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

More documents

Recommendations

Info

Conclusions about the WP 135 -Provides definite relief of vasomotor and menopausal symptoms -Very effective for new bone mineralization -Stabilizes or minimally improves lipid profile -Improves of mood and quality of sleep *Has similar effects of other reported-E2 *Has promising future with further study *Short term use in high risk oncology population does not appear to be detrimental -Clinical trials needed !M ! i; v I , , , -j: 1: .. . . , - ,, .e " , - . . , '_ .tr..
136 Senator SMITH. Thank you very much, Ms. Wiley. You have given us another view, and we respect that. I guess the thing that leads to my questioning of you is clearly the FDA gives a black box warning for hormone therapy when even the slightest amounts or smallest amounts of hormones are used. They tell you to do it for a short duration.! You, however, developed a protocol that uses higher amounts and for longer periods, as I understand it, recommended for lifetime usage. We have heard differing views at this morning's hearing. I wonder, your protocol's approach contradicts that held by the larger-the greater-medical community on hormone therapy. You have said you are not a medical doctor. Can you explain how your proposal doesn't put women at greater risk? Ms. WILEY. Yes. <strong>Hormones</strong>, as I am sure Dr. Wartofsky could agree, are dose-dependent in their effects on cellular systems and different in every organ in the body. The normal menstrual rhythm, or the normal production of hormones over the course of 28 days in a healthy young woman who does not have breast cancer, heart disease, Alzheimer's, arthritis, osteoporosis-we could go on for days-in those healthy young women, is a rhythmic production with a crescendo of estrogen on day 12 and a crescendo of progesterone on day 21. In using bioidentical transdermal hormone creams, it is possible, through justification with blood work, to recreate a dosing schedule that mimics those normally rolling hormones that provoke something called apoptosis, which is cell suicide, in the progesterone phase, that in the estrogen phase on day 12 provoked the progesterone receptor so that apoptosis can happen. Endocrinology is about pulsatility and amplitude. A diabetic, for example, would never take the same amount of insulin day-in and day-out. The diabetic responds to the meal the diabetic ate with the appropriate amount of insulin that his body might have produced could he produce it. I only suggest that women are treated the same way. Senator SMITH. You obviously believe that the bioidentical products ought to have a medical definition. Ms. WILEY. Yes, I do. Senator SMITH. OK. It is not just a marketing term. Ms. WILEY. No. Well, I think "bioidentical" is a marketing term. I think "biomimetic" is more accurate. But there are differences in the effects of the molecule of estradiol versus conjugated equine estrogens, very big differences, certainly on inflammatory response in cardiovascular events. Senator SMITH. Thank you. Dr. Manson, have you reviewed the Wiley Protocol? Dr. MANSON. Yes, I have. Senator SMITH. Do you have any problems or concerns? Dr. MANSON. I think it is an interesting theory, and I would like to see it tested. But I think we have to note that in the post-menopausal woman, there are not these levels of estrogen and progesterone that are achieved with this treatment, so it is not a natural state that is being induced.
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:
Page 83 and 84:
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: 134 *Labor intense for patient and
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

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?