Cadaver scandal - Transplant warning issued

From the Chicago Tribune--

Transplant warning issued
Tissue linked to N.Y. cadaver scandal used in local hospitals

By Tonya Maxwell and Jeremy Manier
Tribune staff reporters
Published February 2, 2006

Tissue taken from cadavers in New York by a firm under state and
federal investigation has made its way into dozens of transplant
patients in at least five Chicago area hospitals, creating what
federal officials describe as a small risk of infection from diseased
tissue.

All of the local hospitals that received the tissue said that they are
advising their patients who received it to get tested for communicable
diseases as a precaution.

Northwestern Memorial Hospital this week informed 17 patients that
they had been implanted with the tissue and is offering them free
tests for communicable diseases, said Kelly Sullivan, director of
communications.

Twenty-two patients at two Evanston Northwestern Healthcare hospitals
and three patients of the University of Chicago Hospitals also have
been affected. Loyola University Health System said a small number of
patients there received the questionable tissue.

"It's wholly distressing that anyone involved in any part of this
process would break the law and bypass protocol designed for utmost
patient safety," Sullivan said.

Public allegations of illegal tissue collection began with an Oct. 7
New York Daily News story that reported the Brooklyn district attorney
was investigating a Fort Lee, N.J.-based company that harvests tissue.

Authorities are investigating whether that company, Biomedical Tissue
Services, arranged with funeral directors in the New York City area to
harvest bone, skin and tendon tissue from corpses without obtaining
consent from families or other authorization. The concern is that the
donors were not properly screened for infections or diseases such as
cancer.

A spokesman for the Brooklyn district attorney's office confirmed
Wednesday the office is investigating the tissue company but declined
to elaborate. No charges have been filed. The U.S. Food and Drug
Administration also is investigating.

Attorney Mario Gallucci, who represents Biomedical's owner, Michael
Mastromarino, said his client has done nothing wrong.

"There was no improper harvesting, and there is no diseased tissue,"
Gallucci said.

Gallucci said an important question is whether families gave consent
for their relatives' body parts to be harvested. Getting that consent
would have been the responsibility of the funeral home directors who
provided Mastromarino with cadavers, Gallucci said.

The tissue in question may have reached as far as Europe and China.
Gallucci said he has been interviewed by German, Dutch and Chinese TV
crews, all of whom said there were affected patients in their
countries.

Gallucci downplayed the risk that the tissue could transmit
infections.

"There's been a feeding frenzy among attorneys who practice in the
personal injury field who think there's been diseased tissue," he
said.

Gallucci said Mastromarino was a dentist who gave up his license in
2000 "because he wanted to go in a different direction." A New York
state Web site indicates Mastromarino's license was suspended, and New
York newspapers reported that was connected to drug abuse.

"He did have a problem, but I'm not going into that," Gallucci said.
"He had to voluntarily surrender his license."

In October, the FDA announced a voluntary recall of tissues harvested
by Biomedical Tissue Services. Infection risks were low for tissues
that already had been implanted, according to the FDA.

Biomedical harvested bone and other tissue for five companies that
processed and sanitized the material. Those companies typically
package tissue for distribution by contractors, who deliver it to
hospitals.

Hospitals as far-flung as Texas, North Carolina, Canada--and now
Illinois--have implanted the questionable tissue in hundreds of
patients, according to published news accounts. Affected patients
nationwide have raised concerns about whom their tissue came from, and
some reportedly are threatening lawsuits, contending they contracted
diseases including syphilis.

Officials are concerned that the tissue did not undergo standard
prescreening, which would have eliminated some potential donors, such
as cancer patients or those with communicable diseases.

The exact number of patients affected is being compiled but has not
been publicly released, FDA spokesman Stephen King said.

King stressed that tissues were subject to rigorous testing by the
five processing companies. He said those companies may have accepted
problematic tissue based on forged paperwork and had no knowledge of
the alleged scheme.

Although FDA inspectors recently reviewed Biomedical Tissue Services
logs and found no problems, King said officials now believe the
inspectors were presented with falsified documents.

Both the Evanston Northwestern Healthcare system hospitals and
Northwestern Memorial Hospital received tissue samples from Medtronic
Sofamor Danek of Memphis, Tenn.

Medtronic distributes for Regeneration Technologies Inc., of Alachua,
Fla. A spokeswoman for Regeneration Technologies declined to comment
except to say all tissues processed by the company have undergone
stringent testing and sanitation.

Bert Kelly, spokesman for Medtronic, said his company has provided
information about the tissue to hospitals and has set up a help line
for patients with concerns.

"We were shocked. We were caught off-guard," Kelly said. "In that
chain of distribution, we immediately went into reaction mode to make
that as right as we could."

Northwestern spokeswoman Sullivan said her hospital began receiving
information from Medtronic in early November, beginning a
labor-intensive process that involved pulling thousands of medical
records and checking tissue lot numbers.

Physicians this week called the 17 Northwestern patients and were in
the process of screening them for communicable diseases, she said.

No patients from other cities have tested positive for infection, said
Scott Brubacker, chief policy officer for the American Association of
Tissue Banks, which accredits tissue organizations.

The situation is unprecedented, Brubacker said, and he worries that
some media characterizations of the tissue transplants as ghoulish
will have a chilling effect on donors.

Legitimate tissue harvesters do go to funeral homes and collect parts
with appropriate consent from donors who were properly screened, he
said.

----------
tmaxwell;@tribune.com
jmanier;@tribune.com
Copyright © 2006, Chicago Tribune

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