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
RON WYDEN, Oregon BLANCHE L: LINCOLN, Arkansas EVAN BAYH, Indiana THOMAS R. CARPER, Delaware BILL NELSON, Florida HILLARY RODHAM CLINTON, New York KEN SALAZAR, Colorado ROBERT P. CASEY, Jr., Pennsylvania CLAIRE McCASKILL, Missouri SHELDON WHITEHOUSE, Rhode Island SPECIAL COMMITTEE ON AGING HERB KOHL, Wisconsin, Chairman GORDON H. SMITH, Oregon RICHARD SHELBY, Alabama SUSAN COLLINS, Maine MEL MARTINEZ, Florida LARRY E. CRAIG, Idaho ELIZABETH DOLE, North Carolina NORM COLEMAN, Minnesota DAVID VITTER, Louisiana BOB CORKER, Tennessee ARLEN SPECTER, Pennsylvania JULIE COHEN, Staff Director CATHERINE FINLEY, Ranking Member Staff Director (II) f
CONTENTS Page Opening Statement of Senator Gordon H. Smith......................... 1 Opening Statement of Senator Larry Craig .......................................................... 3 PANEL I Jacques Rossouw, chief of the Women's Health Initiative Branch, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD ............................................................... 4 Steve Galson, director, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD ............................................................... 15 Eileen Harrington, deputy director, Bureau of Consumer-Protection, Federal Trade Commission, Washington, DC :..............................:.: . 33 PANEL II JoAnn Manson, chief of Preventive Medicine, Brigham and Women's Hospital, professor of-Medicine, Harvard Medical School, Boston, MA ........... ................ 51 Leonard Wartofsky, president, The Endocrine Society, Chevy Chase, MD ........ 66 Loyd Allen, editor-in-chief, International Journal of Pharmaceutical Compounding, on behalf of The International Academy of Compounding Pharmacists, Sugarland, TX ....................... ....................... ................ 73 T.S. Wiley, writer/researcher, Creator of the Wiley Protocol. Santa Barbara, CA ............................................................... 85 APPENDIX Responses to Senator Smith.Questions. from JoAnn Manson ............ .................. 141 Responses to Senator Smith Questions from Leonard Wartofsky .......... ............. 142 Response to Senator McCaskill Question from Leonard Wartofsky ......... ........... 143 Responses to Senator Smith Questions from Loyd Allen ............... ...................... 144 White Paper submitted by Loyd Allen ............................................................... 146 Additional Information submitted by National Institutes of Health ......... ......... 156 Statement of the American Pharmacists Association ................... ........................ 230 Written Testimony of Jane L. Murray, board chair, Women in Balance ............ 239 Written Testimony of Steven F. Hotze, MD ........................ 40 Statement of David Adams, Venable LLP ................................ 242 (111)
- Page 1: S. HRG. 110-129 Bioidentica
- 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 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
RON WYDEN, Oreg<strong>on</strong><br />
BLANCHE L: LINCOLN, Arkansas<br />
EVAN BAYH, Indiana<br />
THOMAS R. CARPER, Delaware<br />
BILL NELSON, Florida<br />
HILLARY RODHAM CLINTON, New York<br />
KEN SALAZAR, Colorado<br />
ROBERT P. CASEY, Jr., Pennsylvania<br />
CLAIRE McCASKILL, Missouri<br />
SHELDON WHITEHOUSE, Rhode Island<br />
SPECIAL COMMITTEE ON AGING<br />
HERB KOHL, Wisc<strong>on</strong>sin, Chairman<br />
GORDON H. SMITH, Oreg<strong>on</strong><br />
RICHARD SHELBY, Alabama<br />
SUSAN COLLINS, Maine<br />
MEL MARTINEZ, Florida<br />
LARRY E. CRAIG, Idaho<br />
ELIZABETH DOLE, North Carolina<br />
NORM COLEMAN, Minnesota<br />
DAVID VITTER, Louisiana<br />
BOB CORKER, Tennessee<br />
ARLEN SPECTER, Pennsylvania<br />
JULIE COHEN, Staff Director<br />
CATHERINE FINLEY, Ranking Member Staff Director<br />
(II)<br />
f
Change language