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

More documents

Recommendations

Info

131 Clinical Characteristics ONon-Hodgkin's Lymphoma 4 *Colorectal 2 *Ovarian 2 "Post BMT 1 *Lung 1 *Leukopenia 3 "No cancer + FHx, hematological 8 WP Data eAverage lennth of use: 22 years as on October 2n06 -Ranges 6 mo to 4.5 years *Blood levels and tests *Dose Adjustments -28/54 oCompliance *Drop out Wiley Protocol AE's "Pulmonary embolism -71y.o. after 3 years; cont'd WP
*Breast cancer 132 -57 y.o. recurrence resected- continued -59 y.o. new cancer opposite breast after 2 years .(present at time of Initiation) Adverse Events 60 y.o. breast cancer mass removed- no nodes taken Started WP 1 year later Axillary mass 1 years after WP Restaged- only axilla 2 nodes present at 2nd surgery Ovarian Cancer IMIc -49 y.o. 2.5 years on WP Wiley Protocol Concerns *Fibroids: for better, stable, or worse- *Endometrial thickening or cancers - 0 *Cardiac events, stroke,-or DVT -0 *Gallbladder disease -3 surgery -2
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: 130 Years # women *1>0.5 8 *1+ 9 *2
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 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 209 and 210:
Page 211 and 212:
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 237 and 238:
Page 239 and 240:
Page 241 and 242:
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
show all

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

Create successful ePaper yourself

Delete template?

Save as template?