Hogwash or Science? Lately I’ve been reading some scary stuff about BOTOX(R). I know enough about headlines to understand that those written to shock, alarm, or titillate grab attention. Not usually the case with headlines written to calm, soothe or reassure. They seem to draw little notice. Latest case in point: Botox Causes Brain Damage. Scary, right? True? Read on. BOTOX(R) was first given FDA clearance for the treatment of ocular conditions such as strabismus, juvenile cerebral palsy and other large muscle, lower limb spasticities. At these high doses, some adverse reactions truly did occur. That much is fact. At times the symptoms were severe, including difficulty swallowing and breathing. Some systemic toxicity was found in patients with neuromuscular disorders and other underlying neuromuscular conditions. It is important to note that most all of these serious events were in children treated with huge doses of botulism ranging from 6.25 to 32 units per kilogram of bodyweight — that is the equivalent of 460 to 2,400 units for an adult. BOTOX(R) prescribed for medical conditions. Let’s think of BOTOX(R) treatments for medical conditions as the apples of our fruit basket. But let’s not compare apples with oranges! The oranges in our fruit basket are the BOTOX(R) treatments administered for aesthetic purposes, (i.e. to soften facial wrinkles). The 20 unit dosage of BOTOX(R) approved for aesthetic treatments is a sharp contrast to the 460 to 2400 unit dosage used to treat medical conditions. So we can’t use the same yardstick when comparing apples with oranges. I discussed these latest BOTOX(R) headlines with Dr. Vic Navurkur, past president of the ASCDAS (www.ascdas.org), with an active aesthetic dermatologic practice in the Bay Area of San Francisco. “The media has taken this completely out of context!” he exclaimed with some amusement. “As a treatment for medical conditions, Botox is often administered in very high strengths and yes, some complications have been noted there. But these dosages are not comparable to those used in aesthetic treatments.” Scare tactics aside, if you are thinking about BOTOX(R) treatments, here are three important questions to ask yourself: 1. Is there anything in my health history that could recommend against it. (If you have any neurological disorder, first discuss possible complications with your physician.) 2. Am I bothered by facial wrinkles in areas that BOTOX(R) could soften? (i..e. forehead, crows feet, neck cords, etc.) 3. Can I afford this expense on an ongoing basis (every 3-5 months) Last year, 4,329,180 aesthetic treatments of BOTOX® were administered to women in the United States to relax their forehead frown lines. The side effects to these treatments have been minimal to non-existent. Slight bruising or swelling at the injection site, if any, resolves within twenty-four to forty-eight hours. Occasionally, an eye temporarily droops after forehead injections, but gradually resolves itself over a period of several weeks. But there have been no reports of any effects on the central nervous system. And as far as risk of death from Botox Cosmetic, the FDA confirmed that: ”there has never been a reported death where a causal link to BOTOX® (Botox Cosmetic) was established.” But new fears about BOTOX® surfaced recently after an Italian study reported in the April 2 issue of the Journal of Neuroscience revealed that when botulinum toxin, type A (the active ingredient in Botox), was injected into one side of adult rats' brains, minute particles of protein in the toxin were found in the other side of the brain. The media went wild with headlines such as: Does Botox Cosmetic (BOTOX(R) Cause Brain Damage. Although the shots the rats received consisted of purified botulinum toxin, NOT BOTOX®, not surprisingly, many BOTOX® users panicked, fearful that they were now at risk for brain damage. But the study did not suggest that at all and was not designed to test the safety of these aesthetic treatments. . "I don't think fear is warranted," said Matteo Caleo, a coauthor of the study and a neuroscientist at the Neuroscience Institute of the National Research Council in Pisa. "I would not recommend that someone stop treatment." American doctors with long experience treating patients with BOTOX® are not alarmed by the study. "There is nothing in this paper that says these injections will damage neurons or that there are long-term side effects," says Gary Borodic, a Boston ophthalmologist and senior surgeon at Harvard, who has no association with Allergan, the manufacturer of Botox and Botox Cosmetic. The safety of Botox Cosmetic (BOTOX(R) is supported by large-scale clinical studies and hundreds of scientific articles. And one small study in rodents cannot discount decades of safe use. "The drug has a proven safety record for cosmetic injections," says Borodic. "In all the time it has been in use, we have seen no chronic negative effects." Keep in mind that botulinum toxin, type A, (the active ingredient in Botox), when administered for the treatment of medical conditions is over 20 times the strength of that administered to soften facial wrinkles. Critics claim that BOTOX(R) is a cash cow for doctors, so they don’t reveal the possible dangers or side effects. After speaking with some highly qualified practitioners whom I deeply respect, I have washed those concerns from my mind, and you can too! Trust me, qualified practitioners are not looking for trouble. Their reputations and ultimately the vitality of their practices depend on ethical behavior and sound professional judgment, based on scientific evidence: carefully structured relevant studies, historical data, statistics, and peer review. So if you are thinking about BOTOX(R) and have passed the little self-quiz found above, let’s talk about what to do next. Here is my best advice: First, put your safety worries to rest and then concentrate on finding a competent practitioner. Doctors in many fields of medicine have suffered severe financial repercussions from the dual impacts of managed care and skyrocketing insurance rates, while those practicing aesthetic medicine continue to reap financial rewards. As a result, a number of doctors of diverse disciplines (and even some without any MD credential) are taking weekend courses and suddenly transforming themselves into practitioners of the aesthetic arts. Although BOTOX(R) is not surgery, it is still a medical procedure that requires skill and experience. Forget the BOTOX(R) parties and shop-at-the-mall BOTOX(R). My philosophy for whatever it’s worth: Spend your time doing research to locate one of the best qualified practitioners in your area. Get referrals from friends and physicians, just as you would for any other medical treatment. It’s great to hunt for bargains at Marshall’s, but look for expertise for your BOTOX(R) treatments. Do you have a Botox experience to share? Send your private message to: mirror@gmail.com You have my permission to reprint this article in part or full providing it contains the following attribution: Lois W. Stern is the author of Sex, Lies and Cosmetic Surgery, (Infinity, 2006), soon to be republished in a revised edition with a CD enclosure. Lois invites prospective cosmetic surgery patients, physicians, and media to visit her website to read other articles and/or sign up for her monthly newsletter at: sexliesandcosmeticsurgery.com |