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More than 1,000 may have taken fake Botox shots

Frederic Corbin, a plastic surgeon in Beverly Hills, Calif., was intrigued last year when he saw an ad for a product that offered the same protein used in the wildly popular wrinkle treatment Botox - only much, much, cheaper.

"My initial reaction was, "Hmm, Botox now has some competition,"' Corbin recalled.

But when Corbin received a vial of the botulinum toxin in the mail, he was puzzled by the warning on the box: "For Research Purposes Only. Not for Human Use."

Corbin returned it and more or less forgot about it, until he heard a news story in December about four people whose mysterious paralysis was linked to the use of a Botox knockoff.

Authorities found that dozens of doctors around the country had bought the unapproved botulinum, which in its raw form is one of the most potent neurotoxins on Earth. And investigative documents indicate that more than 1,000 people may have been injected, many unaware they weren't given Botox.

"We don't know how dangerous it is; it's not as well controlled as the commercially available product," said Dr. Thomas Rohrer, a Boston dermatologic surgeon who has written extensively on botulinum toxin, which he describes as exponentially more powerful than cyanide.

The company accused of selling the unapproved toxin and marketing it as a Botox substitute goes on trial next month in federal court in Fort Lauderdale.

The firm, Tucson, Ariz., Toxin Research International, and owners, Chad Livdahl and Zarah Karim, who are jailed awaiting the trial, are accused of defrauding people who thought they were getting a safe, approved Botox treatment.

Not everyone agrees that the unapproved material is unsafe - and they point to the fact that no one is known to have been hurt by toxin bought from TRI.

While the four people who were paralyzed last year led officials to the discovery of TRI's marketing, the four aren't believed to have been injected with toxin bought from the company, which as a result isn't implicated in their injuries.

Eric and Bonnie Kaplan of Palm Beach Gardens were allegedly injected by Dr. Bach McComb, who also injected himself and his girlfriend, Alma Hall. Federal prosecutors say McComb worked as a consultant for TRI but bypassed the company on that occasion and bought toxin straight from the manufacturer that supplied TRI.

Lawyers in the case also say McComb apparently got the dosage wrong when he injected himself and the three others. They have all since partially recovered.

But while McComb, Hall and the Kaplans lay paralyzed in December, on ventilators and unable to swallow or see, investigators searching the clinic where McComb worked found marketing materials from TRI that set them on a wider inquiry.

Federal prosecutors say a nearly yearlong investigation has shown that TRI held seminars at which there were demonstrations on injecting it. It was represented as a cheap alternative to Botox, said doctors who attended.

TRI's lawyer, Ben England, said he can't comment on the facts of the case. But as for the government's contention that TRI was acting fraudulently, "we disagree," he said.

At least 180 doctors - plastic surgeons, dermatologists and naturopaths - ordered Botulinum Toxin Type A from TRI, according to documents in the case.

A few doctors are now starting to face criminal investigations themselves.

While the fraud alleged by the government has a certain outrage factor, there remains the fact that no one injected with toxin from TRI is reported to have been hurt. Some say that's because the toxin is basically the same as what's used to make Botox - a claim given by some of the doctors and clinics defending themselves.

The unapproved material "is a naturally occurring neurotoxin that . . . appears to be identical," said Scott Hopes, an epidemiologist who also represents a north Florida surgery center where a doctor had his license suspended.

"The physicians who are buying it are just plain stupid," said Dr. Sue Ellen Cox, a dermatologic surgeon in Chapel Hill, N.C., who has written several articles on botulinum toxin. "You could be injecting God knows what."

[Last modified October 16, 2005, 01:31:12]