State Fines, Denies License to Woodinville Biotech Firm

Bias against Biomed
Biomed vows to Fight

By Carol M. Ostrom http://seattlepi.nwsource.com/local/313163_biomed26.html
Seattle Times health reporter

The state Board of Pharmacy has fined the operator of a Woodinville biotechnology company $415,000 and denied her a license to make drugs, saying she falsely claimed to be a physician and illegally manufactured and sold homeopathic "healthy aging" drugs.

The state says that for more than a decade, Barbara Brewitt, 58, illegally manufactured and sold products made from human-growth hormone through her company, Biomed Comm, at retail stores including Costco and General Nutrition Centers, according to a final order issued Wednesday.

In early 2006, the board ordered Biomed Comm to cease operations.

Brewitt says the charges were false and the state closed her down because "they do not understand complementary and alternative medicine — they're committed to conventional health care."

In its final order, the Board of Pharmacy denied Brewitt's application for a license to operate as a drug manufacturer in this state and says she cannot reapply for 10 years.

The impropriety first surfaced in an investigation prompted by Brewitt's application in 2005 for a manufacturing license for Biomed Comm, said Donn Moyer, spokesman for the state Department of Health.

The board alleges she misrepresented herself as a medical doctor to obtain prescription-only materials to manufacture homeopathic-drug products.

In its final order, the Board of Pharmacy said Biomed contracted with another company to make the products, using recombinant human-growth-hormone materials characterized as "research-grade," which were not intended for human use. The Board alleged Biomed requested the company remove "not for human use" language from paperwork, but the company refused.

Brewitt said she has a doctorate in biological structures, a master's degree in divinity and has done research at the National Institutes of Health (NIH). She said she holds several patents and does double-blind studies on her products.

The company's Web site says Brewitt has been "heralded" for products that help autistic children and HIV patients. It says its products help aging baby boomers and others by increasing energy, improving appearance and boosting immune systems. Brewitt said the company did $1 million in annual sales before the Board of Pharmacy shut it down.

In November, she sued the Board of Pharmacy in King County Superior Court, alleging it overstepped its authority. That case is scheduled to be heard next year.

"We're in a bunker taking a bombing from the state," Brewitt said. "We haven't violated any laws, and we would like the state to be reasonable."

Brewitt said she cannot pay the fine and plans to appeal. "It's aimed at bankrupting me and putting me out of business."

Carol M. Ostrom: 206-464-2249 orcostrom@seattletimes.com