Thursday, July 17, 2003

Supplement seller grilled in court

By Casey Laughman
The Associated Press

COLUMBUS - A poultry researcher and her doctor business partner did not claim their company's powdered egg yolks sold as an immune system booster were a drug, the doctor said Wednesday.

At the partners' trial, plastic surgeon Mitchell Kaminski testified that the eggs were never tested as a drug in a formal study, which would have required approval from the federal government. The eggs had been marketed as a food supplement, he said.

Federal prosecutors say Kaminski, of Niles, Ill., and Marilyn Coleman, of Richwood, falsely told people that their product had federal approval and could help the immune system. A federal grand jury indicted the pair and their company, OvImmune Inc., on 23 counts last August, including conspiracy to commit mail fraud and distribution of an unapproved and misbranded drug with intent to defraud.

Coleman said Wednesday during a break in testimony at U.S. District Court that she did not plan to testify. Lawyers said they expected closing arguments today.

Prosecutor Deborah Solove questioned Kaminski about a written statement by him that the eggs helped a man overcome his tuberculosis and regain his appetite. Kaminski said the claim was about one case, which did not amount to a study.

"Speaking as someone who does studies, one of anything is next to nothing," he said.

Kaminski said he should not have included the isolated case in information about the eggs, which came from chickens injected with antibodies.

"We stretched it a bit," he said. "The patient went on to gain 30 pounds and did quite well. I probably shouldn't have put that in there, but scientifically it's a curiosity."

By law, a food supplement becomes a drug when it is advertised as treating a disease and must go through the rigorous drug approval process.

Kaminski said his role in OvImmune Inc. was ceremonial and he did not draw a salary. When shown a check for $10,000 from OvImmune to him, Kaminski said it was for expenses.

Solove has said the defendants told people the egg powders could cure and prevent disease, including treating yeast infections, autism, cancer, chronic fatigue syndrome and AIDS.

Cassandra Lira testified Wednesday that she bought some egg powder from Coleman and it helped improve the memory and responsiveness of her husband who had Alzheimer's disease.

"I could go to the store, and he would remember where I was," Lira said. "I could go out back to the garden, and he would recall where I was."

His memory worsened when he stopped using the egg powder, Lira said. The Food and Drug Administration ordered OvImmune to stop selling the powder last year.

The indictment charges Coleman with selling plastic bags of the pale yellow powder to undercover officers. One bought $200 worth for his rheumatoid arthritis and the other $25 worth to treat his wife's toenail fungus.

Coleman, 57, and Kaminski formed OvImmune in 1993. She has said she sought legal advice from the FDA on what she needed to do legally to market her product. After receiving no response, she relied on a 1998 letter from the U.S. Department of Agriculture that the egg powder was a nutritional supplement, not a drug.

She started researching egg antibodies while an assistant professor of poultry science at Ohio State University from 1977 to 1982.

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