SCIENTIFIC WORKSHOP MENOPAUSAL HORMONE THERAPY

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SCIENTIFIC WORKSHOPMENOPAUSAL HORMONETHERAPY

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

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Menopausal Hormone Therapyltltltgtgtgt

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

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Menopausal Hormone Therapyltltltgtgtgt

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

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The Womens 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.
• gt 68,000 women in 3 overlapping randomized CTs
  and additional 93,676 in parallel OS, to be
  followed through March 2005

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The Womens Health InitiativeJuly 2002 NHLBI
Press Release

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

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Journal of the American Medical AssociationJuly
17, 2002

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

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The Womens Health InitiativeJuly 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)

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The Womens Health InitiativeJuly 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

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The Womens Health InitiativeEstrogen plus
Progestin Results

• Questions
• and
• Passionate Responses
• and
• Questions

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SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

• Responding to questions through a Scientific
  Workshop to
• Review the results from the EP 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
  (EP) HT.

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SCIENTIFIC WORKSHOPMENOPAUSAL 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

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SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

• Participants should
• Have an understanding of the clinical
  implications of the combined EP arm of the WHI
  and other recent or current related studies

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SCIENTIFIC WORKSHOPMENOPAUSAL 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.

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SCIENTIFIC WORKSHOPMENOPAUSAL 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 EP arm of the
  study, within the context of the full study, by
  WHI investigators.

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SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

• How have we planned to accomplish these purposes?
• Discussion of recent considerations regarding
  continuation or cessation of other NIH studies
  utilizing combined EP postmenopausal therapy.
• Presentation of related research studies.

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SCIENTIFIC WORKSHOPMENOPAUSAL 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.

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SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

• How have we planned to accomplish these purposes?
• Hear about perspectives of the FDA and of
  Industry.
• Receive perspectives of professional
  organizations, womens health advocates, health
  care professionals and other interested
  individuals.

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SCIENTIFIC WORKSHOPMENOPAUSAL 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.

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SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

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

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SCIENTIFIC WORKSHOPMENOPAUSAL HORMONE THERAPY

• ltltltgtgtgt
• 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