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

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7 Testimony Before the. <strong>Special</strong> <strong>Committee</strong> on Aging ,. United States <strong>Senate</strong> - - , - i The Women's Health. Initiative Statement of Jacques Rossouw, M.D. Chief, Women's Health Initiative. Branch National Heart, Lung, and Blood institute National Institutes of Health U.S. Department of Health and Human Services For Release on Delivery Expected at 10:00 a.m. Thursday, April 19, 2007
8 I am pleased to appear before this <strong>Committee</strong> in my capacity as the chief of the Women's Health Initiative (WHI) branch of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), an agency of the Department of Health and Human Services.- I am here to tell you what we have learned from the WHI about menopausal hormone therapy using conjugated equine estrogens and to briefly comment on other forms of estrogen therapy. During the second half of the 20th century, estrogen was shown to relieve common menopausal symptoms such as hot flashes and night sweats. Subsequent clinical trials showed that estrogen also prevents bone loss. Based on these findings from rigorous scientific studies, menopausal hormone therapy was approved by the Food and Drug Administration (FDA) and became well accepted for treatment of menopausal symptoms and for prevention of osteoporosis. Most of the prescriptions for menopausal hormone therapy were written by gynecologists and family doctors for women experiencing symptoms shortly after the onset of the menopause transition. A smaller number were for older women to prevent osteoporosis. However, for many years estrogen was also used under circumstances where there was no definitive proof of efficacy. One idea that was promoted and became part of popular lore was that the ebb of estrogen levels after the menopause represented a disease-like condition or 'estrogen deficiency" that needed to be treated using 'estrogen replacement". Many thought that such replacement would keep a woman 'forever young." In the mid-1980s, another potential reason to use menopausal hormone therapy emerged from observational studies: prevention of coronary heart disease. Women taking menopausal hormone therapy appeared to have a lower risk of heart disease, though a higher risk of breast cancer, than women who did not take hormones. Given that heart disease is far more common than breast cancer, many researchers thought that the benefit from menopausal hormone therapy would outweigh the risk. The Women's Health Initiative <strong>Senate</strong> <strong>Special</strong> <strong>Committee</strong> on Aging April 19, 2007
Page 1 and 2: S. HRG. 110-129 Bioidentica
Page 3 and 4: CONTENTS Page Opening Statement of
Page 5 and 6: 2 The sale of bioidentical hormone
Page 7 and 8: 4 ever, as Dr. Wartofsky points out
Page 9: 6 with every stage of the disease:
Page 13 and 14: 10 When the trials began, many rese
Page 15 and 16: Women who began treatment more than
Page 17 and 18: 14 One small trial using oral estra
Page 19 and 20: 16 FDA is aware that a growing numb
Page 21 and 22: 18 DEPARTMENT OF HEALTH & HUMAN SER
Page 23 and 24: 20 safety and efficacy. However, as
Page 25 and 26: 22 adulteration and misbranding pro
Page 27 and 28: 24 The 2002 CPG reflects FDA's curr
Page 29 and 30: 26 Equally concerning are claims by
Page 31 and 32: 28 concerned about the use and mark
Page 33 and 34: 30 Part I: Materials and Partnershi
Page 35 and 36: 32 drugs, when the compounding of t
Page 37 and 38: 34 Our staff identified 34 Web site
Page 39 and 40: 1. Introduction 36 Chairman Kohl, R
Page 41 and 42: diet and fitness products. 5 For ex
Page 43 and 44: include "natural" progesterone crea
Page 45 and 46: 42 unique to the computer age, such
Page 47 and 48: computer users to spam(ftuce.0ov -
Page 49 and 50: 46 accuracy of advertising for heal
Page 51 and 52: 48 Now, you have identified in your
Page 53 and 54: 50 claim." Therefore, since the ter
Page 55 and 56: 52 Such quality control problems ha
Page 57 and 58: 54 Statement Before the U.S. <stron
Page 59 and 60: 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
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150 bleeding of the bowel, locate t
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152 compounding standards can be en
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154 I. The FDA's definition of a "N
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156 ORIIGINAL CONTrMIBTION JANMA-EX
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Initially, the design allowed women
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ards analyses," stratified by clini
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year). These 'drop-in" rates were a
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years of prior use, 11 vs 2; HR, 4.
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trogen plus progestin exposure. Clo
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168 RISKS AND BENEFITS OF ESTROGEN
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EFFECTS OF POSTMENOPAUSAL ESTIROGEN
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EFFECTS OF POSTMENOPAUSAL ESTROGEN
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pEyECTS 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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