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By Deborah L. Shelton
May 6, 2005
"I'm human, I'm hurting": Laurie Post, 38, of Flemington, N.J., shows the scars from donating a piece of her liver to a cousin. The New York state health department substantiated her complaints regarding lack of informed consent and failure to treat complications after surgery. Post's surgeon said she received "outstanding" care. (J. B. Forbes/P-D) |
Healthy people who donate organs to those desperate for transplants enter a world of unknowns.
Even the medical community does not know how big a risk they face.
Some get hurt. Some die. Some need transplants later.
The Post-Dispatch spent a year examining living donations. The newspaper interviewed about 200 donors, family members, transplant surgeons, hospital officials, government officials and scholars, and studied medical records and transplant research.
The newspaper's investigation found:
No one knows how many donors have died or suffered serious injuries or complications, because donors are not systematically tracked.
The lack of comprehensive data makes it impossible for donors to assess the risks of what is portrayed as an ultimate altruistic deed.
There is no agreement on who can donate an organ or how to evaluate potential donors. Those approved to donate include children as young as 10, drug addicts, mentally ill people and people who might be selling their organs, which federal law prohibits.
The government does not regulate organ donations from living donors. Each hospital that performs transplants makes its own rules, which vary widely.
"There is no system and there is no accountability," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "Congress never created an authority. Transplantation has grown up as a mom-and-pop business with centers developing their own rules, and centers can do whatever they want."
The number of transplants performed in 2004 set a national record - 26,984 people got organs, according to data released by the government last month. The organs came from 7,150 deceased and 6,989 living donors.But it still wasn't enough.
About 110 people every day join a waiting list - a rate of about one every 13 minutes.
People who need organs increasingly are looking for live donors because there are not nearly enough deceased donors to meet the skyrocketing demand.
More than 71,000 people across the country have undergone major surgery to give away an organ, according to the United Network for Organ Sharing. Many came through the experience without serious problems. They have saved the lives of their mothers, sons, friends and strangers.
"The new trend toward living donors is a scary prospect to me when I know that there is so much data that the donor, so willing to help, is lacking to make a determination of the risks involved," said Nancy Rocheteau of Cape Cod, Mass. After her husband donated to his brother, his remaining kidney failed. He died despite getting a transplant.
Disease trends have exacerbated the organ shortage. Chronic kidney failure more than doubled in the United States in the 1990s. About 500,000 people are now in end-stage kidney disease. Diabetes and high blood pressure are the two main causes of kidney failure.
Demand for liver transplants also is rising. About 4 million Americans are infected with hepatitis C, and 20 percent or more of those infected eventually could need a new liver. Hepatitis C is the leading cause of liver disease leading to liver transplant.
The vast majority of organs donated are kidneys. In addition to a single kidney, a combination kidney and pancreas, or part of a liver, lung or intestine can be donated while alive.
Every person who gets a transplant is tracked long-term so people who need an organ transplant can find lots of data on death rates and complications.
That's not the case for donors. They face risk, get no medical benefit and find data hard to come by. "If you don't do donor follow-up, how can you get informed consent?" said Gregory Pence, a bioethicist at the University of Alabama at Birmingham. "You have no data to present to a patient about what may happen."
Dr. Arthur Matas, who heads the kidney transplant program at Fairview-University Medical Center in Minneapolis, estimates that three of every 10,000 kidney donors are expected to die as a result of donating, and less than 10 percent will develop complications. He based his estimates on his experience, studies at various centers and a survey in which 171 of 234 transplant centers reported on complications their donors experienced between 1999 and 2001.
A study for the United Network for Organ Sharing in 2001 identified 56 kidney donors who later needed a kidney transplant themselves. The United Network for Organ Sharing is a private group that contracts with the federal government to match organs from deceased donors with recipients.
The researchers said the figures underestimated the actual number of living donors with kidney failure because the study included only patients listed for a transplant.
Estimates of complication rates for liver donors range from 15 percent to as high as 67 percent, according to the federal advisory committee on organ transplantation and an article published in December in a medical journal.
A United Network for Organ Sharing committee makes recommendations on living donors but has no authority to force compliance.
"You are not mandated to report to any agency when you have a donor complication," said Dr. David C. Cronin II, director of liver transplantation at Yale-New Haven Hospital in Connecticut. "Who knows how many are occurring, really?"
Some donors are taking it upon themselves to provide information to potential donors.
When Laurie Post set up a Web site to tell the world about her experiences as a liver donor, she got right to the point. She named her site liverdonornightmare.com.
Today she realizes how little she knew when she offered to be a liver donor 3 1/2 years ago.
She was 34 at the time, healthy, athletic and childless. When a cousin needed a transplant, Post figured she was the right person to volunteer.
Within three weeks of the surgery at New York University Medical Center, Post was feverish, vomiting and in intense pain. An ultrasound revealed a blood clot in the portal vein near her liver.
"I just grew sicker and kept the faith that they knew what they were doing," Post said. "And then I almost died."
Weeks later, with her health continuing to decline, she sought care at University Hospital in Newark, N.J. There she was diagnosed with multiple infections, a stone in her bile duct and a bile leak - in addition to the blood clot. Her liver and a lung were no longer working properly.
Her medical records indicate she was treated with antibiotics and transfusions. Bile fluid was drained from her abdomen.
Her surgeon, Dr. Lewis Teperman, said Post was fully informed about the risks of the surgery and received "outstanding" care afterward.
"Laurie's cousin is the one who is now alive because of Laurie," said Teperman, who is director of transplantation at New York University Medical Center. "I think sometimes in looking at these things we should look at the overall event, of what a good thing has happened. Outcome is important."
A September 2004 letter from the New York state health department said an investigation had substantiated Post's complaints, filed two years earlier, regarding lack of informed consent and failure to treat complications after the surgery. The hospital was ordered to file a plan to correct the problems within 15 days.
New York had published regulations governing live liver donations in December 2002 -- the only state that has established rules on living donations. Teperman headed the subcommittee on postoperative care.
Post realized after the transplant that she didn't understand what she was getting into.
Cronin, the director of liver transplantation at Yale-New Haven Hospital, said the idea that donors are given informed consent is "fictitious."
In the absence of a database of liver donors, Cronin said, "there's no way that you can explain to the majority of donors what really is going on in live donor liver transplant, when, in fact, the surgical community doesn't really know what's going on."
"Think of this conceptually," he explained. "I'm going to sit down and have a medical discussion with you about a highly complex and highly technical operation, which is filled with percentages. What does 1 percent mean to you? . . . Most people get the whole thing wrong because they have a conceptual difficulty with the value of numbers. You see this all the time. When you say it's a million, no one has a concept of what a million really is until you collect a million pennies or a million bottle caps, and you really see what a million is."
Cronin continued: "Now we're going to bring in a lay person of various degrees of education and we sit in an office for 20 minutes, half hour, and we try to impart on them years of experiences, years of risk analysis, years of statistical likelihood of what will occur, and they say: 'OK, sign me up.' Some would say that's informed consent. It's really not - you had a discussion. Thank God you at least had a discussion."
Even though little data has been collected about the long-term impact on live donors, some transplant professionals have been pushing the boundaries of who can give an organ.
In the past, donors were expected to be physically fit, in good overall health and free from high blood pressure, diabetes, cancer, kidney disease and heart disease.
To boost donation, however, some centers are accepting donors who are older, obese or who have a health condition such as high blood pressure that would have ruled them out a few years ago.
"If we say, we'll do the best cases - people at lowest risk, donors with no disease at all - we won't do very many transplants," said kidney specialist Dr. Stephen Textor of the Mayo Clinic in Rochester, Minn. "It's a situation where people in organ failure are on their way to death. The question is: How far are we willing to go to help them get back on track to be well?"
A session in May 2004 at the American Transplant Congress, a major international conference for transplant professionals, focused on whether criteria for live kidney donors should be broadened.
"We are testing people we wouldn't have tested before - for good reasons," said Textor, who chaired the session. "It's time to reconsider those criteria to see if those boundaries should be in place at all."
Transplant professionals are responsible for fully disclosing risks to potential donors, conducting comprehensive medical screening and weeding out those who have psychological problems. They also must assess whether donors are making up their minds free from coercion. No statistics were available on how many people are rejected.
Each center has its own criteria for evaluating donor candidates, which vary widely.
Barnes-Jewish Hospital has the largest living donor program in Missouri. The hospital did 71 kidney transplants using living donors in 2004.
Dr. Will Chapman, director of the abdominal transplant surgical program at the hospital, said Barnes-Jewish is cautious when considering live donors. "We're probably one of the most conservative centers in the country," he said. "From our standpoint, I don't think general guidelines would change our approach."
Textor of the Mayo Clinic said in a phone interview that there are "issues about donors - about whether they ever used drugs, whether they've ever been depressed. You name it. Nobody's a perfect donor."
A questionnaire given to 50 or so professionals from transplant centers across the country at the start of the American Transplant Congress workshop showed wide differences on standards for donors. At least one transplant center represented there set an age-cutoff for donation at 90.
Textor said he prefers older kidney donors because the possibility for developing kidney disease would already be evident by age 60. And fewer years of life would have been lost if the donors died, he said.
"Some disagreement is inevitable in an area where there are many unknowns," said Mark Aulisio, director of the Clinical Ethics Program at MetroHealth Medical Center in Cleveland. Leaders in the field need to work together to develop a more uniform process for deciding who is an appropriate donor, how to do the transplant and how to follow up, he said.
It's important to raise the standards because of the uniquely altruistic nature of live donation - healthy people choosing to undergo surgery that, for them, is medically unnecessary, Aulisio said.
Some surgeons say the variability between centers is not that wide.
The Fairview-University Medical Center in Minneapolis has done more live donor kidney transplants than any center in the world - more than 1,800 since 1988, including 140 last year.
"You'll find consensus on 90 percent of the guidelines," said Matas, head of kidney transplantation at the hospital. "But some centers would use a 65-year-old as a donor and some wouldn't."
Barbara Tarrant was 69 when she gave a kidney. Nearly four years after she donated, her family is still angry and perplexed about the absence of universally accepted standards for donor selection.
"There's not a lot of research on what happens to the donor," said her daughter, Carole Tarrant. "Before Mom did this, I went online to find out how many times bad things happen, but there just wasn't anything."
At the time, Barbara Tarrant was a grandmother who was always on the go. She played tennis, tended her garden, volunteered at a local historical site and worked out with a senior aerobics class. She was the sole caretaker of her father, who suffered from dementia, and her mentally retarded son.
She suffered a massive stroke the day after donating to that son at Pitt County Memorial Hospital in Greenville, N.C. She is partially paralyzed and has trouble communicating, and now lives in a suburban Philadelphia nursing home.
Carole Tarrant said she and other family members couldn't understand why transplant staff accepted their aging mother as a donor when four siblings were available who also shared the same blood type.
Asked whether Barbara Tarrant's age had anything to do with her stroke, her surgeon, Dr. Carl Haisch said, "Obviously, yes."
"The incidence of stroke goes up in people who are older," said Haisch, Pitt County's director of transplantation. "Could we have predicted it based on the information we had at the time? No. We went back and looked, figuring we had missed something, and we didn't."
Since 1988, 689 people age 65 or older had donated an organ, according to United Network for Organ Sharing data through April 22.
Children also are donating. A recent search by the Post-Dispatch of data reports submitted to the United Network for Organ Sharing showed three minors in the 11 to 17 age group donated part of their livers, a risky surgery.
Kidneys have been removed from at least 60 minors, including a 10-year-old, according to an analysis in the American Journal of Transplantation in April 2002. It found a pattern of using minors for live kidney donations in a way not endorsed by a consensus of transplant professionals. The consensus was that minors shouldn't be used except in rare circumstances, such as for a sibling when no other options are available.
It's not clear if the numbers of children and teenagers who donated were accurate because some data reports returned to the United Network for Organ Sharing did not include donors' ages.
In the journal study, some organs went to siblings. But most of the organs transplanted from children and teenagers went to adults, some in their mid-50s.
The biggest age discrepancy was between a 14-year-old donor and a 54-year-old recipient. In one case, the transplanted organ failed within two days.
Even when a sibling is the intended recipient, parents face an ethical dilemma: helping a sick, possibly dying, child while protecting the best interests of the healthy underage donor.
The paper's co-authors were particularly disturbed about cases in which the blood-tissue match between the child donor and the recipient over age 40 was less than ideal, raising questions about why the children were accepted at all.
"Especially concerning was the transplant of minor donor kidneys to adult recipients whose cause of renal failure was recorded as types I and II diabetes," wrote transplant surgeons Francis Delmonico and William Harmon. The minors probably were donating to parents or grandparents, which means they face the possibility of developing diabetes later in life, which then could put them at risk for kidney failure.
The federal agency in charge of overseeing organ transplants, the Health Resources and Services Administration, has maintained a hands-off approach with the live donor process.
"The government has stayed away from living donation, partly out of the fact that it's really not mandated for it," said Dr. James Burdick, director of the agency's division of transplantation. The agency is part of the U.S. Department of Health and Human Services.
The National Organ Act of 1984 doesn't address living donation specifically. However, the agency could regulate the system if it wanted to, he said.
Transplant officials are still feeling their way around a relatively new and rapidly evolving area of medicine, Burdick said.
"The transplant system for both deceased and living donors is really part of the medical care process in the country," said Burdick, a former transplant surgeon. "And the professional and institutional standards are really the dominant factors."
Professional groups include the American Society of Transplant Surgeons and the American Society of Transplantation, a membership organization of doctors, nurses, social workers and others. Their guidelines are voluntary.
"The field of transplantation has developed to a large degree through efforts of people who were doing things that most people thought would never work," Burdick said, echoing the viewpoint of many surgeons. "It isn't a mature field as yet. The field of transplantation is not about to start making complicated rules to get everybody to do the same thing forever.
"We have a lot of things that aren't as good as they should be. But institutional approaches to innovation, which is one of the strengths of American medicine, is where this would fall."
"Think of this conceptually. I'm going to sit down and have a medical discussion with you about a highly complex and highly technical operation, which is filled with percentages. What does 1 percent mean to you? . . . Most people get the whole thing wrong because they have a conceptual difficulty with the value of numbers. You see this all the time. When you say it's a million, no one has a concept of what a million really is until you collect a million pennies or a million bottle caps, and you really see what a million is.
"Now we're going to bring in a lay person of various degrees of education and we sit in an office for 20 minutes, half hour, and we try to impart on them years of experiences, years of risk analysis, years of statistical likelihood of what will occur, and they say: 'OK, sign me up.' Some would say that's informed consent. It's really not - you had a discussion. Thank God you at least had a discussion."
- Dr. David C. Cronin II
Director of liver transplantation at Yale-New Haven Hospital
Reporter Deborah L. Shelton
E-mail: dshelton@post-dispatch.com
Phone: 314-340-8203
Copyright © 2005 St. Louis Post-Dispatch.
This article posted June 12, 2005.