FDA Device Panel Meeting Tanning Bed Classification

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FDA Device Panel Meeting Tanning Bed Classification




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Presentations text content in FDA Device Panel Meeting Tanning Bed Classification

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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

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MELANOMA IS A DEADLY DISEASE

http://www.nepetimaging.com/pdf/feb_05.pdf

(with permission)

Slide4

BIOLOGY

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

Slide5

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

Slide6

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

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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 melanomaIdentified 33,345 mutations (base substitutions)Dominant mutation signature reflects DNA damage secondary to UV

Cancer Genome Project at the Wellcome Trust Sanger Institute

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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.

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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

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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

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Melanoma risk and number of

common melanocytic nevi

.

Bauer & Garbe: Pigment Cell Res. 2003

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Ultraviolet Radiation

Is a human carcinogen

Is involved in the pathogenesis of melanoma

Only comes from 2 sources

Natural

Artificial

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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

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Prevention

Protection from UV

Modify Behavior

EDUCATE

Indoor TanningIntentional SunbathingInadequate Sun Protection

SchoolsParentsHealthcare Providers

POLICY

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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.

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Thank You

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