1 / 13

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.

isha
Download Presentation

Testimony to the FDA Hearing on Tanning Bed Classification

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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

  2. 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.

  3. 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.

  4. 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?

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. Dose-Response Relationships for UV Effects From: Gilchrest BA. Editorial / review in J. Steroid Biochem Mol Biol, 2007.

  10. 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.

  11. 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.

  12. Vitamin D Supplements Are Cheap! 1000 IU Tablets Cost/tablet CVS Pharmacy $.06 Nature Made $.09 Life Fitness $.07 CVS Pharmacy $.05

  13. However much vitamin D people need, they don’t need this!

More Related