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WRAP UP COMMENTS

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Measurement of UVB-induced DNA damage and its consequences in models of ... one of them is 'Yankee Doodle', and the other isn't. Ulysses S. Grant. 12 ... – PowerPoint PPT presentation

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Title: WRAP UP COMMENTS


1
WRAP UP COMMENTS
  • Jonathan K. Wilkin, M.D.
  • February 15, 2005

2
Recent Concerns
  • UNCERTAIN RISK FOR CANCER
  • Biological plausibility
  • Emerging signal in AERS
  • Difficult to study and answers would be late
  • INFORMATIONAL LANDSCAPE
  • Suggests first-line
  • Steroid-free, Direct-to-consumer advertising
  • Other indications
  • Peer and non-peer reviewed literature portrays
    safety
  • CURRENT PRACTICES
  • Overall use increasing
  • Use in lt 2 years increasing

3
  • Measurement of UVB-induced DNA damage and its
    consequences in models of immunosuppression.
  • Yarosh, Daniel B, et al.
  • Methods 28(1) 55-62, 2002.

4
Recent Concerns
  • UNCERTAIN RISK FOR CANCER
  • Biological plausibility
  • Emerging signal in AERS
  • Difficult to study and answers would be late
  • INFORMATIONAL LANDSCAPE
  • Suggests first-line
  • Steroid-free, Direct-to-consumer advertising
  • Other indications
  • Peer and non-peer reviewed literature portrays
    safety
  • CURRENT PRACTICES
  • Overall use increasing
  • Use in lt 2 years increasing

5
Labeled Use
  • For 2 years of age and above
  • As second-line therapy
  • Acute, intermittent

6
Whats Missing in Publications
  • For 2 years of age and above
  • As second-line therapy
  • For acute and intermittent use

7
Off-Label Use Information
  • Use in children under 2 years old (confirmed)
  • Use as first-line therapy (inferred)
  • Use continuous, chronic (inferred)

8
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9
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10
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11
  • I know only two tunes
  • one of them is Yankee Doodle,
  • and the other isnt.
  • Ulysses S. Grant

12
The Ulysses Grant Factor
  • The two major topical drug classes for atopic
    dermatitis have side effects one of them has
    steroid side effects, and the other doesnt.

13
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14
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15
Dermatologic Experience
  • Small children with atrophy and telangiectasia
  • History of use of higher potency corticosteroids
  • - Excessive potency steroid prescribed
  • - Excessive amounts prescribed
  • - Excessive amounts obtained from multiple health
    care providers

16
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17
Recent Concerns
  • UNCERTAIN RISK FOR CANCER
  • Biological plausibility
  • Emerging signal in AERS
  • Difficult to study and answers would be late
  • INFORMATIONAL LANDSCAPE
  • Suggests first-line
  • Steroid-free, Direct-to-consumer advertising
  • Other indications
  • Peer and non-peer reviewed literature portrays
    safety
  • CURRENT PRACTICES
  • Overall use increasing
  • Use in lt 2 years increasing

18
The Question
  • What are the consequences of
  • long-term continuous calcineurin inhibition in
    the skin, and possibly the regional lymph nodes
    and systemically, in children, especially those
    under 2 years of age?

19
  • The Answer on February 15, 2005
  • UNCERTAINTY

20
Goal of Labeling
  • Give information and its
  • level of certainty to
  • physician and patient

21
Disclose Uncertainty
  • We take the view that the public should be told
    about uncertainty when data with public-health
    implications are preliminary or inconclusive.

The Lancet 3491, 1997
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