Screening Risky Organ Donors

This week we learned that four Chicago organ transplant recipients got HIV and hepatitis C from a donor who was considered at high risk of carrying the diseases. These cases are very rare—it's been two decades since the HIV virus was transmitted to an organ recipient. But it turns out that donations by those considered high risk are far more common than most Americans might think. About 9 percent of all organs come from people who have reported the kind of behavior (injecting recreational drugs, spending time in jail or men having sex with other men) that puts them at higher risk for HIV and other diseases.

All donors are tested for the virus, and it's against the law to transplant an organ from a known HIV-positive donor. But it's legal to do so with a donor in the high-risk category, as long as he or she tests negative for the virus. However there's still a small window of time between when someone contracts the virus (usually less than a month) and when it shows up in a test. So if a donor dies in that time period, he or she may test negative but still be capable of transmitting the disease.

So why do surgeons and organ recipients take the chance of infecting their patients (as small as it might be)? The numbers speak for themselves: More than 98,000 Americans are on the wait list for an organ, and last year only 14,755 people donated organs. More than 6,000 people die each year because they fail to receive one in time. "There are many, many more people on the transplant waiting list than there are organs. That's forcing organ-procurement organizations to take donors that might otherwise be excluded," explains Matthew Kuehnert, director of blood, organ and tissue safety for the U.S. Centers for Disease Control. In fact, the risk-benefit equation is so clear that the CDC guidelines actually spell it out saying that high-risk donors are OK if "the risk to the recipient of not performing the transplant is deemed to be greater than the risk of HIV transmission and disease."

Those same CDC guidelines suggest—but do not require—getting the recipient's "informed consent regarding the possibility of HIV transmission." And for now, no one is tracking how often surgeons tell patients that they're receiving an organ from a high-risk donor. The three well-respected Chicago hospitals that in January transplanted the HIV-infected organs cannot, because of federal privacy laws, reveal what they told the recipients about the donor. But a lawyer for one of the patients has revealed that she was not told before surgery that her organ came from a high-risk donor.

So the question remains, should informed consent be mandated? Not necessarily, says Dr. Jim Burdick, who runs the division of transplantation for the U.S. Health Resources and Services Administration, which oversees organ transplantation. "It's not something you can easily put in regulatory text that would be overseen by some sort of policing action." Also, some surgeons don't believe it's in the best interests of the patient. "We're offering them a terrible choice if we say, 'we have an organ, it's probably OK, but there might be a problem'," says Dr. Jay Fishman, director of transplant infectious disease for Harvard's Massachusetts General Hospital. "That's not the kind of decision that patients should have to make."

Others disagree. "There's a need for more disclosure of risk information to potential recipients," says Arthur Caplan, chair of the department of medical ethics at the University of Pennsylvania. And recipients may very well decide to take a chance on an organ from a high-risk donor. "It's hard to say no to it because there aren't that many organs coming up," says Caplan. "Something looks better than nothing."

Ideally, doctors would talk to potential recipients about the percentage of donors who may be high risk very early in the process. "You certainly don't want to bring up this issue for the first time when you basically have an organ out in front of your eyes," says Dr. Michael Millis, director of transplantation at the University of Chicago Medical Center. "We inform them early on and then what is specifically discussed at the time of transplant is between the patient and the surgeon and the coordinator."

Some transplant recipients say they can understand why an infected patient would say yes even if they knew the organ was coming from a high-risk donor. "I would be surprised if anyone who had a terminal illness, guaranteed, would turn away an opportunity to live another few years," says Earl Rosenbaum, 59, a nursing-home consultant who, until he got a liver transplant three months ago, suffered from a rare cancer of the bile duct. "Your whole life is in front of you, and you know you're not going to be here in a year or six months. You see things differently." (Rosenbaum was lucky to get a partial liver transplant from his son-in-law.) Harvey Saver, 56, of Evanston, Ill., who got a pancreas and kidney transplant five years ago, isn't sure whether he would have said yes or no if he had been told his donor was high risk. Maybe, he says, "I would have been so anxious I would have jumped at it."

As rare as the Chicago cases are, the incident has renewed the push for improved HIV testing. "The physicians and surgeons are heartbroken about [the HIV transmission], the patients are devastated," says Joel Newman of the United Network for Organ Sharing. "We have to look for something good to come out of this"—that is, better screening. Still, no test could ever detect HIV the [same] afternoon someone contracts it." Transplant specialists would like to see a test that narrows the window of HIV detection become mandatory for every donor. Until now, a required screening test, called ELISA, has been used to identify HIV-infected donors in most cases. But the ELISA test screens for antibodies which may not appear until 22 days after someone is infected with HIV.

Nucleic acid testing, which detects genetic material from the virus itself (rather than antibodies), shortens the window to about 12 days. But most hospitals don't use it. The reason: many cities, like Chicago, lack a regional testing center—so it can take more than 24 hours to get the test results. That's just too long for a donor's organs to be kept viable. A heart can last only four to six hours from the time the ventilator is turned off to the time it's transplanted into a person. "You don't have the luxury of time. You have to turn it around quickly," says the CDC's Kuehnert.

There is a regional testing center in Los Angeles that turns around the nucleic acid test in four to six hours for California, New Mexico, Nevada and Utah. But there are "logistical and organizational hurdles" to setting up more labs like it around the country, says Tom Mone, president of the Association of Organ Procurement Organizations. "Organ donation is a rare thing and testing for it is such a small market."

For now, government officials haven't said whether they will amend their recommendations on testing or patient consent in the wake of the Chicago HIV transmissions. "We're always looking to change our guidelines. It's a pretty fast-moving field," says HRSA's Burdick. "This is an extremely uncommon event, but we want to do our best to prevent it from ever happening [again]."

A faster, more accurate HIV test would go a long way in reassuring patients, but there will never be a risk-free organ transplant. "Organ transplantation overall is very safe, but there always will be some chance of infectious disease transmission, and [the Chicago case] is one tragic example," says the CDC's Kuehnert. And with the number of donors still so much lower than needy recipients, it doesn't look like that difficult risk-benefit equation is going to change any time soon.

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