The Next Turf War for Botulinum Toxin?

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On January 16, 2017, Time dedicated its cover story to Botox (botulinum toxin A [BTX-A]) and published several articles on this landscape-altering medication. In one piece entitled “Botox: the drug that's treating everything,” Alexandra Sifferlin discussed the history, challenges, and successes of BTX-A and also extolled the multitude of conditions being treated by this incredibly versatile drug.1 While dermatologists tend to most commonly inject BTX-A for aesthetic enhancement, BTX-A has been used for many on- and off-label medical conditions, including strabismus, blepharospasm, overactive bladder, axillary hyperhidrosis, premature ejaculation*, atrial fibrillation*, dyspareunia*, and migraine headaches (*not FDA-approved). However, in Time, Sifferlin presented a clinical vignette of a patient who was seeing a psychiatrist for recalcitrant depression and was recommended BTX-A injections as an adjuvant mood enhancer.
In a 2006 issue of Dermatologic Surgery, Finzi and Wasserman reported improvement in depression scores in 9 of 10 depressed subjects treated with BTX-A injections into glabellar frown lines.2 Since this case series was first reported, 3 randomized controlled trials (total n = 134) have demonstrated that BTX-A injections into the glabellar complex improve depression scores in both physician and patient-reported scales.3 Given the challenges in the treatment of depression, the enormous global burden of this condition, and the robust, albeit preliminary responses of BTX-A trials, a multicenter, randomized, placebo-controlled Phase II trial of BTX-A in depression was launched and has recently been completed. Initial reports indicate that at a 30-unit BTX-A dose, subjects saw a 3.6-point decrease in the Montgomery–Asberg Depression Rating Scale at 6 weeks.4 Although the results did not reach statistical significance, Allergan is optimistic about the potential for BTX-A in depression. Phase III trials will soon follow, as will increased interest from mental health professionals.
Since the Carruthers made the serendipitous observation that BTX-A helped to relax facial rhytids, the dermatology community has embraced BTX-A and become arguably its greatest champion. And while dermatologists were initially joined by ophthalmologists and plastic surgeons in their aesthetic use of this medication, BTX-A cosmetic has since been embraced by physicians from many different specialties as well as nurse practitioners, registered nurses, physician assistants, and unlicensed individuals, many of whom are skilled injectors but have little to no training in the intricacies of facial anatomy or in-office procedures. While most patients still trust a dermatologist to most effectively and safely administer this medication, with a possible indication of BTX-A for depression looming in the not too distant future, a new turf war may become manifest. For those dermatologists who choose to treat depression if BTX-A gains an on-label indication, additional layers of complexity may arise in what is currently relatively seamless cosmetic practice. One obvious pitfall is the risk of providers unfamiliar with the nuances of injectable medications and facial anatomy performing procedures. This could lead to increased side effects, namely bruising, bleeding, insufficient treatment, and asymmetric or distorted results. Roadblocks for the dermatologist may include negotiations with insurance companies, prior authorization forms, decreased revenue, a need for psychiatric evaluation and referral before treatment, and in extreme examples, malingered depressive symptoms in patients who desire aesthetic enhancement but are aware of an on-label antidepressant indication. Those dermatologists who choose not to treat depression may stand to lose patients to yet another set of health care providers. And although most dermatologists are not bothered by a neurologist's decision to use BTX-A to treat migraine headache or a urologist's administration of BTX-A for premature ejaculation, many dermatologists feel differently about competing for the glabellar complex. The possibility of thousands of patients forgoing a dermatologist's expertise to receive glabellar BTX-A from a mental health provider may present unanticipated challenges.
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