FDA Device Panel Meeting Tanning Bed Classification

Suraj Venna, MD, FAADDirector, Melanoma Center

Washington Cancer InstituteWashington, DC

March 25, 2010

I HAVE NO CONFLICTS OF INTEREST

MELANOMA IS A DEADLY DISEASE

http://www.nepetimaging.com/pdf/feb_05.pdf (with permission)

BIOLOGYGenotype

- 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

UV 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

• 2006 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

A 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 melanoma

• Identified 33,345 mutations (base substitutions)• Dominant mutation signature reflects DNA damage secondary

to UV

Cancer Genome Project at the Wellcome Trust Sanger Institute

Ultraviolet 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.

Tanning 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

Recent 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

Melanoma risk and number of common melanocytic nevi.

Bauer & Garbe: Pigment Cell Res. 2003

Ultraviolet Radiation

• Is a human carcinogen

• Is involved in the pathogenesis of melanoma

• Only comes from 2 sources– Natural– Artificial

Tanning

• Inexpensive ($7-10/session, some as little as $3)

• Widespread • Young Women

– Nearly 70 percent of users girls and women aged 16 to 29

Prevention

Protection from UV

Modify Behavior

EDUCATE

Indoor Tanning

Intentional Sunbathing

Inadequate Sun Protection

Schools

Parents

Healthcare Providers

POLICY

Stronger 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.

Thank You