Seizers Keepers, Criminals Weepers
Tamar NordenbergThe maker of unapproved new drugs promoted for the treatment of cancer, heart disease, diabetes, and other serious conditions lost its fight for the return of $600,000 worth of illegal products seized at FDA's request. In a March 1997 order, Judge Lloyd George of the U.S. District Court for the District of Nevada ruled that International Nutrition Inc. of Las Vegas was not entitled to the return of the products sold under the Hans Nieper label, even if the company intended to relabel the products and remove the unsupported drug claims. The judge agreed with FDA that the return of the goods would allow the company and its president, Gene Sylvester Oden, to profit from their past illegal activities.
International Nutrition and Oden said they wanted the products back so they could relabel them and sell them as dietary supplements. But FDA stated in its brief to the court that the company "cannot plausibly argue that a mere change in the labeling today will undo the effects of several years of unsubstantiated therapeutic claims."
The products were mostly orotates, which are made up of orotic acid and various minerals, such as calcium, magnesium, zinc, potassium, and lithium. "Oden said that orotates were the best thing ever discovered for cancer and other serious diseases," says FDA investigator Luis Chavarria of the agency's Las Vegas resident post. "He said their unique transporter system could carry nutrients through the cell wall faster than anything available on the market."
FDA received no reports of injuries from the Hans Nieper products made by Oden. But, as Chavarria points out, the heavy promotion—and subsequent use—of these products for serious ailments could endanger the public health. "For example, you could have a diabetic substituting these unproven products for the insulin their body depends on," he says.
FDA began looking into Oden's business practices after receiving reports in 1992 and early 1993 from consumers and drug manufacturers about the sale of unapproved Hans Nieper products in the United States. Since 1987, FDA had been aware of fraudulently promoted products manufactured in Europe by German physician Hans Nieper and sometimes shipped into the United States. But FDA knew of no U.S.-manufactured Hans Nieper products until FDA's Orlando district office traced some products seen during a plant inspection to a manufacturing facility in Pahrump, Nev. Based on this lead, Chavarria inspected Oden-owned Ramona Manufacturing Inc. in Pahrump in March 1993.
"When I confronted Oden about the illegal manufacture of orotates, he totally denied making them at his plant," Chavarria says. But two Ramona employees who were present during the inspection secretly phoned Chavarria later and told him the plant did manufacture orotates. The informants also told Chavarria that while he was inspecting the plant, one employee ran out the plant's back door carrying boxes of orotates, while another ran into the women's bathroom and hid the products' labels behind a paper towel machine.
On April 30, 1993, an investigator with FDA's Minneapolis district office placed an anonymous order for Hans Nieper products with International Nutrition. Within two days, the district office received shark cartilage and colamine phosphate drugs from International Nutrition, as well as promotional literature with unsubstantiated medical claims sent by another company owned by Oden, Papillon Botanicals Inc.
"To try to circumvent FDA's regulations," Chavarria says, "Oden had set up several companies besides International Nutrition to distribute the literature with the medical claims."
From June to August 1993, FDA investigators and U.S. marshals searched seven Oden-owned facilities, including Ramona, Papillon, and International Nutrition, and seized the unapproved drugs.
Both Oden and International Nutrition pleaded guilty in June 1995 to selling unapproved new drugs across state lines. Oden was sentenced to five years' probation and fined $5,000, and his company received five years' probation and a $60,000 fine.
Almost two years later, FDA was in court with International Nutrition again, this time opposing the company's bid to get back its seized products. "Based on Oden's track record, we were very concerned that if he got the seized items back, he would turn around and continue the criminal enterprise he had been involved in," Chavarria says.
The court, sharing FDA's concern, stated in its order denying return of the products, "International Nutrition's request ... is akin to the creator of a seized pipe bomb asking for the return of the pipe with the promise that the pipe will be used for plumbing, or the manufacturer of seized illegal firearms asking for the return of the metal with the promise that it will manufacture the metal into legal firearms."
The seized drugs will be crushed at a landfill, Chavarria says. To FDA's knowledge, Oden has stopped manufacturing the illegal Hans Nieper products. He still owns International Nutrition Inc., which he has relocated to a town near El Paso, Texas.
This article was reprinted from the September-October issue of FDA Consumer. Tamar Nordenberg was a staff writer for the magazine.
This page was posted on June 24, 2006.