# Presentation: 758363

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONETHERAPY***** 

**Department of Health and Human Services **
**National Institutes of Health**
**Office of the Director**
**October 23-24, 2002**

## Menopausal Hormone Therapy<<<>>>

**Historically...**
**Complexities, Confusion**
**But...**
***Hope***** for Answers From **
**New or Ongoing Research Studies**

## Menopausal Hormone Therapy<<<>>>

**Average number of NIH funded Grants &  Contracts**
**FY 1989-1990****	****	****	****11**
**   ****FY 1999-2000****	****	****	**** 150****	**

## The Women’s Health Initiative

- Multicenter project examining strategies of prevention & control of most common causes of death, disability and impaired quality of life among postmenopausal women.
- Begun in 1991; recruitment completed in 1998; planned study completion in 2007.
**>** 68,000 women in 3 overlapping randomized CT’s and additional 93,676 in parallel OS, to be followed through March 2005

## The Women’s Health InitiativeJuly 2002 NHLBI Press Release

***NHLBI Stops Trial ***
***of Estrogen Plus Progestin***
***Due to ***
***Increased Breast Cancer Risk,***
***Lack of Overall Benefit***

## Journal of the American Medical AssociationJuly 17, 2002

***Risks and Benefits of Estrogen Plus Progestin in Health Postmenopausal Women;***
*Principal Results from the Women’s Health Initiative Randomized Controlled Trial*
***(Writing Group for the Women’s Health Initiative Investigators)**** *

## The Women’s Health InitiativeJuly 2002 Headlines!!!

- Citing Risks, U.S. Will Halt Study of Drugs for 	Hormones
- Hormone Replacement Study a Shock to the 	Medical System (N.Y. Times)
- Goodbye Hormone Replacement Therapy? 	(abcNEWS.com)
- Hormone Treatment Is Called Harmful (Washington 	Post)
- Doubts on Hormones, Heart Risk Bolstered 	(Washington Post)

## The Women’s Health InitiativeJuly 2002 Headlines!!!

- Hormone Treatment is Called Harmful!
- Patients Weigh Quitting Drug After Research 	Indicates Risk
- NIH Cautions on Hormone Therapy
- So Much for Hormone ‘Salvation’

## The Women’s Health InitiativeEstrogen plus Progestin Results

-  *Questions*
*	**	**and*
*	**	**	**Passionate Responses*
*	**	**	**	**and*
*	**	**	**	**	**Questions...*

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

-  _Responding to questions through a Scientific Workshop to:_
- Review the results from the E+P arm of the WHI
- Place results in context of other completed and 	ongoing Federally funded research on 	menopausal combination HT, and
- To facilitate a better understanding of the 	implications of current knowledge on 	decisions regarding short and long term use 	of combination (E+P) HT.

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

_***Participants should:***_
- Have an understanding of the design and scientific rationale for the WHI and other studies of menopausal combination hormone therapy, and an understanding of how decisions have been reached about continuation or halting of such studies..._*** ***_

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

_***Participants should:***_
- Have an understanding of the clinical implications of the combined E+P arm of the WHI and other recent or current related studies...

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

_***Participants should:***_
- Have an understanding of the effect of individual risk factors such as age and medical history on the expected balance of benefits and harms of menopausal combination therapy in order to facilitate informed decision making by women and their health care providers.

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

_***How have we planned to accomplish these purposes?***_
- Review our understanding of clinical trials and related processes to protect participants.
- Presentation of WHI data from the E+P arm of the study, within the context of the full study, by WHI investigators.

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

_***How have we planned to accomplish these purposes?***_
- Discussion of recent considerations regarding continuation or cessation of other NIH studies utilizing combined E+P postmenopausal therapy.
- Presentation of related research studies.

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

_***How have we planned to accomplish these purposes?***_
- Consideration of the basic biology of hormone receptors which may influence beneficial vs. adverse effects.
- Assess the balance of risks and benefits in the individual patient, and how to effectively communicate such information.

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

_***How have we planned to accomplish these purposes?***_
- Hear about perspectives of the FDA and of Industry.
- Receive perspectives of professional organizations, women’s health advocates, health care professionals and other interested individuals.

## SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

_***How have we planned to accomplish these purposes?***_
- Discuss recommendations of the U.S. Preventive Services Task Force for the use of HT for prevention of disease.
- Discuss implications for NIH research programs.

## SCIENTIFIC WORKSHOP:MENOPAUSAL HORMONE THERAPY

***Time for brief questions***
***And comments***
***From participants during discussion times following each panel...***

## SCIENTIFIC WORKSHOP:MENOPAUSAL HORMONE THERAPY

**<<<>>>**
- Informed decision making regarding the
- risks and benefits of postmenopausal combined estrogen and progestin hormone therapy
- by women and their physicians
- based upon research outcomes
- &
- Considerations of/for current and future
- NIH sponsored research* *