10.17.09 ~ 9.00 ~ Rigel ~ Photoprotection Update

10.17.09 ~ 9.00 ~ Rigel ~ Photoprotection Update -...

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1 Darrell S. Rigel, MD Clinical Professor of Dermatology New York University Medical Center Photoprotection Update - 2009 DISCLOSURE OF CONFLICTS OF INTEREST Darrell S. Rigel, MD Photoprotection Update • Neutrogena – A,C,G,I • Johnson and Johnson – A,C,G • Procter and Gamble - C 1 in 5 Americans will get Skin Cancer at Current Rates!!!! More skin cancers than all other cancers combined Cancer USA - 2009 Other 1,200,000 Skin Cancer 1,350,000 Skin Cancer USA - 2009 Basal Cell 1,000,000 Squamous Cell 250,000 Invasive Melanoma 68,720 Cancer Incidence US Males– 1995-2002 Annual % Change 2.5% 1.4% 1.0% -0.2% -0.5% -1.1% -1.2% -1.8% -2.1% -2.2% -3.0% -2.0% -1.0% 0.0% 1.0% 2.0% 3.0% Melanoma Kidney Prostate Bladder NH lymphoma Leukemia Colon Rectal Oral Stomach Lung Edwards et al, JNCI, 2005
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2 Cancer Incidence US Females– 1995-2002 Annual % Change 4.8% 2.3% 0.8% 0.4% 0.3% -0.2% -0.2% -0.4% -0.6% -1.8% -3.0% -2.0% -1.0% 0.0% 1.0% 2.0% 3.0% 4.0% 5.0% 6.0% Thyroid Melanoma NH Lymphoma Breast Pancreas Uterine Lung Bladder Colon/Rectal Cervix/Ovary Edwards et al, JNCI, 2005 1930 1950 1980 1985 1993 2000 2004 2015 1/1500 1/600 1/250 1/65 1/100 1/74 1/150 Lifetime Risk Invasive MM Melanoma USA – 2009 2009 Rigel et al, NYU Melanoma Cooperative Group, 2009 1/58 1/50 Projected Melanoma - US 2009 Invasive = 68,720 In-situ = 53,120 1/30 Lifetime Risk Invasive and Insitu MM Melanoma USA – 2009 2009 Rigel et al, NYU Melanoma Cooperative Group, 2009 121,840 total cases 82% 86% 92% 0% 25% 50% 75% 100% % Survivin 1975-79 1985-89 1995-02 MM US 5 Year Survival by Year of Diagnosis Jemal et al, CA J Clinicians, 2007 7910 8110 8420 8650 0 1000 3000 4000 5000 6000 7000 8000 9000 10000 2006 2007 2008 2009 0 US Annual Deaths from Melanoma Jemal et al, CA J Clinicians, 2009
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3 Over 1 American dies every hour of Melanoma Other 2,800 Melanoma 8,650 Skin Cancer Deaths – US 2009 Melanoma is one of the few cancers that we know the cause – UV radiation exposure and where a simple behavioral change – UV minimization – lowers the risk of getting this cancer Relationship of Melanoma to Sun UV Intensity MM Incidence vs. Latitude US White Population - SEER 2003 CT Utah Detroit Seattle Iowa San Jose New Mexico Atlanta Hawaii Incidence= -33.782Ln(Latitude) + 144.37 R 2 = 0.6989 10 100 20 25 30 35 40 45 50 Latitude (deg N) Incidence/100 SEER 2007 DS Rigel, MD ©2007 What’s on the horizon? Don’t Fry Day (May 22 nd )
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4 Don’t Fry Day (May 22 nd ) FDA Final Monograph for Sunscreen Products Key Issues & Concerns Mandatory “Sun Alert” Warning and Drug Facts Box: UVA Protection ¾ New system of symbols (4-stars) along with descriptors (Low, Medium, High, Highest) to indicate level of UVA protection a sunscreen provides. Example: Sunscreen providing high UVA protection Key Issues & Concerns Mandatory “No UVA Protection” statement In New Ruling, FDA proposing: a)If products provide UVB protection, but not UVA protection, companies will need to state: “No UVA Protection” on PDP and in Drug Facts Box. Increased SPF Values • Existing FM recognizes SPF values up to 30+. • Under new rule, SPF cap will be 50+. • SPF = Sunburn Protection Factor.
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5 Key Issues & Concerns Final Ruling: • When? (late 2009?) • FDA proposing final rule to take effect 18 months after date of publication in Federal Register Sunscreen Agents Have Known for Over 60 Years!
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10.17.09 ~ 9.00 ~ Rigel ~ Photoprotection Update -...

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