The Associated Press

SALEM, Ore. — A doctor who injected cosmetic patients in Tigard and Salem with a Botox substitute has been indicted on federal charges.

Dr. Jerome N. Lentini ran the "A Younger You" clinics until January, when FBI officials began investigating complaints.

A federal grand jury handed up the indictment Thursday, charging Lentini and his assistant, nurse Cathryn Garcia, with more than 50 charges ranging from mail fraud to misbranding drugs.

According to the indictment, Lentini and Garcia injected patients with a form of botulinum toxin that has not been approved for use on humans by the federal Food and Drug Administration.

Unapproved botulinum toxin is cheaper than the approved Botox, which is a registered trademark and the only type of botulinum toxin approved for wrinkle-smoothing treatment on humans.

In an 11-month period in 2003 and 2004, Lentini and Garcia ordered 41,500 units of the substitute, compared with 300 units of approved Botox, the indictment says.

Federal officials think Lentini and Garcia injected more than 800 patients with unapproved drugs in a 13-month span, records show.

"Lentini and Garcia made repeated material misrepresentations and omissions intended to mislead patients into believing they were being treated with an FDA-approved toxin when in fact they were being injected with non-FDA approved (drugs)," the indictment says.

Phone numbers registered to Lentini and Garcia were disconnected, and neither could be reached for comment Thursday

Four people in Florida who were injected with the unapproved drug late last year contracted botulism. Federal investigators in those cases concluded that the botulism was caused by the same nonapproved forms of drug allegedly used by Lentini.

In a prepared statement released in January, Lentini said he stopped using the anti-wrinkle product because of its poor performance. He said he made that decision before the product was linked to the botulism cases in Florida.

Lentini also said he did not know that the substitute had not been approved for use by the FDA. The doctor said he started using the substitute after hearing it praised at a medical conference at the University of Kentucky Medical School.

Two of Lentini's employees, knowing of the Florida cases, became concerned when they witnessed Lentini drawing on what they believed to be large stocks of a non-FDA approved drug.

One of the employees contacted the Oregon Board of Medical Examiners and the FBI, triggering the investigation.

Copyright © 2005 The Seattle Times Company

July 8, 2005
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