Twelve doctors in three states are facing license suspension and hundreds more may get visits from federal regulators in an investigation into sales of $1.5 million worth of an unapproved knockoff of Botox regulators say was used on unsuspecting patients.
An Arizona-based company and its affiliates promoted their own version of botulinum toxin to doctors nationwide as a cheaper alternative to Botox, the only FDA-approved anti-wrinkle drug that uses the toxin, according to court documents. The cheaper treatment was not Botox, nor was it an FDA-approved drug.
More than 200 doctors purchased the toxin one of the most deadly known to man from Toxin Research International (TRI), investigators say.
Despite package labels that said the toxin was not for human use, patients in Florida, Nevada and Oregon were given the injections, regulators say. Many were unaware that it was not Botox, a treatment that temporarily paralyzes muscles so wrinkles appear to smooth. No injuries were reported among those patients.
But one doctor allegedly involved in the distribution of the toxin was not so lucky. Florida doctor Bach McComb and three others were hospitalized in November with botulism, a potentially fatal condition that paralyzes muscles. All four survived but suffered serious complications.
McComb is now facing criminal charges of conspiring to defraud the U.S. government and mislabeling drugs. So are doctors Chad Livdahl and Zarah Karim, who ran TRI in Tucson.
“This deadly toxin wrapped in the guise of medicine represents a grave threat,” says Marcos Daniel Jimenez, U.S. Attorney for the Southern District of Florida, who filed the charges.
Attorneys for Livdahl and Karim say their clients will plead not guilty. McComb’s attorney did not return phone calls.
Prosecutors say TRI widely advertised its toxin, sending brochures to doctors across the country. The firm sold its unapproved treatment for $1,250 a vial, which contained about five doses. The real Botox, which comes in a single-dose vial, has an average wholesale price of $560 a vial. TRI allegedly purchased the toxin for $9.67 a vial.
Based on customer records seized from TRI, regulators say 219 doctors purchased the toxin. TRI has been ordered to stop distribution. The FDA will visit all 219 doctors’ offices, a Justice Department spokesman says.
Botox was approved in 2002 as a wrinkle treatment. It is made of a purified form of the toxin and diluted so that it does not cause botulism.
Regulators say concerned consumers should ask their doctors if they are using the FDA-approved Botox.