October 11th, 2009 - The News and Observer
Sarah Avery
Oct. 10, 2009 (McClatchy-Tribune Regional News delivered by Newstex) -- It's illegal to buy and sell human organs in the United States, but trading in cadaver limbs, skin, ligaments and veins is a billion-dollar industry that makes it possible for doctors to rebuild knees, repair weak bones and fuse teeth implants.
As the federal criminal case concluded this week against Philip Guyett, who ran a business in Raleigh that harvested transplant tissue at local funeral homes, profit motive emerged as a factor behind a scheme which allowed potentially diseased body parts to be used in at least 127 unsuspecting patients around the country.
Guyett, sentenced to eight years in prison, admitted to forging records and manipulating laboratory tests on at least eight donors who were either too old or sick to be eligible for tissue donation. Federal investigators found questionable records for another 40 donors, involving 2,600 human tissue products that went into the marketplace throughout the world.
And while the industry is regulated by the U.S. Food and Drug Administration and policed by a private accrediting agency, Guyett operated Donor Referral Services in Raleigh and Las Vegas for nearly two years with little scrutiny, while collecting as much as $9,000 on the body parts of a single donor.
From March through December 2005, bank records show, Guyett deposited more than $200,000 in his Raleigh business account. Some of the deposits were infusions of personal money, but at least 52 were noted as the proceeds of recovered tissue.
Patient advocates, led by a Charlotte couple who believe Guyett's case is not an isolated incident, said the human tissue industry needs to remove profit from the equation.
"Both blood donations and organ donations are nonprofit," said Steve Cummings of Charlotte, whose wife, Karen, suffered a severe illness after a dental implant at about the same time as Guyett's scheme. "Why isn't tissue donation nonprofit?"
Industry leaders say there is no need to restructure commerce based on the misdeeds of a rogue operator such as Guyett.
Most procedures safe
In more than 30 years, few documented cases of infection have been traced to transplanted bone or tissue, while the industry supplies the material for 1.5 million procedures each year.
"Tissue transplant is one of the safest procedures one can undergo," said Robert Rigney, chief executive officer of the American Association of Tissue Banks, which accredits businesses that recover and process tissue.
He said the last confirmed case of disease transmission from a tissue transplant was four years ago.
But patients who received tissue from Guyett's donors believe otherwise. One Georgia woman said she is certain an infection she suffered after back surgery was the result of tissue supplied by Guyett.
And it's not just infections that raise concern.
Some of Guyett's donors were too old to supply bones and ligaments, and others had battled cancer. Both conditions can diminish bone strength.
Dr. Douglas Dirschl, chief of orthopaedics at UNC Hospitals, said transplant patients who received the ineligible tissue could face repeat operations and potentially life-threatening complications.
"We rely on the integrity of the tissue supply," Dirschl said, noting that doctors use the tissue to fill holes in diseased bones, replace shattered arms and legs, rebuild torn knees, and repair damaged spinal columns.
The accrediting agency sets high standards for how tissue donation should occur, but not everyone in the industry is accredited. Guyett was not, according to Rigney.
How he got started
A one-time land surveyor who got into the tissue recovery business after taking anatomy courses at a community college, Guyett needed only to register with the FDA to start recovering tissue and supplying processors.
In 2004, Guyett moved to Raleigh from Las Vegas -- a quality-of-life decision, Guyett testified last week. Raleigh was where he wanted to raise his two young children, and he bought a home in the Wakefield area and began working with local funeral homes to enlist donors.
People who recover tissue are not technically paid for the body parts -- those, like organs, are illegal to buy and sell -- but they are reimbursed for their efforts, plus "reasonable" fees and expenses.
Bank deposits introduced in Guyett's federal criminal case indicate he was earning revenue not only from transplant tissue processors, but also from medical research firms and companies that run anatomy training courses.
Despite a steady revenue stream, he shut his business down in December 2005, citing financial strains.
But the timing coincided with another industry scam that had just come to light. That fall, Michael Mastromarino, a New Jersey dentist, was accused of plundering bodies from funeral homes and using fake documents in a $4.6 million operation. Mastromarino pleaded guilty last year in Brooklyn and was sentenced to 18 to 54 years in state prison.
The schemes were eerily similar, although Guyett had a much smaller enterprise.
Guyett maintained in court last week that it was not up to him to rule on the suitability of donor tissue.
That step fell to an accredited processor, which approves the tissue, sterilizes it and renders it into various forms used in transplants.
Under accrediting rules, processors are required to have a doctor review the donor's official death certificate and medical records, checking the age, cause of death, time of death and any health factors such as infections or past diseases that might render the tissue ineligible.
In addition, blood samples from the donor are screened for evidence of infectious diseases such as HIV, hepatitis and syphilis, and the information is passed along to the processors.
Bilking the system
While documentation is pending, the donor's tissue is held in quarantine at the processing site.
For at least eight donors, Guyett falsified the information he shipped to the four processors he supplied. He skirted attention by passing off funeral home cremation certificates as legal death certificates, and swapping blood samples from diseased donors with healthy specimens.
All along, he testified, he thought the processing companies would catch the flimsy documentation and keep the ineligible tissue from being shipped to patients.
Calls to the principals at the processing companies were not returned. One company has reportedly filed for bankruptcy.
Rigney said the processors should not be blamed for the frauds of Guyett and Mastromarino.
"The thing I can't stress strongly enough is that these guys, what they did was unconscionable," he said. "There aren't adjectives strong enough to describe it. They weren't accredited by us, they were renegades -- outliers in the system."
He said additional controls have been put into the accrediting system to make sure such frauds are discovered early. And a 2007 inspections blitz of the industry by the FDA found no similar cheats.
Rigney said it wouldn't help the system to remove profits and set up a system like organ donation. With organs, which are in severe shortage compared to patient need, a designated procurement agency serves as a liaison between donor and recipient, and makes no profit from the transaction.
"Tissue donation is a totally different situation," Rigney said. "We're both heavily regulated, but we've got a much better safety record and supply record. I don't know what you would gain by having a (tissue) system the same way the organ system is set."
Without the prospect of making a living on the dead, however, Guyett would not have gone into the business.
David M. Cook, a Cincinnati lawyer who sued Guyett on behalf of one of the tissue transplant patients, said money is at the root of the problem.
"When you make it a for-profit activity, this is the kind of result you get," Cook said.
savery@newsobserver.com or 919-829-4882
Newstex ID: KRTB-0170-38715509
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