The owner of a defunct Raleigh company blamed for a trail of suspect body parts said Wednesday that he complied with all federal regulations for the harvest and distribution of human tissue and wants to clear his name.
"This week has been very difficult on my family and I," said Philip Guyett, who owned Donor Referral Services. "I felt that it was time to give another side of what happened."
The U.S. Food and Drug Administration ordered Guyett to shut down the company last week, saying he failed to properly document the medical histories of several cadavers he harvested. In failing to do so, he risked spreading diseases, FDA officials said.
Guyett, 38, goateed and with a slightly padded frame, sat for a two-hour interview Wednesday in a sofa chair at a Raleigh Starbucks wearing sneakers and shorts.
He has until Wednesday to respond to the FDA order. He said that he no longer wants to work in the tissue trade but that he might file a rebuttal anyway to clear his name. He said he quit the business for good this year and hopes potential donors won't be deterred by negative publicity.
"Tissue donation for any reason is an honorable gift to life, research and education," he said. "Those who choose to make this gift should feel good about their decision."
On Wednesday, the FDA appeared to broaden its investigation from Guyett, who supplied the tissues, to an Ohio company that distributed them for implantation. The company, part of AlloSource of Centennial, Colo., began recalling hundreds of Guyett-supplied tissues July 6 after it had shipped them for use as implants.
The FDA is trying to determine which company, Guyett's or the Colorado tissue bank, was primarily responsible for screening and documenting the donor tissues shipped for transplant, said administration spokesman Paul Richards.
Efforts to reach AlloSource and the Ohio tissue transplant business it bought in March were unsuccessful Wednesday.
Tissue banks collect, process and distribute bone, ligaments, skin and tendons. But FDA rules require banks to register and list which functions they perform. Donor Referral Services was registered only to recover tissues from cadavers. Guyett said his company, which closed several months before the FDA order, did not do tissue screening, storage, processing or distributing.
Most tissues can be frozen for six months to 10 years, depending on the storage temperature. It is often during this period when tissue screeners obtain disease-test results and review death certificates and other records for donor risks such as disease or intravenous drug use.
AlloSource officials did not explain earlier this week why the company shipped Guyett-supplied body tissues that had not been properly screened.
The company in March bought the tissue transplant business of Cincinnati-based U.S. Tissue and Cell, which Guyett had supplied with 19 donors from 2002 to 2004.
The tissue trade industry has gained notoriety for theft and for questionable research on cadavers and body parts. Last year, Biomedical Tissue Services of New Jersey was accused of processing stolen bodies and shipping nearly 20,000 potentially tainted body parts.
Guyett, for his part, pleaded no contest to a 1999 felony charge in California after taking payment for human tissue that belonged to the university donor program he ran.
Distribution channels for human tissues are complex and prone to some level of error, he said.
"The tissue industry is large," he said. "There are multiple chains of custody involved in deciding whether a donor is eligible and how their tissue is processed."