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
(No Transcript)
9
(No Transcript)
10
(No Transcript)
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
(No Transcript)
14
(No Transcript)
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
(No Transcript)
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