The company -- Donor Referral Services -- was ordered to stop its operations after FDA inspections of the Raleigh-based company in June revealed doctored records that had allowed former cancer patients and intravenous drug users to have their organs harvested for transplant.
In the case of at least five of the cadavers at the company, paperwork had been altered on the age and history of the donors. In one case, the company's owner, Philip Guyette, failed to list that the donor had died of cancer, and that intravenous drug use had been a factor in the death. Use of IV drugs increases the risk of HIV/AIDS and hepatitis.
Though all of the tissues the company harvested have been recalled, the FDA says some have already been transplanted. FDA spokesman Paul Richards was unclear on how many people had received tissue from the company, and urged patients who had questions to contact their doctors.
"Allowing the firm to continue to manufacture would present a danger to public health by increasing the risk of communicable disease transmission," says Margaret O'K. Glavin, associate commissioner of the FDA's office of regulatory affairs.
The Donor Referral Services shutdown comes after the tissue industry has struggled to recover from its biggest scandal, which involved a New Jersey company -- Biomedical Tissue Services -- allegedly taking body parts from corpses without the families' permission.
"The organ harvesting industry is shrouded in secrecy," said Mike Adams, consumer health advocate, "but the secrets are starting to come out, and what we're learning is horrifying. The body parts trade is steeped in unethical and grotesque practices, and it profits from the trade of human organs of taken from questionable sources under suspicious circumstances."
Adams has long been an outspoken critic of the profit motive in the organ donor / organ harvesting industries and warns people to think twice before becoming an organ donor. "There are even laws on the books in some countries," he explains, "that allow surgeons to start prepping your body for organ harvesting before you've been declared dead."
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