Claims by Skin Cream Called Into Question

Times Staff Writer

Famed heart surgeon Dr. Christaan Barnard takes on role as spokesman for new products touted as rejuvenators of tired, wrinkled skin.

With a world-famous heart surgeon beckoning them along the path made famous by Ponce de Leon, Southern California women made their ways to department store cosmetic counters over the weekend to ogle the latest product line to make an old, old claim--that it can rejuvenate, even renew, cells and induce tired, wrinkled old skin to feel young again.

Women bellied up to makeup counters at local Robinson's stores to listen to sales pitches carefully scripted by a thin, white loose-leaf sales manual distributed by the makers of Glycel, the new line of products.

In a section called "sales basics," the manual instructs clerks, who the manual refers to as "Glycel consultants," to tell women that the products' active ingredient "not only regenerates skin cells but also rejuvenates them, enabling old skin to act young. It is concentrated to combat facial lines or wrinkles."

Some shoppers--and some sales clerks--were wary, finding all of this reminiscent of the hype and hoopla that has surrounded countless cosmetic product launchings in the past--most recently the arrival products containing collagen in the 1970s.

The U.S. Food and Drug Administration was watching the Glycel promotion with some skepticism, but, pending review, including possible government laboratory analysis, was viewing the product as a cosmetic, not a drug that must meet certain standards of proof. The manufacturer says it makes no claims of a drug or medical nature in its packaging and advertising of Glycel.

While the claims of more youthful skin appearance through chemistry is not unusual in the cosmetics industry, it is the image of Dr. Christaan Barnard as spokesman for the product that gives Glycel the air of a medical breakthrough. One dermatologist, while suggesting that the new product might be an effective skin moisturizer, said it would be "bizarre" to claim that wrinkles can be removed and skin cells renewed. But Barnard does not make that claim.

The South African heart surgeon, who is pictured prominently in Glycel ads, instead has talked about his interest in a key ingredient in the cosmetic as a potential promoter of wound healing in surgery.

"I'm not qualified to talk on the skin-care line, but on the ingredient," Barnard told The Times in a recent telephone interview. "GSL (glycosphingolipid) is not used at all in the medical community. My research cannot authenticate age reversal."

For six months, the speculation has built that this new cosmetic line may have the capacity to reverse the effects of aging--particularly to make wrinkles disappear.

And as the tempo has picked up--with Barnard as Glycel's spokesman in appearances on television talk shows all over the country--the stock price of Alfin Fragrances Inc., the line's distributor, has risen sharply.

Per share prices have ranged from $8 to as much as $40 with the stock hovering around $35 Monday. One woman at the cosmetic counter at the Santa Monica Robinson's on Sunday afternoon bought a sackful of the products--which range from $30 to $75 a jar--after telling the clerk she wished she had never listened to her husband, who told her not to buy Alfin stock when it was trading at about $22.

The $75 item is a one-ounce jar of "anti-aging creme." One jar of each of the nine products in the line would cost a total of $430 but a package of five selected items is being sold for $195.

Sales Claims

At three Robinson's stores--Beverly Hills, Sherman Oaks and Santa Monica--visited by a reporter over the weekend, customers and clerks also focused on Barnard's out-front salesmanship, the new gimmick Alfin Fragrances has thrown into the intensely competitive cosmetics business. Though Barnard's published medical research since 1979 has been dominated by papers on such things as preserving baboon hearts for transplantation, his media spokesman status for Glycel has captured the imaginations of would-be makeup customers hoping to find the secret of youth.

Adroitly, in a variety of media appearances, Alfin Fragrances has used Barnard to lend an air of medical legitimacy to Glycel products even though close scrutiny of what Barnard has told interviewers establishes that the heart surgeon not only makes no claims for the effectiveness of Glycel's key ingredient as a means of making wrinkles disappear, but he says he doesn't have personal knowledge of such things.

Barnard has not published articles in scientific journals on his work with glycosphingolipid, the ingredient said to provide the new anti-aging effect in Glycel, and he said he hasn't studied the effects of the chemical when rubbed on the skin. Barnard said he has done research on the possible effectiveness of intravenous use of glycosphingolipid in wound healing, but it also remains undescribed in scientific media.

Moreover, a San Francisco dermatologist who is the author of one of two dozen studies published in the world in the last five years on the properties of the chemical said that while it is difficult to know just what benefit is being claimed for Glycel, the notion that it can be effective in removing wrinkles, renewing skin cells or combating the effects of aging "is bizarre as far as I'm concerned."

Dr. Peter M. Elias, chief of the dermatology service at the San Francisco Veterans Administration hospital and a clinical professor of dermatology at UC San Francisco Medical School, said he has followed the media meanderings of Glycel for months and has concluded, based on what he has heard and read in the popular media that "the whole thing is weird."

The U.S. Food and Drug Administration doesn't quite know what to make of what's happening, either. A spokesman noted that any substance that can reverse any part of the aging process would be considered to be a drug, not a cosmetic, and that if the Glycel line is found to make explicit age-reversal claims, it could be ordered off the market immediately. The FDA emphasized that a literal reading of the actual wording of Glycel advertising and other claims so far indicates the company carefully has steered clear of promising Glycel is anything more than a reasonably good line of skin-care cosmetics, very much like its competitors.

Drug or Cosmetic?

The FDA said it hopes to acquire product samples for laboratory analysis and that its drug and cosmetic regulatory divisions will determine if Glycel is makeup or actually a new substance promising an approach to the fountain of youth.

"There is no product out there that will slow or reverse the aging process," FDA spokesman Bruce Brown said. "If there is, (the product) is a drug," and not a cosmetic.

Alfin Fragrances maintains that Glycel is a line of cosmetics--nothing less, but nothing more. Irwin Alfin, the company's president, told The Times last week that he couldn't characterize the chemical action of Glycel's ingredients, but he said the line "makes your skin look better and feel better."

As to any ability to reverse the process of aging or permanently smooth wrinkles caused by aging, Alfin said, "I don't think we've said that."

Studies to establish just what the product will or won't do have not been--and will not be--published, Alfin said, because, even though the company relies heavily in its promotion on Barnard's fame, whatever research he may have done on glycosphingolipid remains among the firm's trade secrets.

"In the cosmetics industry, to the best of my knowledge, no one has ever published the results of the activities of their laboratories, and neither will we," Alfin said. "There is no reason to. We're not in academic medicine, we're in the competitive cosmetics business."

The story behind development of Glycel that has been told by Alfin Fragrances and Barnard goes this way:

In 1983, Barnard, who performed the first successful human heart transplant in 1967, retired from surgical practice because of progressive arthritis in his hands that made it impossible to operate.

Subsequently, he became interested in the possible action of glycosphingolipid in promoting wound-healing in surgery, an area in which he apparently is still involved in research although none of the studies he has done has had exposure in a scientific journal.

Barnard has said it was during his work on glycosphingolipid that he became involved with Dr. Rolf Schaefer, of Basel, Switzerland, who operates the Schaefer Institute in that city. Barnard has said he is convinced that glycosphingolipid can promote cell renewal but that it was Schaefer who found a way to make the chemical absorbent through the skin. In its marketing materials, Alfin calls this the "transdermal carrier system."

In sales presentations at Robinson's over the weekend, clerks told customers that Glycel is capable of penetrating the skin deeply enough that skin cells that have "collapsed," permitting wrinkles to form, can be rejuvenated and regenerated. And it is that claim--one for which Barnard repeatedly has said he cannot personally vouch--that apparently underlies scientific skepticism about Glycel and its promotion.

The Skin's Layers

The skin consists of two main layers, the outer epidermis and the deeper corium. The outer layer, in turn, has four layers of its own, the outermost of which is called the stratum corneum. In 1983, Elias and six other San Francisco researchers published a study in the Journal of Lipid Research in which they characterized a variety of chemical substances found naturally in the stratum corneum layer--one of which is glycosphingolipid. The larger class of sphingolipids in general, of which the active ingredient in Glycel is only one, was found to have a direct bearing on skin permeability--and most notably on the ability of the skin to seal itself to moisture or to retain moisture in the dermal layers.

The sphingolipid research and other work the San Francisco team has done, said Elias in a telephone interview, has made it clear that wrinkles normally associated with aging aren't created in the outer skin layer, but rather that wrinkles occur because of a breakdown in cells far lower than the stratum corneum.

"Aging changes (occur) deep under the skin," Elias said. "Topically applied products (cosmetics) cannot get down to those layers." Elias said it seems unlikely that any delivery mechanism could have been devised that would permit any cell-renewing agent to penetrate deeply enough to smooth aging wrinkles. The FDA noted that any product capable of penetrating beyond the outermost layer of the skin would be classified as a drug, anyway.

Elias said he suspects that the chemistry of Glycel may very well make it a highly effective skin moisturizer because lipid chemistry involving sphingolipids means the ingredient apparently in the new cosmetics "could be very effective in trapping water.

"That's how creams and ointments work. They act as barriers to trap water and hydrate the skin. They make the skin more smooth. This doesn't mean that (Glycel) is not a good product. (But) the likelihood (is) close to zero (that Glycel) has even any role in aging.

Fashion writer Mary Rourke contributed to the research for this article.

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