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

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205 HORMONE THERAPY USE AND RISK OF CARDIOVASCULAR DISEASE tenuated after excluding women older mum, screening and treatment of risk For CEE + MPA, the risk of breast than 6Oyesars in the years since meno- factorsforstrokewouldbeadvisable be- cancer also needs to be considered. In pause analyses) implies that, at a mini- fore considerng hormone therapy. women with less than 10 years since Figure 2. Estimated Absolute Excess Risk per 10000 Person-Years by Years Since Menopaase at Baseline Ccom~kdlTdl CEE Thd cEE. 64PA Tha 100 P-10.10 I I 0010000 ,J T r Pa9o t 1201100-140 ~ ~ I ~~ C"D2CEOE CZE P-bo. 1000110 ~~~~~~~~~I ~_a r I mPA P619 CHD 1009 Ehos M-ea vo 0o,0 024 1 t 0.13 0.27 I 019 023 F 01C,9 IV20 043 01 03 00 2 1 -- H. oI.a 077 0sa7 070 I 040 079 0.33 0.49 F- T 4ens 02114 M00poo c'S -10 D 0.11 020 013 0.15 oAD H 10-19 030 030 043 0n 0 030 F03 420 067 04-4 000f~ 045 007 04 slo 024 0e31 023 0.30 024 0.30 0o-19 0053 055 062 0,62 040 049 M20 1.05 03 1.09 090 009 0F92 n1 3 007 1.01 I0' 1.04 093 C12-19 17 0 102 1.22 191 104 220 281 20 00 2240 3.00 2075 -O O40 so 120 - 0 6 0 120 0 9 0 o120 Ev,1ard fbote E0 9 Risk P0 10200 Penon Eg4ne0d Ab126 E.0 1 _srs 10000 P_-Y0_ tkA Ewtha edAb .Er0-60 P0 1Pe 10000 P01900- Y991 The estai-lvd abobate rxcess n9k -ly diffe0 sightly 1'0 the obsolote 011s19i9k de1ived Iror the dien,-s b r04e5 per 10D pe0100-y-a,5 bct~e..tin - h1101900 40d pl-.1b0 0gcu11. 0Rfi-Ltd 4b114.te -1510 rlsk per 1000 p0f.ry0415 cki.a0ld 99 t nnur32cd pelcentAge b the pl-ebo yospx (thaord ratio in th0 pI0bo 1g5p- II 10D. . E6r5b.1 Indkrete 95% rorthdenre i0te0rds, 9thmated sigt bocts1,9114 methro0s. CEE WMcit.s00mj0g4ted e09i50e09trg0e.s: CHDn, --on ry hea4t doio.; MPA. .1d0,10ypr04e,1e101 0cebtte. *PO.03 p.00M1rd w11h the less thn 10 0 0ea sthin Me009 0O-. tP=.O04 Co9pedv1th the I-10 th90 10 yeas rnre me.paDe40 grlp. Table 6. Cardiovaseular and Global Index Events In Sabgroup of Participants vith Moderate or Severe Vasromotor Symptoms at Baseline in the Conobined Tnals Are Goup di Randonmbtn sf-5sy 60-O9 y 70- 7 9 y No. ofCaso No. of CO No. of Crae Vraue Hormo0e Therapy Placebo HR (n=1097) 1n01030) (95%Cil Homnone Thea-ny (n=691) Hormlone Placebo HR Therapy (In9WS) t95% Cn- (n=197) Placebo (nT96i HR (95%CQ- Interamtih With V9rno01t0 Trendt Symptoms* CHD§ 17 19 0.86 (0.44-1.65) 31 25 1.20 (0f70-2.04) 27 6 5.06 (2.08-12.40) 0.01 .04 Stn10,4 14 11 1.09 (D.49-2.43) 16 20 0.75 l0.39-1 45) 12 3 394 (1.09-14.23) 28 .34 Totalrortslidy 20 22 0.05 3S 27 1.27 24 15 1006 .22 .72 (0.46-1.56) (0.77-2.12) (081-3.00) Gohbal1adodf 69 6600 0.98 (070 1.38) 80 05 6 .02 10711-1.37) 62 32 2.10 (1.35-3.27) .02 .1S Abb-,Iex-01 C iD, -00499y hr0 dc r. C.. n0 k9 e: HR1. 1-,5 rr41 tenn 1. Mf rnd 1h4 html- n bi-twi te;2serd ae.~ tgikfhl r0. tt.1 iD, 3-..y intr rti- -- Q hax-e th-ey, ag. n rd M4"vrstoev rmkJ v mrxxr~ ai F sDstrs Wt CHD oe-th. ntn1tri mYorbrar on o de(. iZe ;;~ m~ kikoltk RFD 5.1 sv 5.2)1 Mo~r CHID. -rk% pDtnr~ -mbrsKs. trens cacu. - cx-til -are .td --W -r D. CEE Pbu MPA brJW orr hip Od- ctr dE.4h Fot eer- s 1474 )AMiA, Apni Al, 2007-V.1 297, N.. 13 (Rtepritef) 0200t7 Aralrtdl Idodleet Asdtrordn. All rdgbts t.d. D-os aldd fronm WsJro n.corn M Ntioaml Instit. of HIh. on April 5,2007
206 HORMONE THERAPY USE AND RISK OF CARDIOVASCULAR DISEASE menopause, there were 72 (0.32%) cases ment of vasomotor symptomswith hor- decreasing risk is confounded by dimin- of breast cancer while taking CEE + MP'A mone therapy in younger women reishing compliance over time. Curent or compared with 57 (0.28%) cases while mains an option, the reverse might past hormone users and never users ap- takingplacebo (HR, 1. 19: 95% Cl, 0.84- apply io older women. Rather, the prespeared to have similar trends toward in- 1.70). By contrast, the increasing absoence of moderate or severe vasomotor creasing risks by years since menolute risks of CHD in older women or symptoms at older ages might signal the pause during the rial, providing indirect women more distant from menopause need for identifecaion and treatment of evidence that longer duration of use is (most marked in women aged >70 years risk factors for CHD. Although CHD not protective. It is not feasible to test or 220 years past menopause). to- risk factors were more frequent in hormone effects over very long periods gether with their increased risks of stoke. women with vasomotor symptoms, of use in clinical trials, and observa- breast cancer, and venous thromboem- analyses adjusting for these factors did tional studies have yielded conflicting rebolism, would in general contraindi- not change the trend statistic, suggestsuIts.'cate the use of honnones for disease preing that hormone therapy interactions vention in these groups. with other unmeasured risk factors in The findings for vasomotor symp- women with vasomotorsymptoms may toms are itnguingand ofpotential im- underlie the increasing risk in women portance to clinicians hut need confir- more distant from menopause. mation. The higher risks in women The current analyses are most perti- more distant from menopause apnent to the effects of initiation of exogpeared to be concentrated in the small enous hormone use but also provide subset of women with moderate orse- some limited information regarding the vere vasomotor symptoms. It is pos- potential effects of prolonged use, taksible that vasomotor symptoms in reing into account indicators of horcently menopausal women represent mone status at trial enrollment. Within the reaction of vessels with normal en- the relatively short trial durations, CHD doihelial function to estrogen with- risk related to hormone therapy apdrawal but persistent symptoms may peared to decrease over time. How- signify something different in older ever, the significance of this trend over women. Ifconfirmed elsewhere (eg, by time depends on both the initial in- reanalyses of existing observational crease in risk, as well as the subsequent studies and clinical trials), the clinical decrease, and hence may partially rep- implication might he that while treatresent a survivor effect. In addition, the 0 "Unlike statindnugs, which have beneficial effects for both atherosclerosis and clinical events irrespective of the underlying state of the arteries," 1 hormone therapy has a putative beneficial effect on early atherosclerosis," no eflect on advanced atherosclrosisa 2 and an early increase in risk of CHD events when advanced atherosclerosis may be present.'- 1 " Because age-related progression of atherosclerosis is likely to continue even in the face of hormone therapy, use over decades could potentially result in an eventual increase in CHD events. Hence, even if ongoing imaging trials confirm a slowing of early atherosclerosis, 011 ' it would be unwise to extrapolate such findings to clinical benefit with continued use into old age. These analyses are based on systematically ascertained outcomes in a set- Table 7. Cardiovascular and Global Index Events in Subgroup of Partiopants With Moderate or Severe Vasomotor Symptoms at Baseline in the Combined Trals Year, Since Melnopause
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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
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: mal studies, and laboratory studies
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 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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