April 1, 2002 at 6:14 PM EST - Updated June 29 at 9:00 PM
CLEVELAND (AP) - A biotech company in rural central Ohio is accused of selling eggs from vaccinated hens as drugs.
A federal grand jury in Columbus is investigating OvImmune Inc., a company started a few years ago by a Chicago physician and a former Ohio State University professor.
"Really, it's not much more than a farmhouse," Jim Thompson, the village zoning inspector, said of the company's headquarters in Richwood, about 35 miles northwest of Columbus. "People say it's supposed to be some kind of research place, but exactly what it is, I've not been able to find out."
Court records show that the criminal investigation focuses on allegations by the Food and Drug Administration that OvImmune developed and sold unlicensed drugs and vaccines for diseases ranging from AIDS to pneumonia and yeast infections.
The drugs were eggs gathered from vaccinated hens, according to the FDA. The resulting antibodies supposedly could boost the immune systems of people who ingest them, The Plain Dealer reported.
However, in court documents, the FDA said that antibodies in egg yolks are destroyed by cooking eggs and digesting them.
The company replied that the FDA is wrong, citing research concluding that the amount of antibodies may be reduced but that enough remain to assist the immune system.
The FDA said the company had peddled its egg products across the nation via the Internet and described them as "magic bullets ... to target and destroy unwanted biologic entities such as cancer."
George M. Burditt, the company's Chicago lawyer, accused the FDA of acting as if it had found Frankenstein's laboratory hidden in backwoods Ohio.
"The chickens are vaccinated like all chickens. All you do is crack the eggs, dry 'em and sell the powder. There's absolutely nothing added to the eggs," Burditt told The Plain Dealer. "Our position is that the eggs are not a drug, they're a dietary supplement."
A little over a year ago, Marilyn Coleman, an Ohio State assistant professor from 1976 to 1980, approached the nurse for the nearby North Union County School District for permission to serve the eggs to schoolchildren.
Coleman wanted to monitor the students, according to an FDA search warrant.
As Easter 2001 approached, Coleman held a seminar for about 40 people in the Richwood Church of Christ, the FDA said.
The government contended that a medical consent form was distributed during the church seminar last March 31 that asked people to sign up for an experiment using the eggs. OvImmune's lawyers said the form was not passed out during the seminar.
Sally Wiley, the school nurse, contacted federal authorities. Douglas Loveland, a senior criminal investigator at the FDA's Washington headquarters, got a search warrant after telling a federal judge that he suspected OvImmune of distributing unapproved drugs in interstate commerce.
According to court records, Loveland was investigating allegations that "eggs containing hyperimmune egg yolks" were being produced by Richwood's hens. He said OvImmune was suspected of giving false and misleading information to the FDA.
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 at a commercial egg farm in Zanesville.
Burditt said he has complained to the FDA that it has been overzealous.
"They haven't backed off an inch," he said.
(Copyright 2002 by The Associated Press. All Rights Reserved.)