Botulism supplier ordered to halt sales


Published: Tuesday, January 11, 2005 at 6:01 a.m.
Last Modified: Monday, January 10, 2005 at 11:41 p.m.
FORT LAUDERDALE - An Arizona company was ordered Monday to stop distributing raw botulism bacteria in place of the wrinkle treatment Botox and to recall any of its 3,081 vials still in circulation.
The potent bacteria marketed by Tucson, Ariz.-based Toxin Research International since 2003 was obtained from the same California supplier whose product is blamed for paralyzing four people injected at an Oakland Park clinic.
Toxin Research used misleading and deceptive practices that are "likely to result in tragic consequences to the unsuspecting consumer," U.S. District Judge James Cohn said at the end of a daylong hearing. The company and its operators "have exposed the public to a great health risk."
The judge granted the government's request for a civil injunction to shut down Toxin Research and its botulism sales after hearing testimony from company founder Chad Livdahl and his "life partner" Zahra Karim, who runs an affiliated company from an adjoining suite.
List Biological Laboratories, a Campbell, Calif.-based maker of bulk research-grade botulism and other toxins, allegedly prepared a low-dose batch of botulism, something equivalent to the injectable cosmetic drug, and sold it to Toxin Research for about $30,000.
Bach McComb, who lost his medical license last year, first obtained botulism from Toxin Research and then direct from List in a strength 20,000 times higher.
Witnesses say McComb injected the List botulism that paralyzed himself and three others in late November. All four are still being treated.
Outside of court, attorney Stuart Grossman, who is suing McComb and Toxin Research on behalf of two of the patients, a paralyzed Palm Beach Gardens couple, called Livdahl's testimony "incredible."
Toxin Research pitched List's botulism for sale to 15,000 dermatologists, plastic surgeons and other doctors nationally in 2003, government evidence indicated. One Livdahl e-mail on a promotional seminar was titled "Proposal to make cash."
Livdahl, a microbiologist who owns the company, testified repeatedly that his sales were intended for research only and not for human use in place of Botox and the vial label's said the same thing. He has never bought Botox, a low-dose botulism prescription drug, from the only federally licensed supplier, Allergan.
Robert Gehrke, Livdahl's attorney, said his client "was not aware that some customers were using it on human beings."
Assistant U.S. Attorney Russell Koonin countered: "Those are not researchers that Dr. Livdahl is soliciting. Those are private, in-house physicians."
He told the judge that Toxin Research compared Livdahl's unlicensed product to Botox in an end run around federal regulations.
The federal government sought the injunction to stop Livdahl, Karim and their companies from advertising, shipping or selling any botulism products. Investigators found evidence that two other Livdahl companies, Powderz and Z Spa, were planning promotional seminars this month and in March for its products.
The companies and their operators are targets of a criminal investigation, but no charges have been filed.
Livdahl has not applied for Food and Drug Administration approval for a generic Botox, but he testified that he was building a laboratory to produce a low-dose botulism product.
The FDA seized Toxin Research's sales records showing deliveries of vials with inadequate directions, but neither Livdahl not the agency have publicly accounted for more than 2,300 vials. Livdahl estimated about 530 vials were damaged by lack of refigeration, the FDA seized 134 vials at the Tucson office, and 51 vials were sold in South Florida.
Palm Beach County's top health officer issued a warning Saturday against getting any anti-wrinkle injections because of the current state of uncertainty about the product.

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