Presentations text content in FDA Device Panel Meeting Tanning Bed Classification
Slide1
FDA Device Panel Meeting Tanning Bed Classification
Suraj Venna, MD, FAADDirector, Melanoma CenterWashington Cancer InstituteWashington, DC
March 25, 2010
I HAVE NO CONFLICTS OF INTEREST
Slide2Slide3
MELANOMA IS A DEADLY DISEASE
http://www.nepetimaging.com/pdf/feb_05.pdf
(with permission)
Slide4BIOLOGY
Genotype
- Genodermatoses (e.g. XP, EB & albnism)
- Mutations: p53, p16, BRCA2, BRAF or MC1R
Phenotype
- SPT I & II
- Blue or Green eyes
- Red or Blonde hair
- # of typical &/or atypical nevi
- Large Congenital Nevus
- Hx of prior skin cancer or precursor lesions
- Family hx of skin cancer
- Immune suppressin
BEHAVIOR
- Sun protection
- Duration of sun exposure
Ultraviolet
Exposure
Natural
Artificial
Tanning Beds
ENVIRONMENT
- UV Radiation Exposure
ULTRAVIOLET RADIATION
Risk Factors for Melanoma
Slide5UV and Melanoma
1992 International Agency for Research on Cancer (IARC) classify solar radiation a human carcinogen
1992 IARC classify use of sunbeds/sunlamps as Group 2A
2002 US Dept. of Health and Human Services National Toxicology Program
broad spectrum ultraviolet radiation as
emitted by solar and artificial sources
as ‘reasonably anticipated’ human carcinogens
Slide62006 IARC Working Group
‘….
association of the use of indoor tanning equipment with melanoma risk…….
conclude that there is convincing evidence to support a causal relationship, particularly with exposure before the age of 35 years
.
’
2008 World Health Organization
Recommended banning those younger than age 18 from commercial indoor tanning
2009 World Health Organization
Classified tanning bed exposure as a Class 1 carcinogen-equivalent to arsenic and tobacco use
Slide7A comprehensive catalogue of somatic mutations from a human cancer genomePleasance, Cheetham, Stephens, et al. Nature December 2009. 463, 191-196
Catalogued somatic mutations from a 43yo man with metastatic melanomaIdentified 33,345 mutations (base substitutions)Dominant mutation signature reflects DNA damage secondary to UV
Cancer Genome Project at the Wellcome Trust Sanger Institute
Slide8Ultraviolet Exposure During Childhood Increases Melanoma Incidence
Elwood JM, Gallagher RP, Hill GB, et al. Pigmentation and skin reaction to sun as risk factors for cutaneous melanoma: Western Canada melanoma study. Br J Med J (Clin Res Ed). 1984;288:99-102
Gandini S, Sera F, Cattaruzza MS, et al. Meta-analysis of risk factors for cutaneous melanoma, II: sun exposure. Eur J Cancer. 2005;41:45-60
Weinstock MA, Colditz GA, Willett WC, et al. Nonfamilial cutaneous melanoma incidence in women associated with sun exposure before 20 years of age. Pediatrics. 1989;84:199-204.
Slide9Tanning and Increased Nevus Development in Very-Light-Skinned Children Without Red HairAalborg J, Morelli JG, Mokrohisky ST, et al Arch Dermatol. 2009;145:989-996
Tanning
is associated with an increased risk of nevus or mole counts
Slide10Recent Tanning Bed Use. A Risk Factor for Melanoma. Buckel T, Goldstein A, Fraser M, et al Arch Dermatol. 2006;142:484-488
Tanning bed
use can increase mole counts and cause existing moles to change
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Melanoma risk and number of
common melanocytic nevi
.
Bauer & Garbe: Pigment Cell Res. 2003
Slide12Ultraviolet Radiation
Is a human carcinogen
Is involved in the pathogenesis of melanoma
Only comes from 2 sources
Natural
Artificial
Slide13Tanning
Inexpensive
($7-10/session, some as little as $3)
Widespread
Young Women
Nearly 70 percent of users girls and women aged 16 to 29
Slide14Prevention
Protection from UV
Modify Behavior
EDUCATE
Indoor TanningIntentional SunbathingInadequate Sun Protection
SchoolsParentsHealthcare Providers
POLICY
Slide15Stronger Regulations Are Needed
To protect the public health, the FDA should:
Ban the use and sale of tanning devices in the US; or at a minimum,
Reclassify tanning devices to the strongest possible category;
Restrict access to tanning beds by minors;
Require informed consent for all consumers;
Require posted warning statements;
Implement and enforce labeling recommendations from the TAN Act; and,
Enforce additional state regulations.
Slide16Thank You
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FDA Device Panel Meeting Tanning Bed Classification
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