Number #26 summary

Everything you always wanted to know about FDA approval
Misconceptions abound about what US Food and Drug Administration approval really means. Barbara Rutledge PhD provides the full picture

The drug approval process by the US Food and Drug Administration (FDA) has the reputation of being the most demanding and rigorous in the world. Nonetheless, companies usually consider it worthwhile to seek marketing approval from the FDA, because the US market is regarded as the most lucrative pharmaceutical market in the world.
     The FDA classifies products used in cosmetic dermatology as drugs, biologics, medical devices, or cosmetics. The approval process differs for each category. Marketing approval for drugs and biologics requires evaluation of safety and efficacy results obtained from toxicology studies in animals and clinical trials in human volunteers. Marketing approval is usually obtained more easily for medical devices than for drugs and biologics, as the emphasis in device approval
is primarily on safety rather than efficacy. No pre-marketing approval is needed for products classified only as cosmetics.
     Most of the federal regulations covering the approval process for drugs, biologics and medical devices are found in section 21 of the code of federal regulations, available on-line from websites maintained by the National Archives and Records Administration. The FDA also issues guidance documents and guidelines relevant to various aspects of the approval process (available at www.fda.gov).

Why hyaluronic acid is the leading filler
Despite an early origin, it was only on the cusp of the new century that hyaluronic acid was refined to the standard that has led to its growth as the preferred choice, writes Professor Harryono Judodihardjo

Hyaluronic acid (HA) was discovered by Dr Karl Meyer and his assistant Dr John Palmer in 1934 while they were studying cows’ eyes. One of their findings was that the vitreous humour of the eye was rich in uronic acid, which led them to name the substance hyaluronic acid, from the Greek word hyalos (meaning glass) and the uronic acid.
     Strictly, this term is incorrect because, in its physiological condition, HA is not present in acid form; some purists would rather call it hyaluronan. HA is a polysaccharide consisting of linear chains of alternating D-glucuronic acid and N-acetyl-D-glucosamine. It is ubiquitous in its distribution and it can be found in virtually any interstitial spaces in animal tissues.
     HA is highly hydrophilic and is structurally homogenous across species and tissues. Its main function is as a structural element but it also has other functions depending on its location in the body. During the cellular repair process, HA mediates cell adhesion, differentiation, motility and blood vessel growth. Its hydrophilic nature helps to hydrate and protect tissues. Depletion of HA has been linked with certain cancer, skin diseases, osteoarthritis and rheumatoid arthritis.

Forever thinking young
Growing older doesn't require acting older. David Alpert looks at the psychology of ageing

Does biology influence psychology or is the opposite true? For many years mainstream medicine stuck steadfastly to the former of these notions. After all, it’s relatively easy to show that certain foods (chocolate is a good example) will raise your serotonin levels, exercise will increase your endorphins, and testosterone your verve—all of which lead to an improved mood and feel-good factor.
     We know that sustained levels of anxiety and stress can have a negative impact on health: stomach ulcers and reduced immunity are good examples. So let us look at the role of psychology on ageing and tackle the question of whether aesthetic practices, such as applying make-up or cosmetic surgery, can ever be classed as truly anti-ageing. In other words, can these practices measurably improve your biological age? And what are the implications for today’s anti-ageing clinics, spas and salons.

Secrets of better marketing
Aesthetic surgery is a marketer's dream, writes Drayton Bird. Yet few practitioners truly understand marketing. Drayton shares a few thoughts

I’ve had to sell almost everything you can think of in my career—and what a hard slog! American Express? We competed with Visa and Mastercard. Mercedes? We had to battle with BMW, Audi and Lexus. Everest? Every local installer competes—plus big ones like Anglian.
     Besides lots of competition, what you sell is often boring. Credit cards are plastic. People run a mile at the mere thought of a double-glazing salesman. And how do you explain your car is better? Frankly, give me something people get really excited about. Something they dream about night and day. Something they deeply cherish. Themselves.
     That’s why aesthetic surgery is a marketer’s dream. Look at any magazine rack. Turn on the TV. Open the paper. Never since ancient Greece have people been so obsessed with their looks.
     But what is the secret of marketing this or any other product? Well, an early advertising genius, Claude Hopkins, wrote two-and-a-half immensely wise pages about marketing back in 1926—the shortest chapter in a very short book. The chapter title was, “Just salesmanship”.

Hunger pangs for youth
‘Beauty foods’ may supersize their way into western society should they prove to be popular with consumers hungry to roll back the years. Catherine Quinn reports consumer demand will
inevitably boost demand for more professional products

Self-tanning cola? Skin-renewal yoghurt? Collagen marshmallows? These are among the latest products for ingestion in the nascent beauty foods market. Beauty foods, or what one expert calls “beauty-from-within”, are growing apace. Datamonitor estimates the European market will be worth £2.2bn by 2009. The bellwether of new trends—the US—played host to the first dedicated trade show, Inside Beauty, as part of Health and Beauty America.
     As a medical practitioner you may be forgiven for asking what a beauty food is. It sits somewhere between a nutraceutical and cosmeceutical, the former being a portmanteau of nutrition and pharmaceutical, and the latter forming its name from cosmetics and pharmaceuticals. Moreover, the use of ceutical is misleading, as none of these hybrids approaches the stringent testing required for drugs.

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