Injection Question
Should General Dentists Administer BOTOX®?
By Laurie Bouck
Featured in AGD Impact, December 2008
Posted on Thursday, December 04, 2008
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Depending upon whom you ask, the use of BOTOX® in the dental office is an ethical issue, an economic issue, or a turf war between dental professionals and physicians. To its advocates, BOTOX is merely a natural extension of the therapeutic and cosmetic treatments that dentists already provide every day. To its opponents, BOTOX is unsafe and an invitation to litigation. One thing is certain: A patient base of 76 million aging baby boomers wants access to cosmetic BOTOX treatments. BOTOX use has increased tremendously in the past few years; according to Allergan, Inc., the manufacturer of BOTOX, the injections are consistently the most popular cosmetic medical procedure in the United States. This trend probably will continue but it begs the obvious question: Who will fill the demand?
A brief history of BOTOX
Allergan’s BOTOX (Botulinum Toxin Type A), a protein derived from the Clostridium botulinum bacterium, has both therapeutic and cosmetic applications. Over the last two decades, BOTOX has been approved by the Food and Drug Administration (FDA) for therapeutic treatments of eye muscle problems (in 1989), neck problems (in 2000), and excessive sweating (in 2004). At present, it is being investigated for treating other medical conditions. In 2002, the FDA approved Allergan’s BOTOX Cosmetic for the purpose of temporarily erasing facial lines. For many years, physicians also have used BOTOX “off-label” (that is, without FDA approval) to treat other medical problems. An off-label use of BOTOX to treat muscle spasticity in children with cystic fibrosis, for example, relies on much higher doses than a patient would require for treating facial wrinkles.
According to Allergan, the effects of BOTOX injections last up to six months. Side effects from BOTOX injections, such as eyelid droop or nausea, usually are mild and temporary; however, in rare cases, BOTOX can cause swallowing, breathing, or cardiac problems. Earlier this year, the FDA reported that both BOTOX and Myobloc® (Botulinum Toxin Type B, a product marketed by Solstice Neurosciences to treat neck muscle spasms) have been linked to respiratory problems and patient deaths. These cases involved both FDA-approved and off-label uses of the drugs, with the worst complications arising from off-label BOTOX treatments of cystic fibrosis.
A well-publicized study in the April 2, 2008, issue of the Journal of Neuroscience found that botulinum toxin injected in rats’ whiskers migrated into their brain stems, raising concerns about whether these injections can cause botulism. In a recent lawsuit filed in Texas, 11 injuries and four deaths were attributed to off-label BOTOX use. Two of the deaths occurred in children with cystic fibrosis who were being treated with BOTOX for muscle spasticity. In the lawsuit, attorneys allege that Allergan promoted off-label use of its product, a charge that Allergan denies.
BOTOX in dentistry
As BOTOX use became more prevalent, general dentists began to use it to treat dental problems. One of the strongest proponents of this application of BOTOX is Howard Katz, DDS, a dentist based in La Jolla, Calif. In his Dentox conferences (see “Resources,” page 26), he trains dentists nationally and internationally in using BOTOX to treat temporomandibular disorders (TMD), trismus, sialorrhea, and other dental problems.
The therapeutic use of BOTOX to treat TMD in the dental office is approved nationwide by state dental boards. In addition, many dental insurance companies approve its use, although general dentists who want to use BOTOX therapeutically should check with their insurers first.
These days, more and more dentists are offering cosmetic treatments to their patients, and many, including Dr. Katz, want state dental boards and insurers to approve the use of BOTOX Cosmetic for such treatments. In the United States, the use of BOTOX Cosmetic by general dentists has triggered a passionate debate among insurers, state boards, dentists, and physicians.
Insurers and dental boards weigh in
“When dentists who are not oral and maxillofacial surgeons use BOTOX to improve patients’ smiles or to reduce their brow furrows, they are practicing outside the scope of dentistry,” according to Robyn Thomason, a former risk management analyst at The Dentists Insurance Company (TDIC). In her article “BOTOX in the Dental Office—Is it Worth the Risk?” (Pennsylvania Dental Journal, July-August 2007), she writes that “Even though dentists are educated to treat conditions of the head and neck, they must remember to follow the regulations that govern the practice of dentistry in their states.” In the article, Thomason questions whether BOTOX is the best choice for treating TMD and asserts that BOTOX treatments carry a risk of fetal problems for pregnant women.
Although his company offers therapeutic BOTOX use for TMD problems, the use of BOTOX Cosmetic for such problems is not approved, according to John Carothers, TDIC’s vice president of claims. Carothers says that his company decides coverage based on each state’s Dental Practice Act and that dentists who want to use BOTOX Cosmetic should purchase separate insurance to cover it.
Other insurers agree with TDIC’s policies. “Dentists currently can use BOTOX in all states for what can be determined to be purely dental reasons, but not for cosmetic purposes,” says Philip Barbell, DDS, FAGD, director of dental risk management for the insurance company Dentist’s Advantage in Coral Springs, Fla. According to Dr. Barbell, these “dental reasons” include TMJ and “various muscular types of situations in the oral cavity.”
Like Carothers, Dr. Barbell says that the state dental boards would need to decide that the cosmetic use of BOTOX is within the scope of practice for dentists before Dentist’s Advantage would cover it for cosmetic purposes. In addition, Dr. Barbell says that the boards also must clarify “where in the mouth or around the mouth [dentists] can use it.” For example, the Florida, Pennsylvania, and New Jersey dental boards currently are reviewing the use of both BOTOX Cosmetic and facial fillers in the dental office. Dr. Barbell says that if BOTOX Cosmetic were approved for general dentists, the dentists would need to obtain adequate training before they could use the product.
Dr. Katz believes that it can be difficult to distinguish between the therapeutic and cosmetic benefits of BOTOX injections in the dental office, which complicates the debate about scope of practice and training. “Some physicians may give an esthetic treatment and get a therapeutic outcome, or they may give a therapeutic treatment and get an esthetic outcome,” he says. “For example, a patient may come in for [treatment of] a neuromuscular TMD, but he or she also may end up with an improved esthetic outcome.”
Conversely, says Dr. Katz, therapeutic injections performed incorrectly can create esthetic problems for the patient. “Therefore, it’s essential that dentists learn the esthetic treatment,” he says.
The opposition
Dentists who want to use BOTOX Cosmetic are running into opposition from some physicians; however, if BOTOX Cosmetic use is approved for general dentists, Dr. Barbell says, “We’re going to have a big problem insuring dentists who are using it [in places] other than around the oral cavity.”
Some dentists consider the use of BOTOX Cosmetic in the dental office risky or unnecessary. On his Web site, “The Wealthy Dentist,” marketing consultant Jim Du Molin posted two online surveys of dentists’ attitudes toward BOTOX (see “Resources,” page 26). Some respondents to those surveys expressed concern that BOTOX would create liability issues if patients had adverse reactions to the injections. Others said that dentists did not have adequate training to offer BOTOX Cosmetic to their patients.
Some dentists simply are not interested in expanding their practice to provide BOTOX Cosmetic treatments. However, Gigi Meinecke, DDS, FAGD, who practices in Potomac, Md., is, and she has lobbied her state dental board to include BOTOX Cosmetic within the scope of practice. A general dentist on the board, who is opposed to the idea, told her, “I’m just one of those old-fashioned dentists who thinks that general dentists should be drilling teeth.”
Profits, pressure, and policies
Is the fight to bring BOTOX into the dental office driven by its revenue potential? “BOTOX takes minutes to inject, and it has a profit margin of at least 50 to 100 percent,” says Catherine Maley, a marketing consultant for physicians with esthetic practices. Because patients return every few months, it’s also a steady source of revenue. BOTOX Cosmetic also is a cash practice, Maley says, with no insurance or paperwork headaches. She concludes, “It’s a nice, clean transaction.”
Du Molin agrees that “the economy is hurting dentistry,” making many dentists more interested in profitable cosmetic procedures. Dentists who offer BOTOX treatments can have an influence on their colleagues as well; ultimately, some dentists may feel pressured to provide BOTOX Cosmetic injections simply to stay competitive.
Allergan remains neutral on the issue of dentists administering BOTOX Cosmetic. The company does not take a position on general dentists using the drug, preferring to leave the decision to the state dental boards. Nor does Allergan directly provide training on the use of BOTOX Cosmetic; instead, the company provides grants to third-party vendors who have received accreditation from the American Academy of Continuing Medical Education to conduct the training. “The third-party vendors are responsible for the selection of attendees participating in these training programs and the duration of each program, neither of which is controlled by Allergan,” says Leslie A. Bryant, Allergan’s corporate communications manager. Allergan does not provide information regarding who takes the training or who purchases its product.
Turf wars
Many dentists believe that they are as qualified as physicians to administer BOTOX Cosmetic. Dr. Katz, whose classes train both dentists and physicians around the world, says that physicians often don’t know facial anatomy as well as would be expected. Conversely, he notes, “Dentists are very familiar with the anatomy in the lower half of the face, so they’re very comfortable with the injections.”
Furthermore, physicians who offer BOTOX Cosmetic often don’t administer it personally. In some states, Dr. Meinecke says, a registered nurse administers the injections, and he or she can do so as long as a physician is in the building. “It’s just not a tenable argument to say that the registered nurse has better training than the general dentist,” says Dr. Meneicke, who, by the way, is trained as both a registered nurse and a dentist.
Dr. Katz agrees that the rules are inconsistent. As he notes, a doctor can hire a registered nurse with no oral training to give BOTOX Cosmetic injections near the mouth, “but the general dentist, who has had years and years and years of training on what the mouth is supposed to look like is not allowed to do the treatment. It’s absolutely absurd.”
Dentists who offer BOTOX Cosmetic to their patients may have several logistical and social advantages over physicians. Dr. Meinecke notes that patients who already see their dentists regularly for routine cleanings can easily add BOTOX injections to their dental visits; in addition, the dental office offers anonymity to patients who receive BOTOX injections there. Maley notes that cosmetic dermatologists probably feel the most threatened by the idea of dentists administering BOTOX injections. She says, “Dentists will take away some of their business,” as well as the business of facial plastic surgeons and medical spas.
Looking ahead
Regardless of one’s position on BOTOX Cosmetic injections, it seems inevitable that these procedures will be included someday in the general dentist’s scope of practice. Dr. Barbell thinks that dentists may start using BOTOX Cosmetic within the next five years, while Dr. Meinecke says that, if general dentists in Maryland petition the state dental board more aggressively about using BOTOX Cosmetic, “it could be within our grasp in one to two years. It may even be faster in other states.”
If BOTOX Cosmetic treatment becomes part of the general dentist’s scope of practice, Dr. Barbell predicts that “We in the insurance industry will charge an extra premium for it in the malpractice insurance for the dentists who are using it.”
Dr. Meinecke says that an insurer she spoke with estimated that the malpractice premium increase would be about five percent. “This is not open-heart surgery,” she says. “This is an intramuscular injection that carries with it far fewer potential side effects than administering lidocaine or local anesthesia.”
To comment on this article, e-mail impact@agd.org.
What About Fillers?
Some of the state dental boards that are considering expanding the scope of practice to allow BOTOX Cosmetic also are considering allowing dentists to inject facial fillers, such as Restylane®.
“We are a procedure-driven profession,” says Gigi Meinecke, DDS, FAGD. “Over time, we have honed our skills to become extremely technically adroit, so we probably would be very good at administering fillers, especially with our knowledge of smiles and esthetics.”
However, Catherine Maley, a marketing consultant for physicians with esthetic practices, makes a distinction between injecting BOTOX and injecting facial fillers, suggesting that injecting fillers involves “a lot more artistry than it looks.” Furthermore, she says, board-certified physicians are concerned that bad outcomes by dentists due to inexperience and lack of training could ultimately hurt the entire field. “Bad results are not good for anybody in the industry. So the doctors are very concerned,” she says.
Resources
Allergan
Manufacturers of BOTOX Cosmetic
Dentox
Conferences and training on the use of BOTOX in dentistry
Led by Howard Katz, DDS
The Wealthy Dentist
Dental Marketing Consulting
Principal: Jim Du Molin
Cosmetic Image Marketing
Aesthetic Practice Marketing Consulting
Principal: Catherine Maley, MBA
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AGD Impact, December 2008 , Volume Vol. 36 , Issue No. 12
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