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Bogus Botox Fells 4 in Florida

4 Paralyzed After Apparent Use of Drug Unapproved for Humans

WebMD Health News

Dec. 8, 2004 - Four people remain paralyzed after apparently receiving injections of an unapproved botulism toxin marketed as a less-expensive version of Botox.

The four people include the doctor who may have administered the injections at his clinic outside Fort Lauderdale, Fla. He and his girlfriend, a clinic employee, remain in a New Jersey hospital. They fell ill after traveling to New Jersey for Thanksgiving. Two others -- a Florida chiropractor and his wife -- are hospitalized in Florida.

Exactly what happened isn't clear. None of the four can yet speak to state and federal officials investigating the case, says Lindsay Hodges, a spokeswoman for the Florida Department of Health. The department is leading the public health investigation; a federal criminal investigation is also under way.

"The patients can't participate in the investigation at this time," Hodges tells WebMD. "They are responsive -- they can indicate 'yes' and 'no' or answer briefly -- but they can't carry on a conversation."

All four patients appear to be suffering from acute poisoning with botulism toxin. Botox contains tiny amounts of this toxin, one of the most poisonous substances on earth. It's made by a common bacterium whose spores live in the soil and bloom under the right conditions.

Botulism toxin works by blocking communication between nerves and muscles, effectively paralyzing affected muscles. There's an antitoxin, but it only prevents further damage. It takes months for the toxin to wear off. People with severe botulism toxin poisoning need mechanical ventilation and intensive hospital care. Recovery is slow.

Botox Is Safe; Shady Product Suspected

According to news reports, investigators suspect that the doctor, identified in news reports as Bach McComb, DO, used an unapproved product made by an Arizona company. [Editors Note: Court documents filed by FDA investigators indicate that the product came from a Northern California firm.] McComb's Florida medical license had been suspended pending charges of trafficking in addictive pain medications.

McComb's clinic, Advanced Integrated Medical Center, in Oakland Park, Fla., did receive two vials of Botox, an approved product often used for cosmetic injections. Botox maker Allergan says there were no safety problems with the Botox lots from which the vials came.

According to news reports, the federal investigation centers on Toxin Research International, a sister company of Powderz Inc. of Tucson, Ariz., which markets a "for experimental use only" botulism toxin called Botulinum Neurotoxin type A. [Editors Note: While court documents filed by FDA investigators report evidence that Toxin Research International may have marketed an experimental botulism toxin for human use, Toxin Research International does not appear to be the source of the botulism toxin used in the Florida cases. According to news reports, that product appears to have come from a Northern California company. According to Botox maker Allergan, the California company's product is shipped in vials containing 10 million units of botulism toxin -- 100,000 times the amount of botulism toxin in authentic Botox, the only botulism toxin product approved for human use.]

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