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Testimony to the FDA Hearing on Tanning Bed Classification. Barbara A. Gilchrest, M.D. Practicing Dermatologist & Professor of Dermatology Boston University School of Medicine Boston, MA. March 25, 2010. Drugs and devices are evaluated based on a risk: benefit analysis.

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testimony to the fda hearing on tanning bed classification

Testimony to the FDA Hearing on Tanning Bed Classification

Barbara A. Gilchrest, M.D.

Practicing Dermatologist

&

Professor of Dermatology

Boston University School of Medicine

Boston, MA

March 25, 2010

slide2

Drugs and devices are evaluated based on a risk: benefit analysis.

Tanning beds pose a well documented risk of skin cancer, photoaging, and (less often) exacerbation of multiple skin diseases.

The only claimed benefit, aside from cosmetic tanning, is vitamin D production.

slide3

The Pseudo-Controversy

Tanning

Sunburn

Skin Cancer

Photoaging

Vitamin D

Photosynthesis

vs

Melanoma is unquestionably among the types of skin cancer caused by UV exposure.

the pseudo controversy

Should the public maximize vitamin D levels through intentional UV exposure in order to prevent cancer, hypertension, diabetes, multiple sclerosis … ?

The Pseudo-Controversy

Which is the lesser evil?

Skin cancer and photoaging or cancer of the colon, breast, prostate, and other organs in combination with the other listed diseases?

slide5

What evidence supports the argument that “insufficient vitamin D” or its proxy – lack of UV exposure – causes these diseases?

  • Some but far from all
  • epidemiologic associations.
  • These associations may be
  • confounded by obesity and
  • lifestyle.
  • Very few intervention studies.
  • Most show no effect of
  • vitamin D supplementation,
  • even for many years.

Reddy & Gilchrest. JID 130:321-326, 2010.

the pseudo controversy is irrational

Ample vitamin D can be obtained from diet, supplements, and incidental sun exposure.

The Pseudo-Controversy is Irrational

A supplement of 1000 IU/day is safe and “sufficient” by even generous criteria.

the pseudo controversy is irrational7

The group most responsive to the “unprotected sun exposure” message is at lowest risk of vitamin D deficiency

  • Healthy Caucasian teenagers and young adults – tanning
  • salon customers!

Cutaneous vit D photosynthesis is least efficient for population groups at highest risk of vit D deficiency

The Pseudo-Controversy is Irrational

  • Darkly pigmented individuals
  • The elderly
slide8

UV Action Spectra in Human Skin

100

10

1.0

0.1

Relative Effectiveness

Wavelength (nm)

Wolpowitz & Gilchrest. JAAD, 2006.

Adapted from Matsuoka et al. J ClinEndocrinolMetab, 1987; de Gruijl. Eur J Cancer, 1999; and Parrish et al. PhotochemPhotobiol, 1982

slide9

Dose-Response Relationships

for UV Effects

From: Gilchrest BA. Editorial / review in

J. Steroid Biochem Mol Biol, 2007.

why is there a pseudo controversy

The sun protection message is

  • old (and wimpy).

Why is There a Pseudo-Controversy?

  • People, especially teenagers,
  • want to sunbathe and tan.
  • Sunbathing and making one’s
  • own vitamin D have a back-to
  • nature holistic appeal.
  • The indoor tanning industry
  • knows it’s good for business.
slide11

Roadside advertisement in Ontario.

U.S. state legislatures are bombarded with selected epidemiologic studies that support a cancer prevention effect of high 25(OH)D levels.

slide12

Vitamin D Supplements

Are Cheap!

1000 IU Tablets Cost/tablet

CVS Pharmacy $.06

Nature Made $.09

Life Fitness $.07

CVS Pharmacy $.05