FDA: Paralyzed Botox Victims Got Unapproved Toxin

Four people paralyzed by botulism (search) were injected with large doses of a raw, unapproved botulinum toxin that someone at their anti-wrinkle treatment clinic bought from a California laboratory, federal documents show.

The suspended doctor who administered the shots, Bach McComb (search), used the material as if it were lower-strength Botox, a derivative of botulinum toxin that is a federally approved medication for wrinkle control and other uses, federal agents said in court papers.

McComb and his girlfriend are among the four people who remain hospitalized after getting the shots.

Details of the case surfaced in an application for a search warrant filed last week by the U.S. Food & Drug Administration. On Thursday, the agents searched List Biological Laboratories (search), outside San Jose, Calif.

In the documents, FDA Special Agent Susan Leeds said an assistant at a clinic in suburban Fort Lauderdale said McComb told him to order botulinum bacteria type A toxin from List, which makes deadly substances such as anthrax (search) and diphtheria for animal research.

The company's toxin is not licensed for human use, and it is illegal for the company to sell it for use in people, the affidavit states.

Called for comment Tuesday, Debra Dye, a List vice president, said, "There is an ongoing investigation that we can't comment about."

Neil Garfield, a lawyer for Advanced Integrated Medical Center, where authorities believe the shots were administered, said the clinic was being tainted by the actions of one or two people who bought the material.

"This guy McComb did whatever he did," Garfield said. "And these people (at the clinic) are going to get ruined."

Botox (search) is made from the type A toxin by pharmaceutical giant Allergan. Its product is the only drug made from type A that is approved for use in people in this country for treatment of some neck pain, eye movement spasms and wrinkle removal.

"As these cases show, the use of unapproved and unlicensed botulinum toxin poses a grave danger to patients," Douglas S. Ingram, general counsel for Allergan, said in a written statement.

Investigators said Eric and Bonnie Kaplan were admitted to a Palm Beach Gardens hospital on Nov. 26 suffering from botulism poisoning and reported they received injections of an anti-wrinkle treatment from McComb a few days earlier. Investigators then learned that McComb and his girlfriend, Alma Hall, were hospitalized with similar symptoms in Bayonne, N.J.

McComb is an osteopathic doctor. Florida Department of Health records show his license was suspended in 2003 because of allegations he prescribed excessive amounts of pain medication.

Botulism poisoning is fatal in about 10 percent of cases. It usually paralyzes victims from the head down for several months until affected nerve endings regrow.