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

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35 PREPARED STATEMENT OF THE FEDERAL TRADE COMMISSION on ALTERNATIVE HORMONE REPLACEMENT THERAPY PRODUCTS Before the SENATE SPECIAL COMMITTEE ON AGING Washington. DC Aprfl 19,2907
1. Introduction 36 Chairman Kohl, Ranking Member Smith, and Members of the <strong>Committee</strong>, I am Eileen Harrington, Deputy Director of the Bureau of Consumer Protection of the Federal Trade Commission ("FTC" or "Commission").' I appreciate the opportunity to-discuss the Commission's efforts to address the misleading online advertising of "alternatives" to hormone replacement therapy as well as its work to combat all types of Intemet fraud. Among its many benefits, the Internet provides consumers with access to a vast array of information and products, including health-related items. Unfortunately, the online medium also provides an opportunity for irresponsible marketers to prey on consumers with false or misleading claims that can cause economic injury and have potentially serious consequences for consumers' health. Therefore, pursuant to its broad authority to prevent "unfair or deceptive acts or practices," 2 the FTC has a longstanding and active program to protect consumers in the online environment. This testimony provides an overview of the FTC's efforts with respect to health-related fraud, including an explanation of its jurisdiction over health products and a discussion of the FTC/FDA project to address the misleading marketing of hormone replacement therapy alternatives. Pursuant to the <strong>Committee</strong>'s request, the testimony then discusses the FTC's broader program to combat online scams in general. 'This written statement presents the views of the Commission. My oral testimony and responses to questions reflect my views and do not necessarily represent the views of the Commission or any individual Commissioner. 2 Section 5 of the Federal Trade Commission Act, 15 U.S.C. § 45(a). In addition, Section 12 of the Federal Trade Commission Act prohibits the false advertisement of "food, drugs, devices, services, and cosmetics." 15 U.S.C. § 52.
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: 34 Our staff identified 34 Web site
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 85 and 86: 82 Senator SMITH. Dr. Allen, as I h
Page 87 and 88: 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
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154 I. The FDA's definition of a "N
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156 ORIIGINAL CONTrMIBTION JANMA-EX
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Initially, the design allowed women
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ards analyses," stratified by clini
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year). These 'drop-in" rates were a
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years of prior use, 11 vs 2; HR, 4.
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trogen plus progestin exposure. Clo
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168 RISKS AND BENEFITS OF ESTROGEN
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EFFECTS OF POSTMENOPAUSAL ESTIROGEN
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EFFECTS OF POSTMENOPAUSAL ESTROGEN
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pEyECTS OF POSTMENOPAUSAL ESTROGEN
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10000 isoor i I ea '° a wan 20-24
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~SDt~rpa g~2~Q ~ !~fm~. b~e ~ ng jh
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Is associated with an Increased ris
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188 Postmenopausal hormone therapy
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group (P= 04001), and In this subgr
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Treatmnent recommendations Based on
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21.Grodsteln F. Manson JE, Colditz
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_ ORWIGNAL CONTIuBUTION 196 Postmen
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showed no striking differences in H
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(214 cases; P for trend=.72): howev
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202 HORMONE THERAPY USE AND RISK OF
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mal studies, and laboratory studies
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210 ,lmcCII na: CLI I tr: tarty ver
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212 ,mucmai rimi &ronos farty bstro
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214 LntIucwu miau: rronos nary estr
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XVI. PNharmacy Licensure Requiremen
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XVI. Pharmacy Licensure Requirement
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220 Roster of Board of Pharmacy Ece
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050. 0l7404405400 Al-h. PeVbU 03283
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Conclusions * Age is a powerful ris
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Women's Health Initiative Trials of
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Hormone Therapy after WHI * Change
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Statement of the American Pharmacis
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232 APhA Statement to the S
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240 Written Testimony of Steven F.
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242 STATEMENT OF DAVID G. ADAMS On
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244 Report on State Laws and Regula
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246 Only one state, Utah, requires
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248 5. Compounding Copies of FDA-Ap
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