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NIH CONSENSUS PANEL RECOMMENDS DAILY USE OF SPF 15 SUNSCREEN; RETIN-A DATA "INSUFFICIENT" TO DETERMINE SUSTAINED PHOTOAGING IMPROVEMENT, PANEL FINDS

Executive Summary

A National Institutes of Health Consensus Panel recommended the daily use of waterproof sun protection factor (SPF) 15 sunscreens during "appropriate times of the year" and year-round in the Sunbelt at the conclusion of the May 8-10 conference, "Sunlight, Ultraviolet Radiation and the Skin." While urging the use of sunscreens with SPFs of 15 and above to protect skin against potentially damaging ultraviolet rays (UVR), the panel noted that the SPF rating applies only to ultraviolet B (UVB) rays. Consumers should select a broad spectrum sunscreen also to absorb harmful ultraviolet A (UVA) rays, the panel suggested. The group noted in its consensus that UVA radiation can cause DNA damage, erythema and squamous cell cancer in mice and guinea pigs. The panel advised that use of sunscreens to protect children is particularly important since "it is estimated that as much as 50% of an individual's total sun exposure occurs by 18 years of age." Attitudes toward sun exposure should be altered through education of children, adolescents and adults, the panel suggested. Increased UVR damage may occur with use of certain systemic medications, the consensus statement pointed out, including oral antibiotics, antihypertensives, psoralens, immunosuppressive agents, nonsteroidal anti-inflammatory drugs and "myriad other agents." Topical medications such as psoralens, tretinoin (Retin-A) and other sensitizing and depigmenting agents also call for increased caution, the panel concluded. Suggested directions for future research include: development of "more effective nontoxic sunscreens and nontoxic anti-carcinogenic agents"; studies on the biological effects of UVA radiation; updating epidemiologic data concerning non-melanoma skin cancer in the U.S. beyond current 1978 data; and studies to define "more precisely the phenomenon known as 'photoaging' of the skin and to compare this with chronologic aging." The panel also concluded that currently there is insufficient data to determine sustained improvement in photoaged skin from the use of Ortho's Retin-A. Consensus Panel Chairman David Bickers, MD, Case Western Reserve University, said: "The long-term effects, the long-term toxicity of repeated application of this class of compound to older skin, is in no way available at the present time." He added: "We are talking about several years before we'll be in a position to make any kind of recommendation in that regard." The official consensus on Retin-A was that "although the beneficial cosmetic effects of some of these treatments have received wide publicity, there are insufficient data demonstrating sustained improvement, reversibility of tissue pathology, or the preservation of normal skin function by those agents. There is no information regarding long-term positive, negative, or toxic effects." The panel concurred, noting: "Conflicting data exist regarding the prevention/potentiation of topical retinoids in the development of UVR-induced skin tumors in animals." John Voorhees, PhD, the main researcher conducting studies on Retin-A for the treatment of photoaging, presented his findings at the Consensus Conference. In an open discussion, Voorhees noted that none of his subjects ceased therapy, so no determination could be made of how long Retin-A's effects last after therapy is stopped. In a related development, University Patents, Inc. (UPI) filed suit in Philadephia District Court May 10 on behalf of itself and the University of Pennsylvania against Retin-A inventor Albert Kligman, MD, PhD. The two affiliated organizations are seeking $ 10 mil. in damages and may receive up to $ 20 mil. combined. Ortho is not a plaintiff.

A National Institutes of Health Consensus Panel recommended the daily use of waterproof sun protection factor (SPF) 15 sunscreens during "appropriate times of the year" and year-round in the Sunbelt at the conclusion of the May 8-10 conference, "Sunlight, Ultraviolet Radiation and the Skin."

While urging the use of sunscreens with SPFs of 15 and above to protect skin against potentially damaging ultraviolet rays (UVR), the panel noted that the SPF rating applies only to ultraviolet B (UVB) rays. Consumers should select a broad spectrum sunscreen also to absorb harmful ultraviolet A (UVA) rays, the panel suggested. The group noted in its consensus that UVA radiation can cause DNA damage, erythema and squamous cell cancer in mice and guinea pigs.

The panel advised that use of sunscreens to protect children is particularly important since "it is estimated that as much as 50% of an individual's total sun exposure occurs by 18 years of age." Attitudes toward sun exposure should be altered through education of children, adolescents and adults, the panel suggested.

Increased UVR damage may occur with use of certain systemic medications, the consensus statement pointed out, including oral antibiotics, antihypertensives, psoralens, immunosuppressive agents, nonsteroidal anti-inflammatory drugs and "myriad other agents." Topical medications such as psoralens, tretinoin (Retin-A) and other sensitizing and depigmenting agents also call for increased caution, the panel concluded.

Suggested directions for future research include: development of "more effective nontoxic sunscreens and nontoxic anti-carcinogenic agents"; studies on the biological effects of UVA radiation; updating epidemiologic data concerning non-melanoma skin cancer in the U.S. beyond current 1978 data; and studies to define "more precisely the phenomenon known as 'photoaging' of the skin and to compare this with chronologic aging."

The panel also concluded that currently there is insufficient data to determine sustained improvement in photoaged skin from the use of Ortho's Retin-A.

Consensus Panel Chairman David Bickers, MD, Case Western Reserve University, said: "The long-term effects, the long-term toxicity of repeated application of this class of compound to older skin, is in no way available at the present time." He added: "We are talking about several years before we'll be in a position to make any kind of recommendation in that regard." The official consensus on Retin-A was that "although the beneficial cosmetic effects of some of these treatments have received wide publicity, there are insufficient data demonstrating sustained improvement, reversibility of tissue pathology, or the preservation of normal skin function by those agents. There is no information regarding long-term positive, negative, or toxic effects." The panel concurred, noting: "Conflicting data exist regarding the prevention/potentiation of topical retinoids in the development of UVR-induced skin tumors in animals."

John Voorhees, PhD, the main researcher conducting studies on Retin-A for the treatment of photoaging, presented his findings at the Consensus Conference. In an open discussion, Voorhees noted that none of his subjects ceased therapy, so no determination could be made of how long Retin-A's effects last after therapy is stopped.

In a related development, University Patents, Inc. (UPI) filed suit in Philadephia District Court May 10 on behalf of itself and the University of Pennsylvania against Retin-A inventor Albert Kligman, MD, PhD. The two affiliated organizations are seeking $ 10 mil. in damages and may receive up to $ 20 mil. combined. Ortho is not a plaintiff.

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