COLUMBUS, Ohio - The U.S. Food and Drug Administration has accused a biotech company of selling unapproved drugs in the form of eggs containing antibodies produced from vaccinated hens.
A federal grand jury in Columbus is investigating OvImmune Inc. after the FDA accused the company of developing and selling unlicensed drugs and vaccines for diseases including AIDS, pneumonia and yeast infections.
Company president Marilyn Coleman said antibodies in the eggs could boost the immune systems of people who ate them.
"The eggs are not drugs; they are dietary supplements," said Coleman, an assistant professor at Ohio State University from 1976 to 1980. "The chickens are vaccinated like all chickens. All you do is dry the eggs and sell the powder. There's nothing added to the eggs," she said.
The FDA said the company, headquartered at a farmhouse in Richwood, about 35 miles northwest of Columbus, sold its egg products across the nation over the Internet.
The agency said the company described the eggs as "magic bullets … to target and destroy unwanted biologic entities such as cancer." The Web site is no longer operating.
The FDA said the company also sought to use Richwood residents in unauthorized medical experiments.
It said in court documents that Coleman approached the nurse of the North Union County School District last year seeking permission to serve the eggs to schoolchildren.
Coleman wanted to monitor students, according to an FDA search warrant. Sally Wiley, the school nurse, alerted federal authorities.
Coleman said Monday she had considered giving surplus eggs to the school because it would cost too much to dry and store them.
"I thought we could give the eggs to the kids and let some have cereal and others have eggs and see which one helped them the most," she said. "But the FDA told me, 'If you do an experiment, we will call it a drug.' "
She said she instead gave away the 60,000 eggs to people in Richwood between March and August. She said some people called to say eating the eggs helped them, but that the company didn't keep records of people who took the eggs or called.
The government also contends that in March 2001 the company conducted a seminar for about 40 people where it distributed a medical consent form for an experiment with the eggs. OvImmune's lawyers denied the contention.
On July 31, eight federal agents raided Coleman's farmhouse and seized four boxes of documents, plus notebooks and computer records. A large number of eggs were destroyed, and others were placed under quarantine.
In December, OvImmune went to court to get back its records and argued that the FDA's search warrant contained false information about the company.
"The FDA tried to tell the judge that chickens don't get vaccinated and chicken eggs don't have antibodies naturally," Coleman said.
In February, the company filed a $15 million slander and libel suit against Wiley, the school nurse.
Assistant U.S. Attorney Mark T. D'Alessandro said the suit was an attempt to intimidate a federal witness, and got a restraining order prohibiting OvImmune from contacting Wiley.
The grand jury is expected to hold a hearing sometime before April 30.
An FDA spokeswoman declined to comment on the case Monday.
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