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

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147 .* patients would not have available to them the options of gummy bears, popsicles, most of the transdennal gels, oral inhalation solutions, medication sticks, iontophoresis solutions, phonophoresis.solutions,.etc. - *4 nfants who are, born prematurely would not have available to them many.lifesaving and life-sustaining drugs,,7, a . . ,. . ..- ,, - * infants-would not have available to them many drugs OLoyd-V. Allen, Jr., Ph.D.,.Editor-in-Chief, International Journal of Pharmaceutical Compounding, www.UPC.com '-..; '.i ,_i A. . , ' !': I
148 WHITE PAPER #2 Pharmacy Compounding is Important in Today's Healthcare In the past, Compounding Was Pharmacy! Throughout history, pharmacists have had to compound drugs for individualized dosages for patients when they were prescribed by physicians. In the early 1900s, however, the pharmaceutical industry began manufacturing a myriad of drugs and dosage forms for patients and the need for compounding diminished. Since the late 1900s, a lot has changed and the pharmaceutical industry no longer supplies all the medications needed by patients. Pharmacy Compounding is important for the following reasons: ]. LIMITED DOSAGE STRENGTHS: The pharmaceutical industry supplies only limited strengths of drugs. One size does not fit all and it is often necessary to change the strength of a drug for patients through compounding. 2. LIMITED DOSAGE FORMS: The pharmaceutical industry supplies only limited dosage forms; generally only an oral solid (tablet or capsule) and/or injection are manufactured. This does not address the needs of children, premature infants, the elderly, and special needs patients. In fact, Congress has made it possible for the industry to obtain additional patent protection if they manufacture a pediatric (children's) form of the drug, but most companies still do not do this because it is not economically feasible for them. Therefore, compounding is necessary. 3. HOME HEALTH CARE: A significant percentage of the needs of home healthcare patients are satisfied by compounded medications, including, for example, total parenteral nutrition (intravenous fats, sugars, and amino acids) necessary for the healing of colon disorders post-operatively. These patients cannot be satisfactorily medicated or sustain the nutritional status needed for healing with manufactured dosage forms. 4. HOSPICE AND PALLIATIVE CARE PATIENTS: End-of-life therapy involves the compounding of many different and unique dosage forms to allow patients to live out their lives free of pain and discomfort. Many combinations of drugs are used for these patients who cannot swallow medications and who don't have the muscle mass that is required to receive multiple injections each day. Other methods include compounded medications for oral inhalation, nasal administration, topical/transdermal, and rectal use. 5. DISCONTINUED DRUGS: The pharmaceutical industry has discontinued thousands of drug products over the past 25 years, many due to economic considerations. These were very effective and important medications. The only way they are now available is through pharmacy compounding. 6. DRUG SHORTAGES: With over 70% of all bulk drug chemicals being imported for the U.S. pharmaceutical industry and for compounding, commercially manufactured
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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
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
Page 121 and 122: 118 If this legislation passes, fed
Page 123 and 124: first and second finger on the barr
Page 125 and 126: 122 These products that have been s
Page 127 and 128: 124 Bcl-2, survivin and variant CD4
Page 129 and 130: 126 These are experiments by other
Page 131 and 132: 128 cerebro-cellular inflammation c
Page 133 and 134: 130 Years # women *1>0.5 8 *1+ 9 *2
Page 135 and 136: *Breast cancer 132 -57 y.o. recurre
Page 137 and 138: 134 *Labor intense for patient and
Page 139 and 140: 136 Senator SMITH. Thank you very m
Page 141 and 142: 138 makes these hormones uniquely s
Page 143 and 144: 140 tomize the Wiley Protocol by ra
Page 145 and 146: 142 "natural," because all lead to
Page 147 and 148: 144 maceutical commerce, often with
Page 149: 146 WHITE PAPER #1 DID YOU KNOW THA
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
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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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