Posted by Roger Hartner on December 05, 2002 at 22:50:37:
EGG POWDER KEY INGREDIENT IN LEGAL FIGHT
Supplement was illegally marketed as drug, FDA says
Monday, November 11, 2002
NEWS 01A
By David Lore
THE COLUMBUS DISPATCH
Illustration: Photo, MAP
A case history
* 1993: Former Ohio State poultry scientist Marilyn Coleman incorporates OvImmune Co. to develop egg-yolk antibodies to strengthen the immune system in animals and humans.
* 1997: Coleman enters into discussions with For Your Health, a Seattle distributor, to market an OvImmune egg-yolk supplement to treat candidiasis
infections.
* 1998: OvImmune's claim of product safety is accepted by the U.S. Department of Agriculture. Coleman says the U.S. Food & Drug Administration also provided a verbal OK.
* March 2001: FDA agents visit Coleman at her farm after the agency receives complaints about eggs being offered to schools and neighbors.
* May 2001: FDA investigators in Seattle investigate health claims of For Your Health, an OvImmune distributor.
* July 10, 2001: Coleman's attorneys write the first of three warning letters to For Your Health objecting to misleading advertising.
* July 23, 2001: An undercover FDA investigator buys $225 worth of egg powders from Coleman and reports finding moldy and rotten eggs in her basement.
* July 24, 2001: The FDA warns Coleman by letter that OvImmune is making claims for an unlicensed drug, giving her 15 days to respond. Coleman says she didn't get the letter until Aug. 4.
* July 31, 2001: Eight FDA investigators conduct a
nine-hour search-and-seizure raid at Coleman's farm, carrying off records, computer disks, egg samples and some household items.
* Oct. 19, 2001: OvImmune officially notifies the FDA of intent to market egg powders as a dietary supplement, not a drug.
* Dec. 26, 2001: U.S. District Court Judge James L. Graham denies Coleman's bid to reclaim her property, but approves the return of copies.
* July 30, 2002: Raymond Suen, president of For Your Health, pleads guilty to one count of fraud in federal court.
* July 31, 2002: A federal grand jury indicts Coleman and Dr. Mitchell Kaminski, her Chicago business partner, on 26 counts, including adulteration and misbranding of an unapproved drug. Trial is set for Dec. 9 in U.S. District Court.
Sources: interviews, court filings, U.S. Food and Drug Administration
RICHWOOD, Ohio -- Early one summer morning a convoy of government cars churned up the long gravel lane to Marilyn Coleman's remote Union County farmhouse in search of illegal egg potions.
It was July 31, 2001, and Coleman met her visitors at the garage door, cradling one of her cats, a gray named Smokey.
According to Coleman, Douglas Loveland, the lead investigator for the U.S. Food and Drug Administration, pulled back his coat to show a gun and immediately ordered her to drop her weapon -- apparently meaning Smokey.
Then Loveland's team of eight agents, acting under authority of a federal search warrant, swarmed through the farmhouse for nine hours, filling boxes with Coleman's business records, computer disks, egg-product samples and other items.
"They even took away my rolling pin,'' she said.
Coleman calls the morning of the raid "the beginning of a terrible nightmare. They indicated I was some sort of witch in the backwoods, making up terrible brews for children.''
Federal authorities later charged that Coleman was illegally marketing her patented egg powder as a drug that could cure physical ailments.
Coleman, 56, a former assistant professor of poultry science at Ohio State University, maintains that her "hyperimmunized'' egg yolk products are a "food'' -- not a drug -- but with enhanced antibodies to protect people from disease.
On the one-year anniversary of the raid, a federal grand jury in Columbus released a 26-count criminal indictment against Coleman and Dr. Mitchell Kaminski of Chicago, partners in OvImmune Co.
According to prosecutors, Coleman and Kaminski's fledgling egg business could land them in jail for years and expose them to millions in fines.
Chicago lawyer George Burditt, 80, has spent a half-century defending clients in similar cases. But Burditt, who represented Coleman before her case was switched to a Columbus lawyer, said he was shocked when he heard about this prosecution.
"I don't believe I've ever seen the FDA come down with a hammer like this, and I've been defending these kind of cases for 50 years,'' Burditt said.
Loveland declined an interview, but an FDA supervisor said investigators are authorized to carry weapons. He maintained there was nothing extraordinary about that search.
Coleman and Kaminski are scheduled to go on trial Dec. 9 in U.S. District Court in Columbus, although postponements are likely.
Food or drug?
Eggs are about as natural as you can get, known for their nutritional value. For years, yolks with natural antibodies have been used to strengthen the immune system against disease in animals.
So why wouldn't that work in humans?
"Chicken eggs, we now know, contain high levels of antibodies against the common pathogens and disease-causing 'bugs' that the mother chickens are continually exposed to in the barnyard,'' said an advertisement last year for OvImmune's CandidaTx, an egg-powder "breakthrough technology for the effective treatment of chronic candidiasis infections.''
Candida albicans is a yeast-like fungal organism that can cause vaginal or skin infections.
Until the FDA intervened, CandidaTx was sold on the Internet by a Seattle distributor, For Your Health. The Seattle venture was a first attempt by Coleman and her partner to market "hyperimmunized'' egg products -- yolks from chickens vaccinated with specific disease antigens to trigger the production of protective antibodies.
"The OvImmune products are simply dried eggs with an assured level of Candida or Chlamydia antibodies,'' said OvImmune in court filings. "The eggs are laid by the hen, collected, opened, pasteurized, dried and pasteurized again. Nothing whatsoever is added to the eggs.''
According to the FDA, however, what OvImmune was attempting to sell were adulterated drugs produced under unsanitary conditions without adequate testing and approvals.
Specifically, says the agency, Coleman and her partners were claiming that hyperimmunized egg powder effectively treats a variety of human diseases and conditions, including cancer, Alzheimer's, fibromyalgia, chronic fatigue syndrome and attention deficit disorder.
And there lies the crux of the case: Are hyperimmunized eggs a food, a drug or both?
Coleman said she never promoted her products as drugs and she sought to keep For Your Health from making curative claims.
"Since 1992, we had asked FDA what to do'' to market these eggs as food supplements, Coleman said. "They always said it's OK as food, just don't make claims.''
As a food supplement, the eggs would have been held to a far less stringent standard under FDA regulations.
Immunity boosters?
The use of hyperimmunized eggs was pioneered in the early 1980s by the late Ralph Stolle of Lebanon, Ohio, inventor of the pop-top beverage can and a pioneer researcher in the use of dairy products to strengthen the immune system.
Stolle's patents were licensed to DCV Inc. of Wilmington, Del., which now sells a hyperimmunized egg product called BioChoice Immune26.
The company -- without any objections from the FDA -- makes general claims that the product maintains the body in a healthy condition while increasing energy levels. But the FDA has been satisfied DCV doesn't advertise cures for specific diseases.
Coleman patented her own process for making hyperimmunized eggs and launched OvImmune in 1993.
Though Stolle's original patent was for an egg product to help protect the digestive system from infection, Coleman said her "miracle egg'' would help the whole body fight off disease by strengthening the immune system.
"As early as 1991, Dr. Coleman was seeking answers from FDA and USDA (the U.S. Department of Agriculture) on how she could legally bring her eggs to market,'' her brief states.
Assuming she could market the egg powders as food supplements, Coleman in 1997 agreed to provide For Your Health with up to 6,600 pounds of the product each month for sale on the Internet.
Today she complains the Seattle distributor never purchased the agreed quantities or paid for all they got.
Coleman said her attorneys sent several letters warning For Your Health about excessive medical claims being made of the egg potions.
"We got in bed with the wrong people,'' Coleman said.
Ray Suen, owner of For Your Health, wouldn't discuss the dispute other than to say "her information is wrong -- it's much more complex than that. She did a lot of things without my knowledge.''
Suen pleaded guilty July 30 to one count of fraud in connection with the egg-powder investigation. Sentencing in federal court in Columbus is pending.
It was the For Your Health advertisements, as well as complaints by school officials in Union County, that touched off Loveland's investigation of Coleman.
Finding takers
Hoping to substantiate that hyperimmunized eggs would help students with attention deficit disorder, Coleman had contacted the North Union School District in Richwood about using the antibody-enriched eggs in the school-lunch program.
Coleman had 10,000 hens laying eggs at a Mercer County farm, but her Seattle distributor wasn't taking the product as promised.
As a result, she said, she gave away 60,000 eggs free to anyone who asked and urged local schools and neighbors to try the product. The complaints prompted an undercover FDA agent to visit Coleman's farm in Union County, claiming to need a remedy for his wife's toenail fungus. The agent, after buying $225 worth of bags of egg powder for the fungus and for rheumatoid arthritis, looked around and reported moldy and rotten eggs in the basement of the house, the basis for the adulteration charges.
On July 24, 2001, the FDA sent Coleman a warning letter telling her to stop making curative claims for an unlicensed drug.
The warning letter gave her 15 days to respond. But Coleman said it was addressed to Coleman's former residence in Upper Arlington and did not arrive at the farm in Union County until Aug. 4, four days after Loveland's search party showed up on her door step.
In a Dec. 26 ruling, U.S. District Court Judge James L. Graham said, "The record fails to show that the government has displayed a callous disregard for OvImmune's constitutional rights.''
A miracle cure?
In the spring of 2001, Jeffrey Fedorko, then president of the Ohio Chiropractic Association, was asked by Coleman about the possibility of trying out her eggs on patients with fibromyalgia, a muscle ailment frequently treated by chiropractors.
"Everybody's got a cure for fibromyalgia, and I do what we all do when I get such proposals -- throw them in the trash,'' Fedorko said.
"But in this case, this was someone with an M.D. and a Ph.D. And I grew up on a farm, so this sounded feasible.''
Unlike Kaminski, Coleman is not a medical doctor, although Fedorko and his patients assumed otherwise. Fedorko had been treating more than 35 patients for fibromyalgia with vitamins, diet and lifestyle changes, and stress-reduction techniques. So he invited Coleman to Canton to offer his patients a new blend of the egg powder with antibodies for fibromyalgia.
"If it was a drug, with my exposure as president of the Ohio Chiropractic Association, I wouldn't have touched it,'' he said. "But who would consider eggs to be a drug?''
A half-dozen of his fibromyalgia patients, interviewed by The Dispatch, said Coleman's powder relieved many of their symptoms, including back pain, muscle fatigue, headaches, memory loss and confusion.
Kathy Miller of Canton said the six-month supply of the egg powder she purchased for $100 worked for her.
"It was wonderful. It was a gradual change, but one day I realized I'm not hurting as I was. I could lift my grandchildren again.''
Cindy Johnson of Navarre, an adjunct science instructor at Malone College in Canton, said she had "one bad weekend'' after first taking the powder.
She ascribed the "flu-like symptoms'' to her body ridding itself of toxins.
"I'm skeptical of all claims, but this was the real deal,'' Johnson said of the egg powder.
The patients said the powder relieved a variety of symptoms, including back and joint pain, muscle fatigue, memory loss and confusion.
But the FDA investigation of OvImmune cut short their egg powder supply last fall. Today, the patients express fears their symptoms will return.
Fedorko said he can't understand why the FDA didn't try to work with Coleman to correct the problems, rather than just shut her down.
"I don't care if it's old dead mushrooms; if it works, use it,'' he said.
Sales halted
Coleman's "miracle egg'' won't be available any time soon.
Lacking the money to keep feeding her brood, Coleman said she disposed of her 10,000 chickens in August to a Canadian soup company at a loss of at least $30,000.
About 50 tons of her CandidaTx egg powder remain in storage but can't be sold or distributed.
"I can't get work . . . so we have no way to make money,'' Coleman said.
She said that she and her husband, George, have already spent $500,000 on attorneys.
Lee Beck said he thinks the FDA is trying to make an example of Coleman and OvImmune. Beck is president of Stolle Research and Development Co. in Cincinnati, and co-inventor with Stolle of the original egg-powder patent.
Beck thinks the prosecution is to clarify what the FDA can regulate and what it can't.
"These guys were stepping over the line so they're putting out the message they won't tolerate that,'' he said. "But it's a weak case since there are no safety issues involved here. It's such a small business, that if they left her alone it would have been no big deal.''