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

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67 visory warning, as required for FDA-approved hormones. This is a serious concern for women and their doctors. Compounding pharmacies are not required to adhere to the strict manufacturing processes governing FDA-monitored facilities, raising concerns about purity, potency and quality. In one FDA-conducted post-market survey, 4 out of 11 compounded hormones failed tests for potency and/or uniformity. Our concerns are shared by the broader medical community, including multiple other professional medical organizations. The AMA recently adopted a policy in support of our society's positions. In conclusion, the society supports legislative action to standardize regulation of compounded hormones to include requirements for: (1) surveys for purity and potency; (2) mandatory reporting of adverse events; (3) a registry of these events; (4) inclusion of uniform patient information in the packaging; and finally and (5) limits on the use of this term, "bioidentical hormones." The fact is that scientific evidence is lacking at this time to either negate or support claims that bioidentical hormones are safer and more effective than other commonly prescribed hormones. Until conclusions are based on science, the Federal Government must ensure patients receive safe and effective drugs with accurate information. That concludes my personal remarks, Senator. I would be happy to answer any questions. [The prepared statement of Dr. Wartofsky follows:]
68 Statement of Leonard Wartofsky, M.D. On Behalf of The Endocrine Society Before the <strong>Senate</strong> <strong>Special</strong> <strong>Committee</strong> on Aging April 19, 2007 Mr. Chairman, I would like to thank you, as well as the distinguished Ranking Member, Senator Smith, and the members of the committee, for the opportunity to testify today. My name is Leonard Wartofsky. I am the Chairman of the Department of Medicine at the Washington Hospital Center. I previously served as Director of the Endocrinology Division and the Endocrinology Fellowship Training Program, and Chief of the Department of Medicine and Program Director of the Internal Medicine Residency at Walter Reed Army Medical Center. I am an elected a Master of the American College of Physicians, Professor of Medicine at Georgetown University School of Medicine and Professor of Medicine and Physiology at the Uniformed Services University of Health Sciences. In my professional capacity as a physician, I treat patients suffering from a variety of endocrine disorders, such as thyroid disease, pituitary disease, diabetes, and obesity. I am here today, however, as President of The Endocrine Society, the world's largest and most active professional organization of endocrinologists representing more than 14,000 members worldwide. Our organization is dedicated to promoting excellence in research, education, and clinical practice in the field of endocrinology. Appropriate clinical use of hormone therapy of all kinds falls under the purview of endocrinology and the Endocrine Society. My testimony will address The Endocrine Society's concerns regarding the compounding of what are commonly known as "bioidentical hormones." Specifically, The Endocrine Society believes it is critical that the federal government increase the regulatory oversight of bioidentical hormones, which have been inaccurately touted as safer and more effective than traditional hormone therapies. Claims such as these, which are propagated by the popular media, are leading women to request bioidentical hormones from their doctors. As the leading experts in hormone treatments, endocrinologists are constantly approached by patients who are convinced that bioidentical
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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
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: 66 Dr. MANSON. Well, I think that m
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
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
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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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