Dexpanthenol

A drug that prompted an urgent health warning from the U.S. Food and Drug Administration was made in the spare room of a home here, says a former company employee.

The company that made the drug lacked a permit to do so, say Rathdrum city officials.

The FDA issued a recall last month for alternative drugs made by Rathdrum's Amram Inc. because one of its drugs caused illnesses in three Philadelphia patients last month. In those cases, the gout drug colchicine was 10 times more potent than it should have been, the FDA said.

The agency inspected Amram in Rathdrum and found it was violating FDA requirements for making drugs; for example, it was not using sterile water.

"These requirements help ensure that drug products are safe and effective," the FDA said in a statement. "The violations FDA found demonstrate that the products lack assurance of sterility and potency."

Amram sold its drugs to Phyne Pharmaceuticals, based in Scottsdale, Ariz. The FDA also said Phyne delayed its recall of Amram's drugs.

Phyne officials, however, say both companies did everything they could to expedite recalls. The FDA clogged the process, they claim.

"The only delay has been the FDA micromanaging the wording of the recall letter and postcard," said Holly Gieszl, a Phoenix attorney for Phyne.

But she also made this point clear:

"This is not Phyne's recall. This is Amram's recall."

According to state records, Amram is owned by George and Edith Crawford. The house they listed as their business address has since been sold to Spirit Lake Police Chief Douglas Camster.

Camster said he bought the house in June from Edith Crawford.

"There was nothing here," Camster said. "There was no indication of anything but a normal household."

That's because the Crawfords didn't make Amram drugs at that house, said Melanie Schumacher, a former Amram employee. Her husband, Richard Schumacher, is on Amram's board of directors. He is Edith Crawford's brother.

"It was in someone's house," said Melanie Schumacher, who refused to reveal the location of Amram's Rathdrum lab or the homeowner's name. She said the homeowner had no idea the Crawfords had converted an addition he had built for his parents into a lab.

Shumacher described the room where the drugs were made as white and sterile. She defended Amram and its owners, saying the only problem the company had was with one drug - colchicine.

The real culprit, Shumacher said, is the FDA.

"(The Crawfords) are definitely getting screwed over," Schumacher said. She said the FDA has long been on a witch hunt for Phyne.

"I think they're just using Amram as a tool."

Phyne's past president, James Critchlow, said he knew nothing of the Crawfords using a home to make drugs, only that he had been assured of the operation's quality.

"I don't see anything wrong with it," Critchlow said. "As long as it was a sterile operation. That was the whole problem."

FDA rules weren't the only ones allegedly broken.

Rathdrum doesn't allow such businesses in homes without a conditional use permits, said Jan Hale, city planning administrator.

The Crawfords didn't seek a conditional use permit, Hale said.

"If they were operating out of a home," she said, "they were operating illegally."

Even with a license, a home-based lab is a bad idea, said Al Czap, chief executive officer of Thorne Research. The Sandpoint company makes hypoallergenic products for physicians and pharmacies.

"It's not something I would undertake, by any means," Czap said. Injectable drugs need filtration, sterilization and cross contamination, he said. "Any one of those things is not something I'd be doing out of the back of a house."

Contacted at a new home in Coeur d'Alene, Edith Crawford refused to comment.

Shumacher said the Crawfords have been bombarded with calls from reporters across the country.

"The FDA is out for blood," Schumacher said. "They're not big on alternative medicine, and the drug companies are pushing them to do it."

This sidebar appeared with the story:

AT A GLANCE

Drugs recalled

These drugs, produced by Amram Inc., and sold by Phyne Pharmaceuticals, have been recalled by the Food and Drug Administration:

Adenosine Monophosphate; Ascorbic Acid Injection; Beet Ascorbic Acid Injection; Biotin; Colchicine; Vitamin B-12 (Cyanocobolamin); Dexpanthenol; Disol, USP Brand of EDTA; Echinacea Homeopathic Injection; Edetate Disodium; Endocrine; Folic Acid; Germanium Sesguloxide; L-Glutathione or Glutathione; Human Chorionic Gonadotropin; Hydrochloric Acid; Iron 59 Injection; Liver Injection, Crude; Lypo-Vite Injection; Magnesium Chloride Injection; M.I.C.; Procaine Hydrochloride Injection: Pyridoxine HCL (B-6); Sodium Thiosalicylate; Superoxide Dismutase (S.O.D.); L-Taurine Injection; Thiamine HCL; Thymus Extract; Choline Chloride; Diphenhydramine; Glycyrrhizen; Chlorpheniramine Injection; Hydrogen Peroxide; Hydroxocobalamin; MIC with Folic Acid; Niacin; Pangamic Acid; and Riboflavin.

Thomas Clouse

Copyright 2001 Cowles Publishing Company
Provided by ProQuest Information and Learning Company. All rights Reserved.