- 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 and 10:
6 with every stage of the disease:
- Page 11 and 12:
8 I am pleased to appear before thi
- 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
- Page 61 and 62:
58 between science and hearsay and
- Page 63 and 64:
60 How can we determine whether bio
- Page 65 and 66:
62 doctors-are not getting the obje
- Page 67 and 68:
64 27. Writing Group for the PEPI T
- Page 69 and 70:
66 Dr. MANSON. Well, I think that m
- Page 71 and 72:
68 Statement of Leonard Wartofsky,
- Page 73 and 74:
70 in the WHI. In fact, no study as
- Page 75 and 76:
In summary, the Endocrine Society i
- Page 77 and 78:
74 The FDA also regulates aspects o
- Page 79 and 80:
Statement of Loyd V. Allen, Jr., Ph
- Page 81 and 82:
Statement of Loyd V. Allen, Jr., Ph
- Page 83 and 84:
Statement of Loyd V. Allen, Jr., Ph
- Page 85 and 86:
82 Senator SMITH. Dr. Allen, as I h
- Page 87 and 88:
84 Now, when you are talking about
- Page 89 and 90:
86 The only thing the WHI proved wa
- Page 91 and 92:
88 Testimony Of T.S. Wiley before t
- Page 93 and 94:
Confusion and Media Hype 90 Instead
- Page 95 and 96:
92 see a doctor tell a diabetic nea
- Page 97 and 98:
94 the only compelling reason to ta
- Page 99 and 100:
96 identical hormones synthesized f
- Page 101 and 102:
98 The world as we know it, from ba
- Page 103 and 104:
100 thereby experienced long period
- Page 105 and 106:
102 Bio-identical progesterone repl
- Page 107 and 108:
104 had reached optimum theoretical
- Page 109 and 110:
106 and the patient can be can reas
- Page 111 and 112:
108 Estradiol and Analytical Resear
- Page 113 and 114:
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 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 177 and 178: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 179 and 180: pEyECTS OF POSTMENOPAUSAL ESTROGEN
- Page 181 and 182: EFFECTS OF POSTMENOPAUSAL ESTROGEN
- Page 183 and 184: EFFECTS 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 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: 220 Roster of Board of Pharmacy Ece
- 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 237 and 238: 234 APhA Statement to the S
- Page 239 and 240: 236 APhA Statement to the S
- Page 241 and 242: 238 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
Change language