A Downside of Organ Donation

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Within three months of his kidney transplant last March at New York Presbyterian Hospital, Peter C. Platt was rehospitalized with serious infections that did not respond to treatment. The culprit: strongyloides, an intestinal parasite that had been found in the donated organ. He died on July 15, surrounded by his grieving family.

"The kidney transplant was supposed to be the gift of life, but it ended up taking it away," says his widow, Shirin Platt, who contacted state and federal health officials about the case and is lobbying for more-rigorous testing of donated organs. "At the very least, we need to make sure that possible recipients know more about the dangers from transplants." New York Presbyterian declined to comment, citing patient-privacy laws.

Mr. Platt's death, which is being investigated by the Centers for Disease Control and Prevention, is one of a small but growing number of transplant-related disease-transmission cases. Just last Friday, for example, the University of Mississippi Medical Center disclosed that two recipients had fallen seriously ill after receiving organs from the same deceased donor, whose organs went to four recipients in three states. The CDC found the donor was infected by a rare amoeba the hospital did not detect in routine testing.

The hospital said transplant surgeons deemed the organs suitable for transplant and it is "working closely with the CDC and the Mississippi State Department of Health to revisit our medical evaluation of the donor and what may have happened."

Most transplants do indeed save lives. But as demand grows for donated organs and tissues, so do concerns about the risk of disease transmission, including deadly bacterial infections and viruses, tuberculosis, rabies, parasites and even cancers. Some experts are calling for better testing and tracking of organ donors in order to limit the number of infections, though others warn that this could have the effect of delaying transplants, producing false-positive results that would eliminate safe organs and adding costs to the health-care system.

In late November, the United Network for Organ Sharing, the nonprofit that operates the nation's organ-transplant system, recommended that lungs and intestines from donors known to be infected with the H1N1 swine-flu virus not be used because of infectious risk, and said the lungs of donors with seasonal influenza should also be avoided. A Unos spokeswoman says the group is working on several fronts to "bring risks of transmissible disease to the lowest possible threshold."

Unos, which began collecting data about disease transmission through organs in late 2004, said in a study published earlier this year that it was reported in only about 1% of all deceased-donor donations. But the number of reported cases grew from seven in 2005 to 60 in 2006 and 97 in 2007, and the study acknowledged that the number of disease transmission is underreported.

In a new report commissioned by the U.S. Department of Health and Human Services, experts from the CDC and other government agencies warn that a patchwork of regulations and voluntary efforts by groups such as Unos aren't sufficient. The report, "Biovigilance in the United States: Efforts to Bridge a Critical Gap in Patient Safety and Donor Health," calls for the creation of a centralized system to monitor blood, organ and tissue safety, gather reports of illness or adverse reactions among recipients, and quickly trace organs and tissues from donors who are found to carry infectious diseases. (It is available at hhs.gov/bloodsafety.)

Balancing Need and Risk
The report highlights the growing dilemma of how to balance the need for organs and tissues against the risks of contracting a potentially fatal disease or infection from the donor. There are close to 30,000 organ transplants in the U.S. each year, and medical advances are making it possible to transplant hands, faces and intestines. Live donors may now give portions of a lung, liver or pancreas, in addition to providing kidneys.

Still, about 9,000 people in the U.S. die each year waiting for an organ. And with an ever-expanding waiting list of patients in need, transplant centers are more often accepting deceased donors with high-risk behavioral and social profiles, such as IV drug users, the report says. Moreover, in the scramble to match sick patients with organs, time is often short, increasing the potential for missing a potentially transmissible disease. While organ donors are screened for certain diseases, such as hepatitis C and HIV, screening tests are costly and imperfect and don't cover every infectious disease.

Organ donors are also often the source of donated tissues, ranging from bones and heart valves to skin and tendons. With about two million tissue grafts transplanted each year, new industry standards include more rigorous testing for disease, and tissues—unlike organs, which must be used right away—are typically sterilized before use. But that doesn't always eliminate infectious agents. One donor may be the source of 100 different grafts sent to multiple locations around the world, which can be difficult and sometimes impossible to track down.

"There has to be a balance between safety and availability, but right now all the emphasis is on availability," says Matthew Kuehnert, who oversees blood transfusion and transplant safety at the CDC and was one of the authors of the biovigilance report. Even with a dire need for organs, he says, patient safety should never be compromised, especially when some transplant patients can afford to wait for more-thorough screening.

"It is a horrible waste if a kidney recipient dies from a rabies infection from the donor, when they could have waited for a more suitable organ or remained on dialysis," Dr. Kuehnert says.

Jerry Holmberg, senior advisor for blood policy at the Department of Health and Human Services, says the agency is reviewing the biovigilance report and taking its recommendations "very seriously." He notes that doctors are expected to go over the pros and cons in the "informed consent" discussion prior to transplant and make a "risk-benefit" calculation. But he acknowledges that patients need tools and information to make the calculation. "A patient hanging on at the end of life may make a decision to take an organ from a high-risk donor," concluding that at the primary goal is to stay alive, and worry about treating an infectious disease later, Dr. Holmberg says.

Donor ID System
Unos recently completed a pilot program—dubbed the Transplantation Transmission Sentinel Network—to detect, report and track disease transmission from donors to organ-, tissue- and eye-transplant recipients, using a unique donor identification system. No disease transmissions were identified during the pilot. The CDC has asked industry groups and transplant organizations to help it determine how to operate and fund a national version of such a system, and is working with public health officials in Europe and Canada to coordinate programs for organ and tissue safety.

Michael G. Ison, medical director of Northwestern University's transplant service and head of the disease-transmission risk committee at Unos, says that many diseases transmitted through organs are treatable. And while it is relatively easy to discard donated tissues such as tendons or skin and get substitutes if there is concern about disease risk, it is much harder to make that call with organs, given the pressing need for donors. "The safer you make the organ pool, the fewer organs you are going to have," Dr. Ison says.

However, there is no guarantee that a disease contracted from a donor organ or tissue graft can be successfully treated. When Mr. Platt was readmitted to the hospital, he was vomiting blood and unable to breathe, says Ms. Platt, and didn't respond to blood transfusions, drugs and other treatments.

Ms. Platt says her husband, who was 68, was conscious of the risks of disease transmission in donated organs, and had earlier turned down a kidney from an IV drug user in California because such donors are considered at risk of carrying several infectious diseases. The kidney he accepted was from a 58-year-old woman who lived in Las Vegas but was originally from Honduras. Strongyloides, the parasite that attacked his immune system after the transplant, is common in Central America.

Ms. Platt says the medical staff who cared for her husband told her that the parasite came from the donated kidney. She says the medical staff provided excellent care. But in a letter to the blood safety advisory committee, she said her concerns are "in the procurement of donated organs and how the organs are tested prior to being considered for transplant…. Are the risks from organs not completely tested worth the chance of infection, and the untimely death of my husband of 43 years?"

While transplant centers are required by Unos to report suspected donor-transmitted diseases and infections, doctors may not always recognize symptoms after transplantation or follow patients closely to monitor possible disease outbreaks. Hepatitis C, for example, can emerge more than a year after infection, and if one recipient is found to be infected, transplant centers may not always be able to contact other organ and tissue recipients to notify them and have them tested. They also may not be able to trace all the tissues from that donor, which could infect others.

Donating Hepatitis
In one case, 91 different tissues and organs were provided by a male donor in Oregon in his 40s with a history of alcohol abuse who had tested negative for hepatitis C, which is a leading and potentially fatal cause of chronic liver disease. He was later found to have carried the virus. Forty patients received transplants using his organs and tissues over 22 months. Eight of them were infected, and two later died. The CDC's Dr. Kuehnert says that the outbreaks weren't detected until nearly two years after the donor's death, and with no system to notify the tissue bank that distributed the tissues, some patients were infected who might have avoided using the tissues, while others couldn't be traced.

A study of the case published in the Annals of Internal Medicine in 2005 concluded the donor was probably in the eight-to-10-week window period between infection and the development of detectable disease. Though a process known as nucleic-acid testing can detect disease in the window period, it is costly and can take one to two days—impractical when transplanting organs, which, unlike tissues that can be preserved and frozen, must be immediately transferred from a deceased donor to a live patient to be viable. By one estimate, if such tests were used on all donors, the cost of eliminating one hepatitis C-infected donor would be $2.3 million, the study noted.

It may be impossible to eliminate disease risks or test for all possible infectious agents. But "we need to make transplant centers and surgeons more aware of the risks of disease transmission, and give them a system to rapidly report disease outbreaks," Dr. Kuehnert says. "If we recognize infection in one recipient, we can help the other recipients from the same donor in real time."