Workshop Summary Notes

Speakers for the “Bench to Bedside: Estrogen as a Case Study” workshop prepared the presentation outlines. The topics under “specific points presented” were prepared from notes taken by Drs. Leon Thal and Marilyn Miller; these notes were distributed to the speakers. After the speakers reviewed the notes, revisions were incorporated and are provided below.

Workshop Objectives

• Define and examine the discrepancies between Women's Health Initiative (WHI) findings on brain and cognitive function and the basic and longitudinal/epidemiological studies including different formulations, doses, duration of treatment, timing, and mode of administration
• Examine the effects of estrogens on brain and cognitive function as they relate to aging
• Determine what is known and what is unknown that would determine whether additional hormone “interventions” could be developed
• Determine what lessons have been learned from estrogen studies that will help in designing clinical trials for other classes of drugs

Potential Conflict of Interest Issues

NIA authorized attendees with conflicts of interest to participate in this workshop; these individuals are pre-eminent experts in the field. Participants reported they received or are receiving research funds from the following pharmaceutical companies: Abbot (2), Amgen (1), Bulex (1), Eli Lilly (3), Forest (3), Glaxo Smith Klein (1), Jansson (1), Merck (2), Pfizer (5), Proctor and Gamble (1), Smith Klein (1), Targacept (1), and Wyeth Ayerst (13). Participants reported they gave expert advice to Clark, Thomas, and Winters (1); Berles Holdings (1); and Galen Holdings (1). Participants also reported they hold 28 patents on compounds and procedures relevant to the workshop and had 21 pending patents on compounds and procedures relevant to the workshop.

Presentation Outline

The presentation outline included the following:

1. WHI indicated more needs to be learned about the actions of estrogen (E) and progesterone (P) in relation to the remainder of the body's physiology.
2. WHI changed the patterns of medical practice regarding the major form of hormone therapy (HT) in the United States and suggested topics for further exploration, such as:
   • Critical "windows" for treatment
   • Choice of estrogen and progestin and treatment dose and timing.
3. Basic science is important to clinical trials because it encourages an alternative approach to HT than Prem-Pro®. Moreover, basic science produced evidence E and P have beneficial effects on the brain, but also revealed the complexities of E and P actions not anticipated in the last decade.

1. Basic Science
2. Clinical Studies
3. Longitudinal and Epidemiological Studies
4. Clinical Trials

Workshop Summary Notes in Adobe PDF (348K)