From: Subject: Sky-high SPFs: Dermatologists debate efficacy of rising numbers - - DermatologyTimes Date: Thu, 9 Jul 2009 14:01:38 -0400 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_0000_01CA009D.C7063A20" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.5579 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01CA009D.C7063A20 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://dermatologytimes.modernmedicine.com/dermatologytimes/article/articleDetail.jsp?id=607922&sk=&date=&%0A%09%09%09&pageID=2 Sky-high SPFs: Dermatologists debate efficacy of = rising numbers - - DermatologyTimes

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Sky-high SPFs: Dermatologists debate efficacy = of rising=20 numbers
Jul 1,=20 2009
By:=20 John=20 Jesitus
Dermatology=20 Times

=AB=20 Previous
1<= /A>2

Benefit = limited?

Others say the benefits = of the=20 higher-rated products are limited.

"The main reason for a = higher SPF=20 is the fact that it would provide a higher in-use SPF even = when it=20 is used at lesser amounts," says Henry Lim, M.D., chairman = of=20 dermatology, Henry Ford Hospital, Detroit.

However, he says the very small = difference=20 in UVB transmission between SPF 50 and 100 is most important = when=20 patients have a significant photosensitivity disease or = extremely=20 fair skin.

"Beyond SPF 50," Dr. = Lim says,=20 "the benefit for the average consumer is not all that=20 great."

Jeff Bedard, CEO of = Crown=20 Laboratories, maker of Blue Lizard sunscreens, adds that = SPFs above=20 50 offer "very limited" benefits. Numerous studies show that = their=20 high levels of organic filters can upset users' hormonal = balance, he=20 says.

SPF escalation also = confuses=20 consumers, Dr. Gilchrest and Mr. Bedard say. People who use=20 sunscreens with ultra-high SPFs believe they are "immune to = sun=20 damage," Dr. Gilchrest says. "And that's not the = case."

Dr. Appa counters that=20 Neutrogena's high-SPF products provide "insurance against = consumer=20 underapplication," and says advancing sunscreen technology = and=20 formulation is an important element of Johnson & = Johnson's=20 corporate responsibility.

Moreover, she says = Johnson &=20 Johnson's research has found no evidence that using a = product with=20 an SPF of 85 leads people to remain in the sun longer than = they=20 would when using a product with a lower SPF.

FDA weighs = rule

Regardless of the = current SPF=20 claims, manufacturers may have to scale them back if the = FDA's=20 proposed 50+ limit becomes final.

The regulatory agency = proposed=20 new guidelines in August 2007 that would cap SPFs at 50+ and = introduce a four-star rating system to denote levels of UVA=20 protection.

"Because sunscreen = monograph=20 requirements are currently proposed and not final, = manufacturers are=20 not currently held to the SPF 50+ limit on labels," says = spokeswoman=20 Crystal Rice.

"However, if the SPF = 50+ limit is=20 made final, sunscreen products labeled with SPF higher than = 50+ will=20 be considered misbranded."

The final rule is = targeted for=20 publication by September, says Ms. Rice, who declined to = provide=20 further details before discussions are completed.

Dr. Lim says the = suggested UVA=20 rating represents "a very significant advance for the = regulation of=20 sunscreens in the United States. We are one of very few = countries=20 that have no rating on the UVA protection of = sunscreens."

But Dr. Gilchrest = doesn't favor=20 the "star" system. "We know exactly what the SPF rating = means. We=20 don't know what clinical benefit people get from blocking 80 = or 90=20 percent of UVA rays," she says.

Dr. Rigel says the FDA = probably=20 will rethink the star criteria because it's virtually = impossible to=20 earn four stars with currently approved = ingredients.

Dr. Lim calls the = proposed 50+=20 cap "a reasonable upper limit. Very few patients really need = extremely high SPF." On the other hand, "If patients use SPF = 50 or=20 60 at lower amounts, they could still have reasonable in-use = SPF."

But Dr. Rigel says the = proposed=20 cap would snuff sunscreen researchers' incentive to develop = a better=20 sunscreen, because, "They won't get credit for = it."

Dr. Appa says that = while Johnson=20 & Johnson appreciates the FDA's proposal to raise the = SPF limit=20 from 30+, "The FDA should not impose the (proposed) cap = because it=20 can hinder the continued improvement in sun protection." The = company=20 has submitted data showing that it's possible to accurately = and with=20 reproducibility determine SPFs up to 85, she = says.

Regardless of the = debate,=20 dermatologists say the numbers game isn't the most important = consideration.

"The FDA has been = reviewing this=20 stuff for decades," Dr. Gilchrest says. "Frankly, it's less=20 important that they finish this process and more important = that the=20 public hears about this over and over =97 from = dermatologists,=20 newspapers and magazine articles =97 so they finally get it, = and=20 protect themselves at least moderately well."

Disclosures: Dr. = Gilchrest=20 is a consultant to Schering-Plough and has been a consultant = for=20 other sunscreen manufacturers. Dr. Lim has consulted for=20 LaRoche-Posay and Orfagen, and his department has received = research=20 grants from Orfagen and Johnson & Johnson. Dr. Rigel is = a=20 consultant for Johnson & Johnson (Neutrogena, Aveeno), = L'Or=E9al=20 and Procter & Gamble.

=AB=20 Previous
1<= /A>2
About = the=20 Author

John Jesitus

Staff=20 Correspondent

John Jesitus is a medical writer = based in=20 Denver, Colorado. Articles=20 by John=20 = Jesitus

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