Hundreds of human body parts recalled
Pastor Dale Morgan
Human tissue transplant products recalled*
Corpses carved up in unsterile facility, funeral director says
Wednesday, August 23, 2006 Posted: 0302 GMT (1102 HKT)
WASHINGTON (AP) -- -- A leading medical firm has quietly recalled
hundreds of human tissue products destined for transplants around the
nation that were supplied by a North Carolina body parts broker believed
to have a tainted history.
The broker used an unsterile embalming room to carve up dozens of
corpses to procure tissue, a Raleigh funeral home director said Tuesday.
The U.S. Food and Drug Administration shut down the body broker on
Friday. The FDA refuses to say how many people may have received
potentially risky tissue.
It is the second scandal in less than a year in the booming tissue
transplant industry. Cadaver tissue is used in more than a million
transplants each year in such routine operations as back surgery and
knee repairs. While such donated tissue does tremendous good, it is also
little regulated, a three-month Associated Press investigation found
earlier this year.
Improperly processed or poorly tested tissue can lead to infections like
hepatitis or AIDS or even death. Last year a scandal unfolded around
Biomedical Tissue Services, a New Jersey company accused of using stolen
bodies and of shipping nearly 20,000 potentially tainted body parts.
Federal authorities kept the North Carolina episode quiet until late
last Friday, when the FDA shut down Donor Referral Services of Raleigh,
North Carolina.
The FDA said the company, run by Philip Guyett, had "serious
deficiencies" in its processing, donor screening and record-keeping. The
government accused him of altering records to overlook such problems as
cancer or drug use by the deceased donor.
On July 6 the tissue provider AlloSource of Centennial, Colorado, began
its own recall of about 300 Guyett-provided transplant parts that went
to a company it had acquired, an AlloSource spokeswoman said Tuesday.
Guyett, 38, hung up on a reporter trying to reach him for comment on Friday.
The FDA won't say how many potentially tainted body parts might have
made it to hospitals for transplant. But two companies doing business
with Guyett told AP on Tuesday that they know of at least 60 bodies cut
up and at least 300 body parts that were recalled. And those firms were
not the only business associates that Guyett had, they said.
"This is something of the same magnitude at least of what we saw with
Biomedical Tissue," said former FDA top attorney and tissue safety
expert Areta Kupchyk. "Many people could be affected. Even if it's only
60 donors, that could affect hundreds of people."
It's still too early to tell how big the Guyett tissue scandal will be.
FDA spokeswoman Julie Zawisza would not comment on the recall or how
many parts it involved.
"In specific instances where information has raised concerns about
patient safety, FDA has worked with the firm that distributed the
subject tissue to ensure that physicians are notified to inform patients
and offer testing," Zawisza said an e-mail to AP.
AlloSource, which began its own recall of tissue, was provided tissue
from 19 donor bodies by Guyett from 2002 to 2004, said Tipton Ford,
chief of a company whose tissue transplant business was recently
acquired by AlloSource.
But those parts from 19 bodies represent just a fraction of Guyett's
business. Larry Parker, president of Cremation Society of the Carolinas,
a Raleigh funeral home, said Guyett paid him $1,000 for each of the
roughly 60 donors the funeral home referred. Parker, who began seeking
donor cadavers for Guyett in 2004, said he believed other funeral homes
also dealt with Guyett.
Body parts harvested in unsterile location
"He did the recovery in our facility, in the embalming room. It is not a
sterile facility. It was not built for tissue recovery," said Parker,
adding that he has been working with the FDA since the agency contacted
him several weeks ago.
Tissue must be procured and processed under sterile conditions to avoid
spreading infection to recipients. An industry group, the American
Association of Tissue Banks, has highly detailed standards. But tissue
banks are not required to belong, and Guyett and his company did not.
Guyett, appears to have a felony conviction from a previous tissue
scandal in California.
A Philip Guyett with the same date of birth and other records that match
the body broker in Raleigh pleaded no contest to a felony, embezzlement
stemming from the willed body program he directed at an osteopathic
college in Pomona, California in the late 1990s, said Jane Robison,
spokeswoman for the Los Angeles County District Attorney's office.
In return, two other felony charges were dropped, she said. Guyett had
been accused of 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 was fined and sentenced in April 2000, ordered to perform six months
of community service and was given three years' probation, Robison said.