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

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199 HORMONE THERAPY USE AND RISI< OF CARDIOVASCULAR DISEASE menopause (TABLE I and TABLE 2). vs 1.23; P=.02 after adjusting for Effects of Hormone Therapy Coronary risk factors (except smok- risk factors).' Risk of siroke was by Age at Randomization ing)andpnorcardiovasculardiseasein- increased (HR. 1.32; 95% Cl, 1.12- The numbers of events increased with creased markedly wiuh increasing age 1.56) in the combined trials, with no increasing age but there was no statisand years since menopause (data not dilference between the individual tically significant additional effect of shown). trials. Individual trial results were hormone therapy by age for any outsimilar to those described in previous come in the combined trials Orerall Effectsi of Hormone publications using centrally coded (TABLE 4). The trends in HRs for CHD Therapy (All Participants) dala. 3 °'°.i Esnmated absolute excess appeared to be somewhat more pro- Consistent with previous WHI stud- risks per 10 000 person-years were nounced in women without prior caries, 3t hormone therapy did not reduce approximately 3 for CHD, 9 for stroke. diovascular disease with HRs of 0.91. overall risk of CHD (TABLE 3). As I for total mortality, and 14.5 for the 0.97, and 1.33 across the 3 age groups before, the HR for CHD was lower global index in the combined trials. (535 cases; P for trend= .10) compared when participants were taking CEE under a constant HR model for each with 0.99, 0.98, and 1.12 in women than when taking CEE+MMPA (0.95 trial. with prior cardiovascular disease Table 1. Selected Baseline Characteristics of Participants in the Tial ot Conjugated Equine Estrogens (CEE) In = 10739)7 N., (%) ol Patitipanin Rrndmtcation Aseignen4 Age at Pandonation r..S Sbnce Menopaia CEE (n . 5310) Platebo p .5429) 50-59y /n . 331 0) B0-s9y I- 48592 70-79y In = 2577) .10 tn . 1R43) 10-19 in . 292) 320 (n . 450). Years strie nesopus
(214 cases; P for trend=.72): however, these trends did not differ significantly (P for interaction=.54). There were no significant increases in risk due to hormone therapy for any outcome at ages 50 1o 59 years, but increases in risk for CHD, stroke, and global index events in some older age calegories were noted. There was a reduction in total mortality in the age group of 50 to 59 years (HR, 0.70; 95% Cl, 0.51-0.96), with a nonsignificant trend for increasing HRs across age groups (P=.06). In adjusted models, the HRs of CFD (P=.04) and global index evenis (P=.04) were nonsignificanmly lower in the age group of 50 to 59 years for women taking CEE compared with women taking CEE + MPA but HiRs were comparable at older ages (results not shown). The HR for the global index increased with age in the CEE trial (P for trend=.01). However, the trend statistics for CHD and global index did not differ between the trials. 200 HORMONE THERAPY USE AND RISK OF CARDIOVASCULAR DISEASE Effects of Hormone Therapy menopause without prior cardiovascuby Years Since Menopause tar disease, the HR for stroke was 1.64; The HR for CHD was 0.76 in women after excluding women older than 60 with less than 10 years since meno- years, the HRattenuated to t.23 (all 95% pause, I.10 for women with 10 to less Cis included I). There were no signifithan 20 years since menopause, and 1.28 cant differences in the HRs between the forwomen with more than 20yearssince tials in any category of yearssince menomenopause (P for trend = .02; TABLE 5). passe in the adjusted models (results not Hormone therapy increased the risk of shown),andthetrendstaiisticsfortreat- CHD in women with 20 or more years ment effects by years since menopause since menopause (HR, 1.28; 95% Cl, also were similar for all outcomes. 1.03-1.58). In women without prior cardios-ascular disease, Lhe HRs across cat- Estimated Absolute Excess Risk egories of years since menopause were The combination of low inctdence rates 0.78, 1.10, and 1.35 (464 cases; P for and modest HRs at ages 50 to 59 years trend =.02) and in women with priorcar- led to low or no absolute excess risks of diovascular disease they were 0.59,1.08, CHD, stroke, total mortality, or global and 1.14 (180 cases: P for trend= .44); index eventsdue to hormone therapy in these trends did not differ significantly thatagegroup (FIuGRE 1). With increas- (P for interaction = .68). In contrast to ing age, the higher incidence rates and CHD, the effect of hormone therapy on larger HRs yielded progressively larger stmke risk was similar in all categories estinated absolute excess risks due to of years since menopause, with a HR of hormone therapy. At ages 50 to59years, 1.77 (95% Cl, 1.05-2.98) in women with there were 10 fewer deaths per 10 000 less than 10 years since menopause. In person-years compared with 16 addiwomen with less than 10 years since tional deaths at ages 70 to 79 years Tabli 2. Selected Baseline Characteristics of Participants in the Trial of Conjugated Equine Estrogens Plus Medroxyprogesterone Acetate (CEE + MPA) In = 16608), N. I%) of Paerh ats Randonitataon Aginient Age at Ranililatlon Years Since Menopanuse CEE+MPA (i- 8505) Placebo fn.Sl02 s-59py (n.ss22) 60-89y (n.7510) 70-79y (n.3176)
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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
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: showed no striking differences in H
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 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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