Philip Joe Guyett, the former trader of human tissue who was ordered to shut down, says it was easy to get into the industry, and people who know the body-parts business agree.

Guyett, of Raleigh, is at the center of a federal investigation after an Ohio company began recalling hundreds of tissues he supplied. That spurred the U.S. Food and Drug Administration to order Guyett to close his business this month.

"There's a big problem out there, and it's not Phil Guyett," said Harriet Bartnick of Raleigh, a board member of the Funeral Consumers Association, a national advocacy group that has pushed for reform of the tissue trade since 2003.

"This is an industry anybody can get into, and there are bodies out there that are not being watched. We would expect our federal government to do more."

The only requirement to harvest tissues destined for transplant is to fill out and submit an FDA registration form, which takes about five minutes online. A registration letter comes in the mail in about eight weeks, and there are no federal inspections for two years.

"The industry doesn't have clear regulations, that's certain," said Michael Rulison, president of the Funeral Consumers Alliance of the Triangle, part of the national group.

In a two-page letter to The News & Observer, Guyett, 38, denies any wrongdoing and says that he is being unfairly targeted by a federal agency that lacks clear rules on tissue trade and has little record of enforcing them.

The FDA says Guyett violated several rules and posed a risk of spreading diseases, such as AIDS, through tissues destined for transplant. Guyett misstated the age, cause of death and other risk factors of at least five donors he harvested for transplantation, medical research and commercial use, the agency says.

It is unclear whether Guyett or the Ohio tissue bank he supplied was primarily responsible for screening and documenting the donor tissues shipped for transplant.

Administration spokesman Paul Richards was unable to answer that question during a phone interview last week. The FDA does appear to have broadened its investigation from Guyett to also include the Ohio tissue distributor, now part of AlloSource of Centennial, Colo.

Rules are few

Guyett's career shows that it was not difficult for him to enter the business.

He said he got into the tissue trade in the mid-1990s after a back injury ended his 10-year career as a land surveyor for residential and civil engineering construction projects.

Guyett said he was interested in the science of anatomy and physiology and that there were few regulations to block his entry into the tissue business.

Tissue banks collect, process and distribute bone, ligaments, skin and tendons. FDA rules require banks to register and list which functions they perform.

Guyett's business, 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.

Prices for fresh frozen tissue parts vary. But according to industry expert Annie Cheney, an elbow goes for $350 to $850, a hand for $350 to $850 and a whole cadaver for $4,000 to $5,000.

Cheney, who led a years-long investigation of the trade, is the author of "Body Brokers: Inside America's Underground Trade in Human Remains."

After his back injury, Guyett started courses in anatomy, biology and physiology at Victor Valley Community College in Victorville, Calif., with the idea of entering the medical field, he said. Along the way he met an instructor in the tissue trade, as well as several doctors and lawyers connected to the industry.

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