The organ donation and cadaver transplant campaign received a serious setback in the US when it was reported that a high-risk organ donor infected as many as four patients with the HIV virus and hepatitis.
The transplants occurred in January at three Chicago hospitals, but the patients did not learn until the last two weeks that they were infected with HIV and the virus for hepatitis C. One doctor said the news was "devastating" to the patients. But this is the first documented case of the virus being transmitted by organ donation in the U.S. in more than 20 years, it is contended.
Hospital and organ donation officials said Tuesday the infections arose because of a rarely encountered flaw in the test used to detect those diseases -- a flaw that more sensitive tests could help fix, some experts believe.
A screening questionnaire determined that the organ donor had engaged in high-risk behavior, said officials at Gift of Hope Organ & Tissue Donation, the organ procurement agency that tested and approved the organs for donation.
But tests for HIV, hepatitis and other conditions came back negative, most likely because the donor had acquired the infections in the last three weeks before death.
Officials would not release any personal details about the donor or recipients, citing medical privacy laws. It is unknown how the donor died either.
Based on the negative test results, doctors at Northwestern Memorial Hospital, Rush University Medical Center and the University of Chicago Medical Center went ahead with the transplants, said officials at those centers.
"It's a risk-versus-benefit calculation," said Alison Smith, vice president for operations at Gift of Hope. "Every patient in need of an organ has a significant medical condition that in most circumstances limits life expectancy. The question becomes what degree of risk is appropriate in that situation."
Smith said her agency "followed the right procedures" in testing the donor. She attributed the failure to an inherent limitation of the standard ELISA test that facilities use to detect HIV and hepatitis C.
Patients who contract HIV up to 22 days before being tested turn up negative because their immune systems have not yet made the antibodies that the test is designed to detect. The latent window can be even longer for hepatitis.
A newer test called NAAT appears to reduce the window of time in which infected patients may go undetected, said Dr. Michael Millis, chief of the transplantation program at the Chicago Medical Center.
The hospitals said they are cooperating with an epidemiological investigation that the Centers for Disease Control and Prevention is conducting concerning the cases.
This is the first known example in the U.S. of HIV transmission from an organ donor since a case in 1985, when the AIDS virus was still relatively new and few safeguards were in place to prevent transmission.
Since then, there have been more than 400,000 organ transplants in the U.S. without a reported case of transmission through organs.
The CDC guidelines say doctors must weigh whether a patient is in such great need of a transplant that even using a high-risk donor is preferable to doing nothing.
Also patients should be told about the possibility of HIV infection, regardless of what antibody tests show. None of the hospitals involved would say what kind of informed consent it obtained from the recipients before transplanting the organs.
The guidelines also recommend testing such patients three months after the transplant. But officials at the Medical Center said they did not administer such a test, and it appeared that neither of the other centers did. None of the patients was diagnosed with HIV until late last month, according to Gift of Hope officials.
One of the hospitals notified Gift of Hope that a transplant recipient had tested positive for HIV and hepatitis C, Smith said. Officials would not say what prompted the test. The agency notified the other hospitals and sent the donor's blood serum to a commercial center for retesting.
That lab's ELISA test turned up negative, just as the Gift of Hope test had in January, Smith said. But a further NAAT test performed at the commercial lab revealed the HIV infection that the earlier tests had missed, suggesting that the donor was infected but had not yet produced the antibodies the ELISA test is supposed to detect.
People waiting for organs should be told as much pertinent information as possible about potential donors, said University of Pennsylvania medical ethicist Art Caplan.
Transplant surgeons generally decide what information is given to patients and their families. Sometimes it's not much because of the circumstances patients are very sick, organs are scarce and usable for only a short time, Caplan said.
"You really have to put your faith in the transplant surgeon," agreed Ronald Taubman, who received a kidney-pancreas transplant six years ago.
The suburban Los Angeles man said he rejected one kidney because of concerns raised by his doctor, and was lucky that a better one became available.
But Caplan noted that not all patients have that choice.
"It's obviously very, very difficult because the availability of organs is such that if you pass, there's a possibility you won't get one," he said. Still, the Chicago case shows that to make an informed decision, patients "have a right to more information" than doctors often give, Caplan said.
Not every aspect of a potential donor's life is fair game, but patients have a right to know "if a donor dropped dead in a bathhouse with a needle in his arm," Caplan said.
It's not clear why the donor in the Chicago case was considered high-risk, or how much the four patients were told. But University of Minnesota ethicist Jeffrey Kahn said it underscores the importance of the consent process "and an individual's right to decide what's right for them."
High-risk behaviors include gay men having sex within the past five years, people having sex for money or drugs within the past five years, and intravenous use of recreational drugs within the past five years. The CDC says people in any of these categories should be excluded as organ donors unless the need outweighs the risks.