Mary Schwallenberg used to wear bangs to cover the wrinkles on her forehead, but since she started getting Botox injections, the 53-year-old has been able to pull her hair back without feeling self-conscious. That's because the muscle-paralyzing drug temporarily prevents her muscles from contracting to form unwanted lines, making her skin look smooth and young again.
"People say I look less tired," she says. "I think [Botox] is a simple, quick way to erase some time off your face without having to undergo anything permanent."
Schwallenberg is one of millions of people who have taken advantage of the FDA's April 2002 approval of Botox to reduce frown lines and furrows between the brows. Although the drug has been around for years -- with the government giving the nod to treat eye disorders in 1989 and painful neck and shoulder contractions (cervical dystonia) in 2000, and with doctors unofficially administering it for various curative and aesthetic purposes -- mainstream awareness of the drug only soared after the thumbs-up for cosmetic use.
In fact, cosmetic (as opposed to therapeutic) treatments made up one-third of the 310 million uses of Botox in 2001, according to Allergan Inc., the drug's manufacturer. After the formal government sanction, cosmetic use rose to 40% of 311 million in the first three quarters of 2002. The company forecasts overall sales for the whole year to reach at least 430 million.
The drug's growing popularity has stirred both excitement and grumblings about the impact on doctors' practices and on America's face. Amid promising new developments for future applications, questions have also arisen about its overall safety. And as with many other hot commodities in today's society, there are fears that terrorists may use it as a biological weapon.
The fears, the queries, and the enthusiasm all apparently coexist, albeit less than harmoniously, effectively making Botox a household name.
Botox parties, which have been reported from Los Angeles to London, are said to be more convenient, comfortable, and economic ways to dip into the so-called fountain of youth.
Schwallenberg says she gets a $25 to $30 discount for getting her Botox injections at the "Happy Hour" held at the office of her doctor, Scott A. Greenberg, MD, FACS. For Greenberg, the event, usually a three-hour affair, is a chance to acquire new patients (established ones are encouraged to bring a friend), and to provide an easy setting for nervous clients.
First, he gives a group lecture on the benefits and risks of Botox, after which all patients get a chance to ask questions and hear each other's. Then each person meets with him individually for further consultation, to sign a consent form, and if agreed upon, to get an injection. After the treatment, clients have the chance to mingle with the group while consuming refreshments.
"They have the benefit of a group setting in terms of a discount financially, and the more relaxed setting of a group, but they also have the benefit of an individual medical treatment that's private and confidential," says Greenberg.
Many health experts, however, have frowned upon Botox parties, fearing that the social atmosphere trivializes the risk associated with the procedure. According to a May 2002 news release issued by the American Society for Aesthetic Plastic Surgery (ASAPS), such affairs "have raised red flags for many medical professionals."
The concern apparently originated from media reports of some parties being held in beauty salons, spas, or people's homes, with the injections sometimes administered by untrained personnel.
Gold speculates, however, that the occurrence of these inappropriate gatherings may be slightly exaggerated and actually make up only a small percentage of the drug's use.
Nonetheless, the ASAPS recommends that anyone who undergoes Botox treatment makes sure that they can answer "Yes" to the following questions:
- Have you been asked to provide a complete medical history?
- Have you been advised on alternative treatments?
- Have you been advised of the risks and given your informed consent?
- Is a qualified physician administering the treatment?
- Is the physical setting appropriate for administering medical treatment, including handling emergency situations?
- Are you willing and able to follow posttreatment instructions?
- Will you receive adequate follow-up care?
For more information on these recommendations, call the ASAPS referral line at (888) 272-7711, or visit the web site at www.surgery.org.
In one recent episode of the NBC sitcom Will and Grace, Will decides to get Botox injections to get rid of wrinkles. After the procedure, though, he finds himself unable to move facial muscles to show expression. So when Grace tells him something exciting, she becomes angry when he appears nonchalant, even though he insists he is really happy about her news.
Will's frozen mug may be the stuff of comedy, but it's no laughing matter to health experts who say faces lacking emotion lose the ability to communicate with others.
"Not to be able to show pleasure, interest, or joy is devastating in terms of social relationships," says Doe Lang, PhD, a New York City-based psychotherapist. "People think you're hostile, unfriendly, and they think you don't like them."
Yet stiff faces need not be a consequence of Botox procedures. Lang says reputable plastic surgeons can perform treatments without damage. Also, she says she believes some people may think their face feels paralyzed after an injection because they're not used to paying attention to muscles in the area.
"A lot of people are totally unaware of what their faces usually do. So perhaps when they feel a little stiffness they get frightened," says Lang, who notes that wrinkles are evidence of how people use their face.
Reason to Frown?
Botox is made from a very small dose of botulinum toxin, the single most poisonous substance known. The toxin comes from soil but can be ingested through food that comes in contact with contaminated dirt. The poison paralyzes muscles and may prevent victims from being able to breathe on their own.
Diagnosis and treatment of botulism can be both time-consuming and a strain on hospital resources. This is the reason why the CDC has labeled the toxin as a "Category A" substance in its list of agents of concern, says Gigi Kwik, PhD, a fellow for the Johns Hopkins Center for Civilian Biodefense Strategies. Other Category A agents include smallpox and anthrax.
The Johns Hopkins center even considers the botulinum toxin as a potential major bioweapons threat. Kwik readily points out, however, that there is an extremely tiny amount of the poison in Botox, so the chances that it could be used as a biological weapon are slim.
"Unfortunately, while you can envision all kinds of threats that come from everywhere, you have to look at something more likely," says Kwik, who notes that Botox is not the only place in the world where one could get a hold of the toxin. "Anybody who was going to make it as a weapon would have a much easier time if they weren't to use Botox."
Botox's maker, Allergan, says it takes precautions to safeguard the drug as it does with all its other products.
In terms of cosmetic use, the FDA has only approved Botox for treatment of the brow furrow, the vertical crease frequently seen between the eyebrows, but Allergan spokeswoman Christine Cassiano says the company is now in talks with the agency regarding the treatment of forehead lines and crow's feet.
Yet the company is pitching more than just facial remedies. Allergan is now completing a U.S. study on the drug's effect on stroke injuries. Research has reportedly found that Botox relaxes clenched hands and other muscles that may have been injured after a stroke. Cassiano says the medicine is approved for such use in 23 countries, including Canada and a good portion of Europe.
Canada is also one of nearly a dozen countries that has given its formal nod to use Botox for sweaty palms (palmar hyperhidrosis). U.S. studies are now under way, and Allergan expects to file for approval in mid-2003.
In earlier-stage development is work on using the drug for migraine headaches and back pain. Cassiano estimates that the company probably will not be able to file for approval for treatment of headaches until at least 2006.
Stephen Silberstein, MD, FACP, professor of neurology and director of the Thomas Jefferson University Headache Center in Philadelphia, conducted a study on the effectiveness of Botox in preventing migraine headaches. His research, published in the June 2000 issue of the journal Headache, found that Botox significantly reduced migraine frequency and severity and use of migraine medication. It also cut down on migraine-related vomiting.
"We know it's effective, but we can't predict for which patients," says Silberstein. This is why he is setting up another nationwide study on Botox and migraine headaches.
Is It Safe?
Botox does have its side effects: headache, respiratory infection, flu symptoms, droopy eyelids, and nausea. In some patients (less than 3%) there may be severe reactions such as pain in the face, redness at the injection site, and muscle weakness. Symptoms are usually temporary but could last several months.
Nonetheless, Allergan says that Botox has a long-term safety profile, given that it has been around for 13 years.
The three experts in this article that have used Botox in their practice or research -- Greenberg, Gold, and Silberstein -- also say that the drug is safe when used in an appropriate manner.