Testimony to the fda hearing on tanning bed classification
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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 l.jpg

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


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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.


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The Pseudo-Controversy analysis.

Tanning

Sunburn

Skin Cancer

Photoaging

Vitamin D

Photosynthesis

vs

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


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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?


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  • 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.


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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.


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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


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UV Action Spectra in Human Skin exposure” message is at lowest risk of vitamin D deficiency

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


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Dose-Response Relationships exposure” message is at lowest risk of vitamin D deficiency

for UV Effects

From: Gilchrest BA. Editorial / review in

J. Steroid Biochem Mol Biol, 2007.


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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.


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Roadside advertisement in Ontario. exposure” message is at lowest risk of vitamin D deficiency

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


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Vitamin D Supplements exposure” message is at lowest risk of vitamin D deficiency

Are Cheap!

1000 IU Tablets Cost/tablet

CVS Pharmacy $.06

Nature Made $.09

Life Fitness $.07

CVS Pharmacy $.05


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However much vitamin D people need, they don’t need this! exposure” message is at lowest risk of vitamin D deficiency


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