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  » Botox  »   Cosmetic Botox®: Reading Between Advertising Lines

Cosmetic Botox®: Reading Between Advertising Lines


Cosmetic Botox®: Reading Between Advertising Lines

Last Updated: 1/3/2003
Arm yourself with the facts on Botox® and get the most out of this effective treatment

Charles S. Soparkar, MD, PhD, FACS
James R. Patrinely, MD, FACS

(Editor's Note: Drs. Soparkar and Patrinely are respected authorities and lecturers in the field of oculoplastic surgery. Dr. Soparkar completed fellowship training in oculoplastic surgery at Massachusetts Eye and Ear Infirmary while Dr. Patrinely completed his fellowship training at Johns Hopkins University. Both surgeons are in group practice with offices in Houston, Texas and Pensacola, Florida.)

Despite recent marketing hype, Botox® (botulinum toxin A manufactured by Allergan, Inc) is neither new nor a cure-all against time and gravity; yet Botox® can be highly effective against wrinkles, and a wise consumer would do well to understand the basic facts.

Simplified Background

There are seven disease-causing toxins (A-F) made by a bacterium called Clostridium botulinum. The bacterium can be found throughout nature in both cultivated and non-cultivated soils; stream, lake, cistern, and coastal water sediments; viscera of fish, mammals, crabs and other shellfish; and dust.

When exposed to adverse environmental conditions, the bacterium can "hibernate" or "sporulate" and withstand high temperatures and pressures. The toxins made by the bacterium, however, are quite fragile. So, although the bacterium may have survived mom's peach canning process, heating her preserves to greater than 80oC for 10 minutes destroys any toxins.

The two toxins currently with greatest clinical application in humans are types A and B. Both toxins act in essentially the same manner. They destroy the nerves that make muscles contract. Interrupting the normal function of breathing muscles is how these toxins most commonly kill people. Yet, used intelligently and responsibly, botulinum toxins A and B are safer than Penicillin (a toxin made by the mold Penicillium notatum).

The muscle-nerves affected by botulinum toxins are permanently destroyed, but the effects of these toxins are temporary, because we grow new muscle-nerves all the time. This is analogous to what happens with aspirin (a toxin originally purified from willow tree bark). Aspirin destroys platelets, but we don't bleed to death after taking an aspirin, because we constantly make new platelets.

Importantly, the botulinum toxins do not affect nerves of sensation, only muscle-nerves, so there is no change in feeling after administration of the botulinum toxins.

History of Botulinum Toxin's Clinical Use

Over two decades ago, an ophthalmologist started using purified botulinum toxin A to manage eye muscle imbalances. Since then, the number of applications has grown dramatically. In 1984, our practice began using toxin A in the muscles around the eyes for the management of blepharospasm, a disorder where the eyes can't be kept open. Very quickly, we, and others, recognized the tremendous impact the toxin had on facial wrinkles.

In late 1989, the FDA (U.S. Food and Drug Administration) approved a formulation of botulinum toxin A (Botox®) for the medical treatment of various muscle spasms. In mid 2002, the FDA approved the same medication for the treatment of frown lines, but only those between the eyebrows. Although Botox® has been used without official FDA approval for many reasons (including wrinkle reduction throughout the face) since the mid 1980's, formal FDA approval has only recently allowed people to advertise Botox® for cosmetic use. Therefore, it is only recently that Allergan (the company making Botox®) and many physicians have jumped in with both feet to make up for lost advertising time. So remember, although the advertising is new, the toxin is not.

The Different Toxins Currently Available

Botox® (Allergan, Inc) is the original formulation of type A toxin manufactured and used for over two decades.

Dysport® (Ipsen, Ltd) is another, newer formulation of type A toxin manufactured by a European company that is currently seeking the U.S. FDA's stamp of approval for cosmetic use.

MyoblocTM (Elan Pharmaceuticals) is toxin type B. The same medication is marketed in Europe under the name NeuroblocTM.

All of the companies quantify their toxins in "units." However, each company defines a "unit" in a very different way based either upon activity in animals or upon a purification step. The result? A "unit" of Botox® has no real, reliable relationship to a "unit" of MyoblocTM or a "unit" of Dysport®. In most people, though, 25-50 "units" of MyoblocTM is roughly equivalent to 2-5 "units" of Dysport® which is roughly equivalent to 1 "unit" of Botox®.

Perhaps Allergan says it best:
"Due to specific details such as the vehicle, dilution scheme and laboratory protocols for the various mouse LD50 assays, Units of biological activity of BOTOX® cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. Therefore, differences in species sensitivities to different botulinum neurotoxin serotypes precludes extrapolation of animal-dose activity relationships to human dose estimates."

In their current formulations, type A toxins usually take 4-7 days to achieve maximum effect and last anywhere from 3-9 months. Type B toxin has a faster onset, but a shorter duration of action. Most patients report that MyoblocTM "stings" more than Botox®, and this is likely due to the relative acidities of the preparations.

The Cosmetic Use Of Botulinum Toxins

The toxins are administered just beneath the skin using fine needles. Although there can be some degree of tolerance for injection errors in the upper face, a highly experienced injector is required to treat below the level of the peak of the cheeks.

It is essential to understand that the toxins are most effective on "dynamic wrinkles," those that result from facial movement, as occurs with facial expression.

Most people will observe a progressive lengthening duration of toxin effect with multiple injection cycles. The reason for this does not appear to be biochemical, but is most likely due to something our practice calls "muscle memory." If you learned to play tennis or golf and tried for a long time to concentrate on your swing, then you'll understand how, over time, your swing developed and now "just happens." In the same way, people tend to learn how to move their faces slightly differently (without even thinking about it), so that they develop less muscle contraction and fewer wrinkles.

The Impact Of FDA Cosmetic Approval For Botulinum Toxin

For consumers, FDA approval of Botox® for cosmetic use has been a two-edged sword. Mass marketing and increased consumer awareness has driven up demand. This has dropped injection prices by as much as ten fold, a very good thing, since prices were often scandalously high. For decades, patients have been coming to our practice from all over the country, because it was cheaper for them to fly to Houston from New York or California and have us inject them, than it was for them to get the injections locally. It's good that people don't have to travel great distances anymore for their injections. However, the bad news is that many physicians (and now even their office staff!) who have little or no experience are performing these treatments. Toxin injection into the wrong place or in the wrong dose can be disastrous.

The latest craze has been "Botox parties" where injections are provided to a group of people outside of a physician's office. In most cases, no life support medications or devices are available to help in the rare, but real chance that someone would have a vasovagal or anaphylactic reaction. Physician-patient consultation privacy may be compromised, so that medical conditions in which the toxins are contraindicated may not be revealed. Alcohol may be served at these parties, and that, along with "peer" or "social" pressure may hamper the consent process. For these reasons, all recognized and established medical societies and groups charged with regulating and "policing" physician activity have strongly condemned "Botox parties."

Advertising Traps

Although the vast majority of physicians are scrupulous, there will always be a few who prey on the uninformed consumer. Arm yourself against these common advertising gimmicks.

1.) "Lowest price" - The toxins are expensive, and this cost has to be passed along to consumers, unless an injector is taking a loss, usually so that he/she can gain experience. Unless you are willing to suffer the potential consequences, avoid being someone's guinea pig. Question carefully not only how many "units" are going to be injected for a particular price, but also which toxin is being used. It is easy for an injector to dilute the toxin more and give less medication. Likewise, it is easy for an injector to administer MyoblocTM or Dysport® at a fraction of the price a competitor provides an equal number of "units" of Botox®, because MyoblocTM costs 25 times less and provides roughly 25-50 times less effect "unit" for "unit" than Botox®. So check which of the toxins you're getting.

2.) "Only $150 Per Syringe" - A syringe (whatever size is being used) represents merely an injection volume. The toxins can be diluted to any volume an injector desires. Whether ten "units" of toxin is diluted into five milliliters or a tenth of a milliliter makes no difference in overall toxin effect. Getting twenty times more volume only spreads the same amount of toxin out over a larger space. You don't get more effect with more dilution. Thus, it is important to know how many "units" are being injected. Injections priced by the syringe often end up being more expensive, as the injector then charges for each area being treated. Thirty to fifty "units" of Botox®, 60-200 "units" of Dysport®, or 750-2,500 "units" of MyoblocTM are needed to treat most peoples' facial wrinkles.

3.) "Experienced Injector" - There are very good reasons why the toxins are only approved for administration by an M.D. Don't settle for "physician oversight" which may or may not mean a physician is even on the premises. Your life and well-being are at stake. Insist upon an M.D. injector with at least five years of injection experience. From having performed tens of thousands of injections, we can state with great certainty that the actual number of individuals treated by an injector is far less important than the number of years an injector has been practicing. Understanding the long-term effects of these toxins is very important.

4.) "Erase All Wrinkles" - These toxins do not treat all wrinkles. Dynamic wrinkles (those that become worse with facial expression and movement) are the ones that are most susceptible to treatment by these toxins. Static lines (those that are always present) may enjoy benefit, but many of these types of creases require a filler, such as fat, collagen, or (perhaps best of all) cross-linked hyaluronic acid.

5.) "Cure Migraine Headaches" - The toxins can be very effective in treating "stress" or "tension" headaches caused by chronic contraction of the brow or forehead muscles. However, the toxins have no direct effect on classical migraine headaches. Furthermore, a careful anatomic assessment must be performed to determine why an individual has "tension" headaches. Is it because there is an underlying droopy eyelid or brow problem that needs surgical attention?

6.) "Bring A Friend And Share The Cost" - This idea developed because Botox® has a relatively short shelf life of a couple of hours once the freeze-dried powder is made up as a solution. Each bottle contains 100 units (about what is needed for 2-3 people). The medication is expensive. If half the bottle is thrown away at the end of the day, because it has not been used, then there is significant $ loss for the injector. The truth is that practices that perform toxin injections with any regularity can easily schedule multiple patients appropriately, so they incur no loss. Think about it. How can someone offer you one or more "syringes" of toxin, if they haven't already allotted the remainder to someone else? When you "bring a friend," you are simply marketing for the injector. Are they paying you for this service?