Use of the unapproved toxin is thought to have left four people paralyzed after they were injected at a South Florida clinic.
By wire services
Published December 28, 2004
FORT LAUDERDALE - Two doctors and their Arizona company were barred Monday from selling an unapproved botulism toxin thought to have paralyzed four people who used it instead of the weaker derivative Botox, the popular anti-wrinkle drug.
Drs. Chad Livdahl and Zarah Karim of Toxin Research International Inc. don't have approval from the Food and Drug Administration for the "use, sale, marketing, and promotion of a toxic substance for treatment of wrinkles in human beings," according to a statement from the Miami office of U.S. Attorney Marcos Jimenez.
An emergency restraining order on the company, president and CEO Livdahl and board member Karim was approved Monday by U.S. District Judge James L. Cohn in Fort Lauderdale. It also covers three sister companies, Powderz Inc., The Cosmetic Pharmacy Inc. and Z Spa Inc.
FDA investigators found records that the company made three deliveries to an Oakland Park clinic where the four people were injected last month with an unapproved substance made from Botulinum Toxin Type A.
But the doses that poisoned those people weren't bought from Toxin Research International, prosecutors said.
Records seized from Toxin Research computers showed botulism sales in southern Florida of more than $53,200 to 13 customers, Jimenez said.
Toxin Research International labels its toxin as "for research only" and "not for human use." But the court documents said FDA agents found paperwork at Toxin Research showing the firm had been selling unapproved toxin for at least a year to physicians across the nation.
"They sent letters to (doctors) offering this toxin. That's what really led us to them," said Carlos Castillo, a spokesman for the U.S. Attorney's Office in Miami.
Also, Livdahl and Karim conducted seminars "instructing attendees how to inject this unapproved toxin into human beings, and conducted live demonstrations to this effect," Monday's statement said.
One of their presenters was Dr. Bach McComb, who faces charges for allegedly injecting himself and three others.
McComb faces criminal prosecution after he was accused of practicing medicine after his osteopathic license was suspended. He diluted powdered botulism intended for animal research with saline, creating a solution that was 10 times stronger than Botox, investigators said.
Witnesses told agents of the U.S. Food and Drug Administration that McComb gave shots of undiluted, highly concentrated research toxin to himself, girlfriend Alma "AJ" Hall, Palm Beach Gardens chiropractor Eric Kaplan and his wife, Bonnie Kaplan.
The Kaplans are in stable and improving condition in Palm Beach Gardens. McComb and Hall are in critical but stable condition in Bayonne, N.J.
A man who answered the phone Monday at Toxin Research International's offices in Tucson, Ariz., said Livdahl and Karim weren't available.
He referred questions to the company's attorney, Robert Gehrke, who through an assistant declined to comment.
Botulism is a rare, paralytic disease caused by a nerve toxin produced by a bacteria that, in nature, can enter the system through food or a wound. About 8 percent of those who contract it die. For those who survive, recovery can take years.
Botox is a weakened version of the botulism toxin and is considered safe.
It is injected at the site of a wrinkle to paralyze the nerve, smoothing the skin. Information from the Associated Press and South Florida Sun-Sentinel was used in this report.
