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'Career criminal' faces jail and possible deportation - Basil Wainwright convicted of selling unapproved ozone-generating devices as disease cures

FDA Consumer, Sept, 1994 by Dixie Farley

After an investigation by four FDA district offices, the mastermind of a medical fraud was sentenced to 37 months in a federal prison for selling unapproved ozone generators as a cure for serious illnesses such as cancer and AIDS. The scheme's four conspirators, British citizens, swindled investors and desperate patients out of hundreds of thousands of dollars. At least three patients who bought the "cure" died.

U.S. District Judge Ursula Ungarro-Benages, of the Southern District of Florida, Miami, sentenced Basil Earle Wainwright March 1, 1994. Wainwright had pleaded guilty Sept. 13, 1993, while in jail on state charges, to eight felony counts of distributing adulterated and misbranded ozone generators. His nowdefunct firms included Anglo-American Research, Inc., in Tecate, Calif., and Fort Lauderdale, Fla., and Decadata Research Inc., in Tucson, Ariz.

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Shortly after the four were indicted in the spring of 1991, defendants Edward Frizzell and George Mills fled to England, while David Geary went into hiding and continued making generators until his arrest five months later. Geary pleaded guilty Oct. 20, 1992, served a 27-month sentence, and was deported to England, where he was immediately arrested on an outstanding British warrant for car theft.

FDA Orlando district compliance officer Ken Hester described Wainwright as a "career criminal, who has spent almost his entire adult life perpetrating frauds and left a trail of human misery in his wake."

Ozone is a toxic form of oxygen gas with no accepted medical uses in the United States. FDA considers ozone to be an unapproved drug and Wainwright's generators that produce ozone to be unapproved medical devices. The devices were promoted to individuals to self-administer ozone through the rectum or vagina, or were used to treat the patient's drawn blood with the gas before reinfusion.

According to FDA scientists Kenneth Hastings, Dr.P.H., Gerald Sokol, M.D., and Donna Freeman, M.D., in the agency's Center for Drug Evaluation and Research, ozone reacts with the body to cause several potential ill effects. These include damage to the immune system and potentially damaging irritation of tissues lining the respiratory tract, and possibly the vagina and rectum.

Reinfusing a patient's ozone-treated drawn blood may cause bloodstream infection if sterile procedures are not followed. There also is concern, Hastings says, that the ozone used to treat the blood can damage the red cells. "Putting damaged red cells into the patient's bloodstream," he says, "could cause serious health effects, including kidney damage and anemia."

FDA's Los Angeles district first inspected Decadata on May 23, 1988. During the inspection, investigator Andrew Bonanno (now with the agency's Chicago field office) was told that Wainwright and his associate, Frizzell, no longer planned to make the devices because an agreement to make them for Wainwright's previous employer had fallen apart.

In November, however, FDA received a trade complaint that Decadata was marketing generators. On Dec. 14 to 20, Bonanno revisited the firm with fellow investigator Armando Chavez.

"Frizzell told us they had used the device prototype in a clinical AIDS trial in Mexico," Bonanno says, "and that the six units being manufactured at the firm were slated for a clinical trial at St. Michael's Medical Center, in Newark, N.J. I warned him that human testing requires FDA approval."

There was no evidence of commercial marketing at this point, Bonanno says, but during the inspection visits, he and Chavez warned the firm several times about FDA requirements.

In a letter to Decadata dated March 2, 1989, FDA stated that agency files showed no Decadata registration or listing of the prototype, as required. FDA warned that exporting unapproved devices for clinical studies was illegal and that U.S. studies must meet certain rules, such as supervision by an Institutional Review Board.

That summer, William Berbaum, of FDA's Newark district, and Antoine El Hage, Ph.D., of the agency's division for scientific investigations, inspected St. Michael's. El Hage told the researcher, George Perez, M.D., it was illegal to treat patients with ozone generators without FDA approval.

In a letter to Perez dated Oct. 5, 1989, the agency stated that his unapproved study was illegal and that he was disqualified from doing future studies. Perez signed a statement agreeing the trial was inappropriate, the treatment was ineffective for AIDS, and he was ineligible to conduct studies.

Meanwhile, in August, Robert Rast, AIDS coordinator for FDA's Los Angeles district, was asked to meet with Alvin Bojar, who represented a group of New Jersey investors.

"Bojar told me," Rast says, "that Wainwright had swindled the group out of $500,000 for and AIDS clinic in Tecate, Mexico, that never materialized."

Wainwright had closed Decadata in Tucson, Bojar told Rast, to open Anglo-American Research in Tecate, Calif., across the border from Mexico. On Oct. 31, 1989, Rast tried to inspect the new firm in the new location, but discovered it had been vacated in August.

'Career criminal' faces jail and possible deportation - Basil Wainwright convicted of selling unapproved ozone-generating devices as disease cures

FDA Consumer, Sept, 1994 by Dixie Farley

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