Food and Drug Administration

Endocrinologic & Metabolic Drugs Advisory Committee

October 7, 2003


Regulatory Implications of The WHI Study, Dr. Eric Colman, MD, FDA (HTM) (PPT)

Women's Health Initiative (WHI) Clinical Trials (Diet, Hormones, Calcium/Vit D) and Observational Study, Dr. Rossouw (HTM) (PPT)

Design, Primary Results (JAMA 2002) 2003 Updates - Selected Outcomes, Dr. Marcia Stefanick, PhD., Stanford University (HTM) (PPT)

Breast Cancer in the Women's Health Initative Trial of Estrogen Plus Progestin, Dr. Rowan Chlebowski, MD, PhD (HTM) (PPT)

Part I: Statistical Issues in WHI, Part II: Further Analyses of Prior Hormone Therapy on Breast Cancer, The WHI Estrogen + Progestin Trial, Garnet Anderson, Fred Hutchinson Cancer Research Center (HTM) (PPT)

Estrogen Plus Progestin, BMD and Fractures: Women's Health Initiative, Jane Cauley, University of Pittsburgh (HTM) (PPT)

Additional Analyses of Fracture Risk and the Global Index in the WHI Estrogen + PRogestin Trial, Garnet Anderson, Fred Hutchinson Cancer Research Center (HTM) (PPT)

Wyeth Presentation, Dr. Joseph Camardo, MD (HTM) (PPT)

WHI Trial of Estrogen Plus Progestin: Reviewer's Comments, Dr. Bruce Stadel, MD, MPH, FDA (HTM) (PPT)

Issues for the Committee, Dr. Colman, FDA (HTM) (PPT)

Open Public Hearing

New Data on Ultra Low-Dose Estradiol Therapy in Osteoporosis Prevention, Dr. Marie Foegh, MD, DSc, Berlex (HTM) (PPT)

Statement of the American Medical Women's Association, Omega Silva (PDF)

Letter From Dr. Michele Curtis, MD, MPH, University of Texas (PDF)

Memorandum From Dr. Ethel Siris, MD, National Osteoporosis Foundation (PDF)

Letter From Dr. Charles Hammond, MD, Duke University Medical Center (PDF)

Statement of the American College of Obstetricians and Gynecologists, Dr. Isaac Schiff, MD, FACOG and Dr. Stanley Zinberg, MD MS, FACOG (PDF)