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Subject: Company did not test donated tissues


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Boule: Oregonian
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Date Posted: Mon, October 21 2002, 7:29:32 PDT
In reply to: Anna Lok, MD Thomas Shehab MD Mauricio Orrego, M.D. UMich 's message, "Doctors/Patients Not Following Through on Hepatitis C Screening" on Mon, July 30 2001, 8:16:52 PDT

Boule: Company did not test donated tissues

All Don Payne wanted to do was hike and ski with his kids again. That's why he agreed to have knee surgery last April 10.

He didn't think there would be much risk. It was a fairly standard surgical procedure to replace a knee ligament and a piece of bone with tissue and bone from a cadaver.

If someone had said to Don, "You know, the tissue they're going to transplant into your body comes from a man who had hepatitis C, and you could contract the disease from that tissue," Don would have walked -- or limped-- away from the surgery. More likely, he would have decided to use tissue from his own body to make the knee repair.

But nobody said that to Don, because nobody knew the tissue used in his transplant was infected with hepatitis C, even though at least one person who'd received an organ from the same man, in the hours after he died in 2000, later died from liver disease. Even though the tissue had been stored for 18 months, more than enough time for a viral nucleic acid assay test to be conducted on the blood of the man who died -- a test that is routinely done on all blood that is donated.

The test costs only $50, but it's not required by law. So it wasn't done. And last spring, 82 samples of the infected man's tissues were released. Thirty-four of them were transplanted into patients; one of them was Don.

And now Don has hepatitis C, an incurable disease. Once all he wanted was to hike and ski with his kids again. Now all he wants is to stay alive. Don Payne's troubles began when somebody ran a stop sign on State Route 14, near Skamania, Wash., on Feb. 24, 2001. Don, who's 48 and lives in Vancouver, was out for a ride on his motorcycle when the car slammed into him.

When Candy Payne got a call saying her husband had been in an accident, "I could tell from the sound of the voice that it was serious." Candy is a nurse, although she's not practicing now.

Don was taken by LifeFlight helicopter to Legacy Emanuel Hospital and Health Center, where he remained in intensive care for almost a week; the next weeks and months were filled with hospital stays and surgeries to repair his fractured pelvis, ruptured bladder, crushed right arm and blood clots. Don did not return to work full time at a Portland high-tech company until November.

"Finally we got to the point in my recovery where we started looking at the knee," Don says. "My daughter was getting married on April 6, and I wanted to walk her down the aisle before I had my knee surgery. So we had the surgery on the 10th of April."

Don and his surgeon had two choices: they could use cadaver tissue or tissue from Don's own body . "Because of the trauma my leg had been through," and ensuing circulation problems, "we didn't want to use my own tissue," Don says.

"I didn't think a whole lot about that," Candy says. "Being a nurse, I know this stuff is well scrutinized and tested."

The surgery went well. By summer Don was able to hike.

But unbeknown to Don, a woman who received another ligament from the same donor had developed acute symptoms of hepatitis C six weeks later. Her doctor contacted health officials, who began to investigate.

On July 23 the phone rang at the Payne home. It was a nurse from Community Tissue Services in Dayton, Ohio. There was a possibility Don had hepatitis C, she said. "My wife is a nurse, and my daughter is a nurse," Don says, "and I know of all the things they talked about fearing, it wasn't HIV. It was hepatitis C. That was always their major concern."

"The nurse was very apologetic," Candy says. "She said the team that had procured the organs had checked back and . . . couldn't think of anything they had slipped up on." The donor's blood had been tested for antibodies to hepatitis C when he died, the nurse said, and the test had been negative.

But after a person first gets hepatitis C, there's a window of time before antibodies develop. During that time, the more sophisticated viral nucleic acid assay test can diagnose the presence of the actual disease, not just the antibodies. The test is done routinely on all donated blood but not on transplanted organs because it takes more hours than organ recipients often can wait.

But the test certainly could have been performed in the 18 months the man's tissues were stored, before being released for transplant. "I would have given them $50 cash to do that, if I'd known," Don says.

"We would have paid them more than $50, if they wanted to make a profit," Candy says.

But the test is not yet required by the FDA or by law, and it was not done.

Don tested positive for the disease. "It was bad news," he says. News that changed the way he lives his life, in ways large and small, public and personal. Now Don has to be careful he doesn't infect his family members or his friends.

Don and Candy and their children have gone through "all the emotions," Don says. Hepatitis C is a volatile disease; it can kill quickly or lie dormant for a decade or more. Don is doing research, seeing specialists, going through extensive tests to see how quickly his infection is progressing.

After a lot of thought, Don and Candy have hired attorney Jeffrey Withol and are going to sue the Community Tissue Bank. A spokesperson for the company was unavailable for comment before publication deadline.

"What makes me angriest is it wasn't necessary -- this could have been prevented," Don says. "The technology and the testing is in place and accessible."

Some days Don and Candy handle things well -- they "dance in the daisies," as Don puts it. They understand there are people who are more sick, in greater pain. "But statistics are interesting until you're that statistic," Don says. "And then it becomes very personal and very real. I'm dealing with something I should not have to be dealing with."

Even on the days they struggle, the Paynes' 28-year marriage and their faith provide comfort. "God carried us in his hand through the motorcycle accident," Don says, "and we know he's going to carry us through this. We just don't know where we're going." Margie Boule: 503-221-8450; marboule@aol.com

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Subject Author Date
Screening for antibodies alone does not exclude infection with hepatitis C virusHinrichsen; Gut 2002; 51(3): 429-433Sat, January 04 2003, 6:35:02 PST



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