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Kenneth R. Thiefault and his wife, Mardel Barber, formerly of Jupiter, Florida, were sentenced in the U.S. District Court for the Southern District of Florida in March to prison terms that together total more than eight years and fines that add up to more than $100,000. They illegally distributed ozone generators, devices that turn oxygen into ozone, by claiming that the devices could cure a variety of diseases, including cancer and AIDS. FDA has never approved ozone generators or ozone gas for treating any medical conditions. .
They continued to sell the unapproved medical devices, even after FDA informed them several times that FDA approval was necessary to market medical devices or medical gas in this country. This would require the submission of scientific data to support the devices' safety and effectiveness.
Proponents of medical ozone generators believe ozone can kill viruses and bacteria in the body. While ozone is used as a germicide in the cleaning of manufacturing equipment, FDA is not aware of any scientific data that supports the safety or effectiveness of ozone generators for treating medical conditions. In fact, the agency believes that at the levels needed to work effectively as a germicide, ozone could be detrimental to human health.
"These devices keep popping up," says Bob Gatling, a biomedical engineer and director of the program operations staff in FDA's Center for Devices and Radiological Health. "We always tell their makers": 'Show us some data,' but no one ever pursues it."
FDA's knowledge of Thiefault's involvement in ozone generators dates to at least 1990, when Thiefault was interviewed during an FDA criminal investigation of one of Thiefault's associates. This associate was later prosecuted and imprisoned for, among other things, manufacturing and selling ozone generators for treating medical conditions. After release from prison, he returned to making and distributing ozone generators for treating medical conditions but fled the country before he could be prosecuted again.
In April 1990 and January 1991, Thiefault acknowledged in an FDA-obtained written affidavit that medical ozone generators needed to be approved by FDA before they could be marketed. He also- wrote that his interest in ozone generators was limited to ozone's "antiviral and antibacterial capabilities in relationship to water for dairy cows, swimming pools and spas."
Thiefault's activities came to FDA's attention again, in January 1993, when officials with Florida's Comptroller's Office shared evidence they obtained during a state securities fraud investigation of Thiefault with FDA's Office of Criminal Investigations (OCI). State investigators found that one room in Thiefault's former Lake Park, Fla., home served as a medical treatment center, housing a variety of devices, including a frequency generator on which various frequencies were labeled with the names of diseases. At the high end of the frequencies was "AIDS," followed in descending order by "cancer," "syphilis" and "constipation." This evidence suggested that the business Thiefault operated out of his home, Kanzyme Laboratories, was an unlicensed medical practice.
In early 1993, OCI special agents began to collect evidence, and in July, OCI executed a search warrant at Thiefault's Lake Park home, seizing various records and documents and the generators themselves. With these pieces of evidence, OCI agents learned that:
In addition, OCI special agents learned that since 1988, Thiefault also had been selling illegal drug products called K Z Enzyme, Kanzyme, and Kanzyme II. These products have never been approved by FDA for treating any diseases.
As he, did with the ozone generators, Thiefault touted K Z Enzyme and Kanzyme as cures for many diseases. According to promotional literature and Thiefault, the products were plant extracts. FDA laboratory analysis showed that each product contained about 10% dissolved substances, such as sugars, amino acids, acetic acid, chloride, phosphate, sulfate, and nitrate. The rest was a combination of water and alcohol.
Kanzyme II was colloidal silver, also an unapproved drug. Thiefault promoted and sold it as an accompaniment to ozone therapy for treating cancer. Product literature claimed the product replaced the body's store of silver, a substance lacking in cancer patients. However, FDA is not aware of any scientific studies that support this claim.
OCI's investigation, complemented by a multi-year IRS investigation, led in 1998 to a seven-count indictment against Thiefault and Barber. FDA-related charges focused on the couple's involvement with ozone generators and not the unapproved drugs because the devices appeared to be their main business thrust-and source of income, according to OCI.
Following a two-week trial, in November 1998, a federal jury found Thiefault and Barber guilty of mail fraud, wire fraud, and distribution of an ozone generator. They also were found guilty on one count of impeding the IRS. For illegally selling ozone generators, Thiefault was sentenced to six and a half years in prison, fined $100,000, and ordered to pay $14,400 in restitution. His wife was sentenced to two years and nine months in prison and fined $60,000. The pair were also were ordered to help the IRS compute their back taxes and pay the money due. The judge also banned both from dealing in securities, telemarketing, direct mailings, and nationwide advertising. Thiefault is now in federal prison in Minnesota. His wife is in federal prison in California. Following their prison terms, they also will serve three years of supervised release.
Paula Kurtzweil is a member of FDA's public affairs staff. This article was published in slightly different form in the November-December issue of FDA Consumer.
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