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Open Public Meeting Presentation: Rigel PPT - 474KB

Members performed over 3.1 million skin cancers procedures last year, a 55% increase over 2005 ... or more sunburns and tanning bed use in fair skinned young subjects ...

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Open Public Meeting Presentation: Rigel PPT - 474KB

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    Slide 1:Indoor Tanning and Melanoma: A Direct Link

    Darrell S. Rigel, MD Clinical Professor, New York University Medical School Past President American Society for Dermatologic Surgery

    American Society for Dermatologic Surgery 5200 members who diagnose and treat skin cancers Members performed over 3.1 million skin cancers procedures last year, a 55% increase over 2005 * Regularly see people who have been exposed to tanning beds develop skin cancer *ASDS Survey Perceptions Solutions 2009 UV is a carcinogen UVB complete carcinogen Energy is directly absorbed by DNA Pyrimidine dimer formation UVA indirect carcinogen Excites chromophores and generates free radicals ? DNA strand breaks UV listed as known carcinogen by FDA WHO classified UV tanning beds as carcinogenic to humans Matsumura et al, Toxicol Applied Pharmcol, 2004 http://ntp.niehs.nih.gov/ntp/roc/eleventh/profiles/s183uvrr.pdf, 2005 Lancet Oncology, Aug 2009.

    Slide 4:Is increased melanoma risk associated with tanning bed usage?

    Sunburns, Tanning Bed Usage and MM 413 MM patients vs. 416 controls Risk factors for the development of MM were 10 or more sunburns and tanning bed use in fair skinned young subjects Conclusion: Melanoma risk increased in tanning bed users Risk may be underestimated due to only mean lag time in study of 7 years from tanning bed exposure to MM Bataille et al, Eur J Cancer, 2004 Risk Factors for MM in Women Tanning Beds, Sun Exposure, Pigmentation 106,379 Scandinavian women with 8 years of FU 187 MM diagnosed during study interval Factors that significantly influenced MM risk: larger body surface area number of nevi on legs red hair sunburns per year use of tanning beds >= once a month Conclusion: Tanning bed use influences Melanoma risk Full effects of exposure may not yet be seen Veierod et al, JNCI, 2003 Tanning and Melanoma Risk Significantly increased risk of developing MM (OR=1.8) for persons exposed to UV tanning beds even after accounting for other risk factors by multivariate analysis Conclusion: Significant association with tanning and the later development of Melanoma Westerdahl et al, Br J Cancer, 2000 Tanning Salons and MM Risk 200 MM pts with 804 controls from the Nurse Health Study RR = 2.1 for ever vs. never tanning salon usage Conclusion: Tanning bed use associated with Melanoma Han et al, Int J Epidemiol, 2006 Tanning beds and Melanoma Risk 10 studies comparing ever vs. never exposed to UV tanning beds MM risk OR=1.25 ever using a tanning bed Conclusion: Significant association with ever tanning in UV tanning beds and the later development of Melanoma Gallagher et al, Cancer Epidemiol Biomarkers Prev, 2005 Tanning and Melanoma Risk 1518 dermatology pts surveyed for skin cancer history and tanning bed usage MM risk OR 1.64 ever using a tanning bed OR=3.2 for women <45 (OR=4.2 if tanning sessions >20 mins) Conclusion: Significant association with tanning and the later development of Melanoma (especially in younger women) Ting et al, Int J Dermatol, 2007 Tanning and Melanoma Risk 423 cases of MM vs. 678 controls for tanning and sunlamp usage MM risk OR 1.39 ever using a sunlamp and 1.14 ever using a tanning bed Latency may not yet be long enough to see full effect of risk for developing MM Conclusion: Significant association with tanning and the later development of Melanoma Clough-Corr et al, Cancer Causes Control, 2008 Tanning Bed use and MM risk Meta-analysis of 19 studies RR 1.15 for MM with tanning bed use RR 1.75 if tanning began prior to age 35 Evidence does not support a protective effect of the use of tanning beds against damage to the skin from subsequent sun exposure Conclusion: Young adults should be discouraged from using indoor tanning equipment and restricted access to tanning beds by minors should be strongly considered Green et al, Int J Cancer, 2007 Tanning Beds and MM Risk Risk of Multiple vs. Single Primary MM 531 MM patients (125 Multiple/406 single) 152 reported prior tanning bed usage Results Adjusted for natural UV (sun) exposure history OR = 1.68 for Tanning Bed usage First exposure before age 20 (OR = 2.6) Conclusion: Significant association of Melanoma risk and UV-emitting tanning beds Chiu et al, World Congress on Melanoma, 2005 Dermatologists are seeing: More melanomas in young women in anatomic sites where the sun doesnt shine Something that was very rarely seen a decade ago Virtually every one of these young women with melanoma that I see have a significant indoor tanning history! Invasive MM Rate/100,000 vs. Age US Males SEER 2006 Invasive MM Rate/100,000 vs. Age US Males SEER 2006 Invasive MM Rate/100,000 by Age US Females SEER 2006 Invasive MM Rate/100,000 by Age US Females SEER 2006 Ban the use and sale of tanning devices in the US If this cannot be done: Reclassify tanning devices to the strongest possible category Restrict access to tanning beds by minors Require posted warning statements Require informed consent for all consumers Implement and enforce labeling recommendations from the TAN Act Enforce additional state regulations

    Slide 19:The ASDS Requests the FDA to:

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