Beauty by Injection: Following the Botox Craze

Beauty by Injection: Following the Botox Craze

By Kelli M. Donley

Long considered a secret in Hollywood's toolbox for maintaining a youthful glow, botulism toxin strain A has been recently approved by the U.S. Food and Drug Administration (FDA) for cosmetic purposes.

Botox is hitting the American market with gusto. Television commercials featuring beautiful women with remarkable skin tout the benefits -- relatively no pain or discomfort, low cost in comparison to invasive plastic surgery, quick recovery and results. Print advertisements, a Web site and an 800-number complete the media marketing frenzy.

Quickly becoming a socially acceptable method of fighting aging, botox injections are also a new and booming market. Botox injections were listed as the fastest growing cosmetic trend performed by surgeons in the United States by the American Society for Aesthetic Plastic Surgery and have reportedly increased by 46 percent since 2000.

YOU'RE INJECTING WHAT?

Get botulism from a burger, and you could die of food poisoning. Get botulism injected into frown lines, and you could look well rested and content. From the bacterium familiy Clostridium botulinum, this soil-based organism can fatally affect people in three ways: via foodborne infection, wound infection or infant botulism, where the bacterium grows in the intestines. There are seven types of the bacterium, A through G, of which four can cause illness in humans -- A, B, E and F.¹

A refined form of strain A was approved April 15, 2002 for cosmetic use to improve the appearance of brow furrow lines. Strains of botulism have long been used for medical treatments. In 1989, botox was approved by the FDA for treatment of strabismus -- crossed eyes -- and blepharospasm -- involuntary eye muscle spasms. In 2000, injections were improved to treat cervical dystonia, an abnormal neck tension disorder.

The toxin works by attaching itself to nerve endings, thereby preventing the neurotransmitter acetylcholine from inducing muscle contractions. The muscles surrounding the injection site are temporarily paralyzed. This lack of muscle contraction also is what ultimately can kill a person infected with the toxin when respiratory muscles cannot contract.² However, muscles that cannot contract also cannot wrinkle. Hence the frequent cosmetic "off label" use of botox before its FDA approval.

ECONOMICS SPUR CONTROVERSY

A 12-month double-blind placebo controlled study, involving 537 participants, examined the reduction of glabellar (frown) lines at their maximum 30 days after the first injection. More than 89 percent of those in the botox group and 6 percent in the placebo group noticed significant improvement.

Botox Cosmetic (botulinum toxin type A) is manufactured by Allergan, Inc., based in Irvine, Calif.

"We actually control who can purchase the product," says Christine Cassiano, Allergan's manager of public affairs. "It has to be purchased by a physician or hospital. In terms of its use, in most states it is allowed for a nurse practitioner, under the guidance of a physician, or any other nurse who can normally give an injection, to give a botox injection."

While the controversy of injecting toxins has fading, a new trend in cosmetics is causing some uproar in the plastic surgeon community.

"(Botox Cosmetic) is sold in a 100-unit vial," says Cassiano. "... per vial, it (the dosage) is dependent on the patient and the indication for which it is being used. When used for treating brow furrow, the dosage is approximately 20 units. So 20 units would be necessary for the five injections of four units each."

Cassiano says the 100-unit vial is usually sold to physicians for $400. Additionally, the vial must be used within a specific time frame to prevent contamination.

"There are certain conditions that it needs to be maintained in," she says. "For sterility purposes, it should be used within four hours of being reconstituted."

The economics behind paying for a vial that will potentially treat five, rather than just one patient with the average 20-unit dosage, have led some to create "botox parties." These gatherings are sounding alarms in the medical community because treatments are given in a social setting where alcohol may be present and other variables left uncontrolled.

Fred F. Castrow II, MD, and president of the American Academy of Dermatology (AAD), says participating in such parties is a risky endeavor. Speaking for the AAD, Castrow says, "A casual social activity for the purpose of administering botulinum toxin, such as a 'botox party,' is an inappropriate and potentially dangerous setting for performing medical procedures of any kind. Adding alcohol to the mix is a bad idea for a number of reasons, especially since bruising can be intensified. Because this is a quick method to treat wrinkles with no downtime, many patients are compromising their safety by having this medical procedure performed in an inappropriate setting, often by untrained medical professionals."³

Roberta Sengleman, MD, director of the Center for Dermatologic and Cosmetic Surgery at Washington University School of Medicine in St. Louis couldn't agree more. Sengleman, who has written the forward for the new book "The Botox Miracle," by Deborah Mitchell, says botox parties are the ugly side to a promising innovation.

"I do not support the administration of medical therapeutics in social settings, and hence oppose 'botox parties,'" she says.

However, she has an excellent rating of the procedure, when performed in a medical environment. In the forward, Sengleman writes: "Botox injections are just one dramatic example of the positive changes taking place in cosmetic dermatology, and I think it's important for people to learn all they can before they take that step."

She writes the importance the procedure should not be downplayed because it is quick or not permanent.

"... It can be a big deal: it's a medical procedure, it involves injecting a potent neurotoxin into your facial muscles, and it can give you some very positive and pleasing results."⁴

DEMAND SOARS

A recent survey by SG Cowen asked more than 600 dermatologists and plastic surgeons about "patient appetite" for botox injections. The results were overwhelming.

Researchers estimate the drug will be used by more than 450,000 patients in 2002, with a 25 percent increase in 2003.

Other findings of the study, conducted at the Pharmaceutical Therapeutic Categories conference in New York, were:

• 80 percent of patients found botox treatments effective
• 60 percent of patients received another treatment within six months
• 85 percent of patients received another treatment at some time
• Physicians estimate patients receive three treatments annually
• Cost and the need for additional treatments were the most significant complaints
• Injection-site pain and adverse reactions were least-cited complaints.

"These survey results convince us that the current high level of demand for botox cosmetic is sustainable and, more importantly, the franchise has considerable room for dynamic growth," says Ian Sanderson, senior pharmaceutical analyst at SG Cowen.⁵

Botox has been approved in more than 70 countries. Officials at Allergan also are studying whether injections could also be used as a treatment for hyperhidrosis, poststroke spasticity, back spasms and headache.

For more information about botox, visit: www.Botoxcosmetic.net.

Physician Controls Spastic Side Effects with Botox

CINCINNATI -- Officials at the Drake Center, a post-acute care and rehabilitation hospital, are finding new uses for botox outside of the popular cosmetic arena.

Patients who suffer from stroke, multiple sclerosis, Parkinson's disease and brain and spinal cord injuries often have spasticity as a side effect of their condition. The chronic movement disorder can prevent a person from accomplishing basic daily tasks. Botox injections can temporarily paralyze the spastic muscles causing the disorder.

Susan Pierson, MD, was reportedly one of the first physicians to use botox for medical treatment in the early 1990s.

"Botox has garnered so much attention lately for the cosmetic improvements it can make, but the life-changing effects it can have on stroke patients and people suffering from brain and spinal cord injuries are very important," she says.

Pierson gives three patients as examples to demonstrate the potential of the injections.

Damian Cremisio, an accomplished saxophone player, was diagnosed with multiple sclerosis. Worried about losing his job, he kept his condition secret until a noticeable limp developed. After receiving botox injections, he now has a greater range of motion and his limp is subsiding.

Teresa Spandini suffered from a stroke, leaving her paralyzed on the right side. After combining therapy with botox injections, she has increased flexibility and is now able to walk.

Ken Lazarus suffered from head and spine injuries in a car accident. He lost all movement from the neck down and was unable to move his arms from his chest before receiving botox treatments. The injections have helped release pressure in his arms and increase his flexibility. Since regaining some movement, he has become a watercolor artist.

For more information about the center's groundbreaking work, visit: www.drakecenter.com.