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
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.
The Pseudo-Controversy

  Sunburn              Tanning
 Skin Cancer           Vitamin D
 Photoaging          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 … ?

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?
 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.

 A supplement of 1000
   IU/day is safe and
  “sufficient” by even
   generous criteria.
The Pseudo-Controversy
      is Irrational
Cutaneous vit D photosynthesis is
least efficient for population groups
at highest risk of vit D deficiency
   • Darkly pigmented individuals
   • The elderly
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!
UV Action Spectra in Human Skin




                              100
     Relative Effectiveness




                              10



                              1.0



                              0.1

                                    Wavelength (nm)

Wolpowitz & Gilchrest. JAAD, 2006.

Adapted from Matsuoka et al. J Clin
Endocrinol Metab, 1987; de Gruijl. Eur J
Cancer, 1999; and Parrish et al. Photochem
Photobiol, 1982
 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).

• 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.
 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.
Vitamin D Supplements
     Are Cheap!

     1000 IU Tablets   Cost/tablet


    CVS Pharmacy          $.06



    Nature Made           $.09



    Life Fitness          $.07



    CVS Pharmacy          $.05
However much vitamin D
 people need, they don’t
       need this!