Body-part harvesting company must closeAug 18, 2006 | AP
Health officials ordered a North Carolina company that collected human body parts for transplant to shut down Friday after inspectors found violations that posed a threat to human health.
The Food and Drug Administration said it ordered Donor Referral Services to cease all manufacturing and to retain all cadaver tissues, following June inspections of the company in Raleigh, N.C. The company collected tissue for other firms that later processed it for transplantation.
The inspections found "serious deficiencies" in how the company screened donors and kept records, the FDA said. The FDA said it does not know of any cases of infection in people who received donor tissue harvested by the company.
All tissue products the company took from cadavers have been recalled, although some already have been transplanted, FDA spokesman Paul Richards said. It wasn't immediately clear how many people received tissue harvested by the company.
The FDA believes the risk of infection is low, but that the actual risk is unknown, Richards said. Patients with questions should contact their doctors, he said.
In the case of at least five cadavers, the company and its owner, Philip Guyett, altered paperwork on the health history and age of those donors, the FDA said. For one, Guyett listed in paperwork various reasons for the death of the donor but failed to log correctly that the person had died of cancer, with intravenous drug use a contributing factor, the FDA said. IV drug use is associated with elevated risk for diseases like HIV/AIDS and hepatitis.
"Allowing the firm to continue to manufacture would present a danger to public health by increasing the risk of communicable disease transmission," said Margaret O'K. Glavin, associate commissioner of the FDA's office of regulatory affairs.
A man who answered a telephone listed in Philip Guyett's name in the Raleigh area told The Associated Press he was no longer connected with Donor Referral Services before hanging up.
A Philip J. Guyett Jr. ran for five years in the 1990s the willed body program at an osteopathic college in Pomona, Calif. He was arrested in 1999 for allegedly selling a cadaver to another school and keeping the $1,100 payment. At that time, police raided a warehouse he used and found three freezers containing human heads and hearts. He later pleaded not guilty.
That Guyett later incorporated a Donor Referral Services Inc. in Las Vegas. It wasn't immediately clear if he is the same person involved in Friday's FDA action.
The action comes as the tissue industry struggles to recover from the biggest scandal in its history, involving Biomedical Tissue Services, a now-defunct New Jersey company accused of plundering corpses for body parts without family members' permission.
Among those whose corpses were scavenged was "Masterpiece Theatre" host Alistair Cooke. A former dentist, Michael Mastromarino, and three others face charges in that scandal. Investigators unearthed evidence that death certificates and other paperwork were doctored.
Neither Guyett nor his company belong to the American Association of Tissue Banks, a professional organization that sets strict standards for how tissue is recovered and processed, said the association's president, James Forsell.
More than 1.3 million Americans each year have operations or procedures that use bone, skin, corneas or other types of tissue from donated cadavers. These range from dental implants using ground bone to knee ligament and spine repairs.
The vast majority of cases turn out fine, but serious infections and even death can occur if the tissue has been poorly tested or improperly processed to kill germs.