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

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*25 are compounded for oral, topical, transdermal, suppository, and other routes of administration. FDA's'regulatory approach toward compounded BHRT.products is framed by its general approach to compounded drugs: FDA recognizes the legitimacy of traditional pharmacy compounding of BHRT products, ie., when a pharmacist compounds a BHRT product in response to a licensed practitioner's decision that a patient's specific medical need cannot be met by an FDA-approved drug. FDA will generally continue to defer to state regulators regarding this practice. Claims Reeardine Compounded BHRT Products FDA is concerned, however, that a number of pharmacies make claims about compounded BHRT products that are false and that may mislead patients and practitioners as they decide whether these products are appropriate. Drugs that make false and misleading claims are misbranded under the FD&C Act. FDA believes that some promotional materials for compounded BHRT products contain inaccurate information and do not adequately advise patients and practitioners of the risks associated with compounded hormone products (risks that appear to be the same as the hazards related to FDA-approved hormone products). These promotional materials may also contain unsubstantiated claims about the safety and efficacy of compounded BHRT products. Moreover, some compounding pharmacists claim that their BHRT products are a "natural" alternative to FDA-approved drugs, because the compounded hormones are identical to the hormones produced in the body. These pharmacists may further claim that their "natural" compounded BHRT products are a safe alternative to FDA-approved drugs because they lack the risks and side effects associated.with those drugs. FDA is unaware of any credible scientific evidence supporting the assertions that these bioidentical compounded products are a safe or effective alternative to FDA-approved drugs containing hormones.
26 Equally concerning are claims by compounding pharmacists that compounded BHRT products can be used to prevent serious illnesses, including breast and colon cancers, cardiovascular disease, and Alzheimer's disease. These claims are not substantiated by scientific evidence for these compounded BHRT products, and they risk misleading consumers into using compounded BHRT products to prevent these illnesses in the absence of any evidence supporting there effectiveness. FDA is also not aware of sound evidence showing the superiority of compounded BHRT products over FDA-approved drugs. Likewise, FDA has no information indicating that the side effects and risks of compounded BHRT products are dissimilar to those of FDA-approved drugs. Thus, claims regarding the safety, efficacy, and superiority of compounded BHRT products have not been substantiated by FDA and may mislead patients and practitioners. Lack of Warnings and Information: Compounded BHRT Products FDA regulations require prescription drugs containing estrogen to be dispensed with a patient package insert explaining the drug's benefits and risks. 21 CFR §310.515. Compounded BHRT products are often dispensed without this information. Thus, patients are not explicitly advised of the risks associated with the use of these compounded products. The absence of warnings and risk information may be viewed by patients as implicit evidence that compounded BHRT products are safer than FDA-approved drugs, when there is no data to support this conclusion. FDA's Shared Concerns with Medical Professional Oreanizations FDA is not alone in its concerns regarding compounded BHRT products. A number of medical professional organizations, including the American Medical Association (AMA), the Endocrine Society, and the American College of Obstetricians and Gynecologists have published formal statements regarding compounded BHRT products.' On the See American Medical Association House of Delegates Resolution 706, "TDA Oversight of <strong>Bioidentical</strong> Hormone (BH) Preparations," September 27, 2006; Endocrine Society Position Statement, 'Sioidentical <strong>Hormones</strong>," October 2006; American College of Obstetricians and Gynecologists, <strong>Committee</strong> on Gynecologic Practice Opinion on Compounded Bio-identical <strong>Hormones</strong>, November 2005.
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: 24 The 2002 CPG reflects FDA's curr
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 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
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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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