Botulism cases lead to physician suspensions, company shutdown

Jan 21, 2005 (CIDRAP News) – Several healthcare professionals have been suspended and an Arizona company has been shut down in the investigation launched last November when four Floridians were paralyzed by injections with a botulinum toxin not approved for use in humans.

Florida osteopathic physician Bach McComb and three other people suffered paralysis in November after he allegedly injected himself and them with a botulinum toxin preparation far stronger than Botox, the legal drug used to smooth facial wrinkles.

The Florida Department of Health (FDH) on Dec 17 suspended McComb's medical license and those of three other people associated with the clinic where he worked, Advanced Integrated Medical Center in Oakland Park, Fla. The others were chiropractor Thomas P. Toia, owner of the clinic; Shelly Wolland, DO, who worked at the clinic; and Alfred Boyce, DO, medical director of the clinic, according to the FDH and reports in the Fort Lauderdale Sun-Sentinel.

McComb's license had already been suspended for other reasons before he gave the injections, the FDH said. The Sun-Sentinel said Wolland had given Botox injections several times while under state orders not to dispense prescription drugs.

This week, the FDH suspended the licenses of two other Florida physicians, Norman Cohen and Daniel Campbell Daube Jr., for allegedly buying and using an unapproved botulinum toxin. Cohen is from Jacksonville and Daube from Panama City, according to an Associated Press (AP) report.

A Jan 18 AP report quoted health officials as saying they were not aware of any injuries to patients of Cohen and Daube.

The botulism investigation has led to allegations that Toxin Research International (TRI), a Tucson, Ariz., firm, sold raw botulinum toxin to healthcare practitioners as a Botox substitute. The FDH said the Food and Drug Administration (FDA) obtained TRI records that showed sales to Cohen and Daube.

Florida Health Secretary John O. Agwunobi, MD, stated in a Jan 18 news release, "This company skirted Florida's regulations, placing our citizens at risk, simply to make a fast buck; even worse are these abhorrent licensed practitioners who knowingly placed their patients in harm's way. This is egregious and can not be tolerated."

A federal judge on Jan 10 ordered TRI to stop selling botulinum toxin, according to a Jan 11 AP report. Government investigators allege that the company advertised botulinum toxin to 15,000 dermatologists, plastic surgeons, and other physicians in 2003, the story said.

According to the report, US District Judge James Cohn said TRI used misleading and deceptive practices that were likely to result in "tragic consequences." He ordered TRI to recall any of about 3,000 vials of the toxin remaining in circulation.

Chad Livdahl, owner of TRI, testified that the company sold botulinum toxin for research only, not as a Botox substitute, the story said. His lawyer said Livdahl was not aware that some buyers were using the product on people. But the judge granted the government's request to shut the company down.

Federal investigators said TRI shipped 51 vials of botulinum toxin worth $53,000 to 13 customers in South Florida in 2004, according to a Jan 9 AP story.

The Jan 11 AP story said authorities alleged that TRI bought a batch of botulinum toxin from List Biological Laboratories, a Campbell, Calif., firm that makes the toxin for research use. McComb first obtained botulinum toxin from TRI, and he later bought a much stronger preparation from List Biological, the story said. It said he allegedly used the List preparation when he injected himself and the three other people in November.

Earlier reports based on statements from another employee at McComb's clinic indicated that the doses he injected were hundreds of times stronger than a dose of Botox. Botulinum toxin is among the most potent poisons.

McComb and the three people he injected in November all remained hospitalized as of Jan 19, according to a report by the Palm Beach (Fla.) Post on that date. The others are Eric and Bonnie Kaplan of Palm Beach Gardens, Fla., and Alma Hall, a staff member at McComb's clinic.

See also:

Jan 18 FDH news release
http://www.doh.state.fl.us/communications/office/pressreleases/2005/01.18.05esos.doc

Dec 20 FDH news release
http://www.doh.state.fl.us/communications/office/pressreleases/2004/12.20.04esos.doc

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