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

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213 %-nicat i nai: nronos Early Estrogen Prevention Study (KEEPS) ElbiUlty Study start: September 2005; Expected completion: June 2010 The KEEPS is designed to explore the hypothesis that early initiation of hormone therapy, in women who are at the inception of their menopause, will decrease the rate of accumulation of atherosclerotic plaque. indicating a likely delay in the onset of clinical cardiovascular disease. The study is designed as a multicenter, 4 year randomized clinical trial. It will evaluate the effectiveness of of O.45 mg/day of oral conjugated equine estrogens or 50 mcg/day of transdermal estradiol via skin patch changed weekly (each in combination with cyclic oral, micronized progesterone, 200 mg daily for 12 days per month), versus placebo in preventing progression of carotid intimal medial thickness by sonogram and the aecrual of coronary calcium in women aged 42-58 who are within 36 months of their final menstrual period at initiation of treatment A number of secondary endpoints including biochemical and genetic risk factors for cardiovascular and thrombotic disease, and effects on cognition will also be studied. The study will enroll a total of 720 women in 2005-6, with an anticipated completion of the trial in 2010. Ages Eligible for Study: 42 Years - 58 Ycars, Genders Eligible for Study Female Accepts Healthy Volunteers Criteria Inclusion Criteria: * menses absent for at least 6 months and no more thsn 36 months * good general health * plasma FSH level greater than or equal to 35 mlU/ml * estradiol levels < 40 pg/m1 * normal mammogram within I year of randomization Exclusion Criteria: * use of hormone replacement or supplement within 3 months of randomization * endometrial thickness >5 mm by vaginal ultrasound * in utero exposure to dietrylstilbestrol (DES) * current smoking> IO cigarettes/day . obesity-body mass index > 35 * history of clinical cardiovascular disease * history of cerebrovascular disease * history of thromboembolic disease * coronary calcium score 2 50 units * dyalipidemia-LDL cholesterol >190 mg/dI * hypertrnglyceidemia-triglycerides >400 mg/dI * lipid lowering medication (statin fibrateor> 500 mg/day of niacin) * nut allergy (Prometrium includes peanut oil) * uncontrolled hypertension-systolic BP >150 and/or diastolic BP > 95 * hysterectomy * history of, or prevalent, chronic diseases including any cancer (other than basal cell skin cancers), renal failure, cirrhosis, diabetes mellitus, and endocrinopathies other than adequately treated thyroid disease
214 LntIucwu miau: rronos nary estrogen rreveniuon Stmay (KtEEPl'S) * known HIV infection and/or medications for HIV infection * reaults of any safety laboratory test chemistries, (TSi, CBC, U/A) more than 20% abnormua e Location and Contact Information Please referto this study by ClinicalTrials.gov identifier NCT00154180 Patricia Crenshaw, BA (866) 878-1221 info krqosinsitirtqtrg Mary Barksdale. CNM, CCRP (602) 778-7487 United States, California University of California, San Francisco, San Francisco, California, 94115, United States; Recruiting Nancy Jancar, RN 415-353-4300 kcnstutq~uoftgdM.org Marcelle I Cedars, MD, Principal Investigator United States, Connecticut Yale University. New Haven, Connecticut, 06520, United States; Recruiting Diane Wall, RN 203-737-5169 diane.walliyale.edu Hugh S Taylor, MD, Principal Investigator United States, Massachusetts Brigham and Womenes Hospital, Boston, Massachusetts, 02215, United States; Recruiting Kathryn Kalan, RN 617-732-9871 kkaqtrtaor JoAnn E Manson, MD, DrPH, Principal Investigator United States, Minnesota Mayo Clinic, Rochester, Minnesota, 55905, United States; Recruiting Teresa Zais, RN 507-538-0848 zaisktererafmmayo.edi Virginia E Miller, PhD, Principal Investigator United States, New York Columbia Presbyterian Hospital, New York, New York, 10032, United States; Recruiting Amber Ahmad, MPH 212-305-9672 u24300colurbimeb Luz Sanabria 212-305-9672 l328(clumnabi c Roger Lobo, MD, Principal Investigator Albert Einstein College of Medicine, Bronx. New York, 10461, United States; Recruiting Barbara Isaac, RN 718-430-8656 bimaq ag&=yM Nanette F Santoro, MD, Principal Investigator United States, Utah University of Utah, Salt Lake City, Utah, 84108, United States; Recruiting Stacey Larrinaga-Shum 801-581-3888 Ext. 249 S=M.Lml-nagshumahsc.utah. Eliot Brinton, MD, Principal Investigator United States, Washington University of WashingtonlVA Puget Sound, HCS, Seattle/Tacoma, Washington, 98493, United States; Recruiting Colleen Caney, RN 253-583-2040 - Suzanne Barsness, RN 206-543-3897 barsess'. a,, George R Merriam, MD, Principal Investigator -1,t1.h-/Nr'rAnl ',Al Rng-A.-A Itr;07nn7
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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
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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
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
Page 207 and 208: mal studies, and laboratory studies
Page 213 and 214: 210 ,lmcCII na: CLI I tr: tarty ver
Page 215: 212 ,mucmai rimi &ronos farty bstro
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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