BOTOX Cosmetic
Ophthalmologists should be able to stake a strong claim to these new procedures, but knowledge of the risks is crucial.
BY LOUIS PILLA

Not quite a year after the FDA's approval of Botox Cosmetic for glabellar lines, it is the biggest story in the cosmetic antiaging arena. The demand for Botox Cosmetic, and that it's a fee-for-service procedure, has prompted a range of healthcare practitioners, including dermatologists and plastic surgeons, to climb on board the Botox bandwagon. And there's little doubt that more ophthalmologists are making Botox part of their practices.

And why not? With an aging Baby Boomer population bent on looking good regularly trekking into your office, the opportunity literally stares you in the face.

But incorporating Botox Cosmetic into your practice without careful thought and reflection can lead to trouble. After all, you're injecting Botulinum Toxin Type A into your patient's facial muscles with the intent of weakening their action. And this cosmetic procedure can present a departure from your typical medical offerings.

In this article, we'll provide you with practical tips for incorporating Botox Cosmetic into your practice, look at the potential risks, and offer clinical and marketing advice. First, though, let's look at the burgeoning popularity of this drug.

Allergan, Botox's manufacturer, has scored a big hit with Botox. It now forms one of three business units at the company (the other two units are eyecare pharmaceuticals and skincare pharmaceuticals).

In 2001, according to Allergan, full-year global sales of Botox amounted to $310 million, with 33% attributed to cosmetic use. By comparison, for the first three quarters of 2002, sales were at the same level ($311 million) with 40% attributed to cosmetic use. Allergan projected full-year 2002 sales at 30% to 40% growth over 2001 ­ between $430 and $440 million.

In 2001, Botox was the most frequently used off-label cosmetic product, according to a report from research firm Kalorama Information. Doctors did 1.6 million procedures in 2001, up by almost half from the year before.

Dermatologists and plastic surgeons, according to Allergan spokesperson Christine Cassiano, form the largest base of physicians using Botox for cosmetic purposes. But Botox represents "the hottest topic in ophthalmology these days," according to Richard Anderson, M.D., F.A.C.S., of Oculoplastic Surgery Inc. and medical director of the Center for Facial Appearances, Salt Lake City, Utah. It's been the "best recent advance in facial cosmetic surgery" for his practice. Botox earns high praise from John Shore, M.D., of Texas Oculoplastic Consultants in Austin, Texas. "It's a wonder drug in the cosmetic arena," he says, noting that he was caught somewhat off guard by how much the drug was going to take off. Botox today "is a well-recognized, essential component of any cosmetic practice," says Jill Foster, M.D., F.A.C.S. of Ophthalmic Surgeons and Consultants of Ohio Inc., Columbus, Ohio.

Ophthalmologists are uniquely qualified

Though dermatologists and others provide Botox, ophthalmologists can argue that their expertise is second to none. After all, ophthalmologists have been administering Botox for noncosmetic applications for quite some time. It was first approved in December 1989 to treat blepharospasm and strabismus and in December 2000 for cervical dystonia.

Cosmetic applications followed, with the drug's FDA approval for treatment of glabellar lines in April 2002. Ophthalmologists, says Allergan's Cassiano, are "highly qualified" to give Botox treatments.

The question isn't whether ophthalmologists should administer the drug, says Stuart Seiff, M.D., professor at the University of California, San Francisco, but whether other physicians should. The areas of the face where Botox is most efficient "are in the primary purview of the ophthalmologist," he says. "It's a natural fit," says Dr. Shore.

Ophthalmologists, according to Dr. Anderson, are the best trained in the anatomy and physiology around the eyelids, which is the most critical area of injection, and so should be the major providers. He says he's somewhat disappointed that, despite Botox's original use in ophthalmology, the cosmetic uses have "migrated toward the dermatologists."

Getting started

Incorporating Botox Cosmetic into your practice takes both clinical and marketing effort. Clinically, you may need to brush up on facial anatomy and observe Botox being administered.

Ophthalmologists can't "just get their Botox and start injecting," warns Steven Fagien, M.D., F.A.C.S., an oculoplastic surgeon in Boca Raton, Fla. While instrumentation is minimal, you need a knowledge of facial anatomy and a flair for esthetics. Dr. Fagien puts it succinctly: "Read and go watch before you do."

Being technically able to administer Botox isn't so much an issue for the busy practitioner as taking time to gear up for the procedure, says Dr. Shore. While it's simple compared with other procedures ophthalmologists perform, you can't just "dabble at it and expect to be successful," he says. Allergan sponsors fee-based National Training Centers that instruct member physicians in Botox treatment (www.botoxcosmetic.com).

When you first start, give Botox injections in the glabellar area, recommends Dr. Anderson -- the easiest and safest region that presents the least chance for complications. (Glabellar lines represent the only place that Botox Cosmetic is approved for use, so injecting in areas such as crow's feet or forehead are officially off-label uses.)

If you use Botox on the forehead, you must understand brow position and ptosis, says Dr. Anderson. If you inject crow's feet, watch for the potential side effect of drier eyes. The glabellar region, agrees Dr. Foster, provides dramatic effects and a low possibility of unpleasant outcomes.

As for marketing, don't plan on spending a lot of dollars, at least initially. To start, consider internal marketing through brochures and other in-office literature. (See "Practice Management: A Little 'P.T. Barnum' helps," on page 62.)

While you're learning, you may want to offer patients a free or discounted touch-up, says Dr. Shore. You'll learn more and keep them happy. And don't forget, Dr. Shore adds, that because patients need repeated Botox injections, you have various opportunities to introduce them to your practice's other services.

More keys to success

For many ophthalmologists, giving Botox will represent a departure from their normal eyecare services. Obviously, you're not going to perform a complete eye checkup on a patient who's in your office simply for a Botox treatment.

But more than that, Botox is an esthetic procedure that may require a somewhat different mindset. Giving Botox is "much more patient-driven," says Joan Kaestner, M.D., of Kaestner Eye Care, Encinitas, Calif., and will likely involve "a great deal of talk time." You have to understand what will please the patient, notes Dr. Shore.

Providing a somewhat different view, Dr. Seiff suggests that an ophthalmologist doesn't have to adopt a different practice style to give Botox successfully. He says that the line between a functional and cosmetic procedure can be blurry, and that many patients prefer receiving esthetic treatments in a clinical rather than boutique setting.

Besides these ideas, clinicians offer other keys to success:

• Patients need to understand that the maximum effect isn't immediate.
• Because Botox must be used within a limited time frame after dilution, consider grouping patients so as not to waste the drug. Once reconstituted, it should be used within 4 hours for sterility purposes, according to Allergan. Dr. Shore first marketed Botox to his patients with "Botox Fridays," the day on which he would administer the drug.
• Make sure your staff is fully informed about the pricing strategy.

Handle with care

As much as Botox might seem like a relatively inconsequential procedure to some, the truth is that you're administering a toxin to weaken facial muscles. A laissez-faire attitude is inappropriate at best, dangerous at worst.

These injections can lead to complications, stresses Dr. Seiff. In the past few months, he saw two patients with ptosis that had an onset coincident to Botox injections.

The most common adverse events following injection, according to the FDA, include headache, respiratory infection, flu syndrome, blepharoptosis, and nausea. And the injection can lead to bruising as well, of course.

Still, unlike LASIK for instance, Botox wears off after time. Typically, says Dr. Foster, expect the effects of a Botox treatment to last 4 months.

A big risk with Botox, says Dr. Fagien, is "inducing an esthetic result that may not be optimal." Any cosmetic patient tends to be more educated, have higher expectations, and be more litigious, says attorney William Sarraille of Arent Fox. These patients tend to seek punitive damages more often, seek higher compensatory damages (usually because their income is higher), hire more aggressive counsel, and attack claims made in medical advertising more often and more aggressively, he says.

On a related note, the Ophthalmic Mutual Insurance Company (OMIC) recently stated that its standard policy extends coverage to the use of botulinum toxin for therapeutic purposes. Provided those procedures represent only a portion of the insured's overall private practice and are performed in a clinical setting, coverage will also extend to claims arising from the cosmetic treatment of facial wrinkles, it says.

Botox backlash?

As more clinicians offer Botox and the public clamors for this seemingly miraculous antiaging drug, abuse is inevitable. In late June 2002, the law firm Arent Fox issued an alert against "Botox parties" -- private gatherings in physicians' offices, patient homes, and other settings where clinicians administer the drug to multiple patients, sometimes with alcohol being served.

Dr. Anderson worries that having these events "trivializes and discredits the procedure." Allergan's Cassiano says that the company doesn't support Botox parties and that patients should receive the drug in a medically appropriate setting.

Will such practices and increased competition lead to a Botox backlash a la LASIK? It's hard to tell, but certainly a watchful eye is called for.

With any new surgical procedure, notes Dr. Foster, the initial enthusiasm may lead to going overboard, followed by a "reality check" and then a "steady state." In the future, Dr. Shore looks for a "hardening" of the market, as consumers become more sophisticated in their choice of providers.

You can make it work

Despite the risk, hype, potential for abuse, and competition from other specialties, ophthalmologists can stake the strongest claim to the rightful ownership of Botox procedures. With appropriate education and a careful approach, this agent is likely a useful addition to your practice.

Pilla (pilla@netreach.net) is a freelance healthcare journalist based near Philadelphia, Pa.