The U.S. Food and Drug Administration is expected to approve the use of Botox for cosmetic purposes by the end of March, prompting doctors to predict a major rush on the wrinkle-erasing drug once the manufacturer can begin advertising it.
But the rush already has been substantial, even without advertising.
Botox, which is injected into facial muscles to paralyze them and thus smooth out wrinkles, has won over legions of women who would stop shy of surgery.
“It is a miracle product,” said Janet, 45, an Oak Brook nurse who has been getting Botox injections every six months for four years. A majority of her friends now use it, she said. “And if they told their friends, I’m sure their friends would be doing it too; it’s that effective.”
“I am not the kind of person who would have a face lift down the road,” said Dr. Shannon Smith, 30, an internist who had her sun-wrinkled forehead smoothed with Botox recently. “But this was so quick and painless. I almost felt like I was cheating. It was as easy as getting a manicure or a pedicure.”
“With Botox, almost every patient is a very happy patient,” said Smith’s doctor, Dr. Tomi Pandolfino, a dermatologist with Northwestern Memorial Physicians Group at Northwestern Memorial Hospital.
Botox is a commercially produced botulinum toxin. It works only for wrinkles caused by muscles repeatedly contracting during facial expressions like frowning or squinting. It is most commonly used on furrows between the eyebrows, horizontal lines on the forehead and crow’s-feet around the eyes.
Its effects are temporary. The paralysis, which takes effect within two to 14 days of the injections, usually lasts four months.
The treatments are not cheap, except when compared with plastic surgery. A single Botox treatment costs between about $335 and nearly $500, according to the American Society for Aesthetic Plastic Surgery.
Botox was approved by the FDA in 1989 to treat medical conditions like eye muscle spasms. When patients reported that not only had their spasms stopped but their crow’s-feet had disappeared, dermatologists and plastic surgeons began using it “off-label” to eliminate wrinkles and frown lines. More than 1 million Botox injections were performed in the U.S. in 2000, ASAPS figures show, 89 percent of them on women.
A mind-boggling increase
Even without FDA approval, its cosmetic use increased nearly 1,600 percent between 1997 and 2000, according to the ASAPS.
“It’s non-surgical; it’s relatively inexpensive compared to surgery; it’s relatively painless; and it’s relatively risk-free,” said Dr. Laurie Casas, a plastic surgeon with Evanston Northwestern Healthcare and an associate professor of surgery at Northwestern University Medical School.
Getting your face injected with the bacterium that causes a form of food poisoning might not sound like an attractive prospect. But Botox has built a word-of-mouth reputation from wildly happy customers.
“It’s almost addictive,” said Elizabeth Jacobs, 44, of Northbrook. “I saw such a difference. I have no crow’s-feet around my eyes. No creases on my forehead. I do not have frown lines between my eyes. My skin is totally smooth.”
The pain, she said, was “less than a bikini wax.” Her treatment, which included three areas, cost more than $800.
“It is well worth it to me,” she said. “I told my doctor, `I know this sounds silly, but it makes me feel better about who I am.’ “
You can’t buy advertising like that. But Allergan Inc., manufacturer of Botox, will be able to advertise if the FDA approves its cosmetic use, possibly leading to a marketing campaign that could rival Viagra’s.
A spokeswoman for the Irvine, Calif.-based company said she could not discuss marketing plans before FDA approval, which the company expects by the end of March. Allergan’s sales from Botox were $25.3 million in 1993; in 2001, they had soared to $309.5 million.
“I think that when Botox can be advertised, it’s going to be huge,” said Casas, who is also vice chair of communications for the American Society for Aesthetic Plastic Surgery.
“People will say, `Oh, let me try it once,’ ” she said. And once, say Botox regulars, is enough to make a person come back for more.
The main risk of Botox is that the toxin could migrate to a different muscle and cause drooping in the eyelid that can last up to three months. To minimize the risk, patients are advised not to lean forward or do strenuous activity for four to six hours after the procedure.
Also, Casas said, if a high dose is used in neck muscles to reduce a stringy appearance, it can migrate to nearby muscles and cause difficulties swallowing.
There is no risk of getting botulism, because the dose is too weak.
As both a patient and a doctor, Smith, who lives on the Near North Side, takes the risks seriously. “Even if it’s temporary, that’s a long time to live with eye droopiness,” she said. She said she worries that FDA approval might increase the number of doctors not board-certified in dermatology or plastic surgery who will offer Botox injections.
“You have to be careful exactly where you’re injecting it,” said Dr. Loren Schechter, a plastic surgeon with Rush North Shore Medical Center. He said none of his patients has suffered a drooping eyelid.
Stigma being erased too
Interest in all cosmetic procedures has been growing. The ASAPS reports that the number of procedures increased 25 percent from 1999 to 2000, the last year for which its statistics are available.
“A lot of it is advertising,” said Casas, and some of it is the Greta Van Susteren effect. (Her surgery to remove the bags under her eyes, unrelated to Botox, made headlines recently.) “You have one or two celebrities say, `I did it,’ and that makes it more accepted,” she said.
“We’ve become much more conscious of our looks over the last 10 years or so,” said Dr. Gilbert Tresley, a plastic surgeon with a practice in Oak Brook. “We’re seeing more and more younger people come in for Botox.”
By starting Botox injections early, patients can avoid developing deep lines that would be difficult for Botox to erase completely, he adds.
“In certain anatomical areas, such as the forehead and crow’s-feet, Botox can be more effective than surgery,” he said.
`A bridge to surgery’
“I use it as sort of a bridge to surgery,” Schechter said. “It allows men and women to see the effects of a surgical procedure without going through surgery.”
If Botox becomes even more popular, might there be another risk–of the widespread disappearance of the ability to squint or frown?
“I do have some patients who are actors or actresses, and I do say to them that it does minimize some facial expressions,” Pandolfino said. “In those patients, I go very gently. I say, `Let’s not paralyze everything. I want you to be able to frown, because it’s part of your job.’ “
Botox doesn’t prevent people from looking angry, Casas said; it just keeps them from looking angry all the time.
Jacobs said she doesn’t look expressionless, just better. “People who don’t know I’ve had it done are making comments like, `Gosh, your skin looks beautiful’ and `Gee, you look rested,”‘ she said. Her friends are now flocking to get Botox themselves.
Janet, the Oak Brook nurse, said she has never found herself unable to express anger or surprise with her face. “I have never, and none of my friends have ever, felt it was unnatural,” she said.
What she hopes is that, with FDA approval, it gets less expensive. Competition also may lower the price. Another type of the toxin sold by Elan Pharmaceuticals under the name Myobloc is starting to be used, said Dr. Alan Matarasso, a New York plastic surgeon who teaches a course for ASAPS on the use of both drugs.
Myobloc takes effect more quickly than Botox, appears to require fewer injections and is less prone to diffusing to the wrong muscles, he said. It also works on patients who do not respond to Botox, and has a much longer shelf life.
The equivalent dosages to Botox are just being worked out, he said, but if Myobloc becomes more popular, Allergan may have to lower its prices for Botox. “Up until this point, they’ve had a monopoly,” he said.
But patients are willing to pay the current prices, Pandolfino said, and they are not all wealthy. “I see all social stratifications,” she said. “They come in asking for a payment plan; it’s worthwhile for them.”
