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

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BIOIDENTICAL HORMONES: SOUND SCIENCE OR BAD MEDICINE? THURSDAY, APRIL 19, 2007 U.S. SENATE, SPECIAL COMMITTEE ON AGING, Washington, DC. The <strong>Committee</strong> met, pursuant to notice, at 10:05 a.m., in room 526, Dirksen <strong>Senate</strong> Office Building, Hon. Gordon H. Smith presiding. Present: Senators Smith and Craig. OPENING STATEMENT OF SENATOR GORDON H. SMITH, RANKING MEMBER Senator SMITH. Good morning, ladies and gentlemen. With the permission of the Chairman, Senator Kohl-he has asked us to proceed. We thank you for attending today's hearing, "<strong>Bioidentical</strong> <strong>Hormones</strong>: Sound Science or Bad Medicine?" As the title suggests, we are here today to closely examine the controversy surrounding the production and use of bioidentical hormones as an alternative to conventional hormone therapy.. The intent of this hearing is not to endorse one therapy over another. Rather, it is to ensure that the Federal Government is providing the information and oversight necessary so that consumers, women specifically, are able to make safe and well-informed decisions about their individual health-care needs. From my review, it seems that the Federal Government and medical practitioners are playing a guessing game with women's health in the prescribing of hormone therapies. Today's hearing reflects my belief that women deserve better. I hope to get some answers today regarding the state of the science and the Federal Government's oversight role in this arena. Over a decade ago, the National Institutes of Health set out to shed some light on the effect of hormone therapy on preventing heart disease in women through the largest research initiative ever undertaken of this kind: the Women's Health Initiative. When evidence indicated that the health risks of the therapies studied in the WHI exceeded the benefits, the study was prematurely ended, scaring thousands of women away from traditional hormone therapy. As an alternative, bioidentical hormones have become a popular and controversial option, not only for aging women, but for men and women of all ages seeking a route to the fountain of youth. (1)
2 The sale of bioidentical hormone products are on the rise and have been promoted by such distinguished actresses as Suzanne Somers and major marketing campaigns in doctors' offices, pharmacies and the Internet touting bioidenticals as natural and, thus, safer alternatives to traditional hormone therapies. There has been much debate in the scientific community, however, as to whether the science exists to support these claims. By the end of this hearing, I hope to have a clear understanding of whether additional federally funded studies are needed to address concerns regarding the safety and efficacy of these products. Today, we will also address the regulatory issues relating to the manufacturing of these products, especially those that are custommade or compounded in pharmacies. I am particularly troubled that compounded medications are not routinely tested and are not accompanied by warning labels and risk indicators that are required for traditionally manufactured medications. Further, there is a lack of information available to assist Congress in determining the proper roles of the Federal Government, the State Governments and the industry in regulating pharmacy compounding. That is why I have asked the Congressional Research Service to conduct a 50-State survey that will help me and my colleagues determine the best course of action going forward. Ultimately, the Federal Government must do a better job of empowering consumers to make informed decisions regarding hormone therapies and compounded medications. But the current regulatory framework is hazy and creating confusion between the Federal Trade Commission, the Food and Drug Administration, and State boards of pharmacy, regarding who has ultimate regulatory responsibility. I fear that lack of consistent and certain oversight has created an atmosphere ripe with opportunities for fraud and abuse. By the end of this hearing, I would like to have some confidence that the regulatory agencies are taking these issues seriously and have a concrete plan of action to address the committee's concerns. On our first panel this morning, I am pleased that NIH will be testifying for the first time before Congress regarding the latest findings in the Women's Health Initiative study. Also on the first panel will be the FDA and the FTC, who will speak about the agencies' enforcement efforts. Our second panel promises a lively discussion regarding the science of bioidentical hormones and the regulatory issues relating to pharmacy compounding. I look forward to that dialog. With that, I will turn to my colleague, Senator Craig, from Idaho.
Page 1 and 2: S. HRG. 110-129 Bioidentica
Page 3: CONTENTS Page Opening Statement of
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
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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
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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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Bioidentical Hormones - U.S. Senate Special Committee on Aging

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