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- INVESTIGATION: Act banned by national tissue bank group
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- Here are the key findings from the Orange County Register's
investigation into the human tissue trade. Nonprofit tissue banks solicit
skin, bone, heart valves, veins and tendons from grieving families who
are told nothing about the value of their gifts. The parts from one cadaver
can be worth more than $220,000 to companies and tissue banks. Tissue banks
act as middlemen for corporate partners, some of which are traded on Wall
Street. The human tissue trade is estimated at about $500 million a year.
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- It is against the law to sell body parts, but companies
and tissue banks are allowed to charge "reasonable fees" for
human tissue. The National Organ Transplant Act does not define "reasonable.''
Cadaver skin is used to enhance penis size, puff up lips or erase laugh
lines. Plastic surgeons have reported no trouble obtaining skin for plastic
surgery, but burn centers across the country are struggling to find skin
to treat burn victims. The top executives at nonprofit tissue banks earn
an average of more than $135,000 a year. One Los Angeles nonprofit tissue
bank paid its top executive $533,450 a year and provides a BMW for his
commute. Tissue banks continue to compete for access to cadavers in Southern
California, including Orange County.
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- Eighty-five percent of the nation's organ recovery agencies
have ties to for-profit companies that craft products from body parts.
The ties are not disclosed to donor families when consent is sought to
remove body parts.
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- ABOUT THE COMPANY
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- Regeneration Technologies, based in Alachua, Fla.,
is the fastest growing maker of products from human body parts. The
company's revenue - derived all from sales of donated tissue - soared
from $13.5 million in 1997 to $73 million last year. The company reported
4,000 cadaver donors in 1999 - representing about 34 percent of all human
tissue recovered in the United States.
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- February 1998: The University of Florida Tissue Bank,
a nonprofit organization, spins off a private company called Regeneration
Technologies Inc. The company and tissue bank share office space, phone
lines and employees.
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- November 1999: The company buys most operations of the
nonprofit Georgia Tissue Bank. The firm has also acquired or taken control
of tissue bank operations in Wisconsin and Alabama. The firm now has more
than 30 tissue suppliers nationwide.
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- April 1999: The firm submits plans to sell its stock
to the public in hopes of raising $86.2 million. In its public filings,
the company unveils its new BioCleanse technology allowing the company
to mix bone from up to 100 donors.
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- May 1999: Robert Hoffman, director of the University
of Wisconsin Hospital organ procurement organization, resigns and agrees
to pay back more than $86,000 he received for sending skin and bone to
two tissue banks, including one controlled by Regeneration Technologies.
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- Source: Regeneration Technologies Inc. and Register
research.
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- A Florida company plans to mix bone from up to 100 cadavers
in products it makes from donated human body parts, a practice banned by
most of the nation's tissue banks because of fears it can spread disease.
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- The new methods employed by Regeneration Technologies
Inc. disregard safety standards adopted 12 years ago by the American Association
of Tissue Banks in the wake of an outbreak of deaths in Japan. The methods
fall outside the regulatory guidelines of the federal Food and Drug Administration.
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- The company says it has the technology to combine bone
from up to 100 donors simultaneously, but is currently mixing body parts
from three to five cadavers in a single batch. The products made from those
batches are sold to doctors and hospitals.
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- "I think the public just assumes there are standards
for distribution and handling of tissue,'' said University of Pennsylvania
bioethicist Arthur Caplan. "They'd be shocked to find out how much
variation and discretion there is. It's a bright red flag that has been
waving for some time.''
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- Caplan said the issue of mixing or pooling tissue points
to holes in the regulations, an area he said the federal government needs
to review.
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- The two-year-old firm - which gets bone from Orange County
cadavers through a network of tissue bank suppliers - has set out to revolutionize
the way body parts are handled. Regeneration Technologies is already the
fastest growing maker of products from human parts and is about to sell
its stock to the public. It said in federal filings that its "BioCleanse''
methods are safe, efficient and reliable.
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- "With BioCleanse, the chance of disease transmission
is virtually eliminated,'' Richard Allen, the company's chief financial
officer said earlier this year. The company refused to answer more questions
about the process, citing Securities and Exchange Commission rules about
talking to the media right before an initial public offering.
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- The firm makes specialty pins, screws and dowels from
human bone and reported to the SEC that its methods will speed up production
at its Florida assembly lines.
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- "We believe we are the only tissue processor currently
able to safely process tissue from multiple donors simultaneously,'' the
company states in its SEC filings. The company's stock sale could come
any day.
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- Disease Worries
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- Leaders at the American Association of Tissue Banks,
however, worry about the consequences for patients and the public. More
than 40 deaths were documented in Japan during the 1980s linked to tissue
processed in batches. Association executives say there is no conclusive
proof that pooling body parts is any safer today. The association's ban
on pooling body parts requires all parts be processed one donor at a time
in isolated clean-rooms. Tissue cannot be mixed "during retrieval,
processing, preservation or storage,'' according to the association's policies.
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- Failure to comply with the rules can cost a tissue bank
its accreditation in the voluntary group, but Regeneration Technologies
does not belong to the association and is not bound by its rules.
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- "No one has yet submitted to the FDA, or to us or
in any scientific peer review, any evidence validating a process that would
allow for pooling of donors with protections against cross contamination,''
said Bob Rigney, chief executive officer of the American Association of
Tissue Banks.
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- "We won't even allow tissue from two donors in the
same room,'' said Billy Anderson, president of LifeNet, a Virginia organ
recovery agency and Regeneration Technologies' competitor. "If I had
a process today where I could do it, I wouldn't. I just think there is
a risk that is not worth taking."
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- Anderson knows about the risks. AIDS-tainted body parts
distributed by LifeNet killed three people in the early 1990s even though
the agency screened the tissue for the HIV virus. The test back then was
not as sophisticated as it is today. The tissue and organs tainted with
the AIDS virus were not pooled with other donors, but the case has contributed
to the reluctance of industry leaders to take what they call "unnecessary
risks.''
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- "There is always an unknown factor," Anderson
said, "an unknown virus or something we can't test for.''
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- A single cadaver can provide more than 100 tissue grafts.
If tissue from 100 donors were mixed together, up to 10,000 pieces of tissue
could potentially face a recall if it turned out one of the donors carried
a serious disease, said Anderson. Once infected tissue is implanted in
another human, it's too late to recall it. Tracking down tissue from a
huge pool of donors would be a logistical nightmare, he said.
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- In its public filings, RTI says it has validated its
findings and its technology.
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- "Our validation studies of the BioCleanse system
show this process kills or inactivates all classes of conventional pathogens,
viruses, including HIV, microbes, bacteria and fungi present in the tissue,
while retaining the useful properties,'' according to the company's SEC
filing. But in the same document, the company also notes that "we
can never completely eliminate the risk of errors, defects or failures''
in any of the firm's processing and distribution.
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- The BioCleanse system takes three hours and uses ultrasonic,
temperature and pressure cycle controls to clean body parts in a machine
that is essentially a $500,000 computerized dishwasher. After bone is subjected
to the process, it comes out looking bright white "due to the aggressive
cleansing process,'' according to company literature. The company states
that its validation studies were successful, and that it believes "with
a high degree of confidence that the BioCleanse process adequately reduces
the potential for cross-contamination.''
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- The company says the technology has helped triple the
output of bone products at the Alachua, Florida facility. The firm also
says the state of New York has approved the use of BioCleanse there. New
York is the only state that has requirements against using pooled tissue.
The state Department of Health granted an exemption in February after seeing
validation results from the company, said New York health spokeswoman Claire
Pospisil.
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- Bruce Stroever, who runs the nation's largest nonprofit
tissue bank, said in a statement to the Register that his Musculoskeletal
Transplant Foundation would not pool donors, noting most tissue implant
procedures are not life-saving and do not have to be done immediately.
A patient can wait for the proper graft, Stroever said, so there is no
need to rush the processing or expose a patient to any risks.
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- "A great deal of attention has been directed towards
the rights of the family in giving consent for the use of their loved one's
tissues,'' Stroever said. "There is a similar obligation to the recipient
that the graft comes from the best possible donor available.''
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- Other industry leaders worry about what can happen when
tissue from 100 cadaver donors is placed in the same room.
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- "There's always a potential for something to go
wrong,'' said Lori Schutte, executive director for St. Louis-based Mid-America
Transplant Association, one of the nation's largest organ and tissue recovery
programs. "Why do you wear a seatbelt? Most of the time you don't
get hit by a car, but it minimizes your risk."
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- Few FDA Rules
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- The FDA has few regulations governing use of human tissue.
Federal law prohibits anyone from selling body parts, but allows companies
and tissue banks to charge "reasonable fees" for processing skin,
bone, ligaments and other parts into commercial products.
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- An Orange County Register investigation found that donated
body parts are treated as raw materials crafted into lucrative products
sold to surgeons, dentists and hospitals for treatments ranging from healing
severely fractured bones to enlarging penis size.
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- FDA spokeswoman Lenore Gelb said current regulations
focus on screening donors and that the pooling of human tissue "hasn't
been much of an issue up to this point.''
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- The FDA is "considering addressing pooling more
specifically in future regulations,'' she said but would not give details.
Regeneration Technologies has not submitted any scientific studies to the
FDA validating its new technology, she added.
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- But Ernest Carabillo, a former FDA official hired as
a consultant by Regeneration Technologies, said the company does not have
to file scientific findings with the federal agency.
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- "There is no requirement to do so,'' he said. The
FDA was given a demonstration of the process about a year ago, Carabillo
said, but the agency has no "mechanism to approve a process at this
point in time.''
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- Carabillo said he believes the tissue bank association
critics are simply jealous of the technology.
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- "Quite candidly, I think this is all about the fact
they're left behind,'' said Carabillo, a pharmacist and lawyer.
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- Just 10 years ago, the human tissue business was estimated
as a $20 million niche market. Now it has emerged into a full-fledged industry
expected to hit $1 billion by 2003. The FDA has had trouble keeping pace
with the explosive growth and doesn't even know how many tissue banks exist.
The national tissue bank association has wanted to police itself, but has
no sway over non members.
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- Health and Human Services Secretary Donna Shalala ordered
a sweeping probe of the industry in June in the wake of the Register investigation.
Initial findings are due next month.
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- Fast growing firm
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- Regeneration Technologies is one of the reasons for the
growth. The firm reported $73 million in sales last year - up from $35.3
million the previous year.
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- The company has applied for an international patent for
its new process in hopes of taking its pooling technology overseas.
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- It has been a whirlwind first two years for Regeneration
Technologies. The company has bought or taken control of nonprofit tissue
banks in Georgia, Alabama and Wisconsin. It has a growing list of tissue
bank suppliers, including Baltimore-based Tissue Banks International which
runs the Orange County Eye and Tissue Bank in Santa Ana.
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- The company is more aggressive in the harvesting of body
parts, taking tissue from donors as old as 101 years of age at the time
of death. Most tissue banks take body parts from donors no older than 70
years of age, the Register found in its investigation of the industry.
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- Regeneration Technologies also has developed a bonus
program where employees are paid extra for enlisting new mortuaries, county
coroners or tissue banks as clients, according to its stock proposal. The
program encourages employees to raid the client list of other tissue banks.
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- Its initial public offering is expected to earn anywhere
from $4.5 million to $15.6 million for its founder, James "Jamie"
Grooms, who previously headed the nonprofit University of Florida Tissue
Bank. The tissue bank spun off the private firm and is located in the same
building as Regeneration Technologies. _____
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- Staff Writer William Heisel contributed to this report.
Mark Katches can be reached at (714) 796-7724 or by e-mail at <mailto:Mark_Katches@notes.freedom.com.
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