Status quo

2/7/02


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Table of Contents

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Status quo

The ten minute challenge

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How do we generally make decisions ?

How does the public make personal decisions?

How ought we make decisions ?

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The standard “sound science and evidence” approach

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Dealing with uncertainty: the Precautionary Principle and Biologic Plausibility

Does the process add VALUE with deliberation, debate and dialogue?

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BSE- House of Lords report 2000

Thimerosal June-July, 1999

July-August – A Rippling effect on a Hep B vaccine that could prevent 5000 deaths/year

Reality of how thimerosal risk “played out”

IOM’s Immunization Safety Review Committee October, 2001

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What is the common denominator of these examples?

How does this relate to the future with FDA? Scientific conclusions

If every decision and deliberation by committees (and subsequently the FDA) have health impact - in many cases globally – there are five areas the committee could discuss to address emerging issues proactively ?

Final Questions for the committee to consider

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