FDA Sends Doctors To Jail For Illegal Botox Distribution

FDA investigations that began back in 2004 have resulted in several nationwide convictions with prison sentences, including cosmetic physicians who used the illegal Botox in Houston, New Jersey, Boise, Tigard, Salem, and Albuquerque.

The inquiry was launched after four Florida patients were hospitalized with severe botulism poisoning after being injected with illegal botulinum toxin passed off as Botox Cosmetic. The effects reported by these patients; conditions like temporary paralysis, drew the attention of the FDA's office of criminal investigations, who traced the drug to a California lab involved with botulinum toxin research.

All of the illegal Botox substitute had been labeled "FOR RESEARCH PURPOSES ONLY" but the president of Toxin Research International (TRI), Chad Livdahl, was found guilty of fraud and misbranding of the drug. Livdahl had marketed the drug to doctors as a legitimate Botox alternative and was sentenced to 9 years in prison. Several conspirators, including his wife, were also sentenced to prison time.

FDA criminal investigations branched out through 210 United States health care professionals who had profited from the inexpensive Botox substitute purchased from TRI. Operators of these medical practices were then prosecuted based on their known misrepresentation of the drug and failure to inform patients of the drug's generic and non-FDA approved status for use on humans.

One of the doctors, Dr. Jerome Lentinie of A Younger You in Salem and Tigard, Oregon, used the illegal Botox substitute on roughly 800 patients. The Albuquerque physician, Mark Van Wormer, MD, was sentenced to 366 days in prison, $65,265 in restitution, and a $3000 fine.

Eva Sheie, an internet marketing specialist for cosmetic medicine based in Seattle, told Real Beauty News that when Dr. Van Wormer was found guilty of the charges, he called her office immediately. Ms. Sheie says that "some doctors are always looking for a 'magic bullet' that will make them rich, and after you've worked with enough of them, you know which ones think this way."

"It was no surprise to us that he 'didn't know' it was illegal Botox. An email from Dr. Van Wormer on January 13, 2008, explained, 'Due to the fact that I have been sentenced to a year in prison due to the Botox Scandal where Chad Livdahl and Toxin Research International out of Phoenix, Arizona sold me generic Botox which was not FDA approved, I have been convicted of Felony Medical Misbranding and sentenced to a year in prison. All my cosmetic privileges in the state of NM have been rescinded forever.'"

Houston surgeon and anesthesiologist Dr. Gayle Rothenberg was indicted and convicted of conspiracy, mail fraud, misbranding of a drug and making false statements to an FDA agent. Houston's KHOU reported that Rothenberg and her husband returned from a medical conference in February of 2004 and announced to their staff that they had found a "cheaper alternative to Botox®" and began ordering the illegal substitute from TRI.

For the next seven months, over 170 of "Dr. Gayle's" patients were injected with the unapproved substance, but told it was Botox Cosmetic. Dr. Gayle had previously been an "expert" on cosmetic procedures for KHOU.

Kim Rice, an FDA special agent, says the "FDA will aggressively pursue those who willfully circumvent laws that are in place to protect the consuming public." Allergan, Inc. is currently the only FDA-approved manufacturer of a botulinum toxin product for cosmetic use.

RealSelf.com supports the multi-specialty coalition of physicians known as the Physicians Coalition for Injectable Safety. The mission of the Coalition is to provide the public with unbiased and necessary information on injectable cosmetic treatments, appropriate injectors and where to safely access cosmetic medical procedures. Patients seeking information about injectable safety concerns can read answers to questions like "What does Botox packaging look like?" from Coalition physicians on RealSelf.com.

Kristin Meyer for Real Beauty News

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