NOVEMBER 30, 2004

COMMENTARY
By Pallavi Gogoi

An Ugly Truth About Cosmetics
http://netscape.businessweek.com/bwdaily/dnflash/nov2004/nf20041130_2214_db042.htm

Beauty-seekers beware: Largely unregulated ads for skin creams and wrinkle removers often have dubious claims backed by spurious science
[an error occurred while processing this directive]"Better than Botox?" This StriVectin-SD ad splashed across magazines and newspapers all over the nation has attracted women in droves. Aching to erase the telltale signs of age, they're flocking to high-end department stores like Bloomingdale's to grab 6-oz. tubes of StriVectin at $135 a pop, making it one of hottest launches ever of a wrinkle cream. According to market-research firm NPD Beauty, StriVectin rang in $30 million in the first five months of this year, a feat that even the most successful new skin-care products have needed 12 months to match. StriVectin sales are expected to top $100 million by yearend.

Little do these buyers know that the government is investigating StriVectin's maker, Klein-Becker, and exclusive distributor, Basic Research, for making "false claims" on other products it sells. The U.S. Federal Trade Commission (FTC) has charged them with making unsubstantiated claims in infomercials and ads in magazines such as Cosmopolitan, Redbook, and Muscle and Fitness, and on several products, including Pedialean, a weight-loss supplement for children.

The investigation raises questions about StriVectin's boasts of an anti-wrinkle breakthrough. In an e-mail to BusinessWeek Online, Basic Research says its claims are backed by clinical trials that document a significant reduction in wrinkles.

CONJURING NAMES. StriVectin certainly isn't alone in using high-tech claims to attract customers. In fact, more and more ads for skin care are highlighting the "science" and "technologies" behind products. Take Bo-Hylurox in Avon's (AVP ) Anew Clinical Deep Crease Concentrate, or the Mela-NO complex and dermo-smoothing complex D-Contraxol in Lancome's anti-age serums, or the Triplesphere Refinishing system in Estee Lauder's (EL ) "micro-dermabrasion scrub."

Most of these names don't really exist in cosmetic science. "It's an incredible statement to the consumer that you don't need to get injected when there's all this science to rid you of wrinkles," says Paula Begoun, author of Don't Go To the Cosmetics Counter Without Me. Most of these terms were conjured up in company labs by zealous chemists or marketers, points out Begoun. When asked about the claims and the technologies, none of these companies commented by deadline.

Problem is, it's also hard to challenge the claims for these products, since they've been tested only internally, and cosmetic creams don't need to go through any regulatory clearance before being launched. "Wrinkle-reducing creams are expensive, but to litigate against companies is even more expensive, and at the end of the day the harm to people is mostly economic," says Scott Bass, a partner in charge of international food and drug practice at law firm Sidley Austin Brown & Wood.

BORDER LINES. Since the cosmetic industry is largely left to monitor itself and the Food & Drug Administration gets involved only when products have adverse reactions or change the structure of the body, consumers are left to their own devices to monitor such claims. "A lot of this might be worded to sound scientific, but people need to realize that wrinkles don't just disappear as claimed," says Allen Halper, senior compliance officer in the Office of Cosmetics & Colors at the FDA.

The FTC, which monitors advertising for unfair or deceptive claims, isn't that aggressive on the cosmetics industry either. "Our priority is to ensure that if a product is claiming a health benefit that there are enough trials to back that. If there are general appearance-enhancement claims, those are not high in our prosecution list," says Heather Hippsley, assistant director for the FTC's advertising-practices division.

However, the inclusion of certain drug-like ingredients and chemicals in the creams places them in an area termed "cosmeceuticals," a category that straddles the cosmetic and medical sectors. Cosmeceuticals are one of the personal-care industry's fastest growing segments, but they aren't regulated by the FDA either. According to consumer research publisher Packaged Facts, U.S. retail sales of cosmeceutical skin care are estimated to climb 7.3%, to $6.4 billion, from 2003 to 2004. That would be up 22% from 2000. "Aging baby boomers looking for ways to stay young and cosmeceutical manufacturers capitalizing on their concerns [are] fueling the growth," says Timothy Dowd, senior writer and analyst at Packaged Facts.

DOCTOR WHO? Adding to the allure is the fact that most of these cosmeceuticals are endorsed by physicians, though sometimes their qualifications are dubious. For instance StriVectin-SD is endorsed in ads by a Dr. Daniel B. Mowrey, director of scientific affairs at manufacturer Klein-Becker, and Dr. Nathalie Chevreau, director of women's health at Basic Research. But neither Mowrey or Chevreau is a medical doctor, and the government is challenging Mowrey's credentials.

In the e-mail to BusinessWeek Online, Basic Research said: "Dr. Nathalie Chevreau holds a PhD in inorganic chemistry as well as an RD [registered dietician] license. Dr. Mowrey holds a PhD in experimental psychology." The company says its ads don't claim or imply that Dr. Mowrey is anything more or less than a research scientist and that in other advertisements he's referred to as Dr. Mowery, Phd. But the Web site that markets StriVectin didn't say he's a Phd as of the story deadline.

Meanwhile, FTC counsel Laureen Kapin says the commission is now waiting for answers from the companies in connection with the investigation. If they're found guilty at trial, that wouldn't preclude the government from looking at the companies' other products. "If we prevail, Basic Research could receive a broad order [legally referred to as "fencing-in"] barring the firm from making false and deceptive claims and selling any of its products," says Kapin.

BRING IN THE FEDS. The future of StriVectin, a cream originally marketed as a stretch-mark-reducing emulsion containing an ingredient called oligo-peptide, might be tied to the FTC's investigation. But millions of consumers continue to be hoodwinked by the cosmetics industry's ingenious marketing. The FDA and the FTC might not consider this a priority, since cosmetics makers figure low in the agencies' ranking of companies to go after. However, if people are being deceived, regulators ought to take a closer look.

The creams may not be taking people's lives or inflicting blindness, but the FDA needs to assure that people aren't duped by false claims. The Office of Cosmetics & Colors needs to regulate cosmeceuticals and check out the various supplements and ingredients that go into changing people's appearances.

"If a product's claims have reached a point where they're no longer puffery and are deep-penetrating treatments, where the cosmetics are almost thinly disguised drugs, they have to comply with drug provisions," says Halper from the FDA's Office of Cosmetics & Color. But he adds that the agency prioritizes issues on health and safety, and it doesn't have the resources to examine all the claims out there. So it mostly relies on the cosmetics industry to monitor claims appropriate for the marketplace.

BIG CLAIMS. The FTC says it tries to discern between readily ascertainable claims vs. others. For instance, in 2000 it filed suit against Rexall Sundown for marketing a product that claimed to eliminate cellulite. For topical creams, the FTC's Hippsley says most reputable companies honor their satisfaction guarantees no matter how inflated their marketing claims. "Consumers can see for themselves if the creams work or not, and if they aren't satisfied, they can either return the product or not buy the brand again," she says.

Given this cavalier attitude, cosmetics companies certainly seem to have almost free rein when it comes to claims. Avon says "Look stunning, Not stunned," in one of its ads for a product that contains its "exclusive multipatent-pending Bo-Hylurox technology." Avon didn't comment on the genesis of the name, but Begoun says it might be a concoction of Botox and hyaluronic acid, the main ingredient in Restylane -- a gel that's injected into the skin to fill in creases and is approved by the FDA.

Avon claims that its product smooths creases with an ingredient called portulaca, which relaxes the skin, whereas hyaluronic acid has a filling effect.

Obviously, when examined closely, what looks like a harmless cream might actually be a drug or medical product that's readily available to the masses. With aggressive marketing, such products can also become very popular, as in the case of StriVectin. Cosmetics companies shouldn't be left to their own devices just because they're playing with people's vanity.


Gogoi is a reporter for BusinessWeek Online in New York
Edited by Patricia O'Connell

NEWS ANALYSIS
By Amy Tsao

The Changing Face of Skin Care
The rise of "cosmeceuticals" is blurring the lines between dermatology and cosmetology in ways that many consumers don't understand
[an error occurred while processing this directive]In a classic episode of the sitcom Seinfeld, Jerry dates a dermatologist, who says she's "saving lives" all day by treating skin diseases. Jerry is skeptical, and his sidekick George squawks: "Saving lives? She's one step away from working at the Clinique counter."

Think about that before you rush off to get your forehead smoothed or your skin freshened for the holidays. George's assessment may be a little harsh, but there's no denying that the line between dermatology -– the medical specialty devoted to skin disorders and diseases -– and cosmetology -– the practice of improving a person's appearance –- is becoming increasingly blurred.

Indeed, the term "cosmeceutical" -– a product marketed as a cosmetic that purportedly has biologically active ingredients that affect the user -– has sprung up to define a broad gray area where the practice of medicine and the pursuit of vanity meet.

HEAVILY INVESTED. A variety of factors are behind the rise of cosmeceuticals: the aging of the baby boom generation; increasingly effective alternatives to plastic surgery, such as Allergan's (AGN ) Botox; and the financial disincentives of managed care. Add them all up, and cosmeceuticals comes to a booming business that has implications far beyond the promise of diminished crow's feet and less-visible laugh lines.

From 2003 to 2004, sales of skin-care cosmeceuticals in the U.S. are expected to grow by 7.3%, to $6.4 billion, according to consumer industry tracker Packaged Facts. Major cosmetic companies -– including Estee Lauder (EL ), Avon (AVP ), L'Oreal, and Revlon (REV ) -– are already heavily invested in such products and will continue to be.

So far, relatively few drugmakers, besides Allergan and Johnson & Johnson (JNJ ), with its Vitamin A-based drugs, are in the business. That may change, though. The success of Botox, which was a $564 million product in 2003, and the aging of youth-obsessed baby boomers haven't been lost on the drug industry. Pfizer (PFE ), for one, bought a company called Anaderm in 1996 to focus specifically on cosmeceuticals.

ELEVATED AESTHETICIANS. Certainly, the business of improving appearance by medical means is vast and is growing in many directions. Along with cosmeceuticals, a wide range of treatments are available in doctors' offices. Chemical peels, laser treatments, microdermabrasion, which were once primarily the purview of spas and beauty clinics, are now common offerings at many dermatologists' offices.

Doctors are opening their own spas, lending their names to various product lines, and writing books detailing methods that allegedly keep skin youthful. About half of all dermatologists sell cosmetic products in their offices, estimates Howard Maibach, professor of dermatology at the University of California, San Francisco.

As a result, patients increasingly see dermatologists as having the skills and tools to reverse or halt the aging process -– and many doctors are more than happy to serve as elevated aestheticians. The reality is that doctors in the profession are "tour guides" to patients traversing a confusing world of products and services (Botox, collagen, lasers, and peels) promising youth, says Richard Glogau, clinical professor of dermatology at University of California, San Francisco. (Glogau consults for several cosmeceutical makers.)

Plenty of dermatologists view selling cosmeceuticals as good medical practice. "What we love about dispensing [these products] is we really know what patients are using," says Patricia Farris, a dermatologist based in New Orleans and clinical assistant professor at Tulane University.

A BLEMISHED REPUTATION? There's no denying that they're good business, too. She says such products are the beginning of a "step-up process" to prescription drugs or procedures like Botox injections and laser treatments, which is where the biggest dollars are. "You don't start with the big guns," says Farris. (Farris consults for a number of cosmetic companies.)

This emphasis on the aesthetic rather than the medical has some in the field concerned. "Cosmetic dermatology is really injuring the reputation of dermatology," says Eileen Ringel, a dermatologist in Maine who is also on the Food & Drug Administration's advisory committee for dermatology. "People come to me and think I'm a cosmetologist, and they don't know the difference. That's our fault as dermatologists." (Ringel doesn't perform cosmetic dermatology services of any kind.)

Dermatologists' reputation may not be all that's suffering. As these practitioners spend more time addressing cosmetic complaints, they have less time to treat patients with skin diseases, including potentially fatal skin cancers. The average wait time to see a dermatologist in major cities around the country is 24.3 days -- the longest among high-demand medical specialties including obstetrics and gynecology and cardiology -- according to a 2004 survey by physician staffing firm Merritt, Hawkins & Associates.

"ONE-DIMENSIONAL." According to data from the American Academy of Dermatology's 2002 practice profile survey, 90% of dermatologists interviewed reported a need for more medical or general dermatologists in their local area, while only 13% cited a need for more cosmetic dermatologists. "A severe shortage of dermatologists threatens patients' access to care and is likely to further increase the amount of medical and surgical skin care provided by nondermatologists," the study's authors wrote.

Though dermatology has become one of the most sought-after specialties among medical students, some fear that the field's dynamism is faltering. Funding from universities and industry alike for "basic science and research [on] important diseases is shunted to cosmetics," says Ringel. New York-based dermatologist A. Bernard Ackerman agrees: "Instead of being multifaceted and fascinating, it is one-dimensional." (Ackerman doesn't perform cosmetic dermatology.)

Sheldon Pinnell, professor emeritus at Duke University, disagrees. "I'm bullish about the profession from a number of points of view," says Pinnell. "[We're researching] everything from conditions that are life-threatening to ways of protecting skin that improve the cosmetic nature of skin." Advances in technology could soon spur the FDA and professional societies like the American Academy of Dermatology to make more rigorous demands of skin science and its practitioners, critics say. Both are now largely absent from the debate. (Pinnell is a consultant to a line of products called SkinCeuticals.)

Among consumers, the popularity of cosmeceuticals will continue to rise as long as improving physical appearance remains a top social priority. The question is: What will be the medical and scientific community's role in shaping this fast-rising field?

NEWS ANALYSIS
By Amy Tsao

Despite the Hype, No Elixirs of Youth
Lots of products promise to reverse the signs of aging, while providing little or no proof that they work. Here's what you need to know
[an error occurred while processing this directive] Want to look your best for the holidays? Think you're in need of a more youthful appearance, but you're not willing or ready to go under the knife? You might be tempted to treat yourself to a little something at the dermatologist's office -- or at the corner drugstore. People hoping to reverse the signs of aging are increasingly looking to "cosmeceuticals," nonprescription creams, gels, and lotions that promise dramatic results.

The ugly truth is that most of the age-fighting products available for retail sale lack scientific data to support their claims. While manufacturers promise dramatic improvements, especially on wrinkles, relatively few products have been studied scientifically.

That's because the active ingredients in many popular cosmeceuticals are vitamins and plant extracts, which aren't subject to the rigors of the Food & Drug Administration's drug-approval process, consisting of controlled safety and effectiveness trials in human subjects. Indeed, most manufacturers are content to be in this blurry cosmeceutical zone, with little need –- or incentive -- to conduct expensive studies.

FEEL-GOOD PRODUCTS? "With a few exceptions, there's precious little good data that any of the anti-aging products sold over-the-counter are effective," says Eileen Ringel, a dermatologist based in Waterville, Me. Ringel, who's also a consultant to the FDA's dermatology board, says the only data often available are "testimonials" by users who claim they've seen or felt a change in their appearance. When studies have been done, they often lack "oversight and are poorly designed," she says.

"A lot of skin-care products have rudimentary data to show that they're effective on some level," says Richard Glogau, clinical professor of dermatology at the University of California, San Francisco. "Most are just very fancy overpriced moisturizers that make the skin feel good." (Glogau consults with several cosmeceutical makers.)

Take Avon's (AVP) latest foray into the battle against aging. In October, it launched a new product in its popular Anew line, Anew Deep Crease, which it bills as an alternative to Botox injections. The marketing pitch: "Look stunning, not stunned."

UNDISCLOSED DETAILS. Avon says the gel contains hyaluronic acid (the main component of synthetic collagens) for a filling effect and a "custom" extract of a plant called portulaca for a relaxing effect. "We uncovered it on our own," says Glen Anderson, senior manager in skin-care product development, of portulaca, which Avon imports from Asia.

Avon claims that the product showed strong results. After eight weeks of use, 71% of patients tested saw improvement in their lines. That sounds impressive, but the company declines to disclose the total number of patients tested or any other study details. Anderson says Avon's legal department has the detailed results ready should the Federal Trade Commission, which monitors advertising for unfair or deceptive claims, ever ask for it.

Indeed, the products that are best supported by published, scientific data are prescription drugs like vitamin-A derivatives (Renova, Retin-A, Differin, and Avage) and FDA-approved injectable treatments, such as Botox, Hylaform, and Restylane. In the nonprescription arena, some researchers point to data suggesting that some forms of topical vitamin C may protect the skin from sun damage.

AGGRESSIVE MARKETING. Those, of course, are the minority. A whole universe of cosmeceutical products exist that contain a variety of plants, herbs, vitamins, and antioxidants. Alpha hydroxy acids are also popular. Others use relatively new active ingredients, like palmitoyl-pentapeptide, the basis of StriVectin-SD -- a cream that with aggressive marketing as a youth-restoring alternative to Botox -– has become a big seller in the past year. Creams containing growth factors, which are traditionally used to treat wounds and burns, are also showing up in the marketplace as youth-restoring treatments.

Consumers also may not realize that the products dermatologists hawk aren't likely to be any better than items sold on pharmacy shelves or in department stores, says Ringel. "I don't understand why dermatologists would recommend these products to patients without being able to examine a well-designed, peer-reviewed study," she says. "They might as well base their recommendations on what they heard last week on Oprah."

One silver lining in cosmeceuticals' runaway growth is that for the most part, the giant beauty-products makers won't risk the type of lawsuits that would result from products that might be proved harmful. Avon's Anderson says the company runs "a significant amount of safety testing" for toxicity and allergies. Often Avon will do "exaggerated use" tests in which the ingredient is set on a patch and driven into the skin to see if it causes adverse reactions. "These companies aren't willing to take risks on stuff that's flimsy," says Glogau.

Following is a guide to the good, the bad, and the ugly among popular cosmeceutical products:

Alpha hydroxy acid
Loads of products contain alpha hydroxy acid -- chemicals derived from fruit and milk sugars. Some data suggest that they may help the appearance of aging skin by exfoliating dead cells. But they're also known to have damaging effects, including rashes, swelling, and increased sensitivity to sunlight.

After conducting its own studies, the FDA in 1994 said products containing alpha hydroxy acid are safe in concentrations of 10% or less of the product and provided the acidity is also low. Glycolic acid and lactic acid, which are forms of alpha hydroxy acid, are safe at concentrations of 30% in chemical peels, the FDA said.

Botox
Botulinium toxin type A, popularly known as Botox, works by temporarily paralyzing muscles behind wrinkled skin. For its FDA filing for cosmetic use, Botox was studied in placebo-controlled randomized clinical trials involving 405 patients with moderate-to-severe eyebrow furrows. In the group receiving Botox, after 30 days, both researchers and patients rated frown lines as improved or nonexistent. Very few patients in the placebo group saw similar improvement.

Side effects include headache, respiratory infection, flu syndrome, droopy eyelids, and nausea. Less-common effects are pain in the face, redness at the injection site, and muscle weakness. It's unknown what the impact of long-term use might be. Skeptics worry that the shots will render patients' muscles atrophied over time. It's recommended that Botox not be injected more than once every three months.

Hyaluronic acid
This is the main component of the synthetic, injected products Restylane and Hylaform. They make lips plump up and remove deep skin creases by filling the space between collagen and elastin fibers within the skin. The body absorbs the gel over time, and repeated injections are needed to maintain results.

In studies across the U.S., 138 patients with frown lines were injected with Restylane on one side of the face and with a bovine collagen product on the other side. Pain and bruising occurred in both groups, but at lower rates on the Restylane-treated side.

Hyaluronic acid is showing up as an ingredient in all kinds of lotions, but no credible data show that a topical treatment would penetrate the skin and have a beneficial effect.

Vitamin A
Prescription vitamin A creams and gels such as acne treatment Retin-A, made by Ortho Pharmaceutical, a Johnson & Johnson (JNJ) division, may also help with the appearance of fine lines, coarse skin, and pigmentation problems. "But it's not magic," cautions Jeffrey Dover, associate clinical professor of dermatology at Yale University School of Medicine and director of SkinCare Physicians in Chestnut Hill, Mass. "Results are modest and take a long time."

Dover also cautions that products containing watered-down ingredients that sound like Retin-A (retinol, retinyl, etc.) are popular, but probably useless. (Dover consults for JNJ's Neutrogena division.)

Vitamin C
Some evidence shows that vitamin C is useful in sunscreens. "It quite surprisingly provides an enormous amount of photoprotective power," says Sheldon Pinnell, professor emeritus at Duke University. A 1992 study showed that vitamin C protected pigskin from damage caused by ultraviolet rays.

Another study co-authored by Pinnell was published in the Journal of the American Academy of Dermatology last year. It showed that topical vitamin E and C together protected pigskin better from the sun than vitamin C or E alone. (Pinnell is a consultant to Skinceuticals, a line of cosmeceuticals.)

Such data are "very exciting," says Dan Rivlin, dermatologist at Skin & Cancer Associates in Miami Beach, Fla. But he doesn't typically recommend vitamin C creams to patients since the only available studies didn't involve humans. Also, Pinnell's studies were done with a particular strength and type of vitamin C that may not be the same as those in other vitamin C products.

All the rest
Hundreds of products are presented as age-fighting remedies. And some are becoming blockbusters despite uncertainties about whether they work. Strivectin-SD, for example, is on track to becoming a $100 million product by yearend -- even though relatively little evidence of safety or effectiveness has been shown.

Klein-Becker, the maker of StriVectin-SD, insists the product works and is safe, but it declines to disclose where research of the product was published. And since this summer, the Federal Trade Commission has been investigating Klein-Becker for making unsubstantiated claims on various weight-loss products it sells.

While alleged anti-aging treatments are plentiful, what's in short supply is the evidence that they can really make you look younger. Remember, promises and proof aren't the same.