WAILEA, HAWAII — Leaders in cosmetic dermatology at the annual Hawaii dermatology seminar offered words of caution about the use of unapproved products and cut-rate versions of Food and Drug Administration-approved materials and medications.
“Beware,” warned David J. Goldberg, M.D., J.D., a dermatologist with a specialty practice in New York and New Jersey. A recent scandal in Florida involving the paralysis of four patients with an improperly diluted, unapproved formulation of botulinum toxin type A led to a federal investigation of a network distributing what authorities called “fake Botox” to physicians across the country. (See story on this page.)
Physicians face possible suspension of their licenses following injection of patients with the unapproved toxin, and the repercussions aren't likely to stop there, speakers said at the meeting.
Michael H. Gold, M.D., a dermatologist in a specialty practice in Nashville, Tenn., noted that unapproved products can be “easily obtained” in Canada and elsewhere. “Be careful about where you get your products and how you do it,” he warned his colleagues at the seminar, sponsored by the Skin Disease Education Foundation (SDEF). “Just be reminded that if something goes wrong, you have no leg to stand on.”
Because of recent cases, “the FDA and, more frighteningly, the FBI are considerably more aware of the dangers that can occur to the American people as a result of illegal importation [or use] of material,” noted Alastair Carruthers, M.D., who is credited along with his wife, Jean Carruthers, M.D., with pioneering the cosmetic use of Botox.
Dr. Carruthers, who disclosed financial ties to Allergan Inc., the manufacturer of Botox, said in a later interview that he thinks many physicians may be taking undue risks. “We've lost sight as a group that these regulatory processes are there for a purpose,” said the Vancouver, B.C.-based dermatologic surgeon.
The SDEF and this newspaper both are wholly owned subsidiaries of Elsevier.