McClatchy Tribune Newspapers
October 20, 2009
"People are excited. This is long-awaited," says Dr. Leslie Baumann, a Miami Beach dermatologist and University of Miami researcher who took part in the clinical trials that won Dysport its Food and Drug Administration approval.
"I'm doing this for me," said Laurie Kaye Davis, two months short of 50, who sat in Baumann's chair for the injections on June 17, the first day the drug was available. She's in for a redo of injections between her eyebrows she got as part of Baumann's trials.
"When those frown lines go away, it just brightens your whole face," Davis said.
The new product hits the market at a good time - as boomers near senior-citizen status, with many of them still trying to look their best to become, or stay, employed.
"I just got it yesterday and I did two women and a man today," said Dr. Jacob D. Steiger, a facial plastic surgeon in Delray Beach. "I get a lot of baby boomers. I get women in their 50s who are preparing for job interviews, and I get men in their 50s and early 60s who are trying to stay in the workforce.
"One patient is a man in his 60s, retired, single, very active in the social scene. He's very interested in how he looks." Baumann, who uses Dysport as well as its existing rival, Botox, also treats actors, sports figures and business executives. About 20 percent of her patients are men.
Are patients put off by the stern "black box" warning the FDA is requiring in the packaging = a black-bordered paragraph that warns about swallowing and breathing problems that can be life-threatening, even fatal?
"I'm not concerned," Davis said. "I really studied this during the trials. And I trust the University of Miami."
To be sure, the FDA goes on to say it "has not identified any definitive serious adverse event reports when the product is used cosmetically."
Dr. Peter Lurie, director of health research for the public interest group Public Citizen, whose petition persuaded the FDA to issue the warning, says the chief danger from Botox products is in "off-label" use not studied by the FDA. Some doctors have tried it, for example, to relieve muscle spasms in cerebral palsy patients with adverse results, Lurie says.
Another serious problem occurred in 2004 when a Florida doctor injected himself and three others with a too-pure form of botulinum toxin _ far stronger than the cosmetic type. All four became paralyzed and slipped into comas from botulism poisoning, although they later recovered.
Both Dysport, made by Ipsen Biopharm of the United Kingdom and distributed by Medicis, of Scottsdale, Ariz., and Botox, made by Allergan of Irvine, Calif., must carry the black-box warning. Baumann says Dysport, which won FDA approval in April, and Botox, which has been on the market since 2000, are fairly similar in effect. But Botox needs seven to 10 days to work, she says, while Dysport does its smoothing thing in two to three days. She believes Dysport will last four to six weeks longer than the six-month span of Botox. Price competition should be a plus, too: Three frown-line injections of Botox is $350, Baumann says, and Dysport should be about 25 percent less.
Patient Davis says she may try to persuade her husband, Steve, 53, a Miami Beach lawyer, to try Dysport. "I got him to use face creams," she said. "But I don't know how much of a metrosexual I can make him."