Plastic surgeon Frederic Corbin 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,’ ” recalled Corbin, who practices in Beverly Hills, Calif.
But when he received a vial of the botulinum toxin in the mail, he was puzzled by the warning: “For Research Purposes Only. Not for Human Use.”
He says he returned it and more or less forgot about it until he heard about four people last December whose mysterious paralysis was linked to the use of a Botox knockoff.
Authorities have found that dozens of doctors around the country bought 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 with it, many unaware they weren’t given federally approved Botox.
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, Fla.
“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 about botulinum, which he describes as more powerful than cyanide.
Tucson, Ariz.-based 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.
No one is known to have been hurt by TRI’s toxin; the four paralyzed people were injected with a toxin bought straight from the manufacturer that supplied TRI, not from the company itself.
Eric and Bonnie Kaplan 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.
Lawyers in the case say McComb injected himself and the others with the wrong dose. They have all partially recovered.
But last December, when McComb, Hall and the Kaplans lay paralyzed on ventilators and unable to swallow or see, investigators searching the clinic where McComb worked found marketing materials from TRI.
Although TRI hasn’t been directly linked to the paralysis case, authorities say the Arizona company told other doctors its product was safe and on its way to being approved for people.
According to case documents, at least 180 doctors – plastic surgeons, dermatologists, naturopaths – ordered Botulinum Toxin Type A from TRI. A five-dose vial would cost $1,250, compared to about $2,000 for Botox.
TRI’s lawyer Ben England said “we disagree” that TRI was acting fraudulently, and declined to elaborate.
Most doctors who bought the toxin haven’t been publicly named, and officials say many patients don’t know they got the unapproved toxin.
In Salem, Ore., Dr. Jerome Lentini is one of the few who has been criminally charged, accused of injecting a TRI toxin into hundreds of patients, many of whom signed a consent form that implied they were getting FDA-approved Botox.
All charges against TRI involve misleading patients.
Some doctors and clinics say that’s because the toxin is basically the same as what’s used to make Botox.
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’s license was suspended for buying the unapproved toxin.
“Those people should think themselves very lucky,” countered Dr. John Agwunobi, a U.S. Department of Health and Human Services official and former Florida health secretary.
Agwunobi and others said just because no one was injured yet, doesn’t mean it won’t happen in the future.