Skin DNA.com - Anti-Aging Skin Care News
FDA: 4 injected with potent Botox
ASSOCIATED PRESS, FLORIDA
OAKLAND PARK - Four people who remain paralyzed with botulism were injected with shots that contained a large dose of a raw, unapproved toxin that someone at an anti-wrinkle treatment clinic bought from a California laboratory, federal documents show.
The suspended clinic doctor who administered the shots, Bach McComb, diluted the mixture as if it were made from lower-strength Botox - a federally approved medication - instead of high-potency raw toxin, federal agents said in a statement filed in a California federal court.
The details surfaced in an application for a search warrant filed last week by the U.S. Food and Drug Administration, which is investigating the botulism poisonings in late November. The agents searched a toxin factory, List Biological Laboratories, outside San Jose, Calif., on Thursday.
In the documents, FDA Special Agent Susan Leeds of Miami said a medical technician at the suburban Fort Lauderdale clinic told agents that McComb told him to order botulinum bacteria type A toxin from List, which makes deadly substances such as anthrax and diphtheria for animal research.
Called for comment Tuesday, Debra Dye, a List vice president, said, "There is an ongoing
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(continued from previous column) investigation that we can't comment about." The company's Web site says it has made bacterial toxins for research for 25 years.
Neil Garfield, a lawyer for Advanced Integrated Medical Center, the clinic where the shots are believed by authorities to have been administered, said the clinic was being tainted by the actions of one or two people who worked there who purchased the material.
"This guy McComb did whatever he did," Garfield said. "And these people (at the clinic) are going to get ruined."
The FDA does not regulate chemicals for non-human use, but the Centers for Disease Control and Prevention regulates some biotoxins.
Botox is made from the type A toxin that causes botulism. It is the only drug made from type A that is approved for use in people in this country.
"As these cases show, the use of unapproved and unlicensed botulinum toxin poses a grave danger to patients," Douglas S. Ingram, general counsel for Botox maker Allergan, said in a written statement.
According to federal investigators, Eric and Bonnie Kaplan were admitted to a Palm Beach Gardens hospital Nov. 26 suffering from botulism poisoning and reported receiving injections of a Botox-type 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 who worked at Advanced Integrated Medical Center, but Florida Department of Health records show his medical license was suspended in 2003 because of allegations he prescribed excessive amounts of pain medication.
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