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Special Message for Cancer Patients
A California doctor and his partner viewed their homemade cancer treatment as alternative medicine. But a judge declared it "snake oil."
FDA laboratory analysis indicated the treatment, called "Immunostim," contained substances found in common cleaning fluids, such as dish detergent and toilet bowl cleaner. Patients paid as much as $7,500 per treatment to have the product injected into their veins.
Lawrence Taylor, 72, has since had his medical license revoked by the Medical Board of California, and his partner, William Stacey, 48, is serving five years in the San Diego county jail for continuing to sell Immunostim in violation of his probation. The two men ran the Taylor-Stacey Center for Advanced Medicine in San Diego between 1993 and 1994. Both were sentenced in 1995: Stacey for selling an unapproved cancer treatment, and Taylor for a related but lesser offense, maintaining a public nuisance. Stacey was resentenced earlier this year.
Their illegal activity was uncovered in an investigation by FDA, the San Diego City Attorney's Office, the California Health Department, and the Medical Board of California. An anonymous caller first alerted FDA to Taylor and Stacey's use of Immunostim in early 1994. At about the same time, two TV reporters who had gone to the Taylor-Stacey clinic posing as relatives of AIDS patients sent a videotape of their investigation to the San Diego City Attorney's Office. The reporters, from the USA Network's "Case Closed" show, were following up on a viewer complaint about Stacey's previous activities in North Carolina. While there, he had treated AIDS patients with Immunostim.
A month later, on March 22, 1994, the San Diego City Attorney's Office filed criminal charges against Taylor and Stacey in San Diego Municipal Court. Two days later, city police arrested the two men, and, as allowed under state law, the Medical Board of California shut down the clinic.
That same day, with search warrants in hand, the group of local, state and federal investigators searched the clinic, as well as the two men's San Diego residences. The searches resulted in the seizure of five vials of Immunostim and various documents related to the product, including financial reports, patient records, and patient handbooks.
The Immunostim was sent to FDA's Forensic Chemistry Center in Cincinnati for analysis. The laboratory identified trisodium phosphate, sodium metasilicate, methyldodecylbenzyl trimethyl ammonium chloride, and trimethyl ammonium chloride as the ingredients. No active drug ingredient was present. The solution had an alkaline pH of 12.7.
Referring to the second edition of Comprehensive Review in Toxicology, laboratory scientists found that the substances they identified matched those found in disinfectants, toilet bowl cleaners, and automatic dishwasher detergents.
Investigators, including Will Brannon, a special agent with FDA's Office of Criminal Investigations, began interviewing Taylor's former patients and their family members. The patients had come from throughout the United States for treatment at Taylor's San Diego clinic.
From these interviews, investigators learned that many of Taylor's patients had gone through conventional medical therapies with little or no success and had subsequently been diagnosed with terminal diseases. Taylor and Stacey often told patients their treatment would cure them. Each treatment, administered for three to six hours four times a week over a three-week period, consisted of a small amount of Immunostim mixed with an approved intravenous (IV) solution infused into a vein.
Many of the patients' family members described the treatments as painful. One woman, whose 34-year-old husband was treated with Immunostim for lung cancer, recalled that during a second infusion, the IV solution "leaked into the tissue" of her husband's hand.
"Immediately he began experiencing excruciating, burning pain," she later wrote to the judge. "His pain intensified over the next several hours, necessitating massive quantities of pain medication with little relief." Several months later, she said, she rushed her husband to the hospital after administering Immunostim to him at home. An emergency room doctor prescribed injectable Demerol (meperidine), a narcotic analgesic. The patient continued to take Demerol at home and didn't regain use of his hand until almost a week later, the woman said.
Another woman, whose son underwent Immunostim therapy for brain cancer, recalled nights when her son was "full of pain." She attributed the pain to an "inflamed" infusion site. She recalled another cancer patient who laid on the floor during treatment because "he was in too much pain to sit."
Donald Stevenson, M.D., with the Scripps Clinic and Research Foundation in La Jolla, Calif., reviewed patient records and said in his report to the court that most patients treated with Immunostim experienced inflammation of veins used for infusion. This led to "painful swellings" and then complete closure of the veins, resulting in a hard knot where a vein had previously existed, the doctor wrote. Patients' family members who were interviewed by investigators recalled instances where clinic employees had difficulty finding usable veins. The mother of one patient recalled seeing another patient receiving the IV infusion through his toe because clinic personnel couldn't find another vein to use.
Many patients reported that they spent considerable money, sometimes their life savings, to receive the Immunostim therapy. Parents of one cancer patient said they paid $5,000 for 12 treatments. The woman whose husband suffered from lung cancer said they spent nearly $26,000 for three courses of treatment. According to the San Diego City Attorney's Office, Taylor and Stacey took in more than $670,000 from patients receiving Immunostim during the 18 months the clinic was open in San Diego.
Upon checking the men's backgrounds, investigators learned that Stacey, who referred to himself as a Ph.D. chemist, probably had "a high school education at most," said Tricia Johnson, the deputy city attorney who prosecuted the case. The universities he said he attended had no records of his having graduated, she said. Taylor was licensed as a general practitioner.
In a plea agreement, on May 12, 1995, Taylor and Stacey pleaded no contest to the criminal charges.
On Aug. 18, 1995, Municipal Court Judge H. Ronald Domnitz sentenced Taylor to a 150-day work-furlough facility with three years' probation, fined him $2,000, and ordered him to pay the cost of the government's investigation of the clinic. In addition, he ordered him, along with Stacey, to pay restitution of $46,779 to nine of 108 former patients or their families. By that time, more than half the patients had died, presumably from their diseases. The nine who received restitution were named in the complaint. The judge also ordered Taylor to place a sign in his medical office in letters at least 3 inches high with these words: "This office does not treat cancer or AIDS patients unless referred by another physician."
The judge sentenced Stacey Oct. 17, 1995, to 18 months in jail with five years' probation, fined him $3,000, and ordered him not to work in the health-care industry or sell any health-care product. Stacey failed to appear Oct. 31 to begin his jail sentence. An agent for Stacey's bondsman, whom Stacey failed to repay, tracked Stacey to South Carolina, where he apparently was still selling Immunostim. The agent notified local police, who arrested him. The San Diego City Attorney's Office extradited Stacey to California Dec. 21, 1995.
For violating his probation, the judge ordered Stacey last Feb. 29 to serve five years in custody, the maximum allowed under the plea agreement.
Meanwhile, on Feb. 19, the Medical Board of California revoked Taylor's medical license.
Paula Kurtzweil is a member of FDA's public affairs staff. This article is reprinted from FDA Consumer magazine.
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