Garcia Rodrige LA Recent epidemtologlcal studies of the association between hormone replacement therapy.and venous tiromboembolism A review. DnrgSaf1998;18:1 17-23. 62.Grady D, Wenger NK, Herrington D et at Postmenopausal hor. mone therapy increases risk lr venous thromboeabolic disease. The Heart and Estrogen/progestin Replacement Sludy. Ann Intern Mer2000,l32-689-46. 195 63.Holbraaten E, Ovigstad E, Arnesen H. Larsen S. Wlckstrom E, Sandset PM. increased risk of recutrent venous thromboembolism dsring hormone replacement therapy - result of the randomized, doule-blind, placebo-controlled es-togen in venmus throntoembolsm trial (EVrET). 7hromb Haernost 2000,84961-7. 64.Mooca 1, Collins P, Herrington DM et & Hormone replacement therapy and cardlovascutar disease: a statement for healthcare profssionals from the American Heart Assocation. Circolation 2001;104:499-503. 65.Manson JE, Martin KA. Postnenopausal hormonereplacement therapy NEn4lJMed2002345:34-40. 66.Rosmvuwv JE What we still need to know about hoormone replacement therapy iJnfenoHty Reprod CYIn Nonrh Amn 1999;10-.189-209. 67.Wtting Group for the Women's Health Initiative Investpgatos. Risks end beneds of estrogen pIls progestin In healthy postmenopausal women. Principal rerults from the Women's Heatnh [Intative Randomized Controlled Trial. J4MA 2002; 288 321-33.
_ ORWIGNAL CONTIuBUTION 196 Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause Jacques E. flosouws. MD Ross .. Prentice, PlhD JoAnn E. Manson, MT), IrPH Lieliing Wu, MSC David Barad, MI) Vanessa M. Barnabei, MD, PhD Marcia Ko. MD Andrea Z. LaCroix. PhD Karen l_ Margolis. MD Marcia L. Stefanick. PhD N OBSERVATIONAL STUDIES OF women with and without existing coronary heart disease (CHD), the use of postmenopausal hormone therapy is associated with a reduced risk of CHD events.' In contrast, clinical trials have shown no benefit and some trials have suggested an increased risk of CHD during the first year after randomization.'- The Women's Health Initiative (WHI) reported a hazard ratio (HR) for CHD of 0.95 (959h confidence interval ICI). 0.70-1.16) in the trial of conjugated equine estrogens (CEE) and an HR of 1.24 (95% Cl, 1.00-1.54) in the trial of CEE plus medroxyprogesterone acetate (CEE + MPA).'' While observational studies have evidently overestimated benefit due to confounding, selection biases, and other limniattons,'36 an additional source of discrepancy may be the timing of inRiation of hormone therapy in relaton to the underlying state of the vasculature. Some investigators have hypothesized Context The Uming of initiation of hormone therapy may influence its effect on cardiovascular disease. Objective To explore whether the effects of hormone therapy on nisk of cardiovascular disease vary by age or years since menopause began. Design, Setting, and Partidpants Secondary analysis of the Women's Health Initiative (WHI) randomized controlled trials of hormone therapy in which 10739 postmenopausal women who had undergone a hysterectomy were randomized to conjugated equine estrogens (CEE) or placebo and 16 608 postmenopausal women who had not had a hysterectomy were randomized to CEE plus medroxyprogesterone acetate (CEE + MPA) or placebo. Women aged 50 to 79 years were recruited to the study from 40 US clinical centers between September 1993 and October 1998. Main Outcome Measures Statistical test for trend of the effect of hormone therapy on coronary heart disease (CHD) and stroke across categones of age and years since menopause in the combined trials. Results In the combined inals, therewere 396 cases of CHD and 327 cases of stroke in the hormone therapy group vs 379 cases of CHD and 239 cases of stroke in the placebo group. For women with less than 10 years since menopause began, the hazard ratio (HR) for CHD was 0.76 (95% confidence interval IC] , 0.50-1.16); 10 to 19 years, 1. 10 (95% Cl, 0-84-1.45), and 20 or more years, 1.28 (95% Cl. 1.03-1.58) (P for trend=.02). The estimated absolute excess nsk for CHD forwomen within 10 years of menopause was -6 per 10000 person-years; forwomen 1oto 19years sincemenopause began, 4 per 10000 person-years; and for women 20 or more years from menopause onset, 17 per 10000 person-years. For the age group of 50 to 59 years, the HR for CHD was 0.93 (95% Cl, 0.65-1.33) and the absolute excess dsk was -2 per 10000 person-years; 60 to 69 years. 0.98 (95% Cl, 0.79-1.21) and -1 per 10 00 person-years; and 70 to 79years, 1.26 (95% a. 1.00-1.59)and 19per 10000person-years(Pfortrend=.16). Hormionetherapyincreased the misk of stroke (HR, 1.32; 95% Cl, 1.12-1.56). Risk did not varysignificanty by age or time since menopause. There was a nonsignificant tendency for the effects of hormone therapy on total mortatity to be more favorable in younger than older women (HR of 0.70 for 50-59 years; 1.05 for 60-69 years, and 1.14 for 70-79 years; P for trend=.06). Condusions Women who initiated hormone therapy closer to menopause tended to have reduced CHD risk compared with the increase in CHD risk among women more distant from menopause, but this trend test did not meet our criterion for statistical significance. A similar nonsignificant trend was observed for total mortality but the risk of stroke was elevated regardless of years since menopause. These data should be considered in regard to the short-term treatment of menopausal symptoms. Trl Registration dinicaltrials.gov Identifier. NCT00000611 JAMA 2007.2971465 71777 .j meiccr Atihor Affillaton. are - ted at the end of thl wo-rHtinW#.rsa -h, aimnu.MHe-tL..g, ani.. -,d Bkoed Inrtne. 6701 Reidedede Dr. Bldg 2S Sule Core-ponding A.tBio lacquer. r Ro--w- MD, l1i08, Bethesda. MD 20cea2 ( ar"ierwish.&-). 02007 Ameefr Mdile4I A-sadadtii. Al doige r-e d. twepninted) JAM A. ril 4. 2m07-Sot 297. Ne. i3 1465 Doidaioaded flumn v.ejanacem at National [.,itin of Hlth, on April 5, 29D7
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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
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
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: 21.Grodsteln F. Manson JE, Colditz
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
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
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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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