You thought botox was all about looks? it's also a salve for everything from cerebral palsy to writer's cramp
"There's a lot of experimentation going on," says Christine Cheng, assistant clinical professor in the School of Pharmacy at the University of California-San Francisco, who has studied the body of research on Botox's off-label uses. While there's mounting excitement about the drug's potential, Cheng thinks patients need to be cautious about off-label use, since its effectiveness and safety are yet to be proved in many cases. "Don't demand a certain treatment just because you saw a headline," she advises.
Possible side effects include headache, flulike symptoms, and greater-than-intended muscle weakness-causing a droopy eyelid after treatment for a blinking disorder, for example. Because Botox is not permanent, neither is the weakness, but the comeback can take weeks. No one knows what the effect might be of long-term use. And it's been observed that a small percentage of people develop antibodies to the Botox, making it less effective.
Botox offers "an alternative to drugs in difficult patients" when other therapies have failed, says Seymour Diamond, director of the inpatient headache unit at St. Joseph Hospital in Chicago. He's conducting Allergan-funded research on the use of Botox for headache. "But I'd be reluctant about its generalized use until proven useful," he says.
Where the science is sound, some insurance plans will cover Botox treatments even without the blessing of the FDA. Injections for writer's cramp, certain gastrointestinal disorders, and spasticity caused by brain injury, multiple sclerosis, or hereditary paraplegia are sometimes covered, for example. Aetna and Cigna, among other insurers, say that they may cover other uses if a doctor deems Botox medically necessary. "Where there's inconsistent literature, we'd give case-by-case consideration," says Daniel Winn, a medical director at CareFirst BlueCross BlueShield of greater Washington, D.C. So far, wrinkles don't clear the industry's bar.
Not a cure. Even when it works, Botox doesn't address the underlying condition. Kessler is now scheduled to get deep brain stimulation, a surgery that will implant electrodes in his brain to override the problematic signals caused by his condition, generalized dystonia; he hopes it will make the injections unnecessary. But sometimes just managing symptoms improves a patient's prognosis. In people with dystonias or spasticity, for example, Jankovic believes the drug can alter the disease's progression: Early treatments may head off the permanent contortions that can occur when muscles are contracted for a prolonged period and tendons shorten.
"I wanted to function," says Edward Rosa, 70, who started treatments after a stroke six years ago left him with clenched muscles on his left side. The retired Montville, N.J., businessman, who still does some consulting, says the therapy allowed him to exercise other muscles, improving his range of motion. At first, he went in four times a year for injections in his arm and leg. As he's progressed, the interval has lengthened; his last appointment was a year ago.
Because the delivery of the drug is localized and its effect wears off, some doctors like it as a possible alternative to more systemic and permanent treatments. Compared with drugs or surgery, "this is so minimally invasive," says Michael Chancellor, director of neurourology and female urology programs at the University of Pittsburgh Medical Center. Chancellor uses Botox off label to relieve muscle spasms in the pelvic floor and to manage enlarged prostate. By relaxing muscle tissue that permeates the gland, he says, the drug seems to reduce pressure on other parts of the urinary tract. Chancellor, who has received research funding from Allergan, is now investigating the treatment for overactive bladder.
Ironically, Botox's power is derived from a substance that the federal government classifies as capable of inflicting mass casualties. While using it as a weapon would be extremely difficult technically, botulinum toxin is "the most poisonous substance known," says Zygmunt Dembek, a biochemist and epidemiologist at the U.S. Army Medical Research Institute of Infectious Diseases. "And it has great potential for good."