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
7 Testimony Before the.
8 I am pleased to appear before this
- 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: 6 with every stage of the disease:
- 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
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- 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
8<br />
I am pleased to appear before this <str<strong>on</strong>g>Committee</str<strong>on</strong>g> in my capacity as the chief of the<br />
Women's Health Initiative (WHI) branch of the Nati<strong>on</strong>al Heart, Lung, and Blood Institute<br />
(NHLBI), part of the Nati<strong>on</strong>al Institutes of Health (NIH), an agency of the Department of<br />
Health and Human Services.- I am here to tell you what we have learned from the WHI<br />
about menopausal horm<strong>on</strong>e therapy using c<strong>on</strong>jugated equine estrogens and to briefly<br />
comment <strong>on</strong> other forms of estrogen therapy.<br />
During the sec<strong>on</strong>d half of the 20th century, estrogen was shown to relieve<br />
comm<strong>on</strong> menopausal symptoms such as hot flashes and night sweats. Subsequent<br />
clinical trials showed that estrogen also prevents b<strong>on</strong>e loss. Based <strong>on</strong> these findings<br />
from rigorous scientific studies, menopausal horm<strong>on</strong>e therapy was approved by the<br />
Food and Drug Administrati<strong>on</strong> (FDA) and became well accepted for treatment of<br />
menopausal symptoms and for preventi<strong>on</strong> of osteoporosis. Most of the prescripti<strong>on</strong>s for<br />
menopausal horm<strong>on</strong>e therapy were written by gynecologists and family doctors for<br />
women experiencing symptoms shortly after the <strong>on</strong>set of the menopause transiti<strong>on</strong>. A<br />
smaller number were for older women to prevent osteoporosis.<br />
However, for many years estrogen was also used under circumstances where<br />
there was no definitive proof of efficacy. One idea that was promoted and became part<br />
of popular lore was that the ebb of estrogen levels after the menopause represented a<br />
disease-like c<strong>on</strong>diti<strong>on</strong> or 'estrogen deficiency" that needed to be treated using 'estrogen<br />
replacement". Many thought that such replacement would keep a woman 'forever<br />
young." In the mid-1980s, another potential reas<strong>on</strong> to use menopausal horm<strong>on</strong>e therapy<br />
emerged from observati<strong>on</strong>al studies: preventi<strong>on</strong> of cor<strong>on</strong>ary heart disease. Women<br />
taking menopausal horm<strong>on</strong>e therapy appeared to have a lower risk of heart disease,<br />
though a higher risk of breast cancer, than women who did not take horm<strong>on</strong>es. Given<br />
that heart disease is far more comm<strong>on</strong> than breast cancer, many researchers thought<br />
that the benefit from menopausal horm<strong>on</strong>e therapy would outweigh the risk.<br />
The Women's Health Initiative<br />
<str<strong>on</strong>g>Senate</str<strong>on</strong>g> <str<strong>on</strong>g>Special</str<strong>on</strong>g> <str<strong>on</strong>g>Committee</str<strong>on</strong>g> <strong>on</strong> <strong>Aging</strong><br />
April 19, 2007