Bioidentical Hormones - U.S. Senate Special Committee on Aging
Bioidentical Hormones - U.S. Senate Special Committee on Aging Bioidentical Hormones - U.S. Senate Special Committee on Aging
hormone therapy will cure their ills without risk of side effects such as those reported in the 69 Womens Health Initiative (WHI). Despite their expertise, our doctors often find it extremely difficult to reverse the misinformation held by their patients who hope to find relief of their symptoms without the adverse effects reported in the WHI Study. Initial analysis of The Women's Health Initiative-a large, long-term, prospective study of menopausal and post-menopausal women taking traditional hormone therapy for a period of several years-has raised concerns among some patients and physicians regarding long-term use of hormone replacement therapy. The study was cut short due to evidence of increased risk of cardiovascular disease in women taking estrogen or a combination hormone replacement therapy, and increased risk of breast cancer in women taking combination hormone therapy. Although further analysis of this study shows that the risks vary by age cohort and at what age hormone therapy began, the recent reports of these findings appeared too late to stop women from searching for alternative methods.to treat the.symptoms of menopause. This has created an environment for the proliferation in-the lay-media of the scientifically unproven idea that "bioidentical hormones" are somehow safer and more effective than traditional hormone therapies. !:is imp-ortant a: Lois point to identi, soe con;flsing a-spect-s of th~is topic and to c!!-if~ definitions. Much of the public demand for "bioidentical hormone" therapy has arisen as a result of coverage in the media and popular press that encourages women to aggressively seek out and utilize "bioidentical hormones" that are supposedly customized or individualized for a particular woman's needs. This is misleading in a number of ways. First, women are led to believe that the terms "bioidentical" and "customized" are interchangeable. In fact, the word "bioidentical" simply describes a compound that has exactly the same structure as one produced in the body. Under this appropriate and precise definition, there are bioidentical hormones that exist as FDA- approved drugs that have been available to the public for years. While we do not oppose the use or prescribing of FDA-approved bioidentical hormones, we caution physicians and.patients alike against the presumption that they are safer or more effective than those hormones studied
70 in the WHI. In fact, no study as comprehensive as the WHI has been performed to assess FDA- approved bioidentical hormones. Therefore, it is impossible to directly compare the safety and efficacy of bioidentical hormones with that of the drugs used in the WHI. In order to ensure patient safety, then, we must begin with the assumption that "bioidentical hormones" would perform. similarly to their counterparts if tested in a similar study. Second, women are led to believe that compounded hormones are all bioidentical and are provided in a dose and form that is precisely formulated for their bodies. In reality, compounding does not by default make a hormone bioidentical; non-bioidentical hormones can also be manipulated by compounding pharmacies. The purported customization, while perhaps theoretically logical, is very difficult, if not impossible, to achieve. Some compounding pharmacies are taking things even further by directly marketing their products to the public. Clearly, such activities are outside the scope of compounding pharmacies, which are intended to serve the special needs of patients on an individual basis. The overall result of the activities I've just described has been one of confusion regarding the definition of "bioidentical hormones." A further effect of this confusion is that women have been led to believe that bioidentical hormones are more natural than those studied in the Women's Health Initiative. Given this perception, it is easy to understand why women are drawn to these medications. In truth, bioidentical hormones are produced in labs, just as many other drugs are. Furthermore, compounded hormone preparations are not required to include any black box warning that reflects the findings of the Women's Health Initiative, as is required for FDA-approved estrogens and progesterones, which may also be bioidentical. The lack of patient information in these formulations highlights the reason that the Society is here testifying before your committee today. We are concerned that patients are not receiving accurate information regarding the safety and efficacy of compounded hormones.
- 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 and 70: 66 Dr. MANSON. Well, I think that m
- Page 71: 68 Statement of Leonard Wartofsky,
- 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 81 and 82: Statement of Loyd V. Allen, Jr., Ph
- Page 83 and 84: 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
- Page 121 and 122: 118 If this legislation passes, fed
70<br />
in the WHI. In fact, no study as comprehensive as the WHI has been performed to assess FDA-<br />
approved bioidentical horm<strong>on</strong>es. Therefore, it is impossible to directly compare the safety and<br />
efficacy of bioidentical horm<strong>on</strong>es with that of the drugs used in the WHI. In order to ensure<br />
patient safety, then, we must begin with the assumpti<strong>on</strong> that "bioidentical horm<strong>on</strong>es" would<br />
perform. similarly to their counterparts if tested in a similar study.<br />
Sec<strong>on</strong>d, women are led to believe that compounded horm<strong>on</strong>es are all bioidentical and are<br />
provided in a dose and form that is precisely formulated for their bodies. In reality,<br />
compounding does not by default make a horm<strong>on</strong>e bioidentical; n<strong>on</strong>-bioidentical horm<strong>on</strong>es can<br />
also be manipulated by compounding pharmacies. The purported customizati<strong>on</strong>, while perhaps<br />
theoretically logical, is very difficult, if not impossible, to achieve.<br />
Some compounding pharmacies are taking things even further by directly marketing their<br />
products to the public. Clearly, such activities are outside the scope of compounding<br />
pharmacies, which are intended to serve the special needs of patients <strong>on</strong> an individual basis.<br />
The overall result of the activities I've just described has been <strong>on</strong>e of c<strong>on</strong>fusi<strong>on</strong> regarding the<br />
definiti<strong>on</strong> of "bioidentical horm<strong>on</strong>es."<br />
A further effect of this c<strong>on</strong>fusi<strong>on</strong> is that women have been led to believe that bioidentical<br />
horm<strong>on</strong>es are more natural than those studied in the Women's Health Initiative. Given this<br />
percepti<strong>on</strong>, it is easy to understand why women are drawn to these medicati<strong>on</strong>s. In truth,<br />
bioidentical horm<strong>on</strong>es are produced in labs, just as many other drugs are. Furthermore,<br />
compounded horm<strong>on</strong>e preparati<strong>on</strong>s are not required to include any black box warning that<br />
reflects the findings of the Women's Health Initiative, as is required for FDA-approved<br />
estrogens and progester<strong>on</strong>es, which may also be bioidentical. The lack of patient informati<strong>on</strong><br />
in these formulati<strong>on</strong>s highlights the reas<strong>on</strong> that the Society is here testifying before your<br />
committee today. We are c<strong>on</strong>cerned that patients are not receiving accurate informati<strong>on</strong><br />
regarding the safety and efficacy of compounded horm<strong>on</strong>es.
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