Investigators' Reports

Paroled Clinic Operator
Sentenced on New Charges

After a 10-day jury trial, a Diamondhead, Miss., man and his wife were found guilty of conspiracy and wire fraud in their operation of a clinic that dispensed unapproved treatments for people with AIDS and other serious illnesses.

James Oral Boyce, 59, was sentenced last July 26 to five years of imprisonment for each of nine counts, which will run concurrently. He also must serve three years of supervised probation after release and pay $113,243.25 in restitution to victims and family members. He is barred from having interest in any medical venture in the future.

At sentencing, Boyce already was serving a five-year term in a Mississippi state prison for violating probation, following a 1991 guilty plea of prescription forgery and drug possession with intent to distribute. He must finish this term before beginning the federal sentence.

Margaret Boyce, 51, received 24 months probation for each of two counts, also to run concurrently. She must pay $8,800 restitution to victims and family members, and is under home detention with electronic monitoring for six months at a cost to her of $4.99 a day. She also must perform 200 hours of community service.

James Boyce formed Natural Options Inc. at his Diamondhead home in 1990. Ostensibly, the business was for growing and selling tomatoes. But Boyce also sold an unapproved oral drug he called HAD-A-PAIN, a form of dimethylsulfoxide (DMSO), which has been approved only for external use in a horse liniment and for intravenous treatment of interstitial cystitis in humans.

In November 1992, after FDA's Minneapolis district office reported seeing a magazine ad touting HAD-A-PAIN, an investigator in the agency's Gulfport, Miss., resident post visited Boyce's operation. Boyce told FDA he had stopped selling the drug because of poor sales. He also claimed he was a medical doctor.

In July 1993, Mississippi state officials notified FDA that they suspected Boyce was running a clinic that used unapproved devices, drugs, and therapies. That same month, FDA began investigating the clinic. "We found that Boyce was claiming to cure AIDS, cancer, multiple sclerosis, arthritis, and other serious diseases," says James Blakely, the Gulfport investigator.

In the clinic, which Boyce operated from July 1992 to August 1993, were unapproved intravenous hydrogen peroxide injections, chelation therapy, and drugs smuggled from Germany and Mexico. One drug used was Carnivora, made from the juice of Venus' flytrap plants. Sold over the counter in Germany, Carnivora is illegal in this country. The clinic also had an ozone generator machine, used to introduce toxic ozone gas through a vein or rectally. The gas, which has no known therapeutic value, can prompt an embolism, or obstruction of a blood vessel.

Boyce never advertised the clinic, which at various times was known as B. Boyce Clinic Inc., Natural Options Inc., and Hyperbaric Manufacturing Co. Patients typically were desperately ill, seeking an alternative to conventional treatment. They found the clinic by word-of-mouth or through referrals from alternative-medicine practitioners. Interviews with employees, clients and patients, along with information from seized records, indicated that during the year the clinic was open, Boyce charged patients a total of almost $500,000. One patient from Australia paid $30,428 for 36 treatments. Patients often paid through wire transfer of funds to Boyce's account.

In February 1993, Boyce hired a local physician, Sidney Wong, M.D., as a consultant to add legitimacy to the clinic. Wong administered an initial exam to selected patients at Boyce's direction for a flat $300 fee and didn't see patients again. Boyce then took over treatment. (In December 1993, Mississippi suspended Wong's medical license for his involvement but has since reinstated him.)

In August 1993, an FDA special agent called the clinic asking questions under the guise of someone seeking help for her sick brother. Boyce told the agent the clinic used ozone treatments, various European enzymes (such as Carnivora), and hydrogen peroxide intravenous drips. Also used was a diapulse machine, a radio-wave generating machine that emits radio frequencies touted to treat various maladies. All Boyce's methods, drugs and devices violated the federal Food, Drug, and Cosmetic Act and other U.S. laws, as well as Mississippi state law.

When the FDA agent visited the clinic, Boyce said treatment would cost $2,500 a week, with an additional $2,500 for enzyme treatment.

On Aug. 24, 1993, officials from FDA, U.S. Customs, and the state of Mississippi executed search warrants on Boyce's offices and home. Among items seized were a diapulse machine; about $10,000 worth of smuggled and unapproved drugs; roughly $50,000 worth of prescription drugs and devices; and patient and business records. Narcotics agents also arrested Boyce for violating his earlier parole.

Through the entire clinic enterprise, Margaret Boyce abetted her husband in his criminal activities and committed numerous federal violations.

John Henkel is a staff writer for FDA Consumer.

'Jogging' Drink Seized, Destroyed

But the government didn't buy it. By law, the product--a mixture of grape and apple juices and vinegar called Jogging in a Jug--was considered an unapproved new drug due to claims McWilliams, 64, made for it. Last July 18, FDA officials supervised the disposal of 13,320 half-gallon bottles of the juice, valued at $77,000. The federal government had seized the product on May 19, 1994, because of its unproven drug claims.

McWilliams, his son, Danny, and their firm, Third Option Laboratories of Muscle Shoals, Ala., signed a consent decree last May 17 in the U.S. District Court for the Northern District of Alabama. Under the terms of the decree, Third Option must alert its retail distributors of the court findings, including notification that the product cannot be "promoted, labeled, or advertised" in a way that makes unsubstantiated health claims.

The Federal Trade Commission, in a separate action, fined Third Option $480,000 after charging the firm with making false health claims. FTC also required Third Option to send all consumers who bought the product a letter informing them of the charges.

FDA first became aware of Jogging in a Jug shortly after the product debuted in the early 1990s. The agency received complaints about the product's claims from state regulatory agencies, local government officials, and consumers.

One of the company's main marketing strategies was to promote the product through the news media. McWilliams received coverage in newspapers and broadcast outlets.

"He would go into an area--usually a small community--and actually get the press' attention by holding a news conference touting an amazing new discovery," says Ray McCullough, a compliance officer in FDA's Nashville district office. "Then, instead of an ad in the inside pages, he'd end up with something better--a front-page article."

News stories about McWilliams, a dairy farmer, typically told of his discovery that vinegar had reduced pain and symptoms of his own heart disease and arthritis. He said taking vinegar could reduce the risk of cancer in the internal organs. He suggested that 2 ounces of his product a day could confer the same benefits.

Press accounts said that members of the last two generations of McWilliams' family had used vinegar regularly and lived into their 90s. In one article, McWilliams said that when pregnant women crave pickles, they really are craving acetic acid, the main ingredient in vinegar. McWilliams then used these press clippings as promotional literature.

In a warning letter dated March 27, 1992, FDA advised Third Option that marketing the drink accompanied by articles containing therapeutic claims violated food and drug law. Company representatives met with FDA in April 1992 and agreed to stop making the claims. But over the following months, FDA determined through complaints and reports that Third Option still was making unlawful claims. On May 19, 1994, federal marshals seized 13,320 bottles of the product, which remained stored for a year while FDA and the firm negotiated a consent decree.

Third Option Laboratories is still in business and is working with FDA on ways to market Jogging in a Jug legally.

--John Henkel

California Business Fined for Illegal Drug Use and Sales

U.S. Magistrate Judge Dennis Beck of the U.S. District Court for the Eastern District of California fined Calftech Corp. of Tipton, Calif., $70,000 and its owner and president, Ted Greidanus, $10,000 on Sept. 20, 1994. The company and Greidanus had pleaded guilty May 19, 1993, to charges of using gentamicin, an antibiotic that has not been approved for use in animals, to treat calves and to charges of selling two unapproved veterinary drugs to area ranchers.

The company raised 15,000 to 20,000 calves and sold them to veal producers.

Calftech's and Greidanus' sentencing brings to 60 the number of people and companies sentenced so far in an eight-year FDA investigation of smugglers, distributors and users of illegal animal drugs. A special unit of FDA, the National Animal Drug Investigation, traced the drugs' entry into the United States to a New York firm that imported them from Europe and China into Canada, from where they were smuggled into Iowa and across the United States.

FDA identified Greidanus and his company as users and sellers of illegal drugs through an investigation of a major animal drug dealer, Irving Rossoff, D.V.M., of Illinois Antibiotics, Taylorville, Ill., in the early 1990s. Rossoff was tried twice; both trials resulted in hung juries.

By examining bank transactions, hotel receipts, telephone records, car rental documents, and other various records and through interviews with numerous people, including others who participated in the scheme, the National Animal Drug Investigation team pieced together evidence showing that Greidanus was present at the time previously identified illegal drug transactions were going on.

FDA also learned that Greidanus concocted mixtures of various antibiotics, marked them only as "white meds" and otherwise packaged them without the required labeling information (such as directions for use and recommended doses), and sold them to ranchers.

Unapproved drugs such as gentamicin pose a threat to an animal's health because their safety and effectiveness have not been scientifically proven. They also may endanger humans if they leave cancer-causing or otherwise toxic drug residues in meat, milk or eggs from feed animals.

FDA has had no reports of injuries from people who ate meat or milk from animals treated with the gentamicin.

--Paula Kurtzweil