From The Challenges of Drug Risk Assessment In US FDA to See the Needs of Promoting Pharmacoepidemiology Development In China

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From The Challenges of Drug Risk Assessment In
US FDA to See the Needs of Promoting
Pharmacoepidemiology Development In China

• PUMC Epidemiology Network Meeting
• Beijing China
• December 16, 2006

Zili Li, MD, MPH, Director, Clinical Research
Operations Asia Pacific, Merck Co, Inc.
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Disclosure and Disclaimer

• Employment
• Merck Co, Inc (2005 - )
• US FDA (1998 - 2005)
• The opinions included herein are those of the
  presenter

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Recent Drug Safety Events In the US
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Appropriate Use of Epidemiology and
Evidence-Based Medicine in Drug Risk Assessment
Meta-Analysis ????
RCT ??????
Case Series ????
Cohort Study ????
Expert Opinion ????
Case-Control Study ??????
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Issue 1 Is Expert Opinion Important ?
Expert Opinion ????
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Issue 2 Is Evidence-Based Medicine a Criteria ?
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Issue 3 What is the Focus of Causality
Assessment ?
Question

• Did vaccine cause SIDS in those child ?
• Can vaccine cause SIDS ?

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Issues 4 Is Risk Assessment Free of Risk

• 1. Picking the right risk
• 2. 2-4-6-8 What can we associate
• 3. The Significance of significance
• 4. Data collection
• 5. Mining for statistical associations
• 6. The Mixmaster technique
• 7. Instant risk
• 8. The big risk number
• 9. Cooking up biological plausibility
• 10. Peer review
• 11. The final document
• 12. Where to publish
• 13. Dealing with criticism

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Is Epidemiology Dangerous ?
Epidemiology Faces Its Limits - Gary Taubes -
Science July 14, 1995
Seven curable Sins of Epidemiology - Lewis
Kuller - 1996 Presidential address in Society for
Epidemiology Research Meeting
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US FDA Risk Assessment/Management Guidance
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Drug Risk Assessment A New Focus and
Opportunity For Epidemiologists in China
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