Source: San Francisco Chronicle (CA) Contact: http://www.sfgate.com/chronicle/ Pubdate: Fri, 10 Apr 1998 Author: Carl T. Hall, Chronicle Staff Writer UNCOMMON PRACTICE Patients going beyond drug's label to treat their ailments Dr. Richard Glogau doesn't have the FDA's blessing when he injects patients' armpits with botulism toxin to treat their problems with excess sweat. But the San Francisco dermatologist administers the unorthodox treatment regularly winning raves from drenched hyperhidrosis sufferers, a byline in an upcoming issue of the Journal of Dermatologic Surgery and even a few visits from intrigued network news shows. "This is a significant advance for patients," he said. It also highlights one of the more peculiar features of the American medical system: Fully half of all prescription drugs sold are used for aliments other than those they were approved to treat. Glogan and his patients are pioneers in what's known as "off-label" drug use. That refers to any use other than that listed on the Food & Drug Administration approved product description. FDA regulations allow any drug approved for one condition to be freely prescribed for any other condition, as long as the doctor sees a benefit. There's no solid proof of safety and efficacy, but patients often are the last ones to complain. "I was desperate," said Brandon Burg, 30, a San Francisco medical-management software consultant bedeviled since childhood by wildly overactive sweat glands. Multiple rounds of painful cutting, scraping and liposuction didn't work. Ready to try anything, Burg found his way to Glogau's clinic at the University of California at San Francisco and soon was undergoing injections of a drug called Botox. It's sold by Irvin based Allergan Inc. with full approval of the FDA. But the only FDA-sanctioned use, based on extensive, rigorously controlled clinical trials, is to control certain nervous disorders affecting muscles of the eyelids and face. Botulism toxin is deadly at full strength - a much feared agent of biological warfare that paralyzes victims in seconds. But in its dilute form, the same toxin can be used safely to tame overactive nerve junctions in the muscles. Along with at least two other researchers showing similar results, Glogau found that Botox also keeps sweat glands under control, inhibiting the neurotransmitter that causes muscles surrounding the glands to contract. The only drawback so far seems to be that the effect wears off in a few months, forcing patients back for repeat treatments. Each round of injections costs $600 to $1,000. From the standpoint of practitioners like Glogau, there's no reason to wait for the government's permission to do what he can to help people. "That's not how medicine operates," he said. Glogau notes that only about half of his patients' insurance companies are willing to pay for what some consider an experimental cosmetic procedure. The FDA system doesn't allow Allergan to proclaim Botox's efficacy in fighting sweat - unless the company is willing to finance full-blown c~mical trials of Botox for sweat control. Which it isn't. Instead, Allergan is studying Botox as a treatment for cerebral palsy, migraine headache, adult spasticity, spi~al cord in-jury and lower back pain. "You want to take a look at the bigger markets obviously because they bring are-turn on your investment faster," said an Allergan spokesman. "Excess sweating af-fects a narrow range of the population. It's not a place where we have placed a lot of research money." In fact, the company can't even say very much about what independent researchers are doing. Even while drug ads flourish on TV, manufacturers are strictly forbidden to discuss off-label uses of their products. This policy is supposed to provide an incentive for the company to undergo expensive product testing. Now, though, the restrictions are starting to ease. Congress ordered the FDA to implement new rules by November that allow companies to hand out unsolicited copies of materials on off label drug use. However, only medical-journal articles and other specialty materials can be distributed, and then only if the drugmaker undertakes a clinical trial within three years. "There's an open question as to how much this will change things," said Michael Landa, staff attorney at Fenwick & West in WashingtQn, D.C. Some legal specialists charge the new law doesn't go nearly far enough, suggesting there's no reason to restrict the free flow of information to physicians trained to digest it. "There's a natural conservatism among physicians, a built-in skepticism about any new drug or untried use of an old drug," said Jonathan Emord, a Washington, D.C., lawyer representing doctors and some health-product makers. "Not many doctors are eager to be on the cutting edge experimenting with human beings as guinea pigs. There are some cases where they have no choice. To fear the dissemination of science to scientists is just absurd," Emord said. But most drugmakers seem reluctant to press the point, partly because the 1997 law eased other restrictions, such as those on advertising, that they had chafed against, partly because doctors can find all the information they need and then some just by searching the Internet. "I haven't heard many complaints," said Carl Feldbaum, president of the Biotechnology Industry Organization. He called the new change on off label information "a careful compromise." Many patient groups wanted the off-label rules lifted altogether, but consumer advocates maintain it would be a big mistake to give manufacturers free rein. "The system is supposed to provide an incentive to conduct studies, and this amounts to an end-run around the system," said Arthur Levin, director of the Center for Medical Consumers, an advocacy group based in New York.