40 Unknowingly Got Tissue or Organs Tainted With Hepatitis C

[Guest guest]

40 Unknowingly Got Tissue or Organs Tainted With Hepatitis C

By SANDRA BLAKESLEE

Forty people received tissue or organs from an Oregon man who died two years

ago with an undiagnosed case of viral hepatitis that can spread chronic

liver disease, state health officials say.

Five of the six organ recipients have died, one of them from liver disease

that may have originated with the donor, said Dr. Barna Tugwell, an

epidemiologist from the federal Centers for Disease Control and Prevention

who is assigned to the Oregon Health Department and is in charge of the

investigation. Whether the hepatitis contributed to the other deaths is

still unknown, Dr. Tugwell said. The remaining organ recipient has the liver

disease hepatitis C.

Of the 34 people who received tissue from the Oregon man, 4 have hepatitis

C; 3 tested positive for the disease but were found to have had it before

their transplant; 9 have no sign of liver disease; and health officials are

still trying to find the others, who are scattered through 14 states, South

Korea and Italy.

The case is more bad news for the nation's human tissue industry, which has

come under attack since late last year, when at least one death and scores

of illnesses were traced to tissues contaminated with dangerous bacteria and

fungi.

In August, the Food and Drug Administration restricted the operations of a

major tissue processor, CryoLife Inc. of Kennesaw, Ga., because the methods

it used to cleanse donated tissues were deemed inadequate.

In the Oregon case, however, the tissue bank that collected the organs and

tissues did " everything by the book, " Dr. Tugwell said. Dr. Ian , an

epidemiologist at the federal disease centers, said the donor was probably a

" window case " - that is, he was unknowingly infected shortly before he died

and never showed any symptoms of the disease. (Health officials routinely

withhold the names of those under investigation.)

The donor's blood was tested at death with a standard procedure that cannot

detect the virus for weeks or even months after infection, Dr.

said. A newer blood test, the viral nucleic acid assay, can pick up

infections one to two weeks after they begin, he said, but is not being used

by organ or tissue banks because cadaver blood has properties that make the

test inaccurate.

Dr. Tugwell presented a report on the investigation on Saturday at the

annual meeting of the American Society for Microbiology in San Diego. In an

interview yesterday, she said: " We assume what happened is a very rare

circumstance. But we really don't know how big a problem this is or how

frequently we'll see it. "

Hepatitis C virus is one of the most important causes of chronic liver

disease in the United States, accounting for 70 percent of chronic hepatitis

and up to half of all cases of end-stage liver disease and liver cancer. The

virus is transmitted when blood or body fluids from an infected person

enters the blood of a person who is not infected, most often through needles

shared by drug users.

Of those initially infected, 80 percent show no symptoms, but many go on to

develop liver problems 10 or 20 years later.

In the early 1990's, a handful of people got AIDS or hepatitis from

transplanted tissue. The last known hepatitis C infection from a transplant

occurred in 1995. Since the early cases, blood and tissue banks have been

required to ask donors or their relatives whether they have ever used drugs

intravenously or have had a blood transfusion.

The weakness in this strategy is that a relative may not know that a donor

engaged in risky behavior, Dr. said. Donors may not know they carry

the virus.

The Oregon donor, an unmarried blue-collar worker in his early 40's, died of

a brain hemorrhage two years ago today. Given the healthy state of his body,

the organ and tissue bank in Portland harvested 7 organs (the pancreas was

later discarded), 82 tissues and 2 corneas. Six organs were transplanted

immediately. The two corneas were sent to Italy, Dr. Tugwell said.

The tissue bank froze and held back most of the other tissues until last

March, said Bob Rigney, chief executive of the American Association of

Tissue Banks in andria, Va. Such delays are common in the industry

depending on demand for tissues, he said.

On April 17, a woman received a knee ligament from the donor, Dr. Tugwell

said. Six weeks later she developed acute symptoms of hepatitis C. One of

her physicians alerted the health authorities and the investigation began.

A stored sample of the donor's blood was retested with a newer version of

the antibody test, Dr. Tugwell said. It was negative. The blood was then

tested again with the more sophisticated nucleic acid assay. It was

positive.

The tissue bank learned of the infection on June 27, Mr. Rigney said. It

immediately quarantined everything from the donor in inventory and recalled

44 tissues that had gone out to other tissue processors or to transplant

surgeons.

Only one organ recipient, who got a kidney, was still alive, Dr. Tugwell

said. Tests showed that she contracted hepatitis C virus after her

transplant, although she has no symptoms. " She's doing fine, " Dr. Tugwell

said. " You can live with this disease for a long time. "

In the case of the lung recipient who died, Dr. Tugwell obtained blood

samples taken on the day of her surgery and four days afterward. The first

sample tested negative for hepatitis C, the second positive, suggesting that

the woman got the virus from the donor's lung. No one tested the patient for

hepatitis after her surgery because there was no obvious reason to do so,

Dr. Tugwell said. But her hepatitis C was diagnosed about a year later, and

she died not long after that from liver disease and other complications.

If someone had alerted the tissue bank back then, the other tissues could

have been quarantined, Mr. Rigney said. But by the time the tissue bank

learned of the infection, 34 people had been implanted with other tissues.

Of those, hepatitis C virus has been identified in four transplant patients

so far - two with parts of knees, one with an Achilles' heel and one with a

leg vein.

http://www.nytimes.com/2002/10/04/health/04TISS.html?ex=1034395200 & en=54638c

2ff5f15879 & ei=5040 & partner=MOREOVER

[Guest guest]

40 Unknowingly Got Tissue or Organs Tainted With Hepatitis C

By SANDRA BLAKESLEE

Forty people received tissue or organs from an Oregon man who died two years

ago with an undiagnosed case of viral hepatitis that can spread chronic

liver disease, state health officials say.

Five of the six organ recipients have died, one of them from liver disease

that may have originated with the donor, said Dr. Barna Tugwell, an

epidemiologist from the federal Centers for Disease Control and Prevention

who is assigned to the Oregon Health Department and is in charge of the

investigation. Whether the hepatitis contributed to the other deaths is

still unknown, Dr. Tugwell said. The remaining organ recipient has the liver

disease hepatitis C.

Of the 34 people who received tissue from the Oregon man, 4 have hepatitis

C; 3 tested positive for the disease but were found to have had it before

their transplant; 9 have no sign of liver disease; and health officials are

still trying to find the others, who are scattered through 14 states, South

Korea and Italy.

The case is more bad news for the nation's human tissue industry, which has

come under attack since late last year, when at least one death and scores

of illnesses were traced to tissues contaminated with dangerous bacteria and

fungi.

In August, the Food and Drug Administration restricted the operations of a

major tissue processor, CryoLife Inc. of Kennesaw, Ga., because the methods

it used to cleanse donated tissues were deemed inadequate.

In the Oregon case, however, the tissue bank that collected the organs and

tissues did " everything by the book, " Dr. Tugwell said. Dr. Ian , an

epidemiologist at the federal disease centers, said the donor was probably a

" window case " - that is, he was unknowingly infected shortly before he died

and never showed any symptoms of the disease. (Health officials routinely

withhold the names of those under investigation.)

The donor's blood was tested at death with a standard procedure that cannot

detect the virus for weeks or even months after infection, Dr.

said. A newer blood test, the viral nucleic acid assay, can pick up

infections one to two weeks after they begin, he said, but is not being used

by organ or tissue banks because cadaver blood has properties that make the

test inaccurate.

Dr. Tugwell presented a report on the investigation on Saturday at the

annual meeting of the American Society for Microbiology in San Diego. In an

interview yesterday, she said: " We assume what happened is a very rare

circumstance. But we really don't know how big a problem this is or how

frequently we'll see it. "

Hepatitis C virus is one of the most important causes of chronic liver

disease in the United States, accounting for 70 percent of chronic hepatitis

and up to half of all cases of end-stage liver disease and liver cancer. The

virus is transmitted when blood or body fluids from an infected person

enters the blood of a person who is not infected, most often through needles

shared by drug users.

Of those initially infected, 80 percent show no symptoms, but many go on to

develop liver problems 10 or 20 years later.

In the early 1990's, a handful of people got AIDS or hepatitis from

transplanted tissue. The last known hepatitis C infection from a transplant

occurred in 1995. Since the early cases, blood and tissue banks have been

required to ask donors or their relatives whether they have ever used drugs

intravenously or have had a blood transfusion.

The weakness in this strategy is that a relative may not know that a donor

engaged in risky behavior, Dr. said. Donors may not know they carry

the virus.

The Oregon donor, an unmarried blue-collar worker in his early 40's, died of

a brain hemorrhage two years ago today. Given the healthy state of his body,

the organ and tissue bank in Portland harvested 7 organs (the pancreas was

later discarded), 82 tissues and 2 corneas. Six organs were transplanted

immediately. The two corneas were sent to Italy, Dr. Tugwell said.

The tissue bank froze and held back most of the other tissues until last

March, said Bob Rigney, chief executive of the American Association of

Tissue Banks in andria, Va. Such delays are common in the industry

depending on demand for tissues, he said.

On April 17, a woman received a knee ligament from the donor, Dr. Tugwell

said. Six weeks later she developed acute symptoms of hepatitis C. One of

her physicians alerted the health authorities and the investigation began.

A stored sample of the donor's blood was retested with a newer version of

the antibody test, Dr. Tugwell said. It was negative. The blood was then

tested again with the more sophisticated nucleic acid assay. It was

positive.

The tissue bank learned of the infection on June 27, Mr. Rigney said. It

immediately quarantined everything from the donor in inventory and recalled

44 tissues that had gone out to other tissue processors or to transplant

surgeons.

Only one organ recipient, who got a kidney, was still alive, Dr. Tugwell

said. Tests showed that she contracted hepatitis C virus after her

transplant, although she has no symptoms. " She's doing fine, " Dr. Tugwell

said. " You can live with this disease for a long time. "

In the case of the lung recipient who died, Dr. Tugwell obtained blood

samples taken on the day of her surgery and four days afterward. The first

sample tested negative for hepatitis C, the second positive, suggesting that

the woman got the virus from the donor's lung. No one tested the patient for

hepatitis after her surgery because there was no obvious reason to do so,

Dr. Tugwell said. But her hepatitis C was diagnosed about a year later, and

she died not long after that from liver disease and other complications.

If someone had alerted the tissue bank back then, the other tissues could

have been quarantined, Mr. Rigney said. But by the time the tissue bank

learned of the infection, 34 people had been implanted with other tissues.

Of those, hepatitis C virus has been identified in four transplant patients

so far - two with parts of knees, one with an Achilles' heel and one with a

leg vein.

http://www.nytimes.com/2002/10/04/health/04TISS.html?ex=1034395200 & en=54638c

2ff5f15879 & ei=5040 & partner=MOREOVER