by John M. Curtis
(310) 204-8700

Copyright March 3, 2003
All Rights Reserved.

otox, AKA botulinum toxin, is now touted in some circles as the next "penicillin"—every drug maker's dream. Far from a "miracle cure," the manufacturer Allergan finds more and more applications, despite its limited use of treating facial wrinkles, especially frown lines. Though the Food and Drug Administration only recently approved Botox for facial wrinkles, the drug has been used for eye [blepherospasms] and neck spasms [spastic tortocollis] and spasmodic dysphonia [the strangled voice] since 1990. Now stuttering, migraines, writer's cramp, low back pain, carpal tunnel syndrome, tennis elbow, and, yes, even sexual dysfunction are on the table—what next? Botox is a diluted version of the deadly poison botulinum toxin, the dangerous biologic agent used in germ warfare. Despite its risks—or benefits—Allergan generously sponsors research expanding its potential use.

      New applications—and promises—run the gamut, from treating obesity, ulcers and clubfoot to even curing body odor. But nowhere have the claims stretched more than treating a disabling speech disorder called spasmodic dysphonia or the strangled voice. Here Botox paralyzes the muscles controlling the vocal cords, relieving spasms allegedly due to renegade nerves. Like with facial wrinkles, Botox blocks acetylcholine, a powerful neuromuscular transmitter responsible for healthy muscle contraction. Once injected into the vocal folds, it temporarily stops spasms, allowing patients to recover voices—or so claims Allergan. "There are some obvious drawbacks," said Gerald Berke, M.D. in Dec. 1999, chairman of UCLA Head and Neck Division, warning that Botox acts like a roller coaster, causing breathiness, a brief window of improved voice and eventual regression to the strangled voice.

      Applications abound for Botox, leading some physicians to believe the drug "has enormous potential," or so says Robert B. Daroff, former editor of Neurology magazine, though his own Cleveland neurology practice doesn't use botulinum toxin. Calling Botox the next "penicillin," Dr. Jean Carruthers, an opthalmologist with the University of British Columbia, found Botox effective in treating eye spasms and smoothing out facial wrinkles. Because Botox's effect is short-lived, some think it creates few long-term side effects. Yet, Mitchell Brin, M.D., who introduced Botox for treating strangled voices, asked colleagues, at a conference sponsored by Allergan on March 10, 1991, to withdraw Botox at the earliest possible time fearing its long-term negative side effects. Dr. Brin, who is currently employed as a vice president with Allergan, flip-flopped and now enthusiastically endorses Botox.

      Calling it "very safe," the FDA says Botox doesn't pose problems other than "some examples where it was injected in the wrong places, but those problems are temporary," said Lenore Gelb, an FDA spokeswoman. Yet Gelb doesn't have longitudinal research evaluating Botox's long-term risks. Patients treated for spasmodic dysphonia typically receive 4-10 shots a year. Over the long haul, no one really knows whether repeated exposure to Botox causes eventual toxicity or any unknown side effects. When Dr. Carruthers says its lethal dose is 35 viles, most medications—including aspirin—have toxic limits—especially drugs known as poisons. "Every medical specialty is finding a niche for this drug," said Dr. Richard G. Glogau, a dematologist at the University of California, San Francisco, finding that Botox relieved migraines in patients treated for frown lines.

      By sponsoring research around the globe, Allergan works toward applying Botox to the widest possible swath of maladies. Allergan even supports research at Ludwig-Maximillian University, using Botox in place of underarm deodorant. Going over the top, Munich dermatologist Dr. Marc Heckmann, for instance, sees Botox as "one of the most amazing compounds we've seen in the last two decades," comparing it to discoveries of corticosteriods and chemotherapy. Where the applications end is anyone's guess. "Physicians to take part in research studies often become spokespersons for the companies or join advisory boards," said Jerome Kassirer, a former editor of the New England Journal of Medicine, attesting to how publicly traded corporations influence scientific research. No one begrudges drug companies the right to market products, but skewing scientific research crosses a dangerous line.

      Using Botox to treat strangled voices vividly illustrates how drug companies stretch applications to the breaking point. Paying medical researchers to prove Botox is an effective alternative to underarm deodorant pushes science too far. No matter how innocuous, no drug should replace common sense when it comes to finding new applications. Scientists must test hypotheses not advance the bottom lines of drug companies trying to augment earnings on quarterly reports. Whatever Botox's practical applications, the medical profession shouldn't delude itself or consumers into believing one of the world's most deadly poisons—no matter how diluted—has no adverse side effects with long-term use. It's one thing to treat frown lines, but still another to claim cures of female sexual dysfunction. Drug makers—no matter how zealous—still have to show some restraint.

About the Author

John M. Curtis writes politically neutral commentary analyzing spin in national and global news. He's editor of OnlineColumnist.com and author of Dodging The Bullet and Operation Charisma.

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